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Sample records for pain trial protocol

  1. Acupuncture for post anaesthetic recovery and postoperative pain: study protocol for a randomised controlled trial

    PubMed Central

    2014-01-01

    Background We report on the design and implementation of a study protocol entitled Acupuncture randomised trial for post anaesthetic recovery and postoperative pain - a pilot study (ACUARP) designed to investigate the effectiveness of acupuncture therapy performed in the perioperative period on post anaesthetic recovery and postoperative pain. Methods/Design The study is designed as a randomised controlled pilot trial with three arms and partial double blinding. We will compare (a) press needle acupuncture, (b) no treatment and (c) press plaster acupressure in a standardised anaesthetic setting. Seventy-five patients scheduled for laparoscopic surgery to the uterus or ovaries will be allocated randomly to one of the three trial arms. The total observation period will begin one day before surgery and end on the second postoperative day. Twelve press needles and press plasters are to be administered preoperatively at seven acupuncture points. The primary outcome measure will be time from extubation to ‘ready for discharge’ from the post anaesthesia care unit (in minutes). The ‘ready for discharge’ end point will be assessed using three different scores: the Aldrete score, the Post Anaesthetic Discharge Scoring System and an In-House score. Secondary outcome measures will comprise pre-, intra- and postoperative variables (which are anxiety, pain, nausea and vomiting, concomitant medication). Discussion The results of this study will provide information on whether acupuncture may improve patient post anaesthetic recovery. Comparing acupuncture with acupressure will provide insight into potential therapeutic differences between invasive and non-invasive acupuncture techniques. Trial registration NCT01816386 (First received: 28 October 2012) PMID:25047046

  2. Effectiveness of trigger point dry needling for plantar heel pain: study protocol for a randomised controlled trial

    PubMed Central

    2011-01-01

    Background Plantar heel pain (plantar fasciitis) is a common and disabling condition, which has a detrimental impact on health-related quality of life. Despite the high prevalence of plantar heel pain, the optimal treatment for this disorder remains unclear. Consequently, an alternative therapy such as dry needling is increasingly being used as an adjunctive treatment by health practitioners. Only two trials have investigated the effectiveness of dry needling for plantar heel pain, however both trials were of a low methodological quality. This manuscript describes the design of a randomised controlled trial to evaluate the effectiveness of dry needling for plantar heel pain. Methods Eighty community-dwelling men and woman aged over 18 years with plantar heel pain (who satisfy the inclusion and exclusion criteria) will be recruited. Eligible participants with plantar heel pain will be randomised to receive either one of two interventions, (i) real dry needling or (ii) sham dry needling. The protocol (including needling details and treatment regimen) was formulated by general consensus (using the Delphi research method) using 30 experts worldwide that commonly use dry needling for plantar heel pain. Primary outcome measures will be the pain subscale of the Foot Health Status Questionnaire and "first step" pain as measured on a visual analogue scale. The secondary outcome measures will be health related quality of life (assessed using the Short Form-36 questionnaire - Version Two) and depression, anxiety and stress (assessed using the Depression, Anxiety and Stress Scale - short version). Primary outcome measures will be performed at baseline, 2, 4, 6 and 12 weeks and secondary outcome measures will be performed at baseline, 6 and 12 weeks. Data will be analysed using the intention to treat principle. Conclusion This study is the first randomised controlled trial to evaluate the effectiveness of dry needling for plantar heel pain. The trial will be reported in

  3. Maintained physical activity and physiotherapy in the management of distal upper limb pain – a protocol for a randomised controlled trial (the arm pain trial)

    PubMed Central

    2014-01-01

    Background Distal upper limb pain (pain affecting the elbow, forearm, wrist, or hand) can be non-specific, or can arise from specific musculoskeletal disorders. It is clinically important and costly, the best approach to clinical management is unclear. Physiotherapy is the standard treatment and, while awaiting treatment, advice is often given to rest and avoid strenuous activities, but there is no evidence base to support these strategies. This paper describes the protocol of a randomised controlled trial to determine, among patients awaiting physiotherapy for distal arm pain, (a) whether advice to remain active and maintain usual activities results in a long-term reduction in arm pain and disability, compared with advice to rest; and (b) whether immediate physiotherapy results in a long-term reduction in arm pain and disability, compared with physiotherapy delivered after a seven week waiting list period. Methods/Design Between January 2012 and January 2014, new referrals to 14 out-patient physiotherapy departments were screened for potential eligibility. Eligible and consenting patients were randomly allocated to one of the following three groups in equal numbers: 1) advice to remain active, 2) advice to rest, 3) immediate physiotherapy. Patients were and followed up at 6, 13, and 26 weeks post-randomisation by self-complete postal questionnaire and, at six weeks, patients who had not received physiotherapy were offered it at this time. The primary outcome is the proportion of patients free of disability at 26 weeks, as determined by the modified DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire. We hypothesise (a) that advice to maintain usual activities while awaiting physiotherapy will be superior than advice to rest the arm; and (b) that fast-track physiotherapy will be superior to normal (waiting list) physiotherapy. These hypotheses will be examined using an intention-to-treat analysis. Discussion Results from this trial will contribute to

  4. The optimized acupuncture treatment for neck pain caused by cervical spondylosis: a study protocol of a multicentre randomized controlled trial

    PubMed Central

    2012-01-01

    Background Neck pain is one of the chief symptoms of cervical spondylosis (CS). Acupuncture is a well-accepted and widely used complementary therapy for the management of neck pain caused by CS. In this paper, we present a randomized controlled trial protocol evaluating the use of acupuncture for CS neck pain, comparing the effects of the optimized acupuncture therapy in real practice compared with sham and shallow acupuncture. Methods/Design This trial uses a multicentre, parallel-group, randomized, sham acupuncture and shallow acupuncture, controlled single-blind design. Nine hospitals are involved as trial centres. 945 patients who meet inclusion criteria are randomly assigned to receive optimized acupuncture therapy, sham acupuncture or shallow acupuncture by a computerized central randomization system. The interventions past for 4 weeks with eight to ten treatments in total. The group allocations and interventions are concealed to patients and statisticians. The Northwick Park Neck Pain Questionnaire (NPQ) is used as the primary outcome measure, and the McGill Pain Questionnaire (MPQ) and The Short Form (36) Health Survey (SF-36) are applied as secondary outcome measures. The evaluation is performed at baseline, at the end of the intervention, and at the end of the first month and the third month during follow-up. The statistical analyses will include baseline data comparison and repeated measures of analysis of variance (ANOVA) for primary and secondary outcomes of group and time differences. Adverse events (AEs) will be reported if they occur. Discussion This trial is a multicentre randomized control trial (RCT) on the efficacy of acupuncture for CS neck pain and has a large sample size and central randomization in China. It will strictly follow the CONSORT statement and STRICTA extension guideline to report high-quality study results. By setting the control groups as sham and shallow acupuncture, this study attempts to reveal the effects of real acupuncture

  5. Randomized comparative trial of cervical block protocols for pain management during hysteroscopic removal of polyps and myomas

    PubMed Central

    Lukes, Andrea S; Roy, Kelly H; Presthus, James B; Diamond, Michael P; Berman, Jay M; Konsker, Kenneth A

    2015-01-01

    Purpose To evaluate the efficacy of two cervical block protocols for pain management during hysteroscopic removal of intrauterine polyps and myomas using the MyoSure® device. Patients and methods This was a randomized, comparative treatment trial conducted by five private Obstetrics and Gynecology practices in the USA. Forty premenopausal women aged 18 years and older were randomized to receive either a combination para/intracervical block protocol of 37 cc local anesthetic administered at six injections sites in association with the application of topic 1% lidocaine gel, or an intracervical block protocol of 22 cc local anesthetic administered at three injections sites without topical anesthetic, for pain management during hysteroscopic removal of intrauterine polyps and/or a single type 0 or type 1 submucosal myoma ≤3 cm. The main outcomes were a composite measure of procedure-related pain and pain during the postoperative recovery period, assessed by the Wong-Baker Faces Rating Scale (0= no pain to 10= maximum pain). The lesion characteristics, procedure time, and adverse events were summarized. Results A total of 17 polyps and eight myomas were removed in the para/intracervical block group, with diameters of 1.3±0.5 cm and 1.8±0.8 cm, respectively. In the intracervical block group, 25 polyps with a mean diameter of 1.2±0.7 cm and 7 myomas with a mean diameter of 1.9±0.9 cm were removed. The mean tissue resection time was 1.2±2.0 minutes and 1.2±1.4 minutes for the para/intracervical and intracervical block groups, respectively. The mean composite procedure-related pain score was low for both cervical block protocols, 1.3±1.4 in the para/intracervical block group vs 2.1±1.5 in the intracervical block group. During the postoperative recovery period, the mean pain scores were 0.3±0.7 vs 1.2±1.7 for the para/intracervical and intracervical block groups, respectively. There were no serious adverse events. Conclusion The MyoSure procedure for removal of

  6. Bee venom acupuncture, NSAIDs or combined treatment for chronic neck pain: study protocol for a randomized, assessor-blind trial

    PubMed Central

    2014-01-01

    Background Chronic neck pain (CNP) is a common painful medical condition with a significant socioeconomic impact. In spite of widespread usage, the effectiveness and safety of combined treatments between conventional and complementary alternative medical treatment modalities has not been fully established in a rigorous randomized clinical trial (RCT). This pilot study will provide the clinical evidence to evaluate the feasibility and refine the protocol for a full-scale RCT on combined treatment of bee venom acupuncture (BVA) and non-steroidal anti-inflammatory drugs (NSAIDs) in patients with CNP. Methods/Design This is a randomized, single-blind clinical trial with three parallel arms. Sixty patients between 18 and 65 years of age with non-specific, uncomplicated neck pain lasting for at least three months will be enrolled. Participants will be randomly allocated into the BVA, NSAIDs or combined treatment group. Assessors and statisticians will be blinded to the random allocation. All researchers will receive training to ensure their strict adherence to the study protocol. Patients from the BVA and combined treatment group will be treated with a bee venom increment protocol into predefined acupoints for six sessions over a three week period. BVA intervention is developed through a comprehensive discussion among interdisciplinary spine disorder experts, according to the guidelines of Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA). Patients from the NSAIDs and combined treatment groups will be prescribed loxoprofen (one tablet to be taken orally, three times a day for three weeks). Bothersomeness from CNP measured using a visual analogue scale (VAS) will be the primary outcome assessed at screening, visit two (baseline), four, six, eight (4th week assessment) and nine (8th week assessment) follow-up session. VAS for pain intensity, neck disability index (NDI), quality of life, depressive status and adverse experiences will also be

  7. Neuromuscular training and muscle strengthening in patients with patellofemoral pain syndrome: a protocol of randomized controlled trial

    PubMed Central

    2014-01-01

    Background Patellofemoral pain syndrome (PFPS) is a common musculoskeletal condition, particularly among women. Patients with PFPS usually experience weakness in the gluteal muscles, as well as pain and impaired motor control during activities of daily living. Strengthening the hip muscles is an effective way of treating this disorder. Neuromuscular training has also been identified as a therapeutic tool, although the benefits of this intervention in patients with PFPS patients remain inconclusive. Design This is a protocol of randomized controlled trial with a blind assessor. Thirty-four women with a clinical diagnosis of PFPS participated. These participants were allocated into two groups (experimental and control). The experimental group performed twelve sessions to strengthen the knee extensors, hip abductor and lateral rotator muscles in association with neuromuscular training of the trunk and lower extremities. The control group performed the same number of sessions to strengthen the muscles of the hip and knee. The primary outcome was functional capacity (Anterior Knee Pain Scale – AKPS) at 4 weeks. Pain intensity, muscle strength and kinematic changes were also measured during the step down test after four weeks of intervention. Follow up assessments were conducted after three and six months to assess functional capacity and pain. The effects of the treatment (i.e. between-group differences) were calculated using mixed linear models. Discussion The present study was initiated on the 1st of April 2013 and is currently in progress. The results of this study may introduce another effective technique of conservative treatment and could guide physical therapists in the clinical decision-making process for women with PFPS. Trial registration Current Controlled Trials NCT01804608. PMID:24884455

  8. OPAL: a randomised, placebo-controlled trial of opioid analgesia for the reduction of pain severity in people with acute spinal pain. Trial protocol

    PubMed Central

    Lin, Chung-Wei Christine; McLachlan, Andrew J; Latimer, Jane; Day, Ric O; Billot, Laurent; Koes, Bart W; Maher, Chris G

