Dose postural control improve following application of transcutaneous electrical nerve stimulation in diabetic peripheral neuropathic patients? A randomized placebo control trial.

PubMed

Saadat, Z; Rojhani-Shirazi, Z; Abbasi, L

2017-12-01

peripheral neuropathy is the most common problem of diabetes. Neuropathy leads to lower extremity somatosensory deficits and postural instability in these patients. However, there are not sufficient evidences for improving postural control in these patients. To investigate the effects of transcutaneous electrical nerve stimulation (TENS) on postural control in patients with diabetic neuropathy. Twenty eighth patients with diabetic neuropathy (40-55 Y/O) participated in this RCT study. Fourteen patients in case group received TENS and sham TENS was used for control group. Force plate platform was used to extract sway velocity and COP displacement parameters for postural control evaluation. The mean sway velocity and center of pressure displacement along the mediolateral and anteroposterior axes were not significantly different between two groups after TENS application (p>0.05). Application of 5min high frequency TENS on the knee joint could not improve postural control in patients with diabetic neuropathy. Copyright © 2017. Published by Elsevier Ltd.

Literature Review and Meta-Analysis of Transcutaneous Electrical Nerve Stimulation in Treating Chronic Back Pain

PubMed Central

Wu, Lien-Chen; Weng, Pei-Wei; Chen, Chia-Hsien; Huang, Yi-You; Tsuang, Yang-Hwei; Chiang, Chang-Jung

2018-01-01

Background and Objectives This study is a meta-analysis of randomized controlled trials comparing the efficacy of transcutaneous electrical nerve stimulation (TENS) to a control and to other nerve stimulation therapies (NSTs) for the treatment of chronic back pain. Methods Citations were identified in MEDLINE, the Cochrane Library, Google Scholar, and ClinicalTrials.gov through June 2014 using the following keywords: nerve stimulation therapy, transcutaneous electrical nerve stimulation, back pain, chronic pain. Control treatments included sham, placebo, or medication only. Other NSTs included electroacupuncture, percutaneous electrical nerve stimulation, and percutaneous neuromodulation therapy. Results Twelve randomized controlled trials including 700 patients were included in the analysis. The efficacy of TENS was similar to that of control treatment for providing pain relief (standardized difference in means [SDM] = −0.20; 95% confidence interval [CI], −0.58 to 0.18; P = 0.293). Other types of NSTs were more effective than TENS in providing pain relief (SDM = 0.86; 95% CI, 0.15–1.57; P = 0.017). Transcutaneous electrical nerve stimulation was more effective than control treatment in improving functional disability only in patients with follow-up of less than 6 weeks (SDM = −1.24; 95% CI, −1.83 to −0.65; P < 0.001). There was no difference in functional disability outcomes between TENS and other NSTs. Conclusions These results suggest that TENS does not improve symptoms of lower back pain, but may offer short-term improvement of functional disability. PMID:29394211

A pilot investigation of the hypoalgesic effects of transcutaneous electrical nerve stimulation upon low back pain in people with multiple sclerosis.

PubMed

Al-Smadi, J; Warke, K; Wilson, I; Cramp, A F L; Noble, G; Walsh, D M; Lowe-Strong, A S

2003-11-01

To investigate the hypoalgesic effects of transcutaneous electrical nerve stimulation (TENS) upon low back pain (LBP) in people with multiple sclerosis (MS). A randomized double-blind placebo controlled clinical pilot study. Fifteen people with MS were recruited and randomly allocated to one of the following groups under double blind conditions (n = 5 per group): TENS 1 (4 Hz, 200 micros), TENS 2 (110 Hz, 200 micros), placebo TENS. Treatment was applied for 45 minutes three times a week for six weeks with a four-week follow-up. The following outcome measures were taken at weeks 1, 6, and 10: visual analogue scale (VAS) (for current LBP, right leg pain, left leg pain); Leeds Multiple Sclerosis Quality of Life Questionnaire; Roland Morris Disability Questionnaire; Short Form-36 (SF-36) Version 1; and the McGill Pain Questionnaire (MPQ). VAS for current LBP, right and left leg pain were also taken before and after treatment, and once a week during the follow-up period. Analysis showed no statistically significant effects for any of the data. However, both active treatment groups showed a trend of improvement in the majority of the outcome measures. Active TENS was more effective than placebo TENS in decreasing VAS scores following each treatment although results were not statistically significant. Further work in this area is warranted and should include a larger number of participants in the form of a randomized controlled clinical trial to determine the efficacy of this modality.

A prospective randomized controlled study of VAX-D and TENS for the treatment of chronic low back pain.

PubMed

Sherry, E; Kitchener, P; Smart, R

2001-10-01

Low back pain is one of the most significant medical and socioeconomic problems in modern society. International guidelines call for evidence-based management for the pain and disability associated with musculoskeletal disorders. The purpose of this randomized controlled trial is to address the question of efficacy and appropriateness of vertebral axial decompression (VAX-D) therapy, a new technology that has been shown in clinical research to create negative intradiscal pressures, and has been shown to be effective in treating patients presenting with chronic low back pain (> 3 months duration) with associated leg pain. Successful outcome was defined as a 50% reduction in pain utilizing a 10 cm Visual Analog Pain Scale and an improvement in the level of functioning as measured by patient-nominated disability ratings. Patients were randomly assigned to VAX-D or to TENS which was used as a control treatment or placebo. The TENS treatment demonstrated a success rate of 0%, while VAX-D demonstrated a success rate of 68.4% (p < 0.001). A statistically significant reduction in pain and improvement in functional outcome was obtained in patients with chronic low back pain treated with VAX-D.

Hemodynamic Effects Induced by Transcutaneous Electrical Nerve Stimulation in Apparently Healthy Individuals: A Systematic Review With Meta-Analysis.

PubMed

Campos, Filippe V; Neves, Laura M; Da Silva, Vinicius Z; Cipriano, Graziella F; Chiappa, Gaspar R; Cahalin, Lawrence; Arena, Ross; Cipriano, Gerson

2016-05-01

To determine the immediate effects of transcutaneous electrical nerve stimulation (TENS) on heart rate, systolic blood pressure (SBP), and diastolic blood pressure (DBP) in apparently healthy adults (age ≥18y). The Cochrane Library (online version 2014), PubMed (1962-2014), EMBASE (1980-2014), and LILACS (1980-2014) electronic databases were searched. Randomized controlled trials were included when TENS was administered noninvasively with surface electrodes during rest, and the effect of TENS was compared with that of control or placebo TENS. A sensitive search strategy for identifying randomized controlled trials was used by 2 independent reviewers. The initial search led to the identification of 432 studies, of which 5 articles met the eligibility criteria. Two independent reviewers extracted data from the selected studies. Quality was evaluated using the PEDro scale. Mean differences or standardized mean differences in outcomes were calculated. Five eligible articles involved a total of 142 apparently healthy individuals. Four studies used high-frequency TENS and 3 used low-frequency TENS and evaluated the effect on SBP. Three studies using high-frequency TENS and 2 using low-frequency TENS evaluated the effect on DBP. Three studies using high-frequency TENS and 1 study using low-frequency TENS evaluated the effect on heart rate. A statistically significant reduction in SBP (-3.00mmHg; 95% confidence interval [CI], -5.02 to -0.98; P=.004) was found using low-frequency TENS. A statistically significant reduction in DBP (-1.04mmHg; 95% CI, -2.77 to -0.03; I(2)=61%; P=.04) and in heart rate (-2.55beats/min; 95% CI, -4.31 to -0.78; I(2)=86%; P=.005]) was found using both frequencies. The median value on the PEDro scale was 7 (range, 4-8). TENS seems to promote a discrete reduction in SBP, DBP, and heart rate in apparently healthy individuals. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Testing the Efficacy of a Kindergarten Mathematics Intervention by Small Group Size

ERIC Educational Resources Information Center

Clarke, Ben; Doabler, Christian T.; Kosty, Derek; Kurtz Nelson, Evangeline; Smolkowski, Keith; Fien, Hank; Turtura, Jessica

2017-01-01

This study used a randomized controlled trial design to investigate the ROOTS curriculum, a 50-lesson kindergarten mathematics intervention. Ten ROOTS-eligible students per classroom (n = 60) were randomly assigned to one of three conditions: a ROOTS five-student group, a ROOTS two-student group, and a no-treatment control group. Two primary…

Effects of Transcutaneous Electrical Nerve Stimulation on Pain, Pain Sensitivity, and Function in People With Knee Osteoarthritis: A Randomized Controlled Trial

PubMed Central

Vance, Carol Grace T.; Rakel, Barbara A.; Blodgett, Nicole P.; DeSantana, Josimari Melo; Amendola, Annunziato; Zimmerman, Miriam Bridget; Walsh, Deirdre M.

2012-01-01

Background Transcutaneous electrical nerve stimulation (TENS) is commonly used for the management of pain; however, its effects on several pain and function measures are unclear. Objective The purpose of this study was to determine the effects of high-frequency TENS (HF-TENS) and low-frequency TENS (LF-TENS) on several outcome measures (pain at rest, movement-evoked pain, and pain sensitivity) in people with knee osteoarthritis. Design The study was a double-blind, randomized clinical trial. Setting The setting was a tertiary care center. Participants Seventy-five participants with knee osteoarthritis (29 men and 46 women; 31–94 years of age) were assessed. Intervention Participants were randomly assigned to receive HF-TENS (100 Hz) (n=25), LF-TENS (4 Hz) (n=25), or placebo TENS (n=25) (pulse duration=100 microseconds; intensity=10% below motor threshold). Measurements The following measures were assessed before and after a single TENS treatment: cutaneous mechanical pain threshold, pressure pain threshold (PPT), heat pain threshold, heat temporal summation, Timed “Up & Go” Test (TUG), and pain intensity at rest and during the TUG. A linear mixed-model analysis of variance was used to compare differences before and after TENS and among groups (HF-TENS, LF-TENS, and placebo TENS). Results Compared with placebo TENS, HF-TENS and LF-TENS increased PPT at the knee; HF-TENS also increased PPT over the tibialis anterior muscle. There was no effect on the cutaneous mechanical pain threshold, heat pain threshold, or heat temporal summation. Pain at rest and during the TUG was significantly reduced by HF-TENS, LF-TENS, and placebo TENS. Limitations This study tested only a single TENS treatment. Conclusions Both HF-TENS and LF-TENS increased PPT in people with knee osteoarthritis; placebo TENS had no significant effect on PPT. Cutaneous pain measures were unaffected by TENS. Subjective pain ratings at rest and during movement were similarly reduced by active TENS and placebo TENS, suggesting a strong placebo component of the effect of TENS. PMID:22466027

Transcutaneous Electrical Nerve Stimulation (TENS) for the Control of Pain during Rehabilitation Following Total Knee Arthroplasty (TKA): A Randomized, Blinded, Placebo-Controlled Trial

PubMed Central

Rakel, Barbara; Zimmerman, M. Bridget; Geasland, Katharine; Embree, Jennie; Clark, Charles R; Noiseux, Nicolas O; Callaghan, John J; Herr, Keela; Walsh, Deirdre; Sluka, Kathleen A

2014-01-01

This study evaluated the efficacy of TENS in reducing pain and hyperalgesia and increasing function following total knee arthroplasty (TKA). We hypothesized participants using TENS during rehabilitation exercises would: 1) report significantly lower pain during range-of-motion (ROM) and fast walking but not at rest; 2) have less hyperalgesia; and, 3) have better function than participants receiving Placebo-TENS or Standard Care. We also hypothesized that change in ROM pain would differ based on psychological characteristics (trait anxiety, pain catastrophizing and depression) and treatment group. This prospective, randomized study used intent-to-treat analyses on 317 subjects after primary, unilateral TKA. Assessors, blinded to treatment allocation, measured pain, function (ROM and gait speed), and hyperalgesia (quantitative sensory tests) postoperatively and 6 weeks after surgery. Analgesic intake, anxiety, depression, and pain catastrophizing were also assessed. TENS participants used it 1–2 times/day at 42 mA (on average) and had less pain postoperatively during active knee extension (p=0.019) and fast walking (p=0.006) than Standard Care participants. TENS and Placebo-TENS were not significantly different. TENS participants who scored low on anxiety and pain catastrophizing had a greater reduction in ROM pain at 6 weeks than those scoring high on these factors (p=0.002 and 0.03). Both TENS and Placebo-TENS participants had less postoperative mechanical hyperalgesia (p=0.03 – 0.01) than Standard Care participants. Supplementing pharmacologic analgesia with TENS during rehabilitation exercises reduces movement pain postoperatively but a placebo influence exists and the effect is gone by 6 weeks. Patients with low anxiety and pain catastrophizing may benefit most from TENS. PMID:25270585

Efficacy of the transcutaneous electrical nerve stimulation for the treatment of chronic low back pain: a meta-analysis.

PubMed

Brosseau, Lucie; Milne, Sarah; Robinson, Vivian; Marchand, Serge; Shea, Beverley; Wells, George; Tugwell, Peter

2002-03-15

Low back pain affects a large proportion of the population. Transcutaneous electrical nerve stimulation (TENS) was introduced more than 30 years ago as an alternative therapy to pharmacologic treatments for chronic pain. However, despite its widespread use, the efficacy of TENS is still controversial. The aim of this meta-analysis was to determine the efficacy of TENS in the treatment of chronic low back pain. The authors searched MEDLINE, EMBASE, PEDro, and the Cochrane Controlled Trials Register up to June 1, 2000. Only randomized controlled clinical trials of TENS for the treatment of patients with a clinical diagnosis of chronic low back pain were included. Abstracts were excluded unless further data could be obtained from the authors. Two reviewers independently selected trials and extracted data using predetermined forms. Heterogeneity was tested with Cochrane's Q test. A fixed effects model was used throughout for continuous variables, except where heterogeneity existed, in which case, a random effects model was used. Results are presented as weighted mean differences with 95% confidence intervals, where the difference between the treated and control groups was weighted by the inverse of the variance. Standardized mean differences were calculated by dividing the difference between the treated and control by the baseline variance. Standardized mean differences were used when different scales were integrated to measure the same concept. Dichotomous outcomes were analyzed with odds ratios. Five trials were included, with 170 subjects randomized to the placebo group receiving sham TENS and 251 subjects receiving active TENS (153 for conventional mode, 98 for acupuncture-like TENS). The schedule of treatments varied greatly between studies ranging from one treatment/day for 2 consecutive days, to three treatments/day for 4 weeks. There were no statistically significant differences between the active TENS group compared with the placebo TENS group for any outcome measures. Subgroup analysis performed on TENS application and methodologic quality did not demonstrate a significant statistical difference (P > 0.05). Remaining preplanned subgroup analysis was not conducted because of the small number of included trials and the variety of outcome measures reported. The results of the meta-analysis present no evidence to support the use or nonuse of TENS alone in the treatment of chronic low back pain. Considering the small number of studies responding to the criteria to be included in this meta-analysis, it is clear that more appropriately designed studies are needed before a final conclusion. Clinicians and researchers should consistently report the characteristics of the TENS device and the application techniques used. New trials on TENS should make use of standardized outcome measures. This meta-analysis lacked data on how TENS efficacy is affected by four important factors: type of applications, site of application, treatment duration of TENS, and optimal frequencies and intensities.

Different mechanisms for the short-term effects of real versus sham transcutaneous electrical nerve stimulation (TENS) in patients with chronic pain: a pilot study.

PubMed

Oosterhof, Jan; Wilder-Smith, Oliver H; Oostendorp, Rob A; Crul, Ben J

2012-01-01

Transcutaneous electrical nerve stimulation (TENS) has existed since the early 1970s. However, randomized placebo controlled studies show inconclusive results in the treatment of chronic pain. These results could be explained by assuming that TENS elicits a placebo response. However, in animal research TENS has been found to decrease hyperalgesia, which contradicts this assumption. The aim of this study is to use quantitative sensory testing to explore changes in pain processing during sham versus real TENS in patients with chronic pain. Patients with chronic pain (N = 20) were randomly allocated to real TENS or sham TENS application. Electrical pain thresholds (EPTs) were determined inside and outside the segment stimulated, before and after the first 20 minutes of the intervention, and after a period of 10 days of daily real/sham TENS application. Pain relief did not differ significantly for real versus sham TENS. However, by comparing time courses of EPTs, it was found that EPT values outside the segment of stimulation increased for sham TENS, whereas for real TENS these values decreased. There were, however, no differences for EPT measurements inside the segment stimulated. These results illustrate the importance of including mechanism-reflecting parameters in addition to symptoms when conducting pain research.

Transcutaneous electrical nerve stimulation for the control of pain during rehabilitation after total knee arthroplasty: A randomized, blinded, placebo-controlled trial.

PubMed

Rakel, Barbara A; Zimmerman, M Bridget; Geasland, Katharine; Embree, Jennie; Clark, Charles R; Noiseux, Nicolas O; Callaghan, John J; Herr, Keela; Walsh, Deirdre; Sluka, Kathleen A

2014-12-01

This study evaluated the efficacy of transcutaneous electrical nerve stimulation (TENS) in reducing pain and hyperalgesia and increasing function after total knee arthroplasty (TKA). We hypothesized that participants using TENS during rehabilitation exercises would report significantly lower pain during range-of-motion (ROM) activity and fast walking but not at rest, would have less hyperalgesia, and would have better function than participants receiving placebo-TENS or standard care. We also hypothesized that change in ROM pain would differ based on psychological characteristics (trait anxiety, pain catastrophizing, and depression) and treatment group. This prospective, randomized study used intent-to-treat analyses in 317 participants after primary, unilateral TKA. Assessors, blinded to treatment allocation, measured pain, function (ROM and gait speed), and hyperalgesia (quantitative sensory tests) postoperatively and 6 weeks after surgery. Analgesic intake, anxiety, depression, and pain catastrophizing were also assessed. TENS participants used it 1 to 2 times per day at 42 mA (on average) and had less pain postoperatively during active knee extension (P=.019) and fast walking (P=.006) than standard care participants. TENS and placebo-TENS were not significantly different. TENS participants who scored low on anxiety and pain catastrophizing had a greater reduction in ROM pain at 6 weeks than those who scored high on these factors (P=.002 and P=.03). Both TENS and placebo-TENS participants had less postoperative mechanical hyperalgesia (P=.03-.01) than standard care participants. Supplementing pharmacologic analgesia with TENS during rehabilitation exercises reduces movement pain postoperatively, but a placebo influence exists and the effect is gone by 6 weeks. Patients with low anxiety and pain catastrophizing may benefit most from TENS. Published by Elsevier B.V.

The Effects of Using a Model-Reinforced Video on Information-Seeking Behaviour

ERIC Educational Resources Information Center

McHugh, Elizabeth A.; Lenz, Janet G.; Reardon, Robert C.; Peterson, Gary W.

2012-01-01

This study examined the effects of viewing a ten-minute model-reinforced video on careers information-seeking behaviour of 280 students in ten sections of a university careers course randomly assigned to treatment or control conditions. The video portrayed an undergraduate student seeking careers counselling services and a counsellor using…

Evaluating efficacy and feasibility of transcutaneous electrical nerve stimulation for postoperative pain after video-assisted thoracoscopic surgery: A randomized pilot trial.

PubMed

Engen, Deborah J; Carns, Paul E; Allen, Mark S; Bauer, Brent A; Loehrer, Laura L; Cha, Stephen S; Chartrand, Christine M; Eggler, Eric J; Cutshall, Susanne M; Wahner-Roedler, Dietlind L

2016-05-01

Transcutaneous electrical nerve stimulation (TENS) has been applied for pain relief after surgical procedures. This study evaluated whether TENS after video-assisted thoracoscopic surgery (VATS), in addition to opioid administration, decreased postoperative pain and pain medication use. In a controlled trial, 56 patients scheduled to undergo VATS were randomly assigned to TENS plus opioids (Group 1) or opioids alone (Group 2) for 48 h. Forty patients completed the study. Pain scores and use of oral morphine equivalents (OMEs) were not significantly different between the groups during the first and second 24 h. A decreased use of OMEs between the first and second 24 h was significant for Group 1 (P = .005) but not for Group 2 (P = .11); a decreased use of OMEs between groups was not significant (P = .35). A larger, well-powered clinical trial is indicated to evaluate the effects of TENS for pain control after a VATS procedure. Clinical Trial No.: NCT01046695. Crown Copyright © 2015. Published by Elsevier Ltd. All rights reserved.

Transcutaneous Electrical Nerve Stimulation (TENS) reduces pain, fatigue, and hyperalgesia while restoring central inhibition in primary fibromyalgia

PubMed Central

Dailey, Dana L; Rakel, Barbara A; Vance, Carol GT; Liebano, Richard E; Anand, Amrit S; Bush, Heather M; Lee, Kyoung S; Lee, Jennifer E; Sluka, Kathleen A

2014-01-01

Because TENS works by reducing central excitability and activating central inhibition pathways, we tested the hypothesis that TENS would reduce pain and fatigue and improve function and hyperalgesia in people with fibromyalgia who have enhanced central excitability and reduced inhibition. The current study used a double-blinded randomized, placebo controlled cross-over design to test effects of a single treatment of TENS in people with fibromyalgia. Three treatments were assessed in random order: active TENS, placebo TENS, no TENS. The following measures were assessed before and after each TENS treatment: pain and fatigue at rest and movement, pressure pain thresholds (PPTs), 6 minute walk test (6MWT), range of motion (ROM), five time sit to stand test (FTSTS), and single leg stance (SLS). Conditioned pain modulation (CPM) was completed at end of testing. There was a significant decrease in pain and fatigue with movement for active TENS compared to placebo and no TENS. PPTs increased at site of TENS (spine) and outside site of TENS (leg) when compared to placebo TENS or no TENS. During Active TENS CPM was significantly stronger compared to placebo TENS and no TENS. No changes in functional tasks were observed with TENS. Thus, the current study suggests TENS has short-term efficacy in relieving symptoms of fibromyalgia while the stimulator is active. Future clinical trials should examine the effects of repeated daily delivery of TENS, similar to how TENS is used clinically, on pain, fatigue, function and quality of life in individuals with fibromyalgia. PMID:23900134

Comparison of Transcutaneous Electrical Nerve Stimulation and Lidocaine on Episiotomy Complication in Primiparous Women: A Randomized Clinical Trial

PubMed Central

Rezaeyan, Maryam; Geranmayeh, Mehrnaz; Direkvand-Moghadam, Ashraf

2017-01-01

Introduction: Transcutaneous electrical nerve stimulation (TENS) through the skin is a nonpharmacological method of pain relief. The present study aimed to compare TENS and lidocaine on episiotomy complication in primiparous women. Material and Methods: In a randomized, controlled clinical trial, 80 participants were included from March to July 2011 at the antenatal clinic and postdelivery ward in the Social Security Organization Hospital, Khorramabad, Lorestan, Iran. Data were collected using a demographic questionnaire, visual analog scale and redness, edema, ecchymosis, discharge, and approximation scales. The participants were randomized into two groups with equal number of participants. All participants received 5 cc of local infiltration of 1% lidocaine before episiotomy, and TENS electrodes were placed on He Gu and Shenmen points during the crowning of fetal head. The TENS group received TENS with 100; 250 μs, the output range of 15–20 mm amplifier from crowning of first stage of labor to the end of the episiotomy repairing. The lidocaine group received 10 cc of local infiltration of 1% lidocaine before episiotomy repair while did not receive TENS electrodes. The pain intensity during and after episiotomy repair was recorded. Results: TENS and lidocaine have similar effects on pain relief at the episiotomy cutting, the start of the episiotomy repair, and at end of the episiotomy repair; however, the pain relief of both the interventions was different during the episiotomy repair. The effect of TENS in reducing edema was statistically significant (P = 0.001). Conclusions: TENS and lidocaine are effective for the episiotomy complications during and after episiotomy repair. PMID:28382054

Comparison of Transcutaneous Electrical Nerve Stimulation and Parasternal Block for Postoperative Pain Management after Cardiac Surgery

PubMed Central

Ozturk, Nilgun Kavrut; Baki, Elif Dogan; Kavakli, Ali Sait; Sahin, Ayca Sultan; Ayoglu, Raif Umut; Karaveli, Arzu; Emmiler, Mustafa; Inanoglu, Kerem; Karsli, Bilge

2016-01-01

Background. Parasternal block and transcutaneous electrical nerve stimulation (TENS) have been demonstrated to produce effective analgesia and reduce postoperative opioid requirements in patients undergoing cardiac surgery. Objectives. To compare the effectiveness of TENS and parasternal block on early postoperative pain after cardiac surgery. Methods. One hundred twenty patients undergoing cardiac surgery were enrolled in the present randomized, controlled prospective study. Patients were assigned to three treatment groups: parasternal block, intermittent TENS application, or a control group. Results. Pain scores recorded 4 h, 5 h, 6 h, 7 h, and 8 h postoperatively were lower in the parasternal block group than in the TENS and control groups. Total morphine consumption was also lower in the parasternal block group than in the TENS and control groups. It was also significantly lower in the TENS group than in the control group. There were no statistical differences among the groups regarding the extubation time, rescue analgesic medication, length of intensive care unit stay, or length of hospital stay. Conclusions. Parasternal block was more effective than TENS in the management of early postoperative pain and the reduction of opioid requirements in patients who underwent cardiac surgery through median sternotomy. This trial is registered with Clinicaltrials.gov number NCT02725229. PMID:27445610

Effects of Weight-shifting Exercise Combined with Transcutaneous Electrical Nerve Stimulation on Muscle Activity and Trunk Control in Patients with Stroke.

PubMed

Jung, Kyoung-Sim; Jung, Jin-Hwa; In, Tae-Sung; Cho, Hwi-Young

2016-12-01

This study investigated the effects of weight-shifting exercise (WSE) combined with transcutaneous electrical nerve stimulation (TENS), applied to the erector spinae and external oblique (EO) muscles, on muscle activity and trunk control in patients with hemiparetic stroke. Sixty patients with stroke were recruited to this study and randomly distributed into three treatment groups: (1) WSE + TENS, (2) WSE + placebo TENS, and (3) control. All participants underwent 30 sessions of training (30 minutes five times per week for 6 weeks) and received 1 hour of conventional physical therapy five times per week for 6 weeks. Muscle activity, maximum reaching distance and trunk impairment scale scores were assessed in all patients before and after the training. After training, the WSE + TENS group showed significant increase in the EO activity, maximum reaching distance and trunk impairment scale scores compared with the WSE + placebo TENS and control groups. These findings suggest that WSE with TENS applied to the erector spinae and EO muscles increased the trunk muscle activity and improved trunk control. Therefore, WSE with TENS could be a beneficial intervention in clinical settings for individuals with hemiparetic stroke. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Transcutaneous electrical nerve stimulation reduces pain, fatigue and hyperalgesia while restoring central inhibition in primary fibromyalgia.

PubMed

Dailey, Dana L; Rakel, Barbara A; Vance, Carol G T; Liebano, Richard E; Amrit, Anand S; Bush, Heather M; Lee, Kyoung S; Lee, Jennifer E; Sluka, Kathleen A

2013-11-01

Because transcutaneous electrical nerve stimulation (TENS) works by reducing central excitability and activating central inhibition pathways, we tested the hypothesis that TENS would reduce pain and fatigue and improve function and hyperalgesia in people with fibromyalgia who have enhanced central excitability and reduced inhibition. The current study used a double-blinded randomized, placebo-controlled cross-over design to test the effects of a single treatment of TENS with people with fibromyalgia. Three treatments were assessed in random order: active TENS, placebo TENS and no TENS. The following measures were assessed before and after each TENS treatment: pain and fatigue at rest and in movement; pressure pain thresholds, 6-m walk test, range of motion; 5-time sit-to-stand test, and single-leg stance. Conditioned pain modulation was completed at the end of testing. There was a significant decrease in pain and fatigue with movement for active TENS compared to placebo and no TENS. Pressure pain thresholds increased at the site of TENS (spine) and outside the site of TENS (leg) when compared to placebo TENS or no TENS. During active TENS, conditioned pain modulation was significantly stronger compared to placebo TENS and no TENS. No changes in functional tasks were observed with TENS. Thus, the current study suggests TENS has short-term efficacy in relieving symptoms of fibromyalgia while the stimulator is active. Future clinical trials should examine the effects of repeated daily delivery of TENS, similar to the way in which TENS is used clinically on pain, fatigue, function, and quality of life in individuals with fibromyalgia. Copyright © 2013 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

Comparison of intra-articular hyaluronic acid injections with transcutaneous electric nerve stimulation for the management of knee osteoarthritis: a randomized controlled trial.

PubMed

Chen, Wen-Ling; Hsu, Wei-Chun; Lin, Yi-Jia; Hsieh, Lin-Fen

2013-08-01

To compare the effects of intra-articular hyaluronic acid (HA; ARTZ) and transcutaneous electric nerve stimulation (TENS) in the treatment of patients with knee osteoarthritis. A prospective, randomized controlled trial. Rehabilitation clinic of a teaching hospital. Patients with knee osteoarthritis (N=50; aged 51-80y) were randomly assigned to the HA group (n=27) or the TENS group (n=23). The HA group received intra-articular HA injection into the affected knee once a week for 5 consecutive weeks, and the TENS group received a 20- minute session of TENS 3 times a week for 4 consecutive weeks. The primary outcome measures used were the visual analog scale (VAS) for pain and the Lequesne index. The secondary outcome measures were range of motion of the knee, walking time, pain threshold, patient global assessment, and disability in activities of daily living. All subjects were assessed at baseline, and at 2 weeks, 2 months, and 3 months after the treatments were completed. The TENS group exhibited a significantly greater improvement in VAS than the HA group at 2 weeks' follow-up (4.17 ± 1.98 vs 5.31 ± 1.78, respectively; P=.03). In addition, the TENS group also exhibited a significantly greater improvement in the Lequesne index than the HA group at 2 weeks' follow-up (7.78 ± 2.08 vs 9.85 ± 3.54, respectively; P=.01) and at 3 months' follow-up (7.07 ± 2.85 vs 9.24 ± 4.04, respectively; P=.03). TENS with silver spike point electrodes was observed to be more effective than intra-articular HA injection for patients with knee osteoarthritis in improving the VAS for pain at 2 weeks' follow-up as well as the Lequesne index at 2 weeks' and 3 months' follow-up. Copyright © 2013 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Effect of rotator cuff strengthening as an adjunct to standard care in subjects with adhesive capsulitis: A randomized controlled trial.

PubMed

Rawat, Pallavi; Eapen, Charu; Seema, Kulathuran Pillai

Randomized controlled trial. To study the effect of adding rotator cuff (RC) muscles strengthening to joint mobilization and transcutaneous electrical nerve stimulation (TENS) in patients with adhesive capsulitis. A prospective, parallel-group, randomised clinical trial was conducted on 42 patients. One group received TENS and joint mobilization and in the other group RC muscles strengthening was added. Treatment was given for 12 sessions within 4 weeks. When compared between the groups statistically significant changes were seen in all the outcome measures in the group that received RC muscle strengthening exercises vs TENS and mobilization. VAS 12.76 ± 1.04 vs 4.05 ± 1.32; SPADI 34.66 ± 6.69 vs 54.29 ± 12.17; PFPS 3.06 ± 0.80 vs 4.70 ± 0.81; and ROM (elevation >125 vs >110 degrees and rotations >70 vs >48 degrees). Addition of a structured RC strengthening program to TENS and joint mobilization in the treatment of adhesive capsulitis resulted in improvement in pain, ROM and function. 1b. Copyright © 2016 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.

Transcutaneous electrical nerve stimulation for the treatment of chronic low back pain: a systematic review.

PubMed

Khadilkar, Amole; Milne, Sarah; Brosseau, Lucie; Wells, George; Tugwell, Peter; Robinson, Vivian; Shea, Beverley; Saginur, Michael

2005-12-01

Systematic review. To determine the effectiveness of transcutaneous electrical nerve stimulation (TENS) in the management of chronic LBP. Chronic low back pain (LBP) affects a significant proportion of the population. TENS was introduced more than 30 years ago as an adjunct to pharmacologic pain management. However, despite its widespread use, the usefulness of TENS in chronic LBP is still controversial. We searched MEDLINE, EMBASE, PEDro, and the Cochrane Central Register of Controlled Trials (Issue 2, 2005), up to April 1, 2005. Only randomized controlled clinical trials (RCTs) evaluating the effect of TENS on chronic LBP were included. Two reviewers independently selected trials and extracted data using predetermined forms. Heterogeneity was tested with Cochrane's Q test. A fixed effect model was used throughout for calculating continuous variables, except where heterogeneity existed, in which case a random effects model was used. Results are presented as weighted mean differences with 95% confidence intervals (95% CI), where the difference between the treated and control groups was weighted by the inverse of the variance. Standardized mean differences were calculated by dividing the difference between the treated and control by the baseline variance. Standardized mean differences were used when different scales were used to measure the same concept. Dichotomous outcomes were analyzed with odds ratios. Two RCTs (175 patients) were included. They differed with respect to study design, methodologic quality, inclusion and exclusion criteria, characteristics of TENS application, treatment schedule, cointerventions, and measured outcomes. In one RCT, TENS produced significantly greater pain relief than the placebo control. However, in the other RCT, no statistically significant differences between treatment and control groups were shown for multiple outcome measures. Preplanned subgroup analyses, intended to examine the impact of different stimulation parameters, sites of TENS application, treatment durations, and baseline patient characteristics were not possible because of the small number of included trials. Evidence for the efficacy of TENS as an isolated intervention in the management of chronic LBP is limited and inconsistent. Larger, multicenter, RCTs are needed to better resolve its role in this condition. Increased attention should be given to the risks and benefits of long-term use, which more appropriately addresses the realities of managing chronic low back pain.

Is TENS purely a placebo effect? A controlled study on chronic low back pain.

PubMed

Marchand, S; Charest, J; Li, J; Chenard, J R; Lavignolle, B; Laurencelle, L

1993-07-01

Although high-frequency low-intensity transcutaneous electric nerve stimulation (TENS) has been extensively used to relieve low back pain, experimental studies of its effectiveness have yielded contradictory findings mainly due to methodological problems in pain evaluation and placebo control. In the present study, separate visual analog scales (VAS) were used to measure the sensory-discriminative and motivational-affective components of low back pain. Forty-two subjects were randomly assigned to 1 of 3 groups: TENS, placebo-TENS, and no treatment (control). In order to measure the short-term effect of TENS, VAS pain ratings were taken before and after each treatment session. Also, to measure long-term effects, patients rated their pain at home every 2 h throughout a 3-day period before and 1 week, 3 months and 6 months after the treatment sessions. In comparing the pain evaluations made immediately before and after each treatment session, TENS and placebo-TENS significantly reduced both the intensity and unpleasantness of chronic low back pain. TENS was significantly more efficient than placebo-TENS in reducing pain intensity but not pain unpleasantness. TENS also produced a significant additive effect over repetitive treatment sessions for pain intensity and relative pain unpleasantness. This additive effect was not found for placebo-TENS. When evaluated at home, pain intensity was significantly reduced more by TENS than placebo-TENS 1 week after the end of treatment, but not 3 months and 6 months later. At home evaluation of pain unpleasantness in the TENS group was never different from the placebo-TENS group.(ABSTRACT TRUNCATED AT 250 WORDS)

A Meta-Analysis of Transcutaneous Electrical Nerve Stimulation for Chronic Low Back Pain.

PubMed

Jauregui, Julio J; Cherian, Jeffrey J; Gwam, Chukwuweike U; Chughtai, Morad; Mistry, Jaydev B; Elmallah, Randa K; Harwin, Steven F; Bhave, Anil; Mont, Michael A

2016-04-01

Transcutaneous electrical nerve stimulation (TENS) may provide a safe alternative to current side-effect-heavy narcotics and anti-inflammatories utilized in chronic low back pain. Therefore, we performed a meta-analysis to evaluate the efficacy of TENS for the treatment of chronic low back pain. We included randomized controlled trials (RCTs), cohort studies, and randomized crossover studies on TENS for the management of low back pain. We utilized a visual analogue scale (VAS) for pain as our primary outcome. Effectiveness of treatment was quantified using improvement in outcome scores for each study. Of the studies that met the criteria, 13 allowed for calculation of weighted mean differences in pain reduction. We used a random model effect to evaluate changes in pain produced by the intervention. Included were nine level I and four level II, encompassing 267 patients (39% male) who had a mean follow-up of seven weeks (range; 2 to 24 weeks). The mean duration of treatment was six weeks (range; 2 to 24 weeks). The standardized mean difference in pain from pre- to post-treatment for TENS was 0.844, which demonstrated significant improvement of TENS on pain reduction. When subdividing treatment duration, patients that were treated for < 5 weeks had significant effects on pain, while those treated for > 5 weeks did not. Treatment of chronic low back pain with TENS demonstrated significant pain reduction. The application of TENS may lead to less pain medication usage and should be incorporated into the treatment armamentarium for chronic low back pain.

Efficacy of the device combining high-frequency transcutaneous electrical nerve stimulation and thermotherapy for relieving primary dysmenorrhea: a randomized, single-blind, placebo-controlled trial.

PubMed

Lee, Banghyun; Hong, Seung Hwa; Kim, Kidong; Kang, Wee Chang; No, Jae Hong; Lee, Jung Ryeol; Jee, Byung Chul; Yang, Eun Joo; Cha, Eun-Jong; Kim, Yong Beom

2015-11-01

To investigate the efficacy and safety of the combined therapy with high-frequency transcutaneous electrical nerve stimulation (hf-TENS) and thermotherapy in relieving primary dysmenorrheal pain. In this randomized, single-blind, placebo-controlled study, 115 women with moderate or severe primary dysmenorrhea were assigned to the study or control group at a ratio of 1:1. Subjects in the study group used an integrated hf-TENS/thermotherapy device, whereas control subjects used a sham device. A visual analog scale was used to measure pain intensity. Variables related to pain relief, including reduction rate of dysmenorrheal score, were compared between the groups. The dysmenorrheal score was significantly reduced in the study group compared to the control group following the use of the devices. The duration of pain relief was significantly increased in the study group compared to the control group. There were no differences between the groups in the brief pain inventory scores, numbers of ibuprofen tablets taken orally, and World Health Organization quality of life-BREF scores. No adverse events were observed related to the use of the study device. The combination of hf-TENS and thermotherapy was effective in relieving acute pain in women with moderate or severe primary dysmenorrhea. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Effects of transcutaneous electrical nerve stimulation on pain, walking function, respiratory muscle strength and vital capacity in kidney donors: a protocol of a randomized controlled trial

PubMed Central

2013-01-01

Background Pain is a negative factor in the recovery process of postoperative patients, causing pulmonary alterations and complications and affecting functional capacity. Thus, it is plausible to introduce transcutaneous electrical nerve stimulation (TENS) for pain relief to subsequently reduce complications caused by this pain in the postoperative period. The objective of this paper is to assess the effects of TENS on pain, walking function, respiratory muscle strength and vital capacity in kidney donors. Methods/design Seventy-four patients will be randomly allocated into 2 groups: active TENS or placebo TENS. All patients will be assessed for pain intensity, walk function (Iowa Gait Test), respiratory muscle strength (maximal inspiratory pressure and maximal expiratory pressure) and vital capacity before and after the TENS application. The data will be collected by an assessor who is blinded to the group allocation. Discussion This study is the first to examine the effects of TENS in this population. TENS during the postoperative period may result in pain relief and improvements in pulmonary tests and mobility, thus leading to an improved quality of life and further promoting organ donation. Trial registration Registro Brasileiro de Ensaios Clinicos (ReBEC), number RBR-8xtkjp. PMID:23311705

Sensory trigeminal ULF-TENS stimulation reduces HRV response to experimentally induced arithmetic stress: A randomized clinical trial.

PubMed

Monaco, Annalisa; Cattaneo, Ruggero; Ortu, Eleonora; Constantinescu, Marian Vladimir; Pietropaoli, Davide

2017-05-01

Ultra Low Frequency Transcutaneous Electric Nervous Stimulation (ULF-TENS) is extensively used for pain relief and for the diagnosis and treatment of temporomandibular disorders (TMD). In addition to its local effects, ULF-TENS acts on the autonomic nervous system (ANS), with particular reference to the periaqueductal gray (PAG), promoting the release of endogenous opioids and modulating descending pain systems. It has been suggested that the PAG participates in the coupling between the emotional stimulus and the appropriate behavioral autonomic response. This function is successfully investigated by HRV. Therefore, our goal is to investigate the effects of trigeminal ULF-TENS stimulation on autonomic behavior in terms of HRV and respiratory parameters during an experimentally-induced arithmetic stress test in healthy subjects. Thirty healthy women between 25 and 35years of age were enrolled and randomly assigned to either the control (TENS stimulation off) or test group (TENS stimulation on). Heart (HR, LF, HF, LF/HF ratio, DET, RMSSD, PNN50, RR) and respiratory (BR) rate were evaluated under basal, T1 (TENS off/on), and stress (mathematical task) conditions. Results showed that HRV parameters and BR significantly changed during the arithmetic stress paradigm (p<0.01). Independently of stress conditions, TENS and control group could be discriminated only by non-linear HRV data, namely RR and DET (p=0.038 and p=0.027, respectively). During the arithmetic task, LF/HF ratio was the most sensitive parameter to discriminate between groups (p=0.019). Our data suggest that trigeminal sensory ULF-TENS reduces the autonomic response in terms of HRV and BR during acute mental stress in healthy subjects. Future directions of our work aim at applying the HRV and BR analysis, with and without TENS stimulation, to individuals with dysfunctional ANS among those with TMD. Copyright © 2017 Elsevier Inc. All rights reserved.

Cognitive-Behavioral Therapy for Women with Lifelong Vaginismus: A Randomized Waiting-List Controlled Trial of Efficacy

ERIC Educational Resources Information Center

Van Lankveld, Jacques J. D. M.; ter Kuile, Moniek M.; de Groot, H. Ellen; Melles, Reinhilde; Nefs, Janneke; Zandbergen, Maartje

2006-01-01

Women with lifelong vaginismus (N = 117) were randomly assigned to cognitive-behavioral group therapy, cognitive-behavioral bibliotherapy, or a waiting list. Manualized treatment comprised sexual education, relaxation exercises, gradual exposure, cognitive therapy, and sensate focus therapy. Group therapy consisted of ten 2-hr sessions with 6 to 9…

Linking Implementation Process to Intervention Outcomes in a Middle School Obesity Prevention Curriculum, "Choice, Control and Change"

ERIC Educational Resources Information Center

Gray, Heewon Lee; Contento, Isobel R.; Koch, Pamela A.

2015-01-01

This study investigates the link between process evaluation components and the outcomes of a school-based nutrition curriculum intervention, "Choice, Control and Change". Ten New York City public middle schools were recruited and randomly assigned into intervention or control condition. The curriculum was to improve sixth to seventh…

Analysis of Uniform Random Numbers Generated by Randu and Urn Ten Different Seeds.

DTIC Science & Technology

The statistical properties of the numbers generated by two uniform random number generators, RANDU and URN, each using ten different seeds are...The testing is performed on a sequence of 50,000 numbers generated by each uniform random number generator using each of the ten seeds . (Author)

Transcutaneous electrical nerve stimulation (TENS) for pain control after vaginal delivery and cesarean section.

PubMed

Kayman-Kose, Seda; Arioz, Dagistan Tolga; Toktas, Hasan; Koken, Gulengul; Kanat-Pektas, Mine; Kose, Mesut; Yilmazer, Mehmet

2014-10-01

The present study aims to determine the efficiency and reliability of transcutaneous electrical nerve stimulation (TENS) in the management of pain related with uterine contractions after vaginal delivery and the pain related with both abdominal incision uterine contractions after cesarean section. A hundred healthy women who underwent cesarean section under general anesthesia were randomly assigned to the placebo group (Group 1) or the TENS group (Group 2), while 100 women who delivered by vaginal route without episiotomy were randomized into the placebo group (Group 3) or the TENS group (Group 4). The patients in Group 2 had statistically lower visual analog scale (VAS) and verbal numerical scale (VNS) scores than the patients in Group 1 (p < 0.001 for both). The patients in Group 4 had statistically lower VAS and VNS scores than the patients in Group 3 (p = 0.022 and p = 0.005, respectively). The analgesic requirement at the eighth hour of cesarean section was significantly lower in the patients who were treated with TENS (p = 0.006). The need for analgesics at the eighth hour of vaginal delivery was statistically similar in the patients who were treated with TENS and the patients who received placebo (p = 0.830). TENS is an effective, reliable, practical and easily available modality of treatment for postpartum pain.

Entomological impact and social participation in dengue control: a cluster randomized trial in Fortaleza, Brazil

PubMed Central

Caprara, Andrea; De Oliveira Lima, José Wellington; Rocha Peixoto, Ana Carolina; Vasconcelos Motta, Cyntia Monteiro; Soares Nobre, Joana Mary; Sommerfeld, Johannes; Kroeger, Axel

2015-01-01

Background This study intended to implement a novel intervention strategy, in Brazil, using an ecohealth approach and analyse its effectiveness and costs in reducing Aedes aegypti vector density as well as its acceptance, feasibility and sustainability. The intervention was conducted from 2012 to 2013 in the municipality of Fortaleza, northeast Brazil. Methodology A cluster randomized controlled trial was designed by comparing ten intervention clusters with ten control clusters where routine vector control activities were conducted. The intervention included: community workshops; community involvement in clean-up campaigns; covering the elevated containers and in-house rubbish disposal without larviciding; mobilization of schoolchildren and senior inhabitants; and distribution of information, education and communication (IEC) materials in the community. Results Differences in terms of social participation, commitment and leadership were present in the clusters. The results showed the effectiveness of the intervention package in comparison with the routine control programme. Differences regarding the costs of the intervention were reasonable and could be adopted by public health services. Conclusions Embedding social participation and environmental management for improved dengue vector control was feasible and significantly reduced vector densities. Such a participatory ecohealth approach offers a promising alternative to routine vector control measures. PMID:25604760

Acute, Five- and Ten-Day Inhalation Study of Hydroprocessed Esters and Fatty Acids-Mixed Fats (HEFA-F) Jet Fuel

DTIC Science & Technology

2012-09-01

Groups ...................18 Table 6. Urine Specific Gravity in the Ten-Day Duration Groups ...............................................19 Table 7...exposed rats were not consistently significant compared to control groups and were considered random due to small group sizes. In urine samples...sources. Alternative fuels may be developed by synthesis from simpler molecules (e.g., natural gas) or by refining from non-petroleum sources (e.g

Adding transcutaneous electrical nerve stimulation to visual scanning training does not enhance treatment effect on hemispatial neglect: a randomized, controlled, double-blind study.

PubMed

Seniów, Joanna; Polanowska, Katarzyna; Leśniak, Marcin; Członkowska, Anna

2016-12-01

Left-sided transcutaneous electrical nerve stimulation (TENS) increases right hemispheric activity, which may improve the rehabilitative outcome of hemispatial neglect. To examine the behavioral effect of electrical stimulation of the nerve afferents of the left hand during early neuropsychological rehabilitation of post-stroke patients with hemispatial neglect. This randomized, controlled, double-blind study included 29 patients (enrolled in the experimental or control group) with left hemispatial neglect after right hemispheric stroke. For 3 weeks, patients received 15 therapeutic sessions involving TENS (active or sham) with a mesh glove applied on the entire left hand during the first 30 minutes of a 45-minute conventional visual scanning training (VST). Signs of hemispatial neglect were assessed using a psychometric test before and after treatment. Univariate analysis of covariance revealed that differences between the control and experimental groups were not significant after treatment (F(1, 22) = 0.294, P = 0.593) when adjusted for pre-treatment scores and time since stroke onset. This suggested that electrical stimulation failed to mitigate the severity of hemispatial neglect symptoms. Our study did not provide evidence of the effectiveness of TENS when added to VST during early rehabilitation for patients with post-stroke hemispatial neglect. Other techniques (applied alone or together) should be sought to improve recovery in this population.

Association of HLA-B*5801 allele and allopurinol-induced stevens johnson syndrome and toxic epidermal necrolysis: a systematic review and meta-analysis

PubMed Central

2011-01-01

Background Despite some studies suggesting a possible association between human leukocyte antigen, HLA-B*5801 and allopurinol induced Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), the evidence of association and its magnitude remain inconclusive. This study aims to systematically review and meta-analyze the association between HLA-B*5801 allele and allopurinol-induced SJS/TEN. Methods A comprehensive search was performed in databases including MEDLINE, Pre-MEDLINE, Cochrane Library, EMBASE, International Pharmaceutical Abstracts (IPA), CINAHL, PsychInfo, the WHO International, Clinical Trial Registry, and ClinicalTrial.gov from their inceptions to June 2011. Only studies investigating association between HLA-B*5801 with allopurinol-induced SJS/TEN were included. All studies were extracted by two independent authors. The primary analysis was the carrier frequency of HLA-B*5801 comparison between allopurinol-induced SJS/TEN cases and each comparative group. The pooled odds ratios were calculated using a random effect model. Results A total of 4 studies with 55 SJS/TEN cases and 678 matched-controls (allopurinol-tolerant control) was identified, while 5 studies with 69 SJS/TEN cases and 3378 population-controls (general population) were found. SJS/TEN cases were found to be significantly associated with HLA-B*5801 allele in both groups of studies with matched-control (OR 96.60, 95%CI 24.49-381.00, p < 0.001) and population-control (OR 79.28, 95%CI 41.51-151.35, p < 0.001). Subgroup analysis for Asian and Non-Asian population yielded similar findings. Conclusion We found a strong and significant association between HLA-B*5801 and allopurinol-induced SJS/TEN. Therefore, HLA-B*5801 allele screening may be considered in patients who will be treated with allopurinol. PMID:21906289

Ultrasound combined transcutaneous electrical nerve stimulation (UltraTENS) versus phonophoresis of piroxicam (PhP) in symptomatic knee osteoarthritis: A randomized double-blind, controlled trial.

PubMed

Boonhong, Jariya; Suntornpiyapan, Phitsanu; Piriyajarukul, Apatchanee

2018-02-02

Ultrasound combined with transcutaneous electrical nerve stimulation (UltraTENS) and phonophoresis of piroxicam (PhP) are combined modality therapy that frequently used in musculoskeletal pain including knee osteoarthritis (OA). But it is lack of a good clinical trial to prove and compare their effects. To compare the effects of UltraTENS with PhP on mild to moderate degree of symptomatic knee OA. Sixty-one patients (55 women), mean age of 63.4 ± 8.1 y, 50-90 mm VAS of knee pain and Kellgren-Lawrence score of grade I-III were randomly allocated into UltraTENS and PhP (N = 31 and 30, respectively). The UltraTENS group received a combined ultrasound with TENS program and a non-drug gel, whereas the PhP group got an ultrasound program with piroxicam gel and sham TENS. All patients were treated for a total of 10 sessions, consisting of five times per week and 10 min per session. Before and after treatment, patients were evaluated knee pain by using the 100-mm VAS and functional performance by Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index. The UltraTENS and PhP groups experienced considerable improvement in both VAS and total WOMAC scores post-treatment (P< 0.001). The PhP had better VAS of pain and WOMAC scores but no statistical significance. Results show that UltraTENS and PhP were effective for relieving pain and improve functionality knee OA without significant differences between their effects.

Effectiveness of Transcutaneous Electrical Nerve Stimulation for Treatment of Hyperalgesia and Pain

PubMed Central

DeSantana, Josimari M.; Walsh, Deirdre M.; Vance, Carol; Rakel, Barbara A.; Sluka, Kathleen A.

2009-01-01

Transcutaneous electrical nerve stimulation (TENS) is a nonpharmacologic treatment for pain relief. TENS has been used to treat a variety of painful conditions. This review updates the basic and clinical science regarding the use of TENS that has been published in the past 3 years (ie, 2005−2008). Basic science studies using animal models of inflammation show changes in the peripheral nervous system, as well as in the spinal cord and descending inhibitory pathways, in response to TENS. Translational studies show mechanisms to prevent analgesic tolerance to repeated application of TENS. This review also highlights data from recent randomized, placebo-controlled trials and current systematic reviews. Clinical trials suggest that adequate dosing, particularly intensity, is critical to obtaining pain relief with TENS. Thus, evidence continues to emerge from both basic science and clinical trials supporting the use of TENS for the treatment of a variety of painful conditions while identifying strategies to increase TENS effectiveness. PMID:19007541

Efficacy of botulinum toxin in treating myofascial pain in bruxers: a controlled placebo pilot study.

PubMed

Guarda-Nardini, Luca; Manfredini, Daniele; Salamone, Milena; Salmaso, Luigi; Tonello, Stefano; Ferronato, Giuseppe

2008-04-01

The present investigation is a preliminary double-blind, controlled placebo, randomized clinical trial with a six month follow-up period. The study aimed to assess the efficacy of type A botulinum toxin (Botox, Allergan, Inc. Irvine, CA) to treat myofascial pain symptoms and to reduce muscle hyperactivity in bruxers. Twenty patients (ten males, ten females; age range 25-45) with a clinical diagnosis of bruxism and myofascial pain of the masticatory muscles were enrolled in a double-blind, controlled placebo, randomized clinical trial, with a treatment group (ten subjects treated with botulinum toxin injections- BTX-A) and a control group (ten subjects treated with saline placebo injections). A number of objective and subjective clinical parameters (pain at rest and during chewing; mastication efficiency; maximum nonassisted and assisted mouth opening, protrusive and laterotrusive movements; functional limitation during usual jaw movements; subjective efficacy of the treatment; tolerance of the treatment) were assessed at baseline time and at one week, one month, and six months follow-up appointments. Descriptive analysis showed that improvements in both objective (range of mandibular movements) and subjective (pain at rest; pain during chewing) clinical outcome variables were higher in the Botox treated group than in the placebo treated subjects. Patients treated with BTX-A had a higher subjective improvement in their perception of treatment efficacy than the placebo subjects. Differences were not significant in some cases due to the small sample size. Results from the present study supported the efficacy of BTX-A to reduce myofascial pain symptoms in bruxers, and provided pilot data which need to be confirmed by further research using larger samples.

Do the Effects of Transcutaneous Electrical Nerve Stimulation on Knee Osteoarthritis Pain and Function Last?

PubMed

Cherian, Jeffrey Jai; Harrison, Paige E; Benjamin, Samantha A; Bhave, Anil; Harwin, Steven F; Mont, Michael A

2016-08-01

Transcutaneous electrical nerve stimulation (TENS) has been shown to decrease pain associated with knee osteoarthritis, which potentially leads to better function, improved quality of life, and postpones the need for surgical intervention. The purpose of this study was to perform a 1-year follow-up of a previous prospective group of patients with knee osteoarthritis, randomized to TENS or standard of care, who were asked to rate their changes in: (1) patient pain perception; (2) subjective medication use; (3) subjective functional abilities; (4) quality of life; (5) device use; and (6) conversion to TKA. A population of 70 patients were randomized to receive either a TENS device or a standard conservative therapy regimen. Patients were evaluated based on various subjective outcomes at minimum 1-year (mean, 19 months) follow-up. The TENS cohort had lower visual analog pain scores compared with the matching cohort. Subjective functional outcomes, as well as functional and activity scores, were also greater in the TENS cohort. Patients in TENS cohort showed significant improvements in their subjective and functional outcomes as compared with their initial status, while the control group did not show significant change. A majority of the TENS patients were able to reduce the amount of pain medications. Additionally, a large portion of the patients assigned to the TENS group continue to use the device, after completion of the trial. This study demonstrated the benefit of TENS for improving subjective outcomes in patients with pain due to knee osteoarthritis, compared with standard conservative treatments. The results of the study suggest that TENS is a safe and effective adjunct as part of the spectrum of current nonoperative treatment methods for knee osteoarthritis. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Adjunct High Frequency Transcutaneous Electric Stimulation (TENS) for Postoperative Pain Management during Weaning from Epidural Analgesia Following Colon Surgery: Results from a Controlled Pilot Study.

PubMed

Bjerså, Kristofer; Jildenstaal, Pether; Jakobsson, Jan; Egardt, Madelene; Fagevik Olsén, Monika

2015-12-01

The potential benefit of nonpharmacological adjunctive therapy is not well-studied following major abdominal surgery. The aim of the present study was to investigate transcutaneous electrical nerve stimulation (TENS) as a complementary nonpharmacological analgesia intervention during weaning from epidural analgesia (EDA) after open lower abdominal surgery. Patients were randomized to TENS and sham TENS during weaning from EDA. The effects on pain at rest, following short walk, and after deep breath were assessed by visual analog scale (VAS) grading. Number of patients assessed was lower than calculated because of change in clinical routine. Pain scores overall were low. A trend of lower pain scores was observed in the active TENS group of patients; a statistical significance between the groups was found for the pain lying prone in bed (p < .05). This controlled pilot study indicates benefits of TENS use in postoperative pain management during weaning from EDA after open colon surgery. Further studies are warranted in order to verify the potential beneficial effects from TENS during weaning from EDA after open, lower abdominal surgery. Copyright © 2015 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

Transcutaneous electrical nerve stimulation improves low back pain during pregnancy.

PubMed

Keskin, E A; Onur, O; Keskin, H L; Gumus, I I; Kafali, H; Turhan, N

2012-01-01

To compare the efficiency of transcutaneous electrical nerve stimulation (TENS) with those of exercise and acetaminophen for the treatment of pregnancy-related low back pain (LBP) during the third trimester of pregnancy. This prospective study included 79 subjects (≥32 gestational weeks) with visual analog scale (VAS) pain scores ≥5. Participants were divided randomly into a control group (n = 21) and three treatment groups [exercise (n = 19); acetaminophen (n = 19); TENS (n = 20)]. The VAS and the Roland-Morris disability questionnaire (RMDQ) were completed before and 3 weeks after treatment to assess the impact of pain on daily activities. During the study period, pain intensity increased in 57% of participants in the control group, whereas pain decreased in 95% of participants in the exercise group and in all participants in the acetaminophen and TENS groups. Post-treatment VAS and RMDQ values were significantly lower in the treatment groups (p < 0.001). VAS and RMDQ scores indicated a significantly greater degree of pain relief in the TENS group than in the exercise and acetaminophen groups (p < 0.001). No adverse effect of TENS application on pregnant women was observed during the study. TENS is an effective and safe treatment modality for LBP during pregnancy. TENS improved LBP more effectively than did exercise and acetaminophen. Copyright © 2012 S. Karger AG, Basel.

Short-term transcutaneous electrical nerve stimulation reduces pain and improves the masticatory muscle activity in temporomandibular disorder patients: a randomized controlled trial.

PubMed

Ferreira, Ana Paula de Lima; Costa, Dayse Regina Alves da; Oliveira, Ana Izabela Sobral de; Carvalho, Elyson Adam Nunes; Conti, Paulo César Rodrigues; Costa, Yuri Martins; Bonjardim, Leonardo Rigoldi

2017-01-01

To investigate the short-term effect of transcutaneous electrical nerve stimulation (TENS) by examining pain intensity, pressure pain threshold (PPT) and electromyography (EMG) activity in patients with temporomandibular disorder (TMD). Forty patients with myofascial TMD were enrolled in this randomized placebo-controlled trial and were divided into two groups: active (n=20) and placebo (n=20) TENS. Outcome variables assessed at baseline (T0), immediately after (T2) and 48 hours after treatment (T1) were: pain intensity with the aid of a visual analogue scale (VAS); PPT of masticatory and cervical structures; EMG activity during mandibular rest position (MR), maximal voluntary contraction (MVC) and habitual chewing (HC). Two-way ANOVA for repeated measures was applied to the data and the significance level was set at 5%. There was a decrease in the VAS values at T1 and T2 when compared with T0 values in the active TENS group (p<0.050). The PPT between-group differences were significant at T1 assessment of the anterior temporalis and sternocleidomastoid (SCM) and T2 for the masseter and the SCM (p<0.050). A significant EMG activity reduction of the masseter and anterior temporalis was presented in the active TENS during MR at T1 assessment when compared with T0 (p<0.050). The EMG activity of the anterior temporalis was significantly higher in the active TENS during MVC at T1 and T2 when compared with placebo (p<0.050). The EMG activity of the masseter and anterior temporalis muscle was significantly higher in the active TENS during HC at T1 when compared with placebo (p<0.050). The short-term therapeutic effects of TENS are superior to those of the placebo, because of reported facial pain, deep pain sensitivity and masticatory muscle EMG activity improvement.

Dose-specific effects of transcutaneous electrical nerve stimulation (TENS) on experimental pain: a systematic review.

PubMed

Claydon, Leica S; Chesterton, Linda S; Barlas, Panos; Sim, Julius

2011-09-01

To determine the hypoalgesic effects of transcutaneous electrical nerve stimulation (TENS) parameter combinations on experimental models in healthy humans. Searches were performed using the electronic databases Ovid MEDLINE, CINAHL, AMED, and Web of Science (from inception to December 2009). Manual searches of journals and reference lists of retrieved trials were also performed. Randomized controlled trials (RCTs) were included in the review if they compared the hypoalgesic effect of TENS relative with placebo and control, using an experimental pain model in healthy human participants. Two reviewers independently selected the trials, assessed their methodologic quality and extracted data. Forty-three RCTs were eligible for inclusion. A best evidence synthesis revealed: Overall "conflicting" (inconsistent findings in multiple RCTs) evidence of TENS efficacy on experimental pain irrespective of TENS parameters used. Overall intense TENS has "moderate" evidence of efficacy (1 high-quality and 2 low-quality trials). Conventional TENS has overall conflicting evidence of efficacy, this is derived from "strong" evidence of efficacy (generally consistent findings in multiple high-quality RCTs) on pressure pain but strong evidence of inefficacy on other pain models. "Limited" evidence (positive findings from 1 RCT) of hypoalgesia exists for some novel parameters. Low-intensity, low-frequency, local TENS has strong evidence of inefficacy. Inappropriate TENS (using "barely perceptible" intensities) has moderate evidence of inefficacy. The level of hypoalgesic efficacy of TENS is clearly dependent on TENS parameter combination selection (defined in terms of intensity, frequency, and stimulation site) and experimental pain model. Future clinical RCTs may consider these TENS dose responses.

Therapeutic Exercise Training to Reduce Chronic Headache in Working Women: Design of a Randomized Controlled Trial.

PubMed

Rinne, Marjo; Garam, Sanna; Häkkinen, Arja; Ylinen, Jari; Kukkonen-Harjula, Katriina; Nikander, Riku

2016-05-01

Cervicogenic headache and migraine are common causes of visits to physicians and physical therapists. Few randomized trials utilizing active physical therapy and progressive therapeutic exercise have been previously published. The existing evidence on active treatment methods supports a moderate effect on cervicogenic headache. The aim of this study is to investigate whether a progressive, group-based therapeutic exercise program decreases the intensity and frequency of chronic headache among women compared with a control group receiving a sham dose of transcutaneous electrical nerve stimulation (TENS) and stretching exercises. A randomized controlled trial with 6-month intervention and follow-up was developed. The participants were randomly assigned to either a treatment group or a control group. The study is being conducted at 2 study centers. The participants are women aged 18 to 60 years with chronic cervicogenic headache or migraine. The treatment group's exercise program consisted of 6 progressive therapeutic exercise modules, including proprioceptive low-load progressive craniocervical and cervical exercises and high-load exercises for the neck muscles. The participants in the control group received 6 individually performed sham TENS treatment sessions. The primary outcome is the intensity of headache. The secondary outcomes are changes in frequency and duration of headache, neck muscle strength, neck and shoulder flexibility, impact of headache on daily life, neck disability, fear-avoidance beliefs, work ability, and quality of life. Between-group differences will be analyzed separately at 6, 12, and 24 months with generalized linear mixed models. In the case of count data (eg, frequency of headache), Poisson or negative binomial regression will be used. The therapists are not blinded. The effects of specific therapeutic exercises on frequency, intensity, and duration of chronic headache and migraine will be reported. © 2016 American Physical Therapy Association.

Effect of Spinal Manipulative Therapy on the Singing Voice.

PubMed

Fachinatto, Ana Paula A; Duprat, André de Campos; Silva, Marta Andrada E; Bracher, Eduardo Sawaya Botelho; Benedicto, Camila de Carvalho; Luz, Victor Botta Colangelo; Nogueira, Maruan Nogueira; Fonseca, Beatriz Suster Gomes

2015-09-01

This study investigated the effect of spinal manipulative therapy (SMT) on the singing voice of male individuals. Randomized, controlled, case-crossover trial. Twenty-nine subjects were selected among male members of the Heralds of the Gospel. This association was chosen because it is a group of persons with similar singing activities. Participants were randomly assigned to two groups: (A) chiropractic SMT procedure and (B) nontherapeutic transcutaneous electrical nerve stimulation (TENS) procedure. Recordings of the singing voice of each participant were taken immediately before and after the procedures. After a 14-day period, procedures were switched between groups: participants who underwent SMT on the first day were subjected to TENS and vice versa. Recordings were subjected to perceptual audio and acoustic evaluations. The same recording segment of each participant was selected. Perceptual audio evaluation was performed by a specialist panel (SP). Recordings of each participant were randomly presented thus making the SP blind to intervention type and recording session (before/after intervention). Recordings compiled in a randomized order were also subjected to acoustic evaluation. No differences in the quality of the singing on perceptual audio evaluation were observed between TENS and SMT. No differences in the quality of the singing voice of asymptomatic male singers were observed on perceptual audio evaluation or acoustic evaluation after a single spinal manipulative intervention of the thoracic and cervical spine. Copyright © 2015 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

Teaching Medical Students to Help Patients Quit Smoking: Outcomes of a 10-School Randomized Controlled Trial.

PubMed

Ockene, Judith K; Hayes, Rashelle B; Churchill, Linda C; Crawford, Sybil L; Jolicoeur, Denise G; Murray, David M; Shoben, Abigail B; David, Sean P; Ferguson, Kristi J; Huggett, Kathryn N; Adams, Michael; Okuliar, Catherine A; Gross, Robin L; Bass, Pat F; Greenberg, Ruth B; Leone, Frank T; Okuyemi, Kola S; Rudy, David W; Waugh, Jonathan B; Geller, Alan C

2016-02-01

Early in medical education, physicians must develop competencies needed for tobacco dependence treatment. To assess the effect of a multi-modal tobacco dependence treatment curriculum on medical students' counseling skills. A group-randomized controlled trial (2010-2014) included ten U.S. medical schools that were randomized to receive either multi-modal tobacco treatment education (MME) or traditional tobacco treatment education (TE). Students from the classes of 2012 and 2014 at ten medical schools participated. Students from the class of 2012 (N = 1345) completed objective structured clinical examinations (OSCEs), and 50 % (N = 660) were randomly selected for pre-intervention evaluation. A total of 72.9 % of eligible students (N = 1096) from the class of 2014 completed an OSCE and 69.7 % (N = 1047) completed pre and post surveys. The MME included a Web-based course, a role-play classroom demonstration, and a clerkship booster session. Clerkship preceptors in MME schools participated in an academic detailing module and were encouraged to be role models for third-year students. The primary outcome was student tobacco treatment skills using the 5As measured by an objective structured clinical examination (OSCE) scored on a 33-item behavior checklist. Secondary outcomes were student self-reported skills for performing 5As and pharmacotherapy counseling. Although the difference was not statistically significant, MME students completed more tobacco counseling behaviors on the OSCE checklist (mean 8.7 [SE 0.6] vs. mean 8.0 [SE 0.6], p = 0.52) than TE students. Several of the individual Assist and Arrange items were significantly more likely to have been completed by MME students, including suggesting behavioral strategies (11.8 % vs. 4.5 %, p < 0.001) and providing information regarding quitline (21.0 % vs. 3.8 %, p < 0.001). MME students reported higher self-efficacy for Assist, Arrange, and Pharmacotherapy counseling items (ps ≤0.05). Inclusion of only ten schools limits generalizability. Subsequent interventions should incorporate lessons learned from this first randomized controlled trial of a multi-modal longitudinal tobacco treatment curriculum in multiple U.S. medical schools. NIH Trial Registry Number: NCT01905618.

The effects of Transcutaneous Electrical Nerve Stimulation on postural control in patients with chronic low back pain.

PubMed

Rojhani-Shirazi, Z; Rezaeian, T

2015-01-01

Objective: The effects of transcutaneous electrical nerve stimulation (TENS) on postural control in patients with low back pain which is not well known. This study aimed to evaluate the effects of TENS on postural control in chronic low back pain. Methods: This study was an experimental research design. Twenty-eight patients with chronic LBP (25-45 Y/ O) participated and by using a random allocation, were divided to samples who participated in this study. The mean center of pressure (COP) velocity and displacement were measured before, immediately and 30 min after the intervention. The tests were done with eyes open and closed on a force platform. Sensory electrical stimulation was applied through the TENS device. The descriptive statistics, independent sample T-test and ANOVA with repeated measurement on time were used for data analysis. Results: The results of the present study demonstrated that the application of the sensory electrical stimulation in chronic LBP patients showed a statistically significant improvement in postural control in Medio-lateral direction with no corresponding effect on the anterior-posterior direction immediately following the TENS application and 30 minutes after it in closed eyes conditions as compared to baseline. The application of TENS decreased the displacement and velocity of COP (p≤0.05), 30 minutes after the application of sensory electrical stimulation. The results showed that the mean displacement and velocity of COP decreased in eyes open position (p≤0.05). Also, immediately and 30 minutes after the application of sensory electrical stimulation, COP displacement and velocity in ML direction with eyes closed significantly decreased in the intervention group in comparison with control group (p≤0.05). Conclusion: The application of TENS in patients with chronic low back pain could improve postural control in these patients.

The effects of Transcutaneous Electrical Nerve Stimulation on postural control in patients with chronic low back pain

PubMed Central

Rojhani-Shirazi, Z; Rezaeian, T

2015-01-01

Objective: The effects of transcutaneous electrical nerve stimulation (TENS) on postural control in patients with low back pain which is not well known. This study aimed to evaluate the effects of TENS on postural control in chronic low back pain. Methods: This study was an experimental research design. Twenty-eight patients with chronic LBP (25-45 Y/ O) participated and by using a random allocation, were divided to samples who participated in this study. The mean center of pressure (COP) velocity and displacement were measured before, immediately and 30 min after the intervention. The tests were done with eyes open and closed on a force platform. Sensory electrical stimulation was applied through the TENS device. The descriptive statistics, independent sample T-test and ANOVA with repeated measurement on time were used for data analysis. Results: The results of the present study demonstrated that the application of the sensory electrical stimulation in chronic LBP patients showed a statistically significant improvement in postural control in Medio-lateral direction with no corresponding effect on the anterior-posterior direction immediately following the TENS application and 30 minutes after it in closed eyes conditions as compared to baseline. The application of TENS decreased the displacement and velocity of COP (p≤0.05), 30 minutes after the application of sensory electrical stimulation. The results showed that the mean displacement and velocity of COP decreased in eyes open position (p≤0.05). Also, immediately and 30 minutes after the application of sensory electrical stimulation, COP displacement and velocity in ML direction with eyes closed significantly decreased in the intervention group in comparison with control group (p≤0.05). Conclusion: The application of TENS in patients with chronic low back pain could improve postural control in these patients. PMID:28255392

Duration of Analgesia Induced by Acupuncture-Like TENS on Experimental Heat Pain.

PubMed

Tousignant-Laflamme, Yannick; Brochu, Marilyne; Dupuis-Michaud, Cynthia; Pagé, Catherine; Popovic, Draga; Simard, Marie-Eve

2013-01-01

Background. Acupuncture-like TENS (AL-TENS) is a treatment modality that can be used to temporarily reduce pain. However, there is no clear data in the literature regarding the specific duration of analgesia induced by AL-TENS. Objectives. To describe and quantify the duration and magnitude of AL-TENS analgesia on experimental heat pain in healthy subjects and verify if the duration or magnitude of analgesia induced by the AL-TENS was influenced by the duration of the application of the AL-TENS (15 versus 30 minutes). Methods. A repeated-measures, intrasubject randomized experimental design was used, where each participant was his/her own control. 22 healthy volunteers underwent heat pain stimulations with a contact thermode before (pretest) and after (posttest) AL-TENS application (15 and 30 minutes). Outcome measures included subjective pain during AL-TENS, duration, and magnitude of AL-TENS-induced analgesia. Results. Survival analysis showed that the median duration of AL-TENS analgesia was 10 minutes following the application of either 15 or 30 minutes of AL-TENS. The magnitude of analgesia following either application was comparable at all points in time (P values > 0.05) and ranged between -20% and -36% pain reduction. Conclusion. Only half of the participants still had heat-pain analgesia induced by the AL-TENS at 15 minutes postapplication.

Effect of village-wide use of long-lasting insecticidal nets on visceral Leishmaniasis vectors in India and Nepal: a cluster randomized trial.

PubMed

Picado, Albert; Das, Murari L; Kumar, Vijay; Kesari, Shreekant; Dinesh, Diwakar S; Roy, Lalita; Rijal, Suman; Das, Pradeep; Rowland, Mark; Sundar, Shyam; Coosemans, Marc; Boelaert, Marleen; Davies, Clive R

2010-01-26

Visceral leishmaniasis (VL) control in the Indian subcontinent is currently based on case detection and treatment, and on vector control using indoor residual spraying (IRS). The use of long-lasting insecticidal nets (LN) has been postulated as an alternative or complement to IRS. Here we tested the impact of comprehensive distribution of LN on the density of Phlebotomus argentipes in VL-endemic villages. A cluster-randomized controlled trial with household P. argentipes density as outcome was designed. Twelve clusters from an ongoing LN clinical trial--three intervention and three control clusters in both India and Nepal--were selected on the basis of accessibility and VL incidence. Ten houses per cluster selected on the basis of high pre-intervention P. argentipes density were monitored monthly for 12 months after distribution of LN using CDC light traps (LT) and mouth aspiration methods. Ten cattle sheds per cluster were also monitored by aspiration. A random effect linear regression model showed that the cluster-wide distribution of LNs significantly reduced the P. argentipes density/house by 24.9% (95% CI 1.80%-42.5%) as measured by means of LTs. The ongoing clinical trial, designed to measure the impact of LNs on VL incidence, will confirm whether LNs should be adopted as a control strategy in the regional VL elimination programs. The entomological evidence described here provides some evidence that LNs could be usefully deployed as part of the VL control program. ClinicalTrials.gov CT-2005-015374.

Does transcutaneous electrical nerve stimulation reduce pain and improve quality of life in patients with idiopathic chronic orchialgia? A randomized controlled trial

PubMed Central

Tantawy, Sayed A; Kamel, Dalia M; Abdelbasset, Walid Kamal

2018-01-01

Background Chronic orchialgia is defined as testicular pain, which may be either unilateral or bilateral, lasting for more than 3 months. It disturbs a patient’s daily activities and quality of life (QoL), inciting the patient to search for treatments to alleviate the pain. It is estimated that 25% of chronic orchialgia cases are idiopathic. Purpose The purpose of this study was to investigate how effective transcutaneous electrical nerve stimulation (TENS) is in pain reduction and how it consequently affects the QoL in patients with idiopathic chronic orchialgia (ICO). Patients and methods Seventy-one patients were randomly assigned to group A (study group), which included 36 patients who received TENS and analgesia, and group B (control group), which included 35 patients who received analgesia only. The outcome measures were the participants’ demographic data and results of the visual analog scale (VAS) and QoL questionnaire. These outcomes were measured before and after 4 weeks of treatment and at 2-month follow-up. Results The results showed that compared to pretreatment, there was a significant reduction in pain postintervention and at 2-month follow-up in group A (P<0.0001 and <0.001, respectively; F=7.1) as well as a significant improvement in QoL at these time points (P<0.0001 and <0.0001, respectively). There were no significant differences in the VAS score and QoL in group B at different time points of evaluation. Conclusion The findings indicate that TENS is effective in reducing pain and improving patients’ QoL in cases of ICO. TENS is an easy-to-use, effective, noninvasive, and simple method for ICO-associated pain control and QoL improvement. PMID:29343983

Efficacy of transcutaneous electrical nerve stimulation (tens) for chronic low-back pain in a multiple sclerosis population: a randomized, placebo-controlled clinical trial.

PubMed

Warke, Kim; Al-Smadi, Jamal; Baxter, David; Walsh, Deirdre M; Lowe-Strong, Andrea S

2006-01-01

This study was designed to investigate the hypoalgesic effects of self-applied transcutaneous electrical nerve stimulation (TENS) on chronic low-back pain (LBP) in a multiple sclerosis (MS) population. Ninety participants with probable or definite MS (aged 21 to 78 y) presenting with chronic LBP were recruited and randomized into 3 groups (n=30 per group): (1) low-frequency TENS group (4 Hz, 200 micros); (2) high-frequency TENS group (110 Hz, 200 micros); and (3) placebo TENS. Participants self-applied TENS for 45 minutes, a minimum of twice daily, for 6 weeks. Outcome measures were recorded at weeks 1, 6, 10, and 32. Primary outcome measures included: Visual Analog Scale for average LBP and the McGill Pain Questionnaire. Secondary outcome measures included: Visual Analog Scale for worst and weekly LBP, back and leg spasm; Roland Morris Disability Questionnaire; Barthel Index; Rivermead Mobility Index; Multiple Sclerosis Quality of Life-54 Instrument, and a daily logbook. Data were analyzed blind using parametric and nonparametric tests, as appropriate. Results indicated a statistically significant interactive effect between groups for average LBP (P=0.008); 1-way analysis of covariance did not show any significant effects at any time point once a Bonferonni correction was applied (P>0.05). However, clinically important differences were observed in some of the outcome measures in both active treatment groups during the treatment and follow-up periods. Although not statistically significant, the observed effects may have implications for the clinical prescription and the use of TENS within this population.

Experimental transmission of Corynebacterium pseudotuberculosis in horses by house flies

USDA-ARS?s Scientific Manuscript database

The route of infection of pigeon fever remains undetermined. The purpose of this study was to investigate house flies (Musca domestica L.) as vectors of Corynebacterium pseudotuberculosis in horses. Eight ponies were used in a randomized, controlled, blinded experimental study. Ten wounds were creat...

A pilot study on using acupuncture and transcutaneous electrical nerve stimulation to treat chronic non-specific low back pain.

PubMed

Itoh, Kazunori; Itoh, Satoko; Katsumi, Yasukazu; Kitakoji, Hiroshi

2009-02-01

The present study tests whether a combined treatment of acupuncture and transcutaneous electrical nerve stimulation (TENS) is more effective than acupuncture or TENS alone for treating chronic low back pain (LBP). Thirty-two patients with chronic LBP were randomly allocated to four groups. The acupuncture group (ACP) received only acupuncture treatment at selected acupoints for low back pain; the TENS group (TENS) received only TENS treatment at pain areas; the acupuncture and TENS group (A&T) received both acupuncture and TENS treatments; the control group (CT) received topical poultice (only when necessary). Each group received specific weekly treatment five times during the study. Outcome measures were pain intensity in terms of visual analogue scale (VAS) and QOL of low back in terms of Roland-Morris Disability Questionnaire (RDQ). The ACP, TENS and A&T groups all reported lower VAS and RDQ scores. Significant reduction in pain intensity (P<0.008) and significant improvement in QOL (P<0.008) were shown in the A&T group. Combined acupuncture and TENS treatment is effective in pain relief and QOL of low back improvement for the sampled patients suffering from chronic LBP.

Results of a pilot test of a brief computer-assisted tailored HIV prevention intervention for use with a range of demographic and risk groups.

PubMed

Zule, William A; Bobashev, Georgiy V; Reif, Susan M; Poulton, Winona; Coomes, Curtis M; Wechsberg, Wendee M

2013-11-01

There is a need for brief HIV prevention interventions that can be disseminated and implemented widely. This article reports the results of a small randomized field experiment that compared the relative effects of a brief two-session counselor-delivered computer-tailored intervention and a control condition. The intervention is designed for use with African-American, non-Hispanic white and Hispanic males and females who may be at risk of HIV through unprotected sex, selling sex, male to male sex, injecting drug use or use of stimulants. Participants (n = 120) were recruited using a quota sampling approach and randomized using block randomization, which resulted in ten male and ten female participants of each racial/ethnic group (i.e. African-American, non-Hispanic white and Hispanic) being assigned to either the intervention or a control arm. In logistic regression analyses using a generalized estimating equations approach, at 3-month followup, participants in the intervention arm were more likely than participants in the control arm to report condom use at last sex (Odds ratio [OR] = 4.75; 95 % Confidence interval [CI] = 1.70-13.26; p = 0.003). The findings suggest that a brief tailored intervention may increase condom use. Larger studies with longer followups are needed to determine if these results can be replicated.

Comparison of effectiveness of Transcutaneous Electrical Nerve Stimulation and Kinesio Taping added to exercises in patients with myofascial pain syndrome.

PubMed

Azatcam, Gokmen; Atalay, Nilgun Simsir; Akkaya, Nuray; Sahin, Fusun; Aksoy, Sibel; Zincir, Ozge; Topuz, Oya

2017-01-01

Although there are several studies of Transcutaneous Electrical Nerve Stimulation (TENS) and exercise in myofascial pain syndrome, there are no studies comparing the effectiveness of Kinesio Taping (KT) and TENS in myofascial pain syndrome patients. To compare the early and late effects of TENS and KT on pain, disability and range of motion in myofascial pain syndrome patients. Sixty-nine patients were divided into three groups randomly as TENS+Exercise, KT+Exercise and exercise groups. Visual Analogue Scale (VAS), pain threshold, Neck Disability Index and cervical contralateral lateral flexion were employed in the evaluation of the patients performed before treatment, after treatment and 3rd month after treatment. The VAS, pain threshold, Neck Disability Index and contralateral lateral flexion values were improved in all groups both in after treatment and 3rd month after treatment (p< 0.01). In the comparison of after treatment vs. before treatment evaluations, VAS score was decreased in KT group compared to the TENS and control group (p= 0.001), in the TENS group compared to control group (p= 0.011). In the comparison of 3rd month and before treatment evaluations, VAS score was decreased in the TENS group compared to control group (p= 0.001) and in the KT group compared to the control group (p= 0.001). There was no significant difference between TENS and KT groups. All other parameters did not differ between the groups. TENS and KT added exercises can decrease pain severity and increase pain threshold, function and cervical range of motion in myofascial pain syndrome patients. Addition of TENS or KT to the exercise therapy resulted in more significant improvement compared to exercise therapy alone with a more pronounced improvement in KT group compared to the TENS group in the early period. Because KT was found to be more effective in decreasing the pain and had the advantage of being used in every 3 days, it seems to be beneficial in acute painful periods in myofascial pain syndrome patients.

Effects of transcutaneous electrical nerve stimulation (TENS) on arterial stiffness and blood pressure in resistant hypertensive individuals: study protocol for a randomized controlled trial.

PubMed

Vilela-Martin, José Fernando; Giollo-Junior, Luiz Tadeu; Chiappa, Gaspar Rogério; Cipriano-Junior, Gerson; Vieira, Paulo José Cardoso; dos Santos Ricardi, Fábio; Paz-Landim, Manoel Ildefonso; de Andrade, Days Oliveira; Cestário, Elizabeth do Espírito Santo; Cosenso-Martin, Luciana Neves; Yugar-Toledo, Juan Carlos; Cipullo, José Paulo

2016-03-29

Resistant hypertension (RH) treatment requires an adequate and intense therapeutic approach. However, the results are not always satisfactory despite intensive treatment. Of the different pathophysiological mechanisms involved in the pathogenesis of RH, sympathetic overstimulation and therapies that block the sympathetic system have been widely studied. These approaches, however, are invasive and expensive. Another possible approach is by transcutaneous electrical nerve stimulation (TENS), a noninvasive method that modulates activity by using low-frequency transcutaneous electrical stimulation to inhibit primary afferent pathways. Thus, the current study will evaluate the effect of applying TENS in the cervicothoracic region of subjects with RH and will seek to develop a new low-cost and readily available therapy to treat this group of hypertensive individuals. This is a randomized, single blind (subject), parallel-assignment study controlled with a sham group and including participants aged 40 to 70 years with resistant hypertension. The trial has two arms: the treatment and control (sham group). The treatment group will be submitted to the stimulation procedure (TENS). The sham group will not be submitted to stimulation. The primary outcomes will be a reduction in the peripheral blood pressure and adverse events. The secondary outcomes will be a reduction the central blood pressure. The study will last 30 days. The sample size was calculated assuming an alpha error of 5 % to reject the null hypothesis with a statistical power of 80 %, thereby resulting in 28 participants per group (intervention versus sham). In recent decades, RH has become very common and costly. Adequate control requires several drugs, and in many cases, treatment is not successful. Sympathetic nervous system inhibition by renal denervation and central inhibition have significant effects in reducing BP; however, these treatments are costly and invasive. Another type of sympathetic nervous system inhibition can also be noninvasively achieved by electric current. Therefore, the application of TENS may be a new therapeutic option for treating resistant hypertensive individuals. Clinical Trials NCT02365974.

Comparison of the therapeutic efficacy of TENS versus intra-articular hyaluronic acid injection in patients with knee osteoarthritis: a prospective randomized study.

PubMed

Paker, Nurdan; Tekdös, Demet; Kesiktas, Nur; Soy, Derya

2006-01-01

Knee osteoarthritis (OA) is perceived as a major public health problem, and today, various treatment modalities are used to manage this condition. The purpose of this study was to assess and compare the efficacy of transcutaneous electrical nerve stimulation (TENS) and intra-articular hylan G-F 20 (Synvisc; Genzyme Corporation, Ridgefield, NJ) in patients with symptomatic knee OA. A total of 60 patients with primary knee OA were randomized into 2 treatment groups. TENS was applied for 3 weeks in the first group, and in the second group, hylan G-F 20 was injected intra-articularly once a week for 3 weeks. Patients were then followed for 6 months. Disease severity was measured with the Lequesne Index. Efficacy in terms of pain, functional status, and quality of life was assessed through analysis of changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and short Form 36 Health Survey (SF-36) scores. Adverse events were monitored throughout the study. WOMAC pain scores were improved at the first control visit in the TENS group and in the viscosupplementation group; this improvement was statistically significant. WOMAC stiffness scores showed a statistically significant decrease in the TENS group at the first control visit. Stiffness did not decrease during the first month in the second group; however, these patients exhibited improvement during the sixth month after injection. Physical function scores and SF-36 total scores did not change in either group after treatment. Pain relief was observed at the first month and continued throughout the 6-month follow-up period in both groups. Stiffness decreased by the sixth month in both groups. Improvement in WOMAC physical function scores was greater in the intra-articular hylan group than in the TENS group at the end of follow-up; however, quality of life was not improved in either group. These therapies used in combination may alleviate symptoms in patients with OA.

Perceptions of the Performance of Community College Faculty: Dissertation Research Findings.

ERIC Educational Resources Information Center

Vickers, Mozelle Carver

A sample of 30 instructors nominated as effective teachers to the Piper Foundation and 31 randomly selected control instructors from the same 14 Texas colleges were evaluated by students, former students, administrators, peers, and the instructors themselves. The research instrument incorporated ten sets of characteristics expressed as polar…

Mirror Therapy and Transcutaneous Electrical Nerve Stimulation for Management of Phantom Limb Pain in Amputees - A Single Blinded Randomized Controlled Trial.

PubMed

Tilak, Merlyn; Isaac, Serin Anna; Fletcher, Jebaraj; Vasanthan, Lenny Thinagaran; Subbaiah, Rajalakshmi Sankaran; Babu, Andrew; Bhide, Rohit; Tharion, George

2016-06-01

Phantom limb pain (PLP) can be disabling for nearly two thirds of amputees. Hence, there is a need to find an effective and inexpensive treatment that can be self administered. Among the non-pharmacological treatment for PLP, transcutaneous electrical nerve stimulation (TENS) applied to the contralateral extremity and mirror therapy are two promising options. However, there are no studies to compare the two treatments. The purpose of this study is to evaluate and compare mirror therapy and TENS in the management of PLP in subjects with amputation. The study was an assessor blinded randomized controlled trial conducted at Physiotherapy Gymnasium of Physical Medicine and Rehabilitation Department, Christian Medical College, Vellore. Twenty-six subjects with PLP consented to participate. An initial assessment of pain using visual analogue scale (VAS) and universal pain score (UPS) was performed by a therapist blinded to the treatment given. Random allocation into Group I-mirror therapy and Group II-TENS was carried out. After 4 days of treatment, pain was re-assessed by the same therapist. The mean difference in Pre and Post values were compared among the groups. The change in pre-post score was analyzed using the paired t test. Participants of Group I had significant decrease in pain [VAS ( p = 0.003) and UPS ( p = 0.001)]. Group II also showed a significant reduction in pain [VAS ( p = 0.003) and UPS ( p = 0.002)]. However, no difference was observed between the two groups [VAS ( p = 0.223 and UPS ( p = 0.956)]. Both Mirror Therapy and TENS were found to be effective in pain reduction on a short-term basis. However, no difference between the two groups was found. Substantiation with long-term follow-up is essential to find its long-term effectiveness. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Transcutaneous electrical nerve stimulation for the relief of post-partum uterine contraction pain during breast-feeding: a randomized clinical trial.

PubMed

de Sousa, Ligia; Gomes-Sponholz, Flávia A; Nakano, Ana Márcia S

2014-05-01

To evaluate transcutaneous electrical nerve stimulation (TENS) used to relieve uterine contraction pain during breast-feeding in multiparous women. A controlled and randomized clinical trial was performed with 32 post-partum multiparous women who were breast-feeding. The participants were randomized into an experimental (EG, n = 16) and a control group (CG, n = 16). Pain was assessed using the Numerical Rating Scale and the descriptors of the Present Pain Intensity (PPI - McGill) during two sequential feeds. In the first assessment, the post-partum women in the EG and CG were monitored while breast-feeding and questioned regarding the degree of uterine contraction pain. In the second assessment, which was performed at the next feed, the EG used TENS while the CG was monitored, with pain being reassessed following. In the EG, the TENS electrodes were placed between T10-L1 and S2-S4, with a frequency of 100 Hz, a pulse duration of 75 μs and amplitude adjusted to produce a strong and tolerable sensation for 40 min. A descriptive analysis of the data and comparative intra- and intergroup analyses were performed by means of a non-parametrical test, with a significance level P ≤ 0.05. The level of basal pain was 5.56 in the EG and 5.50 in the CG. In the intragroup analysis, the EG (P < 0.0001) and CG (P = 0.04) presented significant pain reduction. In the intergroup analysis, the EG had significant pain reduction (P < 0.01) in comparison to the CG. In the PPI analysis, a non-significant decrease in pain intensity was observed in the EG. TENS was found to be effective in reducing post-partum uterine contraction pain during breast-feeding. © 2014 The Authors. Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology.

Efficacy of electroacupuncture compared with transcutaneous electric nerve stimulation for functional constipation: Study protocol for a randomized, controlled trial.

PubMed

Zeng, Yuxiao; Zhang, Xuecheng; Zhou, Jing; Wang, Xinwei; Jiao, Ruimin; Liu, Zhishun

2018-05-01

To treat functional constipation, both electroacupuncture (EA) therapy and transcutaneous electric nerve stimulation (TENS) are safe and effective. However, no head-to-head comparison trial has been conducted. This trial compares the efficacy of electroacupuncture relative to transcutaneous electric nerve stimulation for functional constipation. Individuals with functional constipation will be randomly allocated to receive either EA or TENS (n = 51, each), 3 times per week for 8 weeks. The primary outcome is the percentage of participants with an average increase from baseline of 1 or more complete spontaneous bowel movements at week 8. The secondary outcome measures are the following: at the time of visits, changes in the number of complete spontaneous bowel movements, number of spontaneous bowel movements, stool character, difficulty in defecation, patients' assessment of quality of life regarding constipation (self-report questionnaire), and use of auxiliary defecation methods. The results of this trial should verify whether EA is more efficacious than TENS for relieving symptoms of functional constipation. The major limitation of the study is the lack of blinding of the participants and acupuncturist.

Performance aspects of an injury prevention program: a ten-week intervention in adolescent female football players.

PubMed

Steffen, K; Bakka, H M; Myklebust, G; Bahr, R

2008-10-01

The injury rate in football is high, and effective injury prevention methods are needed. An exercise program, the "11," has been designed to prevent the most common injury types in football. However, the effect of such a program on performance is not known. The aim of this randomized-controlled trial was to investigate the effect of the "11" on performance after a 10-week training period. Thirty-four adolescent female football players were randomly assigned to either an intervention (n=18) or a control group (n=16). The "11" is a 15-min program consisting of ten exercises for core stability, lower extremity strength, balance and agility. Performance tests included isokinetic and isometric strength protocols for the quadriceps and hamstrings, isometric hip adduction and abduction strength, vertical jump tests, sprint running and soccer skill tests. There was no difference between the intervention and control groups in the change in performance from the pre- to post-test for any of the tests used. In conclusion, no effect was observed on a series of performance tests in a group of adolescent female football players using the "11" as a structured warm-up program.

Effect of Acu-TENS on recovery heart rate after treadmill running exercise in subjects with normal health.

PubMed

Cheung, Leo Chin-Ting; Jones, Alice Yee-Men

2007-06-01

This study aims to investigate the effect of transcutaneous electrical nerve stimulation, applied at bilateral acupuncture points PC6 (Acu-TENS), on recovery heart rate (HR) in healthy subjects after treadmill running exercise. A single blinded, randomized controlled trial. Laboratory with healthy male subjects (n=28). Each subject participated in three separate protocols in random order. PROTOCOL A: The subject followed the Bruce protocol and ran on a treadmill until their HR reached 70% of their maximum (220-age). At this 'target' HR, the subject adopted the supine position and Acu-TENS to bilateral PC6 was commenced. PROTOCOL B: Identical to protocol A except that Acu-TENS was applied in the supine position for 45min prior to, but not after exercise. PROTOCOL C: Identical to protocol A except that placebo Acu-TENS was applied. Heart rate was recorded before and at 30s intervals after exercise until it returned to the pre-exercise baseline. The time for HR to return to baseline was compared for each protocol. Acu-TENS applied to bilateral PC6 resulted in a faster return to pre-exercise HR compared to placebo. Time required for HR to return to pre-exercise level in protocols A-C was 5.5+/-3.0; 4.8+/-3.3; 9.4+/-3.7 min, respectively (p<0.001). There was no statistical difference in HR recovery time between protocols A and B. Subjects expressed the lowest rate of perceived exertion score (RPE) at 70% maximum HR with protocol B. This study suggests that Acu-TENS applied to PC6 may facilitate HR recovery after high intensity treadmill exercise.

Randomized, controlled trial of TNF-α antagonist in CTL-mediated severe cutaneous adverse reactions.