    2016-01-01

    Introduction Low back pain and neck pain are extremely prevalent and are responsible for an enormous burden of disease globally. Strong analgesics, such as opioid analgesics, are recommended by clinical guidelines for people with acute low back pain or neck pain who are slow to recover and require more pain relief. Opioid analgesics are widely and increasingly used, but there are no strong efficacy data supporting the use of opioid analgesics for acute low back pain or neck pain. Concerns regarding opioid use are further heightened by the risks of adverse events, some of which can be serious (eg, dependency, misuse and overdose). Methods and analysis OPAL is a randomised, placebo-controlled, triple-blinded trial that will investigate the judicious use of an opioid analgesic in 346 participants with acute low back pain and/or neck pain who are slow to recover. Participants will be recruited from general practice and randomised to receive the opioid analgesic (controlled release oxycodone plus naloxone up to 20 mg per day) or placebo in addition to guideline-based care (eg, reassurance and advice of staying active) for up to 6 weeks. Participants will be followed-up for 3 months for effectiveness outcomes. The primary outcome will be pain severity. Secondary outcomes will include physical functioning and time to recovery. Medication-related adverse events will be assessed and a cost-effectiveness analysis will be conducted. We will additionally assess long-term use and risk of misuse of opioid analgesics for up to 12 months. Ethics and dissemination Ethical approval has been obtained. Trial results will be disseminated by publications and conference presentations, and via the media. Trial registration number ACTRN12615000775516: Pre-results. PMID:27558901

  9. Opioids for chronic non-cancer pain: a protocol for a systematic review of randomized controlled trials

    PubMed Central

    2013-01-01

    Background Opioids are prescribed frequently and increasingly for the management of chronic non-cancer pain (CNCP). Current systematic reviews have a number of limitations, leaving uncertainty with regard to the benefits and harms associated with opioid therapy for CNCP. We propose to conduct a systematic review and meta-analysis to summarize the evidence for using opioids in the treatment of CNCP and the risk of associated adverse events. Methods and design Eligible trials will include those that randomly allocate patients with CNCP to treatment with any opioid or any non-opioid control group. We will use the guidelines published by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to inform the outcomes that we collect and present. We will use the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system to evaluate confidence in the evidence on an outcome-by-outcome basis. Teams of reviewers will independently and in duplicate assess trial eligibility, abstract data, and assess risk of bias among eligible trials. To ensure interpretability of our results, we will present risk differences and measures of relative effect for all outcomes reported and these will be based on anchor-based minimally important clinical differences, when available. We will conduct a priori defined subgroup analyses consistent with current best practices. Discussion Our review will evaluate both the effectiveness and the adverse events associated with opioid use for CNCP, evaluate confidence in the evidence using the GRADE approach, and prioritize patient-important outcomes with a focus on functional gains guided by IMMPACT recommendations. Our results will facilitate evidence-based management of patients with CNCP and identify key areas for future research. Trial registration Our protocol is registered on PROSPERO (CRD42012003023), http://www.crd.york.ac.uk/PROSPERO. PMID:23965223

  10. MAGnesium-oral supplementation to reduce PAin in patients with severe PERipheral arterial occlusive disease: the MAG-PAPER randomised clinical trial protocol

    PubMed Central

    Venturini, Monica Aida; Zappa, Sergio; Minelli, Cosetta; Bonardelli, Stefano; Lamberti, Laura; Bisighini, Luca; Zangrandi, Marta; Turin, Maddalena; Rizzo, Francesco; Rizzolo, Andrea; Latronico, Nicola

    2015-01-01

    Introduction Magnesium exerts analgaesic effects in several animal pain models, as well as in patients affected by acute postoperative pain and neuropathic chronic pain. There is no evidence that magnesium can modulate pain in patients with peripheral arterial occlusive disease (PAOD). We describe the protocol of a single-centre randomised double-blind clinical trial aimed at assessing the efficacy of oral magnesium supplementation in controlling severe pain in patients with advanced PAOD. Methods and analysis Adult patients affected by PAOD at stages III and IV of Lèriche-Fontaine classification, who are opioid-naïve, and who have been admitted to our Acute Pain Service for intractable pain, will be eligible. Patients will be randomised to the control group, treated with standard therapy (oxycodone and pregabalin) plus placebo for 2 weeks, or to the experimental group (standard therapy plus magnesium oxide). Patients will be evaluated on days 0, 2, 4, 6, 8, 12 and 14; the following information will being collected: daily oxycodone dose; average and maximum pain (Numerical Rating Scale); pain relief (Pain Relief Scale); characteristics of the pain (Neuropathic Pain Scale); impact of pain on the patient's daily activities (Brief Pain Inventory). The primary outcome will be oxycodone dosage needed to achieve satisfactory analgaesia on day 14. Secondary outcomes will be pain relief on day 2, time needed to achieve satisfactory analgaesia and time needed to achieve a pain reduction of 50%. A sample size calculation was performed for the primary outcome, which estimated a required sample size of 150 patients (75 per group). Ethics and dissemination Ethical approval of the study protocol has been obtained from Comitato Etico Provinciale di Brescia, Brescia, Italy. Trial results will be disseminated through scientific journal manuscripts and scientific conference presentations. Trial registration number NCT02455726. PMID:26674497

  11. Rationale, design, and protocol for the prevention of low back pain in the military (POLM) trial (NCT00373009)

    PubMed Central

    George, Steven Z; Childs, John D; Teyhen, Deydre S; Wu, Samuel S; Wright, Alison C; Dugan, Jessica L; Robinson, Michael E

    2007-01-01

    monthly email that queries whether any LBP was experienced in the previous calendar month. Soldiers reporting LBP will enter episode-specific data related to pain intensity, pain-related disability, fear-avoidance beliefs, and pain catastrophizing. We are hypothesizing that Soldiers receiving the CSEP and PSEP will report the longest duration to first episode of LBP, the lowest frequency of LBP, and the lowest severity of LBP episodes. Statistical comparisons will be made between each of the randomly assigned prevention programs to test our hypotheses related to determining which of the 4 programs is most effective. Discussion We have presented the design and protocol for the POLM trial. Completion of this trial will provide important information on how to effectively train Soldiers for the prevention of LBP. Trial registration NCT00373009 PMID:17868436

  12. Electroacupuncture to treat painful diabetic neuropathy: study protocol for a three-armed, randomized, controlled pilot trial

    PubMed Central

    2013-01-01

    Background The purpose of this study is to conduct a basic analysis of the effectiveness and safety of electroacupuncture in the treatment of painful diabetic neuropathy (PDN) as compared to placebo and usual care and to evaluate the feasibility of large-scale clinical research. Methods/design This study is a protocol for a three-armed, randomized, patient-assessor-blinded (to the type of treatment), controlled pilot trial. Forty-five participants with a ≥ six month history of PDN and a mean weekly pain score of ≥ 4 on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) will be assigned to the electroacupuncture group (n = 15), sham group (n = 15) or usual care group (n = 15). The participants assigned to the electroacupuncture group will receive electroacupuncture (remaining for 30 minutes with a mixed current of 2 Hz/120 Hz and 80% of the bearable intensity) at 12 standard acupuncture points (bilateral ST36, GB39, SP9, SP6, LR3 and GB41) twice per week for eight weeks (a total of 16 sessions) as well as the usual care. The participants in the sham group will receive sham electroacupuncture (no electrical current will be passed to the needle, but the light will be seen, and the sound of the pulse generator will be heard by the participants) at non-acupuncture points as well as the usual care. The participants in the usual care group will not receive electroacupuncture treatment during the study period and will receive only the usual care. The follow-up will be in the 5th, 9th and 17th weeks after random allocation. The PI-NRS score assessed at the ninth week will be the primary outcome measurement used in this study. The Short-Form McGill Pain Questionnaire (SF-MPQ), a sleep disturbance score (11-point Likert scale), the Short-Form 36v2 Health Survey (SF-36), the Beck Depression Inventory (BDI) and the Patient Global Impression of Change (PGIC) will be used as outcome variables to evaluate the effectiveness of the acupuncture. Safety will be assessed

  13. Management of chronic neuropathic pain: a protocol for a multiple treatment comparison meta-analysis of randomised controlled trials

    PubMed Central

    Mulla, Sohail M; Buckley, D Norman; Moulin, Dwight E; Couban, Rachel; Izhar, Zain; Agarwal, Arnav; Panju, Akbar; Wang, Li; Kallyth, Sun Makosso; Turan, Alparslan; Montori, Victor M; Sessler, Daniel I; Thabane, Lehana; Guyatt, Gordon H; Busse, Jason W

    2014-01-01

    Introduction Chronic neuropathic pain is associated with reduced health-related quality of life and substantial socioeconomic costs. Current research addressing management of chronic neuropathic pain is limited. No review has evaluated all interventional studies for chronic neuropathic pain, which limits attempts to make inferences regarding the relative effectiveness of treatments. Methods and analysis We will conduct a systematic review of all randomised controlled trials evaluating therapies for chronic neuropathic pain. We will identify eligible trials, in any language, by a systematic search of CINAHL, EMBASE, MEDLINE, AMED, HealthSTAR, DARE, PsychINFO and the Cochrane Central Registry of Controlled Trials. Eligible trials will be: (1) enrol patients presenting with chronic neuropathic pain, and (2) randomise patients to alternative interventions (pharmacological or non-pharmacological) or an intervention and a control arm. Pairs of reviewers will, independently and in duplicate, screen titles and abstracts of identified citations, review the full texts of potentially eligible trials and extract information from eligible trials. We will use a modified Cochrane instrument to evaluate risk of bias of eligible studies, recommendations from the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to inform the outcomes we will collect, and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to evaluate our confidence in treatment effects. When possible, we will conduct: (1) in direct comparisons, a random-effects meta-analysis to establish the effect of reported therapies on patient-important outcomes; and (2) a multiple treatment comparison meta-analysis within a Bayesian framework to assess the relative effects of treatments. We will define a priori hypotheses to explain heterogeneity between studies, and conduct meta-regression and subgroup analyses consistent with the current best practices

  14. Peer volunteers in an integrative pain management program for frail older adults with chronic pain: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Chronic pain is common among the older population. A literature review on pain management program showed that exercise, yoga, massage therapy, Tai Chi, and music therapy could significantly reduce pain. In spite of the proven benefits of pain management programs, these intervention programs were effective only in the short term, and older adults would resume their old habits. It has been suggested that interventions comprising some type of social support have great potential to increase the participation of older adults. Therefore, we propose the inclusion of peer volunteers in an integrated pain management program to relieve pain among frail older adults. This study aims to explore the effectiveness of an integrated pain management program supplemented with peer volunteers in improving pain intensity, functional mobility, physical activity, loneliness levels, happiness levels, and the use of non-pharmacological pain-relieving methods among frail older adults with chronic pain. Methods/Design We intend to recruit 30 nursing home residents and 30 peer volunteers from the Institute of Active Ageing in Hong Kong in a group trial for an 8-week group-based integrated pain management program. There will be 16 sessions, with two 1-hour sessions each week. The primary outcome will be pain levels, while secondary outcomes will be assessed according to functional mobility, physical activity, loneliness levels, happiness levels, the use of non-pharmacological pain-relieving methods, and through a questionnaire for volunteers. Discussion In view of the high prevalence of chronic pain among older adults and its adverse impacts, it is important to provide older adults with tools to control their pain. We propose the use of peer volunteers to enhance the effects of an integrated pain management program. It is expected that pain can be reduced and improvements can be achieved among older adults in the areas of physical activity, functional mobility, loneliness levels

  15. Electroacupuncture as a complement to usual care for patients with non-acute pain after back surgery: a study protocol for a pilot randomised controlled trial

    PubMed Central

    Hwang, Man-Suk; Heo, Kwang-Ho; Cho, Hyun-Woo; Shin, Byung-Cheul; Lee, Hyeon-Yeop; Heo, In; Kim, Nam-Kwen; Choi, Byung-Kwan; Son, Dong-Wuk; Hwang, Eui-Hyoung

    2015-01-01

    Introduction Recurrent or persistent low back pain is common after back surgery but is typically not well controlled. Previous randomised controlled trials on non-acute pain after back surgery were flawed. In this article, the design and protocol of a randomised controlled trial to treat pain and improve function after back surgery are described. Methods and analysis This study is a pilot randomised, active-controlled, assessor-blinded trial. Patients with recurring or persistent low back pain after back surgery, defined as a visual analogue scale value of ≥50 mm, with or without leg pain, will be randomly assigned to an electroacupuncture-plus-usual-care group or to a usual-care-only group. Patients assigned to both groups will have usual care management, including physical therapy and patient education, twice a week during a 4-week treatment period that would begin at randomisation. Patients assigned to the electroacupuncture-plus-usual-care group will also have electroacupuncture twice a week during the 4-week treatment period. The primary outcome will be measured with the 100 mm pain visual analogue scale of low back pain by a blinded evaluator. Secondary outcomes will be measured with the EuroQol 5-Dimension and the Oswestry Disability Index. The primary and secondary outcomes will be measured at 4 and 8 weeks after treatment. Ethics and dissemination Written informed consent will be obtained from all participants. This study was approved by the Institutional Review Board (IRB) of Pusan National University Korean Hospital in September 2013 (IRB approval number 2013012). The study findings will be published in peer-reviewed journals and presented at national and international conferences. Trial registration number This trial was registered with the US National Institutes of Health Clinical Trials Registry: NCT01966250. PMID:25652804

  16. Motion style acupuncture treatment (MSAT) for acute low back pain with severe disability: a multicenter, randomized, controlled trial protocol

    PubMed Central

    2011-01-01

    Background Acupuncture is widely-used to treat patients with low back pain, despite insufficient evidence of the technique's efficacy for acute back pain. Motion style acupuncture treatment (MSAT) is a non-traditional acupuncture treatment requiring a patient to exercise while receiving acupuncture. In Korea, MSAT is used to reduce musculoskeletal pain and improve functional status. The study aims to evaluate the effect of MSAT on acute low back pain with severe disability. Methods/Design This study is a multicenter, randomized, active-controlled trial with two parallel arms. Participants with acute low back pain and severe functional disability, defined as an Oswestry Disability Index (ODI) value > 60%, will be randomly allocated to the acupuncture group and the nonsteroidal anti-inflammatory drug (NSAID) injection group. The acupuncture group will receive MSAT and the NSAID injection group will receive an intramuscular injection of diclofenac. All procedures will be limited to one session and the symptoms before and after treatment will be measured by assessors blinded to treatment allocation. The primary outcome will be measured at 30 minutes after treatment using the numerical rating scale (NRS) of low back pain while the patient is moving. Secondary outcomes will be measured at 30 minutes after treatment using the NRS of leg pain, ODI, patient global impression of change, range of motion (ROM) of the lumbar spine, and degrees of straight leg raising (SLR). Post-treatment follow-up will be performed to measure primary and secondary outcomes with the exception of ROM and SLR at 2, 4, and 24 weeks after treatment. Discussion The results of this trial will be discussed. Trial Registration ClinicalTrial.gov NCT01315561 PMID:22151475

  17. Acupuncture in acute herpes zoster pain therapy (ACUZoster) – design and protocol of a randomised controlled trial

    PubMed Central

    Fleckenstein, Johannes; Kramer, Sybille; Hoffrogge, Philipp; Thoma, Sarah; Lang, Philip M; Lehmeyer, Lukas; Schober, Gabriel M; Pfab, Florian; Ring, Johannes; Weisenseel, Peter; Schotten, Klaus J; Mansmann, Ulrich; Irnich, Dominik

    2009-01-01

    Background Acute herpes zoster is a prevalent condition. One of its major symptoms is pain, which can highly influence patient's quality of life. Pain therapy is limited. Acupuncture is supposed to soften neuropathic pain conditions and might therefore act as a therapeutic alternative. Objective of the present study is to investigate whether a 4 week semi-standardised acupuncture is non-inferior to sham laser acupuncture and the anticonvulsive drug gabapentine in the treatment of pain associated with herpes zoster. Methods/Design Three-armed, randomised, placebo-controlled trial with a total follow-up time of 6 months. Up to estimated 336 patients (interim analyses) with acute herpes zoster pain (VAS > 30 mm) will be randomised to one of three groups (a) semi-standardised acupuncture (168 patients); (b) gabapentine with individualised dosage between 900–3600 mg/d (84 patients); (c) sham laser acupuncture. Intervention takes place over 4 weeks, all patients will receive analgesic therapy (non-opioid analgesics: metamizol or paracetamol and opioids: tramadol or morphine). Therapy phase includes 4 weeks in which group (a) and (c) consist of 12 sessions per patient, (b) visits depend on patients needs. Main outcome measure is to assess the alteration of pain intensity before and 1 week after treatment sessions (visual analogue scale VAS 0–100 mm). Secondary outcome measure are: alteration of pain intensity and frequency of pain attacks; alteration of different aspects of pain evaluated by standardised pain questionnaires (NPI, PDI, SES); effects on quality of life (SF 36); analgesic demand; alteration of sensoric perception by systematic quantitative sensory testing (QST); incidence of postherpetic neuralgia; side effects and cost effectiveness. Credibility of treatments will be assessed. Discussion This study is the first large-scale randomised placebo controlled trial to evaluate the efficacy of acupuncture compared to gabapentine and sham treatment and will

  18. Enhanced implementation of low back pain guidelines in general practice: study protocol of a cluster randomised controlled trial

    PubMed Central

    2013-01-01

    Background Evidence-based clinical practice guidelines may improve treatment quality, but the uptake of guideline recommendations is often incomplete and slow. Recently new low back pain guidelines are being launched in Denmark. The guidelines are considered to reduce personal and public costs. The aim of this study is to evaluate whether a complex, multifaceted implementation strategy of the low back pain guidelines will reduce secondary care referral and improve patient outcomes compared to the usual simple implementation strategy. Methods/design In a two-armed cluster randomised trial, 100 general practices (clusters) and 2,700 patients aged 18 to 65 years from the North Denmark region will be included. Practices are randomly allocated 1:1 to a simple or a complex implementation strategy. Intervention practices will receive a complex implementation strategy, including guideline facilitator visits, stratification tools, and quality reports on low back pain treatment. Primary outcome is referral to secondary care. Secondary outcomes are pain, physical function, health-related quality of life, patient satisfaction with care and treatment outcome, employment status, and sick leave. Primary and secondary outcomes pertain to the patient level. Assessments of outcomes are blinded and follow the intention-to-treat principle. Additionally, a process assessment will evaluate the degree to which the intervention elements will be delivered as planned, as well as measure changes in beliefs and behaviours among general practitioners and patients. Discussion This study provides knowledge concerning the process and effect of an intervention to implement low back pain guidelines in general practice, and will provide insight on essential elements to include in future implementation strategies in general practice. Trial registration Registered as NCT01699256 on ClinicalTrials.gov. PMID:24139140

  19. Using an internet intervention to support self-management of low back pain in primary care: protocol for a randomised controlled feasibility trial (SupportBack)

    PubMed Central

    Geraghty, Adam W A; Stanford, Rosie; Little, Paul; Roberts, Lisa; Foster, Nadine E; Hill, Jonathan C; Hay, Elaine; Stuart, Beth; Turner, David; Yardley, Lucy

    2015-01-01

    Introduction Low back pain (LBP) is a prevalent and costly condition. The majority of patients experiencing LBP are managed in primary care, where first-line care recommendations consist of advice to self-manage and remain active. Internet interventions present a potential means of providing patients with tailored self-management advice and evidence-based support for increasing physical activity. Methods/analysis This protocol describes a single-blind, randomised controlled feasibility trial of an internet intervention developed to support the self-management of LBP in primary care. Patients are being randomised to 1 of 3 groups receiving either usual primary care, usual primary care with the addition of an internet intervention or an internet intervention with physiotherapist telephone support. Patients are followed up at 3 months. Primary outcomes are the feasibility of (1) the trial design/methods, (2) the delivery of the internet intervention and (3) the provision of telephone support by physiotherapists. Secondary outcomes will include exploratory analysis of estimates and variation in clinical outcomes of pain and disability, in order to inform a future main trial. Ethics/dissemination This feasibility trial has undergone ethical scrutiny and been approved by the National Health Service (NHS) Research Ethics Committee, REC Reference 13/SC/0202. The feasibility findings will be disseminated to the research community through presentations at conferences and publication in peer review journals. Broader dissemination will come following a definitive trial. Trial registration number ISRCTN 31034004. PMID:26399575

  20. Comparison of yoga versus stretching for chronic low back pain: protocol for the Yoga Exercise Self-care (YES) trial

    PubMed Central

    2010-01-01

    Background Back pain, one of the most prevalent conditions afflicting American adults, is the leading reason for using complementary and alternative medicine (CAM) therapies. Yoga is an increasingly popular "mind-body" CAM therapy often used for relieving back pain and several small studies have found yoga effective for this condition. This study will assess whether yoga is effective for treating chronic low back pain compared with self care and exercise and will explore the mechanisms responsible for any observed benefits. Methods/Design A total of 210 participants with low back pain lasting at least 3 months will be recruited from primary care clinics of a large healthcare system based in Seattle. They will be randomized in a 2:2:1 ratio to receive 12 weekly yoga classes, 12 weekly conventional therapeutic exercise classes of comparable physical exertion, or a self-care book. Interviewers masked to participants' treatment group will assess outcomes at baseline and 6, 12 and 26 weeks after randomization. Primary outcomes will be back-related dysfunction and symptom bothersomeness. In addition, data will be collected on physical measurements (e.g., flexion) at baseline and 12 weeks and saliva samples will be obtained at baseline, 6 and 12 weeks. Information will be collected on specific physical, psychological, and physiological factors to allow exploration of possible mechanisms of action through which yoga could relieve back pain and dysfunction. The effectiveness of yoga will be assessed using analysis of covariance (using general estimating equations - GEE) within an intention-to-treat context. If yoga is found effective, further analyses will explore whether yoga's benefits are attributable to physical, psychological and/or physiological factors. Conclusions This study will provide the clearest evidence to date about the value of yoga as a therapeutic option for treating chronic back pain, and if the results are positive, will help focus future, more in

  1. Acupuncture at Houxi (SI 3) acupoint for acute neck pain caused by stiff neck: study protocol for a pilot randomised controlled trial

    PubMed Central

    Sun, Zhong-ren; Yue, Jin-huan; Tian, Hong-zhao; Zhang, Qin-hong

    2014-01-01

    Introduction The use of acupuncture has been suggested for the treatment of acute neck pain caused by stiff neck in China. However, current evidence is insufficient to draw any conclusions about its efficacy. Therefore this pilot study was designed to evaluate the feasibility and efficacy of acupuncture at the Houxi (SI3) acupoint for treatment of acute neck pain. Methods/analysis This pilot study will be a two-parallel-group, assessor-blinded, randomised controlled trial. Thirty-six stiff neck participants with acute neck pain will be recruited and randomly divided into two groups in a 1:1 ratio. Participants in the control group will receive massage on the local neck region (5 min each session, three times a day for 3 days). In addition to massage, patients in the treatment group will receive acupuncture (one session a day for 3 days). Measures will be taken at 0, 3 and 15 days. The primary outcome is the Northwick Park Neck Pain Questionnaire (NPQ). The secondary outcome is the Short Form of the McGill Pain Questionnaire (SF-MPQ). Ethics/dissemination The protocol for this pilot randomised clinical trial has undergone ethics scrutiny and been approved by the ethics review boards of the First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine (Permission number: HZYLL201303502). The findings of this study will provide important clinical evidence on the feasibility and efficacy of acupuncture treatment for stiff neck patients with acute neck pain. In addition, it will explore the feasibility of further acupuncture research. Trial registration number ChiCTR-TRC-13003911. PMID:25537784

  2. Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Chronic low back pain causes substantial morbidity and cost to society while disproportionately impacting low-income and minority adults. Several randomized controlled trials show yoga is an effective treatment. However, the comparative effectiveness of yoga and physical therapy, a common mainstream treatment for chronic low back pain, is unknown. Methods/Design This is a randomized controlled trial for 320 predominantly low-income minority adults with chronic low back pain, comparing yoga, physical therapy, and education. Inclusion criteria are adults 18–64 years old with non-specific low back pain lasting ≥12 weeks and a self-reported average pain intensity of ≥4 on a 0–10 scale. Recruitment takes place at Boston Medical Center, an urban academic safety-net hospital and seven federally qualified community health centers located in diverse neighborhoods. The 52-week study has an initial 12-week Treatment Phase where participants are randomized in a 2:2:1 ratio into i) a standardized weekly hatha yoga class supplemented by home practice; ii) a standardized evidence-based exercise therapy protocol adapted from the Treatment Based Classification method, individually delivered by a physical therapist and supplemented by home practice; and iii) education delivered through a self-care book. Co-primary outcome measures are 12-week pain intensity measured on an 11-point numerical rating scale and back-specific function measured using the modified Roland Morris Disability Questionnaire. In the subsequent 40-week Maintenance Phase, yoga participants are re-randomized in a 1:1 ratio to either structured maintenance yoga classes or home practice only. Physical therapy participants are similarly re-randomized to either five booster sessions or home practice only. Education participants continue to follow recommendations of educational materials. We will also assess cost effectiveness from the perspectives of the individual, insurers, and society using

  3. Acupuncture and rehabilitation of the painful shoulder: study protocol of an ongoing multicentre randomised controlled clinical trial [ISRCTN28687220

    PubMed Central

    Vas, Jorge; Perea-Milla, Emilio; Mendez, Camila; Galante, Antonia Herrera; Madrazo, Fernando; Medina, Ivan; Ortega, Caridad; Olmo, Victoria; Fernandez, Francisco Perez; Hernandez, Luz; Seminario, Jose Maria; Brioso, Mauricio; Luna, Francisco; Gordo, Isabel; Godoy, Ana Maria; Jimenez, Carmen; Ruiz, Manuel Anselmo; Montes, Joaquin; Hidalgo, Alonso; Gonzalez-Quevedo, Rosa; Bosch, Pablo; Vazquez, Antonio; Lozano, Juan Vicente

    2005-01-01

    variables, we will record the changes in diurnal pain intensity on a visual analogue scale (VAS), nocturnal pain intensity on the VAS, doses of non-steroid anti-inflammatory drugs (NSAIDs) taken during the study period, credibility scale for the treatment, degree of improvement perceived by the patient and degree of improvement perceived by the evaluator. A follow up examination will be made at 3, 6 and 12 months after the study period has ended. Two types of population will be considered for analysis: per protocol and per intention to treat. Discussion The discussion will take into account the limitations of the study, together with considerations such as the choice of a simple, safe method to treat this shoulder complaint, the choice of the control group, and the blinding of the patients, evaluators and those responsible for carrying out the final analysis. PMID:16225693

  4. The efficacy of music therapy protocols for decreasing pain, anxiety, and muscle tension levels during burn dressing changes: a prospective randomized crossover trial.