PubMed

Wang, Chuang-Wei; Yang, Lan-Yan; Chen, Chun-Bing; Ho, Hsin-Chun; Hung, Shuen-Iu; Yang, Chih-Hsun; Chang, Chee-Jen; Su, Shih-Chi; Hui, Rosaline Chung-Yee; Chin, See-Wen; Huang, Li-Fang; Lin, Yang Yu-Wei; Chang, Wei-Yang; Fan, Wen-Lang; Yang, Chin-Yi; Ho, Ji-Chen; Chang, Ya-Ching; Lu, Chun-Wei; Chung, Wen-Hung

2018-03-01

Cytotoxic T lymphocyte-mediated (CTL-mediated) severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), are rare but life-threatening adverse reactions commonly induced by drugs. Although high levels of CTL-associated cytokines, chemokines, or cytotoxic proteins, including TNF-α and granulysin, were observed in SJS-TEN patients in recent studies, the optimal treatment for these diseases remains controversial. We aimed to evaluate the efficacy, safety, and therapeutic mechanism of a TNF-α antagonist in CTL-mediated SCARs. We enrolled 96 patients with SJS-TEN in a randomized trial to compare the effects of the TNF-α antagonist etanercept versus traditional corticosteroids. Etanercept improved clinical outcomes in patients with SJS-TEN. Etanercept decreased the SCORTEN-based predicted mortality rate (predicted and observed rates, 17.7% and 8.3%, respectively). Compared with corticosteroids, etanercept further reduced the skin-healing time in moderate-to-severe SJS-TEN patients (median time for skin healing was 14 and 19 days for etanercept and corticosteroids, respectively; P = 0.010), with a lower incidence of gastrointestinal hemorrhage in all SJS-TEN patients (2.6% for etanercept and 18.2% for corticosteroids; P = 0.03). In the therapeutic mechanism study, etanercept decreased the TNF-α and granulysin secretions in blister fluids and plasma (45.7%-62.5% decrease after treatment; all P < 0.05) and increased the Treg population (2-fold percentage increase after treatment; P = 0.002), which was related to mortality in severe SJS-TEN. The anti-TNF-α biologic agent etanercept serves as an effective alternative for the treatment of CTL-mediated SCARs. ClinicalTrials.gov NCT01276314. Ministry of Science and Technology of Taiwan.

Randomized, controlled trial of TNF-α antagonist in CTL-mediated severe cutaneous adverse reactions

PubMed Central

Wang, Chuang-Wei; Yang, Lan-Yan; Ho, Hsin-Chun; Hung, Shuen-Iu; Yang, Chih-Hsun; Chang, Chee-Jen; Su, Shih-Chi; Hui, Rosaline Chung-Yee; Chin, See-Wen; Huang, Li-Fang; Lin, Yang Yu-Wei; Chang, Wei-Yang; Fan, Wen-Lang; Yang, Chin-Yi; Ho, Ji-Chen; Chung, Wen-Hung

2018-01-01

BACKGROUND. Cytotoxic T lymphocyte–mediated (CTL-mediated) severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), are rare but life-threatening adverse reactions commonly induced by drugs. Although high levels of CTL-associated cytokines, chemokines, or cytotoxic proteins, including TNF-α and granulysin, were observed in SJS-TEN patients in recent studies, the optimal treatment for these diseases remains controversial. We aimed to evaluate the efficacy, safety, and therapeutic mechanism of a TNF-α antagonist in CTL-mediated SCARs. METHODS. We enrolled 96 patients with SJS-TEN in a randomized trial to compare the effects of the TNF-α antagonist etanercept versus traditional corticosteroids. RESULTS. Etanercept improved clinical outcomes in patients with SJS-TEN. Etanercept decreased the SCORTEN-based predicted mortality rate (predicted and observed rates, 17.7% and 8.3%, respectively). Compared with corticosteroids, etanercept further reduced the skin-healing time in moderate-to-severe SJS-TEN patients (median time for skin healing was 14 and 19 days for etanercept and corticosteroids, respectively; P = 0.010), with a lower incidence of gastrointestinal hemorrhage in all SJS-TEN patients (2.6% for etanercept and 18.2% for corticosteroids; P = 0.03). In the therapeutic mechanism study, etanercept decreased the TNF-α and granulysin secretions in blister fluids and plasma (45.7%–62.5% decrease after treatment; all P < 0.05) and increased the Treg population (2-fold percentage increase after treatment; P = 0.002), which was related to mortality in severe SJS-TEN. CONCLUSIONS. The anti–TNF-α biologic agent etanercept serves as an effective alternative for the treatment of CTL-mediated SCARs. TRIAL REGISTRATION. ClinicalTrials.gov NCT01276314. FUNDING. Ministry of Science and Technology of Taiwan. PMID:29400697

Short-term transcutaneous electrical nerve stimulation reduces pain and improves the masticatory muscle activity in temporomandibular disorder patients: a randomized controlled trial

PubMed Central

FERREIRA, Ana Paula de Lima; da COSTA, Dayse Regina Alves; de OLIVEIRA, Ana Izabela Sobral; CARVALHO, Elyson Adam Nunes; CONTI, Paulo César Rodrigues; COSTA, Yuri Martins; BONJARDIM, Leonardo Rigoldi

2017-01-01

Abstract Studies to assess the effects of therapies on pain and masticatory muscle function are scarce. Objective To investigate the short-term effect of transcutaneous electrical nerve stimulation (TENS) by examining pain intensity, pressure pain threshold (PPT) and electromyography (EMG) activity in patients with temporomandibular disorder (TMD). Material and Methods Forty patients with myofascial TMD were enrolled in this randomized placebo-controlled trial and were divided into two groups: active (n=20) and placebo (n=20) TENS. Outcome variables assessed at baseline (T0), immediately after (T2) and 48 hours after treatment (T1) were: pain intensity with the aid of a visual analogue scale (VAS); PPT of masticatory and cervical structures; EMG activity during mandibular rest position (MR), maximal voluntary contraction (MVC) and habitual chewing (HC). Two-way ANOVA for repeated measures was applied to the data and the significance level was set at 5%. Results There was a decrease in the VAS values at T1 and T2 when compared with T0 values in the active TENS group (p<0.050). The PPT between-group differences were significant at T1 assessment of the anterior temporalis and sternocleidomastoid (SCM) and T2 for the masseter and the SCM (p<0.050). A significant EMG activity reduction of the masseter and anterior temporalis was presented in the active TENS during MR at T1 assessment when compared with T0 (p<0.050). The EMG activity of the anterior temporalis was significantly higher in the active TENS during MVC at T1 and T2 when compared with placebo (p<0.050). The EMG activity of the masseter and anterior temporalis muscle was significantly higher in the active TENS during HC at T1 when compared with placebo (p<0.050). Conclusions The short-term therapeutic effects of TENS are superior to those of the placebo, because of reported facial pain, deep pain sensitivity and masticatory muscle EMG activity improvement. PMID:28403351

Low and high-frequency TENS in post-episiotomy pain relief: a randomized, double-blind clinical trial.

PubMed

Pitangui, Ana C R; Araújo, Rodrigo C; Bezerra, Michelle J S; Ribeiro, Camila O; Nakano, Ana M S

2014-01-01

To evaluate the effectiveness of low-frequency TENS (LFT) and high-frequency TENS (HFT) in post-episiotomy pain relief. A randomized, controlled, double-blind clinical trial with placebo composed of 33 puerperae with post-episiotomy pain. TENS was applied for 30 minutes to groups: HFT(100 Hz; 100 µs), LFT (5 Hz; 100 µs), and placebo (PT). Four electrodes were placed in parallel near the episiotomy and four pain evaluations were performed with the numeric rating scale. The first and the second evaluation took place before TENS application and immediately after its removal and were done in the resting position and in the activities of sitting and ambulating. The third and fourth evaluation took place 30 and 60 minutes after TENS removal, only in the resting position. Intragroup differences were verified using the Friedman and Wilcoxon tests, and the intergroup analysis employed the Kruskal-Wallis test. In the intragroup analysis, there was no significant difference in the PT during rest, sitting, and ambulation (P>0.05). In the HFT and LFT, a significant difference was observed in all activities (P<0.001). In the intergroup analysis, there was a significant difference in the resting position in the HFT and LFT (P<0.001). In the sitting activity, a significant difference was verified in the second evaluation in the HFT and LFT (P<0.008). No significant difference was verified among the groups in ambulation (P<0.20). LFT and HFT are an effective resource that may be included in the routine of maternity wards.

A pilot randomized controlled trial of deprescribing.

PubMed

Beer, Christopher; Loh, Poh-Kooi; Peng, Yan Gee; Potter, Kathleen; Millar, Alasdair

2011-04-01

Polypharmacy and adverse drug reactions are frequent and important among older people. Few clinical trials have evaluated systematic withdrawal of medications among older people. This small, open, study was conducted to determine the feasibility of a randomized controlled deprescribing trial. Ten volunteers living in the community (recruited by media advertising) and 25 volunteers living in residential aged-care facilities (RCFs) were randomized to intervention or control groups. The intervention was gradual withdrawal of one target medication. The primary outcome was the number of intervention participants in whom medication withdrawal could be achieved. Other outcomes measures were quality of life, medication adherence, sleep quality, and cognitive impairment. Participants were aged 80 ± 11 years and were taking 9 ± 2 medications. Fifteen participants commenced medication withdrawal and all ceased or reduced the dose of their target medication. Two subjects withdrew; one was referred for clinical review, and one participant declined further dose reductions. A randomized controlled trial of deprescribing was acceptable to participants. Recruitment in RCFs is feasible. Definitive trials of deprescribing are required.

Alternating frequencies of transcutaneous electric nerve stimulation: does it produce greater analgesic effects on mechanical and thermal pain thresholds?

PubMed

Tong, K C; Lo, Sing Kai; Cheing, Gladys L

2007-10-01

To determine whether alternating frequency transcutaneous electric nerve stimulation (TENS) at 2 and 100Hz (2/100Hz) has a more potent hypoalgesic effect than a fixed frequency at 2 or 100Hz in healthy participants. A single-blind randomized controlled trial with a convenience sample. University physiotherapy department. Sixty-four healthy volunteers (32 men [mean age, 28.1+/-5.9y], 32 women [mean age, 27.7+/-5.6y]) were recruited and randomly divided into 4 groups. The 4 groups received TENS delivered at (1) 2Hz; (2) 100Hz; (3) 2/100Hz alternating frequency; and (4) no treatment (control group), respectively. Electric stimulation was applied over the anterior aspect of the dominant forearm for 30 minutes. Mechanical pain thresholds (MPTs) and heat pain thresholds (HPTs) were recorded before, during, and after TENS stimulation. The data were analyzed using linear mixed models, with group treated as a between-subject factor and time a within-subject factor. During and shortly after electric stimulation, HPT increased significantly in the alternating frequency stimulation group (P=.024). MPT increased significantly in both the 100Hz (P=.008) and the alternating frequency groups (P=.012), but the increase was substantially larger in the 100Hz group. Alternating frequency stimulation produced a greater elevation in the HPT, but a greater increase in the MPT was achieved using 100Hz stimulation.

Prevention of Mycobacterium avium subsp. paratuberculosis (MAP) Infection in BALB/c Mice by Feeding Probiotic Lactobacillus acidophilus NP-51

USDA-ARS?s Scientific Manuscript database

The objective of this study was to examine effects of feeding Lactobacillus acidophilus strain NP51 to mice challenged with Mycobacterium avium subspecies paratuberculosis (MAP). Mice were randomized to ten treatment groups; sentinels, control, heat-killed MAP, viable MAP, heat-killed NP51, viable ...

Prevention of Mycobacterium avium subsp. paratuberculosis (MAP) infection in BALB/c mice by feeding probiotic Lactobacillus acidophilus NP-51

USDA-ARS?s Scientific Manuscript database

The objective of this study was to examine effects of feeding Lactobacillus acidophilus strain NP51 to mice challenged with Mycobacterium avium subspecies paratuberculosis (MAP). Mice were randomized to ten treatment groups; sentinels, control, heat-killed MAP, viable MAP, heat-killed NP51, viable ...

The use of conventional transcutaneous electrical nerve stimulation in chronic facial myalgia patients.

PubMed

De Giorgi, Ilaria; Castroflorio, Tommaso; Sartoris, Barbara; Deregibus, Andrea

2017-01-01

The aim of this study was to evaluate the efficacy of conventional TENS in women affected by chronic facial myalgia. The study was performed on 49 women affected by chronic facial myalgia randomly allocated in the TENS group (34 women) and the control group (15 women). The subjective level of pain was assessed by the Visual Analogue Scale indicating the mean (VAS MEAN), the maximum (VAS MAX) and the current intensity of pain (VAS NOW). The level of pain at the muscular palpation sites was assessed by the Pericranial Muscle Tenderness Score (PTS) and the Cervical Muscle Tenderness Score (CTS). The TENS therapy lasted for 10 weeks, and data were collected at baseline, after 5, 10, 15 and 25 weeks. The differences between groups before and after treatment were compared with the Mann-Whitney and the Kolmogorov-Smirnov tests. The intra-group differences were compared with the one-way ANOVA test. The results showed that the VAS MEAN, VAS MAX, PTS and CTS were significantly reduced in the TENS group compared to the control group after 10 weeks of TENS (p < 0.05). The intra-group analysis revealed a decreasing tendency of VAS MEAN, VAS MAX, VAS NOW, PTS and CTS in the TENS group in a 25-week period (p < 0.05). The study demonstrated the efficacy of conventional TENS in patients with chronic facial myalgia and the decrease in both subjective and objective pain. Conventional TENS is a safe, non-invasive, easy-to-administer therapy for chronic facial myalgia.

Transcutaneous Electrical Nerve Stimulation Reduces Post-Thoractomy Ipsilateral Shoulder Pain. A Prospective Randomized Study.

PubMed

Esteban González, Pedro; Novoa, Nuria M; Varela, Gonzalo

2015-12-01

The patient's position during an axillary thoracotomy can cause postoperative pain and decrease mobility of the ipsilateral shoulder. In this study, we assessed whether the implementation of a standardized analgesia program using transcutaneous electrical nerve stimulation (TENS) decreases local pain and improves ipsilateral shoulder mobility. Randomized, single-blind, single-center clinical trial of 50 patients who had undergone anatomical lung resection via axillary muscle-sparing thoracotomy. Patients were treated with TENS devices for 30 minutes every 8 hours, beginning on postoperative day 1. Pain and mobility of the affected limb were recorded at the same time on postoperative days 1 through 3. A visual analogue scale was used for pain assessment and shoulder mobility was assessed with a goniometer. Results were compared using a non-parametric test. Twenty-five patients were randomized to each group. Mean age of the control group was 62.7±9.3 years and 63.4±10.2 years in the experimental group. Shoulder mobility parameters were similar in both groups on all postoperative days. However, pain during flexion significantly decreased on day 2 (P=.03) and day 3 (P=.04) in the experimental group. The use of TENS decreases pain from shoulder flexion in patients undergoing axillary thoracotomy for pulmonary resection. Copyright © 2014 SEPAR. Published by Elsevier Espana. All rights reserved.

Transcutaneous electrical nerve stimulation for postoperative pain relief after arthroscopic rotator cuff repair: a prospective double-blinded randomized trial.

PubMed

Mahure, Siddharth A; Rokito, Andrew S; Kwon, Young W

2017-09-01

Arthroscopic rotator cuff repair (ARCR) can be associated with significant postoperative pain. Concern for opioid abuse has led surgeons to identify alternative, efficacious methods of postoperative analgesia. To determine whether transcutaneous electrical nerve stimulation (TENS) can have a similarly beneficial effect after shoulder procedures, we conducted a prospective double-blinded randomized trial in patients undergoing outpatient ARCR. All patients undergoing ARCR of a full-thickness rotator cuff tear by the senior authors were identified. Patients with a history of recent narcotic use or prior narcotic abuse and those under management of a pain control specialist were excluded. Patients were randomized into 2 groups, active or placebo TENS, and used the device for 4 sessions/day for 45 minutes/session for the first postoperative week. All patients received Percocet 5/325 mg (oxycodone/acetaminophen) for use as rescue pain pills. One-week narcotic consumption and visual analog scale pain scores were compared between groups. The final analysis included 37 patients (21 active,16 placebo). Baseline and procedural differences were not different between groups. At 1 week postoperatively, patients in the active group had significantly lower pain scores (3.6 ± 2.1 vs. 5.8 ± 1.2; P= .008). Postoperative Percocet consumption during the initial 48 hours (12.8 ± 4.7 vs. 17.2 ± 6.3; P = .020) and during the first week (25.2 ± 9.9 vs. 33.8 ± 14.3; P = .037) was also significantly lower in the active group. Results from this prospective double-blinded randomized trial demonstrate that compared with placebo TENS, active TENS can result in significantly less pain and reduced opioid use in the immediate postoperative period after ARCR, suggesting that TENS may be potentially useful in a multimodal approach to managing postoperative pain. Copyright © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

Transcutaneous electrical nerve stimulation (TENS) improves the diabetic cytopathy (DCP) via up-regulation of CGRP and cAMP.

PubMed

Ding, Liucheng; Song, Tao; Yi, Chaoran; Huang, Yi; Yu, Wen; Ling, Lin; Dai, Yutian; Wei, Zhongqing

2013-01-01

The objective of this study was to investigate the effects and mechanism of Transcutaneous Electrical Nerve Stimulation (TENS) on the diabetic cytopathy (DCP) in the diabetic bladder. A total of 45 rats were randomly divided into diabetes mellitus (DM)/TENS group (n=15), DM group (n=15) and control group (n=15). The rats in the DM/TENS and TENS groups were electronically stimulated (stimulating parameters: intensity-31 V, frequency-31 Hz, and duration of stimulation of 15 min) for three weeks. Bladder histology, urodynamics and contractile responses to field stimulation and carbachol were determined. The expression of calcitonin gene-related peptide (CGRP) was analyzed by RT-PCR and Western blotting. The results showed that contractile responses of the DM rats were ameliorated after 3 weeks of TENS. Furthermore, TENS significantly increased bladder wet weight, volume threshold for micturition and reduced PVR, V% and cAMP content of the bladder. The mRNA and protein levels of CGRP in dorsal root ganglion (DRG) in the DM/TENS group were higher than those in the DM group. TENS also significantly up-regulated the cAMP content in the bladder body and base compared with diabetic rats. We conclude that TENS can significantly improve the urine contractility and ameliorate the feeling of bladder fullness in DM rats possibly via up-regulation of cAMP and CGRP in DRG.

Relationship of Muscular Strength on Work Performance in High School Students with Mental Retardation

ERIC Educational Resources Information Center

Smail, Karen M.; Horvat, Michael

2006-01-01

The relationship of muscular strength on work performance measures in high school students with mild mental retardation was investigated. Ten students from a self contained Special Education class were matched according to age, gender, height, and weight then randomly assigned to either the treatment group or control group. The treatment group…

Effects of the Paraphrasing Strategy on Expository Reading Comprehension of Young Adults with Intellectual Disability

ERIC Educational Resources Information Center

Hua, Youjia; Woods-Groves, Suzanne; Ford, Jeremy W.; Nobles, Kelly A.

2014-01-01

The purpose of the study was to investigate the effectiveness of teaching a three-step paraphrasing strategy on expository reading comprehension of young adults with intellectual disability. Ten learners from a postsecondary education program for individuals with disability participated in the study. They were randomly assigned to the control and…

Effects of the School-to-Work Group Method among Young People

ERIC Educational Resources Information Center

Koivisto, Petri; Vuori, Jukka; Nykyri, Elina

2007-01-01

This study examines effects of the School-to-Work Group Method among 17-25-year-old young people facing the transition from vocational college to work. After baseline measurement (N=416) participants were randomized into experimental and control groups. The results of ten month follow-up (N=334) showed notable beneficial impacts of the group…

Making Healthy Eating and Physical Activity Policy Practice: Process Evaluation of a Group Randomized Controlled Intervention in Afterschool Programs

ERIC Educational Resources Information Center

Weaver, R. Glenn; Beets, Michael W.; Hutto, Brent; Saunders, Ruth P.; Moore, Justin B.; Turner-McGrievy, Gabrielle; Huberty, Jennifer L.; Ward, Dianne S.; Pate, Russell R.; Beighle, Aaron; Freedman, Darcy

2015-01-01

This study describes the link between level of implementation and outcomes from an intervention to increase afterschool programs' (ASPs) achievement of healthy eating and physical activity (HE-PA) Standards. Ten intervention ASPs implemented the Strategies-To-Enhance-Practice (STEPs), a multi-component, adaptive intervention framework identifying…

Parkinson's Disease Is Associated with Goal Setting Deficits during Task Switching

ERIC Educational Resources Information Center

Meiran, Nachshon; Friedman, Gilad; Yehene, Eynat

2004-01-01

Ten Parkinson's Disease (PD) patients and 10 control participants were tested using a task-switching paradigm in which there was a random task sequence, and the task was cued in every trial. Five PD patients showed a unique error profile. Their performance approximated guessing when accuracy was dependent on correct task identification, and was…

Habit-based interventions for weight loss maintenance in adults with overweight and obesity: a randomized controlled trial.

PubMed

Cleo, Gina; Glasziou, Paul; Beller, Elaine; Isenring, Elisabeth; Thomas, Rae

2018-04-23

The objective of this study was to determine whether habit-based interventions are clinically beneficial in achieving long-term (12-month) weight loss maintenance and explore whether making new habits or breaking old habits is more effective. Volunteer community members aged 18-75 years who had overweight or obesity (BMI ≥ 25 kg/m 2 ) were randomized in a single-blind, three-arm, randomized controlled trial. Ten Top Tips (TTT), Do Something Different (DSD), and the attention-only waitlist (WL) control groups were conducted for 12 weeks from July to October 2015. Participants were followed up post-intervention (all groups) and at 6 and 12-month post-intervention (Ten Top Tips and Do Something Different only). The primary outcome was weight-loss maintenance at 12-month follow-up. Secondary outcomes included weight loss at all time points, fruit and vegetable consumption, exercise, wellbeing, depression, anxiety, habit strength, and openness to change. Of the 130 participants assessed for eligibility, 75 adults (mean BMI 34.5 kg/m 2 [SD 6.2]), with a mean age of 51 years were recruited. Assessments were completed post-intervention by 66/75 (88%) of participants and by 43/50 (86%) at 12 months. At post-intervention, participants in the Ten Top Tips (-3.3 kg; 95% CI -5.2, -1.4) and Do Something Different (-2.9 kg; 95% CI -4.3, -1.4) interventions lost significantly more weight (P = < .001) than those on the waitlist control (-0.4 kg; 95% CI -1.2, 0.3). Both intervention groups continued to lose further weight to the 12-month follow-up; TTT lost an additional -2.4 kg (95% CI -5.1, 0.4) and DSD lost -1.7 kg (95% CI -3.4, -0.1). At 12-month post-intervention, 28/43 (65%) of participants in both intervention groups had reduced their total body weight by ≥5%, a clinically important change. Habit-based weight-loss interventions-forming new habits (TTT) and breaking old habits (DSD), resulted in clinically important weight-loss maintenance at 12-month follow-up.

Percutaneous electrical nerve stimulation for low back pain: a randomized crossover study.

PubMed

Ghoname, E A; Craig, W F; White, P F; Ahmed, H E; Hamza, M A; Henderson, B N; Gajraj, N M; Huber, P J; Gatchel, R J

1999-03-03

Low back pain (LBP) contributes to considerable disability and lost wages in the United States. Commonly used opioid and nonopioid analgesic drugs produce adverse effects and are of limited long-term benefit in the management of this patient population. To compare the effectiveness of a novel nonpharmacologic pain therapy, percutaneous electrical nerve stimulation (PENS), with transcutaneous electrical nerve stimulation (TENS) and flexion-extension exercise therapies in patients with long-term LBP. A randomized, single-blinded, sham-controlled, crossover study from March 1997 to December 1997. An ambulatory pain management center at a university medical center. Twenty-nine men and 31 women with LBP secondary to degenerative disk disease. Four therapeutic modalities (sham-PENS, PENS, TENS, and exercise therapies) were each administered for a period of 30 minutes 3 times a week for 3 weeks. Pretreatment and posttreatment visual analog scale (VAS) scores for pain, physical activity, and quality of sleep; daily analgesic medication usage; a global patient assessment questionnaire; and Health Status Survey Short Form (SF-36). PENS was significantly more effective in decreasing VAS pain scores after each treatment than sham-PENS, TENS, and exercise therapies (after-treatment mean +/- SD VAS for pain, 3.4+/-1.4 cm, 5.5+/-1.9 cm, 5.6+/-1.9 cm, and 6.4+/-1.9 cm, respectively). The average +/- SD daily oral intake of nonopioid analgesics (2.6+/-1.4 pills per day) was decreased to 1.3+/-1.0 pills per day with PENS (P<.008) compared with 2.5+/-1.1, 2.2+/-1.0, and 2.6+/-1.2 pills per day with sham-PENS, TENS, and exercise, respectively. Compared with the other 3 modalities, 91 % of the patients reported that PENS was the most effective in decreasing their LBP. The PENS therapy was also significantly more effective in improving physical activity, quality of sleep, and sense of well-being (P<.05 for each). The SF-36 survey confirmed that PENS improved posttreatment function more than sham-PENS, TENS, and exercise. In this sham-controlled study, PENS was more effective than TENS or exercise therapy in providing short-term pain relief and improved physical function in patients with long-term LBP.

[Effects of radiation emitted from mobile phones on short- term heart rate variability parameters].

PubMed

Yıldız, Metin; Yılmaz, Derya; Güler, Inan; Akgüllü, Cağdaş

2012-08-01

In this study, the effects of radiation emitted from mobile phone (MP) on heart rate variability (HRV) which is accepted a non-invasive indicator of autonomic nervous system (ANS) were investigated with considering the deficiency of previous studies. A randomized controlled study has been designed and utilized with 30 young and healthy volunteers. During the experiment that had three periods, the electrocardiogram (ECG) and respiration signals were recorded and MP was attached to subjects' right ear with a bone. Ten subjects selected randomly were exposed to high -level radiation during the second period (Experimental Group 1). Ten of others were exposed during the third period with maximum level radiation (Experimental Group 2). Ten records were also made while MP was closed as a control. Short -term HRV parameters were obtained and repeated measures ANOVA and suitable post-hoc tests applied to the results. According to the results of the repeated measures ANOVA; there were no significant main effects of groups. However, there were some significant differences in measuring time periods and groups*period interactions. The post-hoc tests showed that mean R to R interval and HF power are significantly changed by maximum radiation emitted from MP. Due to the radiation emitted from MPs at maximum power, some changes may occur in HRV parameters that are associated with increased parasympathetic activity. But, the level of these changes is similar to daily activities as excitement, and stand up.

A Review of the Active Treatments for Toxic Epidermal Necrolysis.

PubMed

Kinoshita, Yuri; Saeki, Hidehisa

2017-01-01

Toxic epidermal necrolysis (TEN) is a severe adverse drug reaction associated with the separation of skin and mucous membranes at the dermal-epidermal junction. Although it is rare, many treatments have been trialed because of its high mortality rate. Active interventions performed to date include the use of systemic corticosteroids, intravenous immunoglobulins (IVIg), cyclosporine, plasmapheresis, anti-tumor necrosis factor drugs and N-acetylcysteine, but none has been established as the most effective therapy. IVIg and short-term high-dose corticosteroids were regarded as the most promising treatments for TEN in a comprehensive review of all reported TEN cases from 1975-2003. When used with an appropriate dose and timing, the beneficial effects of IVIg can be maximized. Although no randomized controlled trials have been conducted, cyclosporine and plasmapheresis are considered to be beneficial. As no gold standard for active intervention for TEN has been established, the choice of treatment relies partly on the available guidelines and the experience of the dermatologist. There is still much to be investigated regarding the pathogenesis of TEN, and new findings may contribute to the identification of an effective active intervention strategy.

Effectiveness of chemotherapy counselling on self-esteem and psychological affects among cancer patients in Malaysia: Randomized controlled trial.

PubMed

Mohd-Sidik, Sherina; Akhtari-Zavare, Mehrnoosh; Periasamy, Ummavathy; Rampal, Lekhraj; Fadhilah, Siti Irma; Mahmud, Rozi

2018-05-01

The aim of this study was to implement and evaluate the outcomes of chemotherapy counselling based on the "Managing Patients on Chemotherapy" module on self-esteem and psychological affect (anxiety, depression) of cancer patients by pharmacists in ten selected government hospitals in Peninsular Malaysia. A randomized control trial was conducted among 2120 cancer patients from April 2016 to January 2017 in ten selected government hospitals in Peninsular Malaysia. Cancer patients were randomly assigned to intervention and control groups. The intervention group received chemotherapy counselling by pharmacists based on the "Managing Patients on Chemotherapy" module. The outcomes were assessed at baseline, 1st, 2nd and 3rd follow-ups after counselling. In the course of data analysis; independent sample t-test, chi-square and two-way repeated measures ANOVA were conducted. Mean scores of self-esteem in the intervention group had significant difference in comparison with those of the control group in the 1st, 2nd and 3rd follow-ups after counselling (P < 0.0001). Also, among those with depression and anxiety at baseline, there was reduction in depression and anxiety scores after the 1st, 2nd and 3rd follow-ups after counselling (p < 0.05). Repetitive counselling by pharmacists based on the "Managing Patients on Chemotherapy" module had positive effect on improving self-esteem and psychological affect of cancer patients undergoing chemotherapy in Peninsular Malaysia. This module can be used for all Malaysian cancer patients undergoing chemotherapy to improving self-esteem and psychological affect. Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

Phase control and fast start-up of a magnetron using modulation of an addressable faceted cathode

DOE Office of Scientific and Technical Information (OSTI.GOV)

Browning, J., E-mail: JimBrowning@BoiseState.edu; Fernandez-Gutierrez, S.; Lin, M. C.

The use of an addressable, faceted cathode has been proposed as a method of modulating current injection in a magnetron to improve performance and control phase. To implement the controllable electron emission, five-sided and ten-sided faceted planar cathodes employing gated field emitters are considered as these emitters could be fabricated on flat substrates. For demonstration, the conformal finite-difference time-domain particle-in-cell simulation, as implemented in VORPAL, has been used to model a ten-cavity, rising sun magnetron using the modulated current sources and benchmarked against a typical continuous current source. For the modulated, ten-sided faceted cathode case, the electrons are injected frommore » three emitter elements on each of the ten facets. Each emitter is turned ON and OFF in sequence at the oscillating frequency with five emitters ON at one time to drive the five electron spokes of the π-mode. The emitter duty cycle is then 1/6th the Radio-Frequency (RF) period. Simulations show a fast start-up time as low as 35 ns for the modulated case compared to 100 ns for the continuous current cases. Analysis of the RF phase using the electron spoke locations and the RF magnetic field components shows that the phase is controlled for the modulated case while it is random, as typical, for the continuous current case. Active phase control during oscillation was demonstrated by shifting the phase of the electron injection 180° after oscillations started. The 180° phase shift time was approximately 25 RF cycles.« less

Continuous Practice-Based Research on the Use of Standardized Patients: Experience from Shanghai Medical College of Fudan University

ERIC Educational Resources Information Center

Zeng, Yong; Wu, Yan; Lai, Yanni; Lu, Yingqing; Zou, Hejian; Feng, Xueshan

2014-01-01

In the past ten years, the objective structured clinical examination (OSCE) project team of the Shanghai Medical College of Fudan University has continuously conducted further study on the development and maintenance of standardized patients and their application in teaching. The team carried out a series of randomized controlled studies on the…

Acupuncture in the management of chronic low back pain: a blinded randomized controlled trial.

PubMed

Kerr, Daniel P; Walsh, Deirdre M; Baxter, David

2003-01-01

To assess the efficacy of acupuncture in the treatment of chronic low back pain. Patients (n = 60) with chronic low back pain were recruited and randomly allocated to either Acupuncture therapy or Placebo transcutaneous electrical nerve stimulation (TENS) groups. Patients were treated weekly for 6 weeks, and blinded assessments were carried out pre- and post-treatment using the McGill Pain Questionnaire (MPQ) and visual analog scales (VAS) for pain, the Short-form 36 quality-of-life questionnaire, and a simple range of motion measurement. A total of 46 patients completed the trial and were followed up at 6 months. Analysis of results using t tests showed that in both groups there were significant pre-post improvements for all scores, except for MPQ scores in the Placebo-TENS group. There was no significant difference between the 2 groups for any of the outcome measures at the end of treatment. Results from the 6-month follow-up would suggest that the response was better in the acupuncture group. Further research is necessary to fully assess the efficacy of this treatment in combating chronic low back pain using larger sample sizes or alternative control groups.

Do antipsychotics lead to cognitive impairment in dementia? A meta-analysis of randomised placebo-controlled trials.

PubMed

Wolf, Alexander; Leucht, Stefan; Pajonk, Frank-Gerald

2017-04-01

Behavioural and psychological symptoms in dementia (BPSD) are common and often treated with antipsychotics, which are known to have small efficacy and to cause many side effects. One potential side effect might be cognitive decline. We searched MEDLINE, Scopus, CENTRAL and www.ClincalStudyResult.org for randomized, double-blind, placebo-controlled trials using antipsychotics for treating BPSD and evaluated cognitive functioning. The studies identified were summarized in a meta-analysis with the standardized mean difference (SMD, Hedges's g) as the effect size. Meta-regression was additionally performed to identify associated factors. Ten studies provided data on the course of cognitive functioning. The random effects model of the pooled analysis showed a not significant effect (SMD = -0.065, 95 % CI -0.186 to 0.057, I 2  = 41 %). Meta-regression revealed a significant correlation between cognitive impairment and treatment duration (R 2  = 0.78, p < 0.02) as well as baseline MMSE (R 2  = 0.92, p < 0.005). These correlations depend on only two out of ten studies and should interpret cautiously.

Antihypertensive effect of low-frequency transcutaneous electrical nerve stimulation (TENS) in comparison with drug treatment.

PubMed

Silverdal, Jonas; Mourtzinis, Georgios; Stener-Victorin, Elisabet; Mannheimer, Clas; Manhem, Karin

2012-10-01

Hypertension is a major risk factor for vascular disease, yet blood pressure (BP) control is unsatisfactory low, partly due to side-effects. Transcutaneous electrical nerve stimulation (TENS) is well tolerated and studies have demonstrated BP reduction. In this study, we compared the BP lowering effect of 2.5 mg felodipin once daily with 30 min of bidaily low-frequency TENS in 32 adult hypertensive subjects (mean office BP 152.7/90.0 mmHg) in a randomized, crossover design. Office BP and 24-h ambulatory BP monitoring (ABPM) were performed at baseline and at the end of each 4-week treatment and washout period. Felodipin reduced office BP by 10/6 mmHg (p <0.001 respectively) and after washout BP rose to a level still significantly lower than at baseline. TENS reduced office BP by 5/1.5 mmHg (p <0.01, ns). After TENS washout, BP was further reduced and significantly lower than at baseline, but at levels similar to BP after felodipin washout and therefore reasonably caused by factors other than the treatment per se. ABPM revealed a significant systolic reduction of 3 mmHg by felodipin, but no significant changes were noted after TENS. We conclude that our study does not present any solid evidence of BP reduction of TENS.

Transcutaneous electrical nerve stimulation (TENS) versus placebo for chronic low-back pain.

PubMed

Khadilkar, Amole; Odebiyi, Daniel Oluwafemi; Brosseau, Lucie; Wells, George A

2008-10-08

Transcutaneous electrical nerve stimulation (TENS) was introduced more than 30 years ago as a therapeutic adjunct to the pharmacological management of pain. However, despite widespread use, its effectiveness in chronic low-back pain (LBP) is still controversial. To determine whether TENS is more effective than placebo for the management of chronic LBP. The Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, PEDro and CINAHL were searched up to July 19, 2007. Only randomized controlled clinical trials (RCTs) comparing TENS to placebo in patients with chronic LBP were included. Two review authors independently selected the trials, assessed their methodological quality and extracted relevant data. If quantitative meta-analysis was not possible, a qualitative synthesis was performed, taking into consideration 5 levels of evidence as recommended by the Cochrane Collaboration Back Review Group. Four high-quality RCTs (585 patients) met the selection criteria. Clinical heterogeneity prevented the use of meta-analysis. Therefore, a qualitative synthesis was completed. There was conflicting evidence about whether TENS was beneficial in reducing back pain intensity and consistent evidence in two trials (410 patients) that it did not improve back-specific functional status. There was moderate evidence that work status and the use of medical services did not change with treatment. Conflicting results were obtained from two studies regarding generic health status, with one study showing no improvement on the modified Sickness Impact Profile and another study showing significant improvements on several, but not all subsections of the SF-36 questionnaire. Multiple physical outcome measures lacked statistically significant improvement relative to placebo. In general, patients treated with acupuncture-like TENS responded similarly to those treated with conventional TENS. However, in two of the trials, an inadequate stimulation intensity was used for acupuncture-like TENS, given that muscle twitching was not induced. Optimal treatment schedules could not be reliably determined based on the available data. Adverse effects included minor skin irritation at the site of electrode placement. At this time, the evidence from the small number of placebo-controlled trials does not support the use of TENS in the routine management of chronic LBP. Further research is encouraged.

Perceptive rehabilitation and trunk posture alignment in patients with Parkinson disease: a single blind randomized controlled trial.

PubMed

Morrone, Michelangelo; Miccinilli, Sandra; Bravi, Marco; Paolucci, Teresa; Melgari, Jean M; Salomone, Gaetano; Picelli, Alessandro; Spadini, Ennio; Ranavolo, Alberto; Saraceni, Vincenzo M; DI Lazzaro, Vincenzo; Sterzi, Silvia

2016-12-01

Recent studies aimed to evaluate the potential effects of perceptive rehabilitation in Parkinson Disease reporting promising preliminary results for postural balance and pain symptoms. To date, no randomized controlled trial was carried out to compare the effects of perceptive rehabilitation and conventional treatment in patients with Parkinson Disease. To evaluate whether a perceptive rehabilitation treatment could be more effective than a conventional physical therapy program in improving postural control and gait pattern in patients with Parkinson Disease. Single blind, randomized controlled trial. Department of Physical and Rehabilitation Medicine of a University Hospital. Twenty outpatients affected by idiopathic Parkinson Disease at Hoehn and Yahr stage ≤3. Recruited patients were divided into two groups: the first one underwent individual treatment with Surfaces for Perceptive Rehabilitation (Su-Per), consisting of rigid wood surfaces supporting deformable latex cones of various dimensions, and the second one received conventional group physical therapy treatment. Each patient underwent a training program consisting of ten, 45-minute sessions, three days a week for 4 consecutive weeks. Each subject was evaluated before treatment, immediately after treatment and at one month of follow-up, by an optoelectronic stereophotogrammetric system for gait and posture analysis, and by a computerized platform for stabilometric assessment. Kyphosis angle decreased after ten sessions of perceptive rehabilitation, thus showing a substantial difference with respect to the control group. No significant differences were found as for gait parameters (cadence, gait speed and stride length) within Su-Per group and between groups. Parameters of static and dynamic evaluation on stabilometric platform failed to demonstrate any statistically relevant difference both within-groups and between-groups. Perceptive training may help patients affected by Parkinson Disease into restoring a correct midline perception and, in turn, to improve postural control. Perceptive surfaces represent an alternative to conventional rehabilitation of postural disorders in Parkinson Disease. Further studies are needed to determine if the association of perceptive treatment and active motor training would be useful in improving also gait dexterity.

Meta-analysis of transcutaneous electrical nerve stimulation for relief of spinal pain.

PubMed

Resende, L; Merriwether, E; Rampazo, É P; Dailey, D; Embree, J; Deberg, J; Liebano, R E; Sluka, K A

2018-04-01

We conducted a systematic review and meta-analysis analysing the existing data on transcutaneous electrical nerve stimulation (TENS) or interferential current (IFC) for chronic low back pain (CLBP) and/or neck pain (CNP) taking into account intensity and timing of stimulation, examining pain, function and disability. Seven electronic databases were searched for TENS or IFC treatment in non-specific CLBP or CNP. Four reviewers independently selected randomized controlled trials (RCTs) of TENS or IFC intervention in adult individuals with non-specific CLBP or CNP. Primary outcomes were for self-reported pain intensity and back-specific disability. Two reviewers performed quality assessment, and two reviewers extracted data using a standardized form. Nine RCTs were selected (eight CLBP; one CNP), and seven studies with complete data sets were included for meta-analysis (655 participants). For CLBP, meta-analysis shows TENS/IFC intervention, independent of time of assessment, was significantly different from placebo/control (p < 0.02). TENS/IFC intervention was better than placebo/control, during therapy (p = 0.02), but not immediately after therapy (p = 0.08), or 1-3 months after therapy (p = 0.99). Analysis for adequate stimulation parameters was not significantly different, and there was no effect on disability. This systematic review provides inconclusive evidence of TENS benefits in low back pain patients because the quality of the studies was low, and adequate parameters and timing of assessment were not uniformly used or reported. Without additional high-quality clinical trials using sufficient sample sizes and adequate parameters and outcome assessments, the outcomes of this review are likely to remain unchanged. These data highlight the need for additional high-quality RCTs to examine the effects of TENS in CLBP. Trials should consider intensity of stimulation, timing of outcome assessment and assessment of pain, disability and function. © 2017 European Pain Federation - EFIC®.

The Role of Transcutaneous Electrical Nerve Stimulation in the Management of Temporomandibular Joint Disorder.

PubMed

Awan, Kamran Habib; Patil, Shankargouda

2015-12-01

Temporomandibular joint disorders (TMD) constitutes of a group of diseases that functionally affect the masticatory system, including the muscles of mastication and temporomandibular joint (TMJ). A number of etiologies with specific treatment have been identified, including the transcutaneous electrical nerve stimulation (TENS). The current paper presents a literature review on the use of TENS in the management of TMD patients. Temporomandibular joint disorder is very common disorder with approximately 75% of people showing some signs, while more than quarter (33%) having at least one symptom. An attempt to treat the pain should be made whenever possible. However, in cases with no defined etiology, starting with less intrusive and reversible techniques is prescribed. Transcutaneous electrical nerve stimulation is one such treatment modality, i.e. useful in the management of TMD. It comprises of controlled exposure of electrical current to the surface of skin, causing hyperactive muscles relaxation and decrease pain. Although the value of TENS to manage chronic pain in TMD patients is still controversial, its role in utilization for masticatory muscle pain is significant. However, an accurate diagnosis is essential to minimize its insufficient use. Well-controlled randomized trials are needed to determine the utilization of TENS in the management of TMD patients.

A controlled trial of transcutaneous electrical nerve stimulation (TENS) and exercise for chronic low back pain.

PubMed

Deyo, R A; Walsh, N E; Martin, D C; Schoenfeld, L S; Ramamurthy, S

1990-06-07

A number of treatments are widely prescribed for chronic back pain, but few have been rigorously evaluated. We examined the effectiveness of transcutaneous electrical nerve stimulation (TENS), a program of stretching exercises, or a combination of both for low back pain. Patients with chronic low back pain (median duration, 4.1 years) were randomly assigned to receive daily treatment with TENS (n = 36), sham TENS (n = 36), TENS plus a program of exercises (n = 37), or sham TENS plus exercises (n = 36). After one month no clinically or statistically significant treatment effect of TENS was found on any of 11 indicators of outcome measuring pain, function, and back flexion; there was no interactive effect of TENS with exercise. Overall improvement in pain indicators was 47 percent with TENS and 42 percent with sham TENS (P not significant). The 95 percent confidence intervals for group differences excluded a major clinical benefit of TENS for most outcomes. By contrast, after one month patients in the exercise groups had significant improvement in self-rated pain scores, reduction in the frequency of pain, and greater levels of activity as compared with patients in the groups that did not exercise. The mean reported improvement in pain scores was 52 percent in the exercise groups and 37 percent in the nonexercise groups (P = 0.02). Two months after the active intervention, however, most patients had discontinued the exercises, and the initial improvements were gone. We conclude that for patients with chronic low back pain, treatment with TENS is no more effective than treatment with a placebo, and TENS adds no apparent benefit to that of exercise alone.

The Impact of Life Skills Training on Behavior Problems in Left-Behind Children in Rural China: A Pilot Study

ERIC Educational Resources Information Center

Liu, Jia; Liu, Shan; Yan, Jin; Lee, Elizabeth; Mayes, Linda

2016-01-01

A randomized controlled experimental pilot study was conducted in order to investigate the effect of life skills training on behavior problems in left-behind children (LBC) in rural China. Sixty-eight LBC were recruited from a middle school in rural China. The intervention group took a ten-week-long life skills training course. The Child Behavior…

Efficacy of an Attachment-Based Intervention Model on Health Indices in Children with Chronic Disease and Their Mothers.

PubMed

Dehghani-Arani, Fateme; Besharat, Mohammad Ali; Fitton, Victoria A; Aghamohammadi, Asghar

2018-05-07

Studies have shown significant relationship between health conditions and attachment. This study aimed to examine an attachment-based intervention model named mother-child-disease triangle (MCDT) on health indices in children with chronic disease and their mothers. This randomized trial study included 22 volunteer children aged 12-18 years undergoing medical treatment for a chronic disease and their mothers. After evaluation by 28-form General Health Questionnaire (GHQ-28), inventory of parent and peer attachment (IPPA), 28-form Child Health Questionnaire (CHQ-28) and Illness Perception Questionnaire (IPQ), the mother-child dyads were paired on the basis of IPPA scores. These pairs were then randomly assigned to an experimental or control group. The experimental group received ten 90-min sessions of MCDT over a 7-week period. Meanwhile, the control group received ten simple conversational sessions as a dummy intervention. In accordance with this study's pre-test/post-test design, both groups were evaluated once again after completing their respective treatment. Multivariate analysis of covariance (MANCOVA) showed members of the experimental group to have significantly stronger attachment and better physiological and psychosocial health than those in the control group. These findings suggest that attachment-based interventions can be used to improve the effectiveness of treatment among children with chronic disease and their mothers.

Microcurrent transcutaneous electric nerve stimulation in painful diabetic neuropathy: a randomized placebo-controlled study.

PubMed

Gossrau, Gudrun; Wähner, Michael; Kuschke, Marion; Konrad, Birgit; Reichmann, Heinz; Wiedemann, Bärbel; Sabatowski, Rainer

2011-06-01

Diabetes is a common health care problem in western countries. Painful diabetic neuropathy (PDN) might be one of the consequences of long ongoing diabetes; it is estimated that approximately 20% of European diabetic patients suffer from PDN. Transcutaneous electrical nerve stimulation (TENS) is often used as additional pain treatment. However, recent studies show inconsistent results. We aimed to assess the effect of micro-TENS in reducing neuropathic pain in patients with PDN in a placebo-controlled, single-blinded, and randomized design. DESIGN/SETTING/PATIENTS/OUTCOME MEASURES: 22 diabetic patients have been treated with a micro-TENS therapy and 19 patients have been treated with a placebo therapy. Treatment duration was 4 weeks with three therapeutical settings per week. Standardized questionnaires (Pain Disability Index [PDI], neuropathic pain score [NPS], Center for Epidemiologic Studies Depression Scale [CES-D]) were used to assess pain intensity, pain disability, as well as quality of life at baseline at the end of the treatment period and 4 weeks after treatment termination. Patients with a minimum of 30% reduction in NPS were defined as therapy responders. After 4 weeks of treatment, 6/21 patients in the verum group vs 10/19 patients in the placebo group responded to therapy. The median PDI score after 4 weeks of treatment showed a reduction of 23% in the verum vs 25% in the placebo group. The differences did not reach statistical significance. The pain reduction with the applied transcutaneous electrotherapy regimen is not superior to a placebo treatment. Wiley Periodicals, Inc.

Randomized Trial of Treatment for Children with Sexual Behavior Problems: Ten-Year Follow-Up

ERIC Educational Resources Information Center

Carpentier, Melissa Y.; Silovsky, Jane F.; Chaffin, Mark

2006-01-01

This study prospectively follows 135 children 5-12 years of age with sexual behavior problems from a randomized trial comparing a 12-session group cognitive-behavioral therapy (CBT) with group play therapy and follows 156 general clinic children with nonsexual behavior problems. Ten-year follow-up data on future juvenile and adult arrests and…

Electrical stimulation of acupuncture points and blood pressure responses to postural changes: a pilot study.

PubMed

Jones, Alice Y M; Kwan, Y L; Leung, Nathan T F; Yu, Rachel P W; Wu, Cindy M Y; Warburton, Darren E R

2011-05-01

Application of transcutaneous electrical stimulation over acupuncture points (Acu-TENS) facilitates heart rate recovery after exercise and restores hemodynamic stability after open heart surgery. The role of Acu-TENS on cardiovascular parameters in response to postural changes has not been reported. To investigate (1) the effect of Acu-TENS on blood pressure responses to -10º head-down postural change and (2) whether such effects were associated with modulation by the autonomic nervous system. Sixteen healthy volunteers, mean age 22.8 (SD, 3.1) years, were subjected to a -10º head-down tilt from the supine position on 3 separate occasions and received in random order the following 3 intervention protocols for 40 minutes before the postural change: Acu-TENS (over bilateral acupuncture points, PC6), sham-TENS (TENS applied to the skin over the patellae), and control (no electrical output from the TENS device applied at PC6). Mean arterial pressure, large artery elasticity index, cardiac output, and heart rate were recorded and compared at different stimulation protocols in the supine and -10º head-down tilt positions. Spectral analysis of heart rate variability was used to determine any modulation by the autonomic nervous system. Change in large artery elasticity index was observed only in the Acu-TENS group (P < .05) and mean arterial pressure appeared most stable during Acu-TENS. Autonomic nervous system modulation was not apparent with spectral analysis, irrespective of intervention. Sympathetic activity predominated in all positions. Acu-TENS seems to reduce blood pressure changes with -10º head-down tilt with concomitant changes in arterial vessel tone.

Object permanence tests on gibbons (Hylobatidae).

PubMed

Fedor, Anna; Skollár, Gabriella; Szerencsy, Nóra; Ujhelyi, Mária

2008-11-01

Ten gibbons of various species (Symphalangus syndactylus, Hylobates lar, Nomascus gabriellae, and Nomascus leucogenys) were tested on object permanence tasks. Three identical wooden boxes, presented in a linear line, were used to hide pieces of food. The authors conducted single visible, single invisible, double invisible, and control displacements, in both random and nonrandom order. During invisible displacements, the experimenter hid the object in her hand before putting it into a box. The performance of gibbons was better than expected by chance in all the tests, except for the randomly ordered double displacement. However, individual analysis of performance showed great variability across subjects, and only 1 gibbon is assumed to have solved single visible and single invisible displacements without recourse to a strategy that the control test eliminated. (PsycINFO Database Record (c) 2008 APA, all rights reserved).

A comparative study of entrepreneurs and managers: stress, burnout, locus of control, and social support.

PubMed

Rahim, M A

1995-01-01

This study investigated the relationships of job stress to job burnout, of locus of control and social support to stress and burnout, and the moderating effects of locus of control and social support on the stress-burnout relationship. These relationships were tested with questionnaire data collected from a random sample of entrepreneurs (N = 238) and managers (N = 288). Results showed that entrepreneurs reported that they had higher internal locus of control, received less social support, and had less job burnout than managers. Hierarchical regression analyses found support for eight of the ten main effects and one of the four moderating effects.

Scattering (stochastic) recoupling of a coupled ten-stripe AlGaAs-GaAs-InGaAs quantum-well heterostructure laser

NASA Astrophysics Data System (ADS)

Kellogg, D. A.; Holonyak, N.

2001-04-01

Data are presented on coupled ten-stripe AlGaAs-GaAs-InGaAs quantum well heterostructure (QWH) lasers recoupled stochastically at the cleaved end mirrors. Recoupling of neighboring elements of a ten-stripe laser is accomplished by the scattering (random feedback) afforded by applying ˜10-μm-diam Al powder or 0.3 μm α-Al2O3 polishing compound in microscopy immersion oil or in epoxy at the cleaved ends (mirrors). Data on QWH samples with the end mirrors coated with the scatterer (Al or Al2O3 powder in "liquid") exhibit spectral and far-field broadening, as well as increased laser threshold because of the reduced cavity Q. Single mode operation is possible with the conventional evanescent wave coupling of the ten-stripe QWH and is destroyed, even the laser operation itself, with the scattering recoupling (dephasing) at the end mirrors, which is reversible (removable). The narrow ten-stripe QWH laser with strong end-mirror scattering, a long amplifier with random feedback, indicates that a photopumped III-V or II-VI powder (a random "wall" cavity) has little or no merit.

A randomized, controlled study of a healthy corner store initiative on the purchases of urban, low-income youth

PubMed Central

Lent, Michelle R.; Veur, Stephanie S. Vander; McCoy, Tara A.; Wojtanowski, Alexis C.; Sandoval, Brianna; Sherman, Sandy; Komaroff, Eugene; Foster, Gary D.

2014-01-01

Objective Although many initiatives exist to improve the availability of healthy foods in corner stores, few randomized trials have assessed their effects. This study evaluated, in a randomized, controlled trial, the effects of a first-generation healthy corner store intervention on students’ food and beverage purchases over a two-year period. Design and Methods Participants (n=767) were 4th-6th grade students. Ten schools and their nearby corner stores (n=24) were randomly assigned to the healthy corner store intervention or an assessment-only control. Intercept surveys directly assessed the nutritional characteristics of students’ corner store purchases at baseline, 1 and 2 years. Students’ weight and heights were measured at baseline, 1 and 2 years. Results There were no differences in energy content per intercept purchased from control or intervention schools at year 1 (p=0.12) or 2 (p=0.58). There were no differences between control and intervention students in BMI-z score (year 1, p=0.83; year 2, p=0. 98) or obesity prevalence (year 1, p=0.96; year 2, p=0.58). Conclusions A healthy corner store initiative did not result in significant changes in the energy content of corner store purchases or in continuous or categorical measures of obesity. These data will help to inform future interventions. PMID:25311881

Current randomized control trials, observational studies and meta analysis in off-pump coronary surgery.

PubMed

Parissis, Haralabos; Lau, Man Chi; Parissis, Mondrian; Lampridis, Savvas; Graham, Victoria; Al-Saudi, Reza; Mhandu, Peter

2015-12-17

The off-pump literature is divided into three eras: the "early phase" with results favouring off-pump surgery supported with randomized control trials (RCTs) mainly from Bristol, UK; an "intermediate phase" dominated by the results of the ROOBY trial and finally a more "contemporary phase" whereby the off/on-pump argument is unsettled. Although the literature has failed to project an overall superiority of off-pump versus on-pump surgery, nevertheless, small randomized control trials and large meta-analysis studies are concluding that the incidence of a stroke is less than 1 % when an aortic off-pump techniques (especially the non-touch technique) are advocated in patients with diseased ascending aorta. Furthermore, off-pump combined with hybrid procedures may lead to a reduction of adverse outcome in the aged high-risk population with concomitant poor left ventricular function and co-morbidities.The current review attempts to bring an insight onto the last ten years knowledge on the on/off-pump debate, with an aim to draw some clear conclusions in order to allow practitioners to reflect on the subject.

Effect of ice on pain after corticosteroid injection in the hand and wrist: a randomized controlled trial.

PubMed

An, T W; Boone, S L; Boyer, M I; Gelberman, R H; Osei, D A; Calfee, R P

2016-11-01

This prospective, randomized controlled study was designed to determine if applying ice to the site of corticosteroid injections in the hand and wrist reduces post-injection pain. Patients receiving corticosteroid injections in the hand or wrist at a tertiary institution were enrolled. Subjects were randomized to apply ice to the injection site and take scheduled over-the-counter analgesics ( n = 36) or take scheduled over-the-counter analgesics alone ( n = 32). There were no significant differences in the mean pain score between the two groups at any time-point (pre-injection or 1-5 days post-injection). In regression modelling, the application of ice did not predict pain after injection. Visual analogue pain scores increased at least 2 points (0-10 scale) after injection in 17 out of 36 patients in the ice group versus ten out of 32 control patients. We conclude that the application of ice in addition to over-the-counter analgesics does not reduce post-injection pain after corticosteroid injection in the hand or wrist. I Therapeutic Study.

Progressive Muscle Relaxation and Pain Perception in Abdominal Surgery Patients

DTIC Science & Technology

1989-05-01

Twenty-one females were randomly assigned to one of three treatment groups: dental splint and physiotherapy , a relaxation program, or a minimal...overall treatment effect was average weekly frequency of pain (F = 5.25, p < .05). The relaxation and dental physiotherapy groups reported lower pain...significantly less pain intensity than the control group (TENS), while the dental/ physiotherapy group reported significantly less frequency of pain than

Community-based control of Aedes aegypti by adoption of eco-health methods in Chennai City, India

PubMed Central

Arunachalam, Natarajan; Tyagi, Brij Kishore; Samuel, Miriam; Krishnamoorthi, R; Manavalan, R; Tewari, Satish Chandra; Ashokkumar, V; Kroeger, Axel; Sommerfeld, Johannes; Petzold, Max

2012-01-01

Background Dengue is highly endemic in Chennai city, South India, in spite of continuous vector control efforts. This intervention study was aimed at establishing the efficacy as well as the favouring and limiting factors relating to a community-based environmental intervention package to control the dengue vector Aedes aegypti. Methods A cluster randomized controlled trial was designed to measure the outcome of a new vector control package and process analysis; different data collection tools were used to determine the performance. Ten randomly selected intervention clusters (neighbourhoods with 100 houses each) were paired with ten control clusters on the basis of ecological/entomological indices and sociological parameters collected during baseline studies. In the intervention clusters, Aedes control was carried out using a community-based environmental management approach like provision of water container covers through community actors, clean-up campaigns, and dissemination of dengue information through schoolchildren. The main outcome measure was reduction in pupal indices (pupae per person index), used as a proxy measure of adult vectors, in the intervention clusters compared to the control clusters. Results At baseline, almost half the respondents did not know that dengue is serious but preventable, or that it is transmitted by mosquitoes. The stakeholder analysis showed that dengue vector control is carried out by vertically structured programmes of national, state, and local administrative bodies through fogging and larval control with temephos, without any involvement of community-based organizations, and that vector control efforts were conducted in an isolated and irregular way. The most productive container types for Aedes pupae were cement tanks, drums, and discarded containers. All ten intervention clusters with a total of 1000 houses and 4639 inhabitants received the intervention while the ten control clusters with a total of 1000 houses and 4439 inhabitants received only the routine government services and some of the information education and communication project materials. The follow-up studies showed that there was a substantial increase in dengue understanding in the intervention group with only minor knowledge changes in the control group. Community involvement and the partnership among stakeholders (particularly women’s self-help groups) worked well. After 10 months of intervention, the pupae per person index was significantly reduced to 0.004 pupae per person from 1.075 (P = 0.020) in the intervention clusters compared to control clusters. There were also significant reductions in the Stegomyia indices: the house index was reduced to 4.2%, the container index to 1.05%, and the Breteau index to 4.3 from the baseline values of 19.6, 8.91, and 30.8 in the intervention arm. Conclusion A community-based approach together with other stakeholders that promoted interventions to prevent dengue vector breeding led to a substantial reduction in dengue vector density. PMID:23318241

Community-based control of Aedes aegypti by adoption of eco-health methods in Chennai City, India.

PubMed

Arunachalam, Natarajan; Tyagi, Brij Kishore; Samuel, Miriam; Krishnamoorthi, R; Manavalan, R; Tewari, Satish Chandra; Ashokkumar, V; Kroeger, Axel; Sommerfeld, Johannes; Petzold, Max

2012-12-01

Dengue is highly endemic in Chennai city, South India, in spite of continuous vector control efforts. This intervention study was aimed at establishing the efficacy as well as the favouring and limiting factors relating to a community-based environmental intervention package to control the dengue vector Aedes aegypti. A cluster randomized controlled trial was designed to measure the outcome of a new vector control package and process analysis; different data collection tools were used to determine the performance. Ten randomly selected intervention clusters (neighbourhoods with 100 houses each) were paired with ten control clusters on the basis of ecological/entomological indices and sociological parameters collected during baseline studies. In the intervention clusters, Aedes control was carried out using a community-based environmental management approach like provision of water container covers through community actors, clean-up campaigns, and dissemination of dengue information through schoolchildren. The main outcome measure was reduction in pupal indices (pupae per person index), used as a proxy measure of adult vectors, in the intervention clusters compared to the control clusters. At baseline, almost half the respondents did not know that dengue is serious but preventable, or that it is transmitted by mosquitoes. The stakeholder analysis showed that dengue vector control is carried out by vertically structured programmes of national, state, and local administrative bodies through fogging and larval control with temephos, without any involvement of community-based organizations, and that vector control efforts were conducted in an isolated and irregular way. The most productive container types for Aedes pupae were cement tanks, drums, and discarded containers. All ten intervention clusters with a total of 1000 houses and 4639 inhabitants received the intervention while the ten control clusters with a total of 1000 houses and 4439 inhabitants received only the routine government services and some of the information education and communication project materials. The follow-up studies showed that there was a substantial increase in dengue understanding in the intervention group with only minor knowledge changes in the control group. Community involvement and the partnership among stakeholders (particularly women's self-help groups) worked well. After 10 months of intervention, the pupae per person index was significantly reduced to 0·004 pupae per person from 1·075 (P = 0·020) in the intervention clusters compared to control clusters. There were also significant reductions in the Stegomyia indices: the house index was reduced to 4·2%, the container index to 1·05%, and the Breteau index to 4·3 from the baseline values of 19·6, 8·91, and 30·8 in the intervention arm. A community-based approach together with other stakeholders that promoted interventions to prevent dengue vector breeding led to a substantial reduction in dengue vector density.

Feasibility study of Transcutaneous Electrical Nerve Stimulation (TENS) for cancer bone pain.

PubMed

Bennett, Michael I; Johnson, Mark I; Brown, Sarah R; Radford, Helen; Brown, Julia M; Searle, Robert D

2010-04-01

This multicenter study assessed the feasibility of conducting a phase III trial of transcutaneous electrical nerve stimulation (TENS) in patients with cancer bone pain recruited from palliative care services. Eligible patients received active and placebo TENS for 1 hour at site of pain in a randomized crossover design; median interval between applications 3 days. Responses assessed at 30 and 60 minutes included numerical and verbal ratings of pain at rest and on movement, and pain relief. Recruitment, tolerability, adverse events, and effectiveness of blinding were also evaluated. Twenty-four patients were randomised and 19 completed both applications. The intervention was well tolerated. Five patients withdrew: 3 due to deteriorating performance status, and 2 due to increased pain (1 each following active and placebo TENS). Confidence interval estimation around the differences in outcomes between active and placebo TENS suggests that TENS has the potential to decrease pain on movement more than pain on rest. Nine patients did not consider that a placebo was used; the remaining 10 correctly identified placebo TENS. Feasibility studies are important in palliative care prior to undertaking clinical trials. Our findings suggest that further work is required on recruitment strategies and refining the control arm before evaluating TENS in cancer bone pain. Cancer bone pain is common and severe, and partly mediated by hyperexcitability. Animal studies suggest that Transcutaneous Electrical Nerve Stimulation can reduce hyperalgesia. This study examined the feasibility of evaluating TENS in patients with cancer bone pain in order to optimize methods before a phase III trial. Copyright 2010 American Pain Society. Published by Elsevier Inc. All rights reserved.

High- and low-frequency transcutaneous electrical nerve stimulation does not reduce experimental pain in elderly individuals

PubMed Central

Bergeron-Vézina, Kayla; Corriveau, Hélène; Martel, Marylie; Harvey, Marie-Philippe; Léonard, Guillaume

2015-01-01

Abstract Despite its widespread clinical use, the efficacy of transcutaneous electrical nerve stimulation (TENS) remains poorly documented in elderly individuals. In this randomized, double-blind crossover study, we compared the efficacy of high-frequency (HF), low-frequency (LF), and placebo (P) TENS in a group of 15 elderly adults (mean age: 67 ± 5 years). The effect of HF-, LF-, and P-TENS was also evaluated in a group of 15 young individuals (26 ± 5 years; same study design) to validate the effectiveness of the TENS protocols that were used in the elderly group. Each participant came to the laboratory on 3 separate occasions to receive, in random order, HF-, LF-, and P-TENS. Pain intensity and pain perception thresholds were assessed before, during, and after TENS, using an experimental heat pain paradigm. For the young group, there was a significant decrease in pain intensity during and after HF- and LF-TENS when compared with baseline, with both HF- and LF-TENS being superior to P-TENS. In the older group, HF- and LF-TENS did not reduce pain when compared with baseline and no difference was observed between the 2 active TENS sessions and P-TENS. High-frequency, LF-, and P-TENS all increased pain thresholds in young individuals, whereas in older individuals, only LF-TENS increased pain thresholds. Taken together, these results suggest that TENS is effective in young, but not in older, individuals. Future studies should be conducted to confirm these results in pain populations and to identify strategies that could enhance the effect of TENS in the elderly. PMID:26101836

Associations of government health expenditures, the supply of health care professionals, and country literacy with prenatal care use in ten West African countries.

PubMed

Taylor, Yhenneko J; Laditka, Sarah B; Laditka, James N; Brunner Huber, Larissa R; Racine, Elizabeth F

2017-03-01

Social and health care context may influence prenatal care use. We studied associations of government health expenditures, supply of health care professionals, and country literacy rates with prenatal care use in ten West African countries, controlling for individual factors. We used data from Demographic and Health Surveys (n = 58,512) and random effect logistic regression models to estimate the likelihood of having any prenatal care and adequate prenatal care. Each percentage increase in the literacy rate was associated with 4% higher odds of having adequate prenatal care (p = .029). Higher literacy rates among women may help to promote adequate prenatal care.

Complementary approaches to decreasing discomfort during shockwave lithotripsy (SWL).

PubMed

Ngee-Ming, Goh; Tamsin, Drake; Rai, B P; Somani, B K

2014-06-01

Shock wave lithotripsy (SWL) is an established treatment for renal stones. Although non-invasive, it can cause significant pain and anxiety during the procedure. Our purpose was to review the literature to look at the effect of complimentary therapy in patients undergoing SWL and whether it led to a reduction in the requirement of analgesics and anxiolytics. A systematic review was performed on the use of acupuncture, auricular acupressure, transcutaneous electrical nerve stimulation (TENS) and music during SWL. Only prospective randomized controlled trials were selected. Two reviewers independently extracted the data from each study. Outcomes relating to analgesia requirement, anxiety and stone-free rates (SFR) were compared. Seven papers were identified reporting on 591 patients (acupuncture-3, TENS-1 and music-3). Pain control/analgesia requirement was significantly better in four studies (music-2, acupuncture-1, TENS-1). Significantly lower anxiety was noted in one study with music and two using acupuncture. No difference in SFR was noted with the use of complementary therapy. No major or minor side effects were noted. Complementary therapy for SWL can help lower analgesia requirement and the anxiety associated with it. However, it does not have any effect on the SFR.

Skin impedance is not a factor in transcutaneous electrical nerve stimulation effectiveness

PubMed Central

Vance, Carol GT; Rakel, Barbara A; Dailey, Dana L; Sluka, Kathleen A

2015-01-01

Objective Transcutaneous electrical nerve stimulation (TENS) is a nonpharmacological intervention used to manage pain using skin surface electrodes. Optimal electrode placement is unclear. We hypothesized that better analgesia would occur if electrodes were placed over sites with lower skin impedance. Optimal site selection (OSS) and sham site selection (SSS) electrode sites on the forearm were identified using a standard clinical technique. Methods Experiment 1 measured skin impedance in the forearm at OSS and SSS. Experiment 2 was a crossover design double-blind randomized controlled trial comparing OSS-TENS, SSS-TENS, and placebo TENS (P-TENS) to confirm differences in skin impedance between OSS and SSS, and measure change in pressure pain threshold (PPT) following a 30-minute TENS treatment. Healthy volunteers were recruited (ten for Experiment 1 [five male, five female] and 24 for Experiment 2 [12 male, 12 female]). TENS was applied for 30 minutes at 100 Hz frequency, 100 µs pulse duration, and “strong but nonpainful” amplitude. Results Experiment 1 results demonstrate significantly higher impedance at SSS (17.69±1.24 Ω) compared to OSS (13.53±0.57 Ω) (P=0.007). For Experiment 2, electrode site impedance was significantly higher over SSS, with both the impedance meter (P=0.001) and the TENS unit (P=0.012) compared to OSS. PPT change was significantly greater for both OSS-TENS (P=0.024) and SSS-TENS (P=0.025) when compared to P-TENS. PPT did not differ between the two active TENS treatments (P=0.81). Conclusion Skin impedance is lower at sites characterized as optimal using the described technique of electrode site selection. When TENS is applied at adequate intensities, skin impedance is not a factor in attainment of hypoalgesia of the forearm in healthy subjects. Further investigation should include testing in patients presenting with painful conditions. PMID:26316808

A telephonic mindfulness-based intervention for persons with sickle cell disease: study protocol for a randomized controlled trial.

PubMed

Williams, Hants; Silva, Susan; Simmons, Leigh Ann; Tanabe, Paula

2017-05-15

One of the most difficult symptoms for persons with sickle cell disease (SCD) to manage is chronic pain. Chronic pain impacts approximately one-third of persons with SCD and is associated with increased pain intensity, pain behavior, and frequency and duration of hospital visits. A promising category of nonpharmacological interventions for managing both physical and affective components of pain are mindfulness-based interventions (MBIs). The primary aim of this study is to conduct a randomized controlled study to evaluate the acceptability and feasibility, as well as to determine the preliminary efficacy, of a telephonic MBI for adults with SCD who have chronic pain. We will enroll 60 adult patients with SCD and chronic pain at an outpatient comprehensive SCD center in the southeastern United States. Patients will be randomized to either an MBI or a wait-listed control group. The MBI group will complete a six-session (60 minutes), telephonically delivered, group-based MBI program. The feasibility, acceptability, and efficacy of the MBI regarding pain catastrophizing will be assessed by administering questionnaires at baseline and weeks 1, 3, and 6. In addition, ten randomly selected MBI participants will complete semistructured interviews to help determine intervention acceptability. In this study protocol, we report detailed methods of the randomized controlled trial. Findings of this study will be useful to determine the acceptability, feasibility, and efficacy of an MBI for persons with SCD and chronic pain. ClinicalTrials.gov identifier: NCT02394587 . Registered on 9 February 2015.

Transcutaneous electrical nerve stimulation combined with task-related training improves lower limb functions in subjects with chronic stroke.

PubMed

Ng, Shamay S M; Hui-Chan, Christina W Y

2007-11-01

Previous studies have shown that repeated sensory inputs could enhance brain plasticity and cortical motor output. The purpose of this study was to investigate whether combining electrically induced sensory inputs through transcutaneous electrical nerve stimulation (TENS) with task-related training (TRT) in a home-based program would augment voluntary motor output in chronic stroke survivors better than either treatment alone or no treatment. Eighty-eight patients with stroke were assigned randomly to receive a home-based program of (1) TENS, (2) TENS+TRT, (3) placebo TENS+TRT, or (4) no treatment (control) 5 days a week for 4 weeks. Outcome measurements included Composite Spasticity Scale, peak torques generated during maximum isometric voluntary contraction of ankle dorsiflexors and plantarflexors, and gait velocity recorded at baseline, after 2 and 4 weeks of treatment, and 4 weeks after treatment ended. When compared with TENS, the combined TENS+TRT group showed significantly greater improvement in ankle dorsiflexion torque at follow-up and in ankle plantarflexion torque at week 2 and follow-up (P<0.01). When compared with placebo+TRT, the TENS+TRT group produced earlier and greater reduction of plantarflexor spasticity and improvement in ankle dorsiflexion torque at week 2 (P<0.01). When compared with all 3 groups, the TENS+TRT group showed significantly greater improvement in gait velocity (P<0.01). In patients with chronic stroke, 20 sessions of a combined TENS+TRT home-based program decreased plantarflexor spasticity, improved dorsiflexor and plantarflexor strength, and increased gait velocity significantly more than TENS alone, placebo+TRT, or no treatment. Such improvements can even be maintained 4 weeks after treatment ended.

Randomized clinical trial of bright light therapy for antepartum depression: preliminary findings.

PubMed

Epperson, C Neill; Terman, Michael; Terman, Jiuan Su; Hanusa, Barbara H; Oren, Dan A; Peindl, Kathleen S; Wisner, Katherine L

2004-03-01

Bright light therapy was shown to be a promising treatment for depression during pregnancy in a recent open-label study. In an extension of this work, we report findings from a double-blind placebo-controlled pilot study. Ten pregnant women with DSM-IV major depressive disorder were randomly assigned from April 2000 to January 2002 to a 5-week clinical trial with either a 7000 lux (active) or 500 lux (placebo) light box. At the end of the randomized controlled trial, subjects had the option of continuing in a 5-week extension phase. The Structured Interview Guide for the Hamilton Depression Scale-Seasonal Affective Disorder Version was administered to assess changes in clinical status. Salivary melatonin was used to index circadian rhythm phase for comparison with antidepressant results. Although there was a small mean group advantage of active treatment throughout the randomized controlled trial, it was not statistically significant. However, in the longer 10-week trial, the presence of active versus placebo light produced a clear treatment effect (p =.001) with an effect size (0.43) similar to that seen in antidepressant drug trials. Successful treatment with bright light was associated with phase advances of the melatonin rhythm. These findings provide additional evidence for an active effect of bright light therapy for antepartum depression and underscore the need for an expanded randomized clinical trial.

Disclosure of funding sources and conflicts of interest in phase III surgical trials: survey of ten general surgery journals.

PubMed

Bridoux, Valérie; Moutel, Grégoire; Schwarz, Lilian; Michot, Francis; Herve, Christian; Tuech, Jean-Jacques

2014-10-01

Discussions regarding disclosure of funding sources and conflicts of interest (COI) in published peer-reviewed journal articles are becoming increasingly more common and intense. The aim of the present study was to examine whether randomized controlled trials (RCTs) published in leading surgery journals report funding sources and COI. All articles reporting randomized controlled phase III trials published January 2005 through December 2010 were chosen for review from ten international journals. We evaluated the number of disclosed funding sources and COI, and the factors associated with such disclosures. From a review of 657 RCT from the ten journals, we discovered that presence or absence of a funding source and COI was disclosed by 47 % (309) and 25.1 % (165), respectively. Most articles in "International Committee of Medical Journal Editors (ICMJE)-affiliated journals" did not disclose COI. Disclosure of funding was associated with a journal impact factor >3 (51.7 vs 41.6 %; p < 0.01), statistician/epidemiologist involvement (64.2 vs 43.7 %; p < 0.001), publication after 2008 (52.9 vs 41.1 %; p < 0.01), and the journal being ICMJE-affiliated (49.3 vs 40 %; p < 0.05). Conflict of interest disclosure was associated with publication after 2008 (38.7 vs 11.3 %; p < 0.001), and with the journal not being affiliated with ICMJE (36.9 vs 21.3 %; p < 0.001). Of the published studies we investigated, over half did not disclose funding sources (i.e., whether or not there was a funding source), and almost three quarters did not disclose whether COI existed. Our findings suggest the need to adopt best current practices regarding disclosure of competing interests to fulfill responsibilities to readers and, ultimately, to patients.

Transcutaneous electrical nerve stimulation for postoperative pain control after total knee arthroplasty

PubMed Central

Li, Jifeng; Song, Yuze

2017-01-01

Abstract Background: This meta-analysis aimed to evaluate the efficiency and safety of transcutaneous electrical nerve stimulation (TENS) for pain control after total knee arthroplasty. Methods: A systematic search was performed in Medline (1966 to June 2017), PubMed (1966 to June 2017), Embase (1980 to June 2017), ScienceDirect (1985 to June 2017), and the Cochrane Library. Only randomized controlled trial (RCT) was included. The fixed/random effect model was used according to the heterogeneity tested by I2 statistic. Meta-analysis was performed using Stata 11.0 software. Results: Five RCTs including 472 patients met the inclusion criteria. The present meta-analysis indicated that there were significant differences between groups in terms of visual analogue scale score at 12 hours (average: 3.58 vs 4.34, SMD = −0.260, 95% CI: −0.442 to −0.078, P = .005), 24 hours (average: 3.18 vs 3.52, SMD = −0.244, 95% CI: −0.426 to −0.063, P = .008), and 48 hours (average: 2.70 vs 2.96, SMD = −0.214, 95% CI: −0.395 to −0.033, P = .021) after total knee arthroplasty. Significant differences were found regarding opioid consumption at 12 hours (average: 14.44 vs 18.54, SMD = −0.503, 95% CI: −0.687 to −0.319, P = .000), 24 hours (average: 16.10 vs 18.40, SMD = −0.262, 95% CI: −0.443 to −0.080, P = .005), and 48 hours (average: 12.92 vs 15.12, SMD = −0.183, 95% CI: −0.364 to −0.002, P = .048). Conclusion: TENS could significantly reduce pain and opioid consumption after total knee arthroplasty. In addition, there were fewer adverse effects in the TENS groups. Higher quality RCTs are required for further research. PMID:28906393

Virtual surgery simulation versus traditional approaches in training of residents in cervical pedicle screw placement.

PubMed

Hou, Yang; Shi, Jiangang; Lin, Yanping; Chen, Huajiang; Yuan, Wen

2018-06-01

The cervical screw placement is one of the most difficult procedures in spine surgery, which often needs a long period of repeated practices and could cause screw placement-related complications. We performed this cadaver study to investigate the effectiveness of virtual surgical training system (VSTS) on cervical pedicle screw instrumentation for residents. A total of ten novice residents were randomly assigned to two groups: the simulation training (ST) group (n = 5) and control group (n = 5). The ST group received a surgical training of cervical pedicle screw placement on VSTS and the control group was given an introductory teaching session before cadaver test. Ten fresh adult spine specimens including 6 males and 4 females were collected, and were randomly allocated to the two groups. The bilateral C3-C6 pedicle screw instrumentation was performed in the specimens of the two groups, respectively. After instrumentation, screw positions of the two groups were evaluated by image examinations. There was significantly statistical difference in screw penetration rates between the ST (10%) and control group (62.5%, P < 0.05). The acceptable rates of screws were 100 and 50% in the ST and control groups with significant difference between each other (P < 0.05). In addition, the average screw penetration distance in the ST group (1.12 ± 0.47 mm) was significantly lower than the control group (2.08 ± 0.39 mm, P < 0.05). This study demonstrated that the VSTS as an advanced training tool exhibited promising effects on improving performance of novice residents in cervical pedicle screw placement compared with the traditional teaching methods.

A randomized trial to determine the duration of analgesia following a 15- and a 30-minute application of acupuncture-like TENS on patients with chronic low back pain.

PubMed

Tousignant-Laflamme, Yannick; Laroche, Claudia; Beaulieu, Christine; Bouchard, Ann-Julie; Boucher, Sabrina; Michaud-Létourneau, Mélanie

2017-05-01

Acupuncture-like TENS (AL-TENS) has been shown to produce prolonged pain relief, but no study has yet investigated its duration on a population suffering from chronic low back pain (CLPB). Our objective was to quantify the duration and magnitude of analgesia induced by a 15- or 30-minute application of AL-TENS. We recruited a sample of 11 participants presenting with CLBP and conducted a randomized, crossover study, where participants were given AL-TENS for 15 and 30 minutes on two separate occasions. The pain intensity of their CLBP was assessed with a visual analogue scale before, during, and after AL-TENS applications. Magnitude and duration of analgesia were determined for each subject and for both AL-TENS application times. The AL-TENS applications induced a clinically and statistically significant (p = 0.003) analgesia in all participants. Median duration of analgesia was 9 hours and 10 hours 30 minutes following the 15- and 30-minute AL-TENS applications, respectively; this 1.5-hour difference was not statistically significant (p = 0.55). Furthermore, we observed no significant difference in the magnitude of analgesia between both applications of AL-TENS (p > 0.56), suggesting that the duration of application of AL-TENS does not influence the magnitude of analgesia. Our results suggest that clinicians could use a 15-minute AL-TENS application to provide significant analgesia in patients presenting with low back pain since if provides a comparable analgesia versus a 30-minute application.

Health effects of cow's milk consumption in infants up to 3 years of age: a systematic review and meta-analysis.

PubMed

Griebler, Ursula; Bruckmüller, Melanie U; Kien, Christina; Dieminger, Birgit; Meidlinger, Bettina; Seper, Katrin; Hitthaller, Ariane; Emprechtinger, Robert; Wolf, Alexandra; Gartlehner, Gerald

2016-02-01

To summarize the best available evidence regarding the short- and long-term health effects of cow's milk intake in healthy, full-term infants up to 3 years of age. We conducted a systematic review and meta-analysis. We searched MEDLINE (via PubMed), EMBASE and the Cochrane Library between 1960 and July 2013 and manually reviewed reference lists of pertinent articles. Two researchers independently reviewed abstracts and full-text articles and extracted relevant data. We included (randomized/non-randomized) controlled trials and observational studies. We included data from twenty-three studies (one randomized controlled trial, four non-randomized controlled trials, eight case-control studies and ten cohort studies) for the evidence synthesis. Pooled results of four studies revealed a higher risk of Fe-deficiency anaemia for infants consuming cow's milk compared with those consuming follow-on formula (relative risk=3·76; 95 % CI 2·73, 5·19). For type 1 diabetes mellitus, six out of seven case-control studies did not show a difference in the risk of developing this disease based on the age of introduction of cow's milk. We did not find negative associations for other health effects. Cow's milk consumption in infancy is associated with an increased risk of developing Fe-deficiency anaemia. Limiting cow's milk consumption may be important to ensure an adequate Fe intake for infants and toddlers. High-quality patient information for caregivers is needed on how infants' Fe requirements can be met.

Application of Early Nutrition Support in Neurosurgical Coma Patients.

PubMed

Ren, Guoqin

2015-12-01

The present study was conducted to investigate the clinical efficacy of early parenteral and enteral nutrition (PN + EN) support in neurosurgical coma patients. Eighty cases of neurosurgical coma patients were randomly divided into intervention group and control group. The intervention group received early PN + EN support, and the control group received only total enteral nutritional (TEN) support. The levels of hemoglobin (HGB), serum albumin (ALB), prealbumin (PA), and retinol-binding protein (RBP) in two groups on days 1, 10, and 20 were observed. The incidences of pneumonia, stress ulcer, abnormal liver function, abdominal distension, and diarrhea between two groups were also compared. Results found that, on day 10, compared with the control group, the levels of HGB, PA, and RBP in the intervention group were significantly increased (P < 0.05). On day 20, ALB in the intervention group significantly increased (P < 0.05), and the incidences of pneumonia, abdominal distension, and diarrhea in the intervention group were significantly lower than those in the control group (P < 0.05). Compared with only TEN support, early PN + EN support can obviously improve the nutritional status of neurosurgical coma patients and reduce the occurrence of complications.

Hyoscine N-Butylbromide for Preventing Propofol Injection Pain: A Randomized, Placebo-Controlled and Double-Blind Study

PubMed Central

Sargın, Mehmet; Uluer, Mehmet Selçuk; Aydoğan, Eyüp

2018-01-01

Objective In this study, the aim was to investigate the effect of hyoscine N-butylbromide (HnBB) pretreatment on pain during propofol injection. Subjects and Methods In this prospective, randomized, placebo-controlled and double-blind trial, 60 patients scheduled to undergo routine outpatient surgery under general anesthesia were randomly allocated to 2 groups, the HnBB (n = 30) and sodium chloride (n = 30) groups. Twenty seconds after the injection of 20 mg HnBB or 0.9 % sodium chloride, a 50-mg dose of propofol was injected in 2–3 s. Ten seconds later, the pain intensity was assessed using a 4-point scale: no pain (0), mild (1), moderate (2), and severe (3) pain. The Student t test was used for the analysis of parametric data and the Pearson χ2 test for categorical data. Results The occurrence of pain in the HnBB group (43.3%) was significantly lower than the control group (73.3%) (p < 0.018). Of the 30 patients in each group, 10 in the control group and 3 in the HnBB group experienced severe pain (p = 0.001). Conclusions Pretreatment with 20 mg HnBB significantly reduced propofol injection pain compared to placebo. PMID:29402789

Efficacy of cognitive behavioral internet-based therapy in parents after the loss of a child during pregnancy: pilot data from a randomized controlled trial.

PubMed

Kersting, Anette; Kroker, Kristin; Schlicht, Sarah; Baust, Katja; Wagner, Birgit

2011-12-01

The loss of a child during pregnancy can be a traumatic event associated with long-lasting grief and psychological distress. This study examined the efficacy of an internet-based cognitive behavioral therapy program for mothers after pregnancy loss. In a randomized controlled trial with a waiting list control group, 83 participants who had lost a child during pregnancy were randomly allocated either to 5 weeks of internet therapy or to a 5-week waiting condition. Within a manualized cognitive behavioral treatment program, participants wrote ten essays on loss-specific topics. Posttraumatic stress, grief, and general psychopathology, especially depression, were assessed pretreatment, posttreatment, and at 3-month follow-up. Intention-to-treat analyses and completer analyses were performed. Relative to controls, participants in the treatment group showed significant improvements in posttraumatic stress, grief, depression, and overall mental health, but not in anxiety or somatization. Medium to large effect sizes were observed, and the improvement was maintained at 3-month follow-up. This internet-based cognitive behavioral therapy program represents an effective treatment approach with stable effects for women after pregnancy loss. Implementation of the program can thus help to improve the health care provision for mothers in this traumatic loss situation.

No Influence of Transcutaneous Electrical Nerve Stimulation on Exercise-Induced Pain and 5-Km Cycling Time-Trial Performance

PubMed Central

Hibbert, Andrew W.; Billaut, François; Varley, Matthew C.; Polman, Remco C. J.

2017-01-01

Introduction: Afferent information from exercising muscle contributes to the sensation of exercise-induced muscle pain. Transcutaneous electrical nerve stimulation (TENS) delivers low–voltage electrical currents to the skin, inhibiting nociceptive afferent information. The use of TENS in reducing perceptions of exercise-induced pain has not yet been fully explored. This study aimed to investigate the effect of TENS on exercise-induced muscle pain, pacing strategy, and performance during a 5-km cycling time trial (TT). Methods: On three separate occasions, in a single-blind, randomized, and cross-over design, 13 recreationally active participants underwent a 30-min TENS protocol, before performing a 5-km cycling TT. TENS was applied to the quadriceps prior to exercise under the following conditions; control (CONT), placebo with sham TENS application (PLAC), and an experimental condition with TENS application (TENS). Quadriceps fatigue was assessed with magnetic femoral nerve stimulation assessing changes in potentiated quadriceps twitch force at baseline, pre and post exercise. Subjective scores of exertion, affect and pain were taken every 1-km. Results: During TTs, application of TENS did not influence pain perceptions (P = 0.68, ηp2 = 0.03). There was no significant change in mean power (P = 0.16, ηp2 = 0.16) or TT duration (P = 0.17, ηp2 = 0.14), although effect sizes were large for these two variables. Changes in power output were not significant but showed moderate effect sizes at 500-m (ηp2 = 0.10) and 750-m (ηp2 = 0.10). Muscle recruitment as inferred by electromyography data was not significant, but showed large effect sizes at 250-m (ηp2 = 0.16), 500-m (ηp2 = 0.15), and 750-m (ηp2 = 0.14). This indicates a possible effect for TENS influencing performance up to 1-km. Discussion: These findings do not support the use of TENS to improve 5-km TT performance. PMID:28223939

Effect of Unmodulated 5-kHz Alternating Currents Versus Transcutaneous Electrical Nerve Stimulation on Mechanical and Thermal Pain, Tactile Threshold, and Peripheral Nerve Conduction: A Double-Blind, Placebo-Controlled Crossover Trial.

PubMed

Avendaño-Coy, Juan; Gómez-Soriano, Julio; Goicoechea-García, Carlos; Basco-López, Julian Angel; Taylor, Julian

2017-05-01

To investigate the effect of unmodulated 5-kHz alternating current on mechanical pain threshold (MPT), heat pain threshold (HPT), tactile threshold (TT), and peripheral nerve conduction (PNC) compared with transcutaneous electrical nerve stimulation (TENS) and sham stimulation. National referral center. Randomized, double-blind, placebo-controlled crossover trial. Healthy volunteers (N=38). No dropouts or adverse events were reported. TENS, unmodulated 5-kHz currents, and sham stimulation were applied on the radial nerve for 20 minutes with a 24-hour washout period between them and concealed intervention allocation. Four measures were taken: before, during, and 2 after the interventions. Algometry was used to assess MPT, a Peltier thermode for HPT using the method of limits, Von Frey filaments for TT, and radial nerve compound action potential. No differences were observed on MPT, HPT, and PNC when 5-kHz current and TENS were compared. However, TT increased 56.2mN (95% confidence interval [CI], 28.8-83.6) in the TENS group compared with the 5-kHz current group during intervention. Compared with sham stimulation during intervention, MPT increased 4.7N (95% CI, 0.3-9.2) using 5-kHz current and 10.4N (95% CI, 3.5-17.3) with TENS. TT increased 17.2mN (95% CI, 4.7-29.7) with 5-kHz current and 73.4mN (95% CI, 47.5-99.2) with TENS. However, HPT increased 1.0°C (95% CI, 0.2-2.0) only with TENS. For the PNC, no differences were found among the 3 groups. Unmodulated 5-kHz current produced an increase in somatosensory thresholds that was greater than placebo but not when compared with TENS; however, participants perceived 5-kHz currents to be more comfortable and showed more habituation to them. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

46 CFR 161.012-13 - Production tests and inspections.

Code of Federal Regulations, 2010 CFR

2010-10-01

... ten lights from each lot of lights produced. Each lot must not exceed 1,000 lights. At least nine of the ten lights, when tested in accordance with the test described in § 161.012-11(c), must meet the... random sample of ten lights must be taken and tested. If less than nine of these lights meet the test...

The Effect of Transcutaneous Electrical Nerve Stimulation of Sympathetic Ganglions and Acupuncture Points on Distal Blood Flow.

PubMed

Kamali, Fahimeh; Mirkhani, Hossein; Nematollahi, Ahmadreza; Heidari, Saeed; Moosavi, Elahesadat; Mohamadi, Marzieh

2017-04-01

Transcutaneous electrical nerve stimulation (TENS) is a widely-practiced method to increase blood flow in clinical practice. The best location for stimulation to achieve optimal blood flow has not yet been determined. We compared the effect of TENS application at sympathetic ganglions and acupuncture points on blood flow in the foot of healthy individuals. Seventy-five healthy individuals were randomly assigned to three groups. The first group received cutaneous electrical stimulation at the thoracolumbar sympathetic ganglions. The second group received stimulation at acupuncture points. The third group received stimulation in the mid-calf area as a control group. Blood flow was recorded at time zero as baseline and every 3 minutes after baseline during stimulation, with a laser Doppler flow-meter. Individuals who received sympathetic ganglion stimulation showed significantly greater blood flow than those receiving acupuncture point stimulation or those in the control group (p<0.001). Data analysis revealed that blood flow at different times during stimulation increased significantly from time zero in each group. Therefore, the application of low-frequency TENS at the thoracolumbar sympathetic ganglions was more effective in increasing peripheral blood circulation than stimulation at acupuncture points. Copyright © 2017 Medical Association of Pharmacopuncture Institute. Published by Elsevier B.V. All rights reserved.

Expression of heat shock protein 72 in atrophied rat skeletal muscles

NASA Technical Reports Server (NTRS)

Oishi, Y.; Ishihara, A.; Talmadge, R. J.; Ohira, Y.; Taniguchi, K.; Matsumoto, H.; Roy, R. R.; Edgerton, V. R.

2001-01-01

Changes in the expression of heat shock protein 72 (HSP72) in response to atrophic-inducing perturbations of muscle involving chronic mechanical unloading and denervation were determined. Adult male Wistar rats were assigned randomly to a sedentary cage control (CON), hind limb unloading (HU, via tail suspension), HU plus tenotomy (HU + TEN), HU plus denervation (HU + DEN), or HU + TEN + DEN group. Tenotomy and DEN involved cutting the Achilles tendon and removing a segment of the sciatic nerve, respectively. After 5 days, HSP72 levels in the soleus of the HU + DEN and HU + TEN + DEN groups were 42 (P < 0.05) and 53% (P < 0.01) less than CON, respectively. Soleus weight decreased in both groups. Heat shock protein 72 levels in the plantaris of the HU + TEN, HU + DEN, and HU + TEN + DEN groups were 31, 25, and 30% lower than CON, respectively (P < 0.05). Plantaris weight decreased in the HU + DEN and HU + TEN + DEN, but not in the HU + TEN group. Hind limb unloading alone had little effect on the HSP72 level in either muscle. Reduced levels of HSP72 were associated with a decreased soleus (r=0.62, P < 0.01) and plantaris (r=0.78, P < 0.001) weight. These results indicate that the levels of HSP72 in both a slow and a fast rat plantarflexor are responsive to a chronic decrease in the levels of loading and/or activation and suggest that the neuromuscular activity level and the presence of innervation of a muscle are important factors that induce HSP72 expression.

Effects of experimental leg length discrepancies on body posture and dental occlusion.

PubMed

Maeda, Nozomi; Sakaguchi, Kiwamu; Mehta, Noshir R; Abdallah, Emad F; Forgione, Albert G; Yokoyama, Atsuro

2011-07-01

The purpose of this study was to quantitatively evaluate the effects of experimental leg length discrepancies on body posture and dental occlusion. Thirty asymptomatic subjects (15 males and 15 females, ages 19-33, mean age 25.6 years) were included in this study and randomly assigned to one of two groups based on a table of random numbers. The only difference between group A and group B was the sequence of testing. Experimental leg length discrepancies were provided by using ten types of insoles with heights ranging from one to ten mm at one mm intervals, placed under both feet. The MatScan (Nitta Corp., Osaka, Japan) system was used to measure changes in body posture (center of foot pressure: COP) while subjects maintained the following three postural positions: 1. natural standing posture (control); 2. control with a heel lift under the right foot; or 3. control with a heel lift under the left foot. The T-Scan II system (Nitta Corp., Osaka, Japan) was used to analyze the results of changes in dental occlusion (center of occlusal force: COF) in the above-mentioned three postural positions. When subjects used a heel lift of six mm or more under the right foot, lateral weight distribution (LWD) shifted to the right side compared to the control (p<0.05). When a heel lift of four mm or more was used under the left foot, LWD shifted to the left side compared to the control (p<0.05). When subjects used a heel lift of eight mm or more under the right foot, occlusal force shifted to the right side compared to the control (p<0.05). When subjects used a heel lift of seven mm or more under the left foot, occlusal force shifted to the left side compared to the control (p<0.05). Based on these findings, it was concluded that leg length discrepancy affected body posture and dental occlusion.

[Randomized, controlled clinical trials with observational follow-up investigations for evaluating efficacy of antihyperglycaemic treatment. II. Features of and lessons from the follow-up investigations].