    PubMed

    Tan, Xueli; Yowler, Charles J; Super, Dennis M; Fratianne, Richard B

    2010-01-01

    The purpose of this study was to explore the efficacy of two music therapy protocols on pain, anxiety, and muscle tension levels during dressing changes in burn patients. Twenty-nine inpatients participated in this prospective, crossover randomized controlled trial. On two consecutive days, patients were randomized to receive music therapy services either on the first or second day of the study. On control days, they received no music. On music days, patients practiced music-based imagery (MBI), a form of music-assisted relaxation with patient-specific mental imagery before and after dressing changes. Also, on music days during dressing changes, the patients engaged in music alternate engagement (MAE), which consisted of active participation in music making. The dependent variables were the patients' subjective ratings of their pain and anxiety levels and the research nurse's objective ratings of their muscle tension levels. Two sets of data were collected before, three sets during, and another two sets after dressing changes. The results showed significant decrease in pain levels before (P < .025), during (P < .05), and after (P < .025) dressing changes on days the patients received music therapy in contrast to control days. Music therapy was also associated with a decrease in anxiety and muscle tension levels during the dressing changes (P < .05) followed by a reduction in muscle tension levels after dressing changes (P < .025). Music therapy significantly decreases the acute procedural pain, anxiety, and muscle tension levels associated with daily burn care.

  5. Effect of spinal manipulation on sensorimotor functions in back pain patients: study protocol for a randomised controlled trial

    PubMed Central

    2011-01-01

    Background Low back pain (LBP) is a recognized public health problem, impacting up to 80% of US adults at some point in their lives. Patients with LBP are utilizing integrative health care such as spinal manipulation (SM). SM is the therapeutic application of a load to specific body tissues or structures and can be divided into two broad categories: SM with a high-velocity low-amplitude load, or an impulse "thrust", (HVLA-SM) and SM with a low-velocity variable-amplitude load (LVVA-SM). There is evidence that sensorimotor function in people with LBP is altered. This study evaluates the sensorimotor function in the lumbopelvic region, as measured by postural sway, response to sudden load and repositioning accuracy, following SM to the lumbar and pelvic region when compared to a sham treatment. Methods/Design A total of 219 participants with acute, subacute or chronic low back pain are being recruited from the Quad Cities area located in Iowa and Illinois. They are allocated through a minimization algorithm in a 1:1:1 ratio to receive either 13 HVLA-SM treatments over 6 weeks, 13 LVVA-SM treatments over 6 weeks or 2 weeks of a sham treatment followed by 4 weeks of full spine "doctor's choice" SM. Sensorimotor function tests are performed before and immediately after treatment at baseline, week 2 and week 6. Self-report outcome assessments are also collected. The primary aims of this study are to 1) determine immediate pre to post changes in sensorimotor function as measured by postural sway following delivery of a single HVLA-SM or LVVA-SM treatment when compared to a sham treatment and 2) to determine changes from baseline to 2 weeks (4 treatments) of HVLA-SM or LVVA-SM compared to a sham treatment. Secondary aims include changes in response to sudden loads and lumbar repositioning accuracy at these endpoints, estimating sensorimotor function in the SM groups after 6 weeks of treatment, and exploring if changes in sensorimotor function are associated with changes in

  6. Comparison of complementary and alternative medicine with conventional mind–body therapies for chronic back pain: protocol for the Mind–body Approaches to Pain (MAP) randomized controlled trial

    PubMed Central

    2014-01-01

    Background The self-reported health and functional status of persons with back pain in the United States have declined in recent years, despite greatly increased medical expenditures due to this problem. Although patient psychosocial factors such as pain-related beliefs, thoughts and coping behaviors have been demonstrated to affect how well patients respond to treatments for back pain, few patients receive treatments that address these factors. Cognitive-behavioral therapy (CBT), which addresses psychosocial factors, has been found to be effective for back pain, but access to qualified therapists is limited. Another treatment option with potential for addressing psychosocial issues, mindfulness-based stress reduction (MBSR), is increasingly available. MBSR has been found to be helpful for various mental and physical conditions, but it has not been well-studied for application with chronic back pain patients. In this trial, we will seek to determine whether MBSR is an effective and cost-effective treatment option for persons with chronic back pain, compare its effectiveness and cost-effectiveness compared with CBT and explore the psychosocial variables that may mediate the effects of MBSR and CBT on patient outcomes. Methods/Design In this trial, we will randomize 397 adults with nonspecific chronic back pain to CBT, MBSR or usual care arms (99 per group). Both interventions will consist of eight weekly 2-hour group sessions supplemented by home practice. The MBSR protocol also includes an optional 6-hour retreat. Interviewers masked to treatment assignments will assess outcomes 5, 10, 26 and 52 weeks postrandomization. The primary outcomes will be pain-related functional limitations (based on the Roland Disability Questionnaire) and symptom bothersomeness (rated on a 0 to 10 numerical rating scale) at 26 weeks. Discussion If MBSR is found to be an effective and cost-effective treatment option for patients with chronic back pain, it will become a valuable

  7. Improving the care for people with acute low-back pain by allied health professionals (the ALIGN trial): A cluster randomised trial protocol

    PubMed Central

    2010-01-01

    Background Variability between clinical practice guideline recommendations and actual clinical practice exists in many areas of health care. A 2004 systematic review examining the effectiveness of guideline implementation interventions concluded there was a lack of evidence to support decisions about effective interventions to promote the uptake of guidelines. Further, the review recommended the use of theory in the development of implementation interventions. A clinical practice guideline for the management of acute low-back pain has been developed in Australia (2003). Acute low-back pain is a common condition, has a high burden, and there is some indication of an evidence-practice gap in the allied health setting. This provides an opportunity to develop and test a theory-based implementation intervention which, if effective, may provide benefits for patients with this condition. Aims This study aims to estimate the effectiveness of a theory-based intervention to increase allied health practitioners' (physiotherapists and chiropractors in Victoria, Australia) compliance with a clinical practice guideline for acute non-specific low back pain (LBP), compared with providing practitioners with a printed copy of the guideline. Specifically, our primary objectives are to establish if the intervention is effective in reducing the percentage of acute non-specific LBP patients who are either referred for or receive an x-ray, and improving mean level of disability for patients three months post-onset of acute LBP. Methods The design of the study is a cluster randomised trial. Restricted randomisation was used to randomise 210 practices (clusters) to an intervention or control group. Practitioners in the control group received a printed copy of the guideline. Practitioners in the intervention group received a theory-based intervention developed to address prospectively identified barriers to practitioner compliance with the guideline. The intervention primarily consisted of

  8. Effect of low-level laser therapy on pain, quality of life and sleep in patients with fibromyalgia: study protocol for a double-blinded randomized controlled trial

    PubMed Central

    2012-01-01

    -groups differences (followed by the Tukey-Kramer post hoc test), and a paired t test will be performed to test within-group differences. The level of significance for the statistical analysis will be set at 5% (P ≤0.05). Trial registration The protocol for this study is registered with the Brazilian Registry of Clinical Trials – ReBEC (RBR-42gkzt) PMID:23171567

  9. IMPLEmenting a clinical practice guideline for acute low back pain evidence-based manageMENT in general practice (IMPLEMENT): Cluster randomised controlled trial study protocol

    PubMed Central

    McKenzie, Joanne E; French, Simon D; O'Connor, Denise A; Grimshaw, Jeremy M; Mortimer, Duncan; Michie, Susan; Francis, Jill; Spike, Neil; Schattner, Peter; Kent, Peter M; Buchbinder, Rachelle; Green, Sally E

    2008-01-01

    Background Evidence generated from reliable research is not frequently implemented into clinical practice. Evidence-based clinical practice guidelines are a potential vehicle to achieve this. A recent systematic review of implementation strategies of guideline dissemination concluded that there was a lack of evidence regarding effective strategies to promote the uptake of guidelines. Recommendations from this review, and other studies, have suggested the use of interventions that are theoretically based because these may be more effective than those that are not. An evidence-based clinical practice guideline for the management of acute low back pain was recently developed in Australia. This provides an opportunity to develop and test a theory-based implementation intervention for a condition which is common, has a high burden, and for which there is an evidence-practice gap in the primary care setting. Aim This study aims to test the effectiveness of a theory-based intervention for implementing a clinical practice guideline for acute low back pain in general practice in Victoria, Australia. Specifically, our primary objectives are to establish if the intervention is effective in reducing the percentage of patients who are referred for a plain x-ray, and improving mean level of disability for patients three months post-consultation. Methods/Design This study protocol describes the details of a cluster randomised controlled trial. Ninety-two general practices (clusters), which include at least one consenting general practitioner, will be randomised to an intervention or control arm using restricted randomisation. Patients aged 18 years or older who visit a participating practitioner for acute non-specific low back pain of less than three months duration will be eligible for inclusion. An average of twenty-five patients per general practice will be recruited, providing a total of 2,300 patient participants. General practitioners in the control arm will receive access

  10. Optimizing Rehabilitation for Phantom Limb Pain Using Mirror Therapy and Transcranial Direct Current Stimulation: A Randomized, Double–Blind Clinical Trial Study Protocol

    PubMed Central

    Bolognini, Nadia; Crandell, David; Merabet, Lotfi B

    2016-01-01

    Background Despite the multiple available pharmacological and behavioral therapies for the management of chronic phantom limb pain (PLP) in lower limb amputees, treatment for this condition is still a major challenge and the results are mixed. Given that PLP is associated with maladaptive brain plasticity, interventions that promote cortical reorganization such as non-invasive brain stimulation and behavioral methods including transcranial direct current stimulation (tDCS) and mirror therapy (MT), respectively, may prove to be beneficial to control pain in PLP. Due to its complementary effects, a combination of tDCS and MT may result in synergistic effects in PLP. Objective The objective of this study is to evaluate the efficacy of tDCS and MT as a rehabilitative tool for the management of PLP in unilateral lower limb amputees. Methods A prospective, randomized, placebo-controlled, double-blind, factorial, superiority clinical trial will be carried out. Participants will be eligible if they meet the following inclusion criteria: lower limb unilateral traumatic amputees that present PLP for at least 3 months after the amputated limb has completely healed. Participants (N=132) will be randomly allocated to the following groups: (1) active tDCS and active MT, (2) sham tDCS and active MT, (3) active tDCS and sham MT, and (4) sham tDCS and sham MT. tDCS will be applied with the anodal electrode placed over the primary motor cortex (M1) contralateral to the amputation side and the cathode over the contralateral supraorbital area. Stimulation will be applied at the same time of the MT protocol with the parameters 2 mA for 20 minutes. Pain outcome assessments will be performed at baseline, before and after each intervention session, at the end of MT, and in 2 follow-up visits. In order to assess cortical reorganization and correlate with clinical outcomes, participants will undergo functional magnetic resonance imaging (fMRI) and transcranial magnetic stimulation (TMS

  11. Occupational rehabilitation programs for musculoskeletal pain and common mental health disorders: study protocol of a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Long-term sick leave has considerably negative impact on the individual and society. Hence, the need to identify effective occupational rehabilitation programs is pressing. In Norway, group based occupational rehabilitation programs merging patients with different diagnoses have existed for many years, but no rigorous evaluation has been performed. The described randomized controlled trial aims primarily to compare two structured multicomponent inpatient rehabilitation programs, differing in length and content, with a comparative cognitive intervention. Secondarily the two inpatient programs will be compared with each other, and with a usual care reference group. Methods/design The study is designed as a randomized controlled trial with parallel groups. The Social Security Office performs monthly extractions of sick listed individuals aged 18–60 years, on sick leave 2–12 months, with sick leave status 50% - 100% due to musculoskeletal, mental or unspecific disorders. Sick-listed persons are randomized twice: 1) to receive one of two invitations to participate in the study or not receive an invitation, where the latter “untouched” control group will be monitored for future sick leave in the National Social Security Register, and 2) after inclusion, to a Long or Short inpatient multicomponent rehabilitation program (depending on which invitation was sent) or an outpatient cognitive behavioral therapy group comparative program. The Long program consists of 3 ½ weeks with full rehabilitation days. The Short program consists of 4 + 4 full days, separated by two weeks, in which a workplace visit will be performed if desirable. Three areas of rehabilitation are targeted: mental training, physical training and work-related problem solving. The primary outcome is number of sick leave days. Secondary outcomes include time until full sustainable return to work, health related quality of life, health related behavior, functional status, somatic and