PubMed

Jermendy, György

2018-04-01

Although the outcomes of the follow-up investigation period of the randomized clinical studies for evaluating the efficacy of a treatment or an antidiabetic drug may be confounded or potentially biased by several factors, the results are widely accepted by the diabetes community. In line with the theory of metabolic memory or metabolic legacy, early and intensive antihyperglycaemic treatment should be provided for all diabetic patients as this strategy can result in beneficial effects even in the long run. The recent cardiovascular safety trials with new, innovative antidiabetic drugs differ in several aspects from the former efficacy studies. Ten cardiovascular safety trials were completed so far enabling to define their unique and common features. It can be anticipated that the era of randomized, controlled efficacy studies with observational follow-up investigations came to an end in diabetes research. Nowadays, cardiovascular safety trials are in the focus of clinical research in diabetology and results of several ongoing studies are expected with interest in the near future. Orv Hetil. 2018; 159(16): 615-619.

Efficacy and safety of tolvaptan in heart failure patients with volume overload despite the standard treatment with conventional diuretics: a phase III, randomized, double-blind, placebo-controlled study (QUEST study).

PubMed

Matsuzaki, Masunori; Hori, Masatsugu; Izumi, Tohru; Fukunami, Masatake

2011-12-01

Diuretics are recommended to treat volume overload with heart failure (HF), however, they may cause serum electrolyte imbalance, limiting their use. Moreover, patients with advanced HF could poorly respond to these diuretics. In this study, we evaluated the efficacy and safety of Tolvaptan, a competitive vasopressin V2-receptor antagonist developed as a new drug to treat volume overload in HF patients. A phase III, multicenter, randomized, double-blind, placebo-controlled parallel study was performed to assess the efficacy and safety of tolvaptan in treating HF patients with volume overload despite the use of conventional diuretics. One hundred and ten patients were randomly assigned to receive either placebo or 15 mg/day tolvaptan for 7 consecutive days. Compared with placebo, tolvaptan administered for 7 days significantly reduced body weight and improved symptoms associated with volume overload. The safety profile of tolvaptan was considered acceptable for clinical use with minimal adverse effects. Tolvaptan reduced volume overload and improved congestive symptoms associated with HF by a potent water diuresis (aquaresis).

The New Portable Transcutaneous Electrical Nerve Stimulation Device Was Efficacious in the Control of Primary Dysmenorrhea Cramp Pain.

PubMed

Lauretti, Gabriela R; Oliveira, Raquel; Parada, Flavia; Mattos, Anita L

2015-08-01

Transcutaneous electrical nerve stimulation (TENS) is an established method for pain relief in dysmenorrhea. A feasible advantage would be the study of a portable device. The purpose of the study was to evaluate the effectiveness and safety of a new portable TENS device (TANYX®) for menstruation cramps. Forty women were evaluated in a double-blind, prospective, randomized fashion, divided into sham and active groups. TENS was applied medially at the suprapubic region, for 30-min duration at eight-hour intervals, up to seven days. The placebo group (PG) received sham device. The TENS group (TG) applied an active 85 Hz frequency TENS. Efficacy measures were pain relief evaluated on a visual analog scale (VAS) and diclofenac intake, and quality of life represented by: 1) capacity to get out of the bed, 2) food or drink intake, 3) missing routine daily activities such as work or school, and 4) quality of sleep. The active TENS device induced a prompt onset of pain relief in a strictly segmental manner nearby the dermatomes where the TENS was applied at the skin, and there was a drop in mean pain score from 8 to 2 cm (p < 0.001). Diclofenac consumption was also significantly reduced (p < 0.01), compared with the PG. Quality of life improved significantly in TG when compared with PG (p < 0.05). Three months after the beginning of the study, 14/20 of the women were still using the active device regularly. No adverse effects were observed. The portable, disposable, active TENS device induced a prompt onset of pain relief and improved the quality of life, without adverse effects, in patients with painful cramps associated with dysmenorrhea. © 2015 International Neuromodulation Society.

Transcutaneous electrical nerve stimulation attenuates CFA-induced hyperalgesia and inhibits spinal ERK1/2-COX-2 pathway activation in rats

PubMed Central

2013-01-01

Background Transcutaneous electrical nerve stimulation (TENS) is a non-pharmacologic treatment for pain relief. In previous animal studies, TENS effectively alleviated Complete Freund’s Adjuvant (CFA)- or carrageenan-induced inflammatory pain. Although TENS is known to produce analgesia via opioid activation in the brain and at the spinal level, few reports have investigated the signal transduction pathways mediated by TENS. Prior studies have verified the importance of the activation of extracellular signal-regulated kinase (ERK) signal transduction pathway in the spinal cord dorsal horn (SCDH) in acute and persistent inflammatory pains. Here, by using CFA rat model, we tested the efficacy of TENS on inhibiting the expressions of p-ERK1/2 and of its downstream cyclooxygenase-2 (COX-2) and the level of prostaglandin E2 (PGE2) at spinal level. Methods Rats were randomly divided into control, model and TENS groups, and injected subcutaneously with 100 μl CFA or saline in the plantar surface of right hind paw. Rats in the TENS group were treated with TENS (constant aquare wave, 2 Hz and 100 Hz alternating frequencies, intensities ranging from 1 to 2 mA, lasting for 30 min each time) at 5 h and 24 h after injection. Paw withdrawal thresholds (PWTs) were measured with dynamic plantar aesthesiometer at 3d before modeling and 5 h, 6 h, and 25 h after CFA injection. The ipsilateral sides of the lumbar spinal cord dosral horns were harvested for detecting the expressions of p-ERK1/2 and COX-2 by western blot analysis and qPCR, and PGE2 by ELISA. Results CFA-induced periphery inflammation decreased PWTs and increased paw volume of rats. TENS treatment significantly alleviated mechanical hyperalgesia caused by CFA. However, no anti-inflammatory effect of TENS was observed. Expression of p-ERK1/2 protein and COX-2 mRNA was significantly up-regualted at 5 h and 6 h after CFA injection, while COX-2 and PGE2 protein level only increased at 6 h after modeling. Furthermore, the high expression of p-ERK1/2 and COX-2, and over-production of PGE2 induced by CFA, were suppressed by TENS administration. Conclusions TENS may be an effective therapy in controlling inflammatory pain induced by CFA. Its analgesic effect may be associated with the inhibition of activation of the spinal ERK1/2-COX-2 pathway. PMID:23768044

Transcutaneous electrical nerve stimulation attenuates CFA-induced hyperalgesia and inhibits spinal ERK1/2-COX-2 pathway activation in rats.

PubMed

Fang, Jun-Fan; Liang, Yi; Du, Jun-Ying; Fang, Jian-Qiao

2013-06-15

Transcutaneous electrical nerve stimulation (TENS) is a non-pharmacologic treatment for pain relief. In previous animal studies, TENS effectively alleviated Complete Freund's Adjuvant (CFA)- or carrageenan-induced inflammatory pain. Although TENS is known to produce analgesia via opioid activation in the brain and at the spinal level, few reports have investigated the signal transduction pathways mediated by TENS. Prior studies have verified the importance of the activation of extracellular signal-regulated kinase (ERK) signal transduction pathway in the spinal cord dorsal horn (SCDH) in acute and persistent inflammatory pains. Here, by using CFA rat model, we tested the efficacy of TENS on inhibiting the expressions of p-ERK1/2 and of its downstream cyclooxygenase-2 (COX-2) and the level of prostaglandin E2 (PGE2) at spinal level. Rats were randomly divided into control, model and TENS groups, and injected subcutaneously with 100 μl CFA or saline in the plantar surface of right hind paw. Rats in the TENS group were treated with TENS (constant aquare wave, 2 Hz and 100 Hz alternating frequencies, intensities ranging from 1 to 2 mA, lasting for 30 min each time) at 5 h and 24 h after injection. Paw withdrawal thresholds (PWTs) were measured with dynamic plantar aesthesiometer at 3d before modeling and 5 h, 6 h, and 25 h after CFA injection. The ipsilateral sides of the lumbar spinal cord dosral horns were harvested for detecting the expressions of p-ERK1/2 and COX-2 by western blot analysis and qPCR, and PGE2 by ELISA. CFA-induced periphery inflammation decreased PWTs and increased paw volume of rats. TENS treatment significantly alleviated mechanical hyperalgesia caused by CFA. However, no anti-inflammatory effect of TENS was observed. Expression of p-ERK1/2 protein and COX-2 mRNA was significantly up-regualted at 5 h and 6 h after CFA injection, while COX-2 and PGE2 protein level only increased at 6 h after modeling. Furthermore, the high expression of p-ERK1/2 and COX-2, and over-production of PGE2 induced by CFA, were suppressed by TENS administration. TENS may be an effective therapy in controlling inflammatory pain induced by CFA. Its analgesic effect may be associated with the inhibition of activation of the spinal ERK1/2-COX-2 pathway.

Interventions for reducing fear of childbirth: A systematic review and meta-analysis of clinical trials.

PubMed

MoghaddamHosseini, Vahideh; Nazarzadeh, Milad; Jahanfar, Shayesteh

2017-11-07

Fear of childbirth is a problematic mental health issue during pregnancy. But, effective interventions to reduce this problem are not well understood. To examine effective interventions for reducing fear of childbirth. The Cochrane Central Register of Controlled Trials, PubMed, Embase and PsycINFO were searched since inception till September 2017 without any restriction. Randomised controlled trials and quasi-randomised controlled trials comparing interventions for treatment of fear of childbirth were included. The standardized mean differences were pooled using random and fixed effect models. The heterogeneity was determined using the Cochran's test and I 2 index and was further explored in meta-regression model and subgroup analyses. Ten studies inclusive of 3984 participants were included in the meta-analysis (2 quasi-randomized and 8 randomized clinical trials). Eight studies investigated education and two studies investigated hypnosis-based intervention. The pooled standardized mean differences of fear for the education intervention and hypnosis group in comparison with control group were -0.46 (95% CI -0.73 to -0.19) and -0.22 (95% CI -0.34 to -0.10), respectively. Both types of interventions were effective in reducing fear of childbirth; however our pooled results revealed that educational interventions may reduce fear with double the effect of hypnosis. Further large scale randomized clinical trials and individual patient data meta-analysis are warranted for assessing the association. Copyright © 2017 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.

ACT2 peer-driven intervention increases enrollment into HIV/AIDS medical studies among African-Americans/Blacks and Hispanics: A cluster randomized controlled trial

PubMed Central

Gwadz, Marya; Cleland, Charles M.; Belkin, Mindy; Ritchie, Amanda; Leonard, Noelle; Riedel, Marion; Banfield, Angela; Colon, Pablo; Elharrar, Vanessa; Kagan, Jonathan; Mildvan, Donna

2014-01-01

African American/Black and Hispanic persons living with HIV/AIDS (“AABH-PLHA”) are under-represented in HIV/AIDS medical studies (HAMS). This paper evaluates the efficacy of a social/behavioral intervention to increase rates of screening for and enrollment into HAMS in these populations. Participants (N=540) were enrolled into a cluster randomized controlled trial of an intervention designed to overcome multi-level barriers to HAMS. Primary endpoints were rates of screening for and enrollment into therapeutic/treatment-oriented and observational studies. Intervention arm participants were 30 times more likely to be screened than controls (49.3% vs. 3.7%; p < .001). Half (55.5%) of those screened were eligible for HAMS, primarily observational studies. Nine out of ten found eligible enrolled (91.7%), almost all into observational studies (95.2%), compared to no enrollments among controls. Achieving appropriate representation of AABH-PLHA in HAMS necessitates modification of study inclusion criteria to increase the proportion found eligible for therapeutic HAMS, in addition to social/behavioral interventions. PMID:24961193

Electrical stimulation for chronic non-specific low back pain in a working-age population: a 12-week double blinded randomized controlled trial.

PubMed

Thiese, Matthew S; Hughes, Matthew; Biggs, Jeremy

2013-03-28

Non-invasive electrotherapy is commonly used for treatment of chronic low back pain. Evidence for efficacy of most electrotherapy modalities is weak or lacking. This study aims to execute a high-quality, double-blinded randomized controlled clinical trial comparing 1) H-Wave(®) Device stimulation plus usual care with 2) transcutaneous electrical nerve stimulation (TENS) plus usual care, and 3) Sham electrotherapy plus usual care to determine comparative efficacy for treatment of chronic non-specific low back pain patients. Chronic non-specific low back pain patients between ages of 18-65 years, with pain of at least 3 months duration and minimal current 5/10 VAS pain. Patients will have no significant signs or symptoms of lumbosacral nerve impingement, malignancy, spinal stenosis, or mood disorders. Double blind RCT with 3 arms and 38 subjects per arm. Randomization by permuted blocks of random length, stratified by Workers Compensation claim (yes vs. no), and use of opioids. The null hypothesis of this study is that there are no statistically significant differences in functional improvement between treatment types during and at the end of a 12-week week treatment period. Subjective data will be collected using Filemaker Pro™ database management collection tools. Objective data will be obtained through functional assessments. Data will be collected at enrollment and at 1, 4, 8, and 12 weeks for each participant by a blinded assessor. H-Wave(®) device stimulation (Intervention A) plus usual care, transcutaneous electrical nerve stimulation (TENS) (Intervention B) plus usual care, and sham electrotherapy plus usual care (control). Each treatment arm will have identical numbers of visits (4) and researcher contact time (approximately 15 hours). Oswestry Disability Index. Secondary measures include: Rowland Morris Instrument, VAS pain score, functional evaluation including strength when pushing and pulling, pain free range of motion in flexion and extension. Outcome measures assessed at baseline, 1, 4, 8, and 12 weeks. Treatment failure will be defined if patient terminates assigned treatment arm for non-efficacy or undergoes invasive procedure or other excluded cointerventions. Data will be analyzed using intention-to-treat analysis and adjusted for covariates related to LBP (e.g. age) as needed. Study strengths include complex randomization, treatment group allocation concealment, double blinding, controlling for co-interventions, rigorous inclusion criteria, assessment of compliance, plans for limiting dropout, identical assessment methods and timing for each treatment arm, and planned intention-to-treat analyses.

Transcutaneous electric nerve stimulation over acupoints for chronic obstructive pulmonary disease: Protocol for a systematic review and meta-analysis.

PubMed

Wang, Jia-Jia; Xie, Yang; Zhao, Hu-Lei; Han, Wei-Hong; Wang, Xiao-Chun

2018-06-01

There is a limited evidence concerning the efficacy of transcutaneous electric nerve stimulation over acupoints (Acu-TENS) for chronic obstructive pulmonary disease (COPD). Thus, this review aims to systematically determine the effect of Acu-TENS on COPD. PubMed, Embase, The Cochrane Library, Web of Science, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, Chongqing VIP, and Wanfang Data will be searched from their inception to May 10, 2018. Randomized controlled trials that evaluated the effect of Acu-TENS on patients with COPD will be included. The primary outcome measures will include 6-minute walk distance and dyspnea visual analog scale scores. The secondary outcome measures will include lung function and St George's Respiratory Questionnaire. Study selection, data extraction, and risk of bias assessment will be independently undertaken, respectively. Statistical analysis will be conducted by RevMan software (version 5.3). This systematic review will provide a detailed summary of current evidences related to the efficacy of Acu-TENS in improving exercise capacity, breathlessness, quality of life, and lung function of patients with COPD. This evidence may be useful to clinicians, patients, and health policy makers with regard to the use of Acu-TENS in the treatment of COPD. This review will not gather original data; hence, ethical approval is not required. The results will be disseminated through a peer-reviewed publication or conference presentations.

Ripening of the cervix with prostaglandin E2-gel. A randomized study with a new ready-to-use compound of triacetin-prostaglandin-E2-gel.

PubMed

Kristoffersen, M; Sande, H A; Sande, O S

1986-08-01

A randomized study with a group of patients treated with a new ready-to-use triacetin-prostaglandin E2-gel compared to a non-treated group was conducted. The gel-treated group showed a distinct difference in cervical score after 12 h and ten patients were delivered during this period without further induction attempt compared to none in the control group. There was a significantly lower need for oxytocin stimulation in the treated group (P less than 0.0005), but there was no difference in the cesarean section rate or instrumental delivery rate. No side-effects were seen. This new gel seems effective and safe.

The effect of referral for genetic counseling on genetic testing and surgical prevention in women at high risk for ovarian cancer: Results from a randomized controlled trial.

PubMed

Drescher, Charles W; Beatty, J David; Resta, Robert; Andersen, M Robyn; Watabayashi, Kate; Thorpe, Jason; Hawley, Sarah; Purkey, Hannah; Chubak, Jessica; Hanson, Nancy; Buist, Diana S M; Urban, Nicole

2016-07-22

Guidelines recommend genetic counseling and testing for women who have a pedigree suggestive of an inherited susceptibility for ovarian cancer. The authors evaluated the effect of referral to genetic counseling on genetic testing and prophylactic oophorectomy in a randomized controlled trial. Data from an electronic mammography reporting system identified 12,919 women with a pedigree that included breast cancer, of whom 625 were identified who had a high risk for inherited susceptibility to ovarian cancer using a risk-assessment questionnaire. Of these, 458 women provided informed consent and were randomized 1:1 to intervention consisting of a genetic counseling referral (n = 228) or standard clinical care (n = 230). Participants were predominantly aged 45 to 65 years, and 30% and 20% reported a personal history of breast cancer or a family history of ovarian cancer, respectively. Eighty-five percent of women in the intervention group participated in a genetic counseling session. Genetic testing was reported by 74 (33%) and 20 (9%) women in the intervention and control arms (P < .005), respectively. Five women in the intervention arm and 2 in the control arm were identified as germline mutation carriers. Ten women in the intervention arm and 3 in the control arm underwent prophylactic bilateral salpingo-oophorectomy (P < .05). Routine referral of women at high risk for ovarian cancer to genetic counseling promotes genetic testing and prophylactic surgery. The findings from the current randomized controlled trial demonstrate the value of implementing strategies that target women at high risk for ovarian cancer to ensure they are offered access to recommended care. CA Cancer J Clin 2016. © 2016 American Cancer Society, Inc. © 2016 American Cancer Society.

Effects on Symptoms of Agitation and Depression in Persons With Dementia Participating in Robot-Assisted Activity: A Cluster-Randomized Controlled Trial.

PubMed

Jøranson, Nina; Pedersen, Ingeborg; Rokstad, Anne Marie Mork; Ihlebæk, Camilla

2015-10-01

To examine effects on symptoms of agitation and depression in nursing home residents with moderate to severe dementia participating in a robot-assisted group activity with the robot seal Paro. A cluster-randomized controlled trial. Ten nursing home units were randomized to either robot-assisted intervention or a control group with treatment as usual during 3 intervention periods from 2013 to 2014. Ten adapted units in nursing homes in 3 counties in eastern Norway. Sixty residents (67% women, age range 62-95 years) in adapted nursing home units with a dementia diagnosis or cognitive impairment (Mini-Mental State Examination score lower than 25/30). Group sessions with Paro took place in a separate room at nursing homes for 30 minutes twice a week over the course of 12 weeks. Local nurses were trained to conduct the intervention. Participants were scored on baseline measures (T0) assessing cognitive status, regular medication, agitation (BARS), and depression (CSDD). The data collection was repeated at end of intervention (T1) and at follow-up (3 months after end of intervention) (T2). Mixed models were used to test treatment and time effects. Statistically significant differences in changes were found on agitation and depression between groups from T0 to T2. Although the symptoms of the intervention group declined, the control group's symptoms developed in the opposite direction. Agitation showed an effect estimate of -5.51, CI 0.06-10.97, P = .048, and depression -3.88, CI 0.43-7.33, P = .028. There were no significant differences in changes on either agitation or depression between groups from T0 to T1. This study found a long-term effect on depression and agitation by using Paro in activity groups for elderly with dementia in nursing homes. Paro might be a suitable nonpharmacological treatment for neuropsychiatric symptoms and should be considered as a useful tool in clinical practice. Copyright © 2015 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

Decreasing Inappropriate Use of Antibiotics in Primary Care in Four Countries in South America—Cluster Randomized Controlled Trial

PubMed Central

Urbiztondo, Inés; Caballero, Lidia; Suarez, Miguel Angel; Olinisky, Monica

2017-01-01

High antibiotic prescribing and antimicrobial resistance in patients attending primary care have been reported in South America. Very few interventions targeting general practitioners (GPs) to decrease inappropriate antibiotic prescribing have been investigated in this region. This study assessed the effectiveness of online feedback on reducing antibiotic prescribing in patients with suspected respiratory tract infections (RTIs) attending primary care. The aim was to reduce antibiotic prescribing in patients with acute bronchitis and acute otitis media. Both are RTIs for which antibiotics have a very limited effect. A cluster randomized two-arm control trial was implemented. Healthcare centres from Bolivia, Argentina, Paraguay and Uruguay participating in the quality improvement program HAPPY AUDIT were randomly allocated to either intervention or control group. During ten consecutive weeks, GPs in the intervention group received evidence-based online feedback on the management of suspected RTIs. In patients with acute bronchitis, the intervention reduced the antibiotic prescribing rate from 71.6% to 56% (control group from 61.2% to 52%). In patients with acute otitis media, the intervention reduced the antibiotic prescribing from 94.8% to 86.2% (no change in the control group). In all RTIs, the intervention reduced antibiotic prescribing rate from 37.4% to 28.1% (control group from 29% to 27.2%). Online evidence-based feedback is effective for reducing antibiotic prescribing in patients with RTIs attending primary care in South America. PMID:29240687

Efficacy of Selected Electrical Therapies on Chronic Low Back Pain: A Comparative Clinical Pilot Study.

PubMed

Rajfur, Joanna; Pasternok, Małgorzata; Rajfur, Katarzyna; Walewicz, Karolina; Fras, Beata; Bolach, Bartosz; Dymarek, Robert; Rosinczuk, Joanna; Halski, Tomasz; Taradaj, Jakub

2017-01-07

BACKGROUND In the currently available research publications on electrical therapy of low back pain, generally no control groups or detailed randomization were used, and such studies were often conducted with relatively small groups of patients, based solely on subjective questionnaires and pain assessment scales (lacking measurement methods to objectify the therapeutic progress). The available literature also lacks a comprehensive and large-scale clinical study. The purpose of this study was to assess the effects of treating low back pain using selected electrotherapy methods. The study assesses the influence of individual electrotherapeutic treatments on reduction of pain, improvement of the range of movement in lower section of the spine, and improvement of motor functions and mobility. MATERIAL AND METHODS The 127 patients qualified for the therapy (ultimately, 123 patients completed the study) and assigned to 6 comparison groups: A - conventional TENS, B - acupuncture-like TENS, C - high-voltage electrical stimulation, D - interferential current stimulation, E - diadynamic current, and F - control group. RESULTS The research showed that using electrical stimulation with interferential current penetrating deeper into the tissues results in a significant and more efficient elimination of pain, and an improvement of functional ability of patients suffering from low back pain on the basis of an analysis of both subjective and objective parameters. The TENS currents and high voltage were helpful, but not as effective. The use of diadynamic currents appears to be useless. CONCLUSIONS Selected electrical therapies (interferential current, TENS, and high voltage) appear to be effective in treating chronic low back pain.

Efficacy of Selected Electrical Therapies on Chronic Low Back Pain: A Comparative Clinical Pilot Study

PubMed Central

Rajfur, Joanna; Pasternok, Małgorzata; Rajfur, Katarzyna; Walewicz, Karolina; Fras, Beata; Bolach, Bartosz; Dymarek, Robert; Rosinczuk, Joanna; Halski, Tomasz; Taradaj, Jakub

2017-01-01

Background In the currently available research publications on electrical therapy of low back pain, generally no control groups or detailed randomization were used, and such studies were often conducted with relatively small groups of patients, based solely on subjective questionnaires and pain assessment scales (lacking measurement methods to objectify the therapeutic progress). The available literature also lacks a comprehensive and large-scale clinical study. The purpose of this study was to assess the effects of treating low back pain using selected electrotherapy methods. The study assesses the influence of individual electrotherapeutic treatments on reduction of pain, improvement of the range of movement in lower section of the spine, and improvement of motor functions and mobility. Material/Methods The 127 patients qualified for the therapy (ultimately, 123 patients completed the study) and assigned to 6 comparison groups: A – conventional TENS, B – acupuncture-like TENS, C – high-voltage electrical stimulation, D – interferential current stimulation, E – diadynamic current, and F – control group. Results The research showed that using electrical stimulation with interferential current penetrating deeper into the tissues results in a significant and more efficient elimination of pain, and an improvement of functional ability of patients suffering from low back pain on the basis of an analysis of both subjective and objective parameters. The TENS currents and high voltage were helpful, but not as effective. The use of diadynamic currents appears to be useless. Conclusions Selected electrical therapies (interferential current, TENS, and high voltage) appear to be effective in treating chronic low back pain. PMID:28062862

Effect of Transcutaneous Electrical Nerve Stimulation on Plantar Flexor Muscle Spasticity and Walking Speed in Stroke Patients.

PubMed

Laddha, Darshan; Ganesh, G Shankar; Pattnaik, Monalisa; Mohanty, Patitapaban; Mishra, Chittaranjan

2016-12-01

Spasticity is a major disabling symptom in patients post stroke. Although studies have demonstrated that transcutaneous electrical nerve stimulation (TENS) can reduce spasticity, the duration of single session TENS is a subject of debate. The purpose of this study was to determine the sustainability of the effects of TENS applied over common peroneal nerve in the reduction of ankle plantar-flexor spasticity and improving gait speed in patients post stroke. Thirty patients (11 women and 19 men) (mean age of 46.46 years) were randomly assigned to group 1 (task oriented exercises), group 2 (TENS for 30 min and task oriented exercises) and group 3 (TENS for 60 min and task oriented exercises) for a period of five sessions per week for 6 weeks. All patients were assessed for ankle plantar-flexor spasticity, passive ankle dorsi-flexion range of motion, clonus and timed up and go test at the time of recruitment to study, at 3 and 6 weeks of therapeutic intervention. The overall results of the study suggest that there was a decrease in ankle plantar flexor spasticity, ankle clonus and timed up and go score in all the groups. A greater reduction of spasticity was seen in TENS groups (groups 2 and 3) when compared to control. No significant improvement was found in timed up and go test (TUG) scores between groups. Both 30 min and 60 min of application of TENS are effective in reducing spasticity of ankle plantar flexors, improving walking ability and increase the effectiveness of task related training. Based on the effect size, we would recommend a longer duration application for the reduction of spasticity. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Improving the diagnosis and treatment of osteoporosis using a senior-friendly peer-led community education and mentoring model: a randomized controlled trial

PubMed Central

Kloseck, Marita; Fitzsimmons, Deborah A; Speechley, Mark; Savundranayagam, Marie Y; Crilly, Richard G

2017-01-01

Background This randomized controlled trial (RCT) evaluated a 6-month peer-led community education and mentorship program to improve the diagnosis and management of osteoporosis. Methods Ten seniors (74–90 years of age) were trained to become peer educators and mentors and deliver the intervention. In the subsequent RCT, 105 seniors (mean age =80.5±6.9; 89% female) were randomly assigned to the peer-led education and mentorship program (n=53) or control group (n=52). Knowledge was assessed at baseline and 6 months. Success was defined as discussing osteoporosis risk with their family physician, obtaining a bone mineral density assessment, and returning to review their risk profile and receive advice and/or treatment. Results Knowledge of osteoporosis did not change significantly. There was no difference in knowledge change between the two groups (mean difference =1.3, 95% confidence interval [CI] of difference −0.76 to 3.36). More participants in the intervention group achieved a successful outcome (odds ratio 0.16, 95% CI 0.06–0.42, P<0.001). Conclusion Peer-led education and mentorship can promote positive health behavior in seniors. This model was effective for improving osteoporosis risk assessment, diagnosis, and treatment in a community setting. PMID:28553091

Improving the diagnosis and treatment of osteoporosis using a senior-friendly peer-led community education and mentoring model: a randomized controlled trial.

PubMed

Kloseck, Marita; Fitzsimmons, Deborah A; Speechley, Mark; Savundranayagam, Marie Y; Crilly, Richard G

2017-01-01

This randomized controlled trial (RCT) evaluated a 6-month peer-led community education and mentorship program to improve the diagnosis and management of osteoporosis. Ten seniors (74-90 years of age) were trained to become peer educators and mentors and deliver the intervention. In the subsequent RCT, 105 seniors (mean age =80.5±6.9; 89% female) were randomly assigned to the peer-led education and mentorship program (n=53) or control group (n=52). Knowledge was assessed at baseline and 6 months. Success was defined as discussing osteoporosis risk with their family physician, obtaining a bone mineral density assessment, and returning to review their risk profile and receive advice and/or treatment. Knowledge of osteoporosis did not change significantly. There was no difference in knowledge change between the two groups (mean difference =1.3, 95% confidence interval [CI] of difference -0.76 to 3.36). More participants in the intervention group achieved a successful outcome (odds ratio 0.16, 95% CI 0.06-0.42, P <0.001). Peer-led education and mentorship can promote positive health behavior in seniors. This model was effective for improving osteoporosis risk assessment, diagnosis, and treatment in a community setting.

Random fiber laser based on artificially controlled backscattering fibers.

PubMed

Wang, Xiaoliang; Chen, Daru; Li, Haitao; She, Lijuan; Wu, Qiong

2018-01-10

The random fiber laser (RFL), which is a milestone in laser physics and nonlinear optics, has attracted considerable attention recently. Most previously reported RFLs are based on distributed feedback of Rayleigh scattering amplified through the stimulated Raman-Brillouin scattering effect in single-mode fibers, which require long-distance (tens of kilometers) single-mode fibers and high threshold, up to watt level, due to the extremely small Rayleigh scattering coefficient of the fiber. We proposed and demonstrated a half-open-cavity RFL based on a segment of an artificially controlled backscattering single-mode fiber with a length of 210 m, 310 m, or 390 m. A fiber Bragg grating with a central wavelength of 1530 nm and a segment of artificially controlled backscattering single-mode fiber fabricated by using a femtosecond laser form the half-open cavity. The proposed RFL achieves thresholds of 25 mW, 30 mW, and 30 mW, respectively. Random lasing at a wavelength of 1530 nm and extinction ratio of 50 dB is achieved when a segment of 5 m erbium-doped fiber is pumped by a 980 nm laser diode in the RFL. A novel RFL with many short cavities has been achieved with low threshold.

Mechanisms for an effect of acetylcysteine on renal function after exposure to radio-graphic contrast material: study protocol.

PubMed

Sandilands, Euan A; Cameron, Sharon; Paterson, Frances; Donaldson, Sam; Briody, Lesley; Crowe, Jane; Donnelly, Julie; Thompson, Adrian; Johnston, Neil R; Mackenzie, Ivor; Uren, Neal; Goddard, Jane; Webb, David J; Megson, Ian L; Bateman, Nicholas; Eddleston, Michael

2012-02-03

Contrast-induced nephropathy is a common complication of contrast administration in patients with chronic kidney disease and diabetes. Its pathophysiology is not well understood; similarly the role of intravenous or oral acetylcysteine is unclear. Randomized controlled trials to date have been conducted without detailed knowledge of the effect of acetylcysteine on renal function. We are conducting a detailed mechanistic study of acetylcysteine on normal and impaired kidneys, both with and without contrast. This information would guide the choice of dose, route, and appropriate outcome measure for future clinical trials in patients with chronic kidney disease. We designed a 4-part study. We have set up randomised controlled cross-over studies to assess the effect of intravenous (50 mg/kg/hr for 2 hrs before contrast exposure, then 20 mg/kg/hr for 5 hrs) or oral acetylcysteine (1200 mg twice daily for 2 days, starting the day before contrast exposure) on renal function in normal and diseased kidneys, and normal kidneys exposed to contrast. We have also set up a parallel-group randomized controlled trial to assess the effect of intravenous or oral acetylcysteine on patients with chronic kidney disease stage III undergoing elective coronary angiography. The primary outcome is change in renal blood flow; secondary outcomes include change in glomerular filtration rate, tubular function, urinary proteins, and oxidative balance. Contrast-induced nephropathy represents a significant source of hospital morbidity and mortality. Over the last ten years, acetylcysteine has been administered prior to contrast to reduce the risk of contrast-induced nephropathy. Randomized controlled trials, however, have not reliably demonstrated renoprotection; a recent large randomized controlled trial assessing a dose of oral acetylcysteine selected without mechanistic insight did not reduce the incidence of contrast-induced nephropathy. Our study should reveal the mechanism of effect of acetylcysteine on renal function and identify an appropriate route for future dose response studies and in time randomized controlled trials. Clinical Trials.gov: NCT00558142; EudraCT: 2006-003509-18.

[Does transcutaneous electrical nerve stimulation or therapeutic ultrasound increase the effectiveness of exercise for knee osteoarthritis: a randomized controlled study].

PubMed

Eyigör, Sibel; Karapolat, Hale; Ibisoğlu, Uğur; Durmaz, Berrin

2008-01-01

The aim of this study was to determine if transcutaneous electrical nerve stimulation (TENS) or therapeutic ultrasound (US) increase the effectiveness of exercise on pain, function, muscle strength and quality of life for knee osteoarthritis (OA). Forty-five patients with primary knee OA diagnosis according to American College Rheumatology criteria were sequentially divided into 3 random groups. The patients in group 1 received TENS (with superficial heat and exercise), group 2 received US (with superficial heat and exercise), and group 3 acted as controls (superficial heat and exercise). Outcome measures were included as visual analog scale (VAS), a 20-meter walking test, Lequesne index, WOMAC scores, isokinetic muscle testing, and the Short Form 36 (SF 36). All treatment groups, physical modalities were carried out for a total fifteen sessions. All of the patients were subjected to six weeks of exercise program. All of the treatment groups had significant improvement on activity VAS, 20 meter walking test, Lequesne index, WOMAC scores, and most of the sub-scores of SF36 when compared with their initial status (p<0.05). All of the treatment groups, a significant muscle strength gain in most of the angular velocity in knee extensor PT values after the treatment (p<0.05). However there was no statistically significant difference after the treatment between the all treatment groups (p>0.05). All of the treatment groups were effective on pain, function, muscle strength and quality of life in patients with knee OA. Statistically significant differences could not be found between the treatment groups. The exercise program, as it is cheaper, more easily performed and efficient, may be preferable for the treatment of knee OA. It is difficult to say, TENS or US could increase the effectiveness of isokinetic exercise for pain, function, muscle strength and quality of life of knee OA in this study.

Clinical evaluation of seven anticalculus dentifrice formulations.

PubMed

Scruggs, R R; Stewart, P W; Samuels, M S; Stamm, J W

1991-01-01

One hundred ninety-two subjects completed a clinical trial to determine the effects of seven dentifrice formulations on calculus inhibition. The double-blind study involved a ten-day control phase and a ten-day experimental phase. For the control phase, subjects were evaluated for calculus present, received a prophylaxis and had pre-weighed mylar strips attached to the lingual surfaces of the mandibular incisors to harvest mineral deposits. Subjects were then assigned the placebo dentifrice for unsupervised twice-daily use and were required to report once a day for a supervised mouthrinse using a 1:3 dilution of the dentrifice. The experimental phase was identical except that subjects were allocated the experimental dentifices using a stratified random assignment based on age, gender and the initial presence of calculus. Simple linear regression analyses of the dry and ash log weights obtained from the strips were performed. The results showed no statistically significant differences among the test products; however, two formulations containing zinc citrate showed some calculus inhibition-potential suggesting that further research and development of such products may be warranted.

Music and 25% glucose pain relief for the premature infant: a randomized clinical trial.

PubMed

Cardoso, Maria Vera Lúcia Moreira Leitão; Farias, Leiliane Martins; de Melo, Gleicia Martins

2014-10-01

To analyze the total Premature Infant Pain Profile scores of premature infants undergoing arterial puncture during music and 25% glucose interventions, and to assess their association with neonatal and therapeutic variables. A randomized clinical trial with 80 premature infants; 24 in the Experimental Group 1 (music), 33 in the Experimental Group 2 (music and 25% glucose), 23 in the Positive Control Group (25% glucose). All premature infants were videotaped and a lullaby was played for ten minutes before puncture in Experimental Groups 1 and 2; 25% glucose administered in Experimental Group 2 and the Positive Control Group two minutes before puncture. 60.0% of premature infants had moderate or maximum pain; pain scores and intervention groups were not statistically significant. Statistically significant variables: Experimental Group 1: head and chest circumference, Apgar scores, corrected gestational age; Experimental Group 2: chest circumference, Apgar scores, oxygen therapy; Positive Control group: birth weight, head circumference. Neonatal variables are associated with pain in premature infants. Brazilian Registry of Clinical Trials: UTN: U1111-1123-4821.

Group Counseling With Emotionally Disturbed School Children in Taiwan.

ERIC Educational Resources Information Center

Chiu, Peter

The application of group counseling to emotionally disturbed school children in Chinese culture was examined. Two junior high schools located in Tao-Yuan Province were randomly selected with two eighth-grade classes randomly selected from each school. Ten emotionally disturbed students were chosen from each class and randomly assigned to two…

Novel Noxipoint Therapy versus Conventional Physical Therapy for Chronic Neck and Shoulder Pain: Multicentre Randomised Controlled Trials

PubMed Central

Koo, Charles C.; Lin, Ray S.; Wang, Tyng-Guey; Tsauo, Jau-Yih; Yang, Pan-Chyr; Yen, Chen-Tung; Biswal, Sandip

2015-01-01

As chronic pain affects 115 million people and costs $600B annually in the US alone, effective noninvasive nonpharmacological remedies are desirable. The purpose of this study was to determine the efficacy and the generalisability of Noxipoint therapy (NT), a novel electrotherapy characterised by site-specific stimulation, intensity-and-submodality-specific settings and a immobilization period, for chronic neck and shoulder pain. Ninety-seven heavily pretreated severe chronic neck/shoulder pain patients were recruited; 34 and 44 patients were randomly allocated to different treatment arms in two patient-and-assessor-blinded, randomised controlled studies. The participants received NT or conventional physical therapy including transcutaneous electrical nerve stimulation (PT-TENS) for three to six 90-minute sessions. In Study One, NT improved chronic pain (−89.6%, Brief Pain Inventory, p < 0.0001, 95% confidence interval), function (+77.4%, range of motion) and quality of life (+88.1%) at follow-up (from 4 weeks to 5 months), whereas PT-TENS resulted in no significant changes in these parameters. Study Two demonstrated similar advantages of NT over PT-TENS and the generalisability of NT. NT-like treatments in a randomised rat study showed a similar reduction in chronic hypersensitivity (−81%, p < 0.01) compared with sham treatments. NT substantially reduces chronic neck and shoulder pain, restores function, and improves quality of life in a sustained manner. PMID:26552835

Evaluation of an exercise concept focusing on eccentric strength training of the rotator cuff for patients with subacromial impingement syndrome.

PubMed

Bernhardsson, Susanne; Klintberg, Ingrid Hultenheim; Wendt, Gunilla Kjellby

2011-01-01

To evaluate the effect on pain intensity and function of an exercise concept focusing on specific eccentric strength training of the rotator cuff in patients with subacromial impingement syndrome. Single-subject research design with baseline and treatment phases (AB design). Home-based training programme supervised and supported by visits to physiotherapy clinic. Ten patients, mean (SD) age 54 (8.6) years, symptom duration 12 (9.1) months. Daily eccentric strengthening exercises of the rotator cuff during 12 weeks. Pain intensity, assessed with a visual analogue scale, and function, using the Patient-Specific Functional Scale. Shoulder function evaluated with the Constant score, and shoulder-related quality of life evaluated with the Western Ontario Rotator Cuff Index. Pain intensity decreased significantly in eight of the ten subjects. Function improved significantly in all ten subjects. Constant score increased in nine subjects and Western Ontario Rotator Cuff Index increased in seven subjects. Mean Constant score for the whole group increased significantly from 44 to 69 points (P = 0.008). Mean Western Ontario Rotator Cuff Index increased from 51 to 71% (P = 0.021). A 12-week eccentric strengthening programme targeting the rotator cuff and incorporating scapular control and correct movement pattern can be effective in decreasing pain and increasing function in patients with subacromial impingement syndrome. A randomized controlled trial is necessary to provide stronger evidence of the method.

Promoting healthful family meals to prevent obesity: HOME Plus, a randomized controlled trial.

PubMed

Fulkerson, Jayne A; Friend, Sarah; Flattum, Colleen; Horning, Melissa; Draxten, Michelle; Neumark-Sztainer, Dianne; Gurvich, Olga; Story, Mary; Garwick, Ann; Kubik, Martha Y

2015-12-15

Family meal frequency has been shown to be strongly associated with better dietary intake; however, associations with weight status have been mixed. Family meals-focused randomized controlled trials with weight outcomes have not been previously conducted. Therefore, this study purpose was to describe weight-related outcomes of the HOME Plus study, the first family meals-focused randomized controlled trial to prevent excess weight gain among youth. Families (n = 160 8-12-year-old children and their parents/guardians) were randomized to intervention (n = 81) or control (n = 79) groups. Data were collected at baseline (2011-2012), post-intervention (12-months post-baseline) and follow-up (21-months post-baseline). The intervention included ten monthly group sessions (nutrition education; hands-on meal and snack planning, preparation, and skill development; screen time reductions) and five motivational, goal-setting phone calls. The main outcome was child body mass index (BMI) z-score. General linear models, adjusted for baseline values and demographics, showed no significant treatment group differences in BMI z-scores at post-intervention or follow-up; however, a promising reduction in excess weight gain was observed. Post-hoc stratification by pubertal onset indicated prepubescent children in the intervention group had significantly lower BMI z-scores than their control group counterparts. The study used a strong theoretical framework, rigorous design, quality measurement and a program with high fidelity to test a family meals-focused obesity prevention intervention. It showed a modest decrease in excess weight gain. The significant intervention effect among prepubescent children suggests the intervention may be more efficacious among relatively young children, although more research with appropriately powered samples are needed to replicate this finding. This study is registered at www.clinicaltrials.gov NCT01538615. Registered 01/17/2012.

Efficacy, Tolerability, and Safety of Blonanserin in Schizophrenia: An Updated and Extended Systematic Review and Meta-Analysis of Randomized Controlled Trials.

PubMed

Kishi, Taro; Matsui, Yuki; Matsuda, Yuki; Katsuki, Asuka; Hori, Hikaru; Yanagimoto, Hiroko; Sanada, Kenji; Morita, Kiichiro; Yoshimura, Reiji; Shoji, Yoshihisa; Hagi, Katsuhiko; Iwata, Nakao

2018-03-07

We conducted an updated systematic review and meta-analysis of randomized controlled trials (RCTs) comparing blonanserin with other antipsychotics (amisulpride, aripiprazole, haloperidol, paliperidone, and risperidone). Weighted mean difference (WMD), risk ratio, and number needed to harm (NNH) with 95% confidence intervals (95% CIs) were calculated using random-effects model. Ten RCTs (n = 1521) were included in this study. Blonanserin was superior to aripiprazole in improvement of Positive and Negative Syndrome Scale total scores (WMD = -10.62, 95% CI = -17.67 to -3.560, p = 0.003). Blonanserin was associated with a higher incidence of all-cause discontinuation (RR = 1.373, 95% CI = 1.088-1.734, p = 0.008, NNH = 11), akathisia, extrapyramidal disorder, and agitation/excitement and a lower risk of hyperprolactinemia compared with risperidone + paliperidone. The current meta-analytic study did not update the comparison of blonanserin vs. haloperidol because there were no new RCTs. Our results suggest that the efficacy of blonanserin for schizophrenia is comparable with that of other antipsychotics, and blonanserin seems to be well tolerated. © Georg Thieme Verlag KG Stuttgart · New York.

Abbreviated closure for remote damage control laparotomy in extreme environments: A randomized trial of sutures versus wound clamps comparing terrestrial and weightless conditions.

PubMed

Kirkpatrick, Andrew W; McKee, Jessica Lynn; Tien, Colonel Homer; LaPorta, Anthony J; Lavell, Kit; Leslie, Tim; McBeth, Paul B; Roberts, Derek J; Ball, Chad G

2017-05-01

Far-Forward Damage Control Laparotomies (DCLs) might provide direct-compression of visceral hemorrhage, however, suturing is a limiting factor, especially for non-physicians. We thus compared abbreviated skin closures comparing skin-suture (SS) versus wound-clamp (WC), on-board a research aircraft in weightlessness (0g) and normal gravity (1g). Surgeons conducted DCLs on a surgical-simulator; onboard the hangered-aircraft (1g), or during parabolic flight (0g), randomized to either WC or SS. Ten surgeons participated. Two (40%) surgeons randomized to suture in 0g were incapacitated with motion-sickness, and none were able to close in either 1 or 0g. With WC, two completely closed in 1g as did three in 0g, despite having longer incisions (p = 0.016). Overall skin-closure with WC was significantly greater in both 1g (p = 0.016) and 0g (p = 0.008). WC was more effective in 1g and particularly 0g. Future studies should address the utility of abbreviated WC abdominal closure to facilitate potential Far-Forward DCL. ID ISRCTN/77929274. Copyright © 2017 Elsevier Inc. All rights reserved.

Overview of clinical use and side effect profile of valsartan in Chinese hypertensive patients

PubMed Central

Huang, Qi-Fang; Li, Yan; Wang, Ji-Guang

2014-01-01

We reviewed the Chinese and English literature for the efficacy and safety data of valsartan monotherapy or combination therapy in Chinese hypertensive patients. According to the data of ten randomized controlled trials, valsartan monotherapy was as efficacious as another angiotensin receptor blocker or other classes of antihypertensive drugs, excepting the slightly inferior diastolic blood pressure-lowering effect in comparison with calcium channel blockers. According to the data of six randomized controlled trials, valsartan combination, with hydrochlorothiazide, amlodipine, or nifedipine gastrointestinal therapeutic system, was more efficacious than monotherapy of valsartan, amlodipine, or nifedipine gastrointestinal therapeutic system. According to these trials, valsartan had an acceptable tolerability, regardless of whether it was used as monotherapy or in combination therapy. Nonetheless, several rare side effects have been reported, indicating that it should still be used with caution. This is of particular importance given that there are millions of hypertensive patients, worldwide, currently exposed to the drug. PMID:24403822

Cognitive-behavioral therapy for women with lifelong vaginismus: a randomized waiting-list controlled trial of efficacy.

PubMed

van Lankveld, Jacques J D M; ter Kuile, Moniek M; de Groot, H Ellen; Melles, Reinhilde; Nefs, Janneke; Zandbergen, Maartje

2006-02-01

Women with lifelong vaginismus (N=117) were randomly assigned to cognitive-behavioral group therapy, cognitive-behavioral bibliotherapy, or a waiting list. Manualized treatment comprised sexual education, relaxation exercises, gradual exposure, cognitive therapy, and sensate focus therapy. Group therapy consisted of ten 2-hr sessions with 6 to 9 participants per group. Assistance with minimal-contact bibliotherapy consisted of 6 biweekly, 15-min telephone contacts. Twenty-one percent of the participants left the study before posttreatment assessment. Intent-to-treat analysis revealed that successful intercourse at posttreatment was reported by 14% of the treated participants compared with none of the participants in the control condition. At the 12-month follow-up 21% of the group therapy participants and 15% of the bibliotherapy participants, respectively, reported successful intercourse. Cognitive-behavioral treatment of lifelong vaginismus was thus found to be efficacious, but the small effect size of the treatment warrants future efforts to improve the treatment. Copyright (c) 2006 APA, all rights reserved.

A Randomized, Crossover Clinical Trial of Exoskeletal-Assisted Walking to Improve Mobility, Bowel Function, and Cardiometabolic Profiles in Persons with SCI

DTIC Science & Technology

2015-10-01

comply with a collection of information if it does not display a currently valid OMB control number. PLEASE DO NOT RETURN YOUR FORM TO THE ABOVE ADDRESS...participants and at three study sites. It is also designed to determine if the body composition and bowel function benefits that were observed with as few...demonstrated that ten participants were able to use the device to successfully walk for four to six hours per week for three months. It is unknown if a

Time-efficiency analysis of the treatment with monolithic implant crowns in a digital workflow: a randomized controlled trial.

PubMed

Joda, Tim; Brägger, Urs

2016-11-01

The aim of the randomized controlled trial was to analyze time-efficiency of a treatment with implant crowns made of monolithic lithium disilicate (LS2) plus titanium base vs. porcelain fuse to zirconium dioxide (ZrO 2 ) in a digital workflow. Twenty study participants were included for single-tooth replacement in premolar and molar sites. Baseline was the start of the prosthetic treatment. All patients received transocclusal screw-retained implant reconstructions on a soft tissue level-type implant. The 3D implant position was captured with intraoral optical scanning (IOS). After randomization, ten patients were restored with CAD-/CAM-produced monolithic LS2-crowns bonded to prefabricated titanium abutments without any physical models (test), and ten patients with CAD-/CAM-fabricated ZrO 2 -suprastructures and hand-layered ceramic veneering with milled master models (control). Every single clinical and laboratory work step was timed in minutes and then analyzed for time-efficiency with Wilcoxon Rank Sum Tests. Direct costs were assessed for laboratory fees for first line production in Swiss Francs (CHF). Two clinical appointments were necessary for IOS and seating of all implant crowns. The mean total production time, as the sum of clinical plus laboratory work steps, was significantly different, resulting in 75.3 min (SD ± 2.1) for test and 156.6 min (SD ± 4.6) for control [P = 0.0001]. Analysis for clinical treatment sessions showed a significantly shorter mean chair time for the complete digital workflow of 20.8 min (SD ± 0.3) compared to 24.1 min (SD ± 1.1) [P = 0.001]. Even more obvious were the results for the mean laboratory work time with a significant reduction of 54.5 min (SD ± 4.9) vs. 132.5 min (SD ± 8.7), respectively [P = 0.0001]. The test workflow was more time-efficient than the controls for implant-supported crowns; notably, laboratory fabrication steps could be effectively shortened with the digital process of monolithic LS2 plus titanium base resulting in more than 30% reduced overall treatment costs. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

The effectiveness of transcutaneous electrical nerve stimulation in the management of patients with complex regional pain syndrome: A randomized, double-blinded, placebo-controlled prospective study.

PubMed

Bilgili, Adem; Çakır, Tuncay; Doğan, Şebnem Koldaş; Erçalık, Tülay; Filiz, Meral Bilgilisoy; Toraman, Füsun

2016-11-21

To investigate the effect of transcutaneous electrical nerve stimulation (TENS) on clinical recovery in the management of patients with complex regional pain syndrome Type I (CRPS Type I). The study included 30 patients with stage 1 and 2 CRPS Type I in the upper extremities. The patients were randomly assigned into 2 groups, group 1 (n= 15) received conventional TENS therapy for 20 minutes, and group 2 (n= 15) received sham TENS therapy. The standard physical therapy program, which included contrast bath for 20 minutes; whirlpool bath for 15 minutes; assisted active and passive range of motion, and static stretching exercises up to the pain threshold, was also conducted in both groups. Therapy was scheduled for 15 sessions. A visual analogue scale (VAS) was used to assess spontaneous pain. The Leeds Assessment of Neuropathic Signs and Symptoms (LANSS) scale and the Douleur Neuropathique en 4 Questions (DN-4) were used to assess neuropathic pain. In addition, range of motion (ROM) was measured using a goniometer and volumetric measurements were taken to assess edema. Functional capacity was assessed using a hand dynamometer and the Duruöz Hand Index (DHI). All measurements were performed at baseline and after therapy. Significant improvements were achieved in spontaneous and neuropathic pain scores, edema, ROM, and functional capacity in both groups (p< 0.05). However, improvement was found to be significantly greater in group 1 regarding pain intensity, neuropathic pain assessed using LANNS, edema, and in the 2nd-3rd finger ROM measurements (p< 0.05). No significant difference was detected between groups regarding improvements in 4th-5th finger and wrist ROM measurements, grip strength, and DN4 and DHI scores (p> 0.05). The addition of TENS to the physical therapy program was seen to make a significant contribution to clinical recovery in CRPS Type 1.

Ten-year mortality and cardiovascular morbidity in the Finnish Diabetes Prevention Study--secondary analysis of the randomized trial.

PubMed

Uusitupa, Matti; Peltonen, Markku; Lindström, Jaana; Aunola, Sirkka; Ilanne-Parikka, Pirjo; Keinänen-Kiukaanniemi, Sirkka; Valle, Timo T; Eriksson, Johan G; Tuomilehto, Jaakko

2009-05-21

The Finnish Diabetes Prevention Study (DPS) was a randomized controlled trial, which showed that it is possible to prevent type 2 diabetes by lifestyle changes. The aim of the present study was to examine whether the lifestyle intervention had an effect on the ten-year mortality and cardiovascular morbidity in the DPS participants originally randomized either into an intervention or control group. Furthermore, we compared these results with a population-based cohort comprising individuals of varying glucose tolerance states. Middle-aged, overweight people with IGT (n = 522) were randomized into intensive intervention (including physical activity, weight reduction and dietary counseling), or control "mini-intervention" group. Median length of the intervention period was 4 years and the mean follow-up was 10.6 years. The population-based reference study cohort included 1881 individuals (1570 with normal glucose tolerance, 183 with IGT, 59 with screen-detected type 2 diabetes, 69 with previously known type 2 diabetes) with the mean follow-up of 13.8 years. Mortality and cardiovascular morbidity data were collected from the national Hospital Discharge Register and Causes of Death Register. Among the DPS participants who consented for register linkage (n = 505), total mortality (2.2 vs. 3.8 per 1000 person years, hazard ratio HR = 0.57, 95% CI 0.21-1.58) and cardiovascular morbidity (22.9 vs. 22.0 per 1000 person years, HR = 1.04, 95% CI 0.72-1.51) did not differ significantly between the intervention and control groups. Compared with the population-based cohort with impaired glucose tolerance, adjusted HRs were 0.21 (95% CI 0.09-0.52) and 0.39 (95% CI 0.20-0.79) for total mortality, and 0.89 (95% CI 0.62-1.27) and 0.87 (0.60-1.27) for cardiovascular morbidity in the intervention and control groups of the DPS, respectively. The risk of death in DPS combined cohort was markedly lower than in FINRISK IGT cohort (adjusted HR 0.30, 95% CI 0.17-0.54), but there was no significant difference in the risk of CVD (adjusted HR 0.88, 95% CI 0.64-1.21). Lifestyle intervention among persons with IGT did not decrease cardiovascular morbidity during the first 10 years of follow-up. However, the statistical power may not be sufficient to detect small differences between the intervention and control groups. Low total mortality among participants of the DPS compared with individuals with IGT in the general population could be ascribed to a lower cardiovascular risk profile at baseline and regular follow-up. ClinicalTrials.gov NCT00518167.

Simultaneous transcutaneous electrical nerve stimulation mitigates simulator sickness symptoms in healthy adults: a crossover study.

PubMed

Chu, Hsin; Li, Min-Hui; Huang, Yu-Cheng; Lee, Shih-Yu

2013-04-15

Flight simulators have been used to train pilots to experience and recognize spatial disorientation, a condition in which pilots incorrectly perceive the position, location, and movement of their aircrafts. However, during or after simulator training, simulator sickness (SS) may develop. Spatial disorientation and SS share common symptoms and signs and may involve a similar mechanism of dys-synchronization of neural inputs from the vestibular, visual, and proprioceptive systems. Transcutaneous electrical nerve stimulation (TENS), a maneuver used for pain control, was found to influence autonomic cardiovascular responses and enhance visuospatial abilities, postural control, and cognitive function. The purpose of present study was to investigate the protective effects of TENS on SS. Fifteen healthy young men (age: 28.6 ± 0.9 years, height: 172.5 ± 1.4 cm, body weight: 69.3 ± 1.3 kg, body mass index: 23.4 ± 1.8 kg/m2) participated in this within-subject crossover study. SS was induced by a flight simulator. TENS treatment involved 30 minutes simultaneous electrical stimulation of the posterior neck and the right Zusanli acupoint. Each subject completed 4 sessions (control, SS, TENS, and TENS + SS) in a randomized order. Outcome indicators included SS symptom severity and cognitive function, evaluated with the Simulator Sickness Questionnaire (SSQ) and d2 test of attention, respectively. Sleepiness was rated using the Visual Analogue Scales for Sleepiness Symptoms (VAS-SS). Autonomic and stress responses were evaluated by heart rate, heart rate variability (HRV) and salivary stress biomarkers (salivary alpha-amylase activity and salivary cortisol concentration). Simulator exposure increased SS symptoms (SSQ and VAS-SS scores) and decreased the task response speed and concentration. The heart rate, salivary stress biomarker levels, and the sympathetic parameter of HRV increased with simulator exposure, but parasympathetic parameters decreased (p < 0.05). After TENS treatment, SS symptom severity significantly decreased and the subjects were more able to concentrate and made fewer cognitive test errors (p < 0.05). Sympathetic activity increased and parasympathetic activity decreased after simulator exposure. TENS was effective in reducing SS symptoms and alleviating cognitive impairment. Australia and New Zealand Clinical Trials Register: http://ACTRN12612001172897.

Simultaneous transcutaneous electrical nerve stimulation mitigates simulator sickness symptoms in healthy adults: a crossover study

PubMed Central

2013-01-01

Background Flight simulators have been used to train pilots to experience and recognize spatial disorientation, a condition in which pilots incorrectly perceive the position, location, and movement of their aircrafts. However, during or after simulator training, simulator sickness (SS) may develop. Spatial disorientation and SS share common symptoms and signs and may involve a similar mechanism of dys-synchronization of neural inputs from the vestibular, visual, and proprioceptive systems. Transcutaneous electrical nerve stimulation (TENS), a maneuver used for pain control, was found to influence autonomic cardiovascular responses and enhance visuospatial abilities, postural control, and cognitive function. The purpose of present study was to investigate the protective effects of TENS on SS. Methods Fifteen healthy young men (age: 28.6 ± 0.9 years, height: 172.5 ± 1.4 cm, body weight: 69.3 ± 1.3 kg, body mass index: 23.4 ± 1.8 kg/m2) participated in this within-subject crossover study. SS was induced by a flight simulator. TENS treatment involved 30 minutes simultaneous electrical stimulation of the posterior neck and the right Zusanli acupoint. Each subject completed 4 sessions (control, SS, TENS, and TENS + SS) in a randomized order. Outcome indicators included SS symptom severity and cognitive function, evaluated with the Simulator Sickness Questionnaire (SSQ) and d2 test of attention, respectively. Sleepiness was rated using the Visual Analogue Scales for Sleepiness Symptoms (VAS-SS). Autonomic and stress responses were evaluated by heart rate, heart rate variability (HRV) and salivary stress biomarkers (salivary alpha-amylase activity and salivary cortisol concentration). Results Simulator exposure increased SS symptoms (SSQ and VAS-SS scores) and decreased the task response speed and concentration. The heart rate, salivary stress biomarker levels, and the sympathetic parameter of HRV increased with simulator exposure, but parasympathetic parameters decreased (p < 0.05). After TENS treatment, SS symptom severity significantly decreased and the subjects were more able to concentrate and made fewer cognitive test errors (p < 0.05). Conclusions Sympathetic activity increased and parasympathetic activity decreased after simulator exposure. TENS was effective in reducing SS symptoms and alleviating cognitive impairment. Trial registration number Australia and New Zealand Clinical Trials Register: http://ACTRN12612001172897 PMID:23587135

Home-based exercise program and fall-risk reduction in older adults with multiple sclerosis: phase 1 randomized controlled trial.

PubMed

Sosnoff, Jacob J; Finlayson, Marcia; McAuley, Edward; Morrison, Steve; Motl, Robert W

2014-03-01

To determine the feasibility, safety, and efficacy of a home-based exercise intervention targeting fall risk in older adults with multiple sclerosis. A randomized controlled pilot trial. A home-based exercise program. Participants were randomly allocated to either a home-based exercise intervention group (n = 13) or a waiting list control group (n = 14). The exercise group completed exercises targeting lower muscle strength and balance three times a week for 12 weeks. The control group continued normal activity. Fall risk (Physiological Profile Assessment scores), balance (Berg Balance Scale), and walking testing prior to and immediately following the 12-week intervention. Each outcome measure was placed in an analysis of covariance with group as the between-subject factor and baseline values as the covariate. Effect sizes were calculated. Twelve participants from the control group and ten from the exercise group completed the study. There were no related adverse events. Fall risk was found to decrease in the exercise group following the intervention (1.1 SD 1.0 vs. 0.6 SD 0.6) while there was an increase in fall risk in the control group (1.9 SD 1.5 vs. 2.2 SD 1.9). Effect sizes for most outcomes were large (η(2) > 0.15). Home-based exercise was found to be feasible, safe, and effective for reducing physiological fall risk in older adults with multiple sclerosis. Our findings support the implementation of a larger trial to reduce fall risk in persons with multiple sclerosis.

Does time-lapse imaging have favorable results for embryo incubation and selection compared with conventional methods in clinical in vitro fertilization? A meta-analysis and systematic review of randomized controlled trials.

PubMed

Chen, Minghao; Wei, Shiyou; Hu, Junyan; Yuan, Jing; Liu, Fenghua

2017-01-01

The present study aimed to undertake a review of available evidence assessing whether time-lapse imaging (TLI) has favorable outcomes for embryo incubation and selection compared with conventional methods in clinical in vitro fertilization (IVF). Using PubMed, EMBASE, Cochrane library and ClinicalTrial.gov up to February 2017 to search for randomized controlled trials (RCTs) comparing TLI versus conventional methods. Both studies randomized women and oocytes were included. For studies randomized women, the primary outcomes were live birth and ongoing pregnancy, the secondary outcomes were clinical pregnancy and miscarriage; for studies randomized oocytes, the primary outcome was blastocyst rate, the secondary outcome was good quality embryo on Day 2/3. Subgroup analysis was conducted based on different incubation and embryo selection between groups. Ten RCTs were included, four randomized oocytes and six randomized women. For oocyte-based review, the pool-analysis observed no significant difference between TLI group and control group for blastocyst rate [relative risk (RR) 1.08, 95% CI 0.94-1.25, I2 = 0%, two studies, including 1154 embryos]. The quality of evidence was moderate for all outcomes in oocyte-based review. For woman-based review, only one study provided live birth rate (RR 1,23, 95% CI 1.06-1.44,I2 N/A, one study, including 842 women), the pooled result showed no significant difference in ongoing pregnancy rate (RR 1.04, 95% CI 0.80-1.36, I2 = 59%, four studies, including 1403 women) between two groups. The quality of the evidence was low or very low for all outcomes in woman-based review. Currently there is insufficient evidence to support that TLI is superior to conventional methods for human embryo incubation and selection. In consideration of the limitations and flaws of included studies, more well designed RCTs are still in need to comprehensively evaluate the effectiveness of clinical TLI use.

The influence of Task-Related Training combined with Transcutaneous Electrical Nerve Stimulation on paretic upper limb muscle activation in patients with chronic stroke.

PubMed

Jung, Kyoungsim; Jung, Jinhwa; In, Taesung; Kim, Taehoon; Cho, Hwi-Young

2017-01-01

This study investigated the efficacy of Task-Related Training (TRT) Combined with Transcutaneous Electrical Nerve Stimulation (TENS) on the improvement of upper limb muscle activation in chronic stroke survivors with mild or moderate paresis. A single-blind, randomized clinical trial was conducted with 46stroke survivors with chronic paresis. They were randomly allocated two groups: the TRT+TENS group (n = 23) and the TRT+ placebo TENS (TRT+PLBO) group (n = 23). The TRT+TENS group received 30 minutes of high-frequency TENS on wrist and elbow extensors, while the TRT+PLBO group received placebo TENS that was not real ES. Both groups did 30 minutes of TRT after TENS application. Intervention was given five days a week for four weeks. The primary outcomes of upper limb muscle activation were measured by integrated EMG (IEMG), a digital manual muscle tester for muscle strength, active range of motion (AROM) and Fugl-Meyer Assessment of the upper extremity (FMA-UE). The measurements were performed before and after the 4 weeks intervention period. Both groups demonstrated significant improvements of outcomes in IEMG, AROM, muscle strength and FMA-UE during intervention period. When compared with the TRT+PLBO group, the TRT+TENS group showed significantly greater improvement in muscle activation (wrist extensors, P = 0.045; elbow extensors, P = 0.004), muscle strength (wrist extensors, P = 0.044; elbow extensors, P = 0.012), AROM (wrist extension, P = 0.042; elbow extensors, P = 0.040) and FMA-UE (total, P < 0.001; shoulder/elbow/forearm, P = 0.001; wrist, P = 0.002; coordination, P = 0.008) at the end of intervention. Our findings indicate that TRT Combined with TENS can improve paretic muscle activity in upper limb paresis, highlighting the benefits of somatosensory stimulation from TENS.

Clinical outcome and patient satisfaction using biodegradable (NasoPore) and non-biodegradable packing, a double-blind, prospective, randomized study.

PubMed

Burduk, Pawel Krzysztof; Wierzchowska, Malgorzata; Grześkowiak, Blazej; Kaźmierczak, Wojciech; Wawrzyniak, Katarzyna

Nasal packing after endoscopic sinus surgery is used as a standard procedure. The optimum solution to minimize or eliminate all disadvantages of this procedure may be accomplished using biodegradable packs. The aim of this study was to compare patient satisfaction and clinical outcome associated with absorbable and non-absorbable packing after FESS. In total, 50 patients were included in a prospective, double-blind, randomized trial. One side was packed with polyurethane foam, while the opposite side was packed with gauze packing. On the 2nd, 10th, and 30th postoperative day, the patients were questioned with the aid of a visual analog scale. The standardized questionnaires for bleeding, nasal breathing, feeling of pressure, and headache were used. The presence of synechiae, infection, or granulation was noted and recorded with the video-endoscopy. A significant difference according to lower pressure was found in the NasoPore group compared to the controls on day ten after surgery. The NasoPore packing had lower scores with respect to postoperative nose blockage on the 2nd and 10th days. Mucosal healing was better for the NasoPore group, both at day ten and 30 compared with the control group. The overall patient comfort is higher when using NasoPore compared to non-resorbable traditional impregnated gauze packing. Intensive saline douches applied three to four times per day are mandatory after the operation to prevent synechiae formation and fluid resorption by the packing. Published by Elsevier Editora Ltda.

A shift in priority in diabetic foot care and research: 75% of foot ulcers are preventable.

PubMed

Bus, Sicco A; van Netten, Jaap J

2016-01-01

Diabetic foot ulceration poses a heavy burden on the patient and the healthcare system, but prevention thereof receives little attention. For every euro spent on ulcer prevention, ten are spent on ulcer healing, and for every randomized controlled trial conducted on prevention, ten are conducted on healing. In this article, we argue that a shift in priorities is needed. For the prevention of a first foot ulcer, we need more insight into the effect of interventions and practices already applied globally in many settings. This requires systematic recording of interventions and outcomes, and well-designed randomized controlled trials that include analysis of cost-effectiveness. After healing of a foot ulcer, the risk of recurrence is high. For the prevention of a recurrent foot ulcer, home monitoring of foot temperature, pressure-relieving therapeutic footwear, and certain surgical interventions prove to be effective. The median effect size found in a total of 23 studies on these interventions is large, over 60%, and further increases when patients are adherent to treatment. These interventions should be investigated for efficacy as a state-of-the-art integrated foot care approach, where attempts are made to assure treatment adherence. Effect sizes of 75-80% may be expected. If such state-of-the-art integrated foot care is implemented, the majority of problems with foot ulcer recurrence in diabetes can be resolved. It is therefore time to act and to set a new target in diabetic foot care. This target is to reduce foot ulcer incidence with at least 75%. Copyright © 2016 John Wiley & Sons, Ltd.

The effect of surface electrical stimulation on swallowing in dysphagic Parkinson patients.

PubMed

Baijens, Laura W J; Speyer, Renée; Passos, Valeria Lima; Pilz, Walmari; Roodenburg, Nel; Clavé, Père

2012-12-01

Surface electrical stimulation has been applied on a large scale to treat oropharyngeal dysphagia. Patients suffering from oropharyngeal dysphagia in the presence of Parkinson's disease have been treated with surface electrical stimulation. Because of controversial reports on this treatment, a pilot study was set up. This study describes the effects of a single session of surface electrical stimulation using different electrode positions in ten patients with idiopathic Parkinson's disease (median Hoehn and Yahr score: II) and oropharyngeal dysphagia compared to ten age- and gender-matched healthy control subjects during videofluoroscopy of swallowing. Three different electrode positions were applied in random order per subject. For each electrode position, the electrical current was respectively turned "on" and "off" in random order. Temporal, spatial, and visuoperceptual variables were scored by experienced raters who were blinded to the group, electrode position, and status (on/off) of the electrical current. Interrater and interrater reliabilities were calculated. Only a few significant effects of a single session of surface electrical stimulation using different electrode positions in dysphagic Parkinson patients could be observed in this study. Furthermore, significant results for temporal and spatial variables were found regardless of the status of the electrical current in both groups suggesting placebo effects. Following adjustment for electrical current status as well as electrode positions (both not significant, P > 0.05) in the statistical model, significant group differences between Parkinson patients and healthy control subjects emerged. Further studies are necessary to evaluate the potential therapeutic effect and mechanism of electrical stimulation in dysphagic patients with Parkinson's disease.

A comparison study of immune-inflammatory response in electroacupuncture and transcutaneous electrical nerve stimulation for patients undergoing supratentorial craniotomy

PubMed Central

Li, Guoyan; Li, Shuqin; Sun, Lizhi; Lin, Fangcai; Wang, Baoguo

2015-01-01

Objective: The effect of transcutaneous electrical nerve stimulation (TENS) on immuno-inflammatory response was tested and the differences between electroacupuncture (EA) and TENS in immuno-inflammatory response in patients undergoing supratentorial craniotomy were explored. Methods: 51 patients received craniotomy were randomly divided into 3 groups: control (group C, n=18), EA (group A, n=19) and TENS (group T, n=14) groups. Blood samples were collected before anesthesia (T0) and 30 min (T1), 2 h (T2) and 4 h (T3) after induction of anesthesia to measure the levels of tumor necrosis factor-α (TNF-α), interleukin (IL)-8, IL-10, IgM, IgA and IgG. Results: No significant difference existed between group A and group T during craniotomy. IgM and IgA decreased significantly in group C compared with groups A and T at T2 and T3 time points. Compared with group C, there were significant differences in TNF-α, IgM and IgA levels at T0 in groups A and T; no significant difference was found in the levels of IgG, IL-10 and IL-8. Conclusion: EA and TENS could reduce immunosuppression in patients undergoing supratentorial craniotomy and it has significance in choice of treatment in immunosuppressive therapy. PMID:25785107

A comparison study of immune-inflammatory response in electroacupuncture and transcutaneous electrical nerve stimulation for patients undergoing supratentorial craniotomy

PubMed Central

Li, Guoyan; Li, Shuqin; Sun, Lizhi; Lin, Fangcai; Wang, Baoguo

2015-01-01

Objective: The effect of transcutaneous electrical nerve stimulation (TENS) on immuno-inflammatory response was tested and the differences between electroacupuncture (EA) and TENS in immuno-inflammatory response in patients undergoing supratentorial craniotomy were explored. Methods: 51 patients received craniotomy were divided randomly into 3 groups: control (group C, n=18), EA (group A, n=19) and TENS (group T, n=14) groups. Blood samples were collected before anesthesia (T0) and 30 min (T1), 2 h (T2) and 4 h (T3) after induction of anesthesia to measure the levels of tumor necrosis factor-α (TNF-α), interleukin (IL)-8, IL-10, IgM, IgA and IgG.. Results: No significant difference existed between groups A and group T during craniotomy. IgM and IgA decreased significantly in group C compared with groups A and T at T2 and T3 time points. Compared with group C, there were significant difference in TNF-α, IgM and IgA level at T0 in groups A and T; no significant difference was found in the levels of IgG, IL-10 and IL-8. Conclusion: EA and TENS could reduce immunosuppression in patients undergoing supratentorial craniotomy and it has significance in choice of treatment in immunosuppressive therapy. PMID:25932216

Effects of intra-aortic balloon counterpulsation pump on mortality of acute myocardial infarction.

PubMed

Ye, Liwen; Zheng, Minming; Chen, Qingwei; Li, Guiqion; Deng, Wei; Ke, Dazhi

2014-01-01

Several randomized controlled trials (RCTs) have evaluated the effect of intra-aortic balloon counterpulsation pump(IABP) on the mortality of acute myocardial infarction (AMI). To analyze the relevant RCT data on the effect of IABP on mortality and the occurrence of bleeding in AMI. Published RCTs on the treatment of AMI by IABP were retrieved in searches of Medline, EMBASE, Cochrane and other related databases. The last search was conducted on July 20, 2014. Randomized clinical trials comparing IABP to controls as treatment for AMI. Patients with AMI. The primary endpoint was mortality, and the secondary endpoint was bleeding events. To account for to heterogeneity, a random-effects model was used to analyze the study data. Ten trials with a total population of 973 patients that were included in the analysis showed no significant difference in 2-month mortality between the IABP and the control groups. The 6-month mortality in the IABP group was not significantly lower than in the control group in the four RCTs that enrolled 59 AMI patients with CS. But in the four that enrolled AMI 66 patients without CS, the data showed opposite conclusion. IABP cannot reduce within 2 months and 6-12 months mortality of AMI patients with CS as well as within 2 months mortality of AMI patients without CS, but can reduce 6-12 months mortality of AMI patients without CS. In addition, IABP can increase the risk of bleeding.

Electroacupuncture versus sham electroacupuncture for urinary retention in poststroke patients: study protocol for a multicenter, randomized controlled trial.

PubMed

Shin, Seungwon; Lee, Jiwon; Yoo, Junghee; Lim, Sung Min; Lee, Euiju

2016-04-12

This study protocol evaluates the effectiveness of adjuvant electroacupuncture (EA) for urinary retention in poststroke patients undergoing conventional treatments, in comparison with that of a sham control. A multicenter, blinded, randomized controlled trial will be conducted in three hospitals in the Republic of Korea. We are recruiting 54 stroke survivors (aged >19 years), who were diagnosed with urinary retention based on the results of two consecutive post-void residual (PVR) tests, and dividing them randomly into two arms: the EA and Park-sham control groups. They will receive ten sessions of EA or sham treatment for 2 weeks. The participants will be blinded with non-penetrating needles and fake sounds of EA stimulators. The daily PVR ratio will be primarily measured at baseline and at the end of the study to statistically test the effectiveness of EA for poststroke urinary retention. Then, the Korean version of the Qualiveen Questionnaire, the Korean version of the International Prostate Symptom Score, and the blinding index will be assessed. After each EA session or sham EA, adverse events will be reported to evaluate the safety of EA. Results will be analyzed by using the independent t-test or Mann-Whitney U test, based on both intention-to-treat and per-protocol principles. The findings will provide clinical evidence for the effectiveness of EA treatment to improve urinary retention in stroke survivors. This study protocol was registered in ClinicalTrials.gov (NCT02472288) on 10 June 2015.

Comparison of antiemetic efficacy of granisetron and ondansetron in Oriental patients: a randomized crossover study.

PubMed Central

Poon, R. T.; Chow, L. W.

1998-01-01

A double-blind randomized crossover trial was performed to compare the antiemetic efficacy of two 5-HT3 receptor antagonists, granisetron and ondansetron, in Chinese patients receiving adjuvant chemotherapy (cyclophosphamide, methotrexate and 5-fluorouracil) for breast cancer. Twenty patients were randomized to receive chemotherapy with either granisetron on day 1 and ondansetron on day 8 of the first cycle followed by the reverse order in the second cycle, or vice versa. The number of vomiting episodes and the severity of nausea in the first 24 h (acute vomiting/nausea) and the following 7 days (delayed vomiting/nausea) were studied. Acute vomiting was completely prevented in 29 (72.5%) cycles with granisetron and 27 (67.5%) cycles with ondansetron, and treatment failure (>5 vomiting episodes) occurred in two (5%) cycles with each agent (P = NS). Acute nausea was completely controlled in 15 (37.5%) cycles with granisetron and 14 (35%) cycles with ondansetron, whereas severe acute nausea occurred in four (10%) cycles with each agent (P = NS). However, complete response for delayed vomiting was observed in only 21 (52.5%) cycles with granisetron and 22 (55%) cycles with ondansetron (P = NS), and delayed nausea was completely controlled in only 11 (27.5%) and ten (25%) cycles respectively (P = NS). In conclusion, both granisetron and ondansetron are effective in controlling acute nausea and vomiting in Chinese patients, with equivalent antiemetic efficacy. Control of delayed nausea and vomiting is less satisfactory. PMID:9635849

"Effect of pranayama and meditation as an add-on therapy in rehabilitation of patients with Guillain-Barré syndrome--a randomized control pilot study".

PubMed

Sendhilkumar, Ragupathy; Gupta, Anupam; Nagarathna, Raghuram; Taly, Arun B

2013-01-01

To study the add-on effects of pranayama and meditation in rehabilitation of patients with Guillain-Barré syndrome (GBS). This randomized control pilot study was conducted in neurological rehabilitation unit of university tertiary research hospital. Twenty-two GBS patients, who consented for the study and satisfied selection criteria, were randomly assigned to yoga and control groups. Ten patients in each group completed the study. The yoga group received 15 sessions in total over a period of 3 weeks (1 h/session), one session per day on 5 days per week that consisted of relaxation, Pranayama (breathing practices) and Guided meditation in addition to conventional rehabilitation therapeutics. The control group received usual rehabilitation care. All the patients were assessed using Pittsburgh Sleep Quality Index, Numeric pain rating scale, Hospital anxiety and Depression scale and Barthel index score. Mann-Whitney U test and Wilcoxon's signed rank test were used for statistical analysis. Quality of sleep improved significantly with reduction of PSQI score in the yoga group (p = 0.04). There was reduction of pain scores, anxiety and depression in both the groups without statistical significance between groups (pain p > 0.05, anxiety p > 0.05 and depression p > 0.05). Overall functional status improved in both groups without significant difference (p > 0.05). Significant improvement was observed in quality of sleep with yogic relaxation, pranayama, and meditation in GBS patients.

Design of a randomized, controlled, comparative-effectiveness trial testing a Family Model of Diabetes Self-Management Education (DSME) vs. Standard DSME for Marshallese in the United States.

PubMed

Kim Yeary, Karen Hye-Cheon; Long, Christopher R; Bursac, Zoran; McElfish, Pearl Anna

2017-06-01

Type 2 diabetes (T2D) is a significant public health problem, with U.S. Pacific Islander communities-such as the Marshallese-bearing a disproportionate burden. Using a community-based participatory approach (CBPR) that engages the strong family-based social infrastructure characteristic of Marshallese communities is a promising way to manage T2D. Led by a collaborative community-academic partnership, the Family Model of Diabetes Self-Management Education (DSME) aimed to change diabetes management behaviors to improve glycemic control in Marshallese adults with T2D by engaging the entire family. To test the Family Model of DSME, a randomized, controlled, comparative effectiveness trial with 240 primary participants was implemented. Half of the primary participants were randomly assigned to the Standard DSME and half were randomly assigned to the Family Model DSME. Both arms received ten hours of content comprised of 6-8 sessions delivered over a 6-8 week period. The Family Model DSME was a cultural adaptation of DSME, whereby the intervention focused on engaging family support for the primary participant with T2D. The Standard DSME was delivered to the primary participant in a community-based group format. Primary participants and participating family members were assessed at baseline and immediate post-intervention, and will also be assessed at 6 and 12 months. The Family Model of DSME aimed to improve glycemic control in Marshallese with T2D. The utilization of a CBPR approach that involves the local stakeholders and the engagement of the family-based social infrastructure of Marshallese communities increase potential for the intervention's success and sustainability.

The Effect of Head Massage on the Regulation of the Cardiac Autonomic Nervous System: A Pilot Randomized Crossover Trial.

PubMed

Fazeli, Mir Sohail; Pourrahmat, Mir-Masoud; Liu, Mailan; Guan, Ling; Collet, Jean-Paul

2016-01-01

To evaluate the effect of a single 10-minute session of Chinese head massage on the activity of the cardiac autonomic nervous system via measurement of heart rate variability (HRV). In this pilot randomized crossover trial, each participant received both head massage and the control intervention in a randomized fashion. The study was conducted at Children's & Women's Health Centre of British Columbia between June and November 2014. Ten otherwise healthy adults (6 men and 4 women) were enrolled in this study. The intervention comprised 10 minutes of head massage therapy (HMT) in a seated position compared with a control intervention of sitting quietly on the same chair with eyes closed for an equal amount of time (no HMT). The primary outcome measures were the main parameters of HRV, including total power (TP), high frequency (HF), HF as a normalized unit, pre-ejection period, and heart rate (HR). A single short session (10 minutes) of head massage demonstrated an increase in TP continuing up to 20 minutes after massage and reaching statistical significance at 10 minutes after massage (relative change from baseline, 66% for HMT versus -6.6% for no HMT; p = 0.017). The effect on HF also peaked up to 10 minutes after massage (59.4% for HMT versus 4% for no HMT; p = 0.139). Receiving head massage also decreased HR by more than three-fold compared to the control intervention. This study shows the potential benefits of head massage by modulating the cardiac autonomic nervous system through an increase in the total variability and a shift toward higher parasympathetic nervous system activity. Randomized controlled trials with larger sample size and multiple sessions of massage are needed to substantiate these findings.

An investigation into the effects of frequency-modulated transcutaneous electrical nerve stimulation (TENS) on experimentally-induced pressure pain in healthy human participants.

PubMed

Chen, Chih-Chung; Johnson, Mark I

2009-10-01

Frequency-modulated transcutaneous electrical nerve stimulation (TENS) delivers currents that fluctuate between preset boundaries over a fixed period of time. This study compared the effects of constant-frequency TENS and frequency-modulated TENS on blunt pressure pain in healthy human volunteers. Thirty-six participants received constant-frequency TENS (80 pps), frequency-modulated TENS (20 to 100 pps), and placebo (no current) TENS at a strong nonpainful intensity in a randomized cross-over manner. Pain threshold was taken from the forearm using pressure algometry. There were no statistical differences between constant-frequency TENS and frequency-modulated TENS after 20 minutes (OR = 1.54; CI, 0.29, 8.23, P = 1.0). Both constant-frequency TENS and frequency-modulated TENS were superior to placebo TENS (OR = 59.5, P < .001 and OR = 38.5, P < .001, respectively). Frequency-modulated TENS does not influence hypoalgesia to any greater extent than constant-frequency TENS when currents generate a strong nonpainful paraesthesia at the site of pain. The finding that frequency-modulated TENS and constant-frequency TENS were superior to placebo TENS provides further evidence that a strong yet nonpainful TENS intensity is a prerequisite for hypoalgesia. This study provides evidence that TENS, delivered at a strong nonpainful intensity, increases pain threshold to pressure algometry in healthy participants over and above that seen with placebo (no current) TENS. Frequency-modulated TENS does not increase hypoalgesia to any appreciable extent to that seen with constant-frequency TENS.

Evaluating the effectiveness of an empowerment program for self-care in type 2 diabetes: a cluster randomized trial.

PubMed

Cortez, Daniel Nogueira; Macedo, Maísa Mara Lopes; Souza, Débora Aparecida Silva; Dos Santos, Jéssica Caroline; Afonso, Gesana Sousa; Reis, Ilka Afonso; Torres, Heloísa de Carvalho

2017-01-06

The prevalence of type 2 diabetes mellitus is increasing substantially worldwide, leading to serious economic effects, complications and deaths. This study evaluated the effectiveness of an empowerment program providing support for psychosocial, behavioral, and clinical aspects of diabetes to help Brazilian users of public health services obtain metabolic control of this condition. In this cluster randomized trial, participants aged 30-80 diagnosed with type 2 diabetes were recruited from ten Brazilian public health units in 2014 and 2015. Five units were randomly assigned to receive the empowerment program based on a behavior change protocol, and five continued to receive only conventional treatment. The primary outcome was the biochemical and anthropometric parameters, and the secondary outcomes were self-care, attitude, knowledge and empowerment related to diabetes. The effect of the experiment was defined as the percentage variation between the values at the initial and final periods. To evaluate this effect and to compare it in the two groups, tests were used for paired and independent samples, respectively. There were 238 participants: 127 and 111 in the intervention and control group, respectively. For glycated hemoglobin, the mean effect in the control and intervention groups was 3.93 and -5.13, respectively (p < 0.001). Levels of glycated hemoglobin and other metabolic indicators, as well as the most part of the secondary outcomes showed a significant difference in the experimental group compared to the control group. The empowerment program improved metabolic control of type 2 diabetes in Brazilian users. NCT02132338 - April 22, 2014.

The effects of preoperative aromatherapy massage on anxiety and sleep quality of colorectal surgery patients: A randomized controlled study.

PubMed

Ayik, Cahide; Özden, Dilek

2018-02-01

To examine the effects of aromatherapy massage on anxiety and sleep quality in patients undergoing colorectal surgery in the preoperative period. In recent years, there has been an increase in the number of studies conducted on aromatherapy massage. It is stated that studies conducted on aromatherapy massage for anxiety and sleep quality reveal contradictory results and that more research is required on the issue. A randomized controlled trial. Eighty patients undergoing colorectal surgery were randomly assigned to experimental and control group. To the experimental group (n = 40), aromatherapy massage was applied in accordance with the "Back Massage Guide" using 5% lavender oil (Lavandula Hybrida) for ten minutes before surgery and the morning of surgery. The control group received standard nursing care in compliance with the hospital procedure. Data were obtained by the State Anxiety Inventory (SAI) and Richard-Campbell Sleep Questionnaire (RCSQ). Results were analyzed using the t-test, Chi-square test or Fisher's exact test. There was no baseline difference between the groups. A statistically significant difference was found between the experimental and control group in terms of the SAI and RCSQ mean scores recorded on the morning of surgery. It was determined that the SAI and RCSQ mean score of the experimental group after aromatherapy massage on the morning of surgery decreased when compared to that of the evening before surgery. It was found that aromatherapy massage with lavender oil increased the sleep quality and reduced the level of anxiety in patients with colorectal surgery in the preoperative period. Copyright © 2017 Elsevier Ltd. All rights reserved.

Random fiber lasers based on artificially controlled backscattering fibers

NASA Astrophysics Data System (ADS)

Chen, Daru; Wang, Xiaoliang; She, Lijuan; Qiang, Zexuan; Yu, Zhangwei

2017-10-01

The random fiber laser (RFL) which is a milestone in laser physics and nonlinear optics, has attracted considerable attention recently. Most previous RFLs are based on distributed feedback of Rayleigh scattering amplified through stimulated Raman/Brillouin scattering effect in single mode fibers, which required long-distance (tens of kilometers) single mode fibers and high threshold up to watt-level due to the extremely small Rayleigh scattering coefficient of the fiber. We proposed and demonstrated a half-open cavity RFL based on a segment of a artificially controlled backscattering SMF(ACB-SMF) with a length of 210m, 310m or 390m. A fiber Bragg grating with the central wavelength of 1530nm and a segment of ACB-SMF forms the half-open cavity. The proposed RFL achieves the threshold of 25mW, 30mW and 30mW, respectively. Random lasing at the wavelength of 1530nm and the extinction ratio of 50dB is achieved when a segment of 5m EDF is pumped by a 980nm LD in the RFL. Another half-open cavity RFL based on a segment of a artificially controlled backscattering EDF(ACBS-EDF) is also demonstrated without an ACB-SMF. The 3m ACB-EDF is fabricated by using the femtosecond laser with pulse energy of 0.34mJ which introduces about 50 reflectors in the EDF. Random lasing at the wavelength of 1530nm is achieved with the output power of 7.5mW and the efficiency of 1.88%. Two novel RFLs with much short cavities have been achieved with low threshold and high efficiency.

Does touch massage facilitate recovery after stroke? A study protocol of a randomized controlled trial.

PubMed

Lämås, Kristina; Häger, Charlotte; Lindgren, Lenita; Wester, Per; Brulin, Christine

2016-02-04

Despite high quality stroke care, decreased sensorimotor function, anxiety and pain often remain one year after stroke which can lead to impaired health and dependence, as well as higher healthcare costs. Touch massage (TM) has been proven to decrease anxiety and pain, and improve quality of health in other conditions of reduced health, where reduced anxiety seems to be the most pronounced benefit. Thus there are reasons to believe that TM may also reduce anxiety and pain, and improve quality of life after stroke. Further, several studies indicate that somatosensory stimulation can increase sensorimotor function, and it seems feasible to believe that TM could increase independence after stroke. In this study we will evaluate effects of TM after stroke compared to sham treatment. This is a prospective randomized open-labelled control trial with blinded evaluation (PROBE-design). Fifty patients with stroke admitted to stroke units will be randomized (1:1) to either a TM intervention or a non-active transcutaneous electrical nerve stimulation (non-TENS) control group. Ten sessions of 30 min treatments (TM or control) will be administered during two weeks. Assessment of status according to the International Classification of Functioning, Disability and Health (ICF), including body function, activity, and participation. Assessment of body function will include anxiety, pain, and stress response (heart rate variability and salivary cortisol), where anxiety is the primary outcome. Activity will be assessed by means of sensorimotor function and disability, and participation by means of health-related quality of life. Assessments will be made at baseline, after one week of treatment, after two weeks of treatment, and finally a follow-up after two months. The trial has been approved by the Regional Ethical Review Board. TM seems to decrease anxiety and pain, increase health-related quality of life, and improve sensorimotor functions after stroke, but the field is largely unexplored. Considering the documented pleasant effects of massage in general, absence of reported adverse effects, and potential effects in relation to stroke, it is essential to evaluate effects of TM during the sub-acute phase after stroke. The results of this project will hopefully provide important knowledge for evidence-based care. ClinicalTrials.gov: NTC01883947.

[Observation on the transient analgesic effect of abdominal acupuncture TENS on pain of neck, shoulder, loin and legs].

PubMed

Wang, Zhang-lian; Chen, Li-fang; Zhu, Wei-ming

2007-09-01

To observe on the transient analgesic effect of abdominal points transcutaneous electrical nerve stimulation (TENS) combined with abdominal acupuncture according to the holographic theory on pain of neck, shoulder, loin and legs. One hundred and twenty cases of pain of neck, shoulder, loin and legs were randomly divided into 4 groups: abdominal acupuncture TENS group, acupoints TENS group, electroacupuneture (EA) group, non-abdominal acupuncture TENS group, 30 cases in each group. All the cases were treated by the same stimulation parameters, but different stimulation points. The VAS scores were recorded before and after treatment. The VAS scores were significantly different before and after treatment in abdominal acupuncture TENS group (P < 0.01); the total effective rate of the transient analgesic effec t was 96.7% in the abdominal acupuncture TENS group, 93.3% in the acupoints TENS group, 96.7% in the EA group with no significant difference among the 3 groups, but with a very significant difference between the abdominal acupuncture TENS group and the non-abdominal acupunctureTENS group (10.0%), P < 0.01. Abdominal acupuncture TENS has a better transient analgesic effect and can use less stimulation points to increase the analgesic effect.

SUSTAINED ISOMETRIC SHOULDER CONTRACTION ON MUSCULAR STRENGTH AND ENDURANCE: A RANDOMIZED CLINICAL TRIAL.

PubMed

Myers, Natalie L; Toonstra, Jenny L; Smith, Jacob S; Padgett, Cooper A; Uhl, Tim L

2015-12-01

The Advanced Throwers Ten Exercise Program incorporates sustained isometric contractions in conjunction with dynamic shoulder movements. It has been suggested that incorporating isometric holds may facilitate greater increases in muscular strength and endurance. However, no objective evidence currently exists to support this claim. The purpose of this research was to compare the effects of a sustained muscle contraction resistive training program (Advanced Throwers Ten Program) to a more traditional exercise training protocol to determine if increases in shoulder muscular strength and endurance occur in an otherwise healthy population. It was hypothesized that utilizing a sustained isometric hold during a shoulder scaption exercise from the Advanced Throwers Ten would produce greater increases in shoulder strength and endurance as compared to a traditional training program incorporating a isotonic scapular plane abduction (scaption) exercise. Randomized Clinical Trial. Fifty healthy participants were enrolled in this study, of which 25 were randomized into the traditional training group (age: 26 ± 8, height:172 ± 10 cm, weight: 73 ± 13 kg, Marx Activity Scale: 11 ± 4) and 25 were randomized to the Advanced Throwers Ten group (age: 28 ± 9, height: 169 ± 23 cm, weight: 74 ± 16 kg, Marx Activity Scale: 11 ± 5). No pre-intervention differences existed between the groups (P>0.05). Arm endurance and strength data were collected pre and post intervention using a portable load cell (BTE Evaluator, Hanover, MD). Both within and between group analyses were done in order to investigate average torque (strength) and angular impulse (endurance) changes. The traditional and Advanced Throwers Ten groups both significantly improved torque and angular impulse on both the dominant and non-dominant arms by 10-14%. There were no differences in strength or endurance following the interventions between the two training groups (p>0.75). Both training approaches increased strength and endurance as the muscle loads were consistent between protocols indicating that either approach will have positive effects. Level 2.

Mechanisms for an effect of acetylcysteine on renal function after exposure to radio-graphic contrast material: study protocol

PubMed Central

2012-01-01

Background Contrast-induced nephropathy is a common complication of contrast administration in patients with chronic kidney disease and diabetes. Its pathophysiology is not well understood; similarly the role of intravenous or oral acetylcysteine is unclear. Randomized controlled trials to date have been conducted without detailed knowledge of the effect of acetylcysteine on renal function. We are conducting a detailed mechanistic study of acetylcysteine on normal and impaired kidneys, both with and without contrast. This information would guide the choice of dose, route, and appropriate outcome measure for future clinical trials in patients with chronic kidney disease. Methods/Design We designed a 4-part study. We have set up randomised controlled cross-over studies to assess the effect of intravenous (50 mg/kg/hr for 2 hrs before contrast exposure, then 20 mg/kg/hr for 5 hrs) or oral acetylcysteine (1200 mg twice daily for 2 days, starting the day before contrast exposure) on renal function in normal and diseased kidneys, and normal kidneys exposed to contrast. We have also set up a parallel-group randomized controlled trial to assess the effect of intravenous or oral acetylcysteine on patients with chronic kidney disease stage III undergoing elective coronary angiography. The primary outcome is change in renal blood flow; secondary outcomes include change in glomerular filtration rate, tubular function, urinary proteins, and oxidative balance. Discussion Contrast-induced nephropathy represents a significant source of hospital morbidity and mortality. Over the last ten years, acetylcysteine has been administered prior to contrast to reduce the risk of contrast-induced nephropathy. Randomized controlled trials, however, have not reliably demonstrated renoprotection; a recent large randomized controlled trial assessing a dose of oral acetylcysteine selected without mechanistic insight did not reduce the incidence of contrast-induced nephropathy. Our study should reveal the mechanism of effect of acetylcysteine on renal function and identify an appropriate route for future dose response studies and in time randomized controlled trials. Trial registration Clinical Trials.gov: NCT00558142; EudraCT: 2006-003509-18. PMID:22305183

Efficacy of supervised exercise combined with transcutaneous electrical nerve stimulation in women with fibromyalgia: a prospective controlled study.