  12. Effectiveness and cost-effectiveness of a novel, group self-management course for adults with chronic musculoskeletal pain: study protocol for a multicentre, randomised controlled trial (COPERS)

    PubMed Central

    Carnes, Dawn; Taylor, Stephanie JC; Homer, Kate; Eldridge, Sandra; Bremner, Stephen; Pincus, Tamar; Rahman, Anisur; Underwood, Martin

    2013-01-01

    Introduction Chronic musculoskeletal pain is a common condition that often responds poorly to treatment. Self-management courses have been advocated as a non-drug pain management technique, although evidence for their effectiveness is equivocal. We designed and piloted a self-management course based on evidence for effectiveness for specific course components and characteristics. Methods/analysis COPERS (coping with persistent pain, effectiveness research into self-management) is a pragmatic randomised controlled trial testing the effectiveness and cost-effectiveness of an intensive, group, cognitive behavioural-based, theoretically informed and manualised self-management course for chronic pain patients against a control of best usual care: a pain education booklet and a relaxation CD. The course lasts for 15 h, spread over 3 days, with a –2 h follow-up session 2 weeks later. We aim to recruit 685 participants with chronic musculoskeletal pain from primary, intermediate and secondary care services in two UK regions. The study is powered to show a standardised mean difference of 0.3 in the primary outcome, pain-related disability. Secondary outcomes include generic health-related quality of life, healthcare utilisation, pain self-efficacy, coping, depression, anxiety and social engagement. Outcomes are measured at 6 and 12 months postrandomisation. Pain self-efficacy is measured at 3 months to assess whether change mediates clinical effect. Ethics/dissemination Ethics approval was given by Cambridgeshire Ethics 11/EE/046. This trial will provide robust data on the effectiveness and cost-effectiveness of an evidence-based, group self-management programme for chronic musculoskeletal pain. The published outcomes will help to inform future policy and practice around such self-management courses, both nationally and internationally. Trial registration ISRCTN24426731. PMID:23358564

  13. Spinal cord stimulation for predominant low back pain in failed back surgery syndrome: study protocol for an international multicenter randomized controlled trial (PROMISE study)

    PubMed Central

    2013-01-01

    Background Although results of case series support the use of spinal cord stimulation in failed back surgery syndrome patients with predominant low back pain, no confirmatory randomized controlled trial has been undertaken in this patient group to date. PROMISE is a multicenter, prospective, randomized, open-label, parallel-group study designed to compare the clinical effectiveness of spinal cord stimulation plus optimal medical management with optimal medical management alone in patients with failed back surgery syndrome and predominant low back pain. Method/Design Patients will be recruited in approximately 30 centers across Canada, Europe, and the United States. Eligible patients with low back pain exceeding leg pain and an average Numeric Pain Rating Scale score ≥5 for low back pain will be randomized 1:1 to spinal cord stimulation plus optimal medical management or to optimal medical management alone. The investigators will tailor individual optimal medical management treatment plans to their patients. Excluded from study treatments are intrathecal drug delivery, peripheral nerve stimulation, back surgery related to the original back pain complaint, and experimental therapies. Patients randomized to the spinal cord stimulation group will undergo trial stimulation, and if they achieve adequate low back pain relief a neurostimulation system using the Specify® 5-6-5 multi-column lead (Medtronic Inc., Minneapolis, MN, USA) will be implanted to capture low back pain preferentially in these patients. Outcome assessment will occur at baseline (pre-randomization) and at 1, 3, 6, 9, 12, 18, and 24 months post randomization. After the 6-month visit, patients can change treatment to that received by the other randomized group. The primary outcome is the proportion of patients with ≥50% reduction in low back pain at the 6-month visit. Additional outcomes include changes in low back and leg pain, functional disability, health-related quality of life, return to work

  14. Collaborative Care for Older Adults with low back pain by family medicine physicians and doctors of chiropractic (COCOA): study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Low back pain is a prevalent and debilitating condition that affects the health and quality of life of older adults. Older people often consult primary care physicians about back pain, with many also receiving concurrent care from complementary and alternative medicine providers, most commonly doctors of chiropractic. However, a collaborative model of treatment coordination between these two provider groups has yet to be tested. The primary aim of the Collaborative Care for Older Adults Clinical Trial is to develop and evaluate the clinical effectiveness and feasibility of a patient-centered, collaborative care model with family medicine physicians and doctors of chiropractic for the treatment of low back pain in older adults. Methods/design This pragmatic, pilot randomized controlled trial will enroll 120 participants, age 65 years or older with subacute or chronic low back pain lasting at least one month, from a community-based sample in the Quad-Cities, Iowa/Illinois, USA. Eligible participants are allocated in a 1:1:1 ratio to receive 12 weeks of medical care, concurrent medical and chiropractic care, or collaborative medical and chiropractic care. Primary outcomes are self-rated back pain and disability. Secondary outcomes include general and functional health status, symptom bothersomeness, expectations for treatment effectiveness and improvement, fear avoidance behaviors, depression, anxiety, satisfaction, medication use and health care utilization. Treatment safety and adverse events also are monitored. Participant-rated outcome measures are collected via self-reported questionnaires and computer-assisted telephone interviews at baseline, and at 4, 8, 12, 24, 36 and 52 weeks post-randomization. Provider-rated expectations for treatment effectiveness and participant improvement also are evaluated. Process outcomes are assessed through qualitative interviews with study participants and research clinicians, chart audits of progress notes and content

  15. Effectiveness of mat Pilates or equipment-based Pilates in patients with chronic non-specific low back pain: a protocol of a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Chronic low back pain is an expensive and difficult condition to treat. One of the interventions widely used by physiotherapists in the treatment of chronic non-specific low back pain is exercise therapy based upon the Pilates principles. Pilates exercises can be performed with or without specific equipment. These two types of Pilates exercises have never been compared on a high-quality randomised controlled trial. Methods/design This randomised controlled trial with a blinded assessor will evaluate eighty six patients of both genders with chronic low back pain, aged between 18 and 60 years, from one Brazilian private physiotherapy clinic. The patients will be randomly allocated into two groups: Mat Group will perform the exercises on the ground while the Equipment-based Group will perform the Pilates method exercises on the following equipment: Cadillac, Reformer, Ladder Barrel, and Step Chair. The general and specific disability of the patient, kinesiophobia, pain intensity and global perceived effect will be evaluated by a blinded assessor before randomisation and at six weeks and six months after randomisation. In addition, the expectation of the participants and their confidence with the treatment will be evaluated before randomisation and after the first treatment session, respectively. Discussion This will be the first study aiming to compare the effectiveness of Mat and Equipment-based Pilates exercises in patients with chronic non-specific low back pain. The results may help health-care professionals in clinical decision-making and could potentially reduce the treatment costs of this condition. Trial registration Brazilian Registry of Clinical Trials RBR-7tyg5j PMID:23298183

  16. 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

  17. Rocker-sole footwear versus prefabricated foot orthoses for the treatment of pain associated with first metatarsophalangeal joint osteoarthritis: study protocol for a randomised trial

    PubMed Central

    2014-01-01

    Background Osteoarthritis affecting the first metatarsophalangeal joint of the foot is a common condition which results in pain, stiffness and impaired ambulation. Footwear modifications and foot orthoses are widely used in clinical practice to treat this condition, but their effectiveness has not been rigorously evaluated. This article describes the design of a randomised trial comparing the effectiveness of rocker-sole footwear and individualised prefabricated foot orthoses in reducing pain associated with first metatarsophalangeal joint osteoarthritis. Methods Eighty people with first metatarsophalangeal joint osteoarthritis will be randomly allocated to receive either a pair of rocker-sole shoes (MBT® Matwa, Masai Barefoot Technology, Switzerland) or a pair of individualised, prefabricated foot orthoses (Vasyli Customs, Vasyli Medical™, Queensland, Australia). At baseline, the biomechanical effects of the interventions will be examined using a wireless wearable sensor motion analysis system (LEGSys™, BioSensics, Boston, MA, USA) and an in-shoe plantar pressure system (Pedar®, Novel GmbH, Munich, Germany). The primary outcome measure will be the pain subscale of the Foot Health Status Questionnaire (FHSQ), measured at baseline and 4, 8 and 12 weeks. Secondary outcome measures will include the function, footwear and general foot health subscales of the FHSQ, severity of pain and stiffness at the first metatarsophalangeal joint (measured using 100 mm visual analog scales), global change in symptoms (using a 15-point Likert scale), health status (using the Short-Form-12® Version 2.0 questionnaire), use of rescue medication and co-interventions to relieve pain, the frequency and type of self-reported adverse events and physical activity levels (using the Incidental and Planned Activity Questionnaire). Data will be analysed using the intention to treat principle. Discussion This study is the first randomised trial to compare the effectiveness of rocker

  18. A Neurofeedback-Based Intervention to Reduce Post-Operative Pain in Lung Cancer Patients: Study Protocol for a Randomized Controlled Trial

    PubMed Central

    Marzorati, Chiara; Casiraghi, Monica; Spaggiari, Lorenzo; Pravettoni, Gabriella

    2015-01-01

    Background Thoracic surgery appears to be the treatment of choice for many lung cancers. Nevertheless, depending on the type of surgery, the chest area may be painful for several weeks to months after surgery. This painful state has multiple physical and psychological implications, including respiratory failure, inability to clear secretions by coughing, and even anxiety and depression that have negative effects on recovery. Objective The aim of this study is to evaluate the effect of a neurofeedback-based intervention on controlling acute post-surgery pain and improving long-term recovery in patients who undergo thoracotomy for lung resection for non-small cell lung cancer (NSCLC) at an academic oncologic hospital. Methods This study will be based on a 2-parallel group randomized controlled trial design, intervention versus usual care, with multiple in-hospital assessments and 2 clinical, radiological, and quality of life follow-ups. Participants will be randomized to either the intervention group receiving a neurofeedback-based relaxation training and usual care, or to a control group receiving only usual care. Pain intensity is the primary outcome and will be assessed using the Numeric Pain Rating Scale (NRS) in the days following the operation. Secondary outcomes will include the effect of the intervention on hospital utilization for pain crisis, daily opioid consumption, anxiety, patient engagement, blood test and chest x-ray results, and long-term clinical, radiological, and quality of life evaluations. Outcome measures will be repeatedly taken during hospitalization, while follow-up assessments will coincide with the follow-up visits. Pain intensity will be assessed by mixed model repeated analysis. Effect sizes will be calculated as mean group differences with standard deviations. Results We expect to have results for this study before the end of 2016. Conclusions The proposed innovative, neurofeedback- and relaxation-based approach to support post

  19. Participatory ergonomic intervention versus strength training on chronic pain and work disability in slaughterhouse workers: study protocol for a single-blind, randomized controlled trial

    PubMed Central

    2013-01-01

    Background The prevalence of musculoskeletal pain in the shoulder, arm and hand is high among slaughterhouse workers, allegedly due to the highly repetitive and forceful exposure of these body regions during work. Work disability is a common consequence of these pains. Lowering the physical exposure through ergonomics intervention is the traditional strategy to reduce the workload. An alternative strategy could be to increase physical capacity of the worker through strength training. This study investigates the effect of two contrasting interventions, participatory ergonomics versus strength training on pain and work disability in slaughterhouse workers with chronic pain. Methods/design 66 slaughterhouse workers were allocated to 10 weeks of (1) strength training of the shoulder, arm and hand muscles for 3 x 10 minutes per week, or (2) participatory ergonomics involving counseling on workstation adjustment and optimal use of work tools (~usual care control group). Inclusion criteria were (1) working at a slaughterhouse for at least 30 hours per week, (2) pain intensity in the shoulder, elbow/forearm, or hand/wrist of at least 3 on a 0–10 VAS scale during the last three months, (3) pain lasting for more than 3 months, (4) frequent pain (at least 3 days per week) (5) at least moderate work disability, (6) no strength training during the last year, (7) no ergonomics instruction during the last year. Perceived pain intensity (VAS scale 0–10) of the shoulder, elbow/forearm and hand/wrist (primary outcome) and Disability of the Arm, Shoulder and Hand (Work module, DASH questionnaire) were measured at baseline and 10-week follow-up. Further, total muscle tenderness score and muscle function were assessed during clinical examination at baseline and follow-up. Discussion This RCT study will provide experimental evidence of the effectiveness of contrasting work-site interventions aiming at reducing chronic pain and work disability among employees engaged in