PubMed

Mutlu, B; Paker, N; Bugdayci, D; Tekdos, D; Kesiktas, N

2013-03-01

The aim of this study was to investigate the results of a supervised exercise with transcutaneous electrical nerve stimulation (TENS) in an exercise controlled study in women with fibromyalgia. Sixty-six women with fibromyalgia who admitted to the outpatient clinic of our hospital were randomized into two treatment groups. The patients in both groups participated in a supervised combined exercise program for 12 weeks. The women in first group had additional TENS in the first 3 weeks of the study. All subjects were analyzed at the baseline, at the end of the 3rd and 12th weeks. Outcome measures were tender point count (TPC), myalgic pain score (MPS), Fibromyalgia Impact Questionnaire (FIQ) and Short Form-36 (SF-36) Health Survey. Sixty women with fibromyalgia completed the study. The patients in both groups showed improvement in terms of TPC, MPS, FIQ, physical and mental summary scores and total scores of SF-36 at the end of the 3rd and 12th weeks. The improvement in MPS at the third week was higher in the first group (p = 0.01). But there was no difference in terms of the improvement in MPS between the groups at the end of the 12th week control (p = 0.87). There was no significant difference between the improvement in the other outcome parameters of the two groups. As a result, supervised exercise program was successful to improve the myalgic pain, functional status and quality of life in women with fibromyalgia. Exercises combined with TENS might be useful due to quick myalgic pain relief in the treatment of fibromyalgia in everyday practice.

Binocular Glaucomatous Visual Field Loss and Its Impact on Visual Exploration - A Supermarket Study

PubMed Central

Aehling, Kathrin; Heister, Martin; Rosenstiel, Wolfgang; Schiefer, Ulrich; Papageorgiou, Elena

2014-01-01

Advanced glaucomatous visual field loss may critically interfere with quality of life. The purpose of this study was to (i) assess the impact of binocular glaucomatous visual field loss on a supermarket search task as an example of everyday living activities, (ii) to identify factors influencing the performance, and (iii) to investigate the related compensatory mechanisms. Ten patients with binocular glaucoma (GP), and ten healthy-sighted control subjects (GC) were asked to collect twenty different products chosen randomly in two supermarket racks as quickly as possible. The task performance was rated as “passed” or “failed” with regard to the time per correctly collected item. Based on the performance of control subjects, the threshold value for failing the task was defined as μ+3σ (in seconds per correctly collected item). Eye movements were recorded by means of a mobile eye tracker. Eight out of ten patients with glaucoma and all control subjects passed the task. Patients who failed the task needed significantly longer time (111.47 s ±12.12 s) to complete the task than patients who passed (64.45 s ±13.36 s, t-test, p<0.001). Furthermore, patients who passed the task showed a significantly higher number of glances towards the visual field defect (VFD) area than patients who failed (t-test, p<0.05). According to these results, glaucoma patients with defects in the binocular visual field display on average longer search times in a naturalistic supermarket task. However, a considerable number of patients, who compensate by frequent glancing towards the VFD, showed successful task performance. Therefore, systematic exploration of the VFD area seems to be a “time-effective” compensatory mechanism during the present supermarket task. PMID:25162522

Binocular glaucomatous visual field loss and its impact on visual exploration--a supermarket study.

PubMed

Sippel, Katrin; Kasneci, Enkelejda; Aehling, Kathrin; Heister, Martin; Rosenstiel, Wolfgang; Schiefer, Ulrich; Papageorgiou, Elena

2014-01-01

Advanced glaucomatous visual field loss may critically interfere with quality of life. The purpose of this study was to (i) assess the impact of binocular glaucomatous visual field loss on a supermarket search task as an example of everyday living activities, (ii) to identify factors influencing the performance, and (iii) to investigate the related compensatory mechanisms. Ten patients with binocular glaucoma (GP), and ten healthy-sighted control subjects (GC) were asked to collect twenty different products chosen randomly in two supermarket racks as quickly as possible. The task performance was rated as "passed" or "failed" with regard to the time per correctly collected item. Based on the performance of control subjects, the threshold value for failing the task was defined as μ+3σ (in seconds per correctly collected item). Eye movements were recorded by means of a mobile eye tracker. Eight out of ten patients with glaucoma and all control subjects passed the task. Patients who failed the task needed significantly longer time (111.47 s ±12.12 s) to complete the task than patients who passed (64.45 s ±13.36 s, t-test, p < 0.001). Furthermore, patients who passed the task showed a significantly higher number of glances towards the visual field defect (VFD) area than patients who failed (t-test, p < 0.05). According to these results, glaucoma patients with defects in the binocular visual field display on average longer search times in a naturalistic supermarket task. However, a considerable number of patients, who compensate by frequent glancing towards the VFD, showed successful task performance. Therefore, systematic exploration of the VFD area seems to be a "time-effective" compensatory mechanism during the present supermarket task.

Thai Massage, and Thai Herbal Compress versus Oral Ibuprofen in Symptomatic Treatment of Osteoarthritis of the Knee: A Randomized Controlled Trial

PubMed Central

2014-01-01

The aim of this study was to verify the clinical responses to Thai massage (TM) and Thai herbal compression (THC) for treating osteoarthritis (OA) of the knee in comparison to oral ibuprofen. This study was a randomized, evaluator-blind, controlled trial. Sixty patients with OA of the knee were randomly assigned to receive either a one-hour session of TM or THC (three times weekly) or oral ibuprofen (three times daily). The duration of treatment was three weeks. The clinical assessments included visual analog scale assessing pain and stiffness, Lequesne's functional index, time for climbing up ten steps, and physician's and patient's overall opinions on improvement. In a within-group comparison, each treatment modality caused a significant improvement of all variables determined for outcome assessments. In an among group comparison, all modalities provided nearly comparable clinical efficacy after a three-week symptomatic treatment of OA of the knee, in which a trend toward greatest improvement was likely to be found in THC group. In conclusion, TM and THC generally provided comparable clinical efficacy to oral ibuprofen after three weeks of treatment and could be considered as complementary and alternative treatments for OA of the knee. PMID:25254207

Lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage: a prospective, randomized, controlled trial (LUMAS).

PubMed

Al-Tamimi, Yahia Z; Bhargava, Deepti; Feltbower, Richard G; Hall, Gregory; Goddard, Anthony J P; Quinn, Audrey C; Ross, Stuart A

2012-03-01

A single-center prospective randomized controlled trial has been conducted to determine if lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage reduces the prevalence of delayed ischemic neurological deficit and improves clinical outcome. Patients with World Federation of Neurological Surgeons Grade 1 to 3 aneurysmal subarachnoid hemorrhage and modified Fisher Grades 2, 3, 4, and 3+4 were randomized to either the study group of standard therapy plus insertion of a lumbar drain or the control group of standard therapy alone. The primary outcome measure was the prevalence of delayed ischemic neurological deficit. Two hundred ten patients with aneurysmal subarachnoid hemorrhage (166 female, 44 male; median age, 54 years; interquartile range, 45-62 years) were recruited into the control (n=105) and study (n=105) groups of the trial. World Federation of Neurological Surgeons grade was: 1 (n=139), 2 (n=60), and 3 (n=11); Fisher grade was: 2 (n=87), 3 (n=85), and 4 (n=38). The prevalence of delayed ischemic neurological deficit was 35.2% and 21.0% in the control and study groups, respectively (P=0.021). The prevalence of a modified Rankin Scale score of 4, 5, or 6 at Day 10 and 6 months, respectively, was 62.5% and 18.6% in the control group and 44.8% and 19.8% in the study group (P=0.009 and 0.83, respectively). Lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage has been shown to reduce the prevalence of delayed ischemic neurological deficit and improve early clinical outcome but failed to improve outcome at 6 months after aneurysmal subarachnoid hemorrhage. URL: www.clinicaltrials.gov. Unique identifier: NCT00842049.

Change in quality of life in older people with dementia participating in Paro-activity: a cluster-randomized controlled trial.

PubMed

Jøranson, Nina; Pedersen, Ingeborg; Rokstad, Anne Marie Mork; Ihlebaek, Camilla

2016-12-01

The aim of this study was to investigate effects of robot-assisted group activity with Paro on quality of life in older people with dementia. Nursing home residents with severe dementia often experience social withdrawal and lower quality of life, which are suggested to be enhanced by non-pharmacological interventions. A cluster-randomized controlled trial. Ten nursing home units were randomized to robot-assisted intervention or control group (treatment as usual). Data were collected between March 2013-September 2014. 27 participants participated in group activity for 30 minutes twice a week over 12 weeks, 26 participated in the control group. Change in quality of life was assessed by local nurses through the Quality of Life in Late-Stage Dementia scale at baseline, after end of intervention and at 3 months follow-up. The scale and regular psychotropic medication were analysed stratified by dementia severity. Analysis using mixed model, one-way anova and linear regression were performed. An effect was found among participants with severe dementia from baseline to follow-up showing stable quality of life in the intervention group compared with a decrease in the control group. The intervention explained most of the variance in change in the total scale and in the subscales describing Tension and Well-being for the group with severe dementia. The intervention group used significantly less psychotropic medication compared with the control group after end of intervention. Pleasant and engaging activities facilitated by nursing staff, such as group activity with Paro, could improve quality of life in people with severe dementia. The trial is in adherence with the CONSORT statement and is registered at www.clinicaltrials.gov (study ID number: NCT02008630). © 2016 John Wiley & Sons Ltd.

Formal Physical Therapy After Total Hip Arthroplasty Is Not Required: A Randomized Controlled Trial.

PubMed

Austin, Matthew S; Urbani, Brian T; Fleischman, Andrew N; Fernando, Navin D; Purtill, James J; Hozack, William J; Parvizi, Javad; Rothman, Richard H

2017-04-19

The value of formal physical therapy after total hip arthroplasty is unknown. With substantial changes that have occurred in surgical and anesthesia techniques, self-directed therapy may be efficacious in restoring function to patients undergoing total hip arthroplasty. We conducted a single-center, randomized trial of 120 patients undergoing primary, unilateral total hip arthroplasty who were eligible for direct home discharge. The experimental group followed a self-directed home exercise program for 10 weeks. The control group received the standard protocol for physical therapy that included in-home visits with a physical therapist for the first 2 weeks followed by formal outpatient physical therapy for 8 weeks. Functional outcomes were measured using validated instruments including the Harris hip score (HHS), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Short Form-36 Health Survey (SF-36) preoperatively, at 1 month postoperatively, and at 6 to 12 months postoperatively. Of 120 randomized patients, 108 were included in the final analysis. Ten patients (19%) were randomized to unsupervised home exercise and 20 patients (37%) were randomized to formal outpatient therapy crossed over between groups. There was no significant difference in any of the measured functional outcomes between patients receiving formal therapy (n = 54) and those participating in unsupervised home exercise (n = 54) at any time point (HHS, p = 0.82; WOMAC, p = 0.80; and SF-36 physical health, p = 0.90). This randomized trial suggests that unsupervised home exercise is both safe and efficacious for a majority of patients undergoing total hip arthroplasty, and formal physical therapy may not be required. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Effectiveness of dry needling versus a classical physiotherapy program in patients with chronic low-back pain: a single-blind, randomized, controlled trial.

PubMed

Tüzün, Emİne Handan; Gıldır, Sıla; Angın, Ender; Tecer, Büşra Hande; Dana, Kezban Öztürk; Malkoç, Mehtap

2017-09-01

[Purpose] We compared the effectiveness of dry needling with a classical physiotherapy program in patients with chronic low-back pain caused by lumbar disc hernia (LHNP). [Subjects and Methods] In total, 34 subjects were allocated randomly to the study (n=18) and control groups (n=16). In the study group, dry needling was applied using acupuncture needles. The control group performed a home exercise program in addition to hot pack, TENS, and ultrasound applications. Pain was assessed with the short form of the McGill Pain Questionnaire. The number of trigger points and their pressure sensitivity were evaluated with a physical examination (palpation). The Beck Depression Inventory was used to assess depression. The Tampa Kinesiophobia Scale was used to assess fear of movement. [Results] In the study group, the calculated Cohen's effect sizes were bigger than those in the control group in terms of pain, trigger point-related variables, and fear of movement. Effect sizes for reducing depressive symptoms were similar in both groups. [Conclusion] These results suggest that dry needling can be an effective treatment for reducing pain, number of trigger points, sensitivity, and kinesiophobia in patients with chronic low-back pain caused by lumbar disc hernia.

Interventions to Promote Colorectal Cancer Screening: An Integrative Review

PubMed Central

Rawl, Susan M.; Menon, Usha; Burness, Allison; Breslau, Erica S.

2012-01-01

Behavior change interventions to promote colorectal cancer (CRC) screening have targeted people in community and primary care settings, health care providers, and health systems. Randomized controlled trials provide the strongest evidence of intervention efficacy. The purpose of this integrative review was to evaluate trials of CRC screening interventions published between 1997 and 2007 and to identify knowledge gaps and future directions for research. Thirty-three randomized trials that met inclusion criteria were evaluated using a modified version of the TREND criteria. Significant intervention effects were reported in six out of ten trials focused on increasing fecal occult blood testing, four of seven trials focused on sigmoidoscopy or colonoscopy completion, and nine of 16 focused on completion of any screening test. Several effective interventions to promote CRC screening were identified. Future trials need to use theory to guide interventions, examine moderators and mediators, consistently report results, and use comparable outcome measures. PMID:22261002

Whole of Systems Trial of Prevention Strategies for Childhood Obesity: WHO STOPS Childhood Obesity.

PubMed

Allender, Steven; Millar, Lynne; Hovmand, Peter; Bell, Colin; Moodie, Marj; Carter, Rob; Swinburn, Boyd; Strugnell, Claudia; Lowe, Janette; de la Haye, Kayla; Orellana, Liliana; Morgan, Sue

2016-11-16

Background : Community-based initiatives show promise for preventing childhood obesity. They are characterized by community leaders and members working together to address complex local drivers of energy balance. Objectives : To present a protocol for a stepped wedge cluster randomized trial in ten communities in the Great South Coast Region of Victoria, Australia to test whether it is possible to: (1) strengthen community action for childhood obesity prevention, and (2) measure the impact of increased action on risk factors for childhood obesity. Methods: The WHO STOPS intervention involves a facilitated community engagement process that: creates an agreed systems map of childhood obesity causes for a community; identifies intervention opportunities through leveraging the dynamic aspects of the system; and, converts these understandings into community-built, systems-oriented action plans. Ten communities will be randomized (1:1) to intervention or control in year one and all communities will be included by year three. The primary outcome is childhood obesity prevalence among grade two (ages 7-8 y), grade four (9-10 y) and grade six (11-12 y) students measured using our established community-led monitoring system (69% school and 93% student participation rate in government and independent schools). An additional group of 13 external communities from other regions of Victoria with no specific interventions will provide an external comparison. These communities will also allow us to assess diffusion of the intervention to control communities during the first three years of the trial. Conclusion : This trial will test effectiveness, over a five-year period, of community-owned, -supported and -led strategies designed to address complex and dynamic causes of childhood obesity.

Benefits of home-based rocking-chair exercise for physical performance in community-dwelling elderly women: a randomized controlled trial.

PubMed

Niemelä, Kristiina; Väänänen, Ilkka; Leinonen, Raija; Laukkanen, Pia

2011-08-01

Home-based exercise is a viable alternative for older adults with difficulties in exercise opportunities outside the home. The aim of this study was to investigate the benefits of home-based rocking-chair training, and its effects on the physical performance of elderly women. Community- dwelling women (n=51) aged 73-87 years were randomly assigned to the rocking-chair group (RCG, n=26) or control group (CG, n=25) by drawing lots. Baseline and outcome measurements were hand grip strength, maximal isometric knee extension, maximal walking speed over 10 meters, rising from a chair five times, and the Berg Balance Scale (BBS). The RCG carried out a six-week rocking-chair training program at home, involving ten sessions per week, twice a day for 15 minutes per session, and ten different movements. The CG continued their usual daily lives. After three months, the RCG responded to a mail questionnaire. After the intervention, the RCG improved and the CG declined. The data showed significant interactions of group by time in the BBS score (p=0.001), maximal knee extension strength (p=0.006) and maximal walking speed (p=0.046), which indicates that the change between groups during the follow-up period was significant. Adherence to the training protocol was high (96%). After three months, the exercise program had become a regular home exercise habit for 88.5% of the subjects. Results indicate that home-based elderly women benefit from this easily implemented rocking-chair exercise program. The subjects became motivated to participate in training and continued the exercises. This is a promising alternative exercise method for maintaining physical activity and leads to improvements in physical performance.

Whole of Systems Trial of Prevention Strategies for Childhood Obesity: WHO STOPS Childhood Obesity

PubMed Central

Allender, Steven; Millar, Lynne; Hovmand, Peter; Bell, Colin; Moodie, Marj; Carter, Rob; Swinburn, Boyd; Strugnell, Claudia; Lowe, Janette; de la Haye, Kayla; Orellana, Liliana; Morgan, Sue

2016-01-01

Background: Community-based initiatives show promise for preventing childhood obesity. They are characterized by community leaders and members working together to address complex local drivers of energy balance. Objectives: To present a protocol for a stepped wedge cluster randomized trial in ten communities in the Great South Coast Region of Victoria, Australia to test whether it is possible to: (1) strengthen community action for childhood obesity prevention, and (2) measure the impact of increased action on risk factors for childhood obesity. Methods: The WHO STOPS intervention involves a facilitated community engagement process that: creates an agreed systems map of childhood obesity causes for a community; identifies intervention opportunities through leveraging the dynamic aspects of the system; and, converts these understandings into community-built, systems-oriented action plans. Ten communities will be randomized (1:1) to intervention or control in year one and all communities will be included by year three. The primary outcome is childhood obesity prevalence among grade two (ages 7–8 y), grade four (9–10 y) and grade six (11–12 y) students measured using our established community-led monitoring system (69% school and 93% student participation rate in government and independent schools). An additional group of 13 external communities from other regions of Victoria with no specific interventions will provide an external comparison. These communities will also allow us to assess diffusion of the intervention to control communities during the first three years of the trial. Conclusion: This trial will test effectiveness, over a five-year period, of community-owned, -supported and -led strategies designed to address complex and dynamic causes of childhood obesity. PMID:27854354

Systematic Review of Three Electrical Stimulation Techniques for Rehabilitation After Total Knee Arthroplasty.

PubMed

Yue, Chen; Zhang, Xue; Zhu, Yingjie; Jia, Yudong; Wang, Huichao; Liu, Youwen

2018-07-01

The comparative effectiveness of neuromuscular electrical stimulation (NMES), transcutaneous electrical nerve stimulation (TENS), and electroacupuncture (EA) for improving patient rehabilitation following total knee arthroplasty (TKA) is controversial. Therefore we conducted this systematic review to assess the available evidence. The PubMed, OVID, and ScienceDirect databases were comprehensively searched and studies were selected and analyzed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) recommendations. Data were extracted and qualitatively synthesized for several outcomes. Data were analyzed from 17 randomized controlled trials involving 1285 procedures: 8 NMES studies (608 procedures), 7 TENS studies (560 procedures), and 2 EA studies (117 procedures). Qualitative analysis suggested that NMES was associated with higher quadriceps strength and functional recovery after TKA. Recovery benefits were maximal when the stimulation was performed once or twice a day for 4-6 weeks at an intensity of 100-120 mA and frequency of 30-100 Hz. The electrode should be sufficiently large (100-200 cm 2 ) to reduce discomfort. TENS at an intensity of 15-40 mA and frequency of 70-150 Hz provided effective analgesia after TKA. EA at an intensity of 2 mA and frequency of 2 Hz may also provide postoperative analgesia of TKA. As adjunct modalities, NMES and TENS can effectively improve rehabilitation after TKA without triggering significant intolerance, and maximal benefits depend on optimized parameters and intervention protocols. EA may be an effective adjunct modality for analgesia after TKA. Copyright © 2018 Elsevier Inc. All rights reserved.

Transcutaneous electrical nerve stimulation for acute pain.

PubMed

Johnson, Mark I; Paley, Carole A; Howe, Tracey E; Sluka, Kathleen A

2015-06-15

This is a second update of a Cochrane Review originally published in Issue 2, 2009. Transcutaneous Electrical Nerve Stimulation (TENS) is a non-pharmacological agent, based on delivering low voltage electrical currents to the skin. TENS is used by people to treat a variety of pain conditions. To assess the analgesic effectiveness of TENS, as a sole treatment, for acute pain in adults. We searched the following databases up to 3 December 2014: the Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library; MEDLINE; EMBASE; CINAHL; and AMED. We also checked the reference lists of included trials. We included randomised controlled trials (RCTs) of adults with acute pain (< 12 weeks) if they examined TENS given as a sole treatment and assessed pain with subjective pain scales. Trials were eligible if they compared TENS to placebo TENS, no treatment controls, pharmacological interventions or non-pharmacological interventions. We excluded trials on experimental pain, case reports, clinical observations, letters, abstracts or reviews. Also we excluded trials investigating the effect of TENS on pain during childbirth (labour), primary dysmenorrhoea or dental procedures. Studies where TENS was given with another treatment as part of the formal trial design were excluded. We did not restrict any articles based on language of publication. Two review authors independently assessed study eligibility and carried out study selection, data extraction, 'Risk of bias' assessment and analyses of data. We extracted data on the following: types of participants and pain condition, trial design and methods, treatment parameters, adverse effects, and outcome measures. We contacted trial authors for additional information if necessary. We included 12 trials in the original review (2009) and included no further trials in the first update (2011). An additional seven new trials met the inclusion criteria in this second update. In total, we included 19 RCTs involving 1346 participants at entry, with 11 trials awaiting classification either because the full text was unavailable or information in the full text failed to clarify eligibility. We excluded most trials because TENS was given in combination with another treatment as part of the formal study design or TENS was not delivered using appropriate TENS technique. The types of acute pain included in this Cochrane Review were procedural pain, e.g. cervical laser treatment, venepuncture, screening flexible sigmoidoscopy and non-procedural pain, e.g. postpartum uterine contractions and rib fractures. We pooled data for pain intensity for six trials (seven comparisons) comparing TENS with placebo but the I(2) statistic suggested substantial heterogeneity. Mean difference (MD) with 95% confidence intervals (CIs) on a visual analogue scale (VAS, 100 mm) was -24.62 mm (95% CI -31.79 to -17.46) in favour of TENS. Data for the proportion of participants achieving ≥ 50% reduction in pain was pooled for four trials (seven comparisons) and relative risk was 3.91 (95% CI 2.42 to 6.32) in favour of TENS over placebo. We pooled data for pain intensity from five trials (seven comparisons) but the I(2) statistic suggested considerable heterogeneity. MD was -19.05 mm (95% CI -27.30 to -10.79) in favour of TENS using a random-effects model. It was not possible to pool other data. There was a high risk of bias associated with inadequate sample sizes in treatment arms and unsuccessful blinding of treatment interventions. Seven trials reported minor adverse effects, such as mild erythema and itching underneath the electrodes and participants disliking TENS sensation. This Cochrane Review update includes seven new trials, in addition to the 12 trials reviewed in the first update in 2011. The analysis provides tentative evidence that TENS reduces pain intensity over and above that seen with placebo (no current) TENS when administered as a stand-alone treatment for acute pain in adults. The high risk of bias associated with inadequate sample sizes in treatment arms and unsuccessful blinding of treatment interventions makes definitive conclusions impossible. There was incomplete reporting of treatment in many reports making replication of trials impossible.

Effect of transcutaneous electrical stimulation treatment on lower urinary tract symptoms after class III radical hysterectomy in cervical cancer patients: study protocol for a multicentre, randomized controlled trial.

PubMed

Sun, Xiu-Li; Wang, Hai-Bo; Wang, Zhi-Qi; Cao, Ting-Ting; Yang, Xin; Han, Jing-Song; Wu, Yang-Feng; Reilly, Kathleen H; Wang, Jian-Liu

2017-06-15

Class III radical hysterectomy (RH III)_plus pelvic lymphadenectomy is the standard surgery for early stage cervical cancer (CC) patients, the 5 year survival rate is about 90%, but pelvic floor disorders especially bladder dysfunction are common due to damaged vessels and nerve fibers following surgery. Transcutaneous electrical stimulation (TENS) treatment has been used to treat bladder disorders for many years, but its effect on cervical cancer patients, the best treatment time point and stimulated protocol, had never been assessed. The aim of this study is to investigate the efficacy of TENS treatment on lower urinary tract symptoms (LUTS) after RH III in CC patients. The study will be conducted as a clinical, multicentre, randomised controlled trial with balanced randomisation (1:1). The planned sample size is 208 participants (at 1:1 ratio, 104 subjects in each group). At 5-7 days after RH III, patients are screened according to operative and pathological findings. Enrolled participants are randomised into an intervention group (TENS plus conventional clinical care) or control group (conventional clinical care), with stratification by menopausal status (menopause vs. non-menopause) and surgical modality (laparoscopic RH or abdominal RH). Participants in both groups will be followed up at 14 days, 21 days, 28 days, 3 months, 6 months, 12 months, 18 months and 24 months after surgery. The primary endpoint is improvement rate of urination function which is defined as recovery (residual urine ≤50 ml) or improvement (residual urine 50-100 ml). Secondary endpoints include urodynamic parameter, urinary incontinence, anorectal function, pelvic function, quality of life (QOL), disease-free survival and adverse events. Primary endpoint analyses will be carried out by Cochran-Mantel-Haenszel tests taking into center effect. To our knowledge this is the first trial to investigate the effect of TENS treatment on bladder function recovery after RH III among CC patients. This study will provide new information on TENS efficacy for bladder function recovery. Once confirmed, it may help to provide a new, non-invisive treatment for those postoperative CC patients with poor pelvic function, which would help improve their quality of life. The study is registered to Clinical Trials.gov ( NCT02492542 ) on June 25, 2015.

Effects of Intra-Aortic Balloon Counterpulsation Pump on Mortality of Acute Myocardial Infarction

PubMed Central

Ye, Liwen; Zheng, Minming; Chen, Qingwei; Li, Guiqion; Deng, Wei; Ke, Dazhi

2014-01-01

Background Several randomized controlled trials (RCTs) have evaluated the effect of intra-aortic balloon counterpulsation pump(IABP) on the mortality of acute myocardial infarction (AMI). Objectives To analyze the relevant RCT data on the effect of IABP on mortality and the occurrence of bleeding in AMI. Data Sources Published RCTs on the treatment of AMI by IABP were retrieved in searches of Medline, EMBASE, Cochrane and other related databases. The last search was conducted on July 20, 2014. Study Eligibility Criteria Randomized clinical trials comparing IABP to controls as treatment for AMI. Participants Patients with AMI. Synthesis Methods The primary endpoint was mortality, and the secondary endpoint was bleeding events. To account for to heterogeneity, a random-effects model was used to analyze the study data. Results Ten trials with a total population of 973 patients that were included in the analysis showed no significant difference in 2-month mortality between the IABP and the control groups. The 6-month mortality in the IABP group was not significantly lower than in the control group in the four RCTs that enrolled 59 AMI patients with CS. But in the four that enrolled AMI 66 patients without CS, the data showed opposite conclusion. Conclusions IABP cannot reduce within 2 months and 6–12 months mortality of AMI patients with CS as well as within 2 months mortality of AMI patients without CS, but can reduce 6–12 months mortality of AMI patients without CS. In addition, IABP can increase the risk of bleeding. PMID:25268800

The impact of occupational therapy in Parkinson's disease: a randomized controlled feasibility study.

PubMed

Sturkenboom, Ingrid H; Graff, Maud J; Borm, George F; Veenhuizen, Yvonne; Bloem, Bastiaan R; Munneke, Marten; Nijhuis-van der Sanden, Maria W

2013-02-01

To evaluate the feasibility of a randomized controlled trial including process and potential impact of occupational therapy in Parkinson's disease. Process and outcome were quantitatively and qualitatively evaluated in an exploratory multicentre, two-armed randomized controlled trial at three months. Forty-three community-dwelling patients with Parkinson's disease and difficulties in daily activities, their primary caregivers and seven occupational therapists. Ten weeks of home-based occupational therapy according to the Dutch guidelines of occupational therapy in Parkinson's disease versus no occupational therapy in the control group. Process evaluation measured accrual, drop-out, intervention delivery and protocol adherence. Primary outcome measures of patients assessed daily functioning: Canadian Occupational Performance Measure (COPM) and Assessment of Motor and Process Skills. Primary outcome for caregivers was caregiver burden: Zarit Burden Inventory. Participants' perspectives of the intervention were explored using questionnaires and in-depth interviews. Inclusion was 23% (43/189), drop-out 7% (3/43) and unblinding of assessors 33% (13/40). Full intervention protocol adherence was 74% (20/27), but only 60% (71/119) of baseline Canadian Occupational Performance Measure priorities were addressed in the intervention. The outcome measures revealed negligible to small effects in favour of the intervention group. Almost all patients and caregivers of the intervention group were satisfied with the results. They perceived: 'more grip on the situation' and used 'practical advices that make life easier'. Therapists were satisfied, but wished for a longer intervention period. The positive perceived impact of occupational therapy warrants a large-scale trial. Adaptations in instructions and training are needed to use the Canadian Occupational Performance Measure as primary outcome measure.

A single blind randomized control trial on support groups for Chinese persons with mild dementia.

PubMed

Young, Daniel K W; Kwok, Timothy C Y; Ng, Petrus Y N

2014-01-01

Persons with mild dementia experience multiple losses and manifest depressive symptoms. This research study aimed to evaluate the effectiveness of a support group led by a social worker for Chinese persons with mild dementia. Participants were randomly assigned to either a ten-session support group or a control group. Standardized assessment tools were used for data collection at pretreatment and post-treatment periods by a research assistant who was kept blind to the group assignment of the participants. Upon completion of the study, 20 treatment group participants and 16 control group participants completed all assessments. At baseline, the treatment and control groups did not show any significant difference on all demographic variables, as well as on all baseline measures; over one-half (59%) of all the participants reported having depression, as assessed by a Chinese Geriatric Depression Scale score ≥8. After completing the support group, the depressive mood of the treatment group participants reduced from 8.83 (standard deviation =2.48) to 7.35 (standard deviation =2.18), which was significant (Wilcoxon signed-rank test; P=0.017, P<0.05), while the control group's participants did not show any significant change. This present study supports the efficacy and effectiveness of the support group for persons with mild dementia in Chinese society. In particular, this present study shows that a support group can reduce depressive symptoms for participants.

One-year outcomes of repeated adjunctive photodynamic therapy during periodontal maintenance: a proof-of-principle randomized-controlled clinical trial.

PubMed

Lulic, Martina; Leiggener Görög, Isabelle; Salvi, Giovanni E; Ramseier, Christoph A; Mattheos, Nikolaos; Lang, Niklaus P

2009-08-01

Single photodynamic therapy (PDT) has been effective in initial periodontal therapy, but only improved bleeding on probing (BoP) in maintenance patients after a single use. Repeated PDT has not been addressed. To study the possible added benefits of repeated adjunctive PDT to conventional treatment of residual pockets in patients enrolled in periodontal maintenance. Ten maintenance patients with 70 residual pockets [probing pocket depth (PPD)>or=5 mm] were randomly assigned for treatment five times in 2 weeks (Days 0, 1, 2, 7, 14) with PDT (test) or non-activated laser (control) following debridement. The primary outcome variable was PPD, and the secondary variables were clinical attachment level (CAL) and BoP. These were assessed at 3, 6 and 12 months following the interventions. Greater PPD reductions were observed in the test (-0.67 +/- 0.34; p=0.01) compared with the control patients (-0.04 +/- 0.33; NS) after 6 months. Significant CAL gain (+0.52 +/- 0.31; p=0.01) was noted for the test, but not in the control (-0.27 +/- 0.52; NS) patients after 6 months. BoP percentages decreased significantly in test (97-64%, 67%, 77%), but not control patients after 3, 6 and 12 months. Repeated (five times) PDT adjunctive to debridement yielded improved clinical outcomes in residual pockets in maintenance patients. The effects were best documented after 6 months.

Effect of a decision aid with patient narratives in reducing decisional conflict in choice for surgery among early-stage breast cancer patients: A three-arm randomized controlled trial.

PubMed

Osaka, Wakako; Nakayama, Kazuhiro

2017-03-01

We aimed to evaluate the effect of a decision aid (DA) with patient narratives on decisional conflict in surgery choice for Japanese women with early-stage breast cancer. Two hundred ten women with early-stage breast cancer were randomly assigned to an intervention or control group. Groups 1 and 2 received standard information and a DA, with or without patient narratives, and Group 3 received standard information (control) before surgery choice. At baseline, post-intervention (Time 2), and 1 month after surgery (Time 3), we evaluated decisional conflict as the primary outcome using a decisional conflict scale (DCS). Sidak corrections for multiple comparisons in analysis of covariate were used to compare Time 2 and Time 3 DCS mean scores between each pair of groups. At Time 3, decisional conflict was significantly reduced for Group 1 vs control (P=0.021, Cohen's d =0.26) and Group 2 vs control (P=0.008, Cohen's d=0.40). The DAs with and without patient narratives are equivalently effective at reducing postoperative decisional conflict in Japanese women with early-stage breast cancer. The DAs with and without patient narratives can be used in clinical practice for women with early-stage breast cancer. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Web-Based Decision Aid to Assist Help-Seeking Choices for Young People Who Self-Harm: Outcomes From a Randomized Controlled Feasibility Trial.

PubMed

Rowe, Sarah L; Patel, Krisna; French, Rebecca S; Henderson, Claire; Ougrin, Dennis; Slade, Mike; Moran, Paul

2018-01-30

Adolescents who self-harm are often unsure how or where to get help. We developed a Web-based personalized decision aid (DA) designed to support young people in decision making about seeking help for their self-harm. The aim of this study was to evaluate the feasibility and acceptability of the DA intervention and the randomized controlled trial (RCT) in a school setting. We conducted a two-group, single blind, randomized controlled feasibility trial in a school setting. Participants aged 12 to 18 years who reported self-harm in the past 12 months were randomized to either a Web-based DA or to general information about mood and feelings. Feasibility of recruitment, randomization, and follow-up rates were assessed, as was acceptability of the intervention and study procedures. Descriptive data were collected on outcome measures examining decision making and help-seeking behavior. Qualitative interviews were conducted with young people, parents or carers, and staff and subjected to thematic analysis to explore their views of the DA and study processes. Parental consent was a significant barrier to young people participating in the trial, with only 17.87% (208/1164) of parents or guardians who were contacted for consent responding to study invitations. Where parental consent was obtained, we were able to recruit 81.7% (170/208) of young people into the study. Of those young people screened, 13.5% (23/170) had self-harmed in the past year. Ten participants were randomized to receiving the DA, and 13 were randomized to the control group. Four-week follow-up assessments were completed with all participants. The DA had good acceptability, but qualitative interviews suggested that a DA that addressed broader mental health problems such as depression, anxiety, and self-harm may be more beneficial. A broad-based mental health DA addressing a wide range of psychosocial problems may be useful for young people. The requirement for parental consent is a key barrier to intervention research on self-harm in the school setting. Adaptations to the research design and the intervention are needed before generalizable research about DAs can be successfully conducted in a school setting. International Standard Randomized Controlled Trial registry: ISRCTN11230559; http://www.isrctn.com/ISRCTN11230559 (Archived by WebCite at http://www.webcitation.org/6wqErsYWG). ©Sarah L Rowe, Krisna Patel, Rebecca S French, Claire Henderson, Dennis Ougrin, Mike Slade, Paul Moran. Originally published in JMIR Mental Health (http://mental.jmir.org), 30.01.2018.

Web-Based Decision Aid to Assist Help-Seeking Choices for Young People Who Self-Harm: Outcomes From a Randomized Controlled Feasibility Trial

PubMed Central

Patel, Krisna; French, Rebecca S; Henderson, Claire; Ougrin, Dennis; Slade, Mike; Moran, Paul

2018-01-01

Background Adolescents who self-harm are often unsure how or where to get help. We developed a Web-based personalized decision aid (DA) designed to support young people in decision making about seeking help for their self-harm. Objective The aim of this study was to evaluate the feasibility and acceptability of the DA intervention and the randomized controlled trial (RCT) in a school setting. Methods We conducted a two-group, single blind, randomized controlled feasibility trial in a school setting. Participants aged 12 to 18 years who reported self-harm in the past 12 months were randomized to either a Web-based DA or to general information about mood and feelings. Feasibility of recruitment, randomization, and follow-up rates were assessed, as was acceptability of the intervention and study procedures. Descriptive data were collected on outcome measures examining decision making and help-seeking behavior. Qualitative interviews were conducted with young people, parents or carers, and staff and subjected to thematic analysis to explore their views of the DA and study processes. Results Parental consent was a significant barrier to young people participating in the trial, with only 17.87% (208/1164) of parents or guardians who were contacted for consent responding to study invitations. Where parental consent was obtained, we were able to recruit 81.7% (170/208) of young people into the study. Of those young people screened, 13.5% (23/170) had self-harmed in the past year. Ten participants were randomized to receiving the DA, and 13 were randomized to the control group. Four-week follow-up assessments were completed with all participants. The DA had good acceptability, but qualitative interviews suggested that a DA that addressed broader mental health problems such as depression, anxiety, and self-harm may be more beneficial. Conclusions A broad-based mental health DA addressing a wide range of psychosocial problems may be useful for young people. The requirement for parental consent is a key barrier to intervention research on self-harm in the school setting. Adaptations to the research design and the intervention are needed before generalizable research about DAs can be successfully conducted in a school setting. Trial Registration International Standard Randomized Controlled Trial registry: ISRCTN11230559; http://www.isrctn.com/ISRCTN11230559 (Archived by WebCite at http://www.webcitation.org/6wqErsYWG) PMID:29382626

Warm-needle moxibustion for spasticity after stroke: A systematic review of randomized controlled trials.

PubMed

Yang, Liu; Tan, Jing-Yu; Ma, Haili; Zhao, Hongjia; Lai, Jinghui; Chen, Jin-Xiu; Suen, Lorna K P

2018-03-22

Spasticity is a common post-stroke complication, and it results in substantial deterioration in the quality of life of patients. Although potential positive effects of warm-needle moxibustion on spasticity after stroke have been observed, evidence on its definitive effect remains uncertain. This study aimed to summarize clinical evidence pertaining to therapeutic effects and safety of warm-needle moxibustion for treating spasticity after stroke. Randomized controlled trials were reviewed systematically on the basis of the Cochrane Handbook for Systematic Reviews of Interventions. The report follows the PRISMA statement. Ten electronic databases (PubMed, CENTRAL, EMBASE, AMED, CINAHL, Web of Science, CBM, CNKI, WanFang, and VIP) were explored, and articles were retrieved manually from two Chinese journals (The Journal of Traditional Chinese Medicine and Zhong Guo Zhen Jiu) through retrospective search. Randomized controlled trials with warm-needle moxibustion as treatment intervention for patients with limb spasm after stroke were included in this review. The risk of bias assessment tool was utilized in accordance with Cochrane Handbook 5.1.0. All included studies reported spasm effect as primary outcome. Effect size was estimated using relative risk, standardized mean difference, or mean difference with a corresponding 95% confidence interval. Review Manager 5.3 was utilized for meta-analysis. Twelve randomized controlled trials with certain methodological flaws and risk of bias were included, and they involved a total of 878 participants. Warm-needle moxibustion was found to be superior to electroacupuncture or acupuncture in reducing spasm and in promoting motor function and daily living activities. Pooled results for spasm effect and motor function were significant when warm-needle moxibustion was compared with electroacupuncture or acupuncture. A comparison of daily living activities indicated significant differences between warm-needle moxibustion and electroacupuncture. However, no difference was observed between warm-needle moxibustion and acupuncture. Warm-needle moxibustion may be a promising intervention to reduce limb spasm as well as improve motor function and daily living activities for stroke patients with spasticity. However, evidence was not conclusive. Rigorously designed randomized controlled trials with sample sizes larger than that in the included trials should be conducted for verification. Copyright © 2018 Elsevier Ltd. All rights reserved.

Analysis of the Habitat of Henslow's Sparrows and Grasshopper Sparrows Compared to Random Grassland Areas

DOE Office of Scientific and Technical Information (OSTI.GOV)

Maier, K.; Walton, R.; Kasper, P.

2006-01-01

ABSTRAC T Henslow’s Sparrows are endangered prairie birds, and Grasshopper Sparrows are considered rare prairie birds. Both of these birds were abundant in Illinois, but their populations have been declining due to loss of the grasslands. This begins an ongoing study of the birds’ habitat so Fermilab can develop a land management plan for the Henslow’s and Grasshoppers. The Henslow’s were found at ten sites and Grasshoppers at eight sites. Once the birds were located, the vegetation at their sites was studied. Measurements of the maximum plant height, average plant height, and duff height were taken and estimates of themore » percent of grass, forbs, duff, and bare ground were recorded for each square meter studied. The same measurements were taken at ten random grassland sites on Fermilab property. Several t-tests were performed on the data, and it was found that both Henslow’s Sparrows and Grasshopper Sparrows preferred areas with a larger percentage of grass than random areas. Henslow’s also preferred areas with less bare ground than random areas, while Grasshoppers preferred areas with more bare ground than random areas. In addition, Grasshopper Sparrows preferred a lower percentage of forbs than was found in random areas and a shorter average plant height than the random locations. Two-sample variance tests suggested significantly less variance for both Henslow’s Sparrows and Grasshopper Sparrows for maximum plant height in comparison to the random sites.« less

Insertional inactivation of oprD in carbapenem-resistant Pseudomonas aeruginosa strains isolated from burn patients in Tehran, Iran.

PubMed

Shariati, A; Azimi, T; Ardebili, A; Chirani, A S; Bahramian, A; Pormohammad, A; Sadredinamin, M; Erfanimanesh, S; Bostanghadiri, N; Shams, S; Hashemi, A

2018-01-01

In this study, we report the insertion sequence IS Ppu 21 in the opr D porin gene of carbapenem-resistant Pseudomonas aeruginosa isolates from burn patients in Tehran, Iran. Antibiotic susceptibility tests for P. aeruginosa isolates were determined. Production of metallo-β-lactamases (MBLs) and carbapenemase was evaluated and the β-lactamase-encoding and aminoglycoside-modifying enzyme genes were investigated by PCR and sequencing methods. The mRNA transcription level of oprD and mex efflux pump genes were evaluated by real-time PCR. The outer membrane protein profile was determined by SDS-PAGE. The genetic relationship between the P. aeruginosa isolates was assessed by random amplified polymorphic DNA PCR. In all, 10.52% (10/95) of clinical isolates of P. aeruginosa harboured the IS Ppu 21 insertion element in the opr D gene. The extended-spectrum β-lactamase-encoding gene in IS Ppu 21-carrying isolates was bla TEM . PCR assays targeting MBL and carbapenemase-encoding genes were also negative in all ten isolates. The rmt A, aad A, aad B and arm A genes were positive in all IS Ppu 21 harbouring isolates. The relative expression levels of the mex X, mex B, mex T and mex D genes in ten isolates ranged from 0.1- to 1.4-fold, 1.1- to 3.68-fold, 0.3- to 8.22-fold and 1.7- to 35.17-fold, respectively. The relative expression levels of the oprD in ten isolates ranged from 0.57- to 35.01-fold, which was much higher than those in the control strain P. aeruginosa PAO1. Evaluation of the outer membrane protein by SDS-PAGE suggested that opr D was produced at very low levels by all isolates. Using random amplified polymorphic DNA PCR genotyping, eight of the ten isolates containing IS Ppu 21 were shown to be clonally related. The present study describes a novel molecular mechanism, IS Ppu 21 insertion of the opr D gene, associated with carbapenem resistance in clinical P. aeruginosa isolates.

A Randomized Control Study on Psycho-Education Group on Improving Health-Related Quality of Life of Chinese Persons with Major Neurocognitive Disorder.

PubMed

Young, Kim-Wan

2016-01-01

People with a major neurocognitive disorder (PwND) are found to have a lower health related quality of life (HRQoL) than those without neurocognitive disorder. This research study aims to evaluate the effectiveness of a psycho-education group in improving the HRQoL of Chinese PwND. By adopting randomized control trial (RCT), Chinese PwND were randomly assigned to either a 10-session psycho-education group or the control group. Family caregivers of treatment group were encouraged to take part in two sessions focusing on the caring and communication skills. Control group and their family caregivers received standardized educational materials on basic information on neurocognitive disorder for them to read at home. Standardized assessment was conducted both with PwND and their caregivers independently to give the self-rated and caregiver-rated HRQoL of PwND in the pre- and post- treatment periods by a research assistant who was blind to the group assignment of the participants. Moreover, qualitative interviews were also conducted for ten participants and five family caregivers of the treatment group to identify those group elements relating to its effectiveness. 2 × 2 repeated measures ANCOVA demonstrated that the treatment group (n = 32) was significantly more effective than the control group (n = 32) in improving the caregiver-rated HRQoL (F[1, 61] = 4.35, p = .04 < .05) with a moderate effect size, but not self-rated HRQoL, Qualitative analysis suggested several group elements relating to its effectiveness. This present RCT shows that the psycho-education group significantly improves caregiver-rated HRQoL of PwND, supporting the feasibility and effectiveness of the psycho-education group.

Efficacy, tolerability and safety of cannabinoids in chronic pain associated with rheumatic diseases (fibromyalgia syndrome, back pain, osteoarthritis, rheumatoid arthritis): A systematic review of randomized controlled trials.

PubMed

Fitzcharles, M-A; Baerwald, C; Ablin, J; Häuser, W

2016-02-01

In the absence of an ideal treatment for chronic pain associated with rheumatic diseases, there is interest in the potential effects of cannabinoid molecules, particularly in the context of global interest in the legalization of herbal cannabis for medicinal use. A systematic search until April 2015 was conducted in Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, www.cannabis-med.org and clinicaltrials.gov for randomized controlled trials with a study duration of at least 2 weeks and at least ten patients per treatment arm with herbal cannabis or pharmaceutical cannabinoid products in fibromyalgia syndrome (FMS), osteoarthritis (OA), chronic spinal pain, and rheumatoid arthritis (RA) pain. Outcomes were reduction of pain, sleep problems, fatigue and limitations of quality of life for efficacy, dropout rates due to adverse events for tolerability, and serious adverse events for safety. The methodology quality of the randomized controlled trials (RCTs) was evaluated by the Cochrane Risk of Bias Tool. Two RCTs of 2 and 4 weeks duration respectively with nabilone, including 71 FMS patients, one 4-week trial with nabilone, including 30 spinal pain patients, and one 5-week study with tetrahydrocannbinol/cannabidiol, including 58 RA patients were included. One inclusion criterion was pain refractory to conventional treatment in three studies. No RCT with OA patients was found. The risk of bias was high for three studies. The findings of a superiority of cannabinoids over controls (placebo, amitriptyline) were not consistent. Cannabinoids were generally well tolerated despite some troublesome side effects and safe during the study duration. Currently, there is insufficient evidence for recommendation for any cannabinoid preparations for symptom management in patients with chronic pain associated with rheumatic diseases.

Tilt Table Therapies for Patients with Severe Disorders of Consciousness: A Randomized, Controlled Trial

PubMed Central

Krewer, Carmen; Luther, Marianne; Koenig, Eberhard; Müller, Friedemann

2015-01-01

One major aim of the neurological rehabilitation of patients with severe disorders of consciousness (DOC) is to enhance patients’ arousal and ability to communicate. Mobilization into a standing position by means of a tilt table has been shown to improve their arousal and awareness. However, due to the frequent occurrence of syncopes on a tilt table, it is easier to accomplish verticalization using a tilt table with an integrated stepping device. The objective of this randomized controlled clinical trial was to evaluate the effectiveness of a tilt table therapy with or without an integrated stepping device on the level of consciousness. A total of 50 participants in vegetative or minimally conscious states 4 weeks to 6 month after injury were treated with verticalization during this randomized controlled trial. Interventions involved ten 1-hour sessions of the specific treatment over a 3-week period. Blinded assessors made measurements before and after the intervention period, as well as after a 3-week follow-up period. The coma recovery scale-revised (CRS-R) showed an improvement by a median of 2 points for the group receiving tilt table with integrated stepping (Erigo). The rate of recovery of the group receiving the conventional tilt table therapy significantly increased by 5 points during treatment and by an additional 2 points during the 3-week follow-up period. Changes in spasticity did not significantly differ between the two intervention groups. Compared to the conventional tilt table, the tilt table with integrated stepping device failed to have any additional benefit for DOC patients. Verticalization itself seems to be beneficial though and should be administered to patients in DOC in early rehabilitation. Trial Registration: Current Controlled Trials Ltd (www.controlled-trials.com), identifier number ISRCTN72853718 PMID:26623651

Tilt Table Therapies for Patients with Severe Disorders of Consciousness: A Randomized, Controlled Trial.

PubMed

Krewer, Carmen; Luther, Marianne; Koenig, Eberhard; Müller, Friedemann

2015-01-01

One major aim of the neurological rehabilitation of patients with severe disorders of consciousness (DOC) is to enhance patients' arousal and ability to communicate. Mobilization into a standing position by means of a tilt table has been shown to improve their arousal and awareness. However, due to the frequent occurrence of syncopes on a tilt table, it is easier to accomplish verticalization using a tilt table with an integrated stepping device. The objective of this randomized controlled clinical trial was to evaluate the effectiveness of a tilt table therapy with or without an integrated stepping device on the level of consciousness. A total of 50 participants in vegetative or minimally conscious states 4 weeks to 6 month after injury were treated with verticalization during this randomized controlled trial. Interventions involved ten 1-hour sessions of the specific treatment over a 3-week period. Blinded assessors made measurements before and after the intervention period, as well as after a 3-week follow-up period. The coma recovery scale-revised (CRS-R) showed an improvement by a median of 2 points for the group receiving tilt table with integrated stepping (Erigo). The rate of recovery of the group receiving the conventional tilt table therapy significantly increased by 5 points during treatment and by an additional 2 points during the 3-week follow-up period. Changes in spasticity did not significantly differ between the two intervention groups. Compared to the conventional tilt table, the tilt table with integrated stepping device failed to have any additional benefit for DOC patients. Verticalization itself seems to be beneficial though and should be administered to patients in DOC in early rehabilitation. Trial Registration: Current Controlled Trials Ltd (www.controlled-trials.com), identifier number ISRCTN72853718.

Educational program for nursing home physicians and staff to reduce use of non-steroidal anti-inflammatory drugs among nursing home residents: a randomized controlled trial.

PubMed

Stein, C M; Griffin, M R; Taylor, J A; Pichert, J W; Brandt, K D; Ray, W A

2001-05-01

The risk for serious gastrointestinal complications due to nonsteroidal anti-inflammatory drugs (NSAIDs) is high in the elderly. Acetaminophen-based regimens are safer and may be as effective as NSAIDs for the treatment of osteoarthritis in many patients. To determine the effects of an educational program on NSAID use and clinical outcomes in nursing homes. Randomized controlled study. Ten pairs of Tennessee nursing homes with > or = 8% of residents receiving NSAIDs were randomized to intervention or control. Nursing home residents (intervention n = 76 and control n = 71) aged 65 years and older taking NSAIDs regularly. An educational program for physicians and nursing home staff that included the risks and benefits of NSAIDs in the elderly and an algorithm that substituted acetaminophen, topical agents, and nonpharmacologic measures for the treatment of noninflammatory musculoskeletal pain. Intervention and control subjects were assessed at baseline and 3 months later. Differences in NSAID and acetaminophen use, and pain, function, and disability scores in intervention and control nursing home subjects. The intervention was effective resulting in markedly decreased NSAID use and increased acetaminophen use. Mean number of days of NSAID use in the 7 day periods before the baseline and 3 month assessments decreased from 7.0 to 1.9 days in intervention home subjects compared with a decrease from 7.0 to 6.2 days in control homes (P = 0.0001). Acetaminophen use in the 7 days immediately before the 3 month assessment increased by 3.1 days in intervention home subjects compared with 0.31 days in control homes (P = 0.0001). A similar proportion of subjects in control (32.5%) and intervention (35.4%) groups had worsening of their arthritis pain score (P = 0.81). An educational intervention effectively reduced NSAID use in nursing homes without worsening of arthritis pain.

Effects of Hypotensive Anesthesia on Reducing Intraoperative Blood Loss, Duration of Operation, and Quality of Surgical Field During Orthognathic Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

PubMed

Lin, Susie; McKenna, Samuel J; Yao, Chuan-Fong; Chen, Yu-Ray; Chen, Chit

2017-01-01

The objective of this study was to evaluate the efficacy of hypotensive anesthesia in reducing intraoperative blood loss, decreasing operation time, and improving the quality of the surgical field during orthognathic surgery. A systematic review and meta-analysis of randomized controlled trials addressing these issues were carried out. An electronic database search was performed. The risk of bias was evaluated with the Jadad Scale and Delphi List. The inverse variance statistical method and a random-effects model were used. Ten randomized controlled trials were included for analysis. Our meta-analysis indicated that hypotensive anesthesia reduced intraoperative blood loss by a mean of about 169 mL. Hypotensive anesthesia was not shown to reduce the operation time for orthognathic surgery, but it did improve the quality of the surgical field. Subgroup analysis indicated that for blood loss in double-jaw surgery, the weighted mean difference favored the hypotensive group, with a reduction in blood loss of 175 mL, but no statistically significant reduction in blood loss was found for anterior maxillary osteotomy. If local anesthesia with epinephrine was used in conjunction with hypotensive anesthesia, the reduction in intraoperative blood loss was increased to 254.93 mL. Hypotensive anesthesia was effective in reducing blood loss and improving the quality of the surgical field, but it did not reduce the operation time for orthognathic surgery. The use of local anesthesia in conjunction with hypotensive general anesthesia further reduced the amount of intraoperative blood loss for orthognathic surgery. Copyright © 2016 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Lung Cancer Risk and Residential Exposure to Air Pollution: A Korean Population-Based Case-Control Study.

PubMed

Lamichhane, Dirga Kumar; Kim, Hwan Cheol; Choi, Chang Min; Shin, Myung Hee; Shim, Young Mog; Leem, Jong Han; Ryu, Jeong Seon; Nam, Hae Seong; Park, Sung Min

2017-11-01

To investigate the association between long-term exposure to ambient air pollution and lung cancer incidence in Koreans. This was a population-based case-control study covering 908 lung cancer patients and 908 controls selected from a random sample of people within each Korean province and matched according to age, sex, and smoking status. We developed land-use regression models to estimate annual residential exposure to particulate matter (PM₁₀) and nitrogen dioxide (NO₂) over a 20-year exposure period. Logistic regression was used to estimate odds ratios (ORs) and their corresponding 95% confidence intervals (CI). Increases in lung cancer incidence (expressed as adjusted OR) were 1.09 (95% CI: 0.96-1.23) with a ten-unit increase in PM₁₀ (μg/m³) and 1.10 (95% CI: 1.00-1.22) with a ten-unit increase in NO₂ (ppb). Tendencies for stronger associations between air pollution and lung cancer incidence were noted among never smokers, among those with low fruit consumption, and among those with a higher education level. Air pollution was more strongly associated with squamous cell and small cell carcinomas than with adenocarcinoma of the lung. This study provides evidence that PM10 and NO₂ contribute to lung cancer incidence in Korea. © Copyright: Yonsei University College of Medicine 2017

Does time-lapse imaging have favorable results for embryo incubation and selection compared with conventional methods in clinical in vitro fertilization? A meta-analysis and systematic review of randomized controlled trials

PubMed Central

Yuan, Jing; Liu, Fenghua

2017-01-01

Objective The present study aimed to undertake a review of available evidence assessing whether time-lapse imaging (TLI) has favorable outcomes for embryo incubation and selection compared with conventional methods in clinical in vitro fertilization (IVF). Methods Using PubMed, EMBASE, Cochrane library and ClinicalTrial.gov up to February 2017 to search for randomized controlled trials (RCTs) comparing TLI versus conventional methods. Both studies randomized women and oocytes were included. For studies randomized women, the primary outcomes were live birth and ongoing pregnancy, the secondary outcomes were clinical pregnancy and miscarriage; for studies randomized oocytes, the primary outcome was blastocyst rate, the secondary outcome was good quality embryo on Day 2/3. Subgroup analysis was conducted based on different incubation and embryo selection between groups. Results Ten RCTs were included, four randomized oocytes and six randomized women. For oocyte-based review, the pool-analysis observed no significant difference between TLI group and control group for blastocyst rate [relative risk (RR) 1.08, 95% CI 0.94–1.25, I2 = 0%, two studies, including 1154 embryos]. The quality of evidence was moderate for all outcomes in oocyte-based review. For woman-based review, only one study provided live birth rate (RR 1,23, 95% CI 1.06–1.44,I2 N/A, one study, including 842 women), the pooled result showed no significant difference in ongoing pregnancy rate (RR 1.04, 95% CI 0.80–1.36, I2 = 59%, four studies, including 1403 women) between two groups. The quality of the evidence was low or very low for all outcomes in woman-based review. Conclusions Currently there is insufficient evidence to support that TLI is superior to conventional methods for human embryo incubation and selection. In consideration of the limitations and flaws of included studies, more well designed RCTs are still in need to comprehensively evaluate the effectiveness of clinical TLI use. PMID:28570713

The Impact of Incentives on Exercise Behavior: A Systematic Review of Randomized Controlled Trials

PubMed Central

Strohacker, Kelley; Galarraga, Omar; Williams, David M.

2015-01-01

Background The effectiveness of reinforcing exercise behavior with material incentives is unclear. Purpose Conduct a systematic review of existing research on material incentives for exercise, organized by incentive strategy. Methods Ten studies conducted between January 1965 and June 2013 assessed the impact of incentivizing exercise compared to a non-incentivized control. Results There was significant heterogeneity between studies regarding reinforcement procedures and outcomes. Incentives tended to improve behavior during the intervention while findings were mixed regarding sustained behavior after incentives were removed. Conclusions The most effective incentive procedure is unclear given the limitations of existing research. The effectiveness of various incentive procedures in promoting initial behavior change and habit formation, as well as the use of sustainable incentive procedures should be explored in future research. PMID:24307474

A cluster-randomized controlled knowledge translation feasibility study in Alberta community pharmacies using the PARiHS framework: study protocol.

PubMed

Rosenthal, Meagen M; Tsuyuki, Ross T; Houle, Sherilyn Kd

2015-01-01

Despite evidence of benefit for pharmacist involvement in chronic disease management, the provision of these services in community pharmacy has been suboptimal. The Promoting Action on Research Implementation in Health Services (PARiHS) framework suggests that for knowledge translation to be effective, there must be evidence of benefit, a context conducive to implementation, and facilitation to support uptake. We hypothesize that while the evidence and context components of this framework are satisfied, that uptake into practice has been insufficient because of a lack of facilitation. This protocol describes the rationale and methods of a feasibility study to test a facilitated pharmacy practice intervention based on the PARiHS framework, to assist community pharmacists in increasing the number of formal and documented medication management services completed for patients with diabetes, dyslipidemia, and hypertension. A cluster-randomized before-after design will compare ten pharmacies from within a single organization, with the unit of randomization being the pharmacy. Pharmacies will be randomized to facilitated intervention based on the PARiHS framework or usual practice. The Alberta Context Tool will be used to establish the context of practice in each pharmacy. Pharmacies randomized to the intervention will receive task-focused facilitation from an external facilitator, with the goal of developing alternative team processes to allow the greater provision of medication management services for patients with diabetes, hypertension, and dyslipidemia. The primary outcome will be a process evaluation of the needs of community pharmacies to provide more clinical services, the acceptability and uptake of modifications made, and the willingness of pharmacies to participate. Secondary outcomes will include the change in the number of formal and documented medication management services in the aforementioned chronic conditions provided 6 months before, versus after, the intervention between the two groups, and identification of feasible quantitative outcomes for evaluating the effect of the intervention on patient care outcomes. To date, the study has identified and enrolled the ten pharmacies required and initiated the intervention process. This study will be the first to examine the role of facilitation in pharmacy practice, with the goal of scalable and sustainable practice change. Clinicaltrials.gov identifier NCT02191111.

The effects of transcutaneous electrical nerve stimulation on joint position sense in patients with knee joint osteoarthritis.

PubMed

Shirazi, Zahra Rojhani; Shafaee, Razieh; Abbasi, Leila

2014-10-01

To study the effects of transcutaneous electrical nerve stimulation (TENS) on joint position sense (JPS) in knee osteoarthritis (OA) subjects. Thirty subjects with knee OA (40-60 years old) using non-random sampling participated in this study. In order to evaluate the absolute error of repositioning of the knee joint, Qualysis Track Manager system was used and sensory electrical stimulation was applied through the TENS device. The mean errors in repositioning of the joint, in two position of the knee joint with 20 and 60 degree angle, after applying the TENS was significantly decreased (p < 0.05). Application of TENS in subjects with knee OA could improve JPS in these subjects.

Use of digital applications in the medicament calculation education for nursing.

PubMed

Fernandes Pereira, Francisco Gilberto; Afio Caetano, Joselany; Marques Frota, Natasha; Gomes da Silva, Maguida

2016-06-01

To evaluate the influence of the use of digital applications in medicament calculation education for nursing students. An experimental study was developed with a sample of 100 nursing students, who were divided randomly into two groups (use of the Calculation Medicines - CalcMed application - available free on the Internet, n=50) and control (conventional method of the calculator use and pre-math skills, n=50). Both groups were assessed before and after the application of the teaching strategy through a test with ten specific questions of medicament calculations. The study group showed a mean score of 8.14 versus an average of 5.02 in the control group. The average time of test execution was faster in the study group compared to the control group (15.7 versus 38.9 minutes). The strategy of using this application positively influences learning and enables greater security in the implementation of medicament calculations.

Value of TENS for relief of chronic low back pain with or without radicular pain.

PubMed

Buchmuller, A; Navez, M; Milletre-Bernardin, M; Pouplin, S; Presles, E; Lantéri-Minet, M; Tardy, B; Laurent, B; Camdessanché, J P

2012-05-01

To evaluate the efficacy of transcutaneous electrical neurostimulation (TENS) in patients with chronic low back pain (LBP). Prospective, randomized, multicentre, single-blind study. Twenty-one French pain centres. Two hundred thirty-six consecutive adult patients consulting for chronic LBP, with or without radicular pain (mean age ± standard deviation: 53 ± 13 years; range: 28-86 years). Patients were randomly assigned to receive either active (n = 117) or sham (n = 119) TENS in four 1-h daily treatment sessions for 3 months. The primary outcome measured was improvement of functional status at 6 weeks (Roland-Morris Disability Questionnaire). Secondary outcome measures were improvement of functional status at 3 months, pain relief (weekly visual analogue scale assessments), positive functional repercussions of pain levels on quality of life, a diminution of the use of analgesic and anti-inflammatory medication, satisfaction with the overall treatment strategy and compliance. Functional status did not differ between the groups, whether at 6 weeks or 3 months (p = 0.351 at 6 weeks). A significant improvement between the first and last visual analogue scale assessments was observed in patients with either lumbar pain alone or lumbar and radicular pain treated with active TENS. Other outcome measures did not differ significantly between the two groups. There was no functional benefit of TENS in the treatment of patients with chronic LBP. © 2011 European Federation of International Association for the Study of Pain Chapters.

Transcutaneous electrical nerve stimulation reduces acute low back pain during emergency transport.

PubMed

Bertalanffy, Alexander; Kober, Alexander; Bertalanffy, Petra; Gustorff, Burkhard; Gore, Odette; Adel, Sharam; Hoerauf, Klaus

2005-07-01

Patients with acute low back pain may require emergency transport because of pain and immobilization. Transcutaneous electrical nerve stimulation (TENS) is a nonpharmaceutical therapy for patients with low back pain. To evaluate the efficacy of paramedic-administered TENS in patients with acute low back pain during emergency transport. This was a prospective, randomized study involving 74 patients transported to hospital. The patients were randomly assigned to two groups: group 1 (n = 36) was treated with true TENS, while group 2 (n = 36) was treated with sham TENS. The authors recorded pain and anxiety as the main outcome variables using a visual analog scale (VAS). The authors recorded a significant (p < 0.01) pain reduction (mean +/- standard deviation) during transport in group 1 (79.2 +/- 6.5 mm VAS to 48.9 +/- 8.2 mm VAS), whereas pain scores remained unchanged in group 2 (75.9 +/- 16.4 mm VAS and 77.1 +/- 11.2 mm VAS). Similarly, the scores for anxiety were significantly reduced (p < 0.01) in group 1 (81.7 +/- 7.9 mm VAS to 69.2 +/- 12.1 mm VAS) after treatment. No significant change was noted (84.5 +/- 5.8 mm VAS and 83.5 +/- 8.9 mm VAS, respectively) in group 2. TENS was found to be effective and rapid in reducing pain during emergency transport of patients with acute low back pain and should be considered due to its ease of use and lack of side effects in the study population.

Transcutaneous Electrical Nerve Stimulation and Conditioned Pain Modulation Influence the Perception of Pain in Humans

PubMed Central

Liebano, Richard E.; Vance, Carol G.T.; Rakel, Barbara; Lee, Jennifer E.; Cooper, Nicholas A.; Marchand, Serge; Walsh, Deirdre M.; Sluka, Kathleen A.

2013-01-01

Background Research in animal models suggest that transcutaneous electrical nerve stimulation (TENS) and conditioned pain modulation (CPM) produce analgesia via two different supraspinal pathways. No known studies have examined whether TENS and CPM applied simultaneously in human subjects will enhance the analgesic effect of either treatment alone. The purpose of the current study was to investigate whether the simultaneous application of TENS and CPM will enhance the analgesic effect of that produced by either treatment alone. Methods Sixty healthy adults were randomly allocated into 2 groups: 1) CPM plus Active TENS; 2) CPM plus Placebo TENS. Pain threshold for heat (HPT) and pressure (PPT) was recorded from subject’s left forearm at baseline, during CPM, during Active or Placebo TENS, and during CPM plus Active or Placebo TENS. CPM was induced by placing the subjects’ contralateral arm in a hot water bath (46.5°C) for two minutes. TENS (100µs, 100Hz) was applied to the forearm for 20 minutes at a strong but comfortable intensity. Results Active TENS alone increased PPT (but not HPT) more than Placebo TENS alone (p=0.011). Combining CPM and Active TENS did not significantly increase PPT (p=0.232) or HPT (p=0.423) beyond CPM plus Placebo TENS. There was a significant positive association between PPT during CPM and during Active TENS (r2=0.46, p=0.003). Conclusions TENS application increases PPT, however combining CPM and TENS does not increase the CPM’s hypoalgesic response. CPM effect on PPT is associated with effects of TENS on PPT. PMID:23650092

A 15-year randomized controlled study of a reduced shrinkage stress resin composite.

PubMed

van Dijken, Jan W V; Lindberg, Anders

2015-09-01

The aim of this randomized controlled study was to evaluate the long term effectiveness of a reduced shrinkage stress resin composite in Class II restorations. The material was compared intra-individually with a microhybrid resin composite. Each of 50 patients with at least one pair of two similar sized Class II cavities participated (22 female, 28 male, mean age 43 years, range 18-64). Each participant received in each pair, in a randomized way, one Class II restoration performed with a reduced shrinkage stress resin composite (InTen-S) and the other restoration with a microhybrid resin composite restoration (Point 4). Both restorations were placed with an etch-and-rinse bonding system and an oblique layering technique. A total of 106 restorations, 33 premolar and 73 molars, were placed. The restorations were evaluated blindly each year using modified USPHS criteria. The overall performance of the experimental restorations was tested after intra-individual comparison using the Friedmańs two-way analysis of variance test. The hypothesis was rejected at the 5% level. At 15 years, 91 restorations were evaluated. The drop out frequency was 15 restorations (5 male, 3 female participants; 2 premolar and 13 molar restorations). Except for 2 participants, who reported slight symptoms during a few weeks after placement, no post-operative sensitivity was observed at the recalls. The overall success rate at 15 years was 77%. Twenty-one non acceptable restorations were observed during the 15 years follow up, 10 InTen-S (21.7%) and 11 Point 4 (24.4%) restorations (p>0.05). Annual failure rates for the resin composites were 1.5% and 1.6%, respectively. The main reasons for failure were secondary caries (8) and resin composite fracture (7). The differences between premolar vs. molar restorations and between restorations in male vs. female participants were not significant. Significant differences were observed between 2-surface vs. 3-surface restorations. During the 15-year follow up, the reduced shrinkage stress resin composite showed a good clinical durability in Class II cavities, but not significantly better than the control microhybrid resin composite. Secondary caries and material fracture were the main reasons of failure. Copyright © 2015 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

Citicoline for Acute Ischemic Stroke: A Systematic Review and Formal Meta-analysis of Randomized, Double-Blind, and Placebo-Controlled Trials.

PubMed

Secades, Julio J; Alvarez-Sabín, José; Castillo, José; Díez-Tejedor, Exuperio; Martínez-Vila, Eduardo; Ríos, José; Oudovenko, Natalia

2016-08-01

Citicoline is a drug approved for the treatment of acute ischemic stroke. Although evidence of its efficacy has been reported, recently published results of a large placebo-controlled clinical trial did not show differences. This study aims to assess whether starting citicoline treatment within 14 days after stroke onset improves the outcome in patients with acute ischemic stroke, as compared with placebo. A systematic search was performed to identify all published, unconfounded, randomized, double-blind, and placebo-controlled clinical trials of citicoline in acute ischemic stroke. Ten randomized clinical trials met our inclusion criteria. The administration of citicoline was associated with a significant higher rate of independence, independently of the method of evaluation used (odds ratio [OR] 1.56, 95% confidence interval [CI] = 1.12-2.16 under random effects; OR 1.20, 95% CI = 1.06-1.36 under fixed effects). After studying the cumulative meta-analysis, and with the results obtained with the subgroup of patients who were not treated with recombinant tissue plasminogen activator (rtPA) (OR 1.63, 95% CI = 1.18-2.24 under random effects; OR 1.42, 95% CI = 1.22-1.66 under fixed effects), our hypothesis of dilution of the effect of citicoline was confirmed. When we analyzed the effect of citicoline in patients who were not treated with rtPA and were receiving the highest dose of citicoline started in the first 24 hours after onset, based on more recent trials, there was no heterogeneity, and the size of the effect has an OR of 1.27 (95% CI = 1.05-1.53). This systematic review supports some benefits of citicoline in the treatment of acute ischemic stroke. But, on top of the best treatment available (rtPA), citicoline offers a limited benefit. Copyright © 2016 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Contribution of spontaneous improvement to placebo response in depression: a meta-analytic review.

PubMed

Rutherford, Bret R; Mori, Shoko; Sneed, Joel R; Pimontel, Monique A; Roose, Steven P

2012-06-01

It is unknown to what degree spontaneous improvement accounts for the large placebo response observed in antidepressant trials for Major Depressive Disorder (MDD). The purpose of this study was to estimate the spontaneous improvement observed in treatment-seeking individuals with acute MDD by determining the symptom change in depressed patients assigned to wait-list controls in psychotherapy studies. The databases PubMed and PsycINFO were searched to identify randomized, prospective studies randomizing outpatients to psychotherapy or a wait-list control condition for the treatment of acute MDD. Standardized effect sizes calculated from each identified study were aggregated in a meta-analysis to obtain a summary statistic for the change in depression scores during participation in a wait-list control. Ten trials enrolling 340 participants in wait-list control conditions were identified. The estimated effect size for the change in depression scores during wait-list control was 0.505 (95% CI 0.271-0.739, p < 0.001), representing an average improvement of 4 points on the Hamilton Rating Scale for Depression. Depressed patients acutely experience improvement even without treatment, but spontaneous improvement is unlikely to account for the magnitude of placebo response typically observed in antidepressant trials. These findings must be interpreted in light of the small number wait-list control participants available for analysis as well as certain methodological heterogeneity in the psychotherapy studies analyzed. Copyright © 2012 Elsevier Ltd. All rights reserved.

The Statistical Fermi Paradox

NASA Astrophysics Data System (ADS)

Maccone, C.

In this paper is provided the statistical generalization of the Fermi paradox. The statistics of habitable planets may be based on a set of ten (and possibly more) astrobiological requirements first pointed out by Stephen H. Dole in his book Habitable planets for man (1964). The statistical generalization of the original and by now too simplistic Dole equation is provided by replacing a product of ten positive numbers by the product of ten positive random variables. This is denoted the SEH, an acronym standing for “Statistical Equation for Habitables”. The proof in this paper is based on the Central Limit Theorem (CLT) of Statistics, stating that the sum of any number of independent random variables, each of which may be ARBITRARILY distributed, approaches a Gaussian (i.e. normal) random variable (Lyapunov form of the CLT). It is then shown that: 1. The new random variable NHab, yielding the number of habitables (i.e. habitable planets) in the Galaxy, follows the log- normal distribution. By construction, the mean value of this log-normal distribution is the total number of habitable planets as given by the statistical Dole equation. 2. The ten (or more) astrobiological factors are now positive random variables. The probability distribution of each random variable may be arbitrary. The CLT in the so-called Lyapunov or Lindeberg forms (that both do not assume the factors to be identically distributed) allows for that. In other words, the CLT "translates" into the SEH by allowing an arbitrary probability distribution for each factor. This is both astrobiologically realistic and useful for any further investigations. 3. By applying the SEH it is shown that the (average) distance between any two nearby habitable planets in the Galaxy may be shown to be inversely proportional to the cubic root of NHab. This distance is denoted by new random variable D. The relevant probability density function is derived, which was named the "Maccone distribution" by Paul Davies in 2008. 4. A practical example is then given of how the SEH works numerically. Each of the ten random variables is uniformly distributed around its own mean value as given by Dole (1964) and a standard deviation of 10% is assumed. The conclusion is that the average number of habitable planets in the Galaxy should be around 100 million ±200 million, and the average distance in between any two nearby habitable planets should be about 88 light years ±40 light years. 5. The SEH results are matched against the results of the Statistical Drake Equation from reference 4. As expected, the number of currently communicating ET civilizations in the Galaxy turns out to be much smaller than the number of habitable planets (about 10,000 against 100 million, i.e. one ET civilization out of 10,000 habitable planets). The average distance between any two nearby habitable planets is much smaller that the average distance between any two neighbouring ET civilizations: 88 light years vs. 2000 light years, respectively. This means an ET average distance about 20 times higher than the average distance between any pair of adjacent habitable planets. 6. Finally, a statistical model of the Fermi Paradox is derived by applying the above results to the coral expansion model of Galactic colonization. The symbolic manipulator "Macsyma" is used to solve these difficult equations. A new random variable Tcol, representing the time needed to colonize a new planet is introduced, which follows the lognormal distribution, Then the new quotient random variable Tcol/D is studied and its probability density function is derived by Macsyma. Finally a linear transformation of random variables yields the overall time TGalaxy needed to colonize the whole Galaxy. We believe that our mathematical work in deriving this STATISTICAL Fermi Paradox is highly innovative and fruitful for the future.

Quality of radiotherapy reporting in randomized controlled trials of prostate cancer.

PubMed

Soon, Yu Yang; Chen, Desiree; Tan, Teng Hwee; Tey, Jeremy

2018-06-07

Good radiotherapy reporting in clinical trials of prostate radiotherapy is important because it will allow accurate reproducibility of radiotherapy treatment and minimize treatment variations that can affect patient outcomes. The aim of our study is to assess the quality of prostate radiotherapy (RT) treatment reporting in randomized controlled trials in prostate cancer. We searched MEDLINE for randomized trials of prostate cancer, published from 1996 to 2016 and included prostate RT as one of the intervention arms. We assessed if the investigators reported the ten criteria adequately in the trial reports: RT dose prescription method; RT dose-planning procedures; organs at risk (OAR) dose constraints; target volume definition, simulation procedures; treatment verification procedures; total RT dose; fractionation schedule; conduct of quality assurance (QA) as well as presence or absence of deviations in RT treatment planning and delivery. We performed multivariate logistic regression to determine the factors that may influence the quality of reporting. We found 59 eligible trials. There was significant variability in the quality of reporting. Target volume definition, total RT dose and fractionation schedule were reported adequately in 97% of included trials. OAR constraints, simulation procedures and presence or absence of deviations in RT treatment planning and delivery were reported adequately in 30% of included trials. Twenty-four trials (40%) reported seven criteria or more adequately. Multivariable logistic analysis showed that trials that published their quality assurance results and cooperative group trials were more likely to have adequate quality in reporting in at least seven criteria. There is significant variability in the quality of reporting on prostate radiotherapy treatment in randomized trials of prostate cancer. We need to have consensus guidelines to standardize the reporting of radiotherapy treatment in randomized trials.

Auto-Targeted Neurostimulation Is Not Superior to Placebo in Chronic Low Back Pain: A Fourfold Blind Randomized Clinical Trial.

PubMed

Aguilar Ferrándiz, Maria Encarnación; Nijs, Jo; Gidron, Yori; Roussel, Nathalie; Vanderstraeten, Rob; Van Dyck, Dries; Huysmans, Eva; De Kooning, Margot

2016-07-01

Myofascial trigger points (MTrPs) are common in people with musculoskeletal pain and may play a role in chronic nonspecific low back pain (CLBP). One of the potential treatments of MTrPs is the Nervomatrix Soleve® auto-targeted neurostimulation device, providing targeted transcutaneous electrical nerve stimulation (TENS) to MTrPs in the lower back muscles. To date, no controlled studies have evaluated the effectiveness of this device for the pain management of this population. To examine whether the Nervomatrix Soleve® auto-targeted neurostimulation device is superior over placebo for the treatment of CLBP. A fourfold-blind randomized controlled trial was conducted. Brussels University Hospital, health care centers and pharmacies around Belgium. Participants with CLBP for at least 3 months were randomly assigned to the experimental (the Nervomatrix Soleve® auto-targeted neurostimulation device providing TENS-stimulation and mechanical pressure) or placebo group (the Nervomatrix Soleve® auto-targeted neurostimulation device providing mechanical pressure alone without current). The treatment protocol in both groups consisted of 6 treatment sessions per patient. Participants were evaluated at baseline prior to the intervention, immediately following treatment, and at one month follow-up. Pain and pain behavior (steps climbed) were assessed as primary outcome measures. Secondary outcome measures were pain functioning, health beliefs, symptoms of central sensitization, pain catastrophizing, and kinesiophobia. In total, 39 participants were included in the study. Participants in both groups improved significantly for pain and functioning, but no significant differences were observed between groups. These improvements were not clinically meaningful for any of the reported measures. The health beliefs changed significantly in both groups (P < 0.05), with superior results at follow-up in the placebo group. The follow-up period is limited to one month. Treatment of MTrPs with the Nervomatrix Soleve® auto-targeted neurostimulation device in patients with CLBP does not result in a better outcome than placebo-treatment in terms of pain, pain behavior, functioning, central sensitization, pain catastrophizing, and health beliefs.

Effectiveness of Cuscuta planiflora Ten. and Nepeta menthoides Boiss. & Buhse in major depression: a triple-blind randomized controlled trial study.

PubMed

Firoozabadi, Ali; Zarshenas, Mohammad M; Salehi, Alireza; Jahanbin, Saye; Mohagheghzadeh, Abdolali

2015-04-01

Depression is one the most common mental disorders that can be seen all over the world. In traditional Persian medicine, some medicinal herbs are recommended for depression treatment. This study aimed to evaluate the effects of Cuscuta planiflora Ten. and Nepeta menthoides Boiss. & Buhse in patients with major depression. This study is a randomized triple-blind controlled clinical trial conducted in the year 2010 in Shiraz University of Medical Sciences on patients with major depression. Pharmaceutical capsules of Cuscuta planiflora (500 mg) and Nepeta menthoides (400 mg) were prepared by a pharmacist. Patients were randomly assigned to 3 groups: group A (treated with Nepeta menthoides capsules and conventional drugs), group B (treated with Cuscuta planiflora capsules and conventional drugs), and group C (treated only with conventional drugs). The study period was 8 weeks and depression was measured before and after the study by Beck Depression Inventory and Hamilton Depression Inventory. The data were analyzed by SPSS version 20 and the P < .05 was considered statistically significant. A total of 43 subjects participated in this study, of whom 81.4% were females (n = 35) and 18.6% were males (n = 8). The mean ± standard deviation of age of the participants was 38 ± 10.9 years. The majority of patients (65.1%, n = 28) were married. There were 15 patients (34.9%) in group A, 13 (30.29%) in group B, and 15 (34.9%) in group C. There was a significant decrease in mean scores of Beck and Hamilton depression inventories in the 3 groups after treatment (P < .01); moreover, there was more decrease in scores of the Beck and Hamilton depression inventories in groups A and B compared with group C after treatment (P < .01). Despite the paucity of the population under study, the findings showed that Cuscuta planiflora and Nepeta menthoides capsules could be effective, affordable herbal medicines with improved cost-benefit in treatment of major depression and it is worth designing further and more extensive studies to get to a more accurate conclusion. © The Author(s) 2014.

Laparoscopic Dor versus Toupet fundoplication following Heller myotomy for achalasia: results of a multicenter, prospective, randomized-controlled trial.

PubMed

Rawlings, Arthur; Soper, Nathaniel J; Oelschlager, Brant; Swanstrom, Lee; Matthews, Brent D; Pellegrini, Carlos; Pierce, Richard A; Pryor, Aurora; Martin, Valeria; Frisella, Margaret M; Cassera, Maria; Brunt, L Michael

2012-01-01

The type of fundoplication that should be performed in conjunction with Heller myotomy for esophageal achalasia is controversial. We prospectively compared anterior fundoplication (Dor) with partial posterior fundoplication (Toupet) in patients undergoing laparoscopic Heller myotomy. A multicenter, prospective, randomized-controlled trial was initiated to compare Dor versus Toupet fundoplication after laparoscopic Heller myotomy. Outcome measures were symptomatic GERD scores (0-4, five-point Likert scale questionnaire) and 24-h pH testing at 6-12 months after surgery. Data are mean ± SD. Statistical analysis was by Mann-Whitney U test, Wilcoxon signed rank test, and Freidman's test. Sixty of 85 originally enrolled and randomized patients who underwent 36 Dor and 24 Toupet fundoplications had follow-up data per protocol for analysis. Dor and Toupet groups were similar in age (46.8 vs. 51.7 years) and gender (52.8 vs. 62.5% male). pH studies at 6-12 months in 43 patients (72%: Dor n = 24 and Toupet n = 19) showed total DeMeester scores and % time pH < 4 were not significant between the two groups. Abnormal acid reflux was present in 10 of 24 Dor group patients (41.7%) and in 4 of 19 Toupet patients (21.0%) (p = 0.152). Dysphagia and regurgitation symptom scores improved significantly in both groups compared to preoperative scores. No significant differences in any esophageal symptoms were noted between the two groups preoperatively or at follow-up. SF-36 quality-of-life measures changed significantly from pre- to postoperative for five of ten domains in the Dor group and seven of ten in the Toupet patients (not significant between groups). Laparoscopic Heller myotomy provides significant improvement in dysphagia and regurgitation symptoms in achalasia patients regardless of the type of partial fundoplication. Although a higher percentage of patients in the Dor group had abnormal 24-h pH test results compared to those of patients who underwent Toupet, the differences were not statistically significant.

Can evidence change the rate of back surgery? A randomized trial of community-based education.

PubMed

Goldberg, H I; Deyo, R A; Taylor, V M; Cheadle, A D; Conrad, D A; Loeser, J D; Heagerty, P J; Diehr, P

2001-01-01

Timely adoption of clinical practice guidelines is more likely to happen when the guidelines are used in combination with adjuvant educational strategies that address social as well as rational influences. To implement the conservative, evidence-based approach to low-back pain recommended in national guidelines, with the anticipated effect of reducing population-based rates of surgery. A randomized, controlled trial. Ten communities in western Washington State with annual rates of back surgery above the 1990 national average (158 operations per 100,000 adults). Spine surgeons, primary care physicians, patients who were surgical candidates, and hospital administrators. The five communities randomized to the intervention group received a package of six educational activities tailored to local needs by community planning groups. Surgeon study groups, primary care continuing medical education conferences, administrative consensus processes, videodisc-aided patient decision making, surgical outcomes management, and generalist academic detailing were serially implemented over a 30-month intervention period. Quarterly observations of surgical rates. After implementation of the intervention, surgery rates declined in the intervention communities but increased slightly in the control communities. The net effect of the intervention is estimated to be a decline of 20.9 operations per 100,000, a relative reduction of 8.9% (P = 0.01). We were able to use scientific evidence to engender voluntary change in back pain practice patterns across entire communities.

Immunogenicity and reactogenicity of tetravalent vaccine for measles, mumps, rubella and varicella (MMRV) in healthy children: a meta-analysis of randomized controlled trials.

PubMed

Leung, Julia Hy; Hirai, Hoyee W; Tsoi, Kelvin Kf

2015-01-01

Varicella is a highly infectious childhood disease. Tetravalent measles-mumps-rubella-varicella (MMRV) vaccine was introduced as one-syringe dose. To evaluate the immunogenicity and reactogenicity of MMRV vaccine versus trivalent MMR with varicella (V) vaccines in healthy children and to assess the respective safety issue. Randomized controlled trials (RCTs) were searched from the OVID databases. Trials were eligible if healthy children were randomized to receive MMRV or MMR+V vaccine. Seroconversions in serum antibody titers were the primary outcomes; adverse events were the secondary outcomes. Ten RCTs with 8961 healthy children were identified. MMRV and MMR+V vaccines showed comparable immunogenicity against measles (relative risk [RR] = 0.99, 95% CI = 0.98-1.00), mumps (RR = 0.99, 95% CI = 0.97-1.00), rubella (RR = 1.00, 95% CI = 1.00-1.01) and varicella (RR = 0.98, 95% CI = 0.95-1.01). At least 93% of children in both groups had seroconverted within 6 weeks. MMRV group showed significantly higher incidences of fever (RR = 1.19, 95% CI = 1.09-1.31) and rash (RR = 1.23, 95% CI = 1.06-1.43). The immunogenicities of MMRV and MMR+V vaccines were comparable in healthy children; however, MMRV vaccination showed higher incidences of fever and rash.

Parent-only interventions in the treatment of childhood obesity: a systematic review of randomized controlled trials.

PubMed

Ewald, H; Kirby, J; Rees, K; Robertson, W

2014-09-01

An effective and cost-effective treatment is required for the treatment of childhood obesity. Comparing parent-only interventions with interventions including the child may help determine this. A systematic review of published and ongoing studies until 2013, using electronic database and manual searches. randomized controlled trials, overweight/obese children aged 5-12 years, parent-only intervention compared with an intervention that included the child, 6 months or more follow-up. Outcomes included measures of overweight. Ten papers from 6 completed studies, and 2 protocols for ongoing studies, were identified. Parent-only groups are either more effective than or similarly effective as child-only or parent-child interventions, in the change in degree of overweight. Most studies were at unclear risk of bias for randomization, allocation concealment and blinding of outcome assessors. Two trials were at high risk of bias for incomplete outcome data. Four studies showed higher dropout from parent-only interventions. One study examined programme costs and found parent-only interventions to be cheaper. Parent-only interventions appear to be as effective as parent-child interventions in the treatment of childhood overweight/obesity, and may be less expensive. Reasons for higher attrition rates in parent-only interventions need further investigation. © The Author 2013. Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

1% hydrocortisone ointment is an effective treatment of pruritus ani: a pilot randomized controlled crossover trial.

PubMed

Al-Ghnaniem, R; Short, K; Pullen, A; Fuller, L C; Rennie, J A; Leather, A J M

2007-12-01

Pruritus ani (PA) is a common condition which is difficult to treat in the absence of obvious predisposing factors. There is paucity of evidence-based guidelines on the treatment of this condition. We examined whether 1% hydrocortisone ointment is an effective treatment for PA. A pilot randomized, double-blind, placebo-controlled, crossover trial was carried out. Eleven patients consented to take part in the trial and ten completed the study. After a 2-week run-in period, patients with primary PA were randomly allocated to receive 1% hydrocortisone ointment or placebo for 2 weeks followed by the opposite treatment for a further 2-week period. There was a washout period of 2 weeks between treatments. The primary outcome measure was reduction in itch using a visual analogue score (VAS). The secondary outcome measures were improvement in quality of life measured using a validated questionnaire (Dermatology Life Quality Index, DLQI) and improvement in clinical appearance of the perianal skin using the Eczema Area and Severity Index (EASI) score. Treatment with 1% hydrocortisone ointment resulted in a 68% reduction in VAS compared with placebo (P=0.019), a 75% reduction in DLQI score (P=0.067), and 81% reduction in EASI score (P=0.01). A short course of mild steroid ointment is an effective treatment for PA.

The influence of transcutaneous electrical nerve stimulation parameters on the level of pain perceived by participants with painful diabetic neuropathy: A crossover study.

PubMed

Upton, Gabrielle A; Tinley, Paul; Al-Aubaidy, Hayder; Crawford, Rachel

This pilot study aimed to investigate and compare the perceived pain relief effectiveness of two different modes of TENS in people with painful diabetic neuropathy (PDN). A cross-over study was conducted at Charles Sturt University, Orange. Five participants with PDN were assessed with a McGill Pain Questionnaire before and after each of the two TENS treatments. Participants were randomly allocated to Traditional TENS (80Hz, 200ms) or Acupuncture-like TENS (2Hz, 200ms) and the treatments were applied daily for 30min over ten days. Following a seven day washout period, the alternate mode of TENS was carried out using the same method. Wilcoxon Signed Rank tests were used to statistically analyse the results. All five participants reported personally meaningful pain relief during one or both of the TENS treatments. The Wilcoxon signed rank testing showed no statistical significance, p=1, likely due to the small sample size. Acupuncture-like TENS had a large effect size (z=-1.625, r=0.514), whilst Traditional TENS produced a medium effect size (z=-1.214, r=0.384). No adverse effects were reported. Acupuncture-like TENS may be more effective for PDN than traditional TENS. A larger scale replication of this pilot study is warranted. Copyright © 2016 Diabetes India. Published by Elsevier Ltd. All rights reserved.

Neurokinin B administration induces hot flushes in women.

PubMed

Jayasena, Channa N; Comninos, Alexander N; Stefanopoulou, Evgenia; Buckley, Adam; Narayanaswamy, Shakunthala; Izzi-Engbeaya, Chioma; Abbara, Ali; Ratnasabapathy, Risheka; Mogford, Julianne; Ng, Noel; Sarang, Zubair; Ghatei, Mohammad A; Bloom, Stephen R; Hunter, Myra S; Dhillo, Waljit S

2015-02-16

Neurokinin B (NKB) is a hypothalamic neuropeptide binding preferentially to the neurokinin 3 receptor. Expression of the gene encoding NKB is elevated in postmenopausal women. Furthermore, rodent studies suggest that NKB signalling may mediate menopausal hot flushes. However, the effects of NKB administration on hot flushes have not been investigated in humans. To address this, we performed a randomised, double-blinded, placebo-controlled, 2-way cross-over study. Ten healthy women were admitted to a temperature and humidity-controlled research unit. Participants received 30 minute intravenous infusions of NKB and vehicle in random order. Symptoms, heart rate, blood pressure, sweating and skin temperature were compared between NKB and vehicle in a double-blinded manner. Eight of ten participants experienced flushing during NKB infusion with none experiencing flushing during vehicle infusion (P = 0.0007). Significant elevations in heart rate (P = 0.0106 vs. pre-symptoms), and skin temperature measured using skin probe (P = 0.0258 vs. pre-symptoms) and thermal imaging (P = 0.0491 vs. pre-symptoms) characteristic of menopausal flushing were observed during hot flush episodes. Our findings provide evidence that NKB administration can cause hot flushes in women. Further studies are required to determine if pharmacological blockade of NKB signalling could inhibit hot flushes during the menopause and during treatment for sex-steroid dependent cancers.

Thinking outside the black box: the importance of context in understanding the impact of a preoperative education nursing intervention among Chinese cardiac patients.

PubMed

Guo, Ping; East, Linda; Arthur, Antony

2014-06-01

In a randomized controlled trial of a preoperative education intervention conducted for Chinese cardiac patients, we observed a greater effect on symptoms of anxiety and depression than that reported with regard to similar interventions in western care settings. The objective of this qualitative study was to help explain the findings of the trial by exploring Chinese patients' experience of seeking and receiving information before cardiac surgery. Semi-structured interviews were conducted with a purposive sample of 20 trial participants before discharge (ten from the preoperative education group; ten from the usual care control group). Data were analyzed using a thematic analysis approach. A total of five themes were generated: the role of reputation and hierarchy; gaining strength from knowledge; information as a low priority; being kept in the dark; and learning through peer support. In health care systems where service users are given relatively little information, interventions designed to inform patients about their treatment are likely to have a much greater impact on their psychological health. Providers of services for patients undergoing cardiac surgery in China should be encouraged to incorporate information giving into routine practice, tailored according to individual need. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Multicentre randomized controlled trial comparing ferric(III)carboxymaltose infusion with oral iron supplementation in the treatment of preoperative anaemia in colorectal cancer patients.

PubMed

Borstlap, W A A; Buskens, C J; Tytgat, K M A J; Tuynman, J B; Consten, E C J; Tolboom, R C; Heuff, G; van Geloven, N; van Wagensveld, B A; C A Wientjes, C A; Gerhards, M F; de Castro, S M M; Jansen, J; van der Ven, A W H; van der Zaag, E; Omloo, J M; van Westreenen, H L; Winter, D C; Kennelly, R P; Dijkgraaf, M G W; Tanis, P J; Bemelman, W A

2015-06-28

At least a third of patients with a colorectal carcinoma who are candidate for surgery, are anaemic preoperatively. Preoperative anaemia is associated with increased morbidity and mortality. In general practice, little attention is paid to these anaemic patients. Some will have oral iron prescribed others not. The waiting period prior to elective colorectal surgery could be used to optimize a patients' physiological status. The aim of this study is to determine the efficacy of preoperative intravenous iron supplementation in comparison with the standard preoperative oral supplementation in anaemic patients with colorectal cancer. In this multicentre randomized controlled trial, patients with an M0-staged colorectal carcinoma who are scheduled for curative resection and with a proven iron deficiency anaemia are eligible for inclusion. Main exclusion criteria are palliative surgery, metastatic disease, neoadjuvant chemoradiotherapy (5 × 5 Gy = no exclusion) and the use of Recombinant Human Erythropoietin within three months before inclusion or a blood transfusion within a month before inclusion. Primary endpoint is the percentage of patients that achieve normalisation of the haemoglobin level between the start of the treatment and the day of admission for surgery. This study is a superiority trial, hypothesizing a greater proportion of patients achieving the primary endpoint in favour of iron infusion compared to oral supplementation. A total of 198 patients will be randomized to either ferric(III)carboxymaltose infusion in the intervention arm or ferrofumarate in the control arm. This study will be performed in ten centres nationwide and one centre in Ireland. This is the first randomized controlled trial to determine the efficacy of preoperative iron supplementation in exclusively anaemic patients with a colorectal carcinoma. Our trial hypotheses a more profound haemoglobin increase with intravenous iron which may contribute to a superior optimisation of the patient's condition and possibly a decrease in postoperative morbidity. ClincalTrials.gov: NCT02243735 .