  20. Protocol for Work place adjusted Intelligent physical exercise reducing Musculoskeletal pain in Shoulder and neck (VIMS): a cluster randomized controlled trial

    PubMed Central

    2010-01-01

    Background Neck and shoulder complaints are common among employees in sedentary occupations characterized by intensive computer use. Specific strength training is a promising type of physical exercise for relieving neck and shoulder pain in office workers. However, the optimal combination of frequency and exercise duration, as well as the importance of exercise supervision, is unknown. The VIMS study investigates in a cluster randomized controlled design the effectiveness of different time wise combinations of specific strength training with identical accumulated volume, and the relevance of training supervision for safe and effective training. Methods/design A cluster randomized controlled trial of 20 weeks duration where employed office workers are randomized to 1 × 60 min, 3 × 20 min, 9 × 7 min per week of specific strength training with training supervision, to 3 × 20 min per week of specific strength training with a minimal amount of training supervision, or to a reference group without training. A questionnaire will be sent to 2000 employees in jobs characterized by intensive computer work. Employees with cardiovascular disease, trauma, hypertension, or serious chronic disease will be excluded. The main outcome measure is pain in the neck and shoulders at week 20. Trial Registration The trial is registered at ClinicalTrials.gov, number NCT01027390. PMID:20687940

  1. A Web- and Mobile-Based Intervention for Women Treated for Breast Cancer to Manage Chronic Pain and Symptoms Related to Lymphedema: Randomized Clinical Trial Rationale and Protocol

    PubMed Central

    Scagliola, Joan

    2016-01-01

    Background Despite current advances in cancer treatment, many breast cancer survivors still face long-term post-operative challenges as a result of suffering from daily pain and other distressing symptoms related to lymphedema, ie, abnormal accumulation of lymph fluid in the ipsilateral upper limb or body. Grounded in research-driven behavioral strategies, The-Optimal-Lymph-Flow is a unique Web- and mobile-based system focusing on self-care strategies to empower, rather than inhibit, how breast cancer survivors manage daily pain and symptoms. It features a set of safe, feasible, and easily-integrated-into-daily-routine exercises to promote lymph flow and drainage, as well as guidance to maintain an optimal body mass index (BMI). Objective To conduct a randomized clinical trial (RCT) to evaluate the efficacy of the Web- and mobile-based The-Optimal-Lymph-Flow system for managing chronic pain and symptoms related to lymphedema. The primary outcome includes pain reduction, and the secondary outcomes focus on symptom relief, limb volume difference by infra-red perometer, BMI, and quality of life (QOL) related to pain. We hypothesize that participants in the intervention group will have improved pain and symptom experiences, limb volume difference, body mass index, and QOL. Methods A parallel RCT with a control-experimental, pre- and post-test, repeated-measures design is used in this study. A total of 120 patients will be randomized according to the occurrence of pain. Participants will be recruited face-to-face at the point of care during clinical visits. Participants in the intervention group will receive the Web- and mobile-based The-Optimal-Lymph-Flow intervention and will have access to and learn about the program during the first in-person research visit. Participants in the control group will receive the Web- and mobile-based Arm Precaution program and will have access to and learn about the program during the first in-person research visit. Participants will be

  2. TOPS: Trial Of Prevention Strategies for low back pain in patients recently recovered from low back pain—study rationale and protocol

    PubMed Central

    Lin, Chung-Wei C; Hancock, Mark J; Latimer, Jane; Buchbinder, Rachelle; Grotle, Margreth; van Tulder, Maurits; New, Charles H; Wisby-Roth, Trish; Maher, Chris G

    2016-01-01

    Introduction Low back pain (LBP) is the health condition that carries the greatest disability burden worldwide; however, there is only modest support for interventions to prevent LBP. The aim of this trial is to establish the effectiveness and cost-effectiveness of group-based exercise and educational classes compared with a minimal intervention control in preventing recurrence of LBP in people who have recently recovered from an episode of LBP. Methods and analysis TOPS will be a pragmatic comparative effectiveness randomised clinical trial with a parallel economic evaluation combining three separate cohorts (TOPS Workers, TOPS Primary Care, TOPS Defence) with the same methodology. 1482 participants who have recently recovered from LBP will be randomised to either a comprehensive exercise and education programme or a minimal intervention control. Participants will be followed up for a minimum of 1 year. The primary outcome will be days till recurrence of LBP. Effectiveness will be assessed using survival analysis. Cost-effectiveness will be assessed from the societal perspective. Ethics and dissemination This trial has been approved by the University of Sydney Human Research Ethics Committee (HREC) (ref: 2015/728) and prospectively registered with the Australian and New Zealand Clinical Trials Registry (ref: 12615000939594). We will also obtain ethics approval from the Australian Defence Force HREC. The results of this study will be submitted for publication in a prominent journal and widely publicised in the general media. Trial registration number Australian and New Zealand Clinical Trial Registry (ANZCTR) 12615000939594. PMID:27217287

  3. Study protocol: Improving patient choice in treating low back pain (IMPACT - LBP): A randomised controlled trial of a decision support package for use in physical therapy

    PubMed Central

    2011-01-01

    Background Low back pain is a common and costly condition. There are several treatment options for people suffering from back pain, but there are few data on how to improve patients' treatment choices. This study will test the effects of a decision support package (DSP), designed to help patients seeking care for back pain to make better, more informed choices about their treatment within a physiotherapy department. The package will be designed to assist both therapist and patient. Methods/Design Firstly, in collaboration with physiotherapists, patients and experts in the field of decision support and decision aids, we will develop the DSP. The work will include: a literature and evidence review; secondary analysis of existing qualitative data; exploration of patients' perspectives through focus groups and exploration of experts' perspectives using a nominal group technique and a Delphi study. Secondly, we will carry out a pilot single centre randomised controlled trial within NHS Coventry Community Physiotherapy. We will randomise physiotherapists to receive either training for the DSP or not. We will randomly allocate patients seeking treatment for non specific low back pain to either a physiotherapist trained in decision support or to receive usual care. Our primary outcome measure will be patient satisfaction with treatment at three month follow-up. We will also estimate the cost-effectiveness of the intervention, and assess the value of conducting further research. Discussion Informed shared decision-making should be an important part of any clinical consultation, particularly when there are several treatments, which potentially have moderate effects. The results of this pilot will help us determine the benefits of improving the decision-making process in clinical practice on patient satisfaction. Trial registration Current Controlled Trials ISRCTN46035546 PMID:21352528

  4. “Push” versus “Pull” for mobilizing pain evidence into practice across different health professions: A protocol for a randomized trial

    PubMed Central

    2012-01-01

    Background Optimizing pain care requires ready access and use of best evidence within and across different disciplines and settings. The purpose of this randomized trial is to determine whether a technology-based “push” of new, high-quality pain research to physicians, nurses, and rehabilitation and psychology professionals results in better knowledge and clinical decision making around pain, when offered in addition to traditional “pull” evidence technology. A secondary objective is to identify disciplinary variations in response to evidence and differences in the patterns of accessing research evidence. Methods Physicians, nurses, occupational/physical therapists, and psychologists (n = 670) will be randomly allocated in a crossover design to receive a pain evidence resource in one of two different ways. Evidence is extracted from medical, nursing, psychology, and rehabilitation journals; appraised for quality/relevance; and sent out (PUSHed) to clinicians by email alerts or available for searches of the accumulated database (PULL). Participants are allocated to either PULL or PUSH + PULL in a randomized crossover design. The PULL intervention has a similar interface but does not send alerts; clinicians can only go to the site and enter search terms to retrieve evidence from the cumulative and continuously updated online database. Upon entry to the trial, there is three months of access to PULL, then random allocation. After six months, crossover takes place. The study ends with a final three months of access to PUSH + PULL. The primary outcomes are uptake and application of evidence. Uptake will be determined by embedded tracking of what research is accessed during use of the intervention. A random subset of 30 participants/ discipline will undergo chart-stimulated recall to assess the nature and depth of evidence utilization in actual case management at baseline and 9 months. A different random subset of 30 participants/ discipline will be tested for

  5. Efficacy of graded activity versus supervised exercises in patients with chronic non-specific low back pain: protocol of a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Low back pain is a relevant public health problem, being an important cause of work absenteeism worldwide, as well as affecting the quality of life of sufferers and their individual functional performances. Supervised active physical routines and of cognitive-behavioral therapies are recommended for the treatment of chronic Low back pain, although evidence to support the effectiveness of different techniques is missing. Accordingly, the aim of this study is to contrast the effectiveness of two types of exercises, graded activity or supervised, in decreasing symptoms of chronic low back pain. Methods/design Sample will consist of 66 patients, blindly allocated into one of two groups: 1) Graded activity which, based on an operant approach, will use time-contingent methods aiming to increase participants’ activity levels; 2) Supervised exercise, where participants will be trained for strengthening, stretching, and motor control targeting different muscle groups. Interventions will last one hour, and will happen twice a week for 6 weeks. Outcomes (pain, disability, quality of life, global perceived effect, return to work, physical activity, physical capacity, and kinesiophobia) will be assessed at baseline, at treatment end, and three and six months after treatment end. Data collection will be conducted by an investigator blinded to treatment allocation. Discussion This project describes the randomisation method that will be used to compare the effectiveness of two different treatments for chronic low back pain: graded activity and supervised exercises. Since optimal approach for patients with chronic back pain have yet not been defined based on evidence, good quality studies on the subject are necessary. Trial registration NCT01719276 PMID:23336703

  6. Efficacy of a Sleep Quality Intervention in People With Low Back Pain: Protocol for a Feasibility Randomized Co-Twin Controlled Trial.

    PubMed

    Pinheiro, Marina B; Ho, Kevin K; Ferreira, Manuela L; Refshauge, Kathryn M; Grunstein, Ron; Hopper, John L; Maher, Christopher G; Koes, Bart W; Ordoñana, Juan R; Ferreira, Paulo H

    2016-10-01

    Poor sleep quality is highly prevalent in patients with low back pain (LBP) and is associated with high levels of pain, psychological distress, and physical disability. Studies have reported a bidirectional relationship between sleep problems and intensity of LBP. Accordingly, effective management of LBP should address sleep quality. In addition, genetics has been found to significantly affect the prevalence of both LBP and insomnia. Our study aims to establish the feasibility of a trial exploring the efficacy of a web-based sleep quality intervention in people with LBP, with the genetic influences being controlled for. 30 twins (15 complete pairs) with subacute or chronic LBP (>6 weeks) will be recruited from the Australian Twin Registry. Participants will be randomly assigned to one of the two groups with each twin within a pair receiving either an interactive web-based sleep intervention based on cognitive behavioral therapy principles (intervention) or a web-based education program (control) for 6 weeks. The feasibility of the trial will be investigated with regard to recruitment rate, feasibility of data collection and outcome measure completion, contamination of intervention, acceptability and experience of intervention, and sample size requirement for the full trial. Patient outcomes will be collected electronically at baseline, immediately post-treatment, and at 3-months' follow-up post-randomization. This trial employs a robust design that will effectively control for the influence of genetics on treatment effect. Additionally, this study addresses sleep quality, a significant but under-explored issue in LBP. Results will inform the design and implementation of the definitive trial. PMID:27571889

  7. Efficacy of temporary work modifications on disability related to musculoskeletal pain or depressive symptoms—study protocol for a controlled trial

    PubMed Central

    Haukka, Eija; Martimo, Kari-Pekka; Kivekäs, Teija; Horppu, Ritva; Lallukka, Tea; Solovieva, Svetlana; Shiri, Rahman; Pehkonen, Irmeli; Takala, Esa-Pekka; MacEachen, Ellen; Viikari-Juntura, Eira

    2015-01-01

    Introduction Previous research suggests that work with a suitable workload may promote health and work retention in people with disability. This study will examine whether temporary work modifications at the early stage of work disability are effective in enhancing return to work (RTW) or staying at work among workers with musculoskeletal or depressive symptoms. Methods and analysis A single-centre controlled trial with modified stepped wedge design will be carried out in eight enterprises and their occupational health services (OHSs) in nine cities in Finland. Patients seeking medical advice due to musculoskeletal pain (≥4 on a scale from 0–10) or depressive symptoms (≥1 positive response to 2 screening questions) and fulfilling other inclusion criteria are eligible. The study involves an educational intervention among occupational physicians to enhance the initiation of work modifications. Primary outcomes are sustained RTW (≥4 weeks at work without a new sickness absence (SA)) and the total number of SA days during a 12-month follow-up. Secondary outcomes are intensity of musculoskeletal pain (scale 0–10), pain interference with work or sleep (scale 0–10) and severity of depressive symptoms (Patient Health Questionnaire, PHQ-9), inquired via online questionnaires at baseline and 3, 6, 9 and 12 months after recruitment. Information on SA days will be collected from the medical records of the OHSs over 12 months, before and after recruitment. The findings will give new information about the possibilities of training physicians to initiate work modifications and their effects on RTW in employees with work disability due to musculoskeletal pain or depressive symptoms. Ethics and dissemination The Coordinating Ethics Committee of Hospital District of Helsinki and Uusimaa has granted approval for this study. The results will be published in peer-reviewed journals. Trial registration number ISRCTN74743666. PMID:25986643