The effects of mental practice in neurological rehabilitation; a systematic review and meta-analysis

PubMed Central

Braun, Susy; Kleynen, Melanie; van Heel, Tessa; Kruithof, Nena; Wade, Derick; Beurskens, Anna

2013-01-01

Objective: To investigate the beneficial and adverse effects of a mental practice intervention on activities, cognition, and emotion in patients after stroke, patients with Parkinson's disease or multiple sclerosis. Methods: Electronic databases PubMed/Medline, PEDro, Science Direct, Cochrane Library, PsycINFO, Rehadat, Embase, and Picarta were searched until June 2012. Fourteen randomized controlled trials in stroke and two randomized controlled trials in Parkinson's disease were included, representing 491 patients (421 with stroke). No randomized controlled trials in multiple sclerosis were identified. The methodologic quality of the included trials was assessed with the Amsterdam-Maastricht-Consensus-List (AMCL). Information on study characteristics and outcomes was summarized and evidence for effects described. Data from individual studies in stroke with same outcome measures were pooled. Results: The included 16 randomized controlled trials were heterogeneous and methodologic quality varied. Ten trials reported significant effects in favor of mental practice in patients with stroke (n = 9) and Parkinson's disease (n = 1). In six studies mental practice had similar effects as therapy as usual (n = 5 in stroke and n = 1 in Parkinson's disease). Of six performed meta-analyses with identical measures in stroke studies only two showed significant effects of mental practice: short-term improvement of arm-hand-ability (ARAT: SMD 0.62; 95% CI: 0.05 to 1.19) and improvement of performance of activities (NRS: SMD 0.9; 95% CI: 0.04 to 1.77). Five studies found effects on cognition (e.g., effects on attention, plan actions in unfamiliar surroundings) and four reported observed side-effects, both positive (e.g., might increase motivation and arousal and reduce depression) and negative (e.g., diminished concentration, irritation). Conclusions: Mental practice might have positive effects on performance of activities in patients with neurological diseases, but this review reports less positive results than earlier published ones. Strengths and limitations of past studies are pointed out. Methodologic recommendations for future studies are given. PMID:23935572

Efficacy of autologous platelet-rich plasma use for orthopaedic indications: a meta-analysis.

PubMed

Sheth, Ujash; Simunovic, Nicole; Klein, Guy; Fu, Freddie; Einhorn, Thomas A; Schemitsch, Emil; Ayeni, Olufemi R; Bhandari, Mohit

2012-02-15

The recent emergence of autologous blood concentrates, such as platelet-rich plasma, as a treatment option for patients with orthopaedic injuries has led to an extensive debate about their clinical benefit. We conducted a systematic review and meta-analysis to determine the efficacy of autologous blood concentrates in decreasing pain and improving healing and function in patients with orthopaedic bone and soft-tissue injuries. We searched MEDLINE and Embase for randomized controlled trials or prospective cohort studies that compared autologous blood concentrates with a control therapy in patients with an orthopaedic injury. We identified additional studies by searching through the bibliographies of eligible studies as well as the archives of orthopaedic conferences and meetings. Twenty-three randomized trials and ten prospective cohort studies were identified. There was a lack of consistency in outcome measures across all studies. In six randomized controlled trials (n = 358) and three prospective cohort studies (n = 88), the authors reported visual analog scale (VAS) scores when comparing platelet-rich plasma with a control therapy across injuries to the acromion, rotator cuff, lateral humeral epicondyle, anterior cruciate ligament, patella, tibia, and spine. The use of platelet-rich plasma provided no significant benefit up to (and including) twenty-four months across the randomized trials (standardized mean difference, -0.34; 95% confidence interval [CI], -0.75 to 0.06) or the prospective cohort studies (standardized mean difference, -0.20; 95% CI, -0.64 to 0.23). Both point estimates suggested a small trend favoring platelet-rich plasma, but the associated wide confidence intervals were consistent with nonsignificant effects. The current literature is complicated by a lack of standardization of study protocols, platelet-separation techniques, and outcome measures. As a result, there is uncertainty about the evidence to support the increasing clinical use of platelet-rich plasma and autologous blood concentrates as a treatment modality for orthopaedic bone and soft-tissue injuries.

Weight Gain Prevention among Midlife Women: A Randomized Controlled Trial to Address Needs Related to the Physical and Social Environment.

PubMed

Perry, Courtney D; Degeneffe, Dennis; Davey, Cynthia; Kollannoor-Samuel, Grace; Reicks, Marla

2016-05-25

Women tend to gain weight at midlife (40-60 years) increasing risk of obesity-related chronic diseases. Within specific eating occasions, needs related to the physical and social environment may result in less healthy eating behavior, which can lead to weight gain over time. The purpose of this study was to determine if a dietitian-delivered nutrition counseling intervention tailored to eating occasion needs could improve diet and prevent weight gain among midlife women over two years. A randomized controlled trial was conducted with healthy midlife women (n = 354) in one U.S. metropolitan area. The intervention group (n = 185) received ten hours of individual nutrition counseling from dietitians over six months, while women in a control group (n = 169) received no counseling. Measured height, weight and waist circumference, and dietary intakes were collected at baseline and every six months over two years. Mixed linear models were used to test for intervention effect on change in outcome variables over time. Dietary intakes of fruit, reduced/low-fat dairy foods and refined grains were significantly improved over time in the intervention compared to control group. However, the intervention had no effect on weight over time (p = 0.48). Nutrition counseling tailored to address eating occasion needs improved self-reported diet but did not significantly affect weight change.

A Web-Based Intervention to Reduce Indoor Tanning Motivations In Adolescents: A Randomized Controlled Trial

PubMed Central

Hillhouse, Joel; Turrisi, Rob; Scaglione, Nichole M.; Cleveland, Michael J.; Baker, Katie; Florence, L. Carter

2016-01-01

Youthful indoor tanning as few as ten sessions can increase the risk of melanoma by 2 to 4 times with each additional session adding another 2% to the risk. Recent research estimates that indoor tanning can be linked to approximately 450,000 cases of skin cancer annually in the United States, Europe, and Australia. Despite these risks, indoor tanning remains popular with adolescents. This study tested the efficacy of a web-based skin cancer prevention intervention designed to reduce indoor tanning motivations in adolescent females. A nationally representative sample of 443 female teens were enrolled from an online panel into a two-arm, parallel group design, randomized controlled trial. Treatment participants received an appearance-focused intervention grounded in established health behavior change models. Controls viewed a teen alcohol prevention website. Outcome variables included willingness and intentions to indoor tan, willingness to sunless tan and measures of indoor tanning attitudes and beliefs. The intervention decreased willingness and intentions to indoor tan and increased sunless tanning willingness relative to controls. We also examined indirect mechanisms of change through intervening variables (e.g., indoor tanning attitudes, norms, positive and negative expectancies) using the product of coefficients approach. The web-based intervention demonstrated efficacy in changing adolescent indoor tanning motivations and improving their orientation toward healthier alternatives. Results from the intervening variable analyses give guidance to future adolescent skin cancer prevention interventions. PMID:27549602

A Web-Based Intervention to Reduce Indoor Tanning Motivations in Adolescents: a Randomized Controlled Trial.

PubMed

Hillhouse, Joel; Turrisi, Rob; Scaglione, Nichole M; Cleveland, Michael J; Baker, Katie; Florence, L Carter

2017-02-01

Youthful indoor tanning as few as ten sessions can increase the risk of melanoma by two to four times with each additional session adding another 2 % to the risk. Recent research estimates that indoor tanning can be linked to approximately 450,000 cases of skin cancer annually in the USA, Europe, and Australia. Despite these risks, indoor tanning remains popular with adolescents. This study tested the efficacy of a web-based skin cancer prevention intervention designed to reduce indoor tanning motivations in adolescent females. A nationally representative sample of 443 female teens was enrolled from an online panel into a two-arm, parallel group design, randomized controlled trial. Treatment participants received an appearance-focused intervention grounded in established health behavior change models. Controls viewed a teen alcohol prevention website. Outcome variables included willingness and intentions to indoor tan, willingness to sunless tan, and measures of indoor tanning attitudes and beliefs. The intervention decreased willingness and intentions to indoor tan and increased sunless tanning willingness relative to controls. We also examined indirect mechanisms of change through intervening variables (e.g., indoor tanning attitudes, norms, positive and negative expectancies) using the product of coefficient approach. The web-based intervention demonstrated efficacy in changing adolescent indoor tanning motivations and improving their orientation toward healthier alternatives. Results from the intervening variable analyses give guidance to future adolescent skin cancer prevention interventions.

Effectiveness of a school-based intervention on physical activity for high school students in Brazil: the Saude na Boa project.

PubMed

de Barros, Mauro Virgílio Gomes; Nahas, Markus Vinicius; Hallal, Pedro Curi; de Farias Júnior, José Cazuza; Florindo, Alex Antônio; Honda de Barros, Simone Storino

2009-03-01

We evaluated the effectiveness of a school-based intervention on the promotion of physical activity among high school students in Brazil: the Saude na Boa project. A school-based, randomized trial was carried out in 2 Brazilian cities: Recife (northeast) and Florianopolis (south). Ten schools in each city were matched by size and location, and randomized into intervention or control groups. The intervention included environmental/organizational changes, physical activity education, and personnel training and engagement. Students age 15 to 24 years were evaluated at baseline and 9 months later (end of school year). Although similar at baseline, after the intervention, the control group reported significantly fewer d/wk accumulating 60 minutes+ moderate-to-vigorous physical activity (MVPA) in comparison with the intervention group (2.6 versus 3.3, P<.001). The prevalence of inactivity (0 days per week) rose in the control and decreased in the intervention group. The odds ratio for engaging at least once per week in physical activity associated with the intervention was 1.83 (95% CI=1.24-2.71) in the unadjusted analysis and 1.88 (95% CI=1.27-2.79) after controlling for gender. The Saude na Boa intervention was effective at reducing the prevalence of physical inactivity. The possibility of expanding the intervention to other locations should be considered.

Psychiatric adverse events in randomized, double-blind, placebo-controlled clinical trials of varenicline: a pooled analysis.

PubMed

Tonstad, Serena; Davies, Simon; Flammer, Martina; Russ, Cristina; Hughes, John

2010-04-01

Varenicline (Chantix), Champix) has shown efficacy and tolerability as an aid to smoking cessation. In postmarketing surveillance, neuropsychiatric symptoms have appeared; however, their incidence and causal relationship to varenicline is not known. We assessed the incidence and relative risk (RR) of psychiatric disorders in ten randomized, double-blind, placebo-controlled trials of varenicline for smoking cessation. All smoking cessation phase II, III and IV randomized controlled clinical trials of varenicline versus placebo completed as of 31 December 2008, on file with the manufacturer (Pfizer, Inc.), were included. All studies have been published. All 3091 participants who received at least one dose of varenicline and all 2005 participants who received placebo were included in this analysis. These were men and women smoking > or =10 cigarettes/day, aged 18-75 years and without current psychiatric disease who received varenicline or placebo for 6 (one study), 12 (eight studies) or 52 (one study) weeks. Adverse events were recorded at each study visit and classified according to standard Medical Dictionary for Regulatory Activities (MedDRA) terms (version 11.0). The incidence of psychiatric disorders other than solely sleep disorders and disturbances was 10.7% in subjects treated with varenicline and 9.7% in subjects treated with placebo, with an RR of 1.02 (95% CI 0.86, 1.22). The RRs (95% CI) versus placebo of psychiatric adverse events with an incidence > or =1% in the varenicline group were 0.86 (0.67, 1.12) for anxiety disorders and symptoms, 0.76 (0.42, 1.39) for changes in physical activity, 1.42 (0.96, 2.08) for depressed mood disorders and disturbances, 1.21 (0.79, 1.83) for mood disorders and disturbances not elsewhere classified and 1.70 (1.50, 1.92) for sleep disorders and disturbances. There were no cases of suicidal ideation or behaviour in varenicline-treated subjects in the ten placebo-controlled studies analysed. However, among three trials that were excluded from the analysis because of their open-label design, two cases of suicidal ideation and one completed suicide were reported in patients who had been treated with varenicline. With the exception of sleep disorders and disturbances, there was no evidence of dose-responsivity. There was no significant increase in overall psychiatric disorders, other than sleep disorders and disturbances, in varenicline-treated subjects in this sample of smokers without current psychiatric disorders. Ongoing studies are testing the use of varenicline in psychiatric patients.

Hypoalgesia in response to transcutaneous electrical nerve stimulation (TENS) depends on stimulation intensity.

PubMed

Moran, Fidelma; Leonard, Tracey; Hawthorne, Stephanie; Hughes, Ciara M; McCrum-Gardner, Evie; Johnson, Mark I; Rakel, Barbara A; Sluka, Kathleen A; Walsh, Deirdre M

2011-08-01

Transcutaneous electrical nerve stimulation (TENS) is an electrophysical modality used for pain management. This study investigated the dose response of different TENS intensities on experimentally induced pressure pain. One hundred and thirty TENS naïve healthy individuals (18-64 years old; 65 males, 65 females) were randomly allocated to 5 groups (n = 26 per group): Strong Non Painful TENS; Sensory Threshold TENS; Below Sensory Threshold TENS; No Current Placebo TENS; and Transient Placebo TENS. Active TENS (80 Hz) was applied to the forearm for 30 minutes. Transient Placebo TENS was applied for 42 seconds after which the current amplitude automatically reset to 0 mA. Pressure pain thresholds (PPT) were recorded from 2 points on the hand and forearm before and after TENS to measure hypoalgesia. There were significant differences between groups at both the hand and forearm (ANOVA; P = .005 and .002). At 30 minutes, there was a significant hypoalgesic effect in the Strong Non Painful TENS group compared to: Below Sensory Threshold TENS, No Current Placebo TENS and Transient Placebo TENS groups (P < .0001) at the forearm; Transient Placebo TENS and No Current Placebo TENS groups at the hand (P = .001). There was no significant difference between Strong Non Painful TENS and Sensory Threshold TENS groups. The area under the curve for the changes in PPT significantly correlated with the current amplitude (r(2) = .33, P = .003). These data therefore show that there is a dose-response effect of TENS with the largest effect occurring with the highest current amplitudes. This study shows a dose response for the intensity of TENS for pain relief with the strongest intensities showing the greatest effect; thus, we suggest that TENS intensity should be titrated to achieve the strongest possible intensity to achieve maximum pain relief. Copyright © 2011 American Pain Society. Published by Elsevier Inc. All rights reserved.

[Medicinal vesiculation combined with quick cupping at Shenque (CV 8) for allergic rhinitis with syndrome of yang deficiency: a randomized controlled trial].

PubMed

Ke, Zheng-hua; Long, Sheng-hua

2014-09-01

To compare the clinical efficacy differences between medicinal vesiculation combined with quick cupping at Shenque (CV 8) and regular medication for allergic rhinitis with syndrome of yang deficiency. Eighty-two cases were randomly divided into an observation group (42 cases) and a control group (40 cases). The observation group was treated with medicinal vesiculation combined with quick cupping at Shenque (CV 8). The medicinal vesiculation was applied at Feishu (BL 13), Gaohuang (BL 43), Fengmen (BL 12), Mingmen (GV 4) on the dog days in the summer, one treatment on the 1st dog-day, 2nd dog-day and last dog-day respectively with an interval of 10 days between two treatments. Three treatments were taken as one course, and totally one course was given. The quick cupping was applied at Shenque (CV 8), once a day, ten treatments were taken as one course, and totally three courses was given. The control group was treated with oral administration of loratadine and nasal spray of budesonide. The loratadine was given 10 mg per time, once a day for continuous 14 days; budesonide was given once a day, ten treatments were taken as one course, and totally three courses was given. The clinical efficacy in two groups after treatment was observed, and the contents of immune globulin E (IgE), interleukin-4 (IL-4), interleukin-5 (IL-5) and tumor necrosis factor-α (TNF-α) in peripheral serum were measured before and after the treatments. Of all the 82 patients, 79 cases completed the treatment, and 1 patient in the observation group and 2 patients in the control group dropped out. The effective rate was 87.8% (36/41) in the observation group, which was superior to 78.9% (30/38) in the control group (P<0.05). After treatment, both groups effectively reduced the contents of IgE, IL-4, IL-5 and TNF-α, and the observation group had superior effect on reducing IgE and IL-4 to the control group (P<0.05). The medicinal vesiculation combined with quick cupping at Shenque (CV 8) have better effect for allergic rhinitis with syndrome of yang deficiency than oral administration of loratadine and nasal spray of budesonide.

Reduction of wound infections in laparoscopic-assisted colorectal resections by plastic wound ring drapes (REDWIL)?--A randomized controlled trial.

PubMed

Lauscher, J C; Grittner, F; Stroux, A; Zimmermann, M; le Claire, M; Buhr, H J; Ritz, J P

2012-10-01

Surgical site infections (SSIs) are frequent complications in colorectal surgery and may lead to burst abdomen, incisional hernia, and increased perioperative costs. Plastic wound ring drapes (RD) were introduced some decades ago to protect the abdominal wound from bacteria and reduce SSIs. There have been no controlled trials examining the benefit of RD in laparoscopic colorectal surgery. The Reduction of wound infections in laparoscopic assisted colorectal resections by plastic wound ring drapes (REDWIL) trial was thus designed to assess their effectiveness in preventing SSIs after elective laparoscopic colorectal resections. REDWIL is a randomized controlled monocenter trial with two parallel groups (experimental group with RD and control group without RD). Patients undergoing elective laparoscopic colorectal resection were included. The primary endpoint was SSIs. Secondary outcomes were colonization of the abdominal wall with bacteria, reoperations/readmissions, early/late postoperative complications, and cost of hospital stay. The duration of follow-up was 6 months. Between January 2008 and October 2010, 109 patients were randomly assigned to the experimental or control group (with or without RD). Forty-six patients in the RD group and 47 patients in the control group completed follow-up. SSIs developed in ten patients with RD (21.7 %) and six patients without RD (12.8 %) (p = 0.28). An intraoperative swab taken from the abdominal wall was positive in 66.7 % of patients with RD and 57.5 % without RD (p = 0.46). The number of species cultured within one swab was significantly higher in those without RD (p = 0.03). The median total inpatient costs including emergency readmissions were 3,402 ± 4,038 in the RD group and 3,563 ± 1,735 in the control group (p = 0.869). RD do not reduce the rate of SSIs in laparoscopic colorectal surgery. The inpatient costs are similar with and without RD.

The association of preterm birth and small birthweight for gestational age on childhood disability screening using the Ten Questions Plus tool in rural Sarlahi district, southern Nepal.

PubMed

Wu, L A; Katz, J; Mullany, L C; Khatry, S K; Darmstadt, G L; LeClerq, S C; Tielsch, J M

2012-05-01

The Ten Questions tool was developed in 1984 as a low-cost, simple screen for childhood disability and referral for diagnosis in low-resource settings, and its use in Nepal has not been previously evaluated. Preterm birth and intrauterine growth restriction are potential risk factors for child disability and loss of developmental potential, but there are few studies examining this relationship from developing settings.   To examine the associations of small for gestational age and preterm birth as predictors of Ten Questions Plus positivity. The Ten Questions Plus questionnaire was administered to caregivers of 680 children between 2 and 5 years of age from August 2007 to March 2008 in rural Sarlahi, southern Nepal. Participants had previously been enrolled in a randomized trial of chlorhexidine cleansing at birth. At 1 month of age, children were then enrolled into a randomized 2 × 2 factorial trial of daily iron and zinc supplementation between October 2001 and January 2006. None. Positive screen on the Ten Questions Plus tool defined as a positive response to one or more questions. Of preterm children, 37 (33.6%) had a positive response to at least one question on the Ten Questions Plus and were considered at risk for disability. One hundred and seventy term children (29.8%) were at risk for disability. The Ten Questions Plus tool can be used in this rural Nepali setting to identify children at increased risk for mental and physical disability to be targeted for further examination. The prevalence of parent-reported disabilities is high in this population (almost one-third of children); children who are both preterm and small-for-gestational age are at increased risk for motor milestone delay, reported learning difficulty, speech and behavioural problems. Intrauterine growth restriction may affect child development and result in disabilities later in childhood. © 2011 Blackwell Publishing Ltd.

[Comparison of the analgesic effect of interferential current (IFC) and TENS in patients with low back pain].

PubMed

Grabiańska, Ewa; Leśniewicz, Joanna; Pieszyński, Ireneusz; Kostka, Joanna

2015-01-01

Electrotherapy, including theTENS and interferential current (IFC) is one of the most frequently used treatments in physical therapy in patients with low back pain. The aim of this study was to assess the influence of TENS and IFC on pain relief and to compare the analgesic efficacy of the two currents. Sixty patients aged 53.5 ± 12.5, with low back pain, were randomly divided into two groups: IFC (gr. I) and TENS (gr. II). Depending on the groups, patients were given series of ten 20-minute sessions using either IF orTENS currents. In all patients VAS and Laitinen modified scale were taken before and after treatment. After 2-weeks therapy there was improvement in the VAS and Laitinen scale (all components) in both groups, except for the part of the Laitinen scale on the reduction of activity in the group II (TENS). There was no statistically significant difference between the TENS and IF groups in reducing the intensity and other aspects of pain (frequency, pain medication and activity limitation) under the influence of therapy (p > 0.05). Interferential current and TENS therapy are effective for pain relief in patients with low back pain. The study showed equal analgesic efficacy of both treatments.

Couples groups for parents of preschoolers: ten-year outcomes of a randomized trial*

PubMed Central

Cowan, Carolyn Pape; Cowan, Philip A.; Barry, Jason

2011-01-01

This paper reports the results of a 10-year follow-up of two variations of a couples group preventive intervention offered to couples in the year before their oldest child made the transition to kindergarten. 100 couples were randomly assigned to (1) a low-dose control condition, (2) a couples group meeting for 16 weeks that focused more on couple relationship issues among other family topics, or (3) a couples group meeting for 16 weeks that focused more on parenting issues among other family issues, with an identical curriculum to condition (2). Earlier papers reported that both variations of the intervention produced positive results on parent-child relationships and on the children’s adaptation to kindergarten and 1st grade, and that the groups emphasizing couple relationships also had additional positive effects on couple interaction quality. The present paper uses growth curve analyses to examine intervention effects extending from the children’s transition to kindergarten to the transition to high school – ten years after the couples groups ended. There were 6-year positive effects of the pre-kindergarten interventions on observed couple interaction and 10-year positive effects on both parents’ marital satisfaction and the children’s adaptation (hyperactivity and aggression). Discussion includes a focus on the implications of these results for family policy, clinical practice, and the need to include a couples focus in preventive interventions to strengthen family relationships and enhance children’s adaptation to school. PMID:21480703

Motivating smokers to quit using computer-generated letters that target either reduction or cessation: A population-based randomized controlled trial among smokers who do not intend to quit.

PubMed

Meyer, Christian; Ulbricht, Sabina; Haug, Severin; Broda, Anja; Bischof, Gallus; Rumpf, Hans-Jürgen; John, Ulrich

2016-09-01

This study examined the long-term efficacy of individualized counseling letters that targeted either smoking abstinence or reducing the number of cigarettes smoked per day to promote future cessation. A nationwide random-digit-dialing telephone sample was used to identify smokers from the general adult population (participation proportion: 54.5%). In total, 1462 participants (48% female) who did not intend to quit within the next six months and who smoked ten or more cigarettes a day were randomized to one of two intervention groups or an assessment-only control condition. The interventions consisted of three tailored letters that were sent after baseline and follow-up assessments after three and six months. Follow-up data on smoking status were provided by 82% and 77% of the participants 12 and 24 months after study inclusion, respectively. Generalized estimation equation (GEE) models adjusted for potential baseline confounders and multiple imputation of missing follow-up data were used to estimate intervention effects. At 24-month follow-up prevalence of 7-day point abstinence was 8.4%, 12.9% and 14.7% in the control, abstinence intervention and reduction intervention condition, which corresponds to a number needed to treat of 22 (95%-CI: 11-707) and 16 (95%-CI: 9-53). Adjusted GEE analyses revealed that the smoking reduction intervention (ORadj=2.3, p<0.01) but not the abstinence intervention (ORadj=1.4, p=0.20) increased the odds of 6-month prolonged abstinence compared with the control condition. No significant differences appear when directly comparing both intervention groups. Smoking reduction should be considered as an alternative intervention goal for smokers who are unable or unwilling to quit. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Effect of Transcranial Direct Current Stimulation on Severely Affected Arm-Hand Motor Function in Patients After an Acute Ischemic Stroke: A Pilot Randomized Control Trial.

PubMed

Rabadi, Meheroz H; Aston, Christopher E

2017-10-01

The aim of this article was to determine whether cathodal transcranial direct current stimulation (c-tDCS) to unaffected primary motor cortex (PMC) plus conventional occupational therapy (OT) improves functional motor recovery of the affected arm hand in patients after an acute ischemic stroke compared with sham transcranial direct current stimulation plus conventional OT. In this prospective, randomized, double-blinded, sham-controlled trial of 16 severe, acute ischemic stroke patients with severe arm-hand weakness were randomly assigned to either experimental (c-tDCS plus OT; n = 8) or control (sham transcranial direct current stimulation plus OT; n = 8) groups. All patients received a standard 3-hr in-patient rehabilitation therapy, plus an additional ten 30-min sessions of tDCS. During each session, 1 mA of cathodal stimulation to the unaffected PMC is performed followed by the patient's scheduled OT. The primary outcome measure was change in Action Research Arm Test (ARAT) total and subscores on discharge. Application of c-tDCS to unaffected PMC resulted in a clinically relevant 10-point improvement in the affected arm-hand function based on ARAT total score compared with a 2-point improvement in the control group. Application of 30-min of c-tDCS to the unaffected PMC showed a 10-point improvement in the ARAT score. This corresponds to a large effect size in improvement of affected arm-hand function in patients with severe, acute ischemic stroke. Although not statistically significant, this suggests that larger studies, enrolling at least 25 patients in each group, and with a longer follow-up are warranted.

A Blinded Randomized Controlled Trial of Motivational Interviewing to Improve Adherence with Osteoporosis Medications: Design of the OPTIMA Trial

PubMed Central

Solomon, Daniel H.; Gleeson, Timothy; Iversen, Maura; Avorn, Jerome; Brookhart, M. Alan; Lii, Joyce; Losina, Elena; May, Frank; Patrick, Amanda; Shrank, William H.; Katz, Jeffrey N.

2010-01-01

Purpose While many effective treatments exist for osteoporosis, most people do not adhere to such treatments long-term. No proven interventions exist to improve osteoporosis medication adherence. We report here on the design and initial enrollment in an innovative randomized controlled trial aimed at improving adherence to osteoporosis treatments. Methods The trial represents a collaboration between academic researchers and a state-run pharmacy benefits program for low-income older adults. Beneficiaries beginning treatment with a medication for osteoporosis are targeted for recruitment. We randomize consenting individuals to receive 12-months of mailed education (control arm) or an intervention consisting of one-on-one telephone-based counseling and the mailed education. Motivational Interviewing forms the basis for the counseling program which is delivered by seven trained and supervised health counselors over ten telephone calls. The counseling sessions include scripted dialogue, open-ended questions about medication adherence and its barriers, as well as structured questions. The primary endpoint of the trial is medication adherence measured over the 12-month intervention period. Secondary endpoints include fractures, nursing home admissions, health care resource utilization, and mortality. Results During the first 7 months of recruitment, we have screened 3,638 potentially eligible subjects. After an initial mailing, 1,115 (30.6%) opted out of telephone recruitment and 1,019 (28.0%) could not be successfully contacted. Of the remaining, 879 (24.2%) consented to participate and were randomized. Women comprise over 90% of all groups, mean ages range from 77–80 years old, and the majority in all groups was white. The distribution of osteoporosis medications was comparable across groups and the median number of different prescription drugs used in the prior year was 8–10. Conclusions We have developed a novel intervention for improving osteoporosis medication adherence. The intervention is currently being tested in a large scale randomized controlled trial. If successful, the intervention may represent a useful model for improving adherence to other chronic treatments. PMID:19436935

Replacing Non-Active Video Gaming by Active Video Gaming to Prevent Excessive Weight Gain in Adolescents.

PubMed

Simons, Monique; Brug, Johannes; Chinapaw, Mai J M; de Boer, Michiel; Seidell, Jaap; de Vet, Emely

2015-01-01

The aim of the current study was to evaluate the effects of and adherence to an active video game promotion intervention on anthropometrics, sedentary screen time and consumption of sugar-sweetened beverages and snacks among non-active video gaming adolescents who primarily were of healthy weight. We assigned 270 gaming (i.e. ≥ 2 hours/week non-active video game time) adolescents randomly to an intervention group (n = 140) (receiving active video games and encouragement to play) or a waiting-list control group (n = 130). BMI-SDS (SDS = adjusted for mean standard deviation score), waist circumference-SDS, hip circumference and sum of skinfolds were measured at baseline, at four and ten months follow-up (primary outcomes). Sedentary screen time, physical activity, consumption of sugar-sweetened beverages and snacks, and process measures (not at baseline) were assessed with self-reports at baseline, one, four and ten months follow-up. Multi-level-intention to treat-regression analyses were conducted. The control group decreased significantly more than the intervention group on BMI-SDS (β = 0.074, 95%CI: 0.008;0.14), and sum of skinfolds (β = 3.22, 95%CI: 0.27;6.17) (overall effects). The intervention group had a significantly higher decrease in self-reported non-active video game time (β = -1.76, 95%CI: -3.20;-0.32) and total sedentary screen time (Exp (β = 0.81, 95%CI: 0.74;0.88) than the control group (overall effects). The process evaluation showed that 14% of the adolescents played the Move video games every week ≥ 1 hour/week during the whole intervention period. The active video game intervention did not result in lower values on anthropometrics in a group of 'excessive' non-active video gamers (mean ~ 14 hours/week) who primarily were of healthy weight compared to a control group throughout a ten-month-period. Even some effects in the unexpected direction were found, with the control group showing lower BMI-SDS and skin folds than the intervention group. The intervention did result in less self-reported sedentary screen time, although these results are likely biased by social desirability. Dutch Trial Register NTR3228.

Analysis of the habitat of Henslow's sparrows and Grasshopper sparrows compared to random grassland areas

DOE Office of Scientific and Technical Information (OSTI.GOV)

Maier, Kristen; Walton, Rod; Kasper, Peter

2005-01-01

Henslow's Sparrows are endangered prairie birds, and Grasshopper Sparrows are considered rare prairie birds. Both of these birds were abundant in Illinois, but their populations have been declining due to loss of the grasslands. This begins an ongoing study of the birds habitat so Fermilab can develop a land management plan for the Henslow's and Grasshoppers. The Henslow's were found at ten sites and Grasshoppers at eight sites. Once the birds were located, the vegetation at their sites was studied. Measurements of the maximum plant height, average plant height, and duff height were taken and estimates of the percent ofmore » grass, forbs, duff, and bare ground were recorded for each square meter studied. The same measurements were taken at ten random grassland sites on Fermilab property. Several t-tests were performed on the data, and it was found that both Henslow's Sparrows and Grasshopper Sparrows preferred areas with a larger percentage of grass than random areas. Henslow's also preferred areas with less bare ground than random areas, while Grasshoppers preferred areas with more bare ground than random areas. In addition, Grasshopper Sparrows preferred a lower percentage of forbs than was found in random areas and a shorter average plant height than the random locations. Two-sample variance tests suggested significantly less variance for both Henslow's Sparrows and Grasshopper Sparrows for maximum plant height in comparison to the random sites. For both birds, the test suggested a significant difference in the variance of the percentage of bare ground compared to random sites, but only the Grasshopper Sparrow showed significance in the variation in the percentage of forbs.« less

Dysregulation of the Descending Pain System in Temporomandibular Disorders Revealed by Low-Frequency Sensory Transcutaneous Electrical Nerve Stimulation: A Pupillometric Study

PubMed Central

Monaco, Annalisa; Cattaneo, Ruggero; Mesin, Luca; Ortu, Eleonora; Giannoni, Mario; Pietropaoli, Davide

2015-01-01

Using computerized pupillometry, our previous research established that the autonomic nervous system (ANS) is dysregulated in patients suffering from temporomandibular disorders (TMDs), suggesting a potential role for ANS dysfunction in pain modulation and the etiology of TMD. However, pain modulation hypotheses for TMD are still lacking. The periaqueductal gray (PAG) is involved in the descending modulation of defensive behavior and pain through μ, κ, and δ opioid receptors. Transcutaneous electrical nerve stimulation (TENS) has been extensively used for pain relief, as low-frequency stimulation can activate µ receptors. Our aim was to use pupillometry to evaluate the effect of low-frequency TENS stimulation of μ receptors on opioid descending pathways in TMD patients. In accordance with the Research Diagnostic Criteria for TMD, 18 females with myogenous TMD and 18 matched-controls were enrolled. All subjects underwent subsequent pupillometric evaluations under dark and light conditions before, soon after (end of stimulation) and long after (recovery period) sensorial TENS. The overall statistics derived from the darkness condition revealed no significant differences in pupil size between cases and controls; indeed, TENS stimulation significantly reduced pupil size in both groups. Controls, but not TMD patients, displayed significant differences in pupil size before compared with after TENS. Under light conditions, TMD patients presented a smaller pupil size compared with controls; the pupil size was reduced only in the controls. Pupil size differences were found before and during TENS and before and after TENS in the controls only. Pupillometry revealed that stimulating the descending opioid pathway with low-frequency sensory TENS of the fifth and seventh pairs of cranial nerves affects the peripheral target. The TMD patients exhibited a different pattern of response to TENS stimulation compared with the controls, suggesting that impaired modulation of the descending pain system may be involved in TMD. PMID:25905862

Quantum random number generation for loophole-free Bell tests

NASA Astrophysics Data System (ADS)

Mitchell, Morgan; Abellan, Carlos; Amaya, Waldimar

2015-05-01

We describe the generation of quantum random numbers at multi-Gbps rates, combined with real-time randomness extraction, to give very high purity random numbers based on quantum events at most tens of ns in the past. The system satisfies the stringent requirements of quantum non-locality tests that aim to close the timing loophole. We describe the generation mechanism using spontaneous-emission-driven phase diffusion in a semiconductor laser, digitization, and extraction by parity calculation using multi-GHz logic chips. We pay special attention to experimental proof of the quality of the random numbers and analysis of the randomness extraction. In contrast to widely-used models of randomness generators in the computer science literature, we argue that randomness generation by spontaneous emission can be extracted from a single source.

Can a Parenting Intervention to Prevent Early Conduct Problems Interrupt Girls' Risk for Intimate Partner Violence 10 Years Later?

PubMed

Ehrensaft, Miriam K; Westfall, Heather Knous; Niolon, Phyllis Holditch; Lopez, Thailyn; Kamboukos, Dimitra; Huang, Keng-Yen; Brotman, Laurie Miller

2018-05-01

This study tests whether a parenting intervention for families of preschoolers at risk for conduct problems can prevent later risk for intimate partner violence (IPV). Ninety-nine preschoolers at familial risk for conduct problems were randomly assigned to intervention or control conditions. Ten years later, 45 preschoolers and 43 of their siblings completed an assessment of their romantic relationships, including measures of physical and psychological IPV. The study focuses on the 54 females, including targets (n = 27) and siblings (n = 27) who participated in a 10-year follow-up (M age = 16.5, SD = 5.2, range = 10-28). Using an intent-to-treat (ITT) design, multivariate regressions suggest that females from families randomly assigned to intervention in early childhood scored lower than those in the control condition on perceptions of dating violence as normative, beliefs about IPV prevalence, exposure to IPV in their own peer group, and expected sanction behaviors for IPV perpetration and victimization. Findings suggest that early parenting intervention may reduce association of high-risk females with aggressive peers and partners in adolescence.

Shiatsu as an adjuvant therapy for depression in patients with Alzheimer's disease: A pilot study.

PubMed

Lanza, Giuseppe; Centonze, Stella Silvia; Destro, Gera; Vella, Veronica; Bellomo, Maria; Pennisi, Manuela; Bella, Rita; Ciavardelli, Domenico

2018-06-01

Among the complementary and alternative medicine, Shiatsu might represent a feasible option for depression in Alzheimer's disease (AD). We evaluated Shiatsu on mood, cognition, and functional independence in patients undergoing physical activity. Single-blind randomized controlled study. Dedicated Community Center for patients with AD. AD patients with depression were randomly assigned to the "active group" (Shiatsu + physical activity) or the "control group" (physical activity alone). Shiatsu was performed by the same therapist once a week for ten months. Global cognitive functioning (Mini Mental State Examination - MMSE), depressive symptoms (Geriatric Depression Scale - GDS), and functional status (Activity of Daily Living - ADL, Instrumental ADL - IADL) were assessed before and after the intervention. We found a within-group improvement of MMSE, ADL, and GDS in the active group. However, the analysis of differences before and after the interventions showed a statistically significant decrease of GDS score only in the active group. The combination of Shiatsu and physical activity improved depression in AD patients compared to physical activity alone. The pathomechanism might involve neuroendocrine-mediated effects of Shiatsu on neural circuits implicated in mood and affect regulation. Copyright © 2018 Elsevier Ltd. All rights reserved.

Preoperative intra-aortic balloon pump in patients undergoing coronary bypass surgery: a systematic review and meta-analysis.

PubMed

Dyub, Adel M; Whitlock, Richard P; Abouzahr, Labib L; Cinà, Claudio S

2008-01-01

To assess the effectiveness of preoperative intra-aortic balloon pump (IABP) placement in high-risk patients undergoing coronary bypass surgery (CABG). The primary outcome was hospital mortality and secondary outcomes were IABP-related complications (bleeding, leg ischemia, aortic dissection). MEDLINE, EMBASE, Cochrane registry of Controlled Trials, and reference lists of relevant articles were searched. We included randomized controlled trials (RCTs), and cohort studies that fulfilled our a priori inclusion criteria. Eligibility decisions, relevance, study validity, and data extraction were performed in duplicate using pre-specified criteria. Meta-analysis was conducted using a random effects model. Ten publications fulfilled our eligibility criteria, of which four were RCTs and six were cohort studies with controls. There were statistical as well as clinical heterogeneity among included studies. A total of 1034 patients received preoperative IABP and 1329 did not receive preoperative IABP. The pooled odds ratio (OR) for hospital mortality in patients treated with preoperative IABP was 0.41 (95% CI, 0.21-0.82, p = 0.01). The number needed to treat was 17. The pooled OR for hospital mortality from randomized trials was 0.18 (95% CI, 0.06-0.57, p = 0.003) and from cohort studies was 0.54 (95% CI, 0.24-1.2, p = 0.13). Overall, 3.7% (13 of 349) of patients who received preoperative IABP developed either limb ischemia or haematoma at the IABP insertion site, and most of these complications improved after discontinuation of IABP. Evidence from this meta-analysis support the use of preoperative IABP in high-risk patients to reduce hospital mortality.

Magnetic resonance therapy for knee osteoarthritis: a randomized, double blind placebo controlled trial.

PubMed

Gökşen, Nurgül; Çaliş, Mustafa; Doğan, Serap; Çaliş, Havva T; Özgöçmen, Salih

2016-08-01

Therapeutic nuclear magnetic resonance therapy (MRT) works based on the electromagnetic fields. To investigate efficacy of MRT in knee osteoarthritis (OA). Prospective, randomized, double-blind, placebo controlled trial. Outpatient clinic, university hospital. Patients who had mild to moderate knee OA at a single knee joint and between 30-75-years-old were randomized by blinded chip cards (1:1). The treatment group received ten sessions of one hour daily MRT, controls received placebo MRT. All patients underwent clinical examination at baseline, after 2 weeks, and 12 weeks. Imaging included blindly assessed ultrasonography and magnetic resonance (MR) of the knee. Ninety-seven patients completed the study. Both groups improved significantly but the average change from baseline in outcome parameters was similar in MRT group (on VAS-pain,-2.6; WOMAC-pain, -2.09; WOMAC-stiffness, -1.81; WOMAC-physical, -1.96) compared to placebo after two weeks (VAS-pain,-1.6; WOMAC-pain, -1.91; WOMAC-stiffness, -1.27; WOMAC-physical, -1.54). Also changes were quite similar at the 12th week after the treatment. SF-36 components at 12th week improved but changes were not significant. Imaging arm also failed to show significant differences between groups in terms of cartilage thickness on US and MR scores. No adverse events were recorded. MRT is safe, but not superior to placebo in terms of improvement in clinical or imaging parameters after a 10-day course of treatment in mild to moderate knee OA. The present study does not promote use of a 10-day course of MRT in mild to moderate knee OA.

The effects of augmented visual feedback during balance training in Parkinson's disease: study design of a randomized clinical trial.

PubMed

van den Heuvel, Maarten R C; van Wegen, Erwin E H; de Goede, Cees J T; Burgers-Bots, Ingrid A L; Beek, Peter J; Daffertshofer, Andreas; Kwakkel, Gert

2013-10-04

Patients with Parkinson's disease often suffer from reduced mobility due to impaired postural control. Balance exercises form an integral part of rehabilitative therapy but the effectiveness of existing interventions is limited. Recent technological advances allow for providing enhanced visual feedback in the context of computer games, which provide an attractive alternative to conventional therapy. The objective of this randomized clinical trial is to investigate whether a training program capitalizing on virtual-reality-based visual feedback is more effective than an equally-dosed conventional training in improving standing balance performance in patients with Parkinson's disease. Patients with idiopathic Parkinson's disease will participate in a five-week balance training program comprising ten treatment sessions of 60 minutes each. Participants will be randomly allocated to (1) an experimental group that will receive balance training using augmented visual feedback, or (2) a control group that will receive balance training in accordance with current physical therapy guidelines for Parkinson's disease patients. Training sessions consist of task-specific exercises that are organized as a series of workstations. Assessments will take place before training, at six weeks, and at twelve weeks follow-up. The functional reach test will serve as the primary outcome measure supplemented by comprehensive assessments of functional balance, posturography, and electroencephalography. We hypothesize that balance training based on visual feedback will show greater improvements on standing balance performance than conventional balance training. In addition, we expect that learning new control strategies will be visible in the co-registered posturographic recordings but also through changes in functional connectivity.

Advisor-Teller Money Manager (ATM) therapy for substance use disorders.

PubMed

Rosen, Marc I; Rounsaville, Bruce J; Ablondi, Karen; Black, Anne C; Rosenheck, Robert A

2010-07-01

Patients with concomitant psychiatric and substance use disorders are commonly assigned representative payees or case managers to help manage their funds, but money management has not been conceptualized as a theory-based treatment. This randomized clinical trial was conducted to determine the effect of a money management-based therapy, advisor-teller money manager (ATM), on substance abuse or dependence. Ninety patients at a community mental health center who had a history of cocaine or alcohol abuse or dependence were assessed after random assignment to 36 weeks of ATM (N=47) or a control condition in which use of a financial workbook was reviewed (N=43). Patients assigned to ATM were encouraged to deposit their funds into a third-party account, plan weekly expenditures, and negotiate monthly budgets. Substance use calendars and urine toxicology tests were collected every other week for 36 weeks and again 52 weeks after randomization. Patients assigned to ATM had significantly more negative toxicologies for cocaine metabolite over time than patients in the control group, and treating clinicians rated ATM patients as significantly more likely to be abstinent from illicit drugs. Self-reported abstinence from alcohol did not significantly differ between groups. Unexpectedly, patients assigned to ATM were more likely to be assigned a representative payee or a conservator than control participants during the follow-up period (ten of 47 versus two of 43). One patient in ATM assaulted the therapist when his check had not arrived. ATM is an efficacious therapy for the treatment of cocaine abuse or dependence among people with concomitant psychiatric illness but requires protection of patient autonomy and staff safety.

Community-based intermittent mass testing and treatment for malaria in an area of high transmission intensity, western Kenya: study design and methodology for a cluster randomized controlled trial.

PubMed

Samuels, Aaron M; Awino, Nobert; Odongo, Wycliffe; Abong'o, Benard; Gimnig, John; Otieno, Kephas; Shi, Ya Ping; Were, Vincent; Allen, Denise Roth; Were, Florence; Sang, Tony; Obor, David; Williamson, John; Hamel, Mary J; Patrick Kachur, S; Slutsker, Laurence; Lindblade, Kim A; Kariuki, Simon; Desai, Meghna

2017-06-07

Most human Plasmodium infections in western Kenya are asymptomatic and are believed to contribute importantly to malaria transmission. Elimination of asymptomatic infections requires active treatment approaches, such as mass testing and treatment (MTaT) or mass drug administration (MDA), as infected persons do not seek care for their infection. Evaluations of community-based approaches that are designed to reduce malaria transmission require careful attention to study design to ensure that important effects can be measured accurately. This manuscript describes the study design and methodology of a cluster-randomized controlled trial to evaluate a MTaT approach for malaria transmission reduction in an area of high malaria transmission. Ten health facilities in western Kenya were purposively selected for inclusion. The communities within 3 km of each health facility were divided into three clusters of approximately equal population size. Two clusters around each health facility were randomly assigned to the control arm, and one to the intervention arm. Three times per year for 2 years, after the long and short rains, and again before the long rains, teams of community health volunteers visited every household within the intervention arm, tested all consenting individuals with malaria rapid diagnostic tests, and treated all positive individuals with an effective anti-malarial. The effect of mass testing and treatment on malaria transmission was measured through population-based longitudinal cohorts, outpatient visits for clinical malaria, periodic population-based cross-sectional surveys, and entomological indices.

Do Technical Aids for Patient Handling Prevent Musculoskeletal Complaints in Health Care Workers?—A Systematic Review of Intervention Studies

PubMed Central

Hegewald, Janice; Berge, Wera; Heinrich, Philipp; Staudte, Ronny; Freiberg, Alice; Scharfe, Julia; Girbig, Maria; Nienhaus, Albert; Seidler, Andreas

2018-01-01

The physical load ensuing from the repositioning and moving of patients puts health care workers at risk of musculoskeletal complaints. Technical equipment developed to aid with patient handling should reduce physical strain and workload; however, the efficacy of these aids in preventing musculoskeletal disorders and complaints is still unclear. A systematic review of controlled intervention studies was conducted to examine if the risk of musculoskeletal complaints and disorders is reduced by technical patient handling equipment. MEDLINE®/PubMed®, EMBASE®, Allied and Complementary Medicine Database (AMED), and Cumulative Index of Nursing and Allied Health Literature (CINAHL®) were searched using terms for nursing, caregiving, technical aids, musculoskeletal injuries, and complaints. Randomized controlled trials and controlled before-after studies of interventions including technical patient handling equipment were included. The titles and abstracts of 9554 publications and 97 full-texts were screened by two reviewers. The qualitative synthesis included one randomized controlled trial (RCT) and ten controlled before-after studies. A meta-analysis of four studies resulted in a pooled risk ratio for musculoskeletal injury claims (post-intervention) of 0.78 (95% confidence interval 0.68–0.90). Overall, the methodological quality of the studies was poor and the results often based on administrative injury claim data, introducing potential selection bias. Interventions with technical patient handling aids appear to prevent musculoskeletal complaints, but the certainty of the evidence according to GRADE approach ranged from low to very low. PMID:29522440

Do Technical Aids for Patient Handling Prevent Musculoskeletal Complaints in Health Care Workers?-A Systematic Review of Intervention Studies.

PubMed

Hegewald, Janice; Berge, Wera; Heinrich, Philipp; Staudte, Ronny; Freiberg, Alice; Scharfe, Julia; Girbig, Maria; Nienhaus, Albert; Seidler, Andreas

2018-03-09

The physical load ensuing from the repositioning and moving of patients puts health care workers at risk of musculoskeletal complaints. Technical equipment developed to aid with patient handling should reduce physical strain and workload; however, the efficacy of these aids in preventing musculoskeletal disorders and complaints is still unclear. A systematic review of controlled intervention studies was conducted to examine if the risk of musculoskeletal complaints and disorders is reduced by technical patient handling equipment. MEDLINE ® /PubMed ® , EMBASE ® , Allied and Complementary Medicine Database (AMED), and Cumulative Index of Nursing and Allied Health Literature (CINAHL ® ) were searched using terms for nursing, caregiving, technical aids, musculoskeletal injuries, and complaints. Randomized controlled trials and controlled before-after studies of interventions including technical patient handling equipment were included. The titles and abstracts of 9554 publications and 97 full-texts were screened by two reviewers. The qualitative synthesis included one randomized controlled trial (RCT) and ten controlled before-after studies. A meta-analysis of four studies resulted in a pooled risk ratio for musculoskeletal injury claims (post-intervention) of 0.78 (95% confidence interval 0.68-0.90). Overall, the methodological quality of the studies was poor and the results often based on administrative injury claim data, introducing potential selection bias. Interventions with technical patient handling aids appear to prevent musculoskeletal complaints, but the certainty of the evidence according to GRADE approach ranged from low to very low.

[Benefits of music therapy as therapy no pharmacology and rehabilitation moderate dementia].

PubMed

Jiménez-Palomares, María; Rodríguez-Mansilla, Juan; González-López-Arza, María Victoria; Rodríguez-Domínguez, María Trinidad; Prieto-Tato, Marta

2013-01-01

An in-depth review is presented the possible benefits of music therapy in relation to the cognitive and/or behavioural level of elderly patients with dementia. We have carried out a systematic review of randomized controlled trials, case-control and pilot studies published from January 2000 to January 2012 using the Cochrane Database of Systematic Reviews, MEDLINE, Dialnet and CSIC. We focused on comparison of music therapy as non-pharmacological therapy, in patients over 65 years of age with moderate dementia, with regular therapeutic and occupational treatment. Ten articles were selected based on the inclusion criteria. The analysis of the results suggest that music Therapy influences the elderly people with dementia in a positive way by improving levels of behavioural and cognitive functioning and social participation. Copyright © 2012 SEGG. Published by Elsevier Espana. All rights reserved.

Red wine polyphenols modulate fecal microbiota and reduce markers of the metabolic syndrome in obese patients.

PubMed

Moreno-Indias, Isabel; Sánchez-Alcoholado, Lidia; Pérez-Martínez, Pablo; Andrés-Lacueva, Cristina; Cardona, Fernando; Tinahones, Francisco; Queipo-Ortuño, María Isabel

2016-04-01

This study evaluated the possible prebiotic effect of a moderate intake of red wine polyphenols on the modulation of the gut microbiota composition and the improvement in the risk factors for the metabolic syndrome in obese patients. Ten metabolic syndrome patients and ten healthy subjects were included in a randomized, crossover, controlled intervention study. After a washout period, the subjects consumed red wine and de-alcoholized red wine over a 30 day period for each. The dominant bacterial composition did not differ significantly between the study groups after the two red wine intake periods. In the metabolic syndrome patients, red wine polyphenols significantly increased the number of fecal bifidobacteria and Lactobacillus (intestinal barrier protectors) and butyrate-producing bacteria (Faecalibacterium prausnitzii and Roseburia) at the expense of less desirable groups of bacteria such as LPS producers (Escherichia coli and Enterobacter cloacae). The changes in gut microbiota in these patients could be responsible for the improvement in the metabolic syndrome markers. Modulation of the gut microbiota by using red wine could be an effective strategy for managing metabolic diseases associated with obesity.

Tonic Investigation Concept of Cervico-vestibular Muscle Afferents

PubMed Central

Dorn, Linda Josephine; Lappat, Annabelle; Neuhuber, Winfried; Scherer, Hans; Olze, Heidi; Hölzl, Matthias

2016-01-01

Introduction Interdisciplinary research has contributed greatly to an improved understanding of the vestibular system. To date, however, very little research has focused on the vestibular system's somatosensory afferents. To ensure the diagnostic quality of vestibular somatosensory afferent data, especially the extra cranial afferents, stimulation of the vestibular balance system has to be precluded. Objective Sophisticated movements require intra- and extra cranial vestibular receptors. The study's objective is to evaluate an investigation concept for cervico-vestibular afferents with respect to clinical feasibility. Methods A dedicated chair was constructed, permitting three-dimensional trunk excursions, during which the volunteer's head remains fixed. Whether or not a cervicotonic provocation nystagmus (c-PN) can be induced with static trunk excursion is to be evaluated and if this can be influenced by cervical monophasic transcutaneous electrical nerve stimulation (c-TENS) with a randomized test group. 3D-video-oculography (VOG) was used to record any change in cervico-ocular examination parameters. The occurring nystagmuses were evaluated visually due to the small caliber of nystagmus amplitudes in healthy volunteers. Results The results demonstrate: no influence of placebo-controlled c-TENS on the spontaneous nystagmus; a significant increase of the vertical nystagmus on the 3D-trunk-excursion chair in static trunk flexion with cervical provocation in all young healthy volunteers (n = 49); and a significant difference between vertical and horizontal nystagmuses during static trunk excursion after placebo-controlled c-TENS, except for the horizontal nystagmus during trunk torsion. Conclusion We hope this cervicotonic investigation concept on the 3D trunk-excursion chair will contribute to new diagnostic and therapeutic perspectives on cervical pathologies in vestibular head-to-trunk alignment. PMID:28050208

Effect of tooth whitening strips on fatigue resistance and flexural strength of bovine dentin in vitro

PubMed Central

Kim, Namhee; De Souza, Grace M.

2017-01-01

Objective To determine the effects of whitening strips on bovine dentin fatigue resistance and flexural strength in vitro. Materials and methods A total of eighty bovine dentin specimens (2x2x17mm) were treated with either: control glycerine gel on plastic film wrap or whitening strips containing 9.5% hydrogen peroxide. Treatment was applied for 30 minutes, twice a day, for 1- or 4-weeks. After the last treatment, ten specimens per group were randomly selected to undergo fatigue testing (106 cycles, 3Hz, 20N) while the other ten were subjected to flexural strength testing after ten days of storage in artificial saliva. Kaplan-Meier method with a log rank test, Wilcoxon test and Cox regression were used to assess fatigue test results (p<0.05). One-way ANOVA and Tukey’s tests were used to compare the flexural strength results (p<0.05). Results There were significant differences in survival during the fatigue test among the groups (p<0.001). Treatment (control or bleach) was a significant factor for specimen survival (p<0.001, Exp(B) = 33.45). There were significant differences in mean flexural strength (p<0.001). No significant difference was found between “1-wk control” and “4-wk control”. The mean flexural strength and fatigue resistance of the “4-wk bleach” were significantly lower than all the other groups. Conclusions The use of whitening strips reduced the fatigue resistance and flexural strength of bovine dentin in vitro. Until the effect of whitening strips on mechanical properties of human dentin is fully elucidated, it remains prudent to advise patients to avoid excessive direct use of whitening strips on dentin. PMID:28278191

Syndrome Evaluation System (SES) versus Blood Culture (BACTEC) in the Diagnosis and Management of Neonatal Sepsis--A Randomized Controlled Trial.

PubMed

Bhat, B Vishnu; Prasad, P; Ravi Kumar, Venkata Banda; Harish, B N; Krishnakumari, K; Rekha, Anand; Manjunath, G; Adhisivam, B; Shruthi, B

2016-05-01

To compare the clinical outcome of a multiplex polymerase chain reaction (PCR) based molecular diagnostic method -- Syndrome Evaluation System (SES) directed treatment strategy vs. standard of care (blood culture) directed treatment strategy for neonatal sepsis. This randomized controlled trial (RCT) included 385 neonates with sepsis who were randomized into two groups -- SES and control (BACTEC). Both tests were performed for all the neonates. However, in the SES group, the results of SES test were revealed to the treating clinicians, while in the control group, SES results were withheld. Two ml of blood was drawn from each baby. One aliquot was sent for blood culture, whereas the remaining aliquot was sent for SES. Babies were then administered empirical IV antibiotics and given supportive care. Further antibiotic changes, if required were done in SES and control groups based on their respective reports. The microbiological profile, immediate outcome, duration of hospital stay, number of antibiotics used and readmission within a month in both groups were compared. SES was better than BACTEC in identifying the causative organism in both the groups (68 % vs. 18 % in SES group and 72 % vs. 18 % in control group). SES had 100 % concordance with blood culture by BACTEC. Detection of bacteria and fungi were four and ten-fold higher respectively with SES when compared to BACTEC culture. Microbiological diagnosis was rapid with SES compared to BACTEC (7 h vs. 72 h). Treatment based on SES resulted in significantly less mortality (3 % vs. 18 %). Readmission rate, duration of hospital stay and change in antibiotics were also significantly less in SES group. This new molecular based diagnostic system (SES) helps in rapid and accurate diagnosis of neonatal sepsis and reduces mortality and morbidity in affected neonates.

The effects of a muscle resistance program on the functional capacity, knee extensor muscle strength and plasma levels of IL-6 and TNF-alpha in pre-frail elderly women: a randomized crossover clinical trial--a study protocol.

PubMed

Lustosa, Lygia P; Coelho, Fernanda M; Silva, Juscelio P; Pereira, Daniele S; Parentoni, Adriana N; Dias, João M D; Dias, Rosangela C; Pereira, Leani S M

2010-07-28

With the increase in the elderly population, a growing number of chronic degenerative diseases and a greater dependency on caregivers have been observed. Elderly persons in states of frailty remain more susceptible to significant health complications. There is evidence of an inverse relationship between plasma levels of inflammatory mediators and levels of functionality and muscle strength, suggesting that muscle-strengthening measures can aid in inflammatory conditions. The purpose of this study will be verified the effect of a muscle-strengthening program with load during a ten-week period in pre-frail elderly women with attention to the following outcomes: (1) plasma levels of interleukin-6 (IL-6) and tumor necrosis factor alpha (TNF-alpha), (2) functional capacity and (3) knee extensor muscle strength. The study design is a randomized crossover clinical trial evaluating 26 elderly women (regardless of their race and/or social condition) who are community residents, older than 65, and classified as pre-frail according to the criteria previously described by Fried et al. (2004). All subjects will be assessed using the Timed up and go and 10-Meter Walk Test functional tests. The plasma levels of IL-6 and TNF-alpha will be assessed by ELISA (enzyme-linked immunosorbent assay) with high sensitivity kits (QuantikineHS, R&D Systems Minneapolis, MN, U.S.). Knee extensor muscle strength will be assessed using the Byodex System 3 Pro(R) isokinetic dynamometer at angular speeds of 60 and 180 degrees/s. The intervention will consist of strengthening exercises of the lower extremities at 50 to 70% of 1RM (maximal resistance) three times per week for ten weeks. The volunteers will be randomized into two groups: group E, the intervention group, and group C, the control group that did not initiate any new activities during the initial study period (ten weeks). After the initial period, group C will begin the intervention and group E will maintain everyday activities without exercising. At the end of the total study period, all volunteers will be reassessed. To demonstrate and discuss possible influences of load-bearing exercises on the modification of plasma levels of IL-6 and TNF-alpha and in the functional performance of pre-frail elderly women. ISRCTN62824599.

Vertical Launch System Loadout Planner

DTIC Science & Technology

2015-03-01

United States Navy USS United States’ Ship VBA Visual Basic for Applications VLP VLS Loadout Planner VLS Vertical Launch System...with 32 gigabytes of random access memory and eight processors, General Algebraic Modeling System (GAMS) CPLEX version 24 (GAMS, 2015) solves this...problem in ten minutes to an integer tolerance of 10%. The GAMS interpreter and CPLEX solver require 75 Megabytes of random access memory for this

Transcutaneous electrical nerve stimulation (TENS) for pain relief in labour.

PubMed

Dowswell, Therese; Bedwell, Carol; Lavender, Tina; Neilson, James P

2009-04-15

Transcutaneous nerve stimulation (TENS) has been proposed as a means of reducing pain in labour. The TENS unit emits low-voltage electrical impulses which vary in frequency and intensity. During labour, TENS electrodes are generally placed on the lower back, although TENS may be used to stimulate acupuncture points or other parts of the body. The physiological mechanisms whereby TENS relieves pain are uncertain. The TENS unit is frequently operated by women, which may increase sense of control in labour. To assess the effects of TENS on pain in labour. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (November 2008). Randomised controlled trials comparing women receiving TENS for pain relief in labour versus routine care, alternative pharmacological methods of pain relief, or placebo devices. We included all types of TENS machines. Two review authors assessed for inclusion all trials identified by the search strategy, carried out data extraction and assessed risk of bias. We have recorded reasons for excluding studies. The search identified 25 studies; we excluded six and included 19 studies including 1671 women. Fifteen examined TENS applied to the back, two to acupuncture points and two to the cranium. Overall, there was little difference in pain ratings between TENS and control groups, although women receiving TENS to acupuncture points were less likely to report severe pain (risk ratio 0.41, 95% confidence interval 0.32 to 0.55). The majority of women using TENS said they would be willing to use it again in a future labour. Where TENS was used as an adjunct to epidural analgesia there was no evidence that it reduced pain. There was no consistent evidence that TENS had any impact on interventions and outcomes in labour. There was little information on outcomes for mothers and babies. No adverse events were reported. There is only limited evidence that TENS reduces pain in labour and it does not seem to have any impact (either positive or negative) on other outcomes for mothers or babies. The use of TENS at home in early labour has not been evaluated. TENS is widely available in hospital settings and women should have the choice of using it in labour.

Increased Release of Serotonin in the Spinal Cord During Low, But Not High, Frequency Transcutaneous Electric Nerve Stimulation in Rats With Joint Inflammation

PubMed Central

Sluka, Kathleen A.; Lisi, Tammy L.; Westlund, Karin N.

2009-01-01

Objective To determine the release pattern of serotonin and noradrenaline in the spinal cord in response to transcutaneous electric nerve stimulation (TENS) delivered at low or high frequency. Design Prospective randomized allocation of 3 treatments. Setting Research laboratory. Animals Male Sprague-Dawley rats (weight range, 250–350g). Intervention Knee joints of rats were inflamed with a mixture of 3% carrageenan and 3% kaolin for 24 hours prior to placement of push-pull cannulae into the dorsal horn of the spinal cord. Push-pull samples were collected in 10-minute intervals before, during, and after treatment with low-frequency TENS (4Hz), high-frequency TENS (100Hz), or sham TENS. TENS was applied to the inflamed knee joint for 20 minutes at sensory intensity and 100-μs pulse duration. Push-pull samples were analyzed for serotonin and noradrenaline by high performance liquid chromatography with coulemetric detection. Main Outcome Measures Spinal concentrations of serotonin and noradrenaline. Results Low-frequency TENS significantly increased serotonin concentrations during and immediately after treatment. There was no change in serotonin with high-frequency TENS, nor was there a change in noradrenaline with low- or high-frequency TENS. Conclusions Low-frequency TENS releases serotonin in the spinal cord to produce antihyperalgesia by activation of serotonin receptors. PMID:16876561

Initial review of Electronic Residency Application Service charts by orthopaedic residency faculty members. Does applicant gender matter?

PubMed

Scherl, S A; Lively, N; Simon, M A

2001-01-01

Orthopaedic surgery is a male-dominated field. As of 1998, women accounted for 42% of medical school graduates, yet only 6.9% of the total number of orthopaedic residents were female. The purpose of our study was to determine whether the Electronic Residency Application Service charts of female candidates for orthopaedic residencies are ranked lower by faculty reviewers than are those of male candidates with similar qualifications. After we obtained permission from the applicants, the Electronic Residency Application Service applications submitted by ninety male and ten female candidates for admission to a university orthopaedic residency program for the 1998 National Residency Matching Program were randomly divided into ten groups, consisting of the charts of nine male candidates and one female candidate. Each chart from a female candidate was altered into a "male" version, in which all names and personal pronouns were changed but which was otherwise identical to the original female version. Therefore, each group of ten charts existed as a paired set: one containing the true female chart and one, the altered "male" chart. The paired sets acted as their own control. One hundred and twenty-one faculty reviewers from fourteen orthopaedic residency programs around the United States each reviewed either the "male" or the female version of one set, without knowledge of the goals of the study, and ranked the ten charts in the order in which they would like to have the candidates as residents in their own programs. Each version of the sets was reviewed by at least five separate reviewers. Reviewers at a given institution were randomized to review different sets, so that there was no overlap among them. The rankings of the female-"male" pairs were compared with use of a standard paired t test. No significant difference was detected in the rankings of the female and "male" charts (p = 0.5). The mean difference in rankings was -0.33, with a 95% confidence interval ranging from -1.41 (favoring females) to 0.74 (favoring "males"). The low percentage of female residents is not due to bias against female applicants in the initial chart-review phase of the orthopaedic residency selection process. It is possible that bias is introduced in other stages of the selection process, such as the interview.

Effect of music therapy on the anxiety levels and pregnancy rate of women undergoing in vitro fertilization-embryo transfer: A randomized controlled trial.

PubMed

Aba, Yilda Arzu; Avci, Dilek; Guzel, Yilmaz; Ozcelik, Semanur Kumral; Gurtekin, Basak

2017-08-01

The aim of this study was to determine the effect of music therapy on the anxiety levels and pregnancy rates of women who underwent in vitro fertilization-embryo transfer. This prospective randomized controlled trial was conducted with 186 infertile women who presented to the In Vitro Fertilization Unit at the American Hospital in Turkey between April 2015 and April 2016. The infertile women who met the inclusion criteria were assigned to the music therapy group or the standard therapy group through block randomization. The study data were collected using the Personal Information Form, and State-Trait Anxiety Inventory. Early treatment success was determined by serum beta human chorionic gonadotrophin levels seven or ten days after the luteal day zero. For the analysis, descriptive statistics, chi-square test, Fisher's exact test, independent sample t-test were used. After the embryo transfer, the mean state anxiety scores decreased in both groups, and the mean trait anxiety score decreased in the music therapy group; however, the difference was not statistically significant (p>0.05). Clinical pregnancy rates did not differ between the music (48.3%) and standard (46.4%) therapy groups. After the two sessions of music therapy, state and trait anxiety levels decreased and pregnancy rates increased, but the difference was not significant. Therefore, larger sample sizes and more sessions are needed to evaluate whether music therapy has an effect on clinical outcomes. Copyright © 2017 Elsevier Inc. All rights reserved.

Sustained effects of neurofeedback in ADHD: a systematic review and meta-analysis.

PubMed

Van Doren, Jessica; Arns, Martijn; Heinrich, Hartmut; Vollebregt, Madelon A; Strehl, Ute; K Loo, Sandra

2018-02-14

Neurofeedback (NF) has gained increasing interest in the treatment of attention-deficit/hyperactivity disorder (ADHD). Given learning principles underlie NF, lasting clinical treatment effects may be expected. This systematic review and meta-analysis addresses the sustainability of neurofeedback and control treatment effects by considering randomized controlled studies that conducted follow-up (FU; 2-12 months) assessments among children with ADHD. PubMed and Scopus databases were searched through November 2017. Within-group and between-group standardized mean differences (SMD) of parent behavior ratings were calculated and analyzed. Ten studies met inclusion criteria (NF: ten studies, N = 256; control: nine studies, N = 250). Within-group NF effects on inattention were of medium effect size (ES) (SMD = 0.64) at post-treatment and increased to a large ES (SMD = 0.80) at FU. Regarding hyperactivity/impulsivity, NF ES were medium at post-treatment (SMD = 0.50) and FU (SMD = 0.61). Non-active control conditions yielded a small significant ES on inattention at post-treatment (SMD = 0.28) but no significant ES at FU. Active treatments (mainly methylphenidate), had large ES for inattention (post: SMD = 1.08; FU: SMD = 1.06) and medium ES for hyperactivity/impulsivity (post: SMD = 0.74; FU: SMD = 0.67). Between-group analyses also revealed an advantage of NF over non-active controls [inattention (post: SMD = 0.38; FU: SMD = 0.57); hyperactivity-impulsivity (post: SMD = 0.25; FU: SMD = 0.39)], and favored active controls for inattention only at pre-post (SMD = - 0.44). Compared to non-active control treatments, NF appears to have more durable treatment effects, for at least 6 months following treatment. More studies are needed for a properly powered comparison of follow-up effects between NF and active treatments and to further control for non-specific effects.

Staying on track: a cluster randomized controlled trial of automated reminders aimed at increasing human papillomavirus vaccine completion.

PubMed

Patel, Ashlesha; Stern, Lisa; Unger, Zoe; Debevec, Elie; Roston, Alicia; Hanover, Rita; Morfesis, Johanna

2014-05-01

To evaluate whether automated reminders increase on-time completion of the three-dose human papillomavirus (HPV) vaccine series. Ten reproductive health centers enrolled 365 women aged 19-26 to receive dose one of the HPV vaccine. Health centers were matched and randomized so that participants received either routine follow-up (control) or automated reminder messages for vaccine doses two and three (intervention). Intervention participants selected their preferred method of reminders - text, e-mail, phone, private Facebook message, or standard mail. We compared vaccine completion rates between groups over a period of 32 weeks. The reminder system did not increase completion rates, which overall were low at 17.2% in the intervention group and 18.9% in the control group (p=0.881). Exploratory analyses revealed that participants who completed the series on-time were more likely to be older (OR=1.15, 95% CI 1.01-1.31), report having completed a four-year college degree or more (age-adjusted OR=2.51, 95% CI 1.29-4.90), and report three or more lifetime sexual partners (age-adjusted OR=3.45, 95% CI 1.20-9.92). The study intervention did not increase HPV vaccine series completion. Despite great public health interest in HPV vaccine completion and reminder technologies, completion rates remain low. Copyright © 2014 Elsevier Ltd. All rights reserved.

Cranberry (poly)phenol metabolites correlate with improvements in vascular function: A double-blind, randomized, controlled, dose-response, crossover study.

PubMed

Rodriguez-Mateos, Ana; Feliciano, Rodrigo P; Boeres, Albert; Weber, Timon; Dos Santos, Claudia Nunes; Ventura, M Rita; Heiss, Christian

2016-10-01

Cranberries are rich in potentially bioactive (poly)phenols. The aim of this paper was to investigate whether cranberry juice intake can improve vascular function in healthy men in a dose- and time-dependent manner, and to understand which of the circulating (poly)phenol metabolites correlate with vascular effects. A double-blind randomized controlled crossover trial was conducted in ten healthy males. Flow-mediated dilation (FMD), blood pressure, pulse wave velocity and augmentation index were investigated at baseline, 1, 2, 4, 6, and 8 h post-consumption of cranberry juices containing 409, 787, 1238, 1534, and 1910 mg of total cranberry (poly)phenols (TP), and a control drink. Plasma (poly)phenol metabolites were analyzed by UPLC-Q-TOF MS using authentic standards. We observed dose-dependent increases in FMD at 1, 2, 4, 6, and 8 h with a peak at 4 h and maximal effects with juice containing 1238 mg TP. A total of 60 metabolites were quantified in plasma after cranberry consumption. Twelve (poly)phenol metabolites significantly correlated with the increases in FMD, including ferulic and caffeic acid sulfates, quercetin-3-O-ß-D-glucuronide and a γ-valerolactone sulfate. (Poly)phenols in cranberry juice can improve vascular function in healthy males and this is linked to the presence of specific newly identified plasma metabolites. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Skin adhesive low-level light therapy for dysmenorrhoea: a randomized, double-blind, placebo-controlled, pilot trial.

PubMed

Shin, Yong-Il; Kim, Nam-Gyun; Park, Kyoung-Jun; Kim, Dong-Wook; Hong, Gi-Youn; Shin, Byung-Cheul

2012-10-01

The cause of dysmenorrhoea is an abnormal function of smooth muscles in the uterus due to long-term deficient blood supply into smooth muscle tissue. The purpose of this study was to evaluate the effectiveness of skin adhesive low-level light therapy (LLLT) in participants with dysmenorrhoea. Thirty-one women were included in this randomized, double-blind, placebo-controlled, pilot trial. Twenty-one women were treated with active LLLT and ten women were treated with placebo one. The therapy was performed in a laboratory room for 20 min a day over a period of 5 days prior to the expected onset of menstruation. The outcome was measured using a visual analog scale (VAS) for each participant's dysmenorrhoeal pain severity. VAS of each subject was measured every month for 6 months. In the active LLLT group, 16 women reported successful results during their first menstrual cycle just after active LLLT and 5 women had successful results from the second menstrual cycle after active LLLT. The pain reduction rate was 83 % in the active LLLT group, whereas there was only a slight and temporary reduction in pain in the placebo LLLT group. Changes of VAS within 6 months of LLLT showed statistical significance (p = 0.001) over placebo control. Our study suggests that skin adhesive LLLT on acupuncture points might be an effective, simple and safe non-pharmacological treatment for dysmenorrhoea.

Mechanisms of behavioural maintenance: Long-term effects of theory-based interventions to promote safe water consumption.

PubMed

Inauen, Jennifer; Mosler, Hans-Joachim

2016-01-01

Theory-based interventions can enhance people's safe water consumption, but the sustainability of these interventions and the mechanisms of maintenance remain unclear. We investigated these questions based on an extended theory of planned behaviour. Seven hundred and ten (445 analysed) randomly selected households participated in two cluster-randomised controlled trials in Bangladesh. Study 1 promoted switching to neighbours' arsenic-safe wells, and Study 2 promoted switching to arsenic-safe deep wells. Both studies included two intervention phases. Structured interviews were conducted at baseline (T1), and at 1-month (T2), 2-month (T3) and 9-month (T4) follow-ups. In intervention phase 1 (between T1 and T2), commitment-based behaviour change techniques--reminders, implementation intentions and public commitment--were combined with information and compared to an information-only control group. In phase 2 (between T2 and T3), half of each phase 1 intervention group was randomly assigned to receive either commitment-based techniques once more or coping planning with reminders and information. Initial well-switching rates of up to 60% significantly declined by T4: 38.3% of T2 safe water users stopped consuming arsenic-safe water. The decline depended on the intervention. Perceived behavioural control, intentions, commitment strength and coping planning were associated with maintenance. In line with previous studies, the results indicate that commitment and reminders engender long-term behavioural change.

[Sacroiliac joint injury treated with oblique insertion at anatomical points: a randomized controlled trial].

PubMed

Kuang, Jiayi; Li, Yuxuan; He, Yufeng; Gan, Lin; Wang, Aiming; Chen, Yanhua; Li, Xiaoting; Guo, Lin; Tang, Rongjun

2016-04-01

To compare the effects of oblique insertion at anatomical points and conventional acupuncture for sacroiliac joint injury. Eighty patients were randomly divided into an observation group and a control group, 40 cases in each one. In the observation group, oblique insertion therapy at anatomical points was used, and the 9 points of equal division (anatomical points) marked by palpating the anatomical symbol were treated as the insertion acupoints. In the control group, conventional acupuncture was applied, and perpendicular insertion was adopted at Huantiao (GB 30), Zhibian (BL 54) and Weizhong (BL 40), etc. In the two groups, the! treatment was given once a day and 5 times per week. Ten treatments were made into one course and two courses were required. The clinical effects, the changes of visual analogue scale (VAS) and Oswestry dysfunctional index. (ODI) before and after treatment were observed in the two groups. The total effective rate of the observation group was 90.0% (36/40), which was better than 72.5% (29/40) of the control group (P < 0.05). After treatment, the results of the VAS and ODI of the two groups were apparently declined (both P < 0.01), and those in the observation group were decreased more obviously (both P < 0.01). The effect of oblique inser-tion at anatomical points for sacroiliac joint injury is superior to that of conventional acupuncture, which can effectively relieve pain and improve the disfunction.

A single trial of transcutaneous electrical nerve stimulation (TENS) improves spasticity and balance in patients with chronic stroke.

PubMed

Cho, Hwi-young; In, Tae Sung; Cho, Ki Hun; Song, Chang Ho

2013-03-01

Spasticity management is pivotal for achieving functional recovery of stroke patients. The purpose of this study was to investigate the effects of a single trial of transcutaneous electrical nerve stimulation (TENS) on spasticity and balance in chronic stroke patients. Forty-two chronic stroke patients were randomly allocated into the TENS (n = 22) or the placebo-TENS (n = 20) group. TENS stimulation was applied to the gastrocnemius for 60 min at 100 Hz, 200 µs with 2 to 3 times the sensory threshold (the minimal threshold in detecting electrical stimulation for subjects) after received physical therapy for 30 min. In the placebo-TENS group, electrodes were placed but no electrical stimulation was administered. For measuring spasticity, the resistance encountered during passive muscle stretching of ankle joint was assessed using the Modified Ashworth Scale, and the Hand held dynamometer was used to assess the resistive force caused by spasticity. Balance ability was measured using a force platform that measures postural sway generated by postural imbalance. The TENS group showed a significantly greater reduction in spasticity of the gastrocnemius, compared to the placebo-TENS group (p < 0.05). TENS resulted in greater balance ability improvements, especially during the eyes closed condition (p < 0.05). However, these effects returned to baseline values within one day. This study shows that TENS provides an immediately effective means of reducing spasticity and of improving balance in chronic stroke patients. The present data may be useful to establish the standard parameters for TENS application in the clinical setting of stroke.

From Planning to Implementation: An Examination of Changes in the Research Design, Sample Size, and Precision of Group Randomized Trials Launched by the Institute of Education Sciences

ERIC Educational Resources Information Center

Spybrook, Jessaca; Puente, Anne Cullen; Lininger, Monica

2013-01-01

This article examines changes in the research design, sample size, and precision between the planning phase and implementation phase of group randomized trials (GRTs) funded by the Institute of Education Sciences. Thirty-eight GRTs funded between 2002 and 2006 were examined. Three studies revealed changes in the experimental design. Ten studies…

Glycaemic index of different coconut (Cocos nucifera)-flour products in normal and diabetic subjects.

PubMed

Trinidad, Trinidad P; Valdez, Divinagracia H; Loyola, Anacleta S; Mallillin, Aida C; Askali, Faridah C; Castillo, Joan C; Masa, Dina B

2003-09-01

The glycaemic index (GI) of commonly consumed bakery products supplemented with increasing levels of coconut (Cocos nucifera) flour was determined in ten normal and ten diabetic subjects. Using a randomized crossover design, the control and test foods were fed in random order on separate occasions after an overnight fast. Blood samples were collected through finger prick before and after feeding and were analysed for glucose levels using a clinical chemistry analyser. The significantly low-GI (<60) foods investigated were: macaroons (GI 45.7 (sem 3.0)) and carrot cake (GI 51.8 (sem 3.3)), with 200-250 g coconut flour/kg (P<0.05). The test foods with 150 g coconut flour/kg had GI ranging from 61.3 to 71.4. Among the test foods, pan de sal (GI 87.2 (sem 5.5)) and multigrain loaf (GI 85.2 (sem 6.8)) gave significantly higher GI with 50 and 100 g coconut flour/kg respectively (P<0.05). On the other hand, granola bar and cinnamon bread with 50 and 100 g coconut flour/kg respectively gave a GI ranging from 62.7 to 71.6 and did not differ significantly from the test foods with 150 g coconut flour/kg (P<0.05). A very strong negative correlation (r -0.85, n 11, P<0.005) was observed between the GI and dietary fibre content of the test foods supplemented with coconut flour. In conclusion, the GI of coconut flour-supplemented foods decreased with increasing levels of coconut flour and this may be due to its high dietary fibre content. The results of the present study may form a scientific basis for the development of coconut flour as a functional food. However, the fat content of coconut flour-supplemented food should always be considered to optimize the functionality of coconut fibre in the proper control and management of diabetes mellitus.

Associations between Tactile Sensory Threshold and Postural Performance and Effects of Healthy Aging and Subthreshold Vibrotactile Stimulation on Postural Outcomes in a Simple Dual Task

PubMed Central

Dettmer, Marius; Pourmoghaddam, Amir; Lee, Beom-Chan; Layne, Charles S.

2016-01-01

Specific activities that require concurrent processing of postural and cognitive tasks may increase the risk for falls in older adults. We investigated whether peripheral receptor sensitivity was associated with postural performance in a dual-task and whether an intervention in form of subthreshold vibration could affect performance. Ten younger (age: 20–35 years) and ten older adults (70–85 years) performed repeated auditory-verbal 1-back tasks while standing quietly on a force platform. Foot sole vibration was randomly added during several trials. Several postural control and performance measures were assessed and statistically analyzed (significance set to α-levels of .05). There were moderate correlations between peripheral sensitivity and several postural performance and control measures (r = .45 to .59). Several postural performance measures differed significantly between older and younger adults (p < 0.05); addition of vibration did not affect outcome measures. Aging affects healthy older adults' performance in dual-tasks, and peripheral sensitivity may be a contributor to the observed differences. A vibration intervention may only be useful when there are more severe impairments of the sensorimotor system. Hence, future research regarding the efficacy of sensorimotor interventions in the form of vibrotactile stimulation should focus on older adults whose balance is significantly affected. PMID:27143967

Large randomized study of thymosin alpha 1, interferon alfa, or both in combination with dacarbazine in patients with metastatic melanoma.

PubMed

Maio, Michele; Mackiewicz, Andrzej; Testori, Alessandro; Trefzer, Uwe; Ferraresi, Virginia; Jassem, Jacek; Garbe, Claus; Lesimple, Thierry; Guillot, Bernard; Gascon, Pere; Gilde, Katalin; Camerini, Roberto; Cognetti, Francesco

2010-04-01

Thymosin alpha 1 (Talpha1) is an immunomodulatory polypeptide that enhances effector T-cell responses. In this large randomized study, we evaluated the efficacy and safety of combining Talpha1 with dacarbazine (DTIC) and interferon alfa (IFN-alpha) in patients with metastatic melanoma. Four hundred eighty-eight patients were randomly assigned to five treatment groups: DTIC+IFN-alpha+Talpha1 (1.6 mg); DTIC+IFN-alpha+Talpha1 (3.2 mg); DTIC+IFN-alpha+Talpha1 (6.4 mg); DTIC+Talpha1 (3.2 mg); DTIC+IFN-alpha (control group). The primary end point was best overall response at study end (12 months). Secondary end points included duration of response, overall survival (OS), and progression-free survival (PFS). Patients were observed for up to 24 months. Ten and 12 tumor responses were observed in the DTIC+IFN-alpha+Talpha1 (3.2 mg) and DTIC+Talpha1 (3.2 mg) groups, respectively, versus four in the control group, which was sufficient to reject the null hypothesis that P(0) < or = .05 (expected response rate of standard therapy) in these two arms. Duration of response ranged from 1.9 to 23.2 months in patients given Talpha1 and from 4.4 to 8.4 months in the control group. Median OS was 9.4 months in patients given Talpha1 versus 6.6 months in the control group (hazard ratio = 0.80; 9% CI, 0.63 to 1.02; P = .08). An increase in PFS was observed in patients given Talpha1 versus the control group (hazard ratio = 0.80; 95% CI, 0.63 to 1.01; P = .06). Addition of Talpha1 to DTIC and IFN-alpha did not lead to any additional toxicity. These results suggest Talpha1 has activity in patients with metastatic melanoma and provide rationale for further clinical evaluation of this agent.

A community-based Argentine tango dance program is associated with increased activity participation among individuals with Parkinson disease

PubMed Central

Foster, Erin R.; Golden, Laura; Duncan, Ryan P.; Earhart, Gammon M.

2012-01-01

Objective To determine the effect of a 12-month community-based tango dance program on activity participation among individuals with Parkinson disease (PD). Design Randomized controlled trial with assessment at baseline, 3, 6, and 12 months. Setting The intervention was administered in the community; assessments were completed in a university laboratory. Participants Sixty-two volunteers with PD enrolled in the study and were randomized to treatment group. Ten participants did not receive the allocated intervention, so the final analyzed sample included 52 participants. Intervention Participants were randomly assigned to the Tango group, which involved 12 months of twice weekly Argentine tango dance classes, or to the no intervention Control group (n = 26 per group). Main Outcome Measures Current, new and retained participation in instrumental, leisure and social activities as measured by the Activity Card Sort (with the “dance” activity removed). Results Total Current participation in the Tango group was higher at 3, 6, and 12 months compared to baseline (ps ≤ 0.008), while the Control group did not change (ps ≥ 0.11). Total Activity Retention (since onset of PD) in the Tango group increased from 77% to 90% (p = 0.006) over the course of the study, whereas the Control group remained around 80% (p = 0.60). These patterns were similar in the separate activity domains. The Tango group gained a significant number of New Social activities (p = 0.003), but the Control group did not (p = 0.71). Conclusions Individuals with PD who participated in a community-based Argentine tango class reported increased participation in complex daily activities, recovery of activities lost since the onset of PD, and engagement in new activities. Incorporating dance into the clinical management of PD may benefit participation and subsequently quality of life for this population. PMID:22902795

Small laser spot versus standard laser spot photodynamic therapy for idiopathic choroidal neovascularization: a randomized controlled study.

PubMed

Li, Xiao-xin; Tao, Yong

2012-12-01

Idiopathic choroidal neovascularization (ICNV) affects young patients and thus may have a significant impact on vision and life quality over a patient's lifespan. This study was designed to compare the visual outcome and retinal pigment epithelium (RPE) damage after photodynamic therapy (PDT) with small laser spot and PDT with standard laser spot for idiopathic choroidal neovascularization (ICNV). This was a randomized controlled study. Fifty-two patients with ICNV were enrolled and randomly divided into a study group (small laser spot PDT, n = 27) and a control group (standard laser spot PDT, n = 25). Best corrected visual acuity (BCVA), optic coherence tomography (OCT) and fluorescein angiography (FA) findings were the main measurements. The patients were followed up 1 week, 1, 3, 6, 9 months and 1 year after PDT. BCVA improvement was statistically significantly higher in the study group than the control group at 6-month ((25.53 ± 15.01) letters vs. (14.71 ± 11.66) letters, P = 0.025) and 9-month follow-ups ((27.53 ± 17.78) letters vs. (15.59 ± 12.21) letters, P = 0.039). At 3- and 6-month follow-ups, the quadrants of RPE damage between the two groups varied significantly (P < 0.001 and P = 0.023, respectively). In each follow-up, the number of cases with decreased or unchanged leakage of choroidal neovascularization by FA and reduced subretinal fluid by OCT did not vary significantly between the two groups. Ten cases (37.0%) in the study group and eight cases (32.0%) in the control group suffered from recurrent CNV (P = 0.703). Better visual improvements, less RPE damage, a similar recurrent rate of CNV and change of subretinal fluid were observed in the small laser spot PDT group than in the standard laser spot PDT group for ICNV.

Enhancing physical and social environments to reduce obesity among public housing residents: rationale, trial design, and baseline data for the Healthy Families study.

PubMed

Quintiliani, Lisa M; DeBiasse, Michele A; Branco, Jamie M; Bhosrekar, Sarah Gees; Rorie, Jo-Anna L; Bowen, Deborah J

2014-11-01

Intervention programs that change environments have the potential for greater population impact on obesity compared to individual-level programs. We began a cluster randomized, multi-component multi-level intervention to improve weight, diet, and physical activity among low-socioeconomic status public housing residents. Here we describe the rationale, intervention design, and baseline survey data. After approaching 12 developments, ten were randomized to intervention (n=5) or assessment-only control (n=5). All residents in intervention developments are welcome to attend any intervention component: health screenings, mobile food bus, walking groups, cooking demonstrations, and a social media campaign; all of which are facilitated by community health workers who are residents trained in health outreach. To evaluate weight and behavioral outcomes, a subgroup of female residents and their daughters age 8-15 were recruited into an evaluation cohort. In total, 211 households completed the survey (RR=46.44%). Respondents were Latino (63%), Black (24%), and had ≤ high school education (64%). Respondents reported ≤2 servings of fruits & vegetables/day (62%), visiting fast food restaurants 1+ times/week (32%), and drinking soft drinks daily or more (27%). The only difference between randomized groups was race/ethnicity, with more Black residents in the intervention vs. control group (28% vs. 19%, p=0.0146). Among low-socioeconomic status urban public housing residents, we successfully recruited and randomized families into a multi-level intervention targeting obesity. If successful, this intervention model could be adopted in other public housing developments or entities that also employ community health workers, such as food assistance programs or hospitals. Copyright © 2014 Elsevier Inc. All rights reserved.

The Interactive Minority Game: a Web-based investigation of human market interactions

NASA Astrophysics Data System (ADS)

Laureti, Paolo; Ruch, Peter; Wakeling, Joseph; Zhang, Yi-Cheng

2004-01-01

The unprecedented access offered by the World Wide Web brings with it the potential to gather huge amounts of data on human activities. Here we exploit this by using a toy model of financial markets, the Minority Game (MG), to investigate human speculative trading behaviour and information capacity. Hundreds of individuals have played a total of tens of thousands of game turns against computer-controlled agents in the Web-based Interactive Minority Game. The analytical understanding of the MG permits fine-tuning of the market situations encountered, allowing for investigation of human behaviour in a variety of controlled environments. In particular, our results indicate a transition in players’ decision-making, as the markets become more difficult, between deductive behaviour making use of short-term trends in the market, and highly repetitive behaviour that ignores entirely the market history, yet outperforms random decision-making.

The effects of passive smoking on olfaction in children.

PubMed

Nageris, B; Hadar, T; Hansen, M C

2002-01-01

The effect of passive smoking on odor identification was studied in 10 children exposed to passive smoke at home. All had at least one parent who smoked at least one pack of cigarettes a day. The control group consisted of 10 children of nonsmoking parents. Ten odorants were tested: vinegar, ammonia, peppermint, roses, bleach, vanilla, cough drops, turpentine, licorice and mothballs. Each child was presented with five test trays containing all 10 odorants in random order. Of the total of 500 odors presented, the control group correctly identified 396 (79%) and the study group, 356 (71%) (p < 0.005). This work demonstrates that children exposed to passive smoke have difficulty identifying odors in comparison to children raised in relatively smoke-free environments. Since the study group tend to misidentify four of the 10 odorants tested--vanilla, roses, mothballs and cough drops--we suggest that these four odorants should suffice in testing odor identification in children.

Omega-3 Fatty Acid and Nutrient Deficits in Adverse Neurodevelopment and Childhood Behaviors

PubMed Central

Hibbeln, Joseph. R.; Gow, Rachel V.

2014-01-01

Synopsis Nutritional insufficiencies of omega-3 highly unsaturated fatty acids (HUFAs) may have adverse effects on brain development and neurodevelopmental outcomes. A recent meta-analysis of ten randomized controlled trials of omega-3 HUFAs reported a small to modest effect size for the efficacy of omega-3 for treating symptoms of ADHD in youth. Several controlled trials of omega-3 HUFAs combined with micronutrients (vitamins, minerals) show sizeable reductions in aggressive, antisocial, and violent behavior in youth and in young adult prisoners. Meta-analyses report efficacy for depressive symptoms in adults, and preliminary findings suggest anti-suicidal properties in adults, but studies in youth are insufficient to draw any conclusions regarding mood. Dietary adjustments to increase omega-3 and reduce omega-6 HUFA consumption are sensible recommendations for youth and adults based on general health considerations, while the evidence base for omega-3 HUFAs as potential psychiatric treatments develops. PMID:24975625

A double-blind, placebo-controlled trial of sibutramine for clozapine-associated weight gain.

PubMed

Henderson, D C; Fan, X; Copeland, P M; Borba, C P; Daley, T B; Nguyen, D D; Zhang, H; Hayden, D; Freudenreich, O; Cather, C; Evins, A E; Goff, D C

2007-02-01

This study sought to examine the effectiveness of sibutramine, a weight loss agent, on clozapine-associated weight gain. This was a 12-week double-blind, placebo controlled, randomized trial of sibutramine for weight loss in obese clozapine-treated schizophrenia or schizoaffective disorder subjects. Ten patients were enrolled into the placebo group and 11 patients into the sibutramine group. There were no significant baseline differences between the two groups on age, gender, education, ethnicity, diagnosis, weight, body mass index (BMI), and blood pressure. At week 12, there were no significant differences in changes in weight, BMI, abdominal and waist circumferences, Hba1c, fasting glucose, or cholesterol levels. Sibutramine treatment did not show significant weight loss compared with placebo in clozapine-treated patients with schizophrenia or schizoaffective disorder. Further research with a larger sample size and longer follow-up duration is warranted.

Piracetam improves children's memory after general anaesthesia.

PubMed

Fesenko, Ułbołgan A

2009-01-01

Surgery and anaesthesia may account for postoperative complications including cognitive impairment. The purpose of the study was to assess the influence of general anaesthetics on children's memory and effectiveness of piracetam for prevention of postoperative cognitive dysfunction. The study included patients receiving different kinds of anaesthesia for various surgical procedures, randomly allocated to two groups. According to immediate postoperative treatment, the study group received intravenous piracetam 30 mg kg(-1) and the control group--placebo. The cognitive functions were examined preoperatively and within 10 consecutive postoperative days using the ten-word memory test. The study group consisted of 123 children, the control one--of 127. Declines in memory indexes were observed in all anaesthetized patients. The most injured function was long-term memory. The intravenous administration of piracetam improved this cognitive function. The study results confirm that general anaesthesia affects the memory function in children. Piracetam is effective for prevention of postoperative cognitive dysfunction after anaesthesia.

Efficacy of transcranial direct-current stimulation (tDCS) in women with provoked vestibulodynia: study protocol for a randomized controlled trial.

PubMed

Morin, Annie; Léonard, Guillaume; Gougeon, Véronique; Waddell, Guy; Bureau, Yves-André; Girard, Isabelle; Morin, Mélanie

2016-05-14

Provoked vestibulodynia is the most common form of vulvodynia. Despite its high prevalence and deleterious sexual, conjugal, and psychological repercussions, effective evidence-based interventions for provoked vestibulodynia remain limited. For a high proportion of women, significant pain persists despite the currently available treatments. Growing evidence suggests that the central nervous system (CNS) could play a key role in provoked vestibulodynia; thus, treatment targeting the CNS, rather than localized dysfunctions, may be beneficial for women suffering from provoked vestibulodynia. In this study, we aim to build on the promising results of a previous case report and evaluate whether transcranial direct-current stimulation, a non-invasive brain stimulation technique targeting the CNS, could be an effective treatment option for women with provoked vestibulodynia. This single-center, triple-blind, parallel group, randomized, controlled trial aims to compare the efficacy of transcranial direct-current stimulation with sham transcranial direct-current stimulation in women with provoked vestibulodynia. Forty women diagnosed with provoked vestibulodynia by a gynecologist, following a standardized treatment protocol, are randomized to either active transcranial direct-current stimulation treatment for ten sessions of 20 minutes at an intensity of 2 mA or sham transcranial direct-current stimulation over a 2-week period. Outcome measures are collected at baseline, 2 weeks after treatment and at 3-month follow-up. The primary outcome is pain during intercourse, assessed with a numerical rating scale. Secondary measurements focus on the sexual function, vestibular pain sensitivity, psychological distress, treatment satisfaction, and the patient's global impression of change. To our knowledge, this study is the first randomized controlled trial to examine the efficacy of transcranial direct-current stimulation in women with provoked vestibulodynia. Findings from this trial are expected to provide significant information about a promising intervention targeting the centralization of pain in women with provoked vestibulodynia. Clinicaltrials.gov, NCT02543593 . Registered on September 4, 2015.