  8. Effects of tailored neck-shoulder pain treatment based on a decision model guided by clinical assessments and standardized functional tests. A study protocol of a randomized controlled trial

    PubMed Central

    2012-01-01

    Background A major problem with rehabilitation interventions for neck pain is that the condition may have multiple causes, thus a single treatment approach is seldom efficient. The present study protocol outlines a single blinded randomised controlled trial evaluating the effect of tailored treatment for neck-shoulder pain. The treatment is based on a decision model guided by standardized clinical assessment and functional tests with cut-off values. Our main hypothesis is that the tailored treatment has better short, intermediate and long-term effects than either non-tailored treatment or treatment-as-usual (TAU) on pain and function. We sub-sequentially hypothesize that tailored and non-tailored treatment both have better effect than TAU. Methods/Design 120 working women with minimum six weeks of nonspecific neck-shoulder pain aged 20–65, are allocated by minimisation with the factors age, duration of pain, pain intensity and disability in to the groups tailored treatment (T), non-tailored treatment (NT) or treatment-as-usual (TAU). Treatment is given to the groups T and NT for 11 weeks (27 sessions evenly distributed). An extensive presentation of the tests and treatment decision model is provided. The main treatment components are manual therapy, cranio-cervical flexion exercise and strength training, EMG-biofeedback training, treatment for cervicogenic headache, neck motor control training. A decision algorithm based on the baseline assessment determines the treatment components given to each participant of T- and NT-groups. Primary outcome measures are physical functioning (Neck Disability Index) and average pain intensity last week (Numeric Rating Scale). Secondary outcomes are general improvement (Patient Global Impression of Change scale), symptoms (Profile Fitness Mapping neck questionnaire), capacity to work in the last 6 weeks (quality and quantity) and pressure pain threshold of m. trapezius. Primary and secondary outcomes will be reported for

  9. Efficacy and safety of acupuncture for the treatment of non-specific acute low back pain: a randomised controlled multicentre trial protocol [ISRCTN65814467

    PubMed Central

    Vas, Jorge; Perea-Milla, Emilio; Mendez, Camila; Silva, Luis Carlos; Herrera Galante, Antonia; Aranda Regules, Jose Manuel; Martinez Barquin, Dulce M; Aguilar, Inmaculada; Faus, Vicente

    2006-01-01

    Background Low back pain and its associated incapacitating effects constitute an important healthcare and socioeconomic problem, as well as being one of the main causes of disability among adults of working age. The prevalence of non-specific low back pain is very high among the general population, and 60–70% of adults are believed to have suffered this problem at some time. Nevertheless, few randomised clinical trials have been made of the efficacy and efficiency of acupuncture with respect to acute low back pain. The present study is intended to assess the efficacy of acupuncture for acute low back pain in terms of the improvement reported on the Roland Morris Questionnaire (RMQ) on low back pain incapacity, to estimate the specific and non-specific effects produced by the technique, and to carry out a cost-effectiveness analysis. Methods/Design Randomised four-branch controlled multicentre prospective study made to compare semi-standardised real acupuncture, sham acupuncture (acupuncture at non-specific points), placebo acupuncture and conventional treatment. The patients are blinded to the real, sham and placebo acupuncture treatments. Patients in the sample present symptoms of non specific acute low back pain, with a case history of 2 weeks or less, and will be selected from working-age patients, whether in paid employment or not, referred by General Practitioners from Primary Healthcare Clinics to the four clinics participating in this study. In order to assess the primary and secondary result measures, the patients will be requested to fill in a questionnaire before the randomisation and again at 3, 12 and 48 weeks after starting the treatment. The primary result measure will be the clinical relevant improvement (CRI) at 3 weeks after randomisation. We define CRI as a reduction of 35% or more in the RMQ results. Discussion This study is intended to obtain further evidence on the effectiveness of acupuncture on acute low back pain and to isolate the

  10. Physiotherapy informed by Acceptance and Commitment Therapy (PACT): protocol for a randomised controlled trial of PACT versus usual physiotherapy care for adults with chronic low back pain

    PubMed Central

    Godfrey, Emma; Galea Holmes, Melissa; Wileman, Vari; McCracken, Lance; Moss-Morris, Rona; Pallet, John; Sanders, Duncan; Barcellona, Massimo; Critchley, Duncan

    2016-01-01

    Introduction Chronic low back pain (CLBP) is a common condition and source of significant suffering, disability and healthcare costs. Current physiotherapy treatment is moderately effective. Combining theory-based psychological methods with physiotherapy could improve outcomes for people with CLBP. The primary aim of this randomised controlled trial (RCT) is to evaluate the efficacy of Physiotherapy informed by Acceptance and Commitment Therapy (PACT) on functioning in patients with CLBP. Methods and analysis The PACT trial is a two-armed, parallel-group, multicentre RCT to assess the efficacy of PACT in comparison with usual physiotherapy care (UC). 240 patients referred to physiotherapy with CLBP will be recruited from three National Health Service (NHS) hospitals trusts. Inclusion criteria are: age ≥18 years, CLBP ≥12-week duration, scoring ≥3 points on the Roland-Morris Disability Questionnaire (RMDQ) and adequate understanding of spoken and written English to participate. Patients will be randomised to PACT or UC (120 per arm stratified by centre) by an independent randomisation service and followed up at 3 and 12 months post randomisation. The sample size of 240 will provide adequate power to detect a standardised mean difference of 0.40 in the primary outcome (RMDQ; 5% significance, 80% power) assuming attrition of 20%. Analysis will be by intention to treat conducted by the trial statistician, blind to treatment group, following a prespecified analysis plan. Estimates of treatment effect at the follow-up assessments will use an intention-to-treat framework, implemented using a linear mixed-effects model. Ethics and dissemination This trial has full ethical approval (14/SC/0277). It will be disseminated via peer-reviewed publications and conference presentations. The results will enable clinicians, patients and health service managers to make informed decisions regarding the efficacy of PACT for patients with CLBP. Trial registration number ISRCTN

  11. Comparison of usual podiatric care and early physical therapy intervention for plantar heel pain: study protocol for a parallel-group randomized clinical trial

    PubMed Central

    2013-01-01

    Background A significant number of individuals suffer from plantar heel pain (PHP) and many go on to have chronic symptoms and continued disability. Persistence of symptoms adds to the economic burden of PHP and cost-effective solutions are needed. Currently, there is a wide variation in treatment, cost, and outcomes of care for PHP with limited information on the cost-effectiveness and comparisons of common treatment approaches. Two practice guidelines and recent evidence of effective physical therapy intervention are available to direct treatment but the timing and influence of physical therapy intervention in the multidisciplinary management of PHP is unclear. The purpose of this investigation is to compare the outcomes and costs associated with early physical therapy intervention (ePT) following initial presentation to podiatry versus usual podiatric care (uPOD) in individuals with PHP. Methods A parallel-group, block-randomized clinical trial will compare ePT and uPOD. Both groups will be seen initially by a podiatrist before allocation to a group that will receive physical therapy intervention consisting primarily of manual therapy, exercise, and modalities, or podiatric care consisting primarily of a stretching handout, medication, injections, and orthotics. Treatment in each group will be directed by practice guidelines and a procedural manual, yet the specific intervention for each participant will be selected by the treating provider. Between-group differences in the Foot and Ankle Ability Measure 6 months following the initial visit will be the primary outcome collected by an independent investigator. In addition, differences in the European Quality of Life – Five Dimensions, Numeric Pain Rating Scale, Global Rating of Change (GROC), health-related costs, and cost-effectiveness at 6 weeks, 6 months, and 1 year will be compared between groups. The association between successful outcomes based on GROC score and participant expectations of recovery

  12. Theory-driven group-based complex intervention to support self-management of osteoarthritis and low back pain in primary care physiotherapy: protocol for a cluster randomised controlled feasibility trial (SOLAS)

    PubMed Central

    Hurley, Deirdre A; Hall, Amanda M; Currie-Murphy, Laura; Pincus, Tamar; Kamper, Steve; Maher, Chris; McDonough, Suzanne M; Lonsdale, Chris; Walsh, Nicola E; Guerin, Suzanne; Segurado, Ricardo; Matthews, James

    2016-01-01

    Introduction International clinical guidelines consistently endorse the promotion of self-management (SM), including physical activity for patients with chronic low back pain (CLBP) and osteoarthritis (OA). Patients frequently receive individual treatment and advice to self-manage from physiotherapists in primary care, but the successful implementation of a clinical and cost-effective group SM programme is a key priority for health service managers in Ireland to maximise long-term outcomes and efficient use of limited and costly resources. Methods/analysis This protocol describes an assessor-blinded cluster randomised controlled feasibility trial of a group-based education and exercise intervention underpinned by self-determination theory designed to support an increase in SM behaviour in patients with CLBP and OA in primary care physiotherapy. The primary care clinic will be the unit of randomisation (cluster), with each clinic randomised to 1 of 2 groups providing the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) intervention or usual individual physiotherapy. Patients are followed up at 6 weeks, 2 and 6 months. The primary outcomes are the (1) acceptability and demand of the intervention to patients and physiotherapists, (2) feasibility and optimal study design/procedures and sample size for a definitive trial. Secondary outcomes include exploratory analyses of: point estimates, 95% CIs, change scores and effect sizes in physical function, pain and disability outcomes; process of change in target SM behaviours and selected mediators; and the cost of the intervention to inform a definitive trial. Ethics/dissemination This feasibility trial protocol was approved by the UCD Human Research Ethics—Sciences Committee (LS-13-54 Currie-Hurley) and research access has been granted by the Health Services Executive Primary Care Research Committee in January 2014. The study findings will be disseminated to the research

  13. Individualised cognitive functional therapy compared with a combined exercise and pain education class for patients with non-specific chronic low back pain: study protocol for a multicentre randomised controlled trial

    PubMed Central

    O'Keeffe, Mary; Purtill, Helen; Kennedy, Norelee; O'Sullivan, Peter; Dankaerts, Wim; Tighe, Aidan; Allworthy, Lars; Dolan, Louise; Bargary, Norma; O'Sullivan, Kieran

    2015-01-01

    Introduction Non-specific chronic low back pain (NSCLBP) is a very common and costly musculoskeletal disorder associated with a complex interplay of biopsychosocial factors. Cognitive functional therapy (CFT) represents a novel, patient-centred intervention which directly challenges pain-related behaviours in a cognitively integrated, functionally specific and graduated manner. CFT aims to target all biopsychosocial factors that are deemed to be barriers to recovery for an individual patient with NSCLBP. A recent randomised controlled trial (RCT) demonstrated the superiority of individualised CFT for NSCLBP compared to manual therapy combined with exercise. However, several previous RCTs have suggested that class-based interventions are as effective as individualised interventions. Therefore, it is important to examine whether an individualised intervention, such as CFT, demonstrates clinical effectiveness compared to a relatively cheaper exercise and education class. The current study will compare the clinical effectiveness of individualised CFT with a combined exercise and pain education class in people with NSCLBP. Methods and analysis This study is a multicentre RCT. 214 participants, aged 18–75 years, with NSCLBP for at least 6 months will be randomised to one of two interventions across three sites. The experimental group will receive individualised CFT and the length of the intervention will be varied in a pragmatic manner based on the clinical progression of participants. The control group will attend six classes which will be provided over a period of 6–8 weeks. Participants will be assessed preintervention, postintervention and after 6 and12 months. The primary outcomes will be functional disability and pain intensity. Non-specific predictors, moderators and mediators of outcome will also be analysed. Ethics and dissemination Ethical approval has been obtained from the Mayo General Hospital Research Ethics Committee (MGH-14-UL). Outcomes will

  14. SPIRIT 2013 Statement: defining standard protocol items for clinical trials.

    PubMed

    Chan, An-Wen; Tetzlaff, Jennifer M; Altman, Douglas G; Laupacis, Andreas; Gøtzsche, Peter C; Krle A-Jerić, Karmela; Hrobjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A; Dore, Caroline J; Parulekar, Wendy R; Summerskill, William S M; Groves, Trish; Schulz, Kenneth F; Sox, Harold C; Rockhold, Frank W; Rennie, Drummond; Moher, David