Virtual reality for stroke rehabilitation: an abridged version of a Cochrane review.

PubMed

Laver, K; George, S; Thomas, S; Deutsch, J E; Crotty, M

2015-08-01

Virtual reality and interactive video gaming have emerged as new treatment approaches in stroke rehabilitation settings over the last ten years. The primary objective of this review was to determine the effectiveness of virtual reality on upper limb function and activity after stroke. The impact on secondary outcomes including gait, cognitive function and activities of daily living was also assessed. Randomized and quasi-randomized controlled trials comparing virtual reality with an alternative intervention or no intervention were eligible to be included in the review. The authors searched a number of electronic databases including: the Cochrane Stroke Group Trials Register, the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, AMED, CINAHL, PsycINFO, clinical trial registers, reference lists, Dissertation Abstracts and contacted key researchers in the field. Search results were independently examined by two review authors to identify studies meeting the inclusion criteria. A total of 37 randomized or quasi randomized controlled trials with a total of 1019 participants were included in the review. Virtual reality was found to be significantly more effective than conventional therapy in improving upper limb function (standardized mean difference [SMD] 0.28, 95% confidence intervals [CI] 0.08 to 0.49) based on 12 studies and significantly more effective than no therapy in improving upper limber function (SMD 0.44 [95% CI 0.15 to 0.73]) based on nine studies. The use of virtual reality also significantly improved activities of daily living function when compared to more conventional therapy approaches (SMD 0.43 [95% CI 0.18 to 0.69]) based on eight studies. While there are a large number of studies assessing the efficacy of virtual reality they tend to be small and many are at risk of bias. While there is evidence to support the use of virtual reality intervention as part of upper limb training programs, more research is required to determine whether it is beneficial in terms of improving lower limb function and gait and cognitive function.

Can We Increase Psychological Well-Being? The Effects of Interventions on Psychological Well-Being: A Meta-Analysis of Randomized Controlled Trials

PubMed Central

Westerhof, Gerben J.; Bohlmeijer, Ernst T.

2016-01-01

Background There is a rapidly growing interest in psychological well-being (PWB) as outcome of interventions. Ryff developed theory-based indicators of PWB that are consistent with a eudaimonic perspective of happiness. Numerous interventions have been developed with the aim to increase PWB. However, the effects on PWB measured as coherent outcome have not been examined across studies yet. This meta-analysis of randomized controlled trials of behavioral interventions aims to answer the question whether it is possible to enhance PWB. Methods A systematic literature search was performed in PsycINFO, Cochrane and Web of Science. To be included, studies had to be randomized controlled trials of behavioral interventions with psychological well-being as primary or secondary outcome measure, measured with either Ryff’s Psychological Well-Being Scales or the Mental Health Continuum—Short Form. The meta-analysis was performed using a random effects model. From the 2,298 articles found, 27 met the inclusion criteria. The included studies involved 3,579 participants. Results We found a moderate effect (Cohen’s d = 0.44; z = 5.62; p < .001). Heterogeneity between the studies was large (Q (26) = 134.12; p < .001; I2 = 80.62). At follow-up after two to ten months, a small but still significant effect size of 0.22 was found. There was no clear indication of publication bias. Interventions were more effective in clinical groups and when they were delivered individually. Effects were larger in studies of lower quality. Conclusions It appears to be possible to improve PWB with behavioral interventions. The results are promising for the further development and implementation of interventions to promote PWB. Delivering interventions face-to-face seems to be the most promising option. We recommend to keep including clinical groups in the research of psychological well-being. Heterogeneity is a limitation of the study and there is need for more high-quality studies. PMID:27328124

Does transcutaneous electrical nerve stimulation (TENS) alleviate the pain experienced during bone marrow sampling in addition to standard techniques? A randomised, double-blinded, controlled trial.

PubMed

Tucker, David L; Rockett, Mark; Hasan, Mehedi; Poplar, Sarah; Rule, Simon A

2015-06-01

Bone marrow aspiration and trephine (BMAT) biopsies remain important tests in haematology. However, the procedures can be moderately to severely painful despite standard methods of pain relief. To test the efficacy of transcutaneous electrical nerve stimulation (TENS) in alleviating the pain from BMAT in addition to standard analgesia using a numerical pain rating scale (NRS). 70 patients requiring BMAT were randomised (1:1) in a double-blind, placebo-controlled trial. -35 patients received TENS impulses at a strong but comfortable amplitude (intervention group) and 35 patients received TENS impulses just above the sensory threshold (control group) (median pulse amplitude 20 and 7 mA, respectively). Patients and operators were blinded to group allocation. Pain assessments were made using a numerical pain scale completed after the procedure. No significant difference in NRS pain recalled after the procedure was detected (median pain score 5.7 (95% CI 4.8 to 6.6) in control vs 5.6 (95% CI 4.8 to 6.4) in the intervention group). However, 100% of patients who had previous experience of BMAT and >94% of participants overall felt they benefited from using TENS and would recommend it to others for this procedure. There were no side effects from the TENS device, and it was well tolerated. TENS is a safe, non-invasive adjunct to analgesia for reducing pain during bone marrow biopsy and provides a subjective benefit to most users; however, no objective difference in pain scores was detected when using TENS in this randomised controlled study. NCT02005354. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Occupational toxic epidermal necrolysis associated with dalbergia cochinchinensis: a retrospective comparative study of eight cases in China.

PubMed

Yang, Yongsheng; Zhang, Zhen; Lu, Xiaonian; Zhu, Xiaohua; Huang, Qiong; Liang, Jun; Xu, Jinhua

2015-12-01

Occupational toxic epidermal necrolysis (TEN) related to Dalbergia cochinchinensis has seldom been reported in the past. Its clinical characteristic needs to be investigated. This study reports eight cases of such disease in China. Eight patients with occupational TEN admitted from 2003 to 2012 were retrospectively analyzed and compared with 15 patients admitted with TEN caused by drugs as controls. Patients all received combination therapy of corticosteroid and intravenous immunoglobulin. The times for bullous ceasing, tapering of corticosteroid, and total hospitalization were compared between the two groups of patients. SCORTEN, a severity-of-illness scoring system for TEN prognosis, was applied to evaluate clinical outcome. The three time measurements in occupational TEN were longer than those in control, and the differences were statistically significant (P = 0.0023, 0.026, 0.0017), which means the total dose of corticosteroid needed in occupational TEN was higher than that in the control. There were no deaths in the two groups, although expected deaths were 0.612 and 0.836, respectively. Occupational TEN has a longer progression than TEN caused by drugs, and there is more difficulty in its treatment. Clinicians should pay attention to this disease. However, its mechanism and target therapy remain unclear. © 2015 The International Society of Dermatology.

Clinical inertia in the pharmacological management of hypertension: A systematic review and meta-analysis.

PubMed

Milman, Tal; Joundi, Raed A; Alotaibi, Naif M; Saposnik, Gustavo

2018-06-01

Clinical Inertia is defined as "failure of health care providers to initiate or intensify therapy according to current guidelines". This phenomenon is gaining increasing attention as a major cause of clinicians' failure to adequately manage hypertension, thus leading to an increased incidence of cardiovascular events. We performed a systematic review and meta-analysis of randomized controlled trials to determine whether interventions aimed at reducing clinical inertia in the pharmacological treatment of hypertension improve blood pressure (BP) control. MEDLINE, Embase, and Cochrane Database of Systematic Reviews were searched from the start of their database until October 3, 2017 for the MESH terms "Hypertension" or "Blood Pressure", their subheadings, and the keywords "Therapeutic Inertia" or "Clinical Inertia". Studies were included if they addressed pharmacologic hypertension management, clinical inertia, were randomized controlled trials, reported an outcome describing prescriber behavior, and were available in English. Data for the included studies was extracted by two independent observers. Quality of studies was analyzed using the Cochrane Risk of Bias Assessment. Data was pooled for statistical analysis using both fixed- and random-effects models. The primary study outcome was the percentage of patients achieving blood pressure control as defined by the Joint National Committee guidelines or study authors. Of 474 citations identified, ten met inclusion criteria comprising a total of 26,871 patients, and eight were selected for meta-analysis. Interventions included Physician Education, Physician Reminders, Patient Education, Patient Reminders, Ambulatory BP Monitoring, Digital Medication Offerings, Physician Peer Visits, and Pharmacist-led Counselling. Pooled event rates revealed more patients with controlled BP in the intervention group versus control (55%, 95% CI 46-63% versus 45%, 95% CI 37-53%) and interventions significantly improved the odds of BP control (OR = 1.19, 95% CI = 1.12-1.27, P < .001). Heterogeneity in the quantitative analysis was moderate. Addressing clinical inertia through physician reminders, ambulatory BP monitoring, and educational interventions for primary care providers was associated with an improvement in blood pressure control. Our findings encourage further research to investigate strategies at reducing clinical inertia in the management of hypertension.

National Randomized Controlled Trial of Virtual House Calls for People with Parkinson's Disease: Interest and Barriers

PubMed Central

Achey, Meredith A.; Beck, Christopher A.; Beran, Denise B.; Biglan, Kevin M.; Boyd, Cynthia M.; Schmidt, Peter N.; Simone, Richard; Willis, Allison W.; Galifianakis, Nicholas B.; Katz, Maya; Tanner, Caroline M.; Dodenhoff, Kristen; Ziman, Nathan; Aldred, Jason; Carter, Julie; Jimenez-Shahed, Joohi; Hunter, Christine; Spindler, Meredith; Mari, Zoltan; Morgan, John C.; McLane, Dedi; Hickey, Patrick; Gauger, Lisa; Richard, Irene Hegeman; Bull, Michael T.; Mejia, Nicte I.; Bwala, Grace; Nance, Martha; Shih, Ludy; Anderson, Lauren; Singer, Carlos; Zadikoff, Cindy; Okon, Natalia; Feigin, Andrew; Ayan, Jean; Vaughan, Christina; Pahwa, Rajesh; Cooper, Jessica; Webb, Sydney; Dhall, Rohit; Hassan, Anhar; Weis, Delana; DeMello, Steven; Riggare, Sara S.; Wicks, Paul; Smith, Joseph; Keenan, H. Tait; Korn, Ryan; Schwarz, Heidi; Sharma, Saloni; Stevenson, E. Anna; Zhu, William

2016-01-01

Abstract Background: Delivering specialty care remotely directly into people's homes can enhance access for and improve the healthcare of individuals with chronic conditions. However, evidence supporting this approach is limited. Materials and Methods: Connect.Parkinson is a randomized comparative effectiveness study that compares usual care of individuals with Parkinson's disease in the community with usual care augmented by virtual house calls with a Parkinson's disease specialist from 1 of 18 centers nationally. Individuals in the intervention arm receive four virtual visits from a Parkinson's disease specialist over 1 year via secure, Web-based videoconferencing directly into their homes. All study activities, including recruitment, enrollment, and assessments, are conducted remotely. Here we report on interest, feasibility, and barriers to enrollment in this ongoing study. Results: During recruitment, 11,734 individuals visited the study's Web site, and 927 unique individuals submitted electronic interest forms. Two hundred ten individuals from 18 states enrolled in the study from March 2014 to June 2015, and 195 were randomized. Most participants were white (96%) and college educated (73%). Of the randomized participants, 73% had seen a Parkinson's disease specialist within the previous year. Conclusions: Among individuals with Parkinson's disease, national interest in receiving remote specialty care directly into the home is high. Remote enrollment in this care model is feasible but is likely affected by differential access to the Internet. PMID:26886406

Recombinant human bone morphogenetic protein-2 versus autogenous iliac crest bone graft for lumbar fusion: a meta-analysis of ten randomized controlled trials.

PubMed

Chen, Zhiguang; Ba, Gen; Shen, Tao; Fu, Qin

2012-12-01

Recombinant human bone morphogenetic protein-2 (rhBMP-2) as a substitute for iliac crest bone graft (ICBG) has been increasingly widely used in lumbar fusion. It has been proven non-inferior in fusion success and clinical outcomes when compared with ICBG. However, increasingly, some potentially uncommon and serious complications associated with the use of rhBMP-2 have been of great concern to surgeons. The purpose of this study was to determine whether rhBMP-2 could be considered an effective and, more importantly, a relatively safe substitute for ICBG in lumbar fusion. Randomized controlled trials that compared rhBMP-2 with ICBG for lumbar fusion were identified by computer and manual searching. The risk of bias and clinical relevance of the included studies were assessed. Publication bias was explored using funnel plot and statistical tests (Egger's test and Begg's test). Meta-analyses were performed using the Cochrane systematic review methods. Ten randomized controlled trials (1,342 patients) met the inclusion criteria. Compared with ICBG, the use of rhBMP-2 significantly decreased the risk of fusion failure at all time intervals (6 months: p < 0.0001, RR = 0.55, 95 % CI = 0.42-0.72; 12 months: p = 0.0003, RR = 0.53, 95 % CI = 0.37-0.75; 24 months: p < 0.00001, RR = 0.31, 95 % CI = 0.21-0.46) and the rate of reoperation (p = 0.0001, RR = 0.52, 95 % CI = 0.37-0.72). There was no statistical difference in clinical improvement on the Oswestry Disability Index, although a favorable trend in the rhBMP-2 group was found (p = 0.12, RR = 0.73, 95 % CI = 0.49-1.08). Subgroup analyses stratified by the type of surgical procedure yielded similar results. Owing to the different data formats, meta-analysis on adverse events was not performed. RhBMP-2 was superior to the ICBG for achieving fusion success and avoiding reoperation. However, evidence from the Food and Drug Administration document and subsequent independent studies has demonstrated that original, industry-sponsored trials underestimated rhBMP-2-related adverse events. There are still security risks in the use of rhBMP-2.

Hypnosis, suggestions, and altered states of consciousness: experimental evaluation of the new cognitive-behavioral theory and the traditional trance-state theory of "hypnosis".

PubMed

Barber, T X; Wilson, S C

1977-10-07

Sixty-six subjects were tested on a new scale for evaluating "hypnotic-like" experiences (The Creative Imagination Scale), which includes ten standardized test-suggestions (e.g. suggestions for arm heaviness, finger anesthesia, time distortion, and age regression). The subjects were randomly assigned to one of three treatment groups (Think-With Instructions, trance induction, and Control), with 22 subjects to each group. The new Cognitive-Behavioral Theory predicted that subjects exposed to preliminary instructions designed to demonstrate how to think and imagine along with the suggested themes (Think-With Instructions) would be more responsive to test-suggestions for anesthesia, time distortion, age regression, and so on, than subjects exposed to a trance-induction procedure. On the other hand, the traditional Trance State Theory predicted that a trance induction would be more effective than Think-With Instructions in enhancing responses to such suggestions. Subjects exposed to the Think-With Instructions obtained significantly higher scores on the test-suggestions than those exposed either to the traditional trance-induction procedure or to the control treatment. Scores of subjects who received the trance-induction procedure were not significantly different from those of the subjects who received the control treatment. The results thus supported the new Cognitive-Behavioral Theory and contradicted the traditional Trance State Theory of hypnosis. Two recent experiments, by De Stefano and by Katz, confirmed the above experimental results and offered further support for the Cognitive-Behavioral Theory. In both recent experiments, subjects randomly assigned to a "Think-With Instructions" treatment were more responsive to test-suggestions than those randomly assigned to a traditional trance-induction treatment.

Impact of tracheal cuff shape on microaspiration of gastric contents in intubated critically ill patients: study protocol for a randomized controlled trial.

PubMed

Jaillette, Emmanuelle; Brunin, Guillaume; Girault, Christophe; Zerimech, Farid; Chiche, Arnaud; Broucqsault-Dedrie, Céline; Fayolle, Cyril; Minacori, Franck; Alves, Isabelle; Barrailler, Stephanie; Robriquet, Laurent; Tamion, Fabienne; Delaporte, Emmanuel; Thellier, Damien; Delcourte, Claire; Duhamel, Alain; Nseir, Saad

2015-09-25

Ventilator-associated pneumonia (VAP) is the most common infection in intubated critically ill patients. Microaspiration of the contaminated gastric and oropharyngeal secretions is the main mechanism involved in the pathophysiology of VAP. Tracheal cuff plays an important role in stopping the progression of contaminated secretions into the lower respiratory tract. Previous in vitro studies suggested that conical cuff shape might be helpful in improving tracheal sealing. However, clinical studies found conflicting results. The aim of this study is to determine the impact of conical tracheal cuff shape on the microaspiration of gastric contents in critically ill patients. This prospective cluster randomized controlled crossover open-label trial is currently being conducted in ten French intensive care units (ICUs). Patients are allocated to intubation with a polyvinyl chloride (PVC) standard (barrel)-shaped or a PVC conical-shaped tracheal tube. The primary objective is to determine the impact of the conical shaped tracheal cuff on abundant microaspiration of gastric contents. Secondary outcomes include the incidence of microaspiration of oropharyngeal secretions, tracheobronchial colonization, VAP and ventilator-associated events. Abundant microaspiration is defined as the presence of pepsin at significant level (>200 ng/ml) in at least 30 % of the tracheal aspirates. Pepsin and amylase are quantitatively measured in all tracheal aspirates during the 48 h following inclusion. Quantitative tracheal aspirate culture is performed at inclusion and twice weekly. We plan to recruit 312 patients in the participating ICUs. BEST Cuff is the first randomized controlled study evaluating the impact of PVC tracheal-cuff shape on gastric microaspirations in patients receiving invasive mechanical ventilation. Enrollment began in June 2014 and is expected to end in October 2015. ClinicalTrials.gov Identifier: NCT01948635 (registered 31 August 2013).

Comparing the Levels of Acute-Phase Reactants Between Smoker and Nonsmoker Diabetic Patients: More Predicted Risk for Cardiovascular Diseases in Smoker Compared to Nonsmoker Diabetics.

PubMed

Rezaei-Adl, Sepideh; Ghahroudi Tali, Arash; Saffar, Hiva; Rajabiani, Afsaneh; Abdollahi, Alireza

2017-09-01

 Due to a close link between cardiovascular disorders and increased acute phase responses, it is now proposed the relation of total sialic acid (TSA) and C Reactive Protein (CRP) as main components of acute phase proteins and cardiovascular risk profiles such as diabetes mellitus and smoking. We hypothesized that the elevation in the level of TSA along with other prototype acute phase reactants such as CRP is expected more in the coexistence of diabetes and smoking than in diabetes mellitus alone. Ninety diabetic patients were randomly selected and entered into this case-control study. Using block randomization method, the patients were randomly assigned into smokers (n=45) and nonsmokers (n=45). A group of ten healthy individuals was also included as the control. The serum levels of TSA, CRP, iron, and hemoglobin were measured by the specific techniques. Comparing laboratory parameters across the three groups indicated significantly higher levels of TSA and CRP in smoker diabetics as compared to non-smoker diabetics and the healthy controls, while there was no difference in other parameters including serum iron and hemoglobin. A significant positive correlation was also revealed between TCA and CRP (r=0.324, P=0.030), but no significant association was found between other parameters. In the background of smoking, increasing the level of both TSA and CRP is predicted more than the existence of diabetes mellitus alone. In fact, the increase in these biomarkers is more predictable in smoker than in nonsmoker diabetics. This finding emphasizes the increased risk for cardiovascular disorders in smoker compared to non-smoker diabetics.

Effect of animal-assisted interventions on depression, agitation and quality of life in nursing home residents suffering from cognitive impairment or dementia: a cluster randomized controlled trial.

PubMed

Olsen, Christine; Pedersen, Ingeborg; Bergland, Astrid; Enders-Slegers, Marie-José; Patil, Grete; Ihlebaek, Camilla

2016-12-01

The prevalence of neuropsychiatric symptoms in cognitively impaired nursing home residents is known to be very high, with depression and agitation being the most common symptoms. The possible effects of a 12-week intervention with animal-assisted activities (AAA) in nursing homes were studied. The primary outcomes related to depression, agitation and quality of life (QoL). A prospective, cluster randomized multicentre trial with a follow-up measurement 3 months after end of intervention was used. Inclusion criteria were men and women aged 65 years or older, with a diagnosis of dementia or having a cognitive deficit. Ten nursing homes were randomized to either AAA with a dog or a control group with treatment as usual. In total, 58 participants were recruited: 28 in the intervention group and 30 in the control group. The intervention consisted of a 30-min session with AAA twice weekly for 12 weeks in groups of three to six participants, led by a qualified dog handler. Norwegian versions of the Cornell Scale for Depression, the Brief Agitation Rating Scale and the Quality of Life in Late-stage Dementia scale were used. A significant effect on depression and QoL was found for participants with severe dementia at follow-up. For QoL, a significant effect of AAA was also found immediately after the intervention. No effects on agitation were found. Animal-assisted activities may have a positive effect on symptoms of depression and QoL in older people with dementia, especially those in a late stage. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Advisor-Teller Money Manager (ATM) Therapy for Substance Use Disorders

PubMed Central

Rosen, Marc I.; Rounsaville, Bruce J.; Ablondi, Karen; Black, Anne C.; Rosenheck, Robert A.

2011-01-01

Objective Patients with concomitant psychiatric and substance use disorders are commonly assigned representative payees or case managers to help manage their funds, but money management has not been conceptualized as a theory-based treatment. This randomized clinical trial was conducted to determine the effect of a money management–based therapy, advisor-teller money manager (ATM), on substance abuse or dependence. Methods Ninety patients at a community mental health center who had a history of cocaine or alcohol abuse or dependence were assessed after random assignment to 36 weeks of ATM (N=47) or a control condition in which use of a financial workbook was reviewed (N=43). Patients assigned to ATM were encouraged to deposit their funds into a third-party account, plan weekly expenditures, and negotiate monthly budgets. Substance use calendars and urine toxicology tests were collected every other week for 36 weeks and again 52 weeks after randomization. Results Patients assigned to ATM had significantly more negative toxicologies for cocaine metabolite over time than patients in the control group, and treating clinicians rated ATM patients as significantly more likely to be abstinent from illicit drugs. Self-reported abstinence from alcohol did not significantly differ between groups. Unexpectedly, patients assigned to ATM were more likely to be assigned a representative payee or a conservator than control participants during the follow-up period (ten of 47 versus two of 43). One patient in ATM assaulted the therapist when his check had not arrived. Conclusions ATM is an efficacious therapy for the treatment of cocaine abuse or dependence among people with concomitant psychiatric illness but requires protection of patient autonomy and staff safety. PMID:20592006

A Two Year Randomized Controlled Trial of Progressive Resistance Exercise for Parkinson’s Disease

PubMed Central

Corcos, Daniel M.; Robichaud, Julie A.; David, Fabian J.; Leurgans, Sue E.; Vaillancourt, David E.; Poon, Cynthia; Rafferty, Miriam R.; Kohrt, Wendy M.; Comella, Cynthia L.

2013-01-01

Background The effects of progressive resistance exercise (PRE) on the motor signs of Parkinson’s disease have not been studied in controlled trials. Our aim was to compare 6, 12, 18, and 24 month outcomes of patients with Parkinson’s disease who received PRE to a stretching, balance, and strengthening exercise program. Methods We conducted a randomized controlled trial between September 2007 and July 2011. Pairs of patients, matched by sex and off-medication Unified Parkinson’s Disease Rating Scale, motor subscale (UPDRS-III), were randomly assigned to the interventions with a 1:1 allocation ratio. The PRE group performed a weight lifting program. The Modified Fitness Counts (mFC) group performed a stretching, balance, and strengthening exercise program. Patients exercised two days per week for 24 months at a gym. A personal trainer directed both weekly sessions for the first six months and one weekly session after six months. The primary outcome was the off-medication UPDRS-III score. Patients were followed for 24 months at six-month intervals. Results Of 51 patients, 20 in PRE and 18 in mFC completed the trial. At 24 months, the mean off-medication UPDRS-III score decreased more with PRE than with mFC (mean difference: - 7·3 points; 95% CI: -11·3 to -3·6; P < 0·001). The PRE group had ten adverse events. The mFC group had seven adverse events. Conclusions PRE demonstrated a statistically and clinically significant reduction in UPDRS-III scores compared to mFC and is recommended as a useful adjunct therapy to improve Parkinsonian motor signs. PMID:23536417

The effect of motor control exercise versus placebo in patients with chronic low back pain [ACTRN012605000262606

PubMed Central

Maher, Chris G; Latimer, Jane; Hodges, Paul W; Refshauge, Kathryn M; Moseley, G Lorimer; Herbert, Robert D; Costa, Leonardo OP; McAuley, James

2005-01-01

Background While one in ten Australians suffer from chronic low back pain this condition remains extremely difficult to treat. Many contemporary treatments are of unknown value. One potentially useful therapy is the use of motor control exercise. This therapy has a biologically plausible effect, is readily available in primary care and it is of modest cost. However, to date, the efficacy of motor control exercise has not been established. Methods This paper describes the protocol for a clinical trial comparing the effects of motor control exercise versus placebo in the treatment of chronic non-specific low back pain. One hundred and fifty-four participants will be randomly allocated to receive an 8-week program of motor control exercise or placebo (detuned short wave and detuned ultrasound). Measures of outcomes will be obtained at follow-up appointments at 2, 6 and 12 months after randomisation. The primary outcomes are: pain, global perceived effect and patient-generated measure of disability at 2 months and recurrence at 12 months. Discussion This trial will be the first placebo-controlled trial of motor control exercise. The results will inform best practice for treating chronic low back pain and prevent its occurrence. PMID:16271149

Impact of glutathione transferases genes polymorphisms in nevirapine adverse reactions: a possible role for GSTM1 in SJS/TEN susceptibility.

PubMed

Ciccacci, Cinzia; Latini, Andrea; Politi, Cristina; Mancinelli, Sandro; Marazzi, Maria C; Novelli, Giuseppe; Palombi, Leonardo; Borgiani, Paola

2017-10-01

Nevirapine (NVP) is used in developing countries as first-line treatment of HIV infection. Unfortunately, its use is associated with common serious adverse drug reactions, such as liver toxicity and the most severe and rare Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). GSTT1 and GSTM1 genes code for enzymes involved in the metabolism of a wide range of drugs. We hypothesized that this gene variability could be implicated in NVP adverse reactions. We analyzed the GSTM1 and GSTT1 null genotypes by multiplex PCR in a population of 181 patients from Mozambique, treated with NVP. A case/control association study was performed. We also counted the number of risk alleles in SJS/TEN patients and in controls, including the GSTM1 null genotype and four previously identified risk alleles in CYP2B6, HCP5, and TRAF3IP2 genes. Among patients, 27 had developed SJS/TEN and 76 had developed hepatotoxicity during the treatment. The GSTM1 null genotype was more frequent in the cases with SJS/TEN than in the controls (OR = 2.94, P = 0.027). This association is also observed when other risk factors are taken into account, by a multivariate analysis (P = 0.024 and OR = 3.58). The risk allele counting analysis revealed a significantly higher risk for SJS/TEN in patients carrying three or four risk alleles. Moreover, all subjects with five or six risk alleles developed SJS/TEN, while subjects without any risk alleles were present only in the control group. We observed an association between GSTM1 and SJS/TEN susceptibility. Moreover, GSTM1 contributes to the definition of a genetic risk profile for SJS/TEN susceptibility.

The short-term effects of TENS plus therapeutic ultrasound combinations in chronic neck pain.

PubMed

Sayilir, Selcuk

2018-05-01

To investigate the effects of TENS plus therapeutic ultrasound combinations on symptom relief, physical functionality, perceived stress levels, daytime sleepiness and neck mobility in patients with chronic neck pain (CNP). A total of 64 patients were divided into two groups as the TENS plus ultrasound group (n = 39) and the control CNP group (n = 25). The therapy comprised TENS and therapeutic ultrasound applications for 10 sessions. The control subjects were discouraged from using analgesics but were allowed to use paracetamol daily, if necessary. The Neck Disability Index (NDI), Epworth Sleepiness Scale (ESS), Perceived Stress Scale (PSS), visual analog scale (VAS) and tragus-wall/chin-manubrium distances were recorded at the baseline and after therapy. Significant improvements were detected in the TENS plus ultrasound group compared to the control CNP subjects in respect of VAS, PSS and NDI scores after the TENS plus therapeutic ultrasound therapies (all p < 0.05). The combination of therapeutic ultrasound plus TENS can be an effective modality for relieving pain/stress levels and improving functionality in the short-term of CNP. Copyright © 2018 Elsevier Ltd. All rights reserved.

Transcutaneous electrical nerve stimulation (TENS) for pain management in labour

PubMed Central

Dowswell, Therese; Bedwell, Carol; Lavender, Tina; Neilson, James P

2014-01-01

Background Transcutaneous nerve stimulation (TENS) has been proposed as a means of reducing pain in labour. The TENS unit emits low-voltage electrical impulses which vary in frequency and intensity. During labour, TENS electrodes are generally placed on the lower back, although TENS may be used to stimulate acupuncture points or other parts of the body. The physiological mechanisms whereby TENS relieves pain are uncertain. TENS machines are frequently operated by women, which may increase a sense of control in labour. Objectives To assess the effects of TENS on pain in labour. Search methods We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (30 April 2011) and reference lists of retrieved papers. Selection criteria Randomised controlled trials comparing women receiving TENS for pain management in labour versus routine care, alternative non-pharmacological methods of pain relief, or placebo devices. We included all types of TENS machines. Data collection and analysis Two review authors assessed for inclusion all trials identified by the search strategy, carried out data extraction and assessed risk of bias. We have recorded reasons for excluding studies. Main results Seventeen trials with 1466 women contribute data to the review. Thirteen examined TENS applied to the back, two to acupuncture points, and two to the cranium. Overall, there was little difference in pain ratings between TENS and control groups, although women receiving TENS to acupuncture points were less likely to report severe pain (average risk ratio 0.41, 95% confidence interval 0.31 to 0.54; measured in two studies). The majority of women using TENS said they would be willing to use it again in a future labour. Where TENS was used as an adjunct to epidural analgesia there was no evidence that it reduced pain. There was no consistent evidence that TENS had any impact on interventions and outcomes in labour. There was little information on outcomes for mothers and babies. No adverse events were reported. Authors’ conclusions There is only limited evidence that TENS reduces pain in labour and it does not seem to have any impact (either positive or negative) on other outcomes for mothers or babies. The use of TENS at home in early labour has not been evaluated. TENS is widely available in hospital settings and women should have the choice of using it in labour. PMID:19370680

Randomized Clinical Trial Comparing Proton Beam Radiation Therapy with Transarterial Chemoembolization for Hepatocellular Carcinoma: Results of an Interim Analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bush, David A., E-mail: dbush@llu.edu; Smith, Jason C.; Slater, Jerry D.

2016-05-01

Purpose: To describe results of a planned interim analysis of a prospective, randomized clinical trial developed to compare treatment outcomes among patients with newly diagnosed hepatocellular carcinoma (HCC). Methods and Materials: Eligible subjects had either clinical or pathologic diagnosis of HCC and met either Milan or San Francisco transplant criteria. Patients were randomly assigned to transarterial chemoembolization (TACE) or to proton beam radiation therapy. Patients randomized to TACE received at least 1 TACE with additional TACE for persistent disease. Proton beam radiation therapy was delivered to all areas of gross disease to a total dose of 70.2 Gy in 15 daily fractionsmore » over 3 weeks. The primary endpoint was progression-free survival, with secondary endpoints of overall survival, local tumor control, and treatment-related toxicities as represented by posttreatment days of hospitalization. Results: At the time of this analysis 69 subjects were available for analysis. Of these, 36 were randomized to TACE and 33 to proton. Total days of hospitalization within 30 days of TACE/proton was 166 and 24 days, respectively (P<.001). Ten TACE and 12 proton patients underwent liver transplantation after treatment. Viable tumor identified in the explanted livers after TACE/proton averaged 2.4 and 0.9 cm, respectively. Pathologic complete response after TACE/proton was 10%/25% (P=.38). The 2-year overall survival for all patients was 59%, with no difference between treatment groups. Median survival time was 30 months (95% confidence interval 20.7-39.3 months). There was a trend toward improved 2-year local tumor control (88% vs 45%, P=.06) and progression-free survival (48% vs 31%, P=.06) favoring the proton beam treatment group. Conclusions: This interim analysis indicates similar overall survival rates for proton beam radiation therapy and TACE. There is a trend toward improved local tumor control and progression-free survival with proton beam. There are significantly fewer hospitalization days after proton treatment, which may indicate reduced toxicity with proton beam therapy.« less

Effect of transcutaneous electrical nerve stimulation therapy for the treatment of primary dysmenorrheal.

PubMed

Bai, Hai-Yan; Bai, Hong-Yan; Yang, Zhi-Qin

2017-09-01

This study aimed to investigate the effect and safety of transcutaneous electrical nerve stimulation (TENS) therapy for relieving pain in women with primary dysmenorrhea (PD). In this study, 134 participants with PD were randomly divided into the intervention group and the sham group, with 67 participants in each group. Participants in the intervention group received TENS, whereas those in the sham group received sham TENS. The primary outcome was measured by the Numeric Rating Scale (NRS). The secondary outcomes were measured by the duration of relief from dysmenorrheal pain, number of ibuprofen tablets taken, and the World Health Organization quality of life (WHOQOL)-BREF score, as well as the adverse events. A total of 122 participants completed the study. Compared to sham TENS, TENS showed a greater effect in pain relief with regard to the NRS (P < .01), duration of relief from dysmenorrheal pain (P < .01), and number of ibuprofen tablets taken (P < .01). However, no significant differences in the quality of life, measured by the WHOQOL-BREF score, were found between 2 groups. The adverse event profiles were also similar between 2 groups. TENS was efficacious and safe in relieving pain in participants with PD.

The effect of India's total sanitation campaign on defecation behaviors and child health in rural Madhya Pradesh: a cluster randomized controlled trial.

PubMed

Patil, Sumeet R; Arnold, Benjamin F; Salvatore, Alicia L; Briceno, Bertha; Ganguly, Sandipan; Colford, John M; Gertler, Paul J

2014-08-01

Poor sanitation is thought to be a major cause of enteric infections among young children. However, there are no previously published randomized trials to measure the health impacts of large-scale sanitation programs. India's Total Sanitation Campaign (TSC) is one such program that seeks to end the practice of open defecation by changing social norms and behaviors, and providing technical support and financial subsidies. The objective of this study was to measure the effect of the TSC implemented with capacity building support from the World Bank's Water and Sanitation Program in Madhya Pradesh on availability of individual household latrines (IHLs), defecation behaviors, and child health (diarrhea, highly credible gastrointestinal illness [HCGI], parasitic infections, anemia, growth). We conducted a cluster-randomized, controlled trial in 80 rural villages. Field staff collected baseline measures of sanitation conditions, behaviors, and child health (May-July 2009), and revisited households 21 months later (February-April 2011) after the program was delivered. The study enrolled a random sample of 5,209 children <5 years old from 3,039 households that had at least one child <24 months at the beginning of the study. A random subsample of 1,150 children <24 months at enrollment were tested for soil transmitted helminth and protozoan infections in stool. The randomization successfully balanced intervention and control groups, and we estimated differences between groups in an intention to treat analysis. The intervention increased percentage of households in a village with improved sanitation facilities as defined by the WHO/UNICEF Joint Monitoring Programme by an average of 19% (95% CI for difference: 12%-26%; group means: 22% control versus 41% intervention), decreased open defecation among adults by an average of 10% (95% CI for difference: 4%-15%; group means: 73% intervention versus 84% control). However, the intervention did not improve child health measured in terms of multiple health outcomes (diarrhea, HCGI, helminth infections, anemia, growth). Limitations of the study included a relatively short follow-up period following implementation, evidence for contamination in ten of the 40 control villages, and bias possible in self-reported outcomes for diarrhea, HCGI, and open defecation behaviors. The intervention led to modest increases in availability of IHLs and even more modest reductions in open defecation. These improvements were insufficient to improve child health outcomes (diarrhea, HCGI, parasite infection, anemia, growth). The results underscore the difficulty of achieving adequately large improvements in sanitation levels to deliver expected health benefits within large-scale rural sanitation programs. ClinicalTrials.gov NCT01465204. Please see later in the article for the Editors' Summary.

The Effect of India's Total Sanitation Campaign on Defecation Behaviors and Child Health in Rural Madhya Pradesh: A Cluster Randomized Controlled Trial

PubMed Central

Patil, Sumeet R.; Arnold, Benjamin F.; Salvatore, Alicia L.; Briceno, Bertha; Ganguly, Sandipan; Colford, John M.; Gertler, Paul J.

2014-01-01

Background Poor sanitation is thought to be a major cause of enteric infections among young children. However, there are no previously published randomized trials to measure the health impacts of large-scale sanitation programs. India's Total Sanitation Campaign (TSC) is one such program that seeks to end the practice of open defecation by changing social norms and behaviors, and providing technical support and financial subsidies. The objective of this study was to measure the effect of the TSC implemented with capacity building support from the World Bank's Water and Sanitation Program in Madhya Pradesh on availability of individual household latrines (IHLs), defecation behaviors, and child health (diarrhea, highly credible gastrointestinal illness [HCGI], parasitic infections, anemia, growth). Methods and Findings We conducted a cluster-randomized, controlled trial in 80 rural villages. Field staff collected baseline measures of sanitation conditions, behaviors, and child health (May–July 2009), and revisited households 21 months later (February–April 2011) after the program was delivered. The study enrolled a random sample of 5,209 children <5 years old from 3,039 households that had at least one child <24 months at the beginning of the study. A random subsample of 1,150 children <24 months at enrollment were tested for soil transmitted helminth and protozoan infections in stool. The randomization successfully balanced intervention and control groups, and we estimated differences between groups in an intention to treat analysis. The intervention increased percentage of households in a village with improved sanitation facilities as defined by the WHO/UNICEF Joint Monitoring Programme by an average of 19% (95% CI for difference: 12%–26%; group means: 22% control versus 41% intervention), decreased open defecation among adults by an average of 10% (95% CI for difference: 4%–15%; group means: 73% intervention versus 84% control). However, the intervention did not improve child health measured in terms of multiple health outcomes (diarrhea, HCGI, helminth infections, anemia, growth). Limitations of the study included a relatively short follow-up period following implementation, evidence for contamination in ten of the 40 control villages, and bias possible in self-reported outcomes for diarrhea, HCGI, and open defecation behaviors. Conclusions The intervention led to modest increases in availability of IHLs and even more modest reductions in open defecation. These improvements were insufficient to improve child health outcomes (diarrhea, HCGI, parasite infection, anemia, growth). The results underscore the difficulty of achieving adequately large improvements in sanitation levels to deliver expected health benefits within large-scale rural sanitation programs. Trial Registration ClinicalTrials.gov NCT01465204 Please see later in the article for the Editors' Summary PMID:25157929

Effects of visual illusion and transcutaneous electrical nerve stimulation on neuropathic pain in patients with spinal cord injury: A randomised controlled cross-over trial.

PubMed

Özkul, Çağla; Kılınç, Muhammed; Yıldırım, Sibel Aksu; Topçuoğlu, Elif Yalçın; Akyüz, Müfit

2015-01-01

Chronic pain is a common consequence of spinal cord injury (SCI). No therapeutic drugs or drug groups are proven to be superior for neuropathic pain and treatments only aim to convert pain from dull to tolerable levels and not to remove it. This study was planned to compare the effect of visual illusion (VI) and transcutaneous electrical nerve stimulation (TENS) on pain intensity, pain quality and functional capacity in SCI patients with neuropathic pain. Twenty-four patients were included and randomly categorized into two groups. In the first group (n= 12), visual illusion was applied for first two weeks, 1 week wash out period and then TENS was applied for 2 weeks. In second group (n= 12), TENS was applied firstly, 1 week wash out and then %visual illusion VI were applied. Pain severity, pain quality, and functional capacity were assessed with the visual analog scale (VAS), the neuropathic pain scale (NPS), and the brief pain inventory (BPI), respectively. A pre-post-treatment and cross over design was used. Wilcoxon signed-rank tests were used for within group analyses. Mann-Whitney U tests were used for analyses that compared different groups. It was observed that pain intensity decrease immediately after both applications (VI: p= 0.07, TENS: p= 0.08). After TENS application for 2 weeks, it was observed that significant decrease in most (p= 0.04) and less (p= 0.02) pain intensity; while there was no significant decrease in pain intensity after 2 weeks for VI (p> 0.05). When findings of NPS were analyzed, hot (p= 0.047), sharp (p= 0.02), unpleasant (p= 0.03) and deep items (p= 0.047) decreased after VI application. When the results of BPI were detected, they were observed that the negative effect of pain on moving ability (p= 0.04) after visual illusion application and the negative effect of pain on mood (p= 0.03), relationships with others (p= 0.04) and sleep (p= 0.04) after TENS application decreased significantly. TENS and VI therapies can be successfully used in clinical practice as an alternative treatment or as a supportive method separetely or together.

The role of eye fixation in memory enhancement under stress - An eye tracking study.

PubMed

Herten, Nadja; Otto, Tobias; Wolf, Oliver T

2017-04-01

In a stressful situation, attention is shifted to potentially relevant stimuli. Recent studies from our laboratory revealed that participants stressed perform superior in a recognition task involving objects of the stressful episode. In order to characterize the role of a stress induced alteration in visual exploration, the present study investigated whether participants experiencing a laboratory social stress situation differ in their fixation from participants of a control group. Further, we aimed at shedding light on the relation of fixation behaviour with obtained memory measures. We randomly assigned 32 male and 31 female participants to a control or a stress condition consisting of the Trier Social Stress Test (TSST), a public speaking paradigm causing social evaluative threat. In an established 'friendly' control condition (f-TSST) participants talk to a friendly committee. During both conditions, the committee members used ten office items (central objects) while another ten objects were present without being used (peripheral objects). Participants wore eye tracking glasses recording their fixations. On the next day, participants performed free recall and recognition tasks involving the objects present the day before. Stressed participants showed enhanced memory for central objects, accompanied by longer fixation times and larger fixation amounts on these objects. Contrasting this, fixation towards the committee faces showed the reversed pattern; here, control participants exhibited longer fixations. Fixation indices and memory measures were, however, not correlated with each other. Psychosocial stress is associated with altered fixation behaviour. Longer fixation on objects related to the stressful situation may reflect enhanced encoding, whereas diminished face fixation suggests gaze avoidance of aversive, socially threatening stimuli. Modified visual exploration should be considered in future stress research, in particular when focussing on memory for a stressful episode. Copyright © 2017 Elsevier Inc. All rights reserved.

A Cluster Randomised Trial Introducing Rapid Diagnostic Tests into Registered Drug Shops in Uganda: Impact on Appropriate Treatment of Malaria

PubMed Central

Mbonye, Anthony K.; Magnussen, Pascal; Lal, Sham; Hansen, Kristian S.; Cundill, Bonnie; Chandler, Clare; Clarke, Siân E.

2015-01-01

Background Inappropriate treatment of malaria is widely reported particularly in areas where there is poor access to health facilities and self-treatment of fevers with anti-malarial drugs bought in shops is the most common form of care-seeking. The main objective of the study was to examine the impact of introducing rapid diagnostic tests for malaria (mRDTs) in registered drug shops in Uganda, with the aim to increase appropriate treatment of malaria with artemisinin-based combination therapy (ACT) in patients seeking treatment for fever in drug shops. Methods A cluster-randomized trial of introducing mRDTs in registered drug shops was implemented in 20 geographical clusters of drug shops in Mukono district, central Uganda. Ten clusters were randomly allocated to the intervention (diagnostic confirmation of malaria by mRDT followed by ACT) and ten clusters to the control arm (presumptive treatment of fevers with ACT). Treatment decisions by providers were validated by microscopy on a reference blood slide collected at the time of consultation. The primary outcome was the proportion of febrile patients receiving appropriate treatment with ACT defined as: malaria patients with microscopically-confirmed presence of parasites in a peripheral blood smear receiving ACT or rectal artesunate, and patients with no malaria parasites not given ACT. Findings A total of 15,517 eligible patients (8672 intervention and 6845 control) received treatment for fever between January-December 2011. The proportion of febrile patients who received appropriate ACT treatment was 72·9% versus 33·7% in the control arm; a difference of 36·1% (95% CI: 21·3 – 50·9), p<0·001. The majority of patients with fever in the intervention arm accepted to purchase an mRDT (97·8%), of whom 58·5% tested mRDT-positive. Drug shop vendors adhered to the mRDT results, reducing over-treatment of malaria by 72·6% (95% CI: 46·7– 98·4), p<0·001) compared to drug shop vendors using presumptive diagnosis (control arm). Conclusion Diagnostic testing with mRDTs compared to presumptive treatment of fevers implemented in registered drug shops substantially improved appropriate treatment of malaria with ACT. Trial Registration ClinicalTrials.gov NCT01194557. PMID:26200467

A Cluster Randomised Trial Introducing Rapid Diagnostic Tests into Registered Drug Shops in Uganda: Impact on Appropriate Treatment of Malaria.

PubMed

Mbonye, Anthony K; Magnussen, Pascal; Lal, Sham; Hansen, Kristian S; Cundill, Bonnie; Chandler, Clare; Clarke, Siân E

2015-01-01

Inappropriate treatment of malaria is widely reported particularly in areas where there is poor access to health facilities and self-treatment of fevers with anti-malarial drugs bought in shops is the most common form of care-seeking. The main objective of the study was to examine the impact of introducing rapid diagnostic tests for malaria (mRDTs) in registered drug shops in Uganda, with the aim to increase appropriate treatment of malaria with artemisinin-based combination therapy (ACT) in patients seeking treatment for fever in drug shops. A cluster-randomized trial of introducing mRDTs in registered drug shops was implemented in 20 geographical clusters of drug shops in Mukono district, central Uganda. Ten clusters were randomly allocated to the intervention (diagnostic confirmation of malaria by mRDT followed by ACT) and ten clusters to the control arm (presumptive treatment of fevers with ACT). Treatment decisions by providers were validated by microscopy on a reference blood slide collected at the time of consultation. The primary outcome was the proportion of febrile patients receiving appropriate treatment with ACT defined as: malaria patients with microscopically-confirmed presence of parasites in a peripheral blood smear receiving ACT or rectal artesunate, and patients with no malaria parasites not given ACT. A total of 15,517 eligible patients (8672 intervention and 6845 control) received treatment for fever between January-December 2011. The proportion of febrile patients who received appropriate ACT treatment was 72·9% versus 33·7% in the control arm; a difference of 36·1% (95% CI: 21·3 - 50·9), p<0·001. The majority of patients with fever in the intervention arm accepted to purchase an mRDT (97·8%), of whom 58·5% tested mRDT-positive. Drug shop vendors adhered to the mRDT results, reducing over-treatment of malaria by 72·6% (95% CI: 46·7- 98·4), p<0·001) compared to drug shop vendors using presumptive diagnosis (control arm). Diagnostic testing with mRDTs compared to presumptive treatment of fevers implemented in registered drug shops substantially improved appropriate treatment of malaria with ACT. ClinicalTrials.gov NCT01194557.

Housing First Reduces Re-offending among Formerly Homeless Adults with Mental Disorders: Results of a Randomized Controlled Trial

PubMed Central

Somers, Julian M.; Rezansoff, Stefanie N.; Moniruzzaman, Akm; Palepu, Anita; Patterson, Michelle

2013-01-01

Background Homelessness and mental illness have a strong association with public disorder and criminality. Experimental evidence indicates that Housing First (HF) increases housing stability and perceived choice among those experiencing chronic homelessness and mental disorders. HF is also associated with lower residential costs than common alternative approaches. Few studies have examined the effect of HF on criminal behavior. Methods Individuals meeting criteria for homelessness and a current mental disorder were randomized to one of three conditions treatment as usual (reference); scattered site HF; and congregate HF. Administrative data concerning justice system events were linked in order to study prior histories of offending and to test the relationship between housing status and offending following randomization for up to two years. Results The majority of the sample (67%) was involved with the justice system, with a mean of 8.07 convictions per person in the ten years prior to recruitment. The most common category of crime was “property offences” (mean = 4.09). Following randomization, the scattered site HF condition was associated with significantly lower numbers of sentences than treatment as usual (Adjusted IRR = 0.29; 95% CI 0.12–0.72). Congregate HF was associated with a marginally significant reduction in sentences compared to treatment as usual (Adjusted IRR = 0.55; 95% CI: 0.26–1.14). Conclusions This study is the first randomized controlled trial to demonstrate benefits of HF among a homeless sample with mental illness in the domain of public safety and crime. Our sample was frequently involved with the justice system, with great personal and societal costs. Further implementation of HF is strongly indicated, particularly in the scattered site format. Research examining interdependencies between housing, health, and the justice system is indicated. Trial registration ISRCTN57595077 PMID:24023796

Interferon versus methotrexate in intermediate uveitis with macular edema: results of a randomized controlled clinical trial.

PubMed

Mackensen, Friederike; Jakob, Eva; Springer, Christina; Dobner, Bianca C; Wiehler, Ute; Weimer, Petra; Rohrschneider, Klaus; Fiehn, Christoph; Max, Regina; Storch-Hagenlocher, Brigitte; Becker, Matthias D

2013-09-01

To compare interferon (IFN) beta with methotrexate (MTX) in the treatment of intermediate uveitis with macular edema. Monocentric, prospective, randomized, controlled clinical trial. Specialized uveitis center at the University of Heidelberg. PATIENT OR STUDY POPULATION: Patients with either primary intermediate uveitis or uveitis associated with multiple sclerosis. MAIN INCLUSION CRITERIA: Visual acuity of 20/30 or worse (0.2 logarithm of the minimal angle of resolution) and macular edema of more than 250 μm (central 1-mm in optical coherence tomography; Stratus). Randomization into either IFN beta 44 μg subcutaneously 3 times weekly or 20 mg MTX subcutaneously once weekly. At 3 months, the primary outcome parameter of mean change in visual acuity was evaluated and efficacy was determined. Secondary parameters were macular edema by optical coherence tomography, inflammatory activity, and retinal sensitivity by microperimetry (MP-1; Nidek). In case of treatment failure, switching to the other treatment arm was possible. Nineteen patients were included. Ten were randomized to MTX, and 9 were randomized to IFN beta. At 3 months, visual acuity improved a mean 0.31 logarithm of the minimal angle of resolution (range, -0.02 to -0.96, 15.6 letters on the Early Treatment Diabetic Retinopathy Study chart) in the IFN beta group versus a mean 0.09 logarithm of the minimal angle of resolution (range, 0.12 to -0.38, 4.7 letters) in the MTX arm (P = .0435, Mann-Whitney U test). Macular thickness decreased by a mean of 206 μm (range, -41 to -416 μm) in the IFN arm, but increased by 47 μm (range, 108 to -28 μm) in the MTX group (P < .0001). Although the sample size is small, results of the trial support superiority of IFN beta over MTX in the treatment of macular edema in the setting of intermediate uveitis. Copyright © 2013 Elsevier Inc. All rights reserved.

The manual control of vehicles undergoing slow transitions in dynamic characteristics

NASA Technical Reports Server (NTRS)

Moriarty, T. E.

1974-01-01

The manual control was studied of a vehicle with slowly time-varying dynamics to develop analytic and computer techniques necessary for the study of time-varying systems. The human operator is considered as he controls a time-varying plant in which the changes are neither abrupt nor so slow that the time variations are unimportant. An experiment in which pilots controlled the longitudinal mode of a simulated time-varying aircraft is described. The vehicle changed from a pure double integrator to a damped second order system, either instantaneously or smoothly over time intervals of 30, 75, or 120 seconds. The regulator task consisted of trying to null the error term resulting from injected random disturbances with bandwidths of 0.8, 1.4, and 2.0 radians per second. Each of the twelve experimental conditons was replicated ten times. It is shown that the pilot's performance in the time-varying task is essentially equivalent to his performance in stationary tasks which correspond to various points in the transition. A rudimentary model for the pilot-vehicle-regulator is presented.

Canoe game-based virtual reality training to improve trunk postural stability, balance, and upper limb motor function in subacute stroke patients: a randomized controlled pilot study.

PubMed

Lee, Myung-Mo; Shin, Doo-Chul; Song, Chang-Ho

2016-07-01

[Purpose] This study was aimed at investigating the preliminary therapeutic efficacy and usefulness of canoe game-based virtual reality training for stroke patients. [Subjects and Methods] Ten stroke patients were randomly assigned to an experimental group (EG; n=5) or a control group (CG; n=5). Patients in both groups participated in a conventional rehabilitation program, but those in the EG additionally participated in a 30-min canoe game-based virtual reality training program 3 days a week for 4 weeks. Therapeutic efficacy was assessed based on trunk postural stability, balance, and upper limb motor function. In addition, the usefulness of canoe game-based virtual reality training was assessed in the EG and therapist group (TG; n=20), which consisted of physical and occupational therapists, by using the System Usability Scale (SUS). [Results] Improvements in trunk postural stability, balance, and upper limb motor function were observed in the EG and CG, but were greater in the EG. The mean SUS scores in the EG and TG were 71 ± 5.2 and 74.2 ± 4.8, respectively. [Conclusion] Canoe game-based virtual reality training is an acceptable and effective intervention for improving trunk postural stability, balance, and upper limb motor function in stroke patients.

Experimental Infection with Sporulated Oocysts of Eimeria maxima (Apicomplexa: Eimeriidae) in Broiler

PubMed Central

Brito, Luciana da S.; Pereira, Elder N.; da Silva, Augusta A.; Bentivóglio Costa Silva, Vinícius; Freitas, Fagner L. da C.

2014-01-01

Through this study we assessed the metabolic and pathological changes in broilers experimentally infected with oocysts of Eimeria maxima. To perform the experiment, we used 150 broiler strain cooB males, with ten days of age, were randomized according to weight and randomly assigned to two experimental groups: the control group was inoculated with 0.5 mL of distilled water; the infected group inoculated with 0.5 mL of solution containing 5 × 104 sporulated oocysts of Eimeria maxima. The live performance was evaluated on day 0 (day of inoculation), 5°, 10°, 15°, 25°, and 35° dpi, being slaughtered by cervical dislocation, fifteen birds/group. Although the sum in meat production was higher in the control group, the weight of the heart and gizzard of the experimental animals showed no significant difference, while the liver had difference on day 5°, 15°, and 35° dpi. The pathologic evaluation showed congested mucosa and presence of large amounts of mucus at 6 dpi. Therefore, it is concluded that the dose of 5 × 104  E. maxima inoculated in the experimental group was enough to cause harm to the animal organism. PMID:26464925

Factors influencing adherence with therapeutic sunlight exposure in older people in intermediate care facilities.

PubMed

Durvasula, Seeta; Sambrook, Philip N; Cameron, Ian D

2012-01-01

The purpose of this study was to investigate the factors influencing low adherence with therapeutic sunlight exposure in a randomized controlled trial conducted with older people living in intermediate care facilities. The study involved participants in the FREEDOM (Falls Risk Epidemiology: Effect of vitamin D on skeletal Outcomes and other Measures) study, a randomized controlled trial of therapeutic sun exposure to reduce falls in older people in intermediate care facilities. Semi-structured interviews were conducted with thirty participants in the FREEDOM trial, and with ten sunlight officers who were employed to facilitate the sun exposure. Two focus groups involving 10 participants in the FREEDOM trial were also held at the end of the intervention period. Common themes were derived from the interview and focus group transcripts. The study showed that the perceived health benefits did not influence adherence with the sun exposure. Factors such as socializing with others and being outdoors were more important in encouraging attendance. The main barriers to adherence included the perceived inflexibility and regimentation of daily attendance, clash with other activities, unsuitable timing and heat discomfort. This study showed that providing greater flexibility and autonomy to older people in how and when they receive sun exposure is likely to improve adherence. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Lidocaine 20% patch vs lidocaine 5% gel for topical anaesthesia of oral mucosa.

PubMed

Bågesund, Mats; Tabrizi, Parisa

2008-11-01

Topical anaesthetics are important to provide pain control at dental injection. The aim was to evaluate the effectiveness of the intraoral topical anaesthetics lidocaine 20% patch (DentiPatch) and lidocaine 5% gel. The randomized unblinded cross-over study included 31 patients (ten boys, 21 girls) aged 13.5 +/- 2.5 years. Application of lidocaine patch or gel was randomly used at first and second visit in the upper premolar region. Heart rate was measured before and at each needle insertion after 2.5, 5, and 15 min and at injection after 15 min. Discomfort and pain were expressed in visual analogue scales (VAS). Paired t-test and Mann-Whitney U-test were used for statistic analyses. Heart rate at buccal injection decreased more when the patch was used (P = 0.0149). Heart rate was lower at the second visit (P = 0.0287). Patients expressed less discomfort when the patch was used on both buccal (P = 0.0150) and palatal (P = 0.0391) site. Boys had lower heart rate and VAS pain scale ratings than girls. Good pain control can reduce the patients' anxiety level--expressed in heart rate--at the second appointment. The patch and gel seem to provide similar pain reduction at needle stick and injection of local anaesthetics.

A systematic review of SNAPO (Smoking, Nutrition, Alcohol, Physical activity and Obesity) randomized controlled trials in young adult men.

PubMed

Ashton, Lee M; Morgan, Philip J; Hutchesson, Melinda J; Rollo, Megan E; Young, Myles D; Collins, Clare E

2015-12-01

To investigate the effectiveness of Smoking, Nutrition, Alcohol, Physical activity and Obesity (SNAPO) interventions in young men exclusively. The secondary aim was to evaluate the recruitment, retention and engagement strategies. A search with no date restrictions was conducted across seven databases. Randomized controlled trials recruiting young men only (aged 18-35 years) into interventions targeting any SNAPO risk factors were included. Ten studies were included (two nutrition, six alcohol use, two targeting multiple SNAPO risk factors). Six studies (two nutrition, three alcohol use and one targeting multiple SNAPO risk factors) demonstrated significant positive short-term intervention effects, but impact was either not assessed beyond the intervention (n=3), had short-term follow-up (≤6 months) (n=2) or not sustained beyond six months (n=1). Overall, a high risk of bias was identified across studies. Only one study undertook a power calculation and recruited the required sample size. Adequate retention was achieved in three studies. Effectiveness of engagement strategies was not reported in any studies. Despite preliminary evidence of short-term effectiveness of SNAPO interventions in young men, few studies characterized by a high risk of bias were identified. High quality SNAPO interventions for young men are warranted. Copyright © 2015 Elsevier Inc. All rights reserved.

Traditional Chinese Mind and Body Exercises for Promoting Balance Ability of Old Adults: A Systematic Review and Meta-Analysis

PubMed Central

Zhang, Yanjie; Wang, Yong Tai; Liu, Xiao Lei

2016-01-01

The purpose of this study was to provide a quantitative evaluation of the effectiveness of traditional Chinese mind and body exercises in promoting balance ability for old adults. The eligible studies were extensively searched from electronic databases (Medline, CINAHL, SportDicus, and Web of Science) until 10 May 2016. Reference lists of relevant publications were screened for future hits. The trials used randomized controlled approaches to compare the effects of traditional Chinese mind and body exercise (TCMBE) on balance ability of old adults that were included. The synthesized results of Berg Balance Scale (BBS), Timed Up and Go Test (TUG), and static balance with 95% confidence intervals were counted under a random-effects model. Ten studies were selected based on the inclusion criteria, and a total of 1,798 participants were involved in this review. The results of the meta-analysis showed that TCMBE had no significant improvement on BBS and TUG, but the BBS and TUG could be obviously improved by prolonging the intervention time. In addition, the results showed that TCMBE could significantly improve the static balance compared to control group. In conclusion, old adults who practiced TCMBE with the time not less than 150 minutes per week for more than 15 weeks could promote the balance ability. PMID:27990168

Traditional Chinese Mind and Body Exercises for Promoting Balance Ability of Old Adults: A Systematic Review and Meta-Analysis.

PubMed

Chen, Shihui; Zhang, Yanjie; Wang, Yong Tai; Liu, Xiao Lei

2016-01-01

The purpose of this study was to provide a quantitative evaluation of the effectiveness of traditional Chinese mind and body exercises in promoting balance ability for old adults. The eligible studies were extensively searched from electronic databases (Medline, CINAHL, SportDicus, and Web of Science) until 10 May 2016. Reference lists of relevant publications were screened for future hits. The trials used randomized controlled approaches to compare the effects of traditional Chinese mind and body exercise (TCMBE) on balance ability of old adults that were included. The synthesized results of Berg Balance Scale (BBS), Timed Up and Go Test (TUG), and static balance with 95% confidence intervals were counted under a random-effects model. Ten studies were selected based on the inclusion criteria, and a total of 1,798 participants were involved in this review. The results of the meta-analysis showed that TCMBE had no significant improvement on BBS and TUG, but the BBS and TUG could be obviously improved by prolonging the intervention time. In addition, the results showed that TCMBE could significantly improve the static balance compared to control group. In conclusion, old adults who practiced TCMBE with the time not less than 150 minutes per week for more than 15 weeks could promote the balance ability.

Clinical effectiveness of a Pilates treatment for forward head posture

PubMed Central

Lee, Sun-Myung; Lee, Chang-Hyung; O’Sullivan, David; Jung, Joo-Ha; Park, Jung-Jun

2016-01-01

[Purpose] This study compared the effects of pilates and an exercise program on the craniovertebral angle, cervical range of motion, pain, and muscle fatigue in subjects with a forward head posture (FHP). [Subjects and Methods] A total of 28 sedentary females (age 20 to 39 years) with FHP were randomly assigned to pilates (n=14) and combined (n=14) exercise groups. The study was a randomized, controlled, double-blind study with the two groups performing exercise 50 min/day, 3 days/week, with an intensity of 11–15 rating of perceived exertion (RPE) for ten weeks. The main outcome measures were craniovertebral angle, cervical range of motion (ROM), pain levels assessed by visual analog scale (VAS), and neck disability index (NDI). Surface electromyography was also used to measure muscle fatigue. [Results] There were significant increases in craniovertebral angle and cervical ROM in the pilates group, but none in the control group. The only significant differences in muscle activity were recorded in the sternocleidomastoid muscle in the pilates group. Both exercise programs had positive effects on pain measures, as VAS and NDI were significantly decreased. [Conclusion] The results suggest that pilates could be recommended as an appropriate exercise for treatment of FHP in sedentary individuals. PMID:27512253

Clinical effectiveness of a Pilates treatment for forward head posture.

PubMed

Lee, Sun-Myung; Lee, Chang-Hyung; O'Sullivan, David; Jung, Joo-Ha; Park, Jung-Jun

2016-07-01

[Purpose] This study compared the effects of pilates and an exercise program on the craniovertebral angle, cervical range of motion, pain, and muscle fatigue in subjects with a forward head posture (FHP). [Subjects and Methods] A total of 28 sedentary females (age 20 to 39 years) with FHP were randomly assigned to pilates (n=14) and combined (n=14) exercise groups. The study was a randomized, controlled, double-blind study with the two groups performing exercise 50 min/day, 3 days/week, with an intensity of 11-15 rating of perceived exertion (RPE) for ten weeks. The main outcome measures were craniovertebral angle, cervical range of motion (ROM), pain levels assessed by visual analog scale (VAS), and neck disability index (NDI). Surface electromyography was also used to measure muscle fatigue. [Results] There were significant increases in craniovertebral angle and cervical ROM in the pilates group, but none in the control group. The only significant differences in muscle activity were recorded in the sternocleidomastoid muscle in the pilates group. Both exercise programs had positive effects on pain measures, as VAS and NDI were significantly decreased. [Conclusion] The results suggest that pilates could be recommended as an appropriate exercise for treatment of FHP in sedentary individuals.

Production of large-scale, freestanding vanadium pentoxide nanobelt porous structures

NASA Astrophysics Data System (ADS)

Yun, Yong Ju; Kim, Byung Hoon; Hong, Won G.; Kim, Chang Hee; Kim, Yark Yeon; Jeong, Eun-Ju; Jang, Won Ick; Yu, Han Young

2012-02-01

Large-scale, freestanding, porous structures of vanadium pentoxide nanobelts (VPNs) were successfully prepared using the template-free freeze-drying method. The porous and multi-layered VPN macrostructures are composed of randomly oriented long nanobelts (over 100 μm) and their side length can be controlled up to a few tens of centimetres. Also, the bulk density and surface area of these macrostructures are 3-5 mg cm-3 and 40-80 m2 g-1, respectively, which are similar to those of the excellent adsorbents. In addition, the removal efficiency measurements of ammonia molecules revealed that the VPN porous structures can adsorb the ammonia molecules with the combinations of van der Waals forces and strong chemical bonding by functional groups on the VPN surface.

Production of large-scale, freestanding vanadium pentoxide nanobelt porous structures.

PubMed

Yun, Yong Ju; Kim, Byung Hoon; Hong, Won G; Kim, Chang Hee; Kim, Yark Yeon; Jeong, Eun-ju; Jang, Won Ick; Yu, Han Young

2012-03-07

Large-scale, freestanding, porous structures of vanadium pentoxide nanobelts (VPNs) were successfully prepared using the template-free freeze-drying method. The porous and multi-layered VPN macrostructures are composed of randomly oriented long nanobelts (over 100 μm) and their side length can be controlled up to a few tens of centimetres. Also, the bulk density and surface area of these macrostructures are 3-5 mg cm(-3) and 40-80 m(2) g(-1), respectively, which are similar to those of the excellent adsorbents. In addition, the removal efficiency measurements of ammonia molecules revealed that the VPN porous structures can adsorb the ammonia molecules with the combinations of van der Waals forces and strong chemical bonding by functional groups on the VPN surface.

Short-term and long-term effects of dipeptidyl peptidase-4 inhibitors in type 2 diabetes mellitus patients with renal impairment: a meta-analysis of randomized controlled trials.

PubMed

Li, Ruifei; Wang, Rui; Li, Haixia; Sun, Sihao; Zou, Meijuan; Cheng, Gang

2016-09-01

To assess the short-term and long-term effects of dipeptidyl peptidase-4 (DPP-4) inhibitors in type 2 diabetes mellitus patients with renal impairment, a meta-analysis of randomized clinical trials of DPP-4 inhibitor interventions in type 2 diabetes mellitus patients with renal impairment was performed. PubMed, Embase, Cochrane Library and ClinicalTrials.gov were searched through the end of March 2015. Randomized clinical trials were selected if (1) DPP-4 inhibitors were compared with a placebo or other active-comparators, (2) the treatment duration was ≥12 weeks and (3) data regarding changes in haemoglobin A1c (HbA1c ), changes in fasting plasma glucose or hypoglycaemia and other adverse events were reported. Of 790 studies, ten studies on eight randomized clinical trials were included. Compared with the control group, DPP-4 inhibitors were associated with a greater HbA1c reduction in both the short-term [mean differences (MD) = -0.45, 95% confidence intervals (-0.57, -0.33), p < 0.0001] and long-term [MD = -0.33, 95% confidence intervals (-0.63, -0.03), p = 0.03] treatments. However, the long-term greater reduction in HbA1c with DPP-4 inhibitor treatment was only significant when the control treatment comprised placebo plus stable background treatment, but not glipizide plus stable background treatment. DPP-4 inhibitors were associated with a greater fasting plasma glucose reduction [MD = -12.59, 95% confidence intervals (-22.01, -3.17), p = 0.009] over the short-term; however, this effect was not present over the long-term. Regarding the hypoglycaemia adverse events assessment, the long-term treatment data indicated there was no increased risk of hypoglycaemia compared with placebo or active-controlled anti-diabetic drugs. The present meta-analysis confirms that DPP-4 inhibitors are effective and equivalent to other agents in type 2 diabetes mellitus patients with renal impairment. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Does caffeine reduce postoperative bowel paralysis after elective laparoscopic colectomy? (CaCo trial): study protocol for a randomized controlled trial.

PubMed

Kruse, Christina; Müller, Sascha A; Warschkow, René; Lüthi, Cornelia; Brunner, Walter; Marti, Lukas; Sulz, Michael Christian; Schmied, Bruno M; Tarantino, Ignazio; Beutner, Ulrich

2016-04-04

Postoperative bowel paralysis is common after abdominal operations, including colectomy. As a result, hospitalization may be prolonged, thereby leading to increased cost. A recent randomized controlled trial showed that the consumption of regular black coffee after colectomy is associated with a significantly faster resumption of intestinal motility. The mechanism by which coffee stimulates intestinal motility is unknown, but caffeine seems to be the most likely stimulating agent. Thus, the effect of caffeine on postoperative bowel activity after colon surgery will be analyzed in this trial, herein referred to as CaCo. Patients scheduled for elective laparoscopic colectomy or upper rectum resection are eligible to participate in this double-blinded, placebo-controlled, randomized trial. Patients fulfilling all inclusion criteria will be allocated after the surgical procedure to one of three treatment arms: 100 mg caffeine, 200 mg caffeine, or placebo (corn starch). Patients will take the capsules containing the study medication three times daily with a meal. The primary endpoint of the study is the time to a solid bowel movement. The study treatment will be stopped after the patient produces a solid bowel movement or has taken ten capsules, whichever occurs first. To determine the colonic passage time, patients will take a capsule with radiopaque markers at breakfast for the first 3 days after surgery. On the fourth day, the location of the markers will be determined with an abdominal X-ray scan. Further secondary objectives are the postoperative morbidity and mortality, well-being, sleeping behavior, and length of hospital stay. The study size was calculated to be 180 patients with an interim analysis occurring after 60 patients. From a previous study investigating coffee, evidence exists that caffeine might have a positive influence on the postoperative bowel activity. This double-blinded, placebo-controlled, randomized trial tries to show that caffeine will shorten the postoperative bowel paralysis and, thus, will improve recovery and shorten the hospital stay after colon surgery. Clinicaltrials.gov NCT02510911 Swiss National Clinical Trials Portal SNCTP000001131.

Transcutaneous Electrical Nerve Stimulation (TENS) and Laryngeal Manual Therapy (LMT): Immediate Effects in Women With Dysphonia.

PubMed

Conde, Mariana de Cásisa Macedo; Siqueira, Larissa Thaís Donalonso; Vendramini, José Eduardo; Brasolotto, Alcione Ghedini; Guirro, Rinaldo Roberto de Jesus; Silverio, Kelly Cristina Alves

2018-05-01

This study aimed to verify the immediate effect of low-frequency transcutaneous electrical nerve stimulation (TENS) and laryngeal manual therapy (LMT) in musculoskeletal pain, voice quality, and self-reported signs in women with dysphonia. Thirty women with behavioral dysphonia were randomly divided into the TENS group and the LMT group. All participants fulfilled the pain survey and had their voices recorded to posterior perceptual and acoustic analysis before and after intervention. The TENS group received a unique low-frequency TENS session (20 minutes). The LMT group received LMT (20 minutes) with soft and superficial massage in the sternocleidomastoid muscle, suprahyoid muscles, and larynx. Afterward, the volunteers reported their voice, larynx, breathing, and articulatory signs. Pre and post data were compared by parametric and nonparametric tests. After TENS, a decrease in pain intensity in the posterior or anterior region of the neck, shoulders, upper or lower back, and masseter was observed. After LMT, a decrease in pain intensity in the neck anterior region, shoulders, lower back, and temporal region was observed. Also, after TENS, there was an improvement in vowel /a/ instability; after LMT, there was a general improvement in voice quality, decrease in tension, and decrease in breathiness in speech. Positive voice and laryngeal signs were reported after TENS, and positive laryngeal signs and articulation were reported after LMT. TENS and LMT may be used in voice treatment of women with behavioral dysphonia, and both may be considered important therapy resources that reduce musculoskeletal pain and cause positive laryngeal signs. Both TENS and LMT are able to partially improve voice quality, but TENS presented better results. Copyright © 2018 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

Low power radiofrequency electromagnetic radiation for the treatment of pain due to osteoarthritis of the knee.

PubMed

Alcidi, L; Beneforti, E; Maresca, M; Santosuosso, U; Zoppi, M

2007-01-01

To investigate the analgesic effect of low power radiofrequency electromagnetic radiation (RF) in osteoarthritis (OA) of the knee. In a randomized study on 40 patients the analgesic effect of RF was compared with the effect of transcutaneous electrical nerve stimulation (TENS). RF and TENS applications were repeated every day for a period of 5 days. The therapeutic effect was evaluated by a visual analogue scale (VAS) and by Lequesne's index: tests were performed before, immediately after and 30 days after therapy. RF therapy induced a statistically significant and long lasting decrease of VAS and of Lequesne's index; TENS induced a decrease of VAS and of Lequesne's index which was not statistically significant. A therapeutic effect of RF was therefore demonstrated on pain and disability due to knee OA. This effect was better than the effect of TENS, which is a largely used analgesic technique. Such a difference of the therapeutic effect may be due to the fact that TENS acts only on superficial tissues and nerve terminals, while RF acts increasing superficial and deep tissue temperature.

Evaluation of Bayesian Sequential Proportion Estimation Using Analyst Labels

NASA Technical Reports Server (NTRS)

Lennington, R. K.; Abotteen, K. M. (Principal Investigator)

1980-01-01

The author has identified the following significant results. A total of ten Large Area Crop Inventory Experiment Phase 3 blind sites and analyst-interpreter labels were used in a study to compare proportional estimates obtained by the Bayes sequential procedure with estimates obtained from simple random sampling and from Procedure 1. The analyst error rate using the Bayes technique was shown to be no greater than that for the simple random sampling. Also, the segment proportion estimates produced using this technique had smaller bias and mean squared errors than the estimates produced using either simple random sampling or Procedure 1.

Replacing Non-Active Video Gaming by Active Video Gaming to Prevent Excessive Weight Gain in Adolescents

PubMed Central

Simons, Monique; Brug, Johannes; Chinapaw, Mai J. M.; de Boer, Michiel; Seidell, Jaap; de Vet, Emely

2015-01-01

Objective The aim of the current study was to evaluate the effects of and adherence to an active video game promotion intervention on anthropometrics, sedentary screen time and consumption of sugar-sweetened beverages and snacks among non-active video gaming adolescents who primarily were of healthy weight. Methods We assigned 270 gaming (i.e. ≥2 hours/week non-active video game time) adolescents randomly to an intervention group (n = 140) (receiving active video games and encouragement to play) or a waiting-list control group (n = 130). BMI-SDS (SDS = adjusted for mean standard deviation score), waist circumference-SDS, hip circumference and sum of skinfolds were measured at baseline, at four and ten months follow-up (primary outcomes). Sedentary screen time, physical activity, consumption of sugar-sweetened beverages and snacks, and process measures (not at baseline) were assessed with self-reports at baseline, one, four and ten months follow-up. Multi-level-intention to treat-regression analyses were conducted. Results The control group decreased significantly more than the intervention group on BMI-SDS (β = 0.074, 95%CI: 0.008;0.14), and sum of skinfolds (β = 3.22, 95%CI: 0.27;6.17) (overall effects). The intervention group had a significantly higher decrease in self-reported non-active video game time (β = -1.76, 95%CI: -3.20;-0.32) and total sedentary screen time (Exp (β = 0.81, 95%CI: 0.74;0.88) than the control group (overall effects). The process evaluation showed that 14% of the adolescents played the Move video games every week ≥1 hour/week during the whole intervention period. Conclusions The active video game intervention did not result in lower values on anthropometrics in a group of ‘excessive’ non-active video gamers (mean ~ 14 hours/week) who primarily were of healthy weight compared to a control group throughout a ten-month-period. Even some effects in the unexpected direction were found, with the control group showing lower BMI-SDS and skin folds than the intervention group. The intervention did result in less self-reported sedentary screen time, although these results are likely biased by social desirability. Trial Registration Dutch Trial Register NTR3228 PMID:26153884

SETI and SEH (Statistical Equation for Habitables)

NASA Astrophysics Data System (ADS)

Maccone, Claudio

2011-01-01

The statistics of habitable planets may be based on a set of ten (and possibly more) astrobiological requirements first pointed out by Stephen H. Dole in his book "Habitable planets for man" (1964). In this paper, we first provide the statistical generalization of the original and by now too simplistic Dole equation. In other words, a product of ten positive numbers is now turned into the product of ten positive random variables. This we call the SEH, an acronym standing for "Statistical Equation for Habitables". The mathematical structure of the SEH is then derived. The proof is based on the central limit theorem (CLT) of Statistics. In loose terms, the CLT states that the sum of any number of independent random variables, each of which may be arbitrarily distributed, approaches a Gaussian (i.e. normal) random variable. This is called the Lyapunov form of the CLT, or the Lindeberg form of the CLT, depending on the mathematical constraints assumed on the third moments of the various probability distributions. In conclusion, we show that The new random variable NHab, yielding the number of habitables (i.e. habitable planets) in the Galaxy, follows the lognormal distribution. By construction, the mean value of this lognormal distribution is the total number of habitable planets as given by the statistical Dole equation. But now we also derive the standard deviation, the mode, the median and all the moments of this new lognormal NHab random variable. The ten (or more) astrobiological factors are now positive random variables. The probability distribution of each random variable may be arbitrary. The CLT in the so-called Lyapunov or Lindeberg forms (that both do not assume the factors to be identically distributed) allows for that. In other words, the CLT "translates" into our SEH by allowing an arbitrary probability distribution for each factor. This is both astrobiologically realistic and useful for any further investigations. An application of our SEH then follows. The (average) distancebetween any two nearby habitable planets in the Galaxy may be shown to be inversely proportional to the cubic root of NHab. Then, in our approach, this distance becomes a new random variable. We derive the relevant probability density function, apparently previously unknown and dubbed "Maccone distribution" by Paul Davies in 2008. Data Enrichment Principle. It should be noticed that ANY positive number of random variables in the SEH is compatible with the CLT. So, our generalization allows for many more factors to be added in the future as long as more refined scientific knowledge about each factor will be known to the scientists. This capability to make room for more future factors in the SEH we call the "Data Enrichment Principle", and we regard it as the key to more profound future results in the fields of Astrobiology and SETI. A practical example is then given of how our SEH works numerically. We work out in detail the case where each of the ten random variables is uniformly distributed around its own mean value as given by Dole back in 1964 and has an assumed standard deviation of 10%. The conclusion is that the average number of habitable planets in the Galaxy should be around 100 million±200 million, and the average distance in between any couple of nearby habitable planets should be about 88 light years±40 light years. Finally, we match our SEH results against the results of the Statistical Drake Equation that we introduced in our 2008 IAC presentation. As expected, the number of currently communicating ET civilizations in the Galaxy turns out to be much smaller than the number of habitable planets (about 10,000 against 100 million, i.e. one ET civilization out of 10,000 habitable planets). And the average distance between any two nearby habitable planets turns out to be much smaller than the average distance between any two neighboring ET civilizations: 88 light years vs. 2000 light years, respectively. This means an ET average distance about 20 times higher than the average distance between any couple of adjacent habitable planets.

Blastocyst culture using single versus sequential media in clinical IVF: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Sfontouris, Ioannis A; Martins, Wellington P; Nastri, Carolina O; Viana, Iara G R; Navarro, Paula A; Raine-Fenning, Nick; van der Poel, Sheryl; Rienzi, Laura; Racowsky, Catherine

2016-10-01

The purpose of this study was to undertake a review of the available evidence comparing the use of a single medium versus sequential media for embryo culture to the blastocyst stage in clinical IVF. We searched the Cochrane Central, PubMed, Scopus, ClinicalTrials.gov, Current Controlled Trials and WHO International Clinical Trials Registry Platform to identify randomized controlled trials comparing single versus sequential media for blastocyst culture and ongoing pregnancy rate. Included studies randomized either oocytes/zygotes or women. Eligible oocyte/zygote studies were analyzed to assess the risk difference (RD) and 95 % confidence intervals (CI) between the two media systems; eligible woman-based studies were analyzed to assess the risk ratio (RR) and 95 % CI for clinical pregnancy rate. No differences were observed between single and sequential media for either ongoing pregnancy per randomized woman (relative risk (RR) = 0.9, 95 % CI = 0.7 to 1.3, two studies including 246 women, I 2  = 0 %) or clinical pregnancy per randomized woman (RR = 1.0, 95 % CI = 0.7 to 1.4, one study including 100 women); or miscarriage per clinical pregnancy: RR = 1.3, 95 % CI = 0.4 to 4.3, two studies including 246 participants, I 2  = 0 %). Single media use was associated with an increase blastocyst formation per randomized oocyte/zygote (relative distribution (RD) = +0.06, 95 % CI = +0.01 to +0.12, ten studies including 7455 oocytes/zygotes, I 2  = 83 %) but not top/high blastocyst formation (RD = +0.05, 95 % CI = -0.01 to +0.11, five studies including 3879 oocytes/zygotes, I 2  = 93 %). The overall quality of the evidence was very low for all these four outcomes. Although using a single medium for extended culture has some practical advantages and blastocyst formation rates appear to be higher, there is insufficient evidence to recommend either sequential or single-step media as being superior for the culture of embryos to days 5/6. Future studies comparing these two media systems in well-designed trials should be performed.

Neurofeedback in children with attention-deficit/hyperactivity disorder (ADHD)--a controlled multicenter study of a non-pharmacological treatment approach.

PubMed

Holtmann, Martin; Pniewski, Benjamin; Wachtlin, Daniel; Wörz, Sonja; Strehl, Ute

2014-08-13

Attention-deficit/hyperactivity disorder (ADHD) is the most common neurobehavioral disorder of childhood and has often a chronic course persisting into adulthood. However, up to 30% of children treated with stimulants either fail to show an improvement or suffer adverse side effects, including decreased appetite, insomnia and irritability and there is no evidence of long term efficacy of stimulants for ADHD. A series of studies has shown that neurofeedback is an effective additional or alternative treatment for children with ADHD, leading to e.g. significant and stable improvement in behavior, attention and IQ. Significant treatment effects of neurofeedback have also been verified in meta-analyses. Most of the trials, however, have been criticized for methodological difficulties, particularly lacking appropriate control conditions and number of patients included. This randomized study examines the efficacy of slow cortical potentials (SCP) -neurofeedback, controlling unspecific effects of the setting by comparing two active treatment modalities. A total of 144 patients with ADHD, older than six and younger than ten years, in some cases with additional pharmacological treatment, are included in this trial. In five trial centres patients are treated either with SCP-feedback or electromyographic (EMG) -feedback in 25 sessions within 3 months. A comprehensive test battery is conducted before and after treatment and at follow-up 6 month later, to assess core symptoms of ADHD, general psychopathology, attentional performance, comorbid symptoms, intelligence, quality of life and cortical arousal. The efficacy of SCP-feedback training for children with ADHD is evaluated in this randomized controlled study. In addition to behavior ratings and psychometric tests neurophysiological parameters serve as dependent variables. Further, the choice of EMG-biofeedback as an active control condition is debated. Current Controlled Trials ISRCTN76187185. Registered 5 February 2009.

Health education via mobile text messaging for glycemic control in adults with type 2 diabetes: a systematic review and meta-analysis.

PubMed

Saffari, Mohsen; Ghanizadeh, Ghader; Koenig, Harold G

2014-12-01

Diabetes type 2 is an increasing problem worldwide that may be managed through education. Text-messaging using a cell phone can assist with self-care. The aim of this study was to systematically review the impact of education through mobile text-messaging on glycemic control. The design was a systematic review with meta-analysis. Five electronic databases were searched to access English studies involving a randomized controlled trial design that used text-messaging educational interventions in patients with type 2 diabetes during an 11-year period (2003-2013). Studies were evaluated using a quality assessment scale adapted from Jadad scale and Cochrane handbook. Extraction of data was carried out by two reviewers. A random-effect model with a standardized mean difference and Hedges's g indices was used for conducting the meta-analysis. Subgroup analyses were conducted and a Funnel plot was used to examine publication bias. Ten studies overall were identified that fulfilled inclusion criteria, involving a total of 960 participants. The mean age of the sample was 52.8 years and majority were females. Data were heterogeneous (I(2)=67.6). Analyses suggested a publication bias based on Egger's regression (P<0.05). HbA1c was reduced significantly in experimental groups compared to control groups (P<0.001). The effect size for glycemic control in studies that used text-messaging only was 44%. For studies that used both text-messaging and Internet, the effect size was 86%. Mobile text-messaging for educating Type 2 diabetics appears to be effective on glycemic control. Further investigations on mobile applications to achieve educational goals involving other diseases are recommended. Copyright © 2014 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

Self-assembling peptide matrix for the prevention of esophageal stricture after endoscopic resection: a randomized controlled trial in a porcine model.

PubMed

Barret, M; Bordaçahar, B; Beuvon, F; Terris, B; Camus, M; Coriat, R; Chaussade, S; Batteux, F; Prat, F

2017-05-01

Esophageal stricture formation after extensive endoscopic resection remains a major limitation of endoscopic therapy for early esophageal neoplasia. This study assessed a recently developed self-assembling peptide (SAP) matrix as a wound dressing after endoscopic resection for the prevention of esophageal stricture. Ten pigs were randomly assigned to the SAP or the control group after undergoing a 5-cm-long circumferential endoscopic submucosal dissection of the lower esophagus. Esophageal diameter on endoscopy and esophagogram, weight variation, and histological measurements of fibrosis, granulation tissue, and neoepithelium were assessed in each animal. The rate of esophageal stricture at day 14 was 40% in the SAP-treated group versus 100% in the control group (P = 0.2). Median interquartile range (IQR) esophageal diameter at day 14 was 8 mm (2.5-9) in the SAP-treated group versus 4 mm (3-4) in the control group (P = 0.13). The median (IQR) stricture indexes on esophagograms at day 14 were 0.32 (0.14-0.48) and 0.26 (0.14-0.33) in the SAP-treated and control groups, respectively (P = 0.42). Median (IQR) weight variation during the study was +0.2 (-7.4; +1.8) and -3.8 (-5.4; +0.6) in the SAP-treated and control groups, respectively (P = 0.9). Fibrosis, granulation tissue, and neoepithelium were not significantly different between the groups. The application of SAP matrix on esophageal wounds after a circumferential endoscopic submucosal dissection delayed the onset of esophageal stricture in a porcine model. © International Society for Diseases of the Esophagus 2017. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Is there a role for TENS application in the control of diabetes mellitus in insulin-dependent patients?

PubMed

Khan, Mueen Ullah

2012-11-01

An 80-year-old man with insulin-dependent diabetes mellitus presented to the hospital with low back pain. He was initially managed with non-steroidal anti-inflammatory drugs, tramadol and epidural steroid injection. Transcutaneous electrical nerve stimulation (TENS), applied on the back and buttocks, was subsequently advised. Initially, TENS was applied once every 24 hours. On improvement of pain symptoms, it was increased to thrice every 24 hours. The patient then complained of symptoms of hypoglycaemia (blood sugar level < 4 mmol/L). Discontinuation of TENS resulted in raised blood sugar level. When TENS was restarted, the same hypoglycaemic response was noted. The insulin dosage was adjusted to half of the patient's routine daily requirement with continued application of TENS. This incidental finding has alerted us to hypoglycaemic episodes following TENS application, which may be due to effective pain control, decreased sympathetic stimulation, enhanced insulin sensitivity or altered muscle metabolism due to electrical stimulation.

A breast-feeding promotion and support program a randomized trial in The Netherlands.

PubMed

Kools, Els J; Thijs, Carel; Kester, Arnold D M; van den Brandt, Piet A; de Vries, Hein

2005-01-01

In the Netherlands, the initiation rate of breast-feeding (BF) was 80% in 2002, but only 35% of the mothers continued to breast-feed for 3 months. This study examined the effectiveness of a breast-feeding promotion program to increase the continuation of breast-feeding. A cluster-randomized intervention trial was used. Ten child health care centers in three regions of the home health care were randomly allocated to the program or usual care. Elements in the program were health counseling, measures to enhance cooperation, early signaling of breast-feeding problems and continuity of care, and lactation consultancy. Pregnant mothers who applied for home health care in the intervention or usual care regions were enrolled and were followed up from pregnancy until 6 months postpartum (n = 683). The primary outcome measure was the continuation of breast-feeding until at least 3 months. The 3-month breast-feeding rate was 32% in the intervention and 38% in the control groups (OR = 0.79, 95% CI = 0.58-1.08). The program was not effective. We discuss possible explanations from the design and execution of the trial and give some points for improvement of our program, such as the categories of caregivers involved and the number and duration of contacts after parturition.

A multilevel model to estimate the within- and the between-center components of the exposure/disease association in the EPIC study.

PubMed

Sera, Francesco; Ferrari, Pietro

2015-01-01

In a multicenter study, the overall relationship between exposure and the risk of cancer can be broken down into a within-center component, which reflects the individual level association, and a between-center relationship, which captures the association at the aggregate level. A piecewise exponential proportional hazards model with random effects was used to evaluate the association between dietary fiber intake and colorectal cancer (CRC) risk in the EPIC study. During an average follow-up of 11.0 years, 4,517 CRC events occurred among study participants recruited in 28 centers from ten European countries. Models were adjusted by relevant confounding factors. Heterogeneity among centers was modelled with random effects. Linear regression calibration was used to account for errors in dietary questionnaire (DQ) measurements. Risk ratio estimates for a 10 g/day increment in dietary fiber were equal to 0.90 (95%CI: 0.85, 0.96) and 0.85 (0.64, 1.14), at the individual and aggregate levels, respectively, while calibrated estimates were 0.85 (0.76, 0.94), and 0.87 (0.65, 1.15), respectively. In multicenter studies, over a straightforward ecological analysis, random effects models allow information at the individual and ecologic levels to be captured, while controlling for confounding at both levels of evidence.

A randomized trial of the effects of an aquatic exercise program on depression, anxiety levels, and functional capacity in of people who suffered an ischemic stroke.

PubMed

Aidar, Felipe J; Jacó de Oliveira, Ricardo; Gama de Matos, Dihogo; Chilibeck, Philip D; de Souza, Raphael F; Carneiro, André L; Machado Reis, Victor

2017-05-09

Aquatic exercise programs are used in rehabilitation and might help to reduce disability after stroke. This was a randomized intervention trial to assess the influence of an aquatic exercise program on people suffering from depression and anxiety after ischemic stroke. Participants were randomized to an experimental group (EG) composed of 19 individuals (51.8 ± 8.5 years; ten males and nine females), and a control group (CG) composed of 17 people (52.7 ± 6.7 years; nine males and eight females). The aquatic exercise program consisted of two sessions per week, each lasting between 45 and 60 minutes and divided into 5 to 10 minutes exercise sections during 12 weeks. The State-Trait Anxiety Inventory (STAI) was used to determine anxiety levels while the Beck Depression Inventory was used as a self-assessment of depression. EG improved measures of depression, anxiety trait and anxiety state between pre- and post-treatment, with no changes in CG. EG improved in all tests related to functional capacity compared to CG. The practice of aquatic exercises promotes improvements in the levels of depression and anxiety in people who suffered an ischemic stroke.

Methods and participant characteristics of a randomized intervention to promote physical activity and healthy eating among brazilian high school students: the Saude na Boa project.

PubMed

Nahas, Markus V; de Barros, Mauro V G; de Assis, Maria Alice A; Hallal, Pedro C; Florindo, Alex A; Konrad, Lisandra

2009-03-01

A cross-cultural, randomized study was proposed to observe the effects of a school-based intervention designed to promote physical activity and healthy eating among high school students in 2 cities from different regions in Brazil: Recife and Florianopolis. The objective of this article is to describe the methodology and subjects enrolled in the project. Ten schools from each region were matched and randomized into intervention and control conditions. A questionnaire and anthropometry were used to collect data in the first and last month of the 2006 school year. The sample (n=2155 at baseline; 55.7% females; 49.1% in the experimental group) included students 15 to 24 years, attending nighttime classes. The intervention focused on simple environmental/organizational changes, diet and physical activity education, and personnel training. The central aspects of the intervention have been implemented in all 10 intervention schools. Problems during the intervention included teachers' strikes in both sites and lack of involvement of the canteen owners in schools. The Saude na Boa study provides evidence that public high schools in Brazil represent an important environment for health promotion. Its design and simple measurements increase the chances of it being sustained and disseminated to similar schools in Brazil.

An evaluation of activity tolerance, patient-reported outcomes and satisfaction with the effectiveness of pulmonary daoyin on patients with chronic obstructive pulmonary disease.

PubMed

Zhang, Hai-Long; Li, Jian-Sheng; Yu, Xue-Qing; Li, Su-Yun; Halmurat, Upur; Xie, Yang; Wang, Yan-Fang; Li, Feng-Sen; Wang, Ming-Hang

2017-01-01

Pulmonary Daoyin (PD) (evolved from ancient Chinese daoyin skills), is a rehabilitation technology that combines specially designed movements of the arms and body and controlled breathing exercises, to improve the physiological and psychological status of patients with chronic respiratory disease. Pulmonary rehabilitation is effective for patients with chronic obstructive pulmonary disease (COPD), and the efficacy of PD is unknown. The aim of this study is to investigate the effect of a PD program in enhancing activity tolerance, patient-reported outcomes and satisfaction with the effectiveness on patients with COPD. The multi-center, randomized controlled trial was conducted from November 2011 to June 2012 in local communities in cities of the 11 research centers in China. It included COPD patients (moderate to very severe) who were recruited from an outpatient clinic. A randomized controlled study included 464 COPD patients who were randomly allocated either to the PD group, participating in a 3-month, ten times-weekly supervised PD-based pulmonary rehabilitation program, or to a control group continuing with regular medical treatment alone. Data were gathered using the 6-minute walking distance (6MWD) test, COPD patient-reported outcomes (COPD-PRO) and Effectiveness Satisfaction Questionnaire for COPD (ESQ-COPD), which was filled out at baseline and 3 months post-intervention. SAS 9.2 was used for statistical analysis. Of the 464 patients in the study, 461 were included in the full analysis set (FAS); 429 were in the per-protocol analysis set (PPS). After 3-month intervention, there was a significant difference between the two groups in 6MWD (FAS; P =0.049; PPS; P =0.041), total score and all domains of COPD-PRO (FAS; P =0.014; PPS; P =0.003) and ESQ-COPD (FAS; P =0.038; PPS; P <0.001). The PD program was able to improve the activity tolerance level and satisfaction of COPD patients because of its effectiveness.

The effectiveness of lifestyle triple P in the Netherlands: a randomized controlled trial.

PubMed

Gerards, Sanne M P L; Dagnelie, Pieter C; Gubbels, Jessica S; van Buuren, Stef; Hamers, Femke J M; Jansen, Maria W J; van der Goot, Odilia H M; de Vries, Nanne K; Sanders, Matthew R; Kremers, Stef P J

2015-01-01

Lifestyle Triple P is a general parenting intervention which focuses on preventing further excessive weight gain in overweight and obese children. The objective of the current study was to assess the effectiveness of the Lifestyle Triple P intervention in the Netherlands. We used a parallel randomized controlled design to test the effectiveness of the intervention. In total, 86 child-parent triads (children 4-8 years old, overweight or obese) were recruited and randomly assigned (allocation ratio 1:1) to the Lifestyle Triple P intervention or the control condition. Parents in the intervention condition received a 14-week intervention consisting of ten 90-minute group sessions and four individual telephone sessions. Primary outcome measure was the children's body composition (BMI z-scores, waist circumference and skinfolds). The research assistant who performed the measurements was blinded for group assignment. Secondary outcome measures were the children's dietary behavior and physical activity level, parenting practices, parental feeding style, parenting style, and parental self-efficacy. Outcome measures were assessed at baseline and 4 months (short-term) and 12 months (long-term) after baseline. Multilevel multiple regression analyses were conducted to determine the effect of the intervention on primary and secondary outcome measures. No intervention effects were found on children's body composition. Analyses of secondary outcomes showed positive short-term intervention effects on children's soft-drink consumption and parental responsibility regarding physical activity, encouragement to eat, psychological control, and efficacy and satisfaction with parenting. Longer-term intervention effects were found on parent's report of children's time spent on sedentary behavior and playing outside, parental monitoring food intake, and responsibility regarding nutrition. Although the Lifestyle Triple P intervention showed positive effects on some parent reported child behaviors and parenting measures, no effects were visible on children's body composition or objectively measured physical activity. Several adjustments of the intervention content are recommended, for example including a booster session. Nederlands Trial Register NTR 2555.

Association of CYP2C9*3 with phenytoin-induced Stevens-Johnson syndrome and toxic epidermal necrolysis: A systematic review and meta-analysis.

PubMed

Wu, X; Liu, W; Zhou, W

2018-06-01

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are severe cutaneous adverse reactions that can be induced by phenytoin (PHT). CYP2C9*3 is the key enzyme in PHT metabolism. The aim of this meta-analysis was to evaluate the association between CYP2C9*3 and PHT-induced SJS/TEN. An extensive search was performed in multiple databases, including the Cochrane Library, EMBASE, PubMed, OVID and EBSCO. Studies exploring the relationship between CYP2C9*3 and PHT-induced SJS and TEN were included. Odds ratios (ORs) with corresponding 95% confidence intervals (CI) were calculated for dichotomous data. Data analysis was performed using Review Manager (version 5.3). Four studies, with 117 PHT-induced SJS/TEN cases and 338 matched controls (PHT-tolerant patients) or 4231 population controls (general population), were identified. SJS and TEN were found to be significantly associated with the CYP2C9*3 allele, comparing both matched controls (OR, 8.93; 95% CI, 2.63-30.36; P = .0005) with substantial heterogeneity (I 2  = 46%) and population controls (OR, 8.88; 95% CI, 5.01-15.74; P < .00001). A significant association between CYP2C9*3 and PHT-induced SJS/TEN was identified, especially in a Thai population. CYP2C9*3 is thus a credible predictive genetic marker of PHT-induced SJS/TEN. Further multicenter studies and large prospective observational studies are, however, still required to determine the influence of CYP2C*3 on blood levels of PHT and its metabolites, and their association with SJS/TEN. © 2017 John Wiley & Sons Ltd.

Adjusting Pulse Amplitude During Transcutaneous Electrical Nerve Stimulation Does Not Provide Greater Hypoalgesia.

PubMed

Bergeron-Vézina, Kayla; Filion, Camille; Couture, Chantal; Vallée, Élisabeth; Laroche, Sarah; Léonard, Guillaume

2018-03-01

Transcutaneous electrical nerve stimulation (TENS) is an electrotherapeutic modality commonly used in rehabilitation to relieve pain. Adjusting pulse amplitude (intensity) during TENS treatment has been suggested to overcome nerve habituation. However, it is still unclear if this procedure leads to greater hypoalgesia. The aim of this study was to determine if the hypoalgesic effect of TENS is greater when pulse amplitude is adjusted throughout the TENS treatment session in chronic low-back pain patients. Randomized double-blind crossover study. Recruitment and assessment were conducted at the Clinique universitaire de réadaptation de l'Estrie (CURE) of the Faculty of Medicine and Health Sciences of the Université de Sherbrooke. Twenty-one volunteers with chronic low-back pain were enrolled and completed this investigation. Each patient received two high-frequency TENS treatments on two separate sessions: (1) with adjustment of pulse amplitude and (2) without pulse amplitude adjustment. Pain intensity and unpleasantness were assessed before, during, and after TENS application with a 10 cm visual analog scale. Both TENS conditions (with and without adjustment of intensity) decreased pain intensity and unpleasantness when compared with baseline. No difference was observed between the two stimulation conditions for both pain intensity and unpleasantness. The current results suggest that adjustment of pulse amplitude during TENS application does not provide greater hypoalgesia in individuals with chronic low-back pain. Future studies are needed to confirm these findings in other pain populations.

Short-duration transcutaneous electrical nerve stimulation in the postoperative period of cardiac surgery.

PubMed

Gregorini, Cristie; Cipriano Junior, Gerson; Aquino, Leticia Moraes de; Branco, João Nelson Rodrigues; Bernardelli, Graziella França

2010-03-01

Respiratory muscle strength has been related to the postoperative outcome of cardiac surgeries. The main documented therapeutic purpose of transcutaneous electrical nerve stimulation (TENS) is the reduction of pain, which could bring secondary benefits to the respiratory muscles and, consequently, to lung capacities and volumes. The objective of the present study was to evaluate the effectiveness of short-duration transcutaneous electrical nerve stimulation (TENS) in the reduction of pain and its possible influence on respiratory muscle strength and lung capacity and volumes of patients in the postoperative period of cardiac surgery. Twenty five patients with mean age of 59.9 +/- 10.3 years, of whom 72% were men, and homogeneous as regards weight and height, were randomly assigned to two groups. One group received therapeutic TENS (n = 13) and the other, placebo TENS (n = 12), for four hours on the third postoperative day of cardiac surgery. Pain was analyzed by means of a visual analogue scale, and of respiratory muscle strength as measured by maximum respiratory pressures and lung capacity and volumes before and after application of TENS. Short-duration TENS significantly reduced pain of patients in the postoperative period (p < 0.001). Respiratory muscle strength (p < 0.001), tidal volume (p < 0.001) and vital capacity (p < 0.05) significantly improved after therapeutic TENS, unlike in the placebo group. Short-duration TENS proved effective for the reduction of pain and improvement of respiratory muscle strength, as well as of lung volumes and capacity.

Effects of different frequencies of transcutaneous electrical nerve stimulation on venous vascular reactivity

PubMed Central

Franco, O.S.; Paulitsch, F.S.; Pereira, A.P.C.; Teixeira, A.O.; Martins, C.N.; Silva, A.M.V.; Plentz, R.D.M.; Irigoyen, M.C.; Signori, L.U.

2014-01-01

Transcutaneous electrical nerve stimulation (TENS) is a type of therapy used primarily for analgesia, but also presents changes in the cardiovascular system responses; its effects are dependent upon application parameters. Alterations to the cardiovascular system suggest that TENS may modify venous vascular response. The objective of this study was to evaluate the effects of TENS at different frequencies (10 and 100 Hz) on venous vascular reactivity in healthy subjects. Twenty-nine healthy male volunteers were randomized into three groups: placebo (n=10), low-frequency TENS (10 Hz, n=9) and high-frequency TENS (100 Hz, n=10). TENS was applied for 30 min in the nervous plexus trajectory from the superior member (from cervical to dorsal region of the fist) at low (10 Hz/200 μs) and high frequency (100 Hz/200 μs) with its intensity adjusted below the motor threshold and intensified every 5 min, intending to avoid accommodation. Venous vascular reactivity in response to phenylephrine, acetylcholine (endothelium-dependent) and sodium nitroprusside (endothelium-independent) was assessed by the dorsal hand vein technique. The phenylephrine effective dose to achieve 70% vasoconstriction was reduced 53% (P<0.01) using low-frequency TENS (10 Hz), while in high-frequency stimulation (100 Hz), a 47% increased dose was needed (P<0.01). The endothelium-dependent (acetylcholine) and independent (sodium nitroprusside) responses were not modified by TENS, which modifies venous responsiveness, and increases the low-frequency sensitivity of α1-adrenergic receptors and shows high-frequency opposite effects. These changes represent an important vascular effect caused by TENS with implications for hemodynamics, inflammation and analgesia. PMID:24820225

A meta-analysis of third wave mindfulness-based cognitive behavioral therapies for older people.

PubMed

Kishita, Naoko; Takei, Yuko; Stewart, Ian

2017-12-01

The aim of this study is to review the effectiveness of third wave mindfulness-based cognitive behavioral therapies (CBTs) for depressive or anxiety symptomatology in older adults across a wide range of physical and psychological conditions. Electronic literature databases were searched for articles, and random-effects meta-analysis was conducted. Ten studies met the inclusion criteria, of which nine reported the efficacy of interventions on depressive symptoms and seven on anxiety symptoms. Effect-size estimates suggested that mindfulness-based CBT is moderately effective on depressive symptoms in older adults (g = 0.55). The results demonstrated a similar level of overall effect size for anxiety symptoms (g = 0.58). However, there was a large heterogeneity, and publication bias was evident in studies reporting outcomes on anxiety symptoms, and thus, this observed efficacy for late-life anxiety may not be robust. The quality of the included studies varied. Only one study used an active psychological control condition. There were a limited number of studies that used an intent-to-treat (last observation carried forward method) analysis and reported appropriate methods for clinical trials (e.g., treatment-integrity reporting). Third wave mindfulness-based CBT may be robust in particular for depressive symptoms in older adults. We recommend that future studies (i) conduct randomized controlled trials with intent-to-treat to compare mindfulness-based CBT with other types of psychotherapy in older people and (ii) improve study quality by using appropriate methods for checking treatment adherence, randomization, and blinding of assessors. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

A randomized, double blinded, placebo-controlled clinical trial of silymarin in ulcerative colitis.

PubMed

Rastegarpanah, Mansoor; Malekzadeh, Reza; Vahedi, Homayoun; Mohammadi, Maryam; Elahi, Elham; Chaharmahali, Meghedi; Safarnavadeh, Tahereh; Abdollahi, Mohammad

2015-12-01

To evaluate the clinical efficacy of silymarin in ulcerative colitis (UC) patients. A randomized double blinded placebo-controlled clinical trial was conducted in 80 UC patients whose disease had been documented and were in remission state between September 2009 and October 2010. Patients were assigned to silymarin group (42 cases) and placebo group (38 cases) using a random number table. Either silymarin (140 mg) or placebo (lactose mono-hydrate, corn starch magnesium stearate) tablets were given once daily for 6 months along with their standard therapy. The efficacies were assessed by disease activity index (DAI), frequency difference of the disease flare-up, and paraclinical data. Ten patients (4 in the silymarin group due to nausea and 6 in the placebo group due to disease flare-up and abdominal pain) discontinued the study. An improvement in hemoglobin level (11.8±1.6 g/dL vs. 13.4±1.2 g/dL,P<0.05) and erythrocyte sedimentation rate (23.7±11.5 mm/h vs.10.8±3.2 mm/h,P<0.05) was observed in the silymarin group but not in the placebo group. DAI significantly decreased in the silymarin group and reached from 11.3±3.5 to 10.7±2.8 (P<0.05). Thirty-five out of 38 patients in the silymarin group were in complete remission with no flare-up after 6 months as compared to 21 out of 32 patients in the placebo group (P=0.5000). Silymarin as a natural supplement may be used in UC patients to maintain remission.

The positive deviance/hearth approach to reducing child malnutrition: systematic review.

PubMed

Bisits Bullen, Piroska A

2011-11-01

The Positive Deviance/Hearth approach aims to rehabilitate malnourished children using practices from mothers in the community who have well-nourished children despite living in poverty. This study assesses its effectiveness in a range of settings. Systematic review of peer reviewed intervention trials and grey literature evaluation reports of child malnutrition programs using the Positive Deviance/Hearth approach. Ten peer reviewed studies and 14 grey literature reports met the inclusion criteria. These described results for 17 unique Positive Deviance/Hearth programs in 12 countries. Nine programs used a pre- and post-test design without a control, which limited the conclusions that could be drawn. Eight used more robust designs such as non-randomized trials, non-randomized cross-sectional sibling studies and randomized controlled trials (RCTs). Of the eight programs that reported nutritional outcomes, five reported some type of positive result in terms of nutritional status - although the improvement was not always as large as predicted, or across the entire target population. Both the two RCTs demonstrated improvements in carer feeding practices. Qualitative results unanimously reported high levels of satisfaction from participants and recipient communities. Overall this study shows mixed results in terms of program effectiveness, although some Positive Deviance/Hearth programs have clearly been successful in particular settings. Sibling studies suggest that the Positive Deviance/Hearth approach may have a role in preventing malnutrition, not just rehabilitation. Further research is needed using more robust study designs and larger sample sizes. Issues related to community participation and consistency in reporting results need to be addressed. © 2011 Blackwell Publishing Ltd.

A blinded randomized controlled trial evaluating the usefulness of a novel diet (aminoprotect care) in dogs with spontaneous food allergy.

PubMed

Olivry, Thierry; Kurata, Keigo; Paps, Judy S; Masuda, Kenichi

2007-10-01

Aminoprotect Care (APC) is a novel diet composed of aminoacids, potato proteins and corn starch. The objectives of this study were to determine whether Maltese-Beagle atopic (MBA) dogs hypersensitive to corn exhibited clinical signs and changes in immunological markers after being fed APC. The study was designed as a blinded randomized controlled crossover experiment. Ten MBA dogs with signs of allergy within five days of ingesting corn were selected. Dogs were randomized to be fed either their maintenance diet with corn or APC for five days. After a washout of two weeks, diets were switched. Before and daily during each intervention, skin lesions were graded by an investigator while pruritus was assessed by another. Before and at the end of each intervention, the percentage of circulating CD4+CCR4+, corn-activated CD4+ T-lymphocytes and serum corn-specific IgE levels were measured and ratios of post:pre values calculated. During this trial, pruritus and skin lesions increased significantly in MBA dogs when ingesting corn while no such increase occurred when fed APC. Total, median and maximal pruritus values were significantly higher in MBA dogs ingesting corn compared to APC. There were no significant differences between interventions in the immunological parameters assessed. In summary, even though APC contains corn starch to which corn-sensitive MBA dogs often react, the ingestion of APC did not lead to significant increases in skin lesions or pruritus. Aminoprotect Care might prove valuable for management of food allergies. These experimental observations must be validated in large field studies.

A randomized control hands-on defibrillation study-Barrier use evaluation.

PubMed

Wampler, David; Kharod, Chetan; Bolleter, Scotty; Burkett, Alison; Gabehart, Caitlin; Manifold, Craig

2016-06-01

Chest compressions and defibrillation are the only therapies proven to increase survival in cardiac arrest. Historically, rescuers must remove hands to shock, thereby interrupting chest compressions. This hands-off time results in a zero blood flow state. Pauses have been associated with poorer neurological recovery. This was a blinded randomized control cadaver study evaluating the detection of defibrillation during manual chest compressions. An active defibrillator was connected to the cadaver in the sternum-apex configuration. The sham defibrillator was not connected to the cadaver. Subjects performed chest compressions using 6 barrier types: barehand, single and double layer nitrile gloves, firefighter gloves, neoprene pad, and a manual chest compression/decompression device. Randomized defibrillations (10 per barrier type) were delivered at 30 joules (J) for bare hand and 360J for all other barriers. After each shock, the subject indicated degree of sensation on a VAS scale. Ten subjects participated. All subjects detected 30j shocks during barehand compressions, with only 1 undetected real shock. All barriers combined totaled 500 shocks delivered. Five (1%) active shocks were detected, 1(0.2%) single layer of Nitrile, 3(0.6%) with double layer nitrile, and 1(0.2%) with the neoprene barrier. One sham shock was reported with the single layer nitrile glove. No shocks were detected with fire gloves or compression decompression device. All shocks detected barely perceptible (0.25(±0.05)cm on 10cm VAS scale). Nitrile gloves and neoprene pad prevent (99%) responder's detection of defibrillation of a cadaver. Fire gloves and compression decompression device prevented detection. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Effect of soy isoflavone supplementation on plasma lipoprotein(a) concentrations: A meta-analysis.

PubMed

Simental-Mendía, Luis E; Gotto, Antonio M; Atkin, Stephen L; Banach, Maciej; Pirro, Matteo; Sahebkar, Amirhossein

Soy supplementation has been shown to reduce total and low-density lipoprotein cholesterol, while increasing high-density lipoprotein cholesterol. However, contradictory effects of soy isoflavone supplementation on lipoprotein(a) [Lp(a)] have been reported suggesting the need for a meta-analysis to be undertaken. The aim of the study was to investigate the impact of supplementation with soy isoflavones on plasma Lp(a) levels through a systematic review and meta-analysis of eligible randomized placebo-controlled trials. The search included PubMed-Medline, Scopus, ISI Web of Knowledge, and Google Scholar databases (by March 26, 2017), and quality of studies was evaluated according to Cochrane criteria. Quantitative data synthesis was performed using a random-effects model, with standardized mean difference and 95% confidence interval as summary statistics. Meta-regression and leave-one-out sensitivity analysis were performed to assess the modifiers of treatment response. Ten eligible studies comprising 11 treatment arms with 973 subjects were selected for the meta-analysis. Meta-analysis did not suggest any significant alteration of plasma Lp(a) levels after supplementation with soy isoflavones (standardized mean difference: 0.08, 95% confidence interval: -0.05, 0.20, P = .228). The effect size was robust in the leave-one-out sensitivity analysis. In meta-regression analysis, neither dose nor duration of supplementation with soy isoflavones was significantly associated with the effect size. This meta-analysis of the 10 available randomized placebo-controlled trials revealed no significant effect of soy isoflavones treatment on plasma Lp(a) concentrations. Copyright © 2017 National Lipid Association. Published by Elsevier Inc. All rights reserved.

Buprenorphine Maintenance Subjects Are Hyperalgesic and Have No Antinociceptive Response to a Very High Morphine Dose.

PubMed

Athanasos, Peter; Ling, Walter; Bochner, Felix; White, Jason M; Somogyi, Andrew A

2018-03-05

Acute pain management in opioid-dependent persons is complicated because of tolerance and opioid-induced hyperalgesia. Very high doses of morphine are ineffective in overcoming opioid-induced hyperalgesia and providing antinociception to methadone-maintained patients in an experimental setting. Whether the same occurs in buprenorphine-maintained subjects is unknown. Randomized double-blind placebo-controlled. Subjects were tested on two occasions, at least five days apart, once with intravenous morphine and once with intravenous saline. Subjects were tested at about the time of putative trough plasma buprenorphine concentrations. Ambulatory. Twelve buprenorphine-maintained subjects: once daily sublingual dose (range = 2-22 mg); no dose change for 1.5-12 months. Ten healthy controls. Intravenous morphine bolus and infusions administered over two hours to achieve two separate pseudo-steady-state plasma concentrations one hour apart. Pain tolerance was assessed by application of nociceptive stimuli (cold pressor [seconds] and electrical stimulation [volts]). Ten blood samples were collected for assay of plasma morphine, buprenorphine, and norbuprenorphine concentrations until three hours after the end of the last infusion; pain tolerance and respiration rate were measured to coincide with blood sampling times. Cold pressor responses (seconds): baseline: control 34 ± 6 vs buprenorphine 17 ± 2 (P = 0.009); morphine infusion-end: control 52 ± 11(P = 0.04), buprenorphine 17 ± 2 (P > 0.5); electrical stimulation responses (volts): baseline: control 65 ± 6 vs buprenorphine 53 ± 5 (P = 0.13); infusion-end: control 74 ± 5 (P = 0.007), buprenorphine 53 ± 5 (P > 0.98). Respiratory rate (breaths per minute): baseline: control 17 vs buprenorphine 14 (P = 0.03); infusion-end: control 15 (P = 0.09), buprenorphine 12 (P < 0.01). Infusion-end plasma morphine concentrations (ng/mL): control 23 ± 1, buprenorphine 136 ± 10. Buprenorphine subjects, compared with controls, were hyperalgesic (cold pressor test), did not experience antinociception, despite high plasma morphine concentrations, and experienced respiratory depression. Clinical implications are discussed.

Electrotherapy for neck pain.

PubMed

Kroeling, Peter; Gross, Anita; Graham, Nadine; Burnie, Stephen J; Szeto, Grace; Goldsmith, Charles H; Haines, Ted; Forget, Mario

2013-08-26

Neck pain is common, disabling and costly. The effectiveness of electrotherapy as a physiotherapeutic option remains unclear. This is an update of a Cochrane review first published in 2005 and previously updated in 2009. This systematic review assessed the short, intermediate and long-term effects of electrotherapy on pain, function, disability, patient satisfaction, global perceived effect, and quality of life in adults with neck pain with and without radiculopathy or cervicogenic headache. We searched CENTRAL, MEDLINE, EMBASE, MANTIS, CINAHL, and ICL, without language restrictions, from their beginning to August 2012; handsearched relevant conference proceedings; and consulted content experts. Randomized controlled trials (RCTs), in any language, investigating the effects of electrotherapy used primarily as unimodal treatment for neck pain. Quasi-RCTs and controlled clinical trials were excluded. We used standard methodological procedures expected by The Cochrane Collaboration. We were unable to statistically pool any of the results, but we assessed the quality of the evidence using an adapted GRADE approach. Twenty small trials (1239 people with neck pain) containing 38 comparisons were included. Analysis was limited by trials of varied quality, heterogeneous treatment subtypes and conflicting results. The main findings for reduction of neck pain by treatment with electrotherapeutic modalities were as follows.Very low quality evidence determined that pulsed electromagnetic field therapy (PEMF) and repetitive magnetic stimulation (rMS) were more effective than placebo, while transcutaneous electrical nerve stimulation (TENS) showed inconsistent results.Very low quality evidence determined that PEMF, rMS and TENS were more effective than placebo.Low quality evidence (1 trial, 52 participants) determined that permanent magnets (necklace) were no more effective than placebo (standardized mean difference (SMD) 0.27, 95% CI -0.27 to 0.82, random-effects model).Very low quality evidence showed that modulated galvanic current, iontophoresis and electric muscle stimulation (EMS) were not more effective than placebo.There were four trials that reported on other outcomes such as function and global perceived effects, but none of the effects were of clinical importance. When TENS, iontophoresis and PEMF were compared to another treatment, very low quality evidence prevented us from suggesting any recommendations. No adverse side effects were reported in any of the included studies. We cannot make any definite statements on the efficacy and clinical usefulness of electrotherapy modalities for neck pain. Since the evidence is of low or very low quality, we are uncertain about the estimate of the effect. Further research is very likely to change both the estimate of effect and our confidence in the results. Current evidence for PEMF, rMS, and TENS shows that these modalities might be more effective than placebo. When compared to other interventions the quality of evidence was very low thus preventing further recommendations.Funding bias should be considered, especially in PEMF studies. Galvanic current, iontophoresis, EMS, and a static magnetic field did not reduce pain or disability. Future trials on these interventions should have larger patient samples, include more precise standardization, and detail treatment characteristics.

Can reduce--the effects of chat-counseling and web-based self-help, web-based self-help alone and a waiting list control program on cannabis use in problematic cannabis users: a randomized controlled trial.

PubMed

Schaub, Michael P; Haug, Severin; Wenger, Andreas; Berg, Oliver; Sullivan, Robin; Beck, Thilo; Stark, Lars

2013-11-14

In European countries, including Switzerland, as well as in many states worldwide, cannabis is the most widely used psychoactive substance after alcohol and tobacco. Although approximately one in ten users develop serious problems of dependency, only a minority attends outpatient addiction counseling centers. The offer of a combined web-based self-help and chat counseling treatment could potentially also reach those users who hesitate to approach such treatment centers and help them to reduce their cannabis use. This paper presents the protocol for a three-armed randomized controlled trial that will test the effectiveness of a web-based self-help intervention in combination with, or independent of, tailored chat counseling compared to a waiting list in reducing or enabling the abstention from cannabis use in problematic users. The primary outcome will be the weekly quantity of cannabis used. Secondary outcome measures will include the number of days per week on which cannabis is used, the severity of cannabis use disorder, the severity of cannabis dependence, cannabis withdrawal symptoms, cannabis craving, the use of alcohol, tobacco, and other non-cannabis illicit drugs, changes in mental health symptoms, and treatment retention. The self-help intervention will consist of 8 modules designed to reduce cannabis use based on the principles of motivational interviewing, self-control practices, and methods of cognitive behavioral therapy. The two additional individual chat-counseling sessions in the additional chat condition will be based on the same therapy approaches and tailored to participants' self-help information data and personal problems. The predictive validity of participants' baseline characteristics on treatment retention and outcomes will be explored. To the best of our knowledge, this will be the first randomized controlled trial to test the effectiveness of online self-help therapy in combination or without chat counseling in reducing or enabling the abstention from cannabis use. It will also investigate predictors of outcome and retention for these interventions. This trial is registered at Current Controlled Trials and is traceable as ISRCTN59948178.

Adult human mesenchymal stem cells delivered via intra-articular injection to the knee following partial medial meniscectomy: a randomized, double-blind, controlled study.

PubMed

Vangsness, C Thomas; Farr, Jack; Boyd, Joel; Dellaero, David T; Mills, C Randal; LeRoux-Williams, Michelle

2014-01-15

There are limited treatment options for tissue restoration and the prevention of degenerative changes in the knee. Stem cells have been a focus of intense preclinical research into tissue regeneration but limited clinical investigation. In a randomized, double-blind, controlled study, the safety of the intra-articular injection of human mesenchymal stem cells into the knee, the ability of mesenchymal stem cells to promote meniscus regeneration following partial meniscectomy, and the effects of mesenchymal stem cells on osteoarthritic changes in the knee were investigated. A total of fifty-five patients at seven institutions underwent a partial medial meniscectomy. A single superolateral knee injection was given within seven to ten days after the meniscectomy. Patients were randomized to one of three treatment groups: Group A, in which patients received an injection of 50 × 10⁶ allogeneic mesenchymal stem cells; Group B, 150 × 10⁶ allogeneic mesenchymal stem cells; and the control group, a sodium hyaluronate (hyaluronic acid/hyaluronan) vehicle control. Patients were followed to evaluate safety, meniscus regeneration, the overall condition of the knee joint, and clinical outcomes at intervals through two years. Evaluations included sequential magnetic resonance imaging (MRI). No ectopic tissue formation or clinically important safety issues were identified. There was significantly increased meniscal volume (defined a priori as a 15% threshold) determined by quantitative MRI in 24% of patients in Group A and 6% in Group B at twelve months post meniscectomy (p = 0.022). No patients in the control group met the 15% threshold for increased meniscal volume. Patients with osteoarthritic changes who received mesenchymal stem cells experienced a significant reduction in pain compared with those who received the control, on the basis of visual analog scale assessments. There was evidence of meniscus regeneration and improvement in knee pain following treatment with allogeneic human mesenchymal stem cells. These results support the study of human mesenchymal stem cells for the apparent knee-tissue regeneration and protective effects.

Physical activity and nutrition behaviour outcomes of a cluster-randomized controlled trial for adults with metabolic syndrome in Vietnam.

PubMed

Tran, Van Dinh; Lee, Andy H; Jancey, Jonine; James, Anthony P; Howat, Peter; Mai, Le Thi Phuong

2017-01-13

Metabolic syndrome is prevalent among Vietnamese adults, especially those aged 50-65 years. This study evaluated the effectiveness of a 6 month community-based lifestyle intervention to increase physical activity levels and improve dietary behaviours for adults with metabolic syndrome in Vietnam. Ten communes, involving participants aged 50-65 years with metabolic syndrome, were recruited from Hanam province in northern Vietnam. The communes were randomly allocated to either the intervention (five communes, n = 214) or the control group (five communes, n = 203). Intervention group participants received a health promotion package, consisting of an information booklet, education sessions, a walking group, and a resistance band. Control group participants received one session of standard advice during the 6 month period. Data were collected at baseline and after the intervention to evaluate programme effectiveness. The International Physical Activity Questionnaire - Short Form and a modified STEPS questionnaire were used to assess physical activity and dietary behaviours, respectively, in both groups. Pedometers were worn by the intervention participants only for 7 consecutive days at baseline and post-intervention testing. To accommodate the repeated measures and the clustering of individuals within communes, multilevel mixed regression models with random effects were fitted to determine the impacts of intervention on changes in outcome variables over time and between groups. With a retention rate of 80.8%, the final sample comprised 175 intervention and 162 control participants. After controlling for demographic and other confounding factors, the intervention participants showed significant increases in moderate intensity activity (P = 0.018), walking (P < 0.001) and total physical activity (P = 0.001), as well as a decrease in mean sitting time (P < 0.001), relative to their control counterparts. Significant improvements in dietary behaviours were also observed, particularly reductions in intake of animal internal organs (P = 0.001) and in using cooking oil for daily meal preparation (P = 0.001). The prescribed community-based physical activity and nutrition intervention programme successfully improved physical activity and dietary behaviours for adults with metabolic syndrome in Vietnam. Australian New Zealand Clinical Trials Registry, ACTRN12614000811606 . Registered on 31 July 2014.

Can reduce - the effects of chat-counseling and web-based self-help, web-based self-help alone and a waiting list control program on cannabis use in problematic cannabis users: a randomized controlled trial

PubMed Central

2013-01-01

Background In European countries, including Switzerland, as well as in many states worldwide, cannabis is the most widely used psychoactive substance after alcohol and tobacco. Although approximately one in ten users develop serious problems of dependency, only a minority attends outpatient addiction counseling centers. The offer of a combined web-based self-help and chat counseling treatment could potentially also reach those users who hesitate to approach such treatment centers and help them to reduce their cannabis use. Methods/design This paper presents the protocol for a three-armed randomized controlled trial that will test the effectiveness of a web-based self-help intervention in combination with, or independent of, tailored chat counseling compared to a waiting list in reducing or enabling the abstention from cannabis use in problematic users. The primary outcome will be the weekly quantity of cannabis used. Secondary outcome measures will include the number of days per week on which cannabis is used, the severity of cannabis use disorder, the severity of cannabis dependence, cannabis withdrawal symptoms, cannabis craving, the use of alcohol, tobacco, and other non-cannabis illicit drugs, changes in mental health symptoms, and treatment retention. The self-help intervention will consist of 8 modules designed to reduce cannabis use based on the principles of motivational interviewing, self-control practices, and methods of cognitive behavioral therapy. The two additional individual chat-counseling sessions in the additional chat condition will be based on the same therapy approaches and tailored to participants’ self-help information data and personal problems. The predictive validity of participants’ baseline characteristics on treatment retention and outcomes will be explored. Discussion To the best of our knowledge, this will be the first randomized controlled trial to test the effectiveness of online self-help therapy in combination or without chat counseling in reducing or enabling the abstention from cannabis use. It will also investigate predictors of outcome and retention for these interventions. This trial is registered at Current Controlled Trials and is traceable as ISRCTN59948178. PMID:24228630

Use of the RenalGuard system to prevent contrast-induced AKI: A meta-analysis.

PubMed

Mattathil, Stephanie; Ghumman, Saad; Weinerman, Jonathan; Prasad, Anand

2017-10-01

Contrast-induced kidney injury (CI-AKI) following cardiovascular interventions results in increased morbidity and mortality. RenalGuard (RG) is a novel, closed loop system which balances volume administration with forced diuresis to maintain a high urine output. We performed a meta-analysis of the existing data comparing use of RG to conventional volume expansion. Ten studies were found eligible, of which four were randomized controlled trials. Of an aggregate sample size (N) of 1585 patients, 698 were enrolled in the four RCTs and 887 belonged to the remaining registries included in this meta-analysis. Primary outcomes included CI-AKI incidence and relative risk. Mortality, dialysis, and major adverse cardiovascular events (MACCE) were secondary outcomes. A random effects model was used and data were evaluated for publication bias. RG was associated with significant risk reduction in CI-AKI compared to control (RR: 0.30, 95%CI: 0.18-0.50, P < 0.01). CI-AKI in RG was found to be 7.7% versus 23.6% in the control group (P < 0.01). Use of RG was associated with decreased mortality (RR: 0.43, 95%CI: 0.18-0.99, P = 0.05), dialysis (RR: 0.20, 95%CI: 0.06-0.61, P = 0.01), and MACCE (RR: 0.42, 95%CI: 0.27-0.65, P < 0.01) compared to control. RG significantly reduces rates of CI-AKI compared to standard volume expansion and is also associated with decreased rates of death, dialysis, and MACCE. © 2017, Wiley Periodicals, Inc.

Effect of Aerobic Training on Peak Oxygen Uptake Among Seniors Aged 70 or Older: A Meta-Analysis of Randomized Controlled Trials.

PubMed

Bouaziz, Walid; Kanagaratnam, Lukshe; Vogel, Thomas; Schmitt, Elise; Dramé, Moustapha; Kaltenbach, Georges; Geny, Bernard; Lang, Pierre Olivier

2018-01-02

Older adults undergo a progressive decline in cardiorespiratory fitness and functional capacity. This lower peak oxygen uptake (VO 2peak ) level is associated with increased risk of frailty, dependency, loss of autonomy, and mortality from all causes. Regular physical activity and particularly aerobic training (AT) have been shown to contribute to better and healthy aging. We conducted a meta-analysis to measure the exact benefit of AT on VO 2peak in seniors aged 70 years or older. A comprehensive, systematic database search for articles was performed in Embase, Medline, PubMed Central, Science Direct, Scopus, and Web of Science using key words. Two reviewers independently assessed interventional studies for potential inclusion. Ten randomized controlled trials (RCTs) were included totaling 348 seniors aged 70 years or older. Across the trials, no high risk of bias was measured and all considered open-label arms for controls. With significant heterogeneity between the RCTs (all p < 0.001), pooled analyses were computed for VO 2peak . Not only was VO 2peak found significantly higher in the training group compared to controls (mean difference [MD] = 1.56; 95% confidence interval [CI]: 0.90-2.23) in pooled analysis of the 10 RCTs but also when the analysis was adjusted on the participants' health statuses. MD among healthy and unhealthy seniors were, respectively, 1.72 (95% CI: 0.34-3.10) and 1.47 (95% CI: 0.60-2.34). This meta-analysis confirms the AT-associated benefits on VO 2peak in healthy and unhealthy seniors.

Drinking water to reduce alcohol craving? A randomized controlled study on the impact of ghrelin in mediating the effects of forced water intake in alcohol addiction.

PubMed

Koopmann, Anne; Lippmann, Katharina; Schuster, Rilana; Reinhard, Iris; Bach, Patrick; Weil, Georg; Rietschel, Marcella; Witt, Stephanie H; Wiedemann, Klaus; Kiefer, Falk

2017-11-01

Recent data suggest that ghrelin is involved in the pathophysiology of alcohol use disorders, affecting alcohol self-administration and craving. Gastric ghrelin secretion is reduced by stomach distension. We now tested the hypothesis whether the clinically well-known effects of high-volume water intake on craving reduction in alcoholism is mediated by acute changes in ghrelin secretion. In this randomized human laboratory study, we included 23 alcohol-dependent male inpatient subjects who underwent alcohol cue exposure. Participants of the intervention group drank 1000ml of mineral water within 10min directly thereafter, compared to the participants of the control group who did not. Craving and plasma concentrations of acetylated ghrelin were measured ten times during the 120min following the alcohol cue exposure session. In the intervention group, a significant decrease in acetylated ghrelin in plasma compared to the control group was observed. This decrease was correlated to a reduction in patients' subjective level of craving. In the control group, no decrease of acetylated ghrelin in plasma and no association between alcohol craving and changes in plasma concentrations of acetylated ghrelin were observed. Our results present new evidence that the modulation in the ghrelin system by oral water intake mediates the effects of volume intake with craving reduction in alcohol use disorders. Hence, in addition to pharmacological interventions with ghrelin antagonists, the reduction of physiological ghrelin secretion might be a target for future interventions in the treatment of alcohol craving. Copyright © 2017 Elsevier Ltd. All rights reserved.

Impact of Pilates Exercise in Multiple Sclerosis: A Randomized Controlled Trial.

PubMed

Duff, Whitney R D; Andrushko, Justin W; Renshaw, Doug W; Chilibeck, Philip D; Farthing, Jonathan P; Danielson, Jana; Evans, Charity D

2018-01-01

Pilates is a series of exercises based on whole-body movement and may improve mobility in people with multiple sclerosis (MS). The purpose of this study was to determine the effect of Pilates on walking performance in people with MS. 30 individuals with MS who were not restricted to a wheelchair or scooter (Patient-Determined Disease Steps scale score <7) were randomized to receive Pilates (twice weekly) and massage therapy (once weekly) or once-weekly massage therapy only (control group). The Pilates was delivered in a group setting (five to ten participants per session). The primary outcome was change in walking performance (6-Minute Walk Test) after 12 weeks. Secondary outcomes included functional ability (Timed Up and Go test), balance (Fullerton Advanced Balance Scale), flexibility (sit and reach test), body composition (dual-energy X-ray absorptiometry), core endurance (plank-hold test), and muscle strength and voluntary activation (quadriceps). Intention-to-treat analysis was performed using a two-factor repeated-measures analysis of variance. Walking distance increased by a mean (SD) of 52.4 (40.2) m in the Pilates group versus 15.0 (34.1) m in the control group (group × time, P = .01). Mean (SD) time to complete the Timed Up and Go test decreased by 1.5 (2.8) seconds in the Pilates group versus an increase of 0.3 (0.9) seconds in the control group (group × time, P = .03). There were no other significant differences between groups over time. Pilates improved walking performance and functional ability in persons with MS and is a viable exercise option to help manage the disease.

Azelaic acid in the treatment of papulopustular rosacea: a systematic review of randomized controlled trials.

PubMed

Liu, Rosemarie H; Smith, Molly K; Basta, Sameh A; Farmer, Evan R

2006-08-01

To evaluate the clinical efficacy of topical 20% azelaic acid cream and 15% azelaic acid gel compared with their respective vehicles and metronidazole gel in the treatment of papulopustular rosacea. Electronic searches of MEDLINE, EMBASE, BIOSIS, and SciSearch through July or August 2004 and the Cochrane Central Register of Controlled Trials through 2004 (issue 3). We performed hand searches of reference lists, conference proceedings, and clinical trial databases. Experts in rosacea and azelaic acid were contacted. Randomized controlled trials involving topical azelaic acid (cream or gel) for the treatment of rosacea compared with placebo or other topical treatments. Two authors independently examined the studies identified by the searches. Ten studies were identified, of which 5 were included (873 patients). Two authors independently extracted data from the included studies, then jointly assessed methodological quality using a quality assessment scale. Because standard deviation data were not available for 4 of the 5 studies, a meta-analysis could not be conducted. Four of the 5 studies demonstrated significant decreases in mean inflammatory lesion count and erythema severity after treatment with azelaic acid compared with vehicle. None of the studies showed any significant decrease in telangiectasia severity. Azelaic acid in 20% cream and 15% gel formulations appears to be effective in the treatment of papulopustular rosacea, particularly in regard to decreases in mean inflammatory lesion count and erythema severity. Compared with metronidazole, azelaic acid appears to be an equally effective, if not better, treatment option.

BounceBack capsules for reduction of DOMS after eccentric exercise: a randomized, double-blind, placebo-controlled, crossover pilot study.

PubMed

Udani, Jay K; Singh, Betsy B; Singh, Vijay J; Sandoval, Elizabeth

2009-06-05

Delayed onset muscle soreness (DOMS) is muscle pain and discomfort experienced approximately one to three days after exercise. DOMS is thought to be a result of microscopic muscle fiber tears that occur more commonly after eccentric exercise rather than concentric exercise. This study sought to test the efficacy of a proprietary dietary supplement, BounceBack, to alleviate the severity of DOMS after standardized eccentric exercise. The study was a randomized, double-blind, placebo-controlled, crossover study. Ten healthy community-dwelling untrained subjects, ranging in age from 18-45 years, were enrolled. Mean differences within and between groups were assessed inferentially at each data collection time-point using t-tests for all outcome measures. In this controlled pilot study, intake of BounceBack capsules for 30 days resulted in a significant reduction in standardized measures of pain and tenderness post-eccentric exercise compared to the placebo group. There were trends towards reductions in plasma indicators of inflammation (high sensitivity C-reactive protein) and muscle damage (creatine phosphokinase and myoglobin). BounceBack capsules were able to significantly reduce standardized measures of pain and tenderness at several post-eccentric exercise time points in comparison to placebo. The differences in the serological markers of DOMS, while not statistically significant, appear to support the clinical findings. The product appears to have a good safety profile and further study with a larger sample size is warranted based on the current results.

BounceBack™ capsules for reduction of DOMS after eccentric exercise: a randomized, double-blind, placebo-controlled, crossover pilot study

PubMed Central

Udani, Jay K; Singh, Betsy B; Singh, Vijay J; Sandoval, Elizabeth

2009-01-01

Background Delayed onset muscle soreness (DOMS) is muscle pain and discomfort experienced approximately one to three days after exercise. DOMS is thought to be a result of microscopic muscle fiber tears that occur more commonly after eccentric exercise rather than concentric exercise. This study sought to test the efficacy of a proprietary dietary supplement, BounceBack™, to alleviate the severity of DOMS after standardized eccentric exercise. Methods The study was a randomized, double-blind, placebo-controlled, crossover study. Ten healthy community-dwelling untrained subjects, ranging in age from 18–45 years, were enrolled. Mean differences within and between groups were assessed inferentially at each data collection time-point using t-tests for all outcome measures. Results In this controlled pilot study, intake of BounceBack™ capsules for 30 days resulted in a significant reduction in standardized measures of pain and tenderness post-eccentric exercise compared to the placebo group. There were trends towards reductions in plasma indicators of inflammation (high sensitivity C-reactive protein) and muscle damage (creatine phosphokinase and myoglobin). Conclusion BounceBack™ capsules were able to significantly reduce standardized measures of pain and tenderness at several post-eccentric exercise time points in comparison to placebo. The differences in the serological markers of DOMS, while not statistically significant, appear to support the clinical findings. The product appears to have a good safety profile and further study with a larger sample size is warranted based on the current results. PMID:19500355

Effects of transcranial direct current stimulation on esophageal motility in patients with gastroesophageal reflux disease.

PubMed

Vigneri, Simone; Bonventre, Sebastiano; Inviati, Angela; Schifano, Domenico; Cosentino, Giuseppe; Puma, Angela; Giglia, Giuseppe; Paladino, Piera; Brighina, Filippo; Fierro, Brigida

2014-09-01

To evaluate the effects of transcranial direct current stimulation (tDCS) on esophageal peristalsis in patients with gastroesophageal reflux disease (GERD). Patients with GERD preliminary diagnosis were included in a randomized double-blind sham-controlled study. Esophageal manometry was performed before and during transcranial direct current stimulation (tDCS) of the right precentral cortex. Half of patients were randomly assigned to anodal, half to sham stimulation. Distal waves amplitude and pathological waves percentage were measured, after swallowing water boli, for ten subsequent times. Last, a 24h pH-bilimetry was done to diagnose non-erosive reflux disease (NERD) or functional heartburn (FH). The values obtained before and during anodal or sham tDCS were compared. Sixty-eight patients were enrolled in the study. Distal waves mean amplitude increased significantly only during anodal tDCS in NERD (p=0.00002) and FH subgroups (p=0.008) while percentage of pathological waves strongly decreased only in NERDs (p=0.002). Transcranial stimulation can influence cortical control of esophageal motility and improve pathological motor pattern in NERD and FH but not in erosive reflux disease (ERD) patients. Pathophysiological processes in GERD are not only due to peripheral damage but to central neural control involvement as well. In ERD patients dysfunctions of the cortico-esophageal circuit seem to be more severe and may affect central nervous system physiology. Copyright © 2014 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

Effects of different photobiomodulation dosimetries on temporomandibular dysfunction: a randomized, double-blind, placebo-controlled clinical trial.

PubMed

Borges, Rosana Mengue Maggi; Cardoso, Daniela Steffen; Flores, Bianca Chuaste; da Luz, Raquel Dimer; Machado, Catiuci Roberta; Cerveira, Guilherme Pessoa; Daitx, Rodrigo Boff; Dohnert, Marcelo Baptista

2018-05-30

Changes involving temporomandibular joint, masticatory musculature, and associated structures characterize temporomandibular dysfunction (TMD). The analgesic and anti-inflammatory effect produced by photobiomodulation has contributed to pain relief and functional improvement. However, the parameters to be used have not yet been well established. The aim of this study is to compare the efficacy of three different photobiomodulation dosimetries in the treatment of patients with TMD. A randomized, double-blind, placebo-controlled clinical trial with 44 subjects divided into the groups 8 J/cm 2 (n = 11), 60 J/cm 2 (n = 11), 105 J/cm 2 (n = 11), and control (n = 11). Pain, symptom severity, and joint mobility were evaluated before and after a ten-session protocol of photobiomodulation with AlGaAs laser (830 nm), at a power density of 30 mW/cm 2 . The mouth opening increased in the 8-J/cm 2 group from 10.49 ± 4.68 to 15.40 ± 6.43 degrees, and in the right protrusion from 9.80 ± 4.2 to 12.56 ± 5.40 degrees after the intervention protocol (p < 0.05). All groups significantly decreased pain (p < 0.05). 830-nm laser photobiomodulation was effective in reducing TMD pain and symptoms at all doses tested. Only the doses of 8 J/cm 2 were effective regarding maximal opening and protrusion of the mandible.

A prospective randomized controlled trial of the two-window technique without membrane versus the solo-window technique with membrane over the osteotomy window for maxillary sinus augmentation.

PubMed

Yu, Huajie; He, Danqing; Qiu, Lixin

2017-12-01

Maturation of the grafted volume after lateral sinus elevation is crucial for the long-term survival of dental implants. To compare endo-sinus histomorphometric bone formation between the solo- and two-window maxillary sinus augmentation techniques with or without membrane coverage for the rehabilitation of multiple missing posterior teeth. Patients with severely atrophic posterior maxillae were randomized to receive lateral sinus floor elevation via the solo-window technique with membrane coverage (Control Group) or the two-window technique without coverage (Test Group). Six months after surgery, bone core specimens harvested from the lateral aspect were histomorphometrically analyzed. Ten patients in each group underwent 21 maxillary sinus augmentations. Histomorphometric analysis revealed mean newly formed bone values of 26.08 ± 16.23% and 27.14 ± 18.11%, mean connective tissue values of 59.34 ± 12.42% and 50.03 ± 17.13%, and mean residual graft material values of 14.6 ± 14.56% and 22.78 ± 10.83% in the Test and Control Groups, respectively, with no significant differences. The two-window technique obtained comparative maturation of the grafted volume even without membrane coverage, and is a viable alternative for the rehabilitation of severely atrophic posterior maxillae with multiple missing posterior teeth. © 2017 Wiley Periodicals, Inc.

Maternal and fetal effects of chocolate consumption during pregnancy: a systematic review.

PubMed

Latif, Rabia

2018-03-13

The purpose of this review is to explore the effects of chocolate consumption during pregnancy on fetus and mother herself. Randomized controlled trials/quasi-experimental/observational/controlled before and after studies involving chocolate/cocoa/cacao consumption (irrespective of type or dose, composition, exposure period, and method of administration) among pregnant women/animals; and measuring any outcome (beneficial or harmful) related to fetus or mother after chocolate exposure were included. Databases searched were PubMed, Web of Science and Scopus; between April and May 2017. Risk of bias within each human randomized controlled trial (RCT) and animals' experimental studies was evaluated by "The Cochrane Collaboration's tool" and SYRCLE's tool respectively. Fourteen human studies including a total of 6639 participants and nine animal studies were selected. Outcome variables investigated in human studies were maternal blood pressure, fetal heart rate, and striae gravidarum. Animal studies explored chocolate-induced teratogenicity and fetal metabolic derangements. Ten out of these 23 studies reported chocolate to be "beneficial"; five studies reported adverse effects, whereas eight studies declared chocolate as "neutral". Maternal chocolate intake has acute stimulatory effects on fetal reactivity and chronic blood pressure reducing effect in mothers. Chocolate is nonteratogenic and does not affect reproductive indices. Metabolic derangements in offsprings born to chocolate fed dams have been reported. Pregnant females must be careful about consumption of cocoa and chocolate. Future studies should be planned, keeping in view heterogeneities identified across the selected studies in this review.

Study protocol for a multi-center, randomized controlled trial to develop Japanese denture adhesive guidelines for patients with complete dentures: the Denture Adhesive Guideline trial: study protocol for a randomized controlled trial.

PubMed

Kimoto, Suguru; Kawai, Yasuhiko; Gunji, Atsuko; Kondo, Hisatomo; Nomura, Taro; Murakami, Tomohiko; Tsuboi, Akito; Hong, Guang; Minakuchi, Shunsuke; Sato, Yusuke; Ohwada, Gaku; Suzuki, Tetsuya; Kimoto, Katsuhiko; Hoshi, Noriyuki; Saita, Makiko; Yoneyama, Yoshikazu; Sato, Yohei; Morokuma, Masakazu; Okazaki, Joji; Maeda, Takeshi; Nakai, Kenichiro; Ichikawa, Tetsuo; Nagao, Kan; Fujimoto, Keiko; Murata, Hiroshi; Kurogi, Tadafumi; Yoshida, Kazuhiro; Nishimura, Masahiro; Nishi, Yasuhiro; Murakami, Mamoru; Hosoi, Toshio; Hamada, Taizo

2016-10-18

Denture adhesives, characterized as medical products in 1935 by the American Dental Association, have been considered useful adjuncts for improving denture retention and stability. However, many dentists in Japan are hesitant to acknowledge denture adhesives in daily practice because of the stereotype that dentures should be inherently stable, without the aid of adhesives. The aim of this study is to verify the efficacy of denture adhesives to establish guidelines for Japanese users. The null hypothesis is that the application of denture adhesives, including the cream and powder types, or a control (isotonic sodium chloride solution) would not produce different outcomes nor would they differentially improve the set outcomes between baseline and day 4 post-application. This ten-center, randomized controlled trial with parallel groups is ongoing. Three hundred edentulous patients with complete dentures will be allocated to three groups (cream-type adhesive, powder-type adhesive, and control groups). The participants will wear their dentures with the denture adhesive for 4 days, including during eight meals (three breakfasts, two lunches, and three dinners). The baseline measurements and final measurements for the denture adhesives will be performed on the first day and after breakfast on the fourth day. The primary outcome is a general satisfaction rating for the denture. The secondary outcomes are denture satisfaction ratings for various denture functions, occlusal bite force, resistance to dislodgement, masticatory performance, perceived chewing ability, and oral health-related quality of life. Between-subjects comparisons among the three groups and within-subjects comparisons of the pre- and post-intervention measurements will be performed. Furthermore, a multiple regression analysis will be performed. The main analyses will be based on the intention-to-treat principle. A sample size of 100 subjects per group, including an assumed dropout rate of 10 %, will be required to achieve 80 % power with a 5 % alpha level. This randomized clinical trial will provide information about denture adhesives to complete denture wearers, prosthodontic educators, and dentists in Japan. We believe this new evidence on denture adhesive use from Japan will aid dentists in their daily practice even in other countries. ClinicalTrials.gov NCT01712802 . Registered on 17 October 2012.

Effects of transcutaneous electrical nerve stimulation on rats with the third lumbar vertebrae transverse process syndrome.

PubMed

Li, Huan; Shang, Xiao-Jun; Dong, Qi-Rong

2015-10-01

To investigate the analgesic and anti-inflammatory effects of transcutaneous electrical nerve stimulation (TENS) at local or distant acupuncture points in a rat model of the third lumbar vertebrae transverse process syndrome. Forty Sprague-Dawley rats were randomly divided into control, model, model plus local acupuncture point stimulation at BL23 (model+LAS) and model plus distant acupuncture point stimulation at ST36 (model+DAS) groups. All rats except controls underwent surgical third lumbar vertebrae transverse process syndrome modelling on day 2. Thereafter, rats in the model+LAS and model+DAS groups were treated daily with TENS for a total of six treatments (2/100 Hz, 30 min/day) from day 16 to day 29. Thermal pain thresholds were measured once a week during treatment and were continued until day 57, when local muscle tissue was sampled for RT-PCR and histopathological examination after haematoxylin and eosin staining. mRNA expression of interleukin-1 β (IL-1β), tumour necrosis factor-α (TNF-α) and inducible nitric oxide synthase (iNOS) was determined. Thermal pain thresholds of all model rats decreased relative to the control group. Both LAS and DAS significantly increased the thermal pain threshold at all but one point during the treatment period. Histopathological assessment revealed that the local muscle tissues around the third lumbar vertebrae transverse process recovered to some degree in both the model+LAS and model+DAS groups; however, LAS appeared to have a greater effect. mRNA expression of IL-1β, TNF-α and iNOS in the local muscle tissues was increased after modelling and attenuated in both model+LAS and model+DAS groups. The beneficial effect was greater after LAS than after DAS. TENS at both local (BL23) and distant (ST36) acupuncture points had a pain-relieving effect in rats with the third lumbar vertebrae transverse process syndrome, and LAS appeared to have greater anti-inflammatory and analgesic effects than DAS. 09073. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

2016 updated MASCC/ESMO consensus recommendations: Anticipatory nausea and vomiting in children and adults receiving chemotherapy.

PubMed

Dupuis, L Lee; Roscoe, Joseph A; Olver, Ian; Aapro, Matti; Molassiotis, Alexander

2017-01-01

We aimed to update the 2011 recommendations for the prevention and treatment of anticipatory nausea and vomiting in children and adults receiving chemotherapy. The original systematic literature search was updated. Randomized studies were included in the evidence to support this guideline if they as follows: were primary studies published in a journal in full text (i.e., abstracts, letters, book chapters, and dissertations were excluded); published in English; evaluated an intervention for the prevention or treatment of anticipatory nausea and vomiting; reported the proportion of patients experiencing complete control of anticipatory nausea and vomiting consistently and; included at least ten participants per study arm for comparative studies and at least ten participants overall for noncomparative studies. Eighty-eight new citations were identified. Of these, nine were brought to full-text screening; none met inclusion criteria. The guideline panel continues to recommend that anticipatory nausea and vomiting are best prevented through optimization of acute and delayed phase chemotherapy-induced nausea and vomiting control. Benzodiazepines and behavioral therapies, in particular progressive muscle relaxation training, systematic desensitization and hypnosis, continue to be recommended for the treatment of anticipatory nausea and vomiting. No new information regarding interventions aimed at treating or preventing ANV that met criteria for inclusion in this systematic review was identified. The 2015 MASCC recommendations affirm the content of the 2009 MASCC recommendations for the prevention and treatment of anticipatory nausea and vomiting.

Influence of time restriction, 20 minutes and 94.6 months, of visual information on angular displacement during the sit-to-stand (STS) task in three planes.

PubMed

Aylar, Mozhgan Faraji; Firouzi, Faramarz; Araghi, Mandana Rahnama

2016-12-01

[Purpose] The purpose of this investigation was to assess whether or not restriction of visual information influences the kinematics of sit-to-stand (STS) performance in children. [Subjects and Methods] Five girls with congenital blindness (CB) and ten healthy girls with no visual impairments were randomly selected. The girls with congenital blindness were placed in one group and the ten girls with no visual impairments were divided into two groups of five, control and treatment groups. The participants in the treatment group were asked to close their eyes (EC) for 20 minutes before the STS test, whereas those in the control group kept their eyes open (EO). The performance of the participants in all three groups was measured using a motion capture system and two force plates. [Results] The results show that the constraint duration of visual sensory information affected the range of motion (ROM), the excursion of the dominant side ankle, and the ROM of the dominant side knee in the EC group. However, only ankle excursion on the non-dominant side was affected in the CB group, and this was only observed in the sagittal plane. [Conclusion] These results indicate that visual memory does not affect the joint angles in the frontal and transverse planes. Moreover, all of the participants could perform the STS transition without falling, indicating; the participants performed the STS maneuver correctly in all planes except the sagittal one.

Comparison of NSAID patch given as monotherapy and NSAID patch in combination with transcutaneous electric nerve stimulation, a heating pad, or topical capsaicin in the treatment of patients with myofascial pain syndrome of the upper trapezius: a pilot study.

PubMed

Kim, Do-Hyeong; Yoon, Kyung Bong; Park, SangHa; Jin, Tae Eun; An, Yoo Jin; Schepis, Eric A; Yoon, Duck Mi

2014-12-01

This study compared the therapeutic effect of monotherapy with a nonsteroidal anti-inflammatory drug (NSAID) patch vs an NSAID patch combined with transcutaneous electric nerve stimulation (TENS), a heating pad, or topical capsaicin in the treatment of patients with myofascial pain syndrome (MPS) of the upper trapezius. A randomized, single-blind, controlled study of combination therapy for patients with MPS was performed. Ninety-nine patients were randomly assigned to one of four different self-management methods for treatment: NSAID patch (N = 25), NSAID patch + TENS (N = 24), NSAID patch + heating pad (N = 25), and NSAID patch + topical capsaicin (N = 25). The NSAID patch used in this study was a ketoprofen patch. All treatment groups were observed for 2 weeks, and the numeric rating scale (NRS) pain score, cervical active range of motion, pressure pain threshold, and Neck Disability Index were assessed. There was no significant difference between the NSAID patch alone group and the three combination therapy groups with respect to decrease in NRS score from baseline (day 0) to each period of observation. In covariate analysis, although there was no difference among the groups in most of the periods, the data at day 14 indicated a trend (P = 0.057). There were no significant differences in the other variables. We did not observe a statistical difference in improvements to the clinical variables among the four different methods. However, further studies regarding the effectiveness of a mixture of topical capsaicin and ketoprofen in patients with MPS should be considered. Wiley Periodicals, Inc.

Design and baseline characteristics of the Short bouTs of Exercise for Preschoolers (STEP) study.

PubMed

Alhassan, Sofiya; Nwaokelemeh, Ogechi; Mendoza, Albert; Shitole, Sanyog; Whitt-Glover, Melicia C; Yancey, Antronette K

2012-08-01

Most preschool centers provide two 30-min sessions of gross-motor/outdoor playtime per preschool day. Within this time frame, children accumulate most of their activity within the first 10 min. This paper describes the design and baseline participant characteristics of the Short bouTs of Exercise for Preschoolers (STEP) study. The STEP study is a cluster randomized controlled study designed to examine the effects of short bouts of structured physical activity (SBS-PA) implemented within the classroom setting as part of designated gross-motor playtime on during-school physical activity (PA) in preschoolers. Ten preschool centers serving low-income families were randomized into SBS-PA versus unstructured PA (UPA). SBS-PA schools were asked to implement age-appropriate 10 min structured PA routines within the classroom setting, twice daily, followed by 20 min of usual unstructured playtime. UPA intervention consisted of 30 min of supervised unstructured free playtime twice daily. Interventions were implemented during the morning and afternoon designated gross-motor playtime for 30 min/session, five days/week for six months. Outcome measures were between group difference in during-preschool PA (accelerometers and direct observation) over six-months. Ten preschool centers, representing 34 classrooms and 315 children, enrolled in the study. The average age and BMI percentile for the participants was 4.1 ± 0.8 years and 69th percentile, respectively. Participants spent 74% and 6% of their preschool day engaged in sedentary and MVPA, respectively. Results from the STEP intervention could provide evidence that a PA policy that exposes preschoolers to shorter bouts of structured PA throughout the preschool day could potentially increase preschoolers' PA levels.

What's normal? Influencing women's perceptions of normal genitalia: an experiment involving exposure to modified and nonmodified images.

PubMed

Moran, C; Lee, C

2014-05-01

Examine women's perceptions of what is 'normal' and 'desirable' in female genital appearance. Experiment with random allocation across three conditions. Community. A total of 97 women aged 18-30 years. Women were randomly assigned to view a series of images of (1) surgically modified vulvas or (2) nonmodified vulvas, or (3) no images. They then viewed and rated ten target images of surgically modified vulvas and ten of unmodified vulvas. Women used a four-point Likert scale ('strongly agree' to 'strongly disagree'), to rate each target image for 'looks normal' and 'represents society's ideal'. For each woman, we created two summary scores that represented the extent to which she rated the unmodified vulvas as more 'normal' and more 'society's ideal' than the modified vulvas. For ratings of 'normality,' there was a significant effect for condition (F2,94  = 2.75 P = 0.007, radj2 = 0.082): women who had first viewed the modified images rated the modified target vulvas as more normal than the nonmodified vulvas, significantly different from the control group, who rated them as less normal. For ratings of 'society's ideal', there was again a significant effect for condition (F2,92  = 7.72, P < 0.001, radj2 = 0.125); all three groups rated modified target vulvas as more like society's ideal than the nonmodified target vulvas, with the effect significantly strongest for the women who had viewed the modified images. Exposure to images of modified vulvas may change women's perceptions of what is normal and desirable. This may explain why some healthy women seek labiaplasty. © 2013 Royal College of Obstetricians and Gynaecologists.

Effects of web-based interventions on cancer patients' symptoms: review of randomized trials.

PubMed

Fridriksdottir, N; Gunnarsdottir, S; Zoëga, S; Ingadottir, B; Hafsteinsdottir, E J G

2018-02-01

Symptom management is of high priority in cancer care. Information and communication technology allows interventions to be provided through the internet to enhance the delivery of care. This study aimed to review the effects of web-based interventions on cancer patients' symptoms. MEDLINE, PSychINFO, PubMed, CINAHL, and Cochrane databases were systematically searched. Included were randomized controlled trials (RCTs), pilot RCTs, or quasi-experimental (QE) studies focusing on web-based interventions in adult cancer patients with at least one outcome primary or secondary, in terms of symptoms, treatment side effects, or distress. Data were analyzed study by study. Twenty studies were identified. All web interventions included information, 16 included self-management support, 14 included self-monitoring, 13 included feedback/tailored information, 12 used communication with health-care professionals, and eight used communication with other patients. Overall, 13 studies reported positive symptom outcomes. Psychological distress was reported in eight studies with positive intervention effects in three. Symptoms of anxiety/depression were reported in ten studies with positive intervention effects in five. Somatic symptom severity was reported in ten studies with intervention effects found in six, and symptom distress was reported in six studies with intervention effects found in all. This review shows the promising potential of web-based interventions for cancer symptom management, although it was limited by considerable heterogeneity in the interventions tested and targeted outcomes. The multidimensional nature of symptoms was partly addressed; only one study was guided by a comprehensive theoretical model of cancer symptom management. It can only be speculated which web elements are important for effective symptom outcomes. Further testing is needed for web-based cancer symptom management.

A randomized controlled trial of physical activity, dietary habit, and distress management with the Leadership and Coaching for Health (LEACH) program for disease-free cancer survivors.

PubMed

Yun, Young Ho; Kim, Young Ae; Lee, Myung Kyung; Sim, Jin Ah; Nam, Byung-Ho; Kim, Sohee; Lee, Eun Sook; Noh, Dong-Young; Lim, Jae-Young; Kim, Sung; Kim, Si-Young; Cho, Chi-Heum; Jung, Kyung Hae; Chun, Mison; Lee, Soon Nam; Park, Kyong Hwa; Park, Sohee

2017-05-02

We aimed to evaluate the potential benefits of the Leadership and Coaching for Health (LEACH) program on physical activity (PA), dietary habits, and distress management in cancer survivors. We randomly assigned 248 cancer survivors with an allocation ratio of two-to-one to the LEACH program (LP) group, coached by long-term survivors, or the usual care (UC) group. At baseline, 3, 6, and 12 months, we used PA scores, the intake of vegetables and fruits (VF), and the Post Traumatic Growth Inventory (PTGI) as primary outcomes and, for secondary outcomes, the Ten Rules for Highly Effective Health Behavior adhered to and quality of life (QOL), the Hospital Anxiety and Depression Scale (HADS), and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). For primary outcomes, the two groups did not significantly differ in PA scores or VF intake but differed marginally in PTGI. For secondary outcomes, the LP group showed a significantly greater improvement in the HADS anxiety score, the social functioning score, and the appetite loss and financial difficulties scores of the EORTC QLQ-C30 scales from baseline to 3 months. From baseline to 12 months, the LP group showed a significantly greater decrease in the EORTC QLQ-C30 fatigue score and a significantly greater increase in the number of the Ten Rules for Highly Effective Health Behavior. Our findings indicate that the LEACH program, coached by long-term survivors, can provide effective management of the QOL of cancer survivors but not of their PA or dietary habits. Clinical trial information can be found for the following: NCT01527409 (the date when the trial was registered: February 2012).

Design and baseline characteristics of the Short bouTs of Exercise for Preschoolers (STEP) study

PubMed Central

2012-01-01

Background Most preschool centers provide two 30-min sessions of gross-motor/outdoor playtime per preschool day. Within this time frame, children accumulate most of their activity within the first 10 min. This paper describes the design and baseline participant characteristics of the Short bouTs of Exercise for Preschoolers (STEP) study. The STEP study is a cluster randomized controlled study designed to examine the effects of short bouts of structured physical activity (SBS-PA) implemented within the classroom setting as part of designated gross-motor playtime on during-school physical activity (PA) in preschoolers. Methods/Design Ten preschool centers serving low-income families were randomized into SBS-PA versus unstructured PA (UPA). SBS-PA schools were asked to implement age-appropriate 10 min structured PA routines within the classroom setting, twice daily, followed by 20 min of usual unstructured playtime. UPA intervention consisted of 30 min of supervised unstructured free playtime twice daily. Interventions were implemented during the morning and afternoon designated gross-motor playtime for 30 min/session, five days/week for six months. Outcome measures were between group difference in during-preschool PA (accelerometers and direct observation) over six-months. Ten preschool centers, representing 34 classrooms and 315 children, enrolled in the study. The average age and BMI percentile for the participants was 4.1 ± 0.8 years and 69th percentile, respectively. Participants spent 74% and 6% of their preschool day engaged in sedentary and MVPA, respectively. Discussion Results from the STEP intervention could provide evidence that a PA policy that exposes preschoolers to shorter bouts of structured PA throughout the preschool day could potentially increase preschoolers’ PA levels. Trial registration Clinicaltrials.gov, NCT01588392 PMID:22853642

Pelvic Floor Muscle Training With and Without Electrical Stimulation in the Treatment of Lower Urinary Tract Symptoms in Women With Multiple Sclerosis.

PubMed

Lúcio, Adélia; Dʼancona, Carlos Arturo Levi; Perissinotto, Maria Carolina; McLean, Linda; Damasceno, Benito Pereira; de Moraes Lopes, Maria Helena Baena

2016-01-01

The aim of this study was to evaluate the effect of intravaginal neuromuscular electrical stimulation (NMES) and transcutaneous tibial nerve stimulation (TTNS) on lower urinary tract symptoms (LUTS) and health-related quality of life in women undergoing pelvic floor muscle (PFM) training (PFMT) with multiple sclerosis (MS) and to compare the efficacy of these 2 approaches. Randomized controlled trial. Thirty women with MS and LUTS were randomly allocated to 1 of 3 groups and received treatment for 12 weeks. Ten women in group 1 received PFMT with electromyographic (EMG) biofeedback and sham NMES. Ten women in group 2 underwent PFMT with EMG biofeedback and intravaginal NMES, and 10 subjects in group 3 received PFMT with EMG biofeedback and TTNS. Multiple assessments, performed before and after treatment, included a 24-hour pad test, 3-day bladder diary, assessment of PFM function (strength and muscle tone), urodynamic studies, and validated questionnaires including Overactive Bladder Questionnaire (OAB-V8), International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and Qualiveen instrument. All groups showed reductions in pad weight, frequency of urgency and urge urinary incontinence episodes, improvement in all domains of the PFM assessment, and lower scores on the OAB-V8 and ICIQ-SF questionnaires following treatment. Subjects in group 2 achieved significantly greater improvement in PFM tone, flexibility, ability to relax PFMs, and OAB-V8 scores when compared to subjects in groups 1 and 3. Results suggest that PFMT alone or in combination with intravaginal NMES or TTNS is effective in the treatment of LUTS in patients with MS. The combination of PFMT and NMES offers some advantage in the reduction of PFM tone and symptoms of overactive bladder.

Assessing the performance of multiplexed tandem PCR for the diagnosis of pathogenic genotypes of Theileria orientalis using pooled blood samples from cattle.

PubMed

Gebrekidan, Hagos; Gasser, Robin B; Stevenson, Mark A; McGrath, Sean; Jabbar, Abdul

2017-02-01

Oriental theileriosis caused by multiple genotypes of Theileria orientalis is an important tick-borne disease of bovines. Here, we assessed the performance of an established multiplexed tandem PCR (MT-PCR) for the diagnosis of the two recognized, pathogenic genotypes (chitose and ikeda) of T. orientalis in cattle using pooled blood samples. We used a total of 265 cattle blood samples, which were divided into two groups according to previous MT-PCR results for individual samples. Samples in group 1 (n = 155) were from a herd with a relatively high prevalence of T. orientalis infection; and those in group 2 (n = 110) were from four herds with a low prevalence. For group 1, 31 and 15 batches of five- and ten-pooled samples (selected at random), respectively, were formed. For group 2, 22 and 11 batches of five- and ten-pooled samples (selected at random), respectively, were formed. DNAs from individual pooled samples in each batch and group were then tested by MT-PCR. For group 1, the apparent prevalences estimated using the 31 batches of five-pooled samples (97%) and 15 batches of ten-pooled samples (100%) were significantly higher compared with individual samples (75%). For group 2, higher apparent prevalences (9% and 36%) were also recorded for the 22 and 11 batches of pooled samples, respectively, compared with individual samples (7%). Overall, the average infection intensity recorded for the genotypes of chitose and ikeda were considerably lower in pooled compared with individual samples. The diagnostic specificities of MT-PCR were estimated at 95% and 94%, respectively, when batches of five- and ten-pooled samples were tested, and 94% for individual samples. The diagnostic sensitivity of this assay was estimated at 98% same for all individual, five- and ten-pooled samples. This study shows that screening batches of five- and ten-pooled blood samples from cattle herds are similar to those obtained for individual samples, and, importantly, that the reduced cost for the testing of pooled samples represents a considerable saving to herd managers. Copyright © 2016 Elsevier Ltd. All rights reserved.

Simulation-based Randomized Comparative Assessment of Out-of-Hospital Cardiac Arrest Resuscitation Bundle Completion by Emergency Medical Service Teams Using Standard Life Support or an Experimental Automation-assisted Approach.

PubMed

Choi, Bryan; Asselin, Nicholas; Pettit, Catherine C; Dannecker, Max; Machan, Jason T; Merck, Derek L; Merck, Lisa H; Suner, Selim; Williams, Kenneth A; Jay, Gregory D; Kobayashi, Leo

2016-12-01

Effective resuscitation of out-of-hospital cardiac arrest (OHCA) patients is challenging. Alternative resuscitative approaches using electromechanical adjuncts may improve provider performance. Investigators applied simulation to study the effect of an experimental automation-assisted, goal-directed OHCA management protocol on EMS providers' resuscitation performance relative to standard protocols and equipment. Two-provider (emergency medical technicians (EMT)-B and EMT-I/C/P) teams were randomized to control or experimental group. Each team engaged in 3 simulations: baseline simulation (standard roles); repeat simulation (standard roles); and abbreviated repeat simulation (reversed roles, i.e., basic life support provider performing ALS tasks). Control teams used standard OHCA protocols and equipment (with high-performance cardiopulmonary resuscitation training intervention); for second and third simulations, experimental teams performed chest compression, defibrillation, airway, pulmonary ventilation, vascular access, medication, and transport tasks with goal-directed protocol and resuscitation-automating devices. Videorecorders and simulator logs collected resuscitation data. Ten control and 10 experimental teams comprised 20 EMT-B's; 1 EMT-I, 8 EMT-C's, and 11 EMT-P's; study groups were not fully matched. Both groups suboptimally performed chest compressions and ventilations at baseline. For their second simulations, control teams performed similarly except for reduced on-scene time, and experimental teams improved their chest compressions (P=0.03), pulmonary ventilations (P<0.01), and medication administration (P=0.02); changes in their performance of chest compression, defibrillation, airway, and transport tasks did not attain significance against control teams' changes. Experimental teams maintained performance improvements during reversed-role simulations. Simulation-based investigation into OHCA resuscitation revealed considerable variability and improvable deficiencies in small EMS teams. Goal-directed, automation-assisted OHCA management augmented select resuscitation bundle element performance without comprehensive improvement.

Beneficial Effects of Adding Ketamine to Intravenous Patient-Controlled Analgesia with Fentanyl after the Nuss Procedure in Pediatric Patients

PubMed Central

Cha, Moon Ho; Eom, Ji Hye; Lee, Yoon Sook; Kim, Woon Young; Park, Young Cheol; Min, Sam Hong

2012-01-01

Purpose The aim of this prospective, double-blind, randomized study was to investigate the analgesic effects of low-dose ketamine on intravenous patient-controlled analgesia (IV-PCA) with fentanyl for pain control in pediatric patients following the Nuss procedure for pectus excavatum. Materials and Methods Sixty pediatric patients undergoing the Nuss procedure were randomly assigned to receive fentanyl (Group F, n=30) or fentanyl plus ketamine (Group FK, n=30). Ten minutes before the end of surgery, following the loading dose of each solution, 0.5 µg/kg/hr of fentanyl or 0.5 µg/kg/hr of fentanyl plus 0.15 mg/kg/hr of ketamine was infused via an IV-PCA pump (basal rate, 1 mL/hr; bolus, 0.5 mL; lock out interval, 30 min). Fentanyl consumption, pain score, ketorolac use, nausea/vomiting, ondansetron use, pruritus, respiratory depression, hallucination, dreaming, and parent satisfaction with pain control were measured throughout the 48 hours following surgery. Results The pain scores, ketorolac use, and fentanyl consumption of Group FK were significantly lower than in Group F (p<0.05). The incidence of nausea/vomiting and ondansetron use in Group FK was significantly lower than in Group F (p<0.05). There were no reports of respiratory depression, hallucination or dreaming. Parent satisfaction with pain control was similar between the two groups. Conclusion We concluded that low-dose ketamine added to IV-PCA with fentanyl after the Nuss procedure in pediatric patients can reduce pain scores, consumption of fentanyl, and incidence of nausea/vomiting without increasing side effects. PMID:22318834

Gaze training enhances laparoscopic technical skill acquisition and multi-tasking performance: a randomized, controlled study.

PubMed

Wilson, Mark R; Vine, Samuel J; Bright, Elizabeth; Masters, Rich S W; Defriend, David; McGrath, John S

2011-12-01

The operating room environment is replete with stressors and distractions that increase the attention demands of what are already complex psychomotor procedures. Contemporary research in other fields (e.g., sport) has revealed that gaze training interventions may support the development of robust movement skills. This current study was designed to examine the utility of gaze training for technical laparoscopic skills and to test performance under multitasking conditions. Thirty medical trainees with no laparoscopic experience were divided randomly into one of three treatment groups: gaze trained (GAZE), movement trained (MOVE), and discovery learning/control (DISCOVERY). Participants were fitted with a Mobile Eye gaze registration system, which measures eye-line of gaze at 25 Hz. Training consisted of ten repetitions of the "eye-hand coordination" task from the LAP Mentor VR laparoscopic surgical simulator while receiving instruction and video feedback (specific to each treatment condition). After training, all participants completed a control test (designed to assess learning) and a multitasking transfer test, in which they completed the procedure while performing a concurrent tone counting task. Not only did the GAZE group learn more quickly than the MOVE and DISCOVERY groups (faster completion times in the control test), but the performance difference was even more pronounced when multitasking. Differences in gaze control (target locking fixations), rather than tool movement measures (tool path length), underpinned this performance advantage for GAZE training. These results suggest that although the GAZE intervention focused on training gaze behavior only, there were indirect benefits for movement behaviors and performance efficiency. Additionally, focusing on a single external target when learning, rather than on complex movement patterns, may have freed-up attentional resources that could be applied to concurrent cognitive tasks.

Strength training, walking, and social activity improve sleep in nursing home and assisted living residents: randomized controlled trial.

PubMed

Richards, Kathy C; Lambert, Corinne; Beck, Cornelia K; Bliwise, Donald L; Evans, William J; Kalra, Gurpreet K; Kleban, Morton H; Lorenz, Rebecca; Rose, Karen; Gooneratne, Nalaka S; Sullivan, Dennis H

2011-02-01

To compare the effects of physical resistance strength training and walking (E), individualized social activity (SA), and E and SA (ESA) with a usual care control group on total nocturnal sleep time in nursing home and assisted living residents. Pretest-posttest experimental design with assignment to one of four groups for 7 weeks: E (n=55), SA (n=50), ESA (n=41), and usual care control (n=47). Ten nursing homes and three assisted living facilities. One hundred ninety-three residents were randomly assigned; 165 completed the study. The E group participated in high-intensity physical resistance strength training 3 days a week and on 2 days walked for up to 45 minutes, the SA group received social activity 1 hour daily 5 days a week, the ESA group received both E and SA, and the control group participated in usual activities provided in the homes. Total nocturnal sleep time was measured using 2 nights of polysomnography before and 2 nights of polysomnography after the intervention. Sleep efficiency (SE), non-rapid eye movement (NREM) sleep, rapid eye movement sleep, and sleep onset latency were also analyzed. Total nocturnal sleep time was significantly greater in the ESA group than in the control group (adjusted means 364.2 minutes vs 328.9 minutes), as was SE and NREM sleep. High-intensity physical resistance strength training and walking combined with social activity significantly improved sleep in nursing home and assisted living residents. The interventions by themselves did not have significant effects on sleep in this population. © 2011, Copyright the Authors. Journal compilation © 2011, The American Geriatrics Society.

[Effect of Sijunzi Decoction and enteral nutrition on T-cell subsets and nutritional status in patients with gastric cancer after operation: a randomized controlled trial].

PubMed

Cai, Jun; Wang, Hua; Zhou, Sheng; Wu, Bin; Song, Hua-Rong; Xuan, Zheng-Rong

2008-01-01

To observe the effect of perioperative application of Sijunzi Decoction and enteral nutrition on T-cell subsets and nutritional status in patients with gastric cancer after operation. In this prospective, single-blinded, controlled clinical trial, fifty-nine patients with gastric cancer were randomly divided into three groups: control group (n=20) and two study groups (group A, n=21; group B, n=18). Sjunzi Decoction (100 ml) was administered via nasogastric tube to the patients in the study group B from the second postoperation day to the 9th postoperation day. Patients in the two study groups were given an isocaloric and isonitrogonous enteral diet, which was started on the second day after operation, and continued for eight days. Patients in the control group were given an isocaloric and isonitrogonous parenteral diet for 9 days. All variables of nutritional status such as serum albumin (ALB), prealbumin (PA), transferrin (TRF) and T-cell subsets were measured one day before operation, and one day and 10 days after operation. All the nutritional variables and the levels of CD3(+), CD4(+), CD4(+)/CD8(+) were decreased significantly after operation. Ten days after operation, T-cell subsets and nutritional variables in the two study groups were increased as compare with the control group. The levels of ALB, TRF and T-cell subsets in the study group B were increased significantly as compared with the study group A (P<0.05). Enteral nutrition assisted with Sijunzi Decoction can positively improve and optimize cellular immune function and nutritional status in the patients with gastric cancer after operation.

Sweating responses during heat acclimation and moderate conditioning

NASA Technical Reports Server (NTRS)

Shvartz, E.; Bhattacharya, A.; Sperinde, S. J.; Brock, P. J.; Sciaraffa, D.; Van Beaumont, W.

1979-01-01

Experiments were conducted on ten young male subjects to determine sweating onset, distribution, and patterns as well as the relationships of these responses to body temperature during heat acclimation and moderate conditioning performed in temperate (24 C) conditions. The subjects are randomly assigned to two groups of five subjects each. The experimental period consisted of eight successive days of either graded exercise to exhaustion on a bicycle ergometer in heat (acclimation group) or in a temperate environment (control group). Major conclusions are that (1) acclimation and conditioning result in relatively more sweat rate on the limbs than on the torso, but that these changes are less related to body temperature than torso sweat rate; and (2) sweating sensitivity increases during acclimation and conditioning, but its contribution to heat acclimation is minor.

Effect of dexamethasone on intelligence and hearing in preterm infants: a meta-analysis.

PubMed

Zhang, Ruolin; Bo, Tao; Shen, Li; Luo, Senlin; Li, Jian

2014-03-15

A meta-analysis of published randomized controlled trials investigating the long-term effect of dexamethasone on the nervous system of preterm infants. Online literature retrieval was conducted using The Cochrane Library (from January 1993 to June 2013), EMBASE (from January 1980 to June 2013), MEDLINE (from January 1963 to June 2013), OVID (from January 1993 to June 2013), Springer (from January 1994 to June 2013) and Chinese Academic Journal Full-text Database (from January 1994 to June 2013). Key words were preterm infants and dexamethasone in English and Chinese. Selected studies were randomized controlled trials assessing the effect of intravenous dexamethasone in preterm infants. The quality of the included papers was evaluated and those without the development of the nervous system and animal experiments were excluded. Quality assessment was performed through bias risk evaluation in accordance with Cochrane Handbook 5.1.0 software in the Cochrane Collaboration. The homogeneous studies were analyzed and compared using Revman 5.2.6 software, and then effect model was selected and analyzed. Those papers failed to be included in the meta-analysis were subjected to descriptive analysis. Nervous system injury in preterm infants. Ten randomized controlled trials were screened, involving 1,038 subjects. Among them 512 cases received dexamethasone treatment while 526 cases served as placebo control group and blank control group. Meta-analysis results showed that the incidence of cerebral palsy, visual impairment and hearing loss in preterm infants after dexamethasone treatment within 7 days after birth was similar to that in the control group (RR = 1.47, 95%CI: 0.97-2.21; RR = 1.46, 95%CI: 0.97-2.20; RR = 0.80, 95%CI: 0.54-1.18; P > 0.05), but intelligence quotient was significantly decreased compared with the control group (MD = -3.55, 95%CI: -6.59 to -0.51; P = 0.02). Preterm infants treated with dexamethasone 7 days after birth demonstrated an incidence of cerebral palsy and visual impairment, and changes in intelligence quotient similar to those in the control group (RR = 1.26, 95%CI: 0.89-1.79; RR = 1.37, 95%CI: 0.73-2.59; RR = 0.53, 95%CI: 0.32-0.89; RR = 1.66, 95%CI: -4.7 to 8.01; P > 0.05). However, the incidence of hearing loss was significantly increased compared with that in the control group (RR = 0.53, 95%CI: 0.32-0.89; P = 0.02). Dexamethasone may affect the intelligence of preterm infants in the early stages after birth, but may lead to hearing impairment at later stages after birth. More reliable conclusions should be made through large-size, multi-center, well-designed randomized controlled trials.

The fentanyl concentration required for immobility under propofol anesthesia is reduced by pre-treatment with flurbiprofen axetil.

PubMed

Kodaka, Mitsuharu; Tsukakoshi, Mikiko; Miyao, Hideki; Tsuzaki, Koichi; Ichikawa, Junko; Komori, Makiko

2013-12-01

We hypothesized that nonsteroidal anti-inflammatory drugs decrease the plasma fentanyl concentration required to produce immobility in 50% of patients in response to skin incision (Cp50incision) compared with placebo under target-controlled infusion (TCI) propofol anesthesia. Sixty-two unpremedicated patients scheduled to undergo gynecologic laparoscopy were randomly assigned to receive placebo (control group) or flurbiprofen axetil 1 mg·kg(-1) (flurbiprofen group) preoperatively. General anesthesia was induced with fentanyl and propofol, and intubation was performed after succinylcholine 1 mg·kg(-1). Propofol was administered via a target-controlled infusion (TCI) system (Diprifusor™) set at an effect-site concentration of 5 μg·mL(-1). Fentanyl was given by a TCI system using the STANPUMP software (Schafer model). The concentration for the first patient was set at 3 ng·mL(-1) and modified in each group according to the up-down method. Skin incision was performed after more than ten minutes equilibration time. Serum fentanyl concentration, bispectral index (BIS), and hemodynamic parameters were measured two minutes before and after skin incision. The Cp50incision of fentanyl was derived from the mean of the crossovers (i.e., the serum fentanyl concentrations of successive participants who responded and those who did not or vice versa). Ten and 11 independent crossover pairs were collected in the control and flurbiprofen groups, respectively, representing 42 of 62 enrolled patients. The mean (SD) fentanyl Cp50incision was less in the flurbiprofen group [0.84 (0.63) ng·mL(-1)] than in the control group [1.65 (1.15) ng·mL(-1)]; P = 0.007; however, there were no differences in BIS, blood pressure, or heart rate, between groups. Preoperative flurbiprofen axetil decreased the Cp50incision of fentanyl by 49% during propofol anesthesia without changing the BIS or hemodynamic variables.

Effects of electroacupuncture on stress-related symptoms in medical students: a randomised placebo-controlled study.

PubMed

Dias, Marcio; Vellarde, Guillermo Coca; Olej, Beni; Teófilo Salgado, Ana Emília; de Barros Rezende, Ighor

2014-02-01

To assess the effects of electroacupuncture (EA) on relieving stress-related symptoms-sleep disorders, anxiety, depression and burnout-in medical students. Eighty-two students were randomised into an EA treatment group (n=30), a sham TENS group (n=18) and an untreated control group (n=34). EA was applied at a continuous frequency of 2 Hz to the limbs, face, ears and scalp for 20 min once a week, over 6-8 weeks. Sham transcutaneous electrical nerve stimulation (TENS) was performed on similar sites for the same number of times in each session and for the same length of time. Outcome measurements included a comparison of the indices obtained by different self-applied questionnaires before and after treatment. The surveys used were the Mini-Sleep Questionnaire (MSQ), Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), the Beck Depression and Anxiety Inventories (BDI and BAI) and the Maslach Burnout Inventory-Student Survey (MBI-SS), in addition to the Quality of Life Questionnaire-abbreviated version (WHOQOL-bref). EA significantly improved scores on the MSQ, PSQI, BDI and the cynicism and academic efficacy (AE) dimensions of the MBI-SS in relation to the control. Sleep quality (MSQ) improved from 36.9 (SD 7.6) to 25.0 (5.7) with EA, 37.6 (6.0) to 32.1 (6.9) with sham TENS, and 36.5 (5.9) to 33.6 (6.7) in the controls (p=0.0000). Compared with the sham TENS group, EA significantly reduced scores on the PSQI. Score improvements in the sham TENS group in relation to control group were significant in the MSQ, BDI and AE. In the EA group, the number of students with better scores after intervention was significantly higher for the MSQ, PSQI, ESS and BAI. This only occurred for the MSQ in the sham TENS group and for the MSQ and ESS in the control group. EA significantly reduced stress-related mental symptoms. The improvement obtained by sham TENS compared with the control group confirmed the presence of a placebo effect resulting from the treatment ritual.

A comparison of mental strategies during athletic skills performance.

PubMed

Peluso, Eugenio A; Ross, Michael J; Gfeller, Jeffrey D; Lavoie, Donna J

2005-12-01

The current study examined the effects of performance enhancement techniques (PET's) on motor skill performance. Specifically, one hundred fifty college student volunteers (Men = 41; 27.3% and Women = 109; 72.6%) were randomly assigned to one of the nine conditions (Cond): Cond 1 and 2, simultaneous, externally verbalized self-talk or imagery (e.g., participants were instructed to say "aim, back, birdie "or engaged in imagery out loud while putting); Cond 3 and 4, delayed externally verbalized self-talk or imagery (e.g., participants were instructed to say "aim, back, birdie "or engaged in imagery out loud before putting); Cond 5 and 6, simultaneous, internally verbalized self-talk or imagery (e.g., participants were instructed to say "aim, back, birdie "or engaged in imagery silently to oneself while putting); Cond 7 and 8, delayed internally verbalized (e.g., participant were instructed to say "aim, back, birdie "or engaged in imagery silently to oneself before putting); and Cond 9, no instruction control group. All participants were asked to perform a golf-putting task. Results indicated that participants who implemented several (PET's) increased their putting accuracy across overall difference score evaluations F (8, 141) = 4.01, p < 0.05 when compared to a no instruction control condition. Follow-up analyses indicated that participants who reportedly engaged in ten hours or less of athletic activities per week preferred self-talk strategies F (2, 119) = 4.38, p < 0.05 whereas participants who endorsed ten hours or more of athletic activity per week preferred imagery strategies F (2, 25) = 5.27, p < 0.05. Key PointsMental imagery and self-talk strategies are implemented by athletes in order to regulate arousal, reduce maladaptive behaviors, reconstruct negative thoughts, and to increase one's concentration and focus.Results of the current study suggest that participants who engaged in several performance enhancement techniques exhibited enhanced performance on a golf putting task when compared to participants in a control condition.Participants who endorsed limited athletic familiarity and activity (e.g., ten hours or less) preferred self-talk practice whereas participants who endorsed higher ratings scores of athletic familiarity and activity (e.g., ten hours or more) preferred imagery strategies.The results of this study demonstrate the flexibility of Performance Enhancement Techniques (e.g., imagery v. self-talk, internal v. external, simultaneous v. delayed) and how they can be implemented to help an athlete reach his or her full potential.

The Effectiveness of the Barton's Intervention Program on Reading Comprehension and Reading Attitude of Students with Dyslexia.

PubMed

Mihandoost, Zeinab; Elias, Habibah

2011-01-01

The current research tested the differences in reading attitude and reading comprehension in the dyslexic students between the control group and the experimental group following the Barton intervention program. Dyslexia screening instrument and reading text were employed in order to identify dyslexic students. The population of the study included 138 dyslexic students studying in schools in Ilam, Iran. From this population, 64 students were randomly selected and assigned to an experimental group as well as a control group. The experimental group was taught for 36 sessions, using the Barton's method at two levels, and ten lessons were provided to improve the reading skill. The reading comprehension and reading attitude instruments were employed for the measurement of the attitude and comprehension before and after the intervention program. The analysis of covariance showed a significant difference between the control group and the experimental group following the Barton intervention program. This study showed that dyslexic students learned to read, and a more direct instruction related to decoding could influence their progress more than the general exposure to education.

Comparison of education group strategies and home visits in type 2 diabetes mellitus: clinical trial.

PubMed

Santos, Jéssica Caroline Dos; Cortez, Daniel Nogueira; Macedo, Maísa Mara Lopes; Reis, Edna Afonso; Reis, Ilka Afonso; Torres, Heloísa Carvalho

2017-12-21

to compare the adherence and empowerment of patients with type 2 diabetes mellitus for self-care practices and glycemic control in group education strategies and home visits. Clinical trial with ten randomized clusters, performed with 238 patients with type 2 diabetes mellitus distributed in group education, home visit, and control group. Socio-demographic data, glycated hemoglobin and those obtained from the self-care and empowerment questionnaires were collected. Statistical analysis was performed separately by educational strategy. the mean age of the patients was 57.8 years old (SD = 9.4 years old), with a predominantly female participation (66.4%). Both strategies presented similar results regarding adherence to self-care practices and patient empowerment. There was also a reduction in glycated hemoglobin levels; however, only in the education group, the difference presented statistical significance (p <0.001). the strategies were effective; however, group education presented better glycemic control results in relation to the home visit. International registry: NCT02132338 and national: RBR-92j38t in the clinical trials registry.

COMPARISON OF SOME PROPERTIES OF MINESOILS AND CONTIGUOUS NATURAL SOILS

EPA Science Inventory

Four minesoil pits located within the disturbed area and four natural soil pits located in adjacent undisturbed areas were described and sampled. Bulk densities were determined at ten randomly located sites. Microlysimeters were subsequently installed at these sites and used to d...

A pilot study: Horticulture-related activities significantly reduce stress levels and salivary cortisol concentration of maladjusted elementary school children.

PubMed

Lee, Min Jung; Oh, Wook; Jang, Ja Soon; Lee, Ju Young

2018-04-01

The effects of three horticulture-related activities (HRAs), including floral arranging, planting, and flower pressing were compared to see if they influenced changes on a stress scale and on salivary cortisol concentrations (SCC) in maladjusted elementary school children. Twenty maladjusted elementary school children were randomly assigned either to an experimental or control group. The control group carried out individual favorite indoor activities under the supervision of a teacher. Simultaneously, the ten children in the experimental group participated in a HRA program consisting of flower arrangement (FA), planting (P), and flower pressing (PF) activities, in which the other ten children in the control group did not take part. During nine sessions, the activities were completed as follows: FA-FA-FA, P-P-P, and PF-PF-PF; each session lasted 40 min and took place once a week. For the quantitative analysis of salivary cortisol, saliva was collected from the experimental group one week before the HRAs and immediately after the activities for 9 consecutive weeks at the same time each session. In the experimental group, stress scores of interpersonal relationship, school life, personal problems, and home life decreased after the HRAs by 1.3, 1.8, 4.2, and 1.3 points, respectively. In particular, the stress score of school life was significantly reduced (P < 0.01). In addition, from the investigation of the SCCs for the children before and after repeating HRAs three times, it was found that flower arrangement, planting, and flower pressing activities reduced the SCCs by ≥37% compared to the SCCs prior to taking part in the HRAs. These results indicate that HRAs are associated with a reduction in the stress levels of maladjusted elementary school children. Copyright © 2018. Published by Elsevier Ltd.

The effects of organic nitrates on osteoporosis: a systematic review.

PubMed

Jamal, S A; Reid, L S; Hamilton, C J

2013-03-01

Current treatments for osteoporosis are limited by lack of effect on cortical bone, side effects, and, in some cases, cost. Organic nitrates, which act as nitric oxide donors, may be a potential alternative. This systematic review summarizes the clinical data that reports on the effects of organic nitrates and bone. Organic nitrates, which act as nitric oxide donors, are novel agents that have several advantages over the currently available treatments for osteoporosis. This systematic review summarizes the clinical data that reports on the effects of organic nitrates on bone. We searched Medline (1966 to November 2012), EMBASE (1980 to November 2012), and the Cochrane Central Register of Controlled Trials (Issue 11, 2012). Keywords included nitrates, osteoporosis, bone mineral density (BMD), and fractures. We identified 200 citations. Of these, a total of 29 were retrieved for more detailed evaluation and we excluded 19 manuscripts: 15 because they did not present original data and four because they did not provide data on the intervention or outcome of interest. As such, we included ten studies in literature review. Of these ten studies two were observational cohort studies reporting nitrate use was associated with increased BMD; two were case control studies reporting that use of nitrates were associated with lower risk of hip fracture; two were randomized controlled trials (RCT) comparing alendronate to organic nitrates for treatment of postmenopausal women and demonstrating that both agents increased lumbar spine BMD. The two largest RCT with the longest follow-up, both of which compared effects of organic nitrates to placebo on BMD in women without osteoporosis, reported conflicting results. Headaches were the most common adverse event among women taking nitrates. No studies have reported on fracture efficacy. Further research is needed before recommending organic nitrates for the treatment of postmenopausal osteoporosis.

[Use of intravenous immunoglobulin for the treatment of toxic epidermal necrolysis and Stevens-Johnson/toxic epidermal necrolysis overlap syndrome. Review of 15 cases].

PubMed

Molgó, Montserrat; Carreño, Néstor; Hoyos-Bachiloglu, Rodrigo; Andresen, Max; González, Sergio

2009-03-01

Toxic epidemial necrolysis (TEN) is an acute adverse drug reaction, that has an unpredictableprogression and a 30% mortality. The incidence of TEN in the general population is approximately 0.4 to 1.2 cases/million/year. It is characterized pathologically by keratinocyte apoptosis which leads to epidemial detachment. Keratinocyte apoptosis is triggered by activation of the Fas-FasL, pathway and could be prevented by the use of intravenous immunoglobulin (IVIG). To report the experience with the use of IVIG in TEN. Retrospective study of 15 patients with a diagnosis of Stevens-Johnson/TEN overlap (SJS/TEN) or TEN, that received a total dose of 23 +/- 0.6 mg/kg ofIVIG over aperiod of 3 to 4 days. The infusión was initiated during thefirst 24 hours after diagnosis and was associated with standard care for burn victims. Steroids were avoided if the patient was not in chronic steroidal therapy. Allpatients responded to IVIG in a lapse of 46.4 +/- 14.2 hours from the beginning of infusión. Eighty percent of patients survived, but one developed acute renal failure due to IVIG, and another became blind due to corneal opacities, a complication of TEN. Those who survived were discharged after a lapse of 19-8 +/- 6.6 days from the beginning ofthe disease. Despite the lack of blind, multicentric and randomized triáis, we agree with some international studies that TVIG is beneficial as a treatment for SSJ/NETand TEN .

An exploratory study of a number sense program to develop kindergarten students' number proficiency.

PubMed

Sood, Sheetal; Jitendra, Asha K

2013-01-01

This study examined the effectiveness of a number sense program on kindergarten students' number proficiency and responsiveness to treatment as a function of students' risk for mathematics difficulties. The program targeted development of relationships among numbers (e.g., spatial, more and less). A total of 101 kindergarten students (not at risk: 22 control and 36 experimental; at risk: 18 and 25) from five classrooms in a high-poverty elementary school participated in the study. Using a quasi-experimental design, classrooms were randomly assigned to either the intervention (number sense instruction, NSI) or control condition. Results indicated significant differences favoring the treatment students on all measures of number sense (e.g., spatial relationships, more and less relationships, benchmarks of five and ten, nonverbal calculations) at posttest and on a 3-week retention test. Furthermore, the effects were not mediated by at-risk status, suggesting that NSI may benefit a wide range of students. Implications in terms of preventing early mathematical learning difficulties are discussed.

Effectiveness of clinical pathways for total knee and total hip arthroplasty: literature review.

PubMed

Kim, Stephen; Losina, Elena; Solomon, Daniel H; Wright, John; Katz, Jeffrey N

2003-01-01

Although many hospitals have implemented clinical pathways to standardize the process of care, the effectiveness of clinical pathways for total hip and knee arthroplasties has not been reviewed critically. We searched for articles comparing outcomes of total hip or knee arthroplasty for patients who were treated using clinical pathways as opposed to patients treated without these pathways. Eleven studies met criteria for inclusion. Ten used historical controls, and 1 was a randomized trial. The studies had important methodological limitations. In general, the articles showed that patients treated using pathways experienced shorter hospital stays and lower costs, with comparable clinical outcomes as compared with patients treated without clinical pathways. We concluded that clinical pathways appear successful in reducing costs and length of stay in the acute care hospital, with no compromise in patient outcomes. However, interpretation of these studies is complicated by substantial methodological limitations, particularly the use of historical controls and failure to account for length of stay in rehabilitation facilities. Copyright 2003, Elsevier Science (USA). All rights reserved.

The immediate effects of therapeutic keyboard music playing for finger training in adults undergoing hand rehabilitation.

PubMed

Zhang, Xiaoying; Liu, Songhuai; Yang, Degang; Du, Liangjie; Wang, Ziyuan

2016-08-01

[Purpose] The purpose of this study was to examine the immediate effects of therapeutic keyboard music playing on the finger function of subjects' hands through measurements of the joint position error test, surface electromyography, probe reaction time, and writing time. [Subjects and Methods] Ten subjects were divided randomly into experimental and control groups. The experimental group used therapeutic keyboard music playing and the control group used grip training. All subjects were assessed and evaluated by the joint position error test, surface electromyography, probe reaction time, and writing time. [Results] After accomplishing therapeutic keyboard music playing and grip training, surface electromyography of the two groups showed no significant change, but joint position error test, probe reaction time, and writing time obviously improved. [Conclusion] These results suggest that therapeutic keyboard music playing is an effective and novel treatment for improving joint position error test scores, probe reaction time, and writing time, and it should be promoted widely in clinics.

Expression of prostaglandin E receptor subtype EP4 in conjunctival epithelium of patients with ocular surface disorders: case-control study.

PubMed

Ueta, Mayumi; Sotozono, Chie; Yamada, Keiko; Yokoi, Norihiko; Inatomi, Tsutomu; Kinoshita, Shigeru

2012-01-01

To confirm the downregulation of PTGER4 mRNA in the conjunctiva of Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) and ocular cicatricial pemphigoid (OCP) patients and to examine the expression of its EP4 protein in the conjunctival epithelium of patients with various ocular surface disorders. Case-control study. We performed quantitative reverse transcription-PCR (RT-PCR) analysis of PTGER4 mRNA in conjunctival tissue sections from patients with SJS/TEN and OCP to confirm the downregulation of PTGER4 mRNA expression. We also analysed EP4 immunohistologically in other ocular surface disorders. Conjunctival tissues were obtained from patients undergoing surgical reconstruction of the ocular surface due to chemical eye burns, subacute SJS/TEN or chronic SJS/TEN, chronic OCP, severe graft versus host disease (GVHD) and from patients with Mooren's ulcers treated by resection of the inflammatory conjunctiva. The expression of PTGER4 mRNA and EP4 protein assessed by quantitative RT-PCR assay and immunohistological methods. PTGER4 mRNA was significantly lower in conjunctival tissues from SJS and OCP patients than in the control conjunctivochalasis samples. EP4 protein was detected in conjunctival epithelium from patients with chemical eye burn and in control conjunctival epithelium from patients with conjunctivochalasis. Its expression varied in conjunctival epithelium from patients with Mooren's ulcer. We did not detect EP4 immunoreactivity in conjunctival epithelium from patients with subacute SJS/TEN, severe GVHD, chronic SJS/TEN or OCP. The strong downregulation of EP4 expression in conjunctival epithelium from patients with OCP or SJS/TEN may be attributable to ocular surface inflammation.

Expression of prostaglandin E receptor subtype EP4 in conjunctival epithelium of patients with ocular surface disorders: case-control study

PubMed Central

Ueta, Mayumi; Sotozono, Chie; Yamada, Keiko; Yokoi, Norihiko; Inatomi, Tsutomu; Kinoshita, Shigeru

2012-01-01

Objectives To confirm the downregulation of PTGER4 mRNA in the conjunctiva of Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) and ocular cicatricial pemphigoid (OCP) patients and to examine the expression of its EP4 protein in the conjunctival epithelium of patients with various ocular surface disorders. Design Case-control study. Setting and participants We performed quantitative reverse transcription-PCR (RT-PCR) analysis of PTGER4 mRNA in conjunctival tissue sections from patients with SJS/TEN and OCP to confirm the downregulation of PTGER4 mRNA expression. We also analysed EP4 immunohistologically in other ocular surface disorders. Conjunctival tissues were obtained from patients undergoing surgical reconstruction of the ocular surface due to chemical eye burns, subacute SJS/TEN or chronic SJS/TEN, chronic OCP, severe graft versus host disease (GVHD) and from patients with Mooren's ulcers treated by resection of the inflammatory conjunctiva. Primary and secondary outcome measures The expression of PTGER4 mRNA and EP4 protein assessed by quantitative RT-PCR assay and immunohistological methods. Results PTGER4 mRNA was significantly lower in conjunctival tissues from SJS and OCP patients than in the control conjunctivochalasis samples. EP4 protein was detected in conjunctival epithelium from patients with chemical eye burn and in control conjunctival epithelium from patients with conjunctivochalasis. Its expression varied in conjunctival epithelium from patients with Mooren's ulcer. We did not detect EP4 immunoreactivity in conjunctival epithelium from patients with subacute SJS/TEN, severe GVHD, chronic SJS/TEN or OCP. Conclusions The strong downregulation of EP4 expression in conjunctival epithelium from patients with OCP or SJS/TEN may be attributable to ocular surface inflammation. PMID:23065448

Early vibration assisted physiotherapy in toddlers with cerebral palsy - a randomized controlled pilot trial.

PubMed

Stark, C; Herkenrath, P; Hollmann, H; Waltz, S; Becker, I; Hoebing, L; Semler, O; Hoyer-Kuhn, H; Duran, I; Hero, B; Hadders-Algra, M; Schoenau, E

2016-09-07

to investigate feasibility, safety and efficacy of home-based side-alternating whole body vibration (sWBV) to improve motor function in toddlers with cerebral palsy (CP). Randomized controlled trial including 24 toddlers with CP (mean age 19 months (SD±3.1); 13 boys). 14 weeks sWBV with ten 9-minute sessions weekly (non-individualized). Group A started with sWBV, followed by 14 weeks without; in group B this order was reversed. Feasibility (≥70% adherence) and adverse events were recorded; efficacy evaluated with the Gross Motor Function Measure (GMFM-66), Pediatric Evaluation of Disability Inventory (PEDI), at baseline (T0), 14 (T1) and 28 weeks (T2). Developmental change between T0 and T1 was similar in both groups; change scores in group A and B: GMFM-66 2.4 (SD±2.1) and 3.3 (SD±2.9) (p=0.412); PEDI mobility 8.4 (SD±6.6) and 3.5 (SD±9.2) (p=0.148), respectively. In two children muscle tone increased post-sWBV. 24 children received between 67 and 140 sWBV sessions, rate of completed sessions ranged from 48 to 100% and no dropouts were observed. A 14-week home-based sWBV intervention was feasible and safe in toddlers with CP, but was not associated with improvement in gross motor function.

Randomized clinical trial of virtual reality simulation for laparoscopic skills training.

PubMed

Grantcharov, T P; Kristiansen, V B; Bendix, J; Bardram, L; Rosenberg, J; Funch-Jensen, P

2004-02-01

This study examined the impact of virtual reality (VR) surgical simulation on improvement of psychomotor skills relevant to the performance of laparoscopic cholecystectomy. Sixteen surgical trainees performed a laparoscopic cholecystectomy on patients in the operating room (OR). The participants were then randomized to receive VR training (ten repetitions of all six tasks on the Minimally Invasive Surgical Trainer-Virtual Reality (MIST-VR)) or no training. Subsequently, all subjects performed a further laparoscopic cholecystectomy in the OR. Both operative procedures were recorded on videotape, and assessed by two independent and blinded observers using predefined objective criteria. Time to complete the procedure, error score and economy of movement score were assessed during the laparoscopic procedure in the OR. No differences in baseline variables were found between the two groups. Surgeons who received VR training performed laparoscopic cholecystectomy significantly faster than the control group (P=0.021). Furthermore, those who had VR training showed significantly greater improvement in error (P=0.003) and economy of movement (P=0.003) scores. Surgeons who received VR simulator training showed significantly greater improvement in performance in the OR than those in the control group. VR surgical simulation is therefore a valid tool for training of laparoscopic psychomotor skills and could be incorporated into surgical training programmes. Copyright 2003 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.

Quality of reporting of patient decision aids in recent randomized controlled trials: A descriptive synthesis and comparative analysis.

PubMed

Lewis, Krystina B; Wood, Brianne; Sepucha, Karen R; Thomson, Richard G; Stacey, Dawn

2017-07-01

Variable reporting of patient decision aids (PDAs) in published articles raises uncertainty about whether the intervention meets the definition of a PDA. We appraised the quality of reporting of PDA characteristics in randomized controlled trials (RCTs). RCTs eligible for the Cochrane review of PDAs and published June 2012 to April 2015 were included. Quality of PDA reporting was appraised using the International Patient Decision Aid Standards Instrument (v4.0). We descriptively synthesized and comparatively analysed qualifying and certification criteria reported in each publication against their presence in actual PDAs. Seventeen RCTs evaluating sixteen PDAs were included. Ten PDAs (58.8%) were reported using all qualifying criteria. Two (11.8%) were reported using all certification criteria. The median score for reporting qualifying criteria was 6 of 6 (range 4-6). The median score for reporting certification criteria was 2 of 10 (range 2-3) for screening and 1 of 6 (range 0-6) for treatment decisions. Reporting of PDAs in RCTs is suboptimal. Incomplete reporting poses challenges for clinicians and researchers needing to identify PDA content for clinical practice and/or future research. Authors should report IPDASi (v4.0) criteria in published articles. Reporting guidelines for PDA evaluation studies are in development to improve reporting within the scientific literature. Copyright © 2017 Elsevier B.V. All rights reserved.

Early vibration assisted physiotherapy in toddlers with cerebral palsy – a randomized controlled pilot trial

PubMed Central

Stark, C.; Herkenrath, P.; Hollmann, H.; Waltz, S.; Becker, I.; Hoebing, L.; Semler, O.; Hoyer-Kuhn, H.; Duran, I.; Hero, B.; Hadders-Algra, M.; Schoenau, E.

2016-01-01

Objectives: to investigate feasibility, safety and efficacy of home-based side-alternating whole body vibration (sWBV) to improve motor function in toddlers with cerebral palsy (CP). Methods: Randomized controlled trial including 24 toddlers with CP (mean age 19 months (SD±3.1); 13 boys). Intervention: 14 weeks sWBV with ten 9-minute sessions weekly (non-individualized). Group A started with sWBV, followed by 14 weeks without; in group B this order was reversed. Feasibility (≥70% adherence) and adverse events were recorded; efficacy evaluated with the Gross Motor Function Measure (GMFM-66), Pediatric Evaluation of Disability Inventory (PEDI), at baseline (T0), 14 (T1) and 28 weeks (T2). Results: Developmental change between T0 and T1 was similar in both groups; change scores in group A and B: GMFM-66 2.4 (SD±2.1) and 3.3 (SD±2.9) (p=0.412); PEDI mobility 8.4 (SD±6.6) and 3.5 (SD±9.2) (p=0.148), respectively. In two children muscle tone increased post-sWBV. 24 children received between 67 and 140 sWBV sessions, rate of completed sessions ranged from 48 to 100% and no dropouts were observed. Conclusion: A 14-week home-based sWBV intervention was feasible and safe in toddlers with CP, but was not associated with improvement in gross motor function. PMID:27609033

Cold therapy to prevent paclitaxel-induced peripheral neuropathy.

PubMed

Griffiths, Claire; Kwon, Nancy; Beaumont, Jennifer L; Paice, Judith A

2018-04-21

This case-control study was designed to assess the efficacy of cryotherapy to prevent paclitaxel-induced painful peripheral neuropathy in women with breast cancer. Participants served as their own paired control, with randomization of the cooled glove/sock to either the dominant or the non-dominant hand/foot, worn for 15 min prior to, during, and 15 min after completion of the paclitaxel infusion. Outcome measures included the Neuropathic Pain Symptom Inventory, the Brief Pain Inventory, and quantitative sensory testing. Data were measured at each of six time points-baseline, post-treatment (approximately 2 weeks after the last paclitaxel infusion), and at the first, fifth, ninth, and final weekly paclitaxel treatments. Of 29 randomized participants, 20 (69%) received at least one cryotherapy treatment, and 11 (38%) received all four cryotherapy treatments. Ten (34%) participants could not tolerate the cryotherapy, and six (21%) declined further participation at some point during the trial. Only seven participants (24%) were available for the final post-chemotherapy QST and questionnaires. There were no significant differences in measures of neuropathy or pain between treated and untreated hands or feet. Strategies to prevent painful peripheral neuropathy are urgently needed. In this current trial, dropout due to discomfort precluded adequate power to fully understand the potential benefits of cryotherapy. Much more research is needed to discover safe and effective preventive strategies that can be easily implemented within busy infusion centers.

Assessment of generalizability, applicability and predictability (GAP) for evaluating external validity in studies of universal family-based prevention of alcohol misuse in young people: systematic methodological review of randomized controlled trials.

PubMed

Fernandez-Hermida, Jose Ramon; Calafat, Amador; Becoña, Elisardo; Tsertsvadze, Alexander; Foxcroft, David R

2012-09-01

To assess external validity characteristics of studies from two Cochrane Systematic Reviews of the effectiveness of universal family-based prevention of alcohol misuse in young people. Two reviewers used an a priori developed external validity rating form and independently assessed three external validity dimensions of generalizability, applicability and predictability (GAP) in randomized controlled trials. The majority (69%) of the included 29 studies were rated 'unclear' on the reporting of sufficient information for judging generalizability from sample to study population. Ten studies (35%) were rated 'unclear' on the reporting of sufficient information for judging applicability to other populations and settings. No study provided an assessment of the validity of the trial end-point measures for subsequent mortality, morbidity, quality of life or other economic or social outcomes. Similarly, no study reported on the validity of surrogate measures using established criteria for assessing surrogate end-points. Studies evaluating the benefits of family-based prevention of alcohol misuse in young people are generally inadequate at reporting information relevant to generalizability of the findings or implications for health or social outcomes. Researchers, study authors, peer reviewers, journal editors and scientific societies should take steps to improve the reporting of information relevant to external validity in prevention trials. © 2012 The Authors. Addiction © 2012 Society for the Study of Addiction.

Effect of Fluoride Varnish on Streptococcus mutans Count in Saliva of Caries Free Children Using Dentocult SM Strip Mutans Test: A Randomized Controlled Triple Blind Study.

PubMed

A, Deepti; Jeevarathan, J; Muthu, Ms; Prabhu V, Rathna; Chamundeswari

2008-09-01

The aim of this study was to estimate the count of Streptococcus mutans in saliva of caries free children using Dentocult SM strip mutans and to evaluate the effect of fluoride varnish on the Streptococcus mutans count in saliva of these caries free children. Thirty caries free children were selected for the study based on the information obtained from a questionnaire prepared. They were randomly assigned into the control group and the study group consisting of ten and twenty children respectively. Samples of saliva were collected using the saliva strips from the Dentocult SM kit and after incubation the presence of the Streptococcus mutans was evaluated using the manufacturers' chart. The study group was subjected to Fluor Protector fluoride varnish application after 24 hours following which the samples were collected again. The average Streptococcus mutans count in primary dentition of caries free children was in the range of 10(4) to 10(5) colony forming units/ml. The average Streptococcus mutans count in primary dentition of caries free children after Fluor Protector fluoride varnish application was below 10(4) colony forming units/ml. Fluor Protector fluoride varnish application showed a statistically significant reduction in the Streptococcus mutans count in saliva of the caries free children in the study group.

Findings From the EASY Minds Cluster Randomized Controlled Trial: Evaluation of a Physical Activity Integration Program for Mathematics in Primary Schools.

PubMed

Riley, Nicholas; Lubans, David R; Holmes, Kathryn; Morgan, Philip J

2016-02-01

To evaluate the impact of a primary school-based physical activity (PA) integration program delivered by teachers on objectively measured PA and key educational outcomes. Ten classes from 8 Australian public schools were randomly allocated to treatment conditions. Teachers from the intervention group were taught to embed movement-based learning in their students' (n = 142) daily mathematics program in 3 lessons per week for 6 weeks. The control group (n = 98) continued its regular mathematics program. The primary outcome was accelerometer-determined PA across the school day. Linear mixed models were used to analyze treatment effects. Significant intervention effects were found for PA across the school day (adjusted mean difference 103 counts per minute [CPM], 95% confidence interval [CI], 36.5-169.7, P = .008). Intervention effects were also found for PA (168 CPM, 95% CI, 90.1-247.4, P = .008) and moderate-to-vigorous PA (2.6%, 95% CI, 0.9-4.4, P = .009) in mathematics lessons, sedentary time across the school day (-3.5%, 95% CI, -7.0 to -0.13, P = .044) and during mathematics (-8.2%, CI, -13.0 to -2.0, P = .010) and on-task behavior (13.8%, 95% CI, 4.0-23.6, P = .011)-but not for mathematics performance or attitude. Integrating movement across the primary mathematics syllabus is feasible and efficacious.

Efficacy of Clarithromycin-Naproxen-Oseltamivir Combination in the Treatment of Patients Hospitalized for Influenza A(H3N2) Infection: An Open-label Randomized, Controlled, Phase IIb/III Trial.

PubMed

Hung, Ivan F N; To, Kelvin K W; Chan, Jasper F W; Cheng, Vincent C C; Liu, Kevin S H; Tam, Anthony; Chan, Tuen-Ching; Zhang, Anna Jinxia; Li, Patrick; Wong, Tin-Lun; Zhang, Ricky; Cheung, Michael K S; Leung, William; Lau, Johnson Y N; Fok, Manson; Chen, Honglin; Chan, Kwok-Hung; Yuen, Kwok-Yung

2017-05-01

Influenza causes excessive hospitalizations and deaths. The study assessed the efficacy and safety of a clarithromycin-naproxen-oseltamivir combination for treatment of serious influenza. From February to April 2015, we conducted a prospective open-label, randomized, controlled trial. Adult patients hospitalized for A(H3N2) influenza were randomly assigned to a 2-day combination of clarithromycin 500 mg, naproxen 200 mg, and oseltamivir 75 mg twice daily, followed by 3 days of oseltamivir or to oseltamivir 75 mg twice daily without placebo for 5 days as a control method (1:1). The primary end point was 30-day mortality. The secondary end points were 90-day mortality, serial nasopharyngeal aspirate (NPA) virus titer, percentage of neuraminidase-inhibitor-resistant A(H3N2) virus (NIRV) quasispecies, pneumonia severity index (PSI), and duration of hospital stay. Among the 217 patients with influenza A(H3N2) enrolled, 107 were randomly assigned to the combination treatment. The median age was 80 years, and 53.5% were men. Adverse events were uncommon. Ten patients died during the 30-day follow-up. The combination treatment was associated with lower 30-day mortality (P = .01), less frequent high dependency unit admission (P = .009), and shorter hospital stay (P < .0001). The virus titer and PSI (days 1-3; P < .01) and the NPA specimens with NIRV quasispecies ≥ 5% (days 1-2; P < .01) were significantly lower in the combination treatment group. Multivariate analysis showed that combination treatment was the only independent factor associated with lower 30-day mortality (OR, 0.06; 95% CI, 0.004-0.94; P = .04). Combination treatment reduced both 30- and 90-day mortality and length of hospital stay. Further study of the antiviral and immunomodulatory effects of this combination treatment of severe influenza is warranted. BioMed Central; No.: ISRCTN11273879 DOI 10.1186/ISRCTN11273879; URL: www.isrctn.com/ISRCTN11273879. Copyright © 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

School-based suicide prevention programmes: the SEYLE cluster-randomised, controlled trial.

PubMed

Wasserman, Danuta; Hoven, Christina W; Wasserman, Camilla; Wall, Melanie; Eisenberg, Ruth; Hadlaczky, Gergö; Kelleher, Ian; Sarchiapone, Marco; Apter, Alan; Balazs, Judit; Bobes, Julio; Brunner, Romuald; Corcoran, Paul; Cosman, Doina; Guillemin, Francis; Haring, Christian; Iosue, Miriam; Kaess, Michael; Kahn, Jean-Pierre; Keeley, Helen; Musa, George J; Nemes, Bogdan; Postuvan, Vita; Saiz, Pilar; Reiter-Theil, Stella; Varnik, Airi; Varnik, Peeter; Carli, Vladimir

2015-04-18

Suicidal behaviours in adolescents are a major public health problem and evidence-based prevention programmes are greatly needed. We aimed to investigate the efficacy of school-based preventive interventions of suicidal behaviours. The Saving and Empowering Young Lives in Europe (SEYLE) study is a multicentre, cluster-randomised controlled trial. The SEYLE sample consisted of 11,110 adolescent pupils, median age 15 years (IQR 14-15), recruited from 168 schools in ten European Union countries. We randomly assigned the schools to one of three interventions or a control group. The interventions were: (1) Question, Persuade, and Refer (QPR), a gatekeeper training module targeting teachers and other school personnel, (2) the Youth Aware of Mental Health Programme (YAM) targeting pupils, and (3) screening by professionals (ProfScreen) with referral of at-risk pupils. Each school was randomly assigned by random number generator to participate in one intervention (or control) group only and was unaware of the interventions undertaken in the other three trial groups. The primary outcome measure was the number of suicide attempt(s) made by 3 month and 12 month follow-up. Analysis included all pupils with data available at each timepoint, excluding those who had ever attempted suicide or who had shown severe suicidal ideation during the 2 weeks before baseline. This study is registered with the German Clinical Trials Registry, number DRKS00000214. Between Nov 1, 2009, and Dec 14, 2010, 168 schools (11,110 pupils) were randomly assigned to interventions (40 schools [2692 pupils] to QPR, 45 [2721] YAM, 43 [2764] ProfScreen, and 40 [2933] control). No significant differences between intervention groups and the control group were recorded at the 3 month follow-up. At the 12 month follow-up, YAM was associated with a significant reduction of incident suicide attempts (odds ratios [OR] 0·45, 95% CI 0·24-0·85; p=0·014) and severe suicidal ideation (0·50, 0·27-0·92; p=0·025), compared with the control group. 14 pupils (0·70%) reported incident suicide attempts at the 12 month follow-up in the YAM versus 34 (1·51%) in the control group, and 15 pupils (0·75%) reported incident severe suicidal ideation in the YAM group versus 31 (1·37%) in the control group. No participants completed suicide during the study period. YAM was effective in reducing the number of suicide attempts and severe suicidal ideation in school-based adolescents. These findings underline the benefit of this universal suicide preventive intervention in schools. Coordination Theme 1 (Health) of the European Union Seventh Framework Programme. Copyright © 2015 Elsevier Ltd. All rights reserved.

Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial.

PubMed

Bolinder, Jan; Antuna, Ramiro; Geelhoed-Duijvestijn, Petronella; Kröger, Jens; Weitgasser, Raimund

2016-11-05

Tight control of blood glucose in type 1 diabetes delays onset of macrovascular and microvascular diabetic complications; however, glucose levels need to be closely monitored to prevent hypoglycaemia. We aimed to assess whether a factory-calibrated, sensor-based, flash glucose-monitoring system compared with self-monitored glucose testing reduced exposure to hypoglycaemia in patients with type 1 diabetes. In this multicentre, prospective, non-masked, randomised controlled trial, we enrolled adult patients with well controlled type 1 diabetes (HbA 1c ≤58 mmol/mol [7·5%]) from 23 European diabetes centres. After 2 weeks of all participants wearing the blinded sensor, those with readings for at least 50% of the period were randomly assigned (1:1) to flash sensor-based glucose monitoring (intervention group) or to self-monitoring of blood glucose with capillary strips (control group). Randomisation was done centrally using the biased-coin minimisation method dependent on study centre and type of insulin administration. Participants, investigators, and study staff were not masked to group allocation. The primary outcome was change in time in hypoglycaemia (<3·9 mmol/L [70 mg/dL]) between baseline and 6 months in the full analysis set (all participants randomised; excluding those who had a positive pregnancy test during the study). This trial was registered with ClinicalTrials.gov, number NCT02232698. Between Sept 4, 2014, and Feb 12, 2015, we enrolled 328 participants. After the screening and baseline phase, 120 participants were randomly assigned to the intervention group and 121 to the control group, with outcomes being evaluated in 119 and 120, respectively. Mean time in hypoglycaemia changed from 3·38 h/day at baseline to 2·03 h/day at 6 months (baseline adjusted mean change -1·39) in the intervention group, and from 3·44 h/day to 3·27 h/day in the control group (-0·14); with the between-group difference of -1·24 (SE 0·239; p<0·0001), equating to a 38% reduction in time in hypoglycaemia in the intervention group. No device-related hypoglycaemia or safety issues were reported. 13 adverse events were reported by ten participants related to the sensor-four of allergy events (one severe, three moderate); one itching (mild); one rash (mild); four insertion-site symptom (severe); two erythema (one severe, one mild); and one oedema (moderate). There were ten serious adverse events (five in each group) reported by nine participants; none were related to the device. Novel flash glucose testing reduced the time adults with well controlled type 1 diabetes spent in hypoglycaemia. Future studies are needed to assess the effectiveness of this technology in patients with less well controlled diabetes and in younger age groups. Abbott Diabetes Care. Copyright © 2016 Elsevier Ltd. All rights reserved.

Decreased Brain Neurokinin-1 Receptor Availability in Chronic Tennis Elbow.

PubMed

Linnman, Clas; Catana, Ciprian; Svärdsudd, Kurt; Appel, Lieuwe; Engler, Henry; Långström, Bengt; Sörensen, Jens; Furmark, Tomas; Fredrikson, Mats; Borsook, David; Peterson, Magnus

Substance P is released in painful and inflammatory conditions, affecting both peripheral processes and the central nervous system neurokinin 1 (NK1) receptor. There is a paucity of data on human brain alterations in NK1 expression, how this system may be affected by treatment, and interactions between central and peripheral tissue alterations. Ten subjects with chronic tennis elbow (lateral epicondylosis) were selected out of a larger (n = 120) randomized controlled trial evaluating graded exercise as a treatment for chronic tennis elbow (lateral epicondylosis). These ten subjects were examined by positron emission tomography (PET) with the NK1-specific radioligand 11C-GR205171 before, and eight patients were followed up after treatment with graded exercise. Brain binding in the ten patients before treatment, reflecting NK1-receptor availability (NK1-RA), was compared to that of 18 healthy subjects and, longitudinally, to the eight of the original ten patients that agreed to a second PET examination after treatment. Before treatment, patients had significantly lower NK1-RA in the insula, vmPFC, postcentral gyrus, anterior cingulate, caudate, putamen, amygdala and the midbrain but not the thalamus and cerebellum, with the largest difference in the insula contralateral to the injured elbow. No significant correlations between brain NK1-RA and pain, functional severity, or peripheral NK1-RA in the affected limb were observed. In the eight patients examined after treatment, pain ratings decreased in everyone, but there were no significant changes in NK1-RA. These findings indicate a role for the substance P (SP) / NK1 receptor system in musculoskeletal pain and tissue healing. As neither clinical parameters nor successful treatment response was reflected in brain NK1-RA after treatment, this may reflect the diverse function of the SP/NK1 system in CNS and peripheral tissue, or a change too small or slow to capture over the three-month treatment.

Effect of Pseudomonas spp on infection of Peronosporaparasitica (Pers. Fr), the pathogen of downy mildew on Chinese cabbage

NASA Astrophysics Data System (ADS)

Damiri, N.; Mulawarman; Umayah, A.; Agustin, S. E.; Rahmiyah, M.

2018-01-01

This research was conducted to study the effect of the application of Pseudomonasspp on infection of Peronosporaparasitica (Pers. Fr), the pathogen of Downy mildew on Chinese cabbage. The research was conducted in the laboratory and greenhouse Department of Plant Pests and Diseases Faculty of Agriculture Sriwijaya University, Inderalaya, OganIlir South Sumatra Indonesia. The research was conducted in the laboratory and greenhouse Department of Plant Pests and Diseases Faculty of Agriculture Sriwijaya University, Inderalaya, Ogan Ilir South Sumatra Indonesia. The research was conducted using Completely Randomized Design with ten treatments including control. ie: isolate A, Isolate B, isolate C, isolate D, isolate E, isolate F, isolate G, isolate H, isolate I and control. Each treatment consists of four replications. Results of the study showed that the application of Pseudomonas spp. can suppress the infection of P. parasitica on Chinese cabbage. The lowest disease intensity was shown by treatment C (isolate Pseudomonas sp.) which was significantly different from control. The best treatment in suppressing disease severity of downy mildew on chinese cabbage was isolate H which had disease severity of 37.07 percent, which was significantly different from control and other treatment.

Does sensory transcutaneous electrical stimulation enhance motor recovery following a stroke? A systematic review.

PubMed

Laufer, Yocheved; Elboim-Gabyzon, Michal

2011-01-01

Somatosensory input may lead to long-lasting cortical plasticity enhanced by motor recovery in patients with neurological impairments. Sensory transcutaneous electrical stimulation (TENS) is a relatively risk-free and easy-to-implement modality for rehabilitation. The authors systematically examine the effects of sensory TENS on motor recovery after stroke. Eligible randomized or quasi-randomized trials were identified via searches of computerized databases. Two assessors reviewed independently the eligibility and methodological quality of the retrieved articles. In all, 15 articles satisfied the inclusion criteria. Methodological quality was generally good, with a mean (standard deviation) PEDro score of 6.7/10 (1.2). Although the majority of studies reported significant effects on at least 1 outcome measure, effect sizes were generally small. Meta-analysis could not be performed for the majority of outcome measures because of variability between studies and insufficient data. A moderate effect was determined for force production of the ankle dorsiflexors and for the Timed Up and Go test. Sensory stimulation via TENS may be beneficial to enhance aspects of motor recovery following a stroke, particularly when used in combination with active training. Because of the great variability between studies, particularly in terms of the timing of the intervention after the stroke, the outcome measures used, and the stimulation protocols, insufficient data are available to provide guidelines about strategies and efficacy.

Zinc supplementation for the prevention of acute lower respiratory infection in children in developing countries: meta-analysis and meta-regression of randomized trials.

PubMed

Roth, Daniel E; Richard, Stephanie A; Black, Robert E

2010-06-01

Routine zinc supplementation is a potential intervention for the prevention of acute lower respiratory infection (ALRI) in developing countries. However, discrepant findings from recent randomized trials remain unexplained. Randomized trials of zinc supplementation in young children in developing countries were identified by a systematic literature review. Trials included in the meta-analysis met specific criteria, including participants <5 years of age, daily/weekly zinc and control supplementation for greater than 3 months, active household surveillance for respiratory morbidity and use of a case definition that included at least one sign of lower respiratory tract illness. ALRI case definitions were classified on the basis of specificity/severity. Incidence rate ratios (IRRs) were pooled by random-effects models. Meta-regression and sub-group analysis were performed to assess potential sources of between-study heterogeneity. Ten trials were eligible for inclusion (n = 49 450 children randomized). Zinc reduced the incidence of ALRI defined by specific clinical criteria [IRR 0.65, 95% confidence interval (CI) 0.52-0.82], but had no effect on lower-specificity ALRI case definitions based on caregiver report (IRR 1.01, 95% CI 0.91-1.12) or World Health Organization 'non-severe pneumonia' (0.96, 95% CI 0.86-1.08). By meta-regression, the effect of zinc was associated with ALRI case definition, but not with mean baseline age, geographic location, nutritional status or zinc dose. Routine zinc supplementation reduced the incidence of childhood ALRI defined by relatively specific clinical criteria, but the effect was null if lower specificity case definitions were applied. The choice of ALRI case definition may substantially influence inferences from community trials regarding the efficacy of preventive interventions.

Effects of tea or tea extract on metabolic profiles in patients with type 2 diabetes mellitus: a meta-analysis of ten randomized controlled trials.

PubMed

Li, Yanchuan; Wang, Cheng; Huai, Qingjie; Guo, Fuchuan; Liu, Liyan; Feng, Rennan; Sun, Changhao

2016-01-01

As consumption of tea has been confirmed as a protective factor for type 2 diabetes mellitus (T2DM), it would be interesting to know if T2DM patients could benefit from tea. Because of small sample sizes and inconsistent results of previous studies, we performed this meta-analysis to reevaluate the effects of tea or tea extract on all available outcomes in patients with T2DM. We systematically searched electronic databases of PubMed, Cochrane Library and EMBASE to identify randomized controlled trials of tea in T2DM patients up to January 2015. Weight mean differences for the changes in all outcomes were pooled by Review Manager 5.2 (Cochrane Collaboration, Oxford, England). A total of ten trials including 608 subjects were identified. The meta-analysis found that tea could alleviate the decrease of fasting blood insulin [1.30 U/L, 95% CI (0.36, 2.24)], and reduced waist circumference only in more than 8-week intervention [-2.70 cm, 95% CI (-4.72, -0.69)], whereas there were no statistically significant differences with regard to homeostasis model of insulin resistance 0.38 (-0.18, 0.95), fasting blood glucose -0.05 mmol/L (-0.51, 0.40), low density lipoprotein-cholesterol 0.07 mmol/L (-0.15, 0.29), high density lipoprotein-cholesterol 0.01 mmol/L (-0.08, 0.09), body mass index -0.15 kg/m(2) (-0.50, 0.21), SBP 0.35 mmHg (-3.54, 4.24), DBP -1.02 mmHg (-3.53, 1.48), triglycerides -0.11 mmol/L (-0.28, 0.05) and fasting cholesterol -0.05 mmol/L (-0.20, 0.11) in patients with T2DM, and leptin, ADPN, CRE and UA were also non-significant. The intervention of tea or tea extraction could maintain a stable fasting blood insulin and reduce waist circumference in the T2DM patients; however, the effects on other outcomes were not significant. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Ten-day bismuth-containing quadruple therapy is effective as first-line therapy for Helicobacter pylori-related chronic gastritis: a prospective randomized study in China.

PubMed

Wang, L; Lin, Z; Chen, S; Li, J; Chen, C; Huang, Z; Ye, B; Ding, J; Li, W; Wu, L; Jiang, Y; Meng, L; Du, Q; Si, J

2017-06-01

To investigate the effectiveness of 10-day bismuth-containing quadruple (B-quadruple) treatment as first-line therapy in patients with Helicobacter pylori-related chronic gastritis. A randomized controlled trial was conducted from October 2011 to December 2013 in Zhejiang, China, including patients with H. pylori-related chronic gastritis who were randomly provided either 10-day omeprazole-based triple therapy (OM-triple; omeprazole 20 mg twice daily, clarithromycin 500 mg twice daily and amoxicillin 1 g twice daily) or 10-day B-quadruple therapy (OM-triple + bismuth subcitrate 120 mg four times daily). H. pylori status, pathologic findings and dyspeptic symptoms were assessed at baseline and after 3 months. The primary outcome was H. pylori eradication rates by intention-to-treat (ITT) and per-protocol (PP) analyses. The secondary outcomes were the histologic and symptomatic benefits from H. pylori eradication. A total of 351 patients with H. pylori-related chronic gastritis were recruited. The eradication rates of the OM-triple and B-quadruple groups were 58.4% (108/185) and 86.1% (143/166) respectively according to ITT analysis (p <0.01). PP rates of H. pylori eradication were 63.2% (108/171) and 92.3% (143/155) respectively (p <0.01). According to the PP analysis, active and chronic inflammation in gastric mucosa was substantially improved in all treated patients (n=326). However, pathologic atrophic gastritis and intestinal metaplasia did not regress in both groups (n=326). The reduction of dyspeptic symptoms score was significantly higher in the B-quadruple group than in the OM-triple group (0.59±0.057 vs. 0.39±0.046) (p <0.01). Ten-day B-quadruple therapy is more effective than OM-triple therapy as first-line therapy for patients with H. pylori-induced chronic gastritis in China. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Immediate postpartum initiation of etonogestrel-releasing implant: A randomized controlled trial on breastfeeding impact.

PubMed

Braga, Giordana Campos; Ferriolli, Eduardo; Quintana, Silvana Maria; Ferriani, Rui Alberto; Pfrimer, Karina; Vieira, Carolina Sales

2015-12-01

Breast milk volume has never been evaluated when the etonogestrel (ENG) implant was inserted immediately postpartum. Thus, this study evaluated if the immediate postpartum insertion of the ENG implant alters breast milk volume. Twenty-four postpartum women and their newborns (NBs) were randomized into two groups: Implant group (ENG implant inserted within 48 h after delivery) and Control group (absence of contraceptive method). The primary outcome was the amount of breast milk intake by the NBs in the first 6 weeks after delivery. Five and ten grams of deuterium (D(2)O) were orally administered to the postpartum women on the day of randomization (day 0) and on the 29th study day, respectively. Saliva samples were collected from the mother-NB pairs prior to each D(2)O dose administration and after D(2)O ingestion (periodic collection). The amount of breast milk ingested by the NBs was estimated by the amount of deuterium (D(2)O) ingested by the NBs through breastfeeding, using mass spectrometry in the saliva samples. Twenty-four postpartum women and their NB were randomized (12 per group). The median of breast milk intake by NBs following the two D(2)O doses were similar between groups {first D(2)O dose [Implant: 340 mL/day (240-420 mL/day) vs. 330 mL/day (300-530 mL/day), p=.54]; second D(2)O dose [Implant: 845 mL/day (770-980 mL/day) vs. 785 mL/day (680-980 mL/day), p=.63]}. The exclusive breastfeeding rate and NB weight were similar between groups in the first 6 weeks postpartum. ENG implant insertion immediately postpartum does not alter the volume of breast milk intake by NBs. Considering the benefits of immediate postpartum initiation of ENG implant on reducing unintended pregnancy and pregnancy recurrence, especially in vulnerable populations, our study adds safety data on breastfeeding effect of this practice. Copyright © 2015 Elsevier Inc. All rights reserved.

Maraviroc, a chemokine receptor-5 antagonist, fails to demonstrate efficacy in the treatment of patients with rheumatoid arthritis in a randomized, double-blind placebo-controlled trial

PubMed Central

2012-01-01

Introduction The purpose of this study was to determine whether maraviroc, a human CC chemokine receptor 5 (CCR5) antagonist, is safe and effective in the treatment of active rheumatoid arthritis (RA) in patients on background methotrexate (MTX). Methods This phase IIa study comprised two distinct components: an open-label safety study of the pharmacokinetics (PK) of MTX in the presence of maraviroc, and a randomized, double-blind, placebo-controlled, proof-of-concept (POC) component. In the PK component, patients were randomized 1:1 to receive maraviroc 150 or 300 mg twice daily (BID) for four weeks. In the POC component, patients were randomized 2:1 to receive maraviroc 300 mg BID or placebo for 12 weeks. Patients were not eligible for inclusion in both components. Results Sixteen patients were treated in the safety/PK component. Maraviroc was well tolerated and there was no evidence of drug-drug interaction with MTX. One hundred ten patients were treated in the POC component. The study was terminated after the planned interim futility analysis due to lack of efficacy, at which time 59 patients (38 maraviroc; 21 placebo) had completed their week 12 visit. There was no significant difference in the number of ACR20 responders between the maraviroc (23.7%) and placebo (23.8%) groups (treatment difference -0.13%; 90% CI -20.45, 17.70; P = 0.504). The most common all-causality treatment-emergent adverse events in the maraviroc group were constipation (7.8%), nausea (5.2%), and fatigue (3.9%). Conclusions Maraviroc was generally well tolerated over 12 weeks; however, selective antagonism of CCR5 with maraviroc 300 mg BID failed to improve signs and symptoms in patients with active RA on background MTX. Trial Registration ClinicalTrials.gov: NCT00427934 PMID:22251436

Modal identification of structures from the responses and random decrement signatures

NASA Technical Reports Server (NTRS)

Brahim, S. R.; Goglia, G. L.

1977-01-01

The theory and application of a method which utilizes the free response of a structure to determine its vibration parameters is described. The time-domain free response is digitized and used in a digital computer program to determine the number of modes excited, the natural frequencies, the damping factors, and the modal vectors. The technique is applied to a complex generalized payload model previously tested using sine sweep method and analyzed by NASTRAN. Ten modes of the payload model are identified. In case free decay response is not readily available, an algorithm is developed to obtain the free responses of a structure from its random responses, due to some unknown or known random input or inputs, using the random decrement technique without changing time correlation between signals. The algorithm is tested using random responses from a generalized payload model and from the space shuttle model.

Contamination Control Changes to the Reusable Solid Rocket Motor Program: A Ten Year Review

NASA Technical Reports Server (NTRS)

Bushman, David M.

1998-01-01

During the post Challenger period, the National Aeronautics and Space Administration and Thiokol implemented changes to the Reusable Solid Rocket Motor (RSRM) contract to include provisions for contamination control to enhance the production environment. During the ten years since those agreements for contamination controls were made, many changes have taken place in the production facilities at Thiokol. These changes have led to the production of much higher quality shuttle solid rocket motors and improved cleanliness and safety of operations in the production facilities. The experience in contamination control over this past decade highlights the value these changes have brought to the RSRM program, and how the system can be improved to meet the challenges the program will face in the next ten years.

Does transcutaneous nerve stimulation have effect on sympathetic skin response?

PubMed

Okuyucu, E Esra; Turhanoğlu, Ayşe Dicle; Guntel, Murat; Yılmazer, Serkan; Savaş, Nazan; Mansuroğlu, Ayhan

2018-01-01

This study examined the effects of transcutaneous electrical nerve stimulation (TENS) on the sympathetic nerve system by sympathetic skin response test. Fifty-five healthy volunteers received either: (i) 30minutes TENS (25 participants) (ii) 30minutes sham TENS (30 participants) and SSR test was performed pre- and post-TENS. The mean values of latency and peak-to-peak amplitude of five consecutive SSRs were calculated. A significant amplitude difference was found between TENS and sham TENS group both in right and left hand (p=0.04, p=0.01, respectively). However there was no significant latancy difference between two groups (p>0.05 ). TENS has an inhibitory effect on elicited SNS responses when compared with sham TENS control group. Copyright © 2017 Elsevier Ltd. All rights reserved.

A Multilevel Model to Estimate the Within- and the Between-Center Components of the Exposure/Disease Association in the EPIC Study

PubMed Central

2015-01-01

In a multicenter study, the overall relationship between exposure and the risk of cancer can be broken down into a within-center component, which reflects the individual level association, and a between-center relationship, which captures the association at the aggregate level. A piecewise exponential proportional hazards model with random effects was used to evaluate the association between dietary fiber intake and colorectal cancer (CRC) risk in the EPIC study. During an average follow-up of 11.0 years, 4,517 CRC events occurred among study participants recruited in 28 centers from ten European countries. Models were adjusted by relevant confounding factors. Heterogeneity among centers was modelled with random effects. Linear regression calibration was used to account for errors in dietary questionnaire (DQ) measurements. Risk ratio estimates for a 10 g/day increment in dietary fiber were equal to 0.90 (95%CI: 0.85, 0.96) and 0.85 (0.64, 1.14), at the individual and aggregate levels, respectively, while calibrated estimates were 0.85 (0.76, 0.94), and 0.87 (0.65, 1.15), respectively. In multicenter studies, over a straightforward ecological analysis, random effects models allow information at the individual and ecologic levels to be captured, while controlling for confounding at both levels of evidence. PMID:25785729

Follow-up home visits with registered dietitians have a positive effect on the functional and nutritional status of geriatric medical patients after discharge: a randomized controlled trial.

PubMed

Beck, Anne Marie; Kjær, Stine; Hansen, Birthe Stenbæk; Storm, Rikke Lunau; Thal-Jantzen, Kirsten; Bitz, Christian

2013-06-01

To assess the additional benefits of individualized nutritional counselling by a registered dietitian in geriatric patients' home after discharge from hospital, in relation to risk of re-admissions, functional status, nutritional status, use of social services and mortality. Twelve-week single-blind randomized controlled study. Geriatric medical patients (65+ years) at nutritional risk. Participants were randomly allocated to receive a visit in their homes, either three individualized nutritional counselling by a registered dietitian complemented with three follow-up visits by general practitioners or three follow-up visits by general practitioners alone. Primary outcome was risk of re-admissions. Secondary outcomes were functional status (hand grip strength, chair stand, mobility, disability and tiredness in daily activities, rehabilitation capacity), nutritional status (weight, BMI, energy and protein intake), need of social services (home care, home nursing, meals-on-wheels) and mortality. One hundred and fifty-two patients were included; 132 (87%) completed the first and 124 (82%) the second data collection after 12 weeks. Ten per cent of the participants had three contacts with their general practitioner, while compliance with the dietetic intervention was almost 100%. Odds ratio for re-admission and mortality after 26 weeks was 1.62 (95% confidence interval (CI) 0.85 to 3.10) and 0.60 (95% CI 0.17 to 2.13). The intervention had a positive effect on functional status (i.e. mobility, P = 0.029), and nutritional status (i.e. weight, P = 0.035; energy intake, P < 0.001; protein intake, P = 0.001) and the use of meals-on wheels was reduced (P = 0.084). Follow-up home visits with registered dietitians have a positive effect on the functional and nutritional status of geriatric medical patients after discharge.

Ziprasidone Augmentation of Escitalopram for Major Depressive Disorder: Efficacy Results From a Randomized, Double-Blind, Placebo-Controlled Study.

PubMed

Papakostas, George I; Fava, Maurizio; Baer, Lee; Swee, Michaela B; Jaeger, Adrienne; Bobo, William V; Shelton, Richard C

2015-12-01

The authors sought to test the efficacy of adjunctive ziprasidone in adults with nonpsychotic unipolar major depression experiencing persistent symptoms after 8 weeks of open-label treatment with escitalopram. This was an 8-week, randomized, double-blind, parallel-group, placebo-controlled trial conducted at three academic medical centers. Participants were 139 outpatients with persistent symptoms of major depression after an 8-week open-label trial of escitalopram (phase 1), randomly assigned in a 1:1 ratio to receive adjunctive ziprasidone (escitalopram plus ziprasidone, N=71) or adjunctive placebo (escitalopram plus placebo, N=68), with 8 weekly follow-up assessments. The primary outcome measure was clinical response, defined as a reduction of at least 50% in score on the 17-item Hamilton Depression Rating Scale (HAM-D). The Hamilton Anxiety Rating scale (HAM-A) and Visual Analog Scale for Pain were defined a priori as key secondary outcome measures. Rates of clinical response (35.2% compared with 20.5%) and mean improvement in HAM-D total scores (-6.4 [SD=6.4] compared with -3.3 [SD=6.2]) were significantly greater for the escitalopram plus ziprasidone group. Several secondary measures of antidepressant efficacy also favored adjunctive ziprasidone. The escitalopram plus ziprasidone group also showed significantly greater improvement on HAM-A score but not on Visual Analog Scale for Pain score. Ten (14%) patients in the escitalopram plus ziprasidone group discontinued treatment because of intolerance, compared with none in the escitalopram plus placebo group. Ziprasidone as an adjunct to escitalopram demonstrated antidepressant efficacy in adult patients with major depressive disorder experiencing persistent symptoms after 8 weeks of open-label treatment with escitalopram.

Early Weightbearing and Range of Motion Versus Non-Weightbearing and Immobilization After Open Reduction and Internal Fixation of Unstable Ankle Fractures: A Randomized Controlled Trial.

PubMed

Dehghan, Niloofar; McKee, Michael D; Jenkinson, Richard J; Schemitsch, Emil H; Stas, Venessa; Nauth, Aaron; Hall, Jeremy A; Stephen, David J; Kreder, Hans J

2016-07-01

The aim of this study was to compare early weightbearing and range of motion (ROM) to nonweightbearing and immobilization in a cast after surgical fixation of unstable ankle fractures. Multicentre randomized controlled trial. Two-level one trauma centers. One hundred ten patients who underwent open reduction and internal fixation of an unstable ankle fracture were recruited and randomized. One of 2 rehabilitation protocols: (1) Early weightbearing (weightbearing and ROM at 2 weeks, Early WB) or (2) Late weightbearing (nonweightbearing and cast immobilization for 6 weeks, Late WB). The primary outcome measure was time to return to work (RTW). Secondary outcome measures included: ankle ROM, SF-36 heath outcome scores, Olerud/Molander ankle function score, and rates of complications. There was no difference in RTW. At 6 weeks postoperatively, patients in the Early WB group had significantly improved ankle ROM (41 vs. 29, P < 0.0001); Olerud/Molander ankle function scores (45 vs. 32, P = 0.0007), and SF-36 scores on both the physical (51 vs. 42, P = 0.008) and mental (66 vs. 54, P = 0.0008) components. There were no differences with regard to wound complications or infections and no cases of fixation failure or loss of reduction. Patients in the Late WB group had higher rates of planned/performed hardware removal due to plate irritation (19% vs. 2%, P = 0.005). Given the convenience for the patient, early improved functional outcome, and the lack of an increased complication rate, we recommend early postoperative weightbearing and ROM in patients with surgically treated ankle fractures. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Melatonin improves sleep in children with epilepsy: randomized, double-blind cross-over study

PubMed Central

Jain, Sejal V; Horn, Paul S; Simakajornboon, Narong; Beebe, Dean W; Holland, Katherine; Byars, Anna W; Glauser, Tracy A

2015-01-01

Objective Insomnia, especially maintenance insomnia is widely prevalent in epilepsy. Although melatonin is commonly used, limited data address its efficacy. We performed a randomized, double-blind, placebo-controlled, cross-over study to identify the effects of melatonin on sleep and seizure control in children with epilepsy. Methods Eleven pre-pubertal, developmentally normal children aged 6–11 years with epilepsy were randomized by software algorithm to receive placebo or 9 mg sustained release melatonin for 4 weeks, followed by a 1-week washout and 4-week crossover condition. The pharmacy performed blinding; patients, parents and study staff other than a statistician were blinded. Primary outcomes were sleep onset latency and wakefulness after sleep onset (WASO) measured on polysomnography. Secondary outcomes included seizure frequency, epileptiform spike density per hour of sleep on EEG and reaction time measures on psychomotor vigilance task. Statistical tests appropriate for cross-over designs were used for analysis. Results Data were analyzed from ten subjects who completed the study. Melatonin decreased sleep latency (Mean difference (MD): 11.4 min, p= 0.02) and WASO (MD 22 min, p=0.04) as compared to placebo. No worsening of spike density or seizure frequency was seen. Additionally, Slow-wave sleep duration and REM latency were increased with melatonin and REM sleep duration was decreased. These changes were statistically significant. Worsening of headache was noted in one subject with migraine on melatonin. Conclusion Sustained-release melatonin resulted in statistically significant decreases in sleep latency and WASO. No clear effects on seizures were observed but the study was too small to allow any conclusions to be drawn in this regard. PMID:25862116

Effect of oil gum massage therapy on common pathogenic oral microorganisms - A randomized controlled trial

PubMed Central

Singla, Nishu; Acharya, Shashidhar; Martena, Suganthi; Singla, Ritesh

2014-01-01

Objectives: (i) To assess reduction in Streptococcus mutans and Lactobacillus species count in saliva sample after ten minutes of oil gum massage therapy (massage of gingival tissues) per day for three weeks with sesame oil, olive oil, and coconut oil in three different groups of subjects. (ii) To compare the efficacy between three different oils and the “gold standard” chlorhexidine gel. (iii) To assess reduction in gingival scores and plaque scores of study subjects. Materials and Methods: Study design – Single center, parallel design, and triple blind randomized clinical study with four treatment groups. Participants: 32 of the 40 study subjects working as housekeeping personnel at Kasturba Hospital, Manipal; aged 18-55 years completed the three-week study period. Interventions: Subjects were randomly assigned to massage their gingiva everyday for three weeks with sesame oil, olive oil, coconut oil (tests), and Chlorhexidine gel (control). Oral health status and paraffin stimulated saliva samples were obtained at baseline and after three weeks of oil gum massage therapy. Outcome measures: Microbial culture, plaque index, and gingival index. Statistical analysis: Paired t test and Kruskal Wallis test. Results: There was a significant reduction in mean Streptococcus mutans count, Lactobacillus count, plaque scores, and gingival scores in all four groups after the study. However, there was no significant difference found in percentage reduction of these variables between the four groups. Conclusion: These oils can be used as valuable preventive agents in maintaining and improving oral health in low socioeconomic status population. However, it is recommended that further research should be conducted in other populations with a larger sample and longer duration of follow-up period. PMID:25210256

Physical Examination-Indicated Cerclage: A Systematic Review and Meta-analysis.

PubMed

Ehsanipoor, Robert M; Seligman, Neil S; Saccone, Gabriele; Szymanski, Linda M; Wissinger, Christina; Werner, Erika F; Berghella, Vincenzo

2015-07-01

To estimate the effectiveness of physical examination-indicated cerclage in the setting of second-trimester cervical dilatation by systematic review and meta-analysis of published studies. We searched MEDLINE, EMBASE, Scopus, ClinicalTrials.gov, Web of Science, and the Cochrane Library for studies published between 1966 and 2014 that evaluated cervical cerclage for the treatment of cervical insufficiency. The search yielded 6,314 citations. We included cohort studies and randomized controlled trials comparing cerclage placement with expectant management of women with cervical dilatation between 14 and 27 weeks of gestation. Two investigators independently reviewed each citation for inclusion or exclusion and discordant decisions were arbitrated by a third reviewer. Summary estimates were reported as the mean difference and 95% confidence interval (CI) for continuous variables or relative risk and with 95% CI for dichotomous outcomes. Fixed- and random-effects meta-analysis was used, depending on heterogeneity. Ten studies met inclusion criteria and were included in the final analysis. One was a randomized controlled trial, two were prospective cohort studies, and the remaining seven were retrospective cohort studies. Of the 757 women, 485 (64%) underwent physical examination-indicated cerclage placement and 272 (36%) were expectantly managed. Cerclage was associated with increased neonatal survival (71% compared with 43%; relative risk 1.65, 95% CI 1.19-2.28) and prolongation of pregnancy (mean difference 33.98 days, 95% CI 17.88-50.08). Physical examination-indicated cerclage is associated with a significant increase in neonatal survival and prolongation of pregnancy of approximately 1 month when compared with no such cerclage. The strength of this conclusion is limited by the potential for bias in the included studies.

Repetitive transcranial magnetic stimulation of the right parietal cortex for comorbid generalized anxiety disorder and insomnia: A randomized, double-blind, sham-controlled pilot study.

PubMed

Huang, Zhaoyang; Li, Yue; Bianchi, Matt T; Zhan, Shuqin; Jiang, Fengying; Li, Ning; Ding, Yan; Hou, Yue; Wang, Li; Ouyang, Quping; Wang, Yuping

2018-05-29

Repetitive transcranial magnetic stimulation (rTMS) has been considered to be a promising technique for the treatment of neuropsychiatric disorders. However, little is known about the effectiveness of rTMS in the treatment of generalized anxiety disorder (GAD). Moreover, treatment data on comorbid GAD and insomnia remain lacking. The aim of this study was to examine the therapeutic effects of 1 Hz rTMS applied over the right parietal lobe on both anxiety and insomnia symptoms in patients with comorbid GAD and insomnia. 36 patients were randomized to either sham or active rTMS group (n = 18 each group). The rTMS was administered over the right posterior parietal cortex (P4 electrode site) at a frequency of 1 Hz and an intensity of 90% of the resting motor threshold. Ten days of 1 Hz rTMS to the right parietal lobe significantly improved both anxiety and insomnia symptoms in the active group. Although the anxiety severity was not significantly correlated with insomnia severity at baseline, the improvement in the Hamilton Rating Scale for Anxiety (HRSA) scores were positively correlated with improvement in the Pittsburgh Sleep Quality Index (PSQI) scores. The present study is the first randomized sham-controlled study to assess the effectiveness of low frequency rTMS on the right parietal lobe in patients with comorbid GAD and insomnia. Our results suggested that 1 Hz low frequency rTMS administered over the parietal cortex is effective for both anxiety and insomnia symptoms in patients with comorbid GAD and insomnia. Copyright © 2018 Elsevier Inc. All rights reserved.

Does topical amethocaine gel reduce pain from heel prick blood sampling in premature infants? A randomized double-blind cross-over controlled study

PubMed Central

Patel, Amita; Czerniawski, Barbara; Gray, Shari; Lui, Eric

2003-01-01

BACKGROUND: Heel prick blood sampling is the most common painful invasive procedure performed on neonates. Currently, there are no effective ways to provide pain relief from this painful procedure. OBJECTIVE: To assess the efficacy of the topical anesthetic amethocaine 4% gel (Ametop, Smith & Nephew Inc, St Laurent) in reducing the pain of heel prick blood sampling in neonates. METHODS: A randomized, double-blind, placebo controlled, crossover trial was conducted. Neonates between 33 to 37 weeks’ gestational age in their first seven days of life were eligible. Heel prick blood sampling was performed on each participant twice. Each infant was randomly assigned to receive either amethocaine 4% gel or placebo to the heel for the first prick, and then received the alternative agent for the second prick. Prick pain was assessed using both Premature Infant Pain Profile (PIPP) and Neonatal Infant Pain Scale (NIPS). Squeeze pain was assessed by NIPS. RESULTS: Ten babies were recruited. There were no significant differences in the average PIPP and NIPS scores between the treatment and placebo groups for both prick and squeeze pains from heel prick blood sampling. For prick pain, linear-regression showed significant correlation between the PIPP and NIPS scores. No adverse reactions were observed after application of either the active or placebo agents. CONCLUSION: Topical amethocaine 4% gel is not shown to reduce prick and squeeze pains significantly from heel prick blood sampling in neonates between 33 to 37 weeks’ gestational age. Further studies are needed to find ways to provide effective pain relief from this common procedure. PMID:20020001

The Development and Evaluation of a Vocational Rehabilitation Training Programme for Rheumatology Occupational Therapists†

PubMed Central

O'Brien, Rachel; Woodbridge, Sarah; Hammond, Alison; Adkin, Julie; Culley, June

2013-01-01

People with inflammatory arthritis rapidly develop work disability, yet there is limited provision of vocational rehabilitation (VR) in rheumatology departments. As part of a randomized, controlled trial, ten occupational therapists (OTs) were surveyed to identify their current VR provision and training needs. As a result, a VR training course for OTs was developed which included both taught and self-directed learning. The course included: employment and health and safety legislation, work assessment and practical application of ergonomic principles at work. Pre-, immediately post- and two months post-training, the ten OTs completed a questionnaire about their VR knowledge and confidence On completion, they reported a significant increase (p < 0.01)in their knowledge and confidence when delivering vocational rehabilitation. They rated the course as very or extremely relevant, although seven recommended more practical sessions. The preference for practical sessions was highlighted, in that the aspects they felt most beneficial were role-playing assessments and sharing ideas through discussion and presentations. In conclusion, the course was considered effective in increasing both knowledge and confidence in using VR as an intervention, but, due to time constraints within the working day, some of the self-directed learning should be incorporated into the training days. Copyright © 2013 John Wiley & Sons, Ltd. PMID:23703966

The development and evaluation of a vocational rehabilitation training programme for rheumatology occupational therapists.

PubMed

O'Brien, Rachel; Woodbridge, Sarah; Hammond, Alison; Adkin, Julie; Culley, June

2013-06-01

People with inflammatory arthritis rapidly develop work disability, yet there is limited provision of vocational rehabilitation (VR) in rheumatology departments. As part of a randomized, controlled trial, ten occupational therapists (OTs) were surveyed to identify their current VR provision and training needs. As a result, a VR training course for OTs was developed which included both taught and self-directed learning. The course included: employment and health and safety legislation, work assessment and practical application of ergonomic principles at work. Pre-, immediately post- and two months post-training, the ten OTs completed a questionnaire about their VR knowledge and confidence On completion, they reported a significant increase (p < 0.01)in their knowledge and confidence when delivering vocational rehabilitation. They rated the course as very or extremely relevant, although seven recommended more practical sessions. The preference for practical sessions was highlighted, in that the aspects they felt most beneficial were role-playing assessments and sharing ideas through discussion and presentations. In conclusion, the course was considered effective in increasing both knowledge and confidence in using VR as an intervention, but, due to time constraints within the working day, some of the self-directed learning should be incorporated into the training days. Copyright © 2013 John Wiley & Sons, Ltd.

The KiVa antibullying program in primary schools in Chile, with and without the digital game component: study protocol for a randomized controlled trial.

PubMed

Gaete, Jorge; Valenzuela, Daniela; Rojas-Barahona, Cristian; Valenzuela, Eduardo; Araya, Ricardo; Salmivalli, Christina

2017-02-20

Bullying is a major problem worldwide and Chile is no exception. Bullying is defined as a systematic aggressive behavior against a victim who cannot defend him or herself. Victims suffer social isolation and psychological maladjustment, while bullies have a higher risk for conduct problems and substance use disorders. These problems appear to last over time. The KiVa antibullying program has been evaluated in Finland and other European countries, showing preventive effects on victimization and self-reported bullying. The aims of this study are (1) to develop a culturally appropriate version of the KiVa material and (2) to test the effectiveness of the KiVa program, with and without the online game, on reducing experiences of victimization and bullying behavior among vulnerable primary schools in Santiago (Chile), using a cluster randomized controlled trial (RCT) design with three arms: (1) full KiVa program group, (2) partial KiVa (without online game) program group and (3) control group. This is a three-arm, single-blind, cluster randomized controlled trial (RCT) with a target enrolment of 1495 4th and 5th graders attending 13 vulnerable schools per arm. Students in the full and partial KiVa groups will receive universal actions: ten 2-h lessons delivered by trained teachers during 1 year; they will be exposed to posters encouraging them to support victims and behave constructively when witnessing bullying; and a person designated by the school authorities will be present in all school breaks and lunchtimes using a visible KiVa vest to remind everybody that they are in a KiVa school. KiVa schools also will have indicated actions, which consist of a set of discussion groups with the victims and with the bullies, with proper follow-up. Only full KiVa schools will also receive an online game which has the aim to raise awareness of the role of the group in bullying, increase empathy and promote strategies to support victimized peers. Self-reported victimization, bullying others and peer-reported bullying actions, psychological and academic functioning, and sense of school membership will be measured at baseline and 12 months after randomization. This is the first cluster RCT of the KiVa antibullying program in Latin America. ClinicalTrials.gov, Identifier: NCT02898324 . Registered on 8 September 2016.

Thinking Deeply about Area and Perimeter

ERIC Educational Resources Information Center

Nirode, Wayne

2011-01-01

While contemplating ways to extend the author's ninth-grade honors geometry students' thinking and knowledge about area and perimeter, he discovered an interesting type of problem based on Erickson's (2001) rectangle problem, which he had been using for ten years. Erickson's original problem involves creating random rectangles with lengths and…

Student Conduct Systems at Public Colleges and Universities in China

ERIC Educational Resources Information Center

Luo, Wenyan

2012-01-01

The purpose of this qualitative study was to use the systems theory as the analytic framework to examine student conduct systems (SCSs) in Chinese colleges and universities. analyze environmental factors that influence SCSs. and explore administrators' recommendations for improvement of SCSs. Ten public universities were randomly selected from…

Random Fill Cache Architecture (Preprint)

DTIC Science & Technology

2014-10-01

a concrete example, we show how the cache collision attack works to extract the AES encryption keys (e.g., in the OpenSSL implementation of AES). AES...each round are implemented as table lookups for performance reasons. OpenSSL uses ten 1-KB lookup tables, five for encryption and five for decryption

A Study of Micro-Teaching in the Preservice Education of Science Teachers.

ERIC Educational Resources Information Center

Goldwaite, Daniel Thaddeus

The effectiveness of microteaching techniques for improving presentation of science demonstrations by perspective science teachers was investigated. Three groups of students of ten members each were randomly selected from professional education courses for science teachers. Group A students presented two trials of two different demonstrations.…

Learning What Works in Sensory Disabilities: Establishing Causal Inference

ERIC Educational Resources Information Center

Cooney, John B.; Young, John, III; Luckner, John L.; Ferrell, Kay Alicyn

2015-01-01

This article is intended to assist teachers and researchers in designing studies that examine the efficacy of a particular intervention or strategy with students with sensory disabilities. Ten research designs that can establish causal inference (the ability to attribute any effects to the intervention) with and without randomization are discussed.

Effectiveness of the Thoracic Pedicle Screw Placement Using the Virtual Surgical Training System: A Cadaver Study.

PubMed

Hou, Yang; Lin, Yanping; Shi, Jiangang; Chen, Huajiang; Yuan, Wen

2018-03-14

The virtual simulation surgery has initially exhibited its promising potentials in neurosurgery training. To evaluate effectiveness of the Virtual Surgical Training System (VSTS) on novice residents placing thoracic pedicle screws in a cadaver study. A total of 10 inexperienced residents participated in this study and were randomly assigned to 2 groups. The group using VSTS to learn thoracic pedicle screw fixation was the simulation training (ST) group and the group receiving an introductory teaching session was the control group. Ten fresh adult spine specimens including 6 males and 4 females with a mean age of 58.5 yr (range: 33-72) were collected and randomly allocated to the 2 groups. After exposing anatomic structures of thoracic spine, the bilateral pedicle screw placement of T6-T12 was performed on each cadaver specimen. The postoperative computed tomography scan was performed on each spine specimen, and experienced observers independently reviewed the placement of the pedicle screws to assess the incidence of pedicle breach. The screw penetration rates of the ST group (7.14%) was significantly lower in comparison to the control group (30%, P < .05). Statistically significant difference in acceptable rates of screws also occurred between the ST (100%) and control (92.86%) group (P < .05). In addition, the average screw penetration distance in control group (2.37 mm ± 0.23 mm) was significantly greater than ST group (1.23 mm ± 0.56 mm, P < .05). The virtual reality surgical training of thoracic pedicle screw instrumentation effectively improves surgical performance of novice residents compared to those with traditional teaching method, and can help new beginners to master the surgical technique within shortest period of time.

Long-term efficacy of pressure immobilization bandages in a porcine model of coral snake envenomation.

PubMed

Smyrnioudis, Mary E; O'Rourke, Dorcas P; Rosenbaum, Matthew D; Brewer, Kori L; Meggs, William J

2014-09-01

Pressure immobilization bandages delay mortality for 8 hours after coral snake envenomation, but long-term efficacy has not been established. The objective of this study is to determine the long-term efficacy of pressure immobilization bandages after coral snake envenomation in the absence of antivenom therapy. A randomized, observational pilot study was conducted. Ten pigs (17.3-25.6 kg) were sedated, intubated for 5 hours, and injected subcutaneously with 10 mg of lyophilized Micrurus fulvius venom resuspended in water. Pigs were randomly assigned to a control group (no treatment) or a treatment group (compression bandage and splint) approximately 1 minute after envenomation. Bandage pressure was not controlled. Pigs were monitored daily for 21 days for signs of respiratory depression, decreased oxygen saturations, and paralysis. In case of respiratory depression, pigs were humanely euthanized and time to death recorded. Statistical analysis was performed with Fisher exact test, Mann-Whitney U test, and Kaplan-Meier survival curve as appropriate. Median survival time of control animals was 307 minutes compared with 1172 minutes in treated animals (P = .10). Sixty percent of pigs in the treatment group survived to 24 hours vs 0% of control pigs (P = .08). Two of the treatment pigs survived to the end point of 21 days but showed necrosis of the distal lower extremity. Long-term survival after coral snake envenomation is possible in the absence of antivenom with the use of pressure immobilization bandages. The applied pressure of the bandage is critical to allowing survival without necrosis. Future studies should be designed to accurately monitor the pressures applied. Copyright © 2014 Elsevier Inc. All rights reserved.

The Falls In Care Home study: a feasibility randomized controlled trial of the use of a risk assessment and decision support tool to prevent falls in care homes

PubMed Central

Walker, Gemma M; Armstrong, Sarah; Gordon, Adam L; Gladman, John; Robertson, Kate; Ward, Marie; Conroy, Simon; Arnold, Gail; Darby, Janet; Frowd, Nadia; Williams, Wynne; Knowles, Sue; Logan, Pip A

2015-01-01

Objective: To explore the feasibility of implementing and evaluating the Guide to Action Care Home fall prevention intervention. Design: Two-centre, cluster feasibility randomized controlled trial and process evaluation. Setting: Purposive sample of six diverse old age/learning disability, long stay care homes in Nottinghamshire, UK. Subjects: Residents aged over 50 years, who had fallen at least once in the past year, not bed-bound, hoist-dependent or terminally ill. Interventions: Intervention homes (n = 3) received Guide to Action Care Home fall prevention intervention training and support. Control homes (n = 3) received usual care. Outcomes: Recruitment, attrition, baseline and six-month outcome completion, contamination and intervention fidelity, compliance, tolerability, acceptance and impact. Results: A total of 81 of 145 (56%) care homes expressed participatory interest. Six of 22 letter respondent homes (27%) participated. The expected resident recruitment target was achieved by 76% (52/68). Ten (19%) residents did not complete follow-up (seven died, three moved). In intervention homes 36/114 (32%) staff attended training. Two of three (75%) care homes received protocol compliant training. Staff valued the training, but advised greater management involvement to improve intervention implementation. Fall risks were assessed, actioned and recorded in care records. Of 115 recorded falls, 533/570 (93%) of details were complete. Six-month resident fall rates were 1.9 and 4.0 per year for intervention and control homes, respectively. Conclusions: The Guide to Action Care Home is implementable under trial conditions. Recruitment and follow-up rates indicate that a definitive trial can be completed. Falls (primary outcome) can be ascertained reliably from care records. PMID:26385358

Reduction in the Incidence of Influenza A but Not Influenza B Associated with Use of Hand Sanitizer and Cough Hygiene in Schools: A Randomized Controlled Trial

PubMed Central

STEBBINS, SAMUEL; CUMMINGS, DEREK A.T.; STARK, JAMES H.; VUKOTICH, CHUCK; MITRUKA, KIREN; THOMPSON, WILLIAM; RINALDO, CHARLES; ROTH, LOREN; WAGNER, MICHAEL; WISNIEWSKI, STEPHEN R.; DATO, VIRGINIA; ENG, HEATHER; BURKE, DONALD S.

2012-01-01

Background Laboratory-based evidence is lacking regarding the efficacy of non-pharmaceutical interventions such as alcohol-based hand sanitizer and respiratory hygiene to reduce the spread of influenza. Methods The Pittsburgh Influenza Prevention Project was a cluster-randomized trial conducted in ten Pittsburgh, PA elementary schools during the 2007-2008 influenza season. Children in five intervention schools received training in hand and respiratory hygiene, and were provided and encouraged to use hand sanitizer regularly. Children in five schools acted as controls. Children with influenza-like illness were tested for influenza A and B by RT-PCR. Results 3360 children participated. Using RT-PCR, 54 cases of influenza A and 50 cases of influenza B were detected. We found no significant effect of the intervention on the primary study outcome of all laboratory confirmed influenza cases (IRR 0.81 95% CI 0.54, 1.23). However, we did find statistically significant differences in protocol-specified ancillary outcomes. Children in intervention schools had significantly fewer laboratory-confirmed influenza A infections than children in control schools, with an adjusted IRR of 0.48 (95% CI 0.26, 0.87). Total absent episodes were also significantly lower among the intervention group than among the control group; adjusted IRR 0.74 (95% CI 0.56, 0.97). Conclusions Non-pharmaceutical interventions (respiratory hygiene education and the regular use of hand sanitizer) did not reduce total laboratory confirmed influenza. However the interventions did reduce school total absence episodes by 26% and laboratory-confirmed influenza A infections by 52%. Our results suggest that NPIs can be an important adjunct to influenza vaccination programs to reduce the number of influenza A infections among children. PMID:21691245

Mental and physical activities delay cognitive decline in older persons with dementia.

PubMed

Cheng, Sheung-Tak; Chow, Pizza K; Song, You-Qiang; Yu, Edwin C S; Chan, Alfred C M; Lee, Tatia M C; Lam, John H M

2014-01-01

To examine the effects of cognitive stimulation (mahjong) and physical exercise (tai chi [TC]) on cognitive performance in persons with dementia. Cluster-randomized open-label controlled design. Nursing homes. One hundred ten residents, most of whom were cholinesterase-inhibitor naive. Inclusion criteria were Mini-Mental State Examination (MMSE) = 10-24 and suffering from at least very mild dementia (Clinical Dementia Rating ≥ 0.5). Exclusion criteria were being bedbound, audio/visual impairment, regular activity participation before study, or contraindications for physical or group activities. Homes were randomized into three conditions (mahjong, TC, and simple handicrafts [control]). Activities were conducted three times weekly for 12 weeks. Primary outcome was MMSE. Secondary outcomes were immediate/delayed recall, categorical fluency, and digit span. Various biological risk factors, including apolipoprotein E ε4 allele, were included as covariates. Measures were collected at 0 (baseline), 3 (posttreatment), 6, and 9 months. Intent-to-treat analyses were performed using mixed-effects regression. Mahjong's effect varied by time for MMSE, delayed recall, and forward digit span. TC had similar effects but not for delayed recall. The typical pattern was that control participants deteriorated while mahjong and TC participants maintained their abilities over time, leading to enlarged treatment effects as time progressed. By 9 months, mahjong and TC differed from control by 4.5 points (95% confidence interval: 2.0-6.9; d = 0.48) and 3.7 points (95% confidence interval: 1.4-6.0; d = 0.40), respectively, on MMSE. No treatment effects were observed for immediate recall and backward digit span. Mahjong and TC can preserve functioning or delay decline in certain cognitive domains, even in those with significant cognitive impairment. Copyright © 2014 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

Effects of garlic on blood pressure in patients with and without systolic hypertension: a meta-analysis.

PubMed

Reinhart, Kurt M; Coleman, Craig I; Teevan, Colleen; Vachhani, Payal; White, C Michael

2008-12-01

Garlic has been suggested to lower blood pressure; however, studies evaluating this parameter have provided conflicting results. To examine the effect of garlic on blood pressure in patients with and without elevated systolic blood pressure (SPB) through meta-analyses of randomized controlled trials. A systematic search of MEDLINE, CINAHL, and the Cochrane Central Register of Controlled Trials was conducted to identify randomized controlled trials in humans evaluating garlic's effect on blood pressure. All databases were searched from their inception through June 26, 2008, using the key words garlic, Allium sativum, and allicin. A manual search of published literature was used to identify additional relevant studies. To be included in the analysis, studies must have been written in English or German and reported endpoints of SBP or diastolic blood pressure (DBP). Studies whose population had a mean baseline SBP greater than 140 mm Hg were evaluated separately from those whose population had lower baseline blood pressures. Garlic's effect on SBP and DBP was treated as a continuous variable and weighted mean differences were calculated using a random-effects model. Ten trials were included in the analysis; 3 of these had patients with elevated SBP. Garlic reduced SBP by 16.3 mm Hg (95% CI 6.2 to 26.5) and DBP by 9.3 mm Hg (95% CI 5.3 to 13.3) compared with placebo in patients with elevated SBP. However, the use of garlic did not reduce SBP or DBP in patients without elevated SBP. There was only a minor degree of heterogeneity in the analyses and publication bias did not appear to influence the results. This meta-analysis suggests that garlic is associated with blood pressure reductions in patients with an elevated SBP although not in those without elevated SBP. Future research should focus on the impact of garlic on clinical events and the assessment of the long-term risk of harm.

Intravenous N-Acetylcysteine for Prevention of Contrast-Induced Nephropathy: A Meta-Analysis of Randomized, Controlled Trials

PubMed Central

Sun, Zikai; Fu, Qiang; Cao, Longxing; Jin, Wen; Cheng, LingLing; Li, Zhiliang

2013-01-01

Background Contrast-induced nephropathy (CIN) is one of the common causes of acute renal insufficiency after contrast procedures. Whether intravenous N-acetylcysteine (NAC) is beneficial for the prevention of contrast-induced nephropathy is uncertain. In this meta-analysis of randomized controlled trials, we aimed to assess the efficacy of intravenous NAC for preventing CIN after administration of intravenous contrast media. Study Design Relevant studies published up to September 2012 that investigated the efficacy of intravenous N-acetylcysteine for preventing CIN were collected from MEDLINE, OVID, EMBASE, Web of Science, Cochrane Central Register of Controlled Trials, and the conference proceedings from major cardiology and nephrology meetings. The primary outcome was CIN. Secondary outcomes included renal failure requiring dialysis, mortality, and length of hospitalization. Data were combined using random-effects models with the performance of standard tests to assess for heterogeneity and publication bias. Meta-regression analyses were also performed. Results Ten trials involving 1916 patients met our inclusion criteria. Trials varied in patient demographic characteristics, inclusion criteria, dosing regimens, and trial quality. The summary risk ratio for contrast-induced nephropathy was 0.68 (95% CI, 0.46 to 1.02), a nonsignificant trend towards benefit in patients treated with intravenous NAC. There was evidence of significant heterogeneity in NAC effect across studies (Q = 17.42, P = 0.04; I2 = 48%). Meta-regression revealed no significant relation between the relative risk of CIN and identified differences in participant or study characteristics. Conclusion This meta-analysis showed that research on intravenous N-acetylcysteine and the incidence of CIN is too inconsistent at present to warrant a conclusion on efficacy. A large, well designed trial that incorporates the evaluation of clinically relevant outcomes in participants with different underlying risks of CIN is required to more adequately assess the role for intravenous NAC in CIN prevention. PMID:23383076

Active video games as a tool to prevent excessive weight gain in adolescents: rationale, design and methods of a randomized controlled trial.

PubMed

Simons, Monique; Chinapaw, Mai J M; van de Bovenkamp, Maaike; de Boer, Michiel R; Seidell, Jacob C; Brug, Johannes; de Vet, Emely

2014-03-24

Excessive body weight, low physical activity and excessive sedentary time in youth are major public health concerns. A new generation of video games, the ones that require physical activity to play the games--i.e. active games--may be a promising alternative to traditional non-active games to promote physical activity and reduce sedentary behaviors in youth. The aim of this manuscript is to describe the design of a study evaluating the effects of a family oriented active game intervention, incorporating several motivational elements, on anthropometrics and health behaviors in adolescents. The study is a randomized controlled trial (RCT), with non-active gaming adolescents aged 12-16 years old randomly allocated to a ten month intervention (receiving active games, as well as an encouragement to play) or a waiting-list control group (receiving active games after the intervention period). Primary outcomes are adolescents' measured BMI-SDS (SDS=adjusted for mean standard deviation score), waist circumference-SDS, hip circumference and sum of skinfolds. Secondary outcomes are adolescents' self-reported time spent playing active and non-active games, other sedentary activities and consumption of sugar-sweetened beverages. In addition, a process evaluation is conducted, assessing the sustainability of the active games, enjoyment, perceived competence, perceived barriers for active game play, game context, injuries from active game play, activity replacement and intention to continue playing the active games. This is the first adequately powered RCT including normal weight adolescents, evaluating a reasonably long period of provision of and exposure to active games. Next, strong elements are the incorporating motivational elements for active game play and a comprehensive process evaluation. This trial will provide evidence regarding the potential contribution of active games in prevention of excessive weight gain in adolescents. Dutch Trial register NTR3228.

Meta-analysis: protein and energy supplementation in older people.

PubMed

Milne, Anne C; Avenell, Alison; Potter, Jan

2006-01-03

Protein and energy undernutrition is common in older people, and further deterioration may occur during illness. To assess whether oral protein and energy supplementation improves clinical and nutritional outcomes for older people in the hospital, in an institution, or in the community. Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, HealthStar, CINAHL, BIOSIS, and CAB abstracts. The authors included English- and non-English-language studies and hand-searched journals, contacted manufacturers, and sought information from trialists. The date of the most recent search of CENTRAL and MEDLINE is June 2005. Randomized and quasi-randomized controlled trials of oral protein and energy supplementation compared with placebo or control treatment in older people. Two reviewers independently assessed trials for inclusion, extracted data, and assessed trial quality. Differences were resolved by consensus. Fifty-five trials were included (n = 9187 randomly assigned participants). For patients in short-term care hospitals who were given oral supplements, evidence suggested fewer complications (Peto odds ratio, 0.72 [95% CI, 0.53 to 0.97]) and reduced mortality (Peto odds ratio, 0.66 [CI, 0.49 to 0.90]) for those undernourished at baseline. Few studies reported evidence that suggested any change in mortality, morbidity, or function for those given supplements at home. Ten trials reported gastrointestinal disturbances, such as nausea, vomiting, and diarrhea, with oral supplements. The quality of most studies, as reported, was poor, particularly for concealment of allocation and blinding of outcome assessors. Many studies were too small or the follow-up time was too short to detect a statistically significant change in clinical outcome. The clinical results are dominated by 1 very large recent trial in patients with stroke. Although this was a high-quality trial, few participants were undernourished at baseline. Oral nutritional supplements can improve nutritional status and seem to reduce mortality and complications for undernourished elderly patients in the hospital. Current evidence does not support routine supplementation for older people at home or for well-nourished older patients in any setting.

Effects of the Nordic Hamstring exercise on sprint capacity in male football players: a randomized controlled trial.

PubMed

Ishøi, Lasse; Hölmich, Per; Aagaard, Per; Thorborg, Kristian; Bandholm, Thomas; Serner, Andreas

2018-07-01

This assessor-blinded, randomized controlled superiority trial investigated the efficacy of the 10-week Nordic Hamstring exercise (NHE) protocol on sprint performance in football players. Thirty-five amateur male players (age: 17-26 years) were randomized to a do-as-usual control group (CG; n = 17) or to 10-weeks of supervised strength training using the NHE in-season (IG; n = 18). A repeated-sprint test, consisting of 4 × 6 10 m sprints, with 15 s recovery period between sprints and 180 s between sets, was conducted to evaluate total sprint time as the primary outcome. Secondary outcomes were best 10 m sprint time (10mST) and sprint time during the last sprint (L10mST). Additionally, peak eccentric hamstring strength (ECC-P HS ) and eccentric hamstring strength capacity (ECC-CAP HS ) were measured during the NHE. Ten players were lost to follow-up, thus 25 players were analyzed (CG n = 14; IG n = 11). Between-group differences in mean changes were observed in favor of the IG for sprint performance outcomes; TST (-0.649 s, p = 0.056, d = 0.38), 10mST (-0.047 s, p = 0.005, d = 0.64) and L10mST (-0.052 s, p = 0.094, d = 0.59), and for strength outcomes; ECC-P HS (62.3 N, p = 0.006, d = 0.92), and ECC-CAP HS (951 N, p = 0.005, d = 0.95). In conclusion, the NHE showed small-to-medium improvements in sprint performance and large increases in peak eccentric hamstring strength and capacity. NCT02674919.

A Multicomponent Behavioral Intervention to Reduce Stroke Risk Factor Behaviors: The Stroke Health and Risk Education Cluster-Randomized Controlled Trial.

PubMed

Brown, Devin L; Conley, Kathleen M; Sánchez, Brisa N; Resnicow, Kenneth; Cowdery, Joan E; Sais, Emma; Murphy, Jillian; Skolarus, Lesli E; Lisabeth, Lynda D; Morgenstern, Lewis B

2015-10-01

The Stroke Health and Risk Education Project was a cluster-randomized, faith-based, culturally sensitive, theory-based multicomponent behavioral intervention trial to reduce key stroke risk factor behaviors in Hispanics/Latinos and European Americans. Ten Catholic churches were randomized to intervention or control group. The intervention group received a 1-year multicomponent intervention (with poor adherence) that included self-help materials, tailored newsletters, and motivational interviewing counseling calls. Multilevel modeling, accounting for clustering within subject pairs and parishes, was used to test treatment differences in the average change since baseline (ascertained at 6 and 12 months) in dietary sodium, fruit and vegetable intake, and physical activity, measured using standardized questionnaires. A priori, the trial was considered successful if any one of the 3 outcomes was significant at the 0.05/3 level. Of 801 subjects who consented, 760 completed baseline data assessments, and of these, 86% completed at least one outcome assessment. The median age was 53 years; 84% subjects were Hispanic/Latino; and 64% subjects were women. The intervention group had a greater increase in fruit and vegetable intake than the control group (0.25 cups per day [95% confidence interval: 0.08, 0.42], P=0.002), a greater decrease in sodium intake (-123.17 mg/d [-194.76, -51.59], P=0.04), but no difference in change in moderate- or greater-intensity physical activity (-27 metabolic equivalent-minutes per week [-526, 471], P=0.56). This multicomponent behavioral intervention targeting stroke risk factors in predominantly Hispanics/Latinos was effective in increasing fruit and vegetable intake, reaching its primary end point. The intervention also seemed to lower sodium intake. Church-based health promotions can be successful in primary stroke prevention efforts. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01378780. © 2015 American Heart Association, Inc.

Active video games as a tool to prevent excessive weight gain in adolescents: rationale, design and methods of a randomized controlled trial

PubMed Central

2014-01-01

Background Excessive body weight, low physical activity and excessive sedentary time in youth are major public health concerns. A new generation of video games, the ones that require physical activity to play the games –i.e. active games- may be a promising alternative to traditional non-active games to promote physical activity and reduce sedentary behaviors in youth. The aim of this manuscript is to describe the design of a study evaluating the effects of a family oriented active game intervention, incorporating several motivational elements, on anthropometrics and health behaviors in adolescents. Methods/Design The study is a randomized controlled trial (RCT), with non-active gaming adolescents aged 12 – 16 years old randomly allocated to a ten month intervention (receiving active games, as well as an encouragement to play) or a waiting-list control group (receiving active games after the intervention period). Primary outcomes are adolescents’ measured BMI-SDS (SDS = adjusted for mean standard deviation score), waist circumference-SDS, hip circumference and sum of skinfolds. Secondary outcomes are adolescents’ self-reported time spent playing active and non-active games, other sedentary activities and consumption of sugar-sweetened beverages. In addition, a process evaluation is conducted, assessing the sustainability of the active games, enjoyment, perceived competence, perceived barriers for active game play, game context, injuries from active game play, activity replacement and intention to continue playing the active games. Discussion This is the first adequately powered RCT including normal weight adolescents, evaluating a reasonably long period of provision of and exposure to active games. Next, strong elements are the incorporating motivational elements for active game play and a comprehensive process evaluation. This trial will provide evidence regarding the potential contribution of active games in prevention of excessive weight gain in adolescents. Trial registration Dutch Trial register NTR3228. PMID:24661535

[Comparative study on effects of manipulation treatment and transcutaneous electrical nerve stimulation on patients with cervicogenic headache].

PubMed

Li, Chen; Zhang, Xiu-ling; Ding, Hong; Tao, Yue-qiang; Zhan, Hong-sheng

2007-07-01

To compare the effects of manipulation treatment and transcutaneous electrical nerve stimulation (TENS) on patients with cervicogenic headache. Seventy patients with cervicogenic headache were randomly allocated to receive manipulation treatment and TENS treatment, which were given every other day respectively for total 40 days. The headache degree (numeric rating scale, NRS), frequency, lasting time and the range of motion (ROM) of the cervical spine 2 weeks before treatment and 4 weeks after treatment, were compared. Before treatment, there were no significant differences in the headache NRS scores , frequency, lasting time and the ROM scores between the two groups (P>0.05). After treatment, the headache NRS score, frequency, lasting time in the manipulation group decreased significantly (P<0.01), while in the TENS group just the headache NRS score decreased significantly (P<0.05). The ROM scores in both groups showed no significant changes (P>0.05). The response rate of manipulation treatment is 94.5%, significantly higher than 64.5% of TENS treatment (P<0.05). The manipulation treatment is an effective method for patients with cervicogenic headache.

Seroprevalence of egg drop syndrome--76 virus as cause of poor egg productivity of poultry in Nsukka, South East Nigeria.

PubMed

Ezeibe, M C O; Okoroafor, O N; Eze, J I; Eze, I C

2008-02-01

To determine if egg drop syndrome 76 virus infection is among the causes of lowered egg productivity in commercial poultry farms in South Eastern Part of Nigeria and to know the prevalence of the infection, ten farms with history of lowered egg production in Nsukka local government area of Enugu State were randomly selected. Sera from ten hens in each of the selected farms were assayed for antibodies against EDS 76 virus by the haemagglutination-inhibition (HI) test. The mean HI titre of the ten hens in each of the farms was recorded as EDS - 76 antibody titre for the farm. Nine out of the 10 farms tested were positive for EDS - 76 antibodies with HI titres ranging between 16 and 256. Out of 10 flocks with production of 65% and above 9 were EDS-76 HI negative.

75 FR 81718 - Unblocking of Specially Designated Nationals and Blocked Persons Pursuant to Executive Order...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-28

... Foreign Assets Control (``OFAC'') is publishing the names of ten individuals whose property and interests... Designated Nationals and Blocked Persons (``SDN List'') of the ten individuals identified in this notice... Annex to Executive Order 13288 included 77 individuals, including nine of the ten individuals identified...

77 FR 44717 - Unblocking of Specially Designated Nationals and Blocked Persons Pursuant to the Foreign...

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2012-07-30

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75 FR 54697 - Unblocking of Thirteen Specially Designated Nationals Pursuant to Executive Order 13224

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2010-09-08

... removing the names of ten entities and three individuals from the list of Specially Designated Nationals... Commit, Threaten To Commit, or Support Terrorism. DATES: The removal of ten entities and three... Foreign Assets Control has determined that these ten entities and three individuals no longer meet the...

Neuroprotective Effect of Exogenous Melatonin on Dopaminergic Neurons of the Substantia Nigra in Ovariectomized Rats

PubMed Central

Mehraein, Fereshteh; Talebi, Reza; Jameie, Behnamedin; Joghataie, Mohammad Taghi; Madjd, Zahra

2011-01-01

Background: Melatonin has receptors in substantia nigra pars compacta (SNc) and regulates development of dopaminergic (DA) neurons. This study was undertaken to determine ability of melatonin to protect SNc dopaminergic neuron loss induced by estrogen deficiency in ovariectomized rats. Methods: Female rats were randomized into four groups of seven each: control, ethanol sham, ovariectomy (ovx) and ovx with melatonin (ovx + m). In ovx, ovaries were removed. Ovx + m group was intraperitoneally injected with melatonin for 10 days, while the ethanol sham group received only ethanol. All rats were perfused with 4% paraformaldehyde, midbrains removed, fixed and paraffin embedded, then processed for Nissl and tyrosine hydroxylase staining (IHC). Ten sections of SNc in Nissl and IHC staining were analyzed in each animal, Nissl stained and tyrosine hydroxylase (TH) immunoreactive cells were counted in five experimental groups randomly. Data was analyzed using SPSS by ANOVA and t-test. Differences were considered significant for P<0.05. Results: There was less cell number in ovx compared to control and ethanol sham groups significantly (P<0.001). The ovx + m group had more cells than the ovx group in the SNc significantly (P<0.001). Furthermore, there was significant decrease of TH positive cell number in the ovx group compared to control and ethanol sham groups (P<0.05). The number of TH immunoreactive cells was higher in ovx + m compared to the ovx group (P<0.05). Conclusion: These findings can be compared with human and used in clinical application for prevention of DA neuron death of SNc after ovariectomy. PMID:21725499