    2015-12-01

    The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders. PMID:27440100

  15. Role of multidetector computed tomography in the diagnosis and management of patients attending the rapid access chest pain clinic, The Scottish computed tomography of the heart (SCOT-HEART) trial: study protocol for randomized controlled trial

    PubMed Central

    2012-01-01

    Background Rapid access chest pain clinics have facilitated the early diagnosis and treatment of patients with coronary heart disease and angina. Despite this important service provision, coronary heart disease continues to be under-diagnosed and many patients are left untreated and at risk. Recent advances in imaging technology have now led to the widespread use of noninvasive computed tomography, which can be used to measure coronary artery calcium scores and perform coronary angiography in one examination. However, this technology has not been robustly evaluated in its application to the clinic. Methods/design The SCOT-HEART study is an open parallel group prospective multicentre randomized controlled trial of 4,138 patients attending the rapid access chest pain clinic for evaluation of suspected cardiac chest pain. Following clinical consultation, participants will be approached and randomized 1:1 to receive standard care or standard care plus ≥64-multidetector computed tomography coronary angiography and coronary calcium score. Randomization will be conducted using a web-based system to ensure allocation concealment and will incorporate minimization. The primary endpoint of the study will be the proportion of patients diagnosed with angina pectoris secondary to coronary heart disease at 6 weeks. Secondary endpoints will include the assessment of subsequent symptoms, diagnosis, investigation and treatment. In addition, long-term health outcomes, safety endpoints, such as radiation dose, and health economic endpoints will be assessed. Assuming a clinic rate of 27.0% for the diagnosis of angina pectoris due to coronary heart disease, we will need to recruit 2,069 patients per group to detect an absolute increase of 4.0% in the rate of diagnosis at 80% power and a two-sided P value of 0.05. The SCOT-HEART study is currently recruiting participants and expects to report in 2014. Discussion This is the first study to look at the implementation of computed

  16. Rationale, design, and implementation protocol of the Dutch clinical practice guideline Pain in patients with cancer: a cluster randomised controlled trial with short message service (SMS) and interactive voice response (IVR)

    PubMed Central

    2011-01-01

    Background One-half of patients with cancer have pain. In nearly one out of two cancer patients with pain, this was undertreated. Inadequate pain control still remains an important problem in this group of patients. Therefore, in 2008 a national, evidence-based multidisciplinary clinical practice guideline 'pain in patients with cancer' has been developed. Yet, publishing a guideline is not enough. Implementation is needed to improve pain management. An innovative implementation strategy, Short Message Service with Interactive Voice Response (SVS-IVR), has been developed and pilot tested. This study aims to evaluate on effectiveness of this strategy to improve pain reporting, pain measurement and adequate pain therapy. In addition, whether the active role of the patient and involvement of caregivers in pain management may change. Methods/design A cluster randomised controlled trial with two arms will be performed in six oncology outpatient clinics of hospitals in the Southeastern region of the Netherlands, with three hospitals in the intervention and three in the control condition. Follow-up measurements will be conducted in all hospitals to study the long-term effect of the intervention. The intervention includes training of professionals (medical oncologists, nurses, and general practitioners) and SMS-IVR to report pain in patients with cancer to improve pain reporting by patients, pain management by medical oncologists, nurses, and general practitioners, and decrease pain intensity. Discussion This innovative implementation strategy with technical tools and the involvement of patients, may enhance the use of the guideline 'pain in patients with cancer' for pain management. Short Message Service alerts may serve as a tool to support self-management of patients. Therefore, the SMS-IVR intervention may increase the feeling of having control over one's life. Trail registration Netherlands Trial Register (NTR): NTR2739 PMID:22142327

  17. Effectiveness of three treatment strategies on occupational limitations and quality of life for patients with non-specific chronic low back pain: Is a multidisciplinary approach the key feature to success: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Chronic low back pain (cLBP) is a significant public health problem, being the primary cause of work absenteeism, as well as affecting sufferers’ quality of life, in industrialized society. International guidelines recommend intensive multidisciplinary approaches for patients with cLBP. However, these costly and time-consuming programs can only be offered to a minority of the most heavily affected patients and therefore do not seem likely to respond to public health requirements. Lighter programs may be an alternative to full time hospital-based programs with valuable results in terms of disability and occupational activity for cLBP patients. It is therefore important to define both what the determining components of management to improve activity restriction are and how to treat a larger number of patients more effectively at a lower cost. The aim of this study is to compare three programs with various levels of intensity and multidisciplinary. Methods/Design This paper describes the protocol for a prospective, randomized, controlled, clinical trial in working aged patients with cLBP. Three treatment strategies are compared: (1) intensive and multidisciplinary program conducted in a rehabilitation center; (2) less intensive outpatient program conducted by a private physiotherapist; (3) mixed strategy combining the same out program with a multidisciplinary intervention. The primary outcome of the trial is the impact of the mixed strategy on being able to work compared to hospital centered-program and out program. The secondary outcome is the impact of the mixed strategy on quality of life and social ability compared to the two others programs. The intervention part of the trial programs will take 5 weeks and observational follow-up will take 12 months. The sample size will be 180 participants (60 for each arm). The project has been approved by the Ethical Committee of Angers Hospital, France. Discussion On the hypothesis that a multidisciplinary

  18. Study protocol for a pilot, randomised, double-blinded, placebo controlled trial of perineural local anaesthetics and steroids for chronic post-traumatic neuropathic pain in the ankle and foot: the PREPLANS study

    PubMed Central

    Bhatia, Anuj; Bril, Vera; Brull, Richard T; Perruccio, Anthony; Wijeysundera, Duminda; Alvi, Sabbeh; Lau, Johnny; Gandhi, Rajiv; Mahomed, Nizar; Davis, Aileen M

    2016-01-01

    Introduction Peripheral neuropathic pain (PNP) associated with trauma is often refractory to treatment. Administration of local anaesthetics (LA) and steroids around injured nerves has been proposed as an option for patients unresponsive to conventional treatments for refractory PNP following trauma. There is insufficient evidence to support a large, potentially expensive, full-scale randomised controlled trial (RCT) that involves comparison of effects of perineural steroids and LA against LA or saline injections on analgesia, physical and psychological functioning, and quality of life. There is also a lack of data that would allow estimation of analgesic efficacy or sample size for the full-scale RCT. The objective of this pilot RCT is to yield information to support planning of a full-scale RCT in this population. Methods and Analysis 30 participants with post-traumatic PNP in the ankle and foot of moderate-to-severe intensity and duration of more than 3 months will be enrolled in this pilot RCT. Participants will be randomised to receive three ultrasound-guided perineural injections of 0.9% saline, 0.25% bupivacaine (a long-acting LA) or a combination of 0.25% bupivacaine and a steroid (methylprednisolone 16 mg per nerve) at weekly intervals. The primary objectives are to determine the feasibility and sample size of a full-scale RCT in this population. The secondary objectives are to evaluate the effect of study interventions on analgesia, persistence of neuropathic pain, psychological and physical function, quality of life and participants' global impression of change at 1 and 3 months after the interventions. In addition, adverse effects associated with perineural injections and with systemic absorption of steroids will also be recorded. Ethics and Dissemination The protocol was approved by the University Health Network Research Ethics Board (UHN REB number 15-9584-A). The results will be disseminated in peer-reviewed journals and at scientific

  19. Duloxetine in OsteoArthritis (DOA) study: study protocol of a pragmatic open-label randomised controlled trial assessing the effect of preoperative pain treatment on postoperative outcome after total hip or knee arthroplasty

    PubMed Central

    Blikman, T; Rienstra, W; van Raaij, T M; ten Hagen, A J; Dijkstra, B; Zijlstra, W P; Bulstra, S K; van den Akker-Scheek, I; Stevens, M

    2016-01-01

    Introduction Residual pain is a major factor in patient dissatisfaction following total hip arthroplasty or total knee arthroplasty (THA/TKA). The proportion of patients with unfavourable long-term residual pain is high, ranging from 7% to 34%. There are studies indicating that a preoperative degree of central sensitisation (CS) is associated with poorer postoperative outcomes and residual pain. It is thus hypothesised that preoperative treatment of CS could enhance postoperative outcomes. Duloxetine has been shown to be effective for several chronic pain syndromes, including knee osteoarthritis (OA), in which CS is most likely one of the underlying pain mechanisms. This study aims to evaluate the postoperative effects of preoperative screening and targeted duloxetine treatment of CS on residual pain compared with care-as-usual. Methods and analysis This multicentre, pragmatic, prospective, open-label, randomised controlled trial includes patients with idiopathic hip/knee OA who are on a waiting list for primary THA/TKA. Patients at risk for CS will be randomly allocated to the preoperative duloxetine treatment programme group or the care-as-usual control group. The primary end point is the degree of postoperative pain 6 months after THA/TKA. Secondary end points at multiple time points up to 12 months postoperatively are: pain, neuropathic pain-like symptoms, (pain) sensitisation, pain catastrophising, joint-associated problems, physical activity, health-related quality of life, depressive and anxiety symptoms, and perceived improvement. Data will be analysed on an intention-to-treat basis. Ethics and dissemination The study is approved by the local Medical Ethics Committee (METc 2014/087) and will be conducted according to the principles of the Declaration of Helsinki (64th, 2013) and the Good Clinical Practice standard (GCP), and in compliance with the Medical Research Involving Human Subjects Act (WMO). Trial registration number 2013-004313-41; Pre

  20. Comparing the clinical-effectiveness and cost-effectiveness of an internet-delivered Acceptance and Commitment Therapy (ACT) intervention with a waiting list control among adults with chronic pain: study protocol for a randomised controlled trial

    PubMed Central

    Hayes, Sara; Hogan, Michael; Dowd, Haulie; Doherty, Edel; O'Higgins, Siobhan; Nic Gabhainn, Saoirse; MacNeela, Padraig; Murphy, Andrew W; Kropmans, Thomas; O'Neill, Ciaran; Newell, John; McGuire, Brian E

    2014-01-01

    Introduction Internet-delivered psychological interventions among people with chronic pain have the potential to overcome environmental and economic barriers to the provision of evidence-based psychological treatment in the Irish health service context. While the use of internet-delivered cognitive–behavioural therapy programmes has been consistently shown to have small-to-moderate effects in the management of chronic pain, there is a paucity in the research regarding the effectiveness of an internet-delivered Acceptance and Commitment Therapy (ACT) programme among people with chronic pain. The current study will compare the clinical-effectiveness and cost-effectiveness of an online ACT intervention with a waitlist control condition in terms of the management of pain-related functional interference among people with chronic pain. Methods and analysis Participants with non-malignant pain that persists for at least 3 months will be randomised to one of two study conditions. The experimental group will undergo an eight-session internet-delivered ACT programme over an 8-week period. The control group will be a waiting list group and will be offered the ACT intervention after the 3-month follow-up period. Participants will be assessed preintervention, postintervention and at a 3-month follow-up. The primary outcome will be pain-related functional interference. Secondary outcomes will include: pain intensity, depression, global impression of change, acceptance of chronic pain and quality of life. A qualitative evaluation of the perspectives of the participants regarding the ACT intervention will be completed after the trial. Ethics and dissemination The study will be performed in agreement with the Declaration of Helsinki and is approved by the National University of Ireland Galway Research Ethics Committee (12/05/05). The results of the trial will be published according to the CONSORT statement and will be presented at conferences and reported in peer

  1. Effectiveness of a biopsychosocial e-learning intervention on the clinical judgements of medical students and GP trainees regarding future risk of disability in patients with chronic lower back pain: study protocol for a randomised controlled trial

    PubMed Central

    Dwyer, Christopher P; MacNeela, Pádraig; Reynolds, Bronagh; Hamm, Robert M; Main, Christopher J; O'Connor, Laura L; Conneely, Sinéad; Taheny, Darragh; Slattery, Brian W; O'Neill, Ciaran; NicGabhainn, Saoirse; Murphy, Andrew W; Kropmans, Thomas; McGuire, Brian E

    2016-01-01

    Introduction Chronic lower back pain (CLBP) is a major healthcare problem with wide ranging effects. It is a priority for appropriate management of CLBP to get individuals back to work as early as possible. Interventions that identify biopsychosocial barriers to recovery have been observed to lead to successfully reduced pain-related work absences and increased return to work for individuals with CLBP. Modern conceptualisations of pain adopt a biopsychosocial approach, such as the flags approach. Biopsychosocial perspectives have been applied to judgements about future adjustment, recovery from pain and risk of long-term disability; and provide a helpful model for understanding the importance of contextual interactions between psychosocial and biological variables in the experience of pain. Medical students and general practitioner (GP) trainees are important groups to target with education about biopsychosocial conceptualisations of pain and related clinical implications. Aim The current study will compare the effects of an e-learning intervention that focuses on a biopsychosocial model of pain, on the clinical judgements of medical students and trainees. Methods and analysis Medical student and GP trainee participants will be randomised to 1 of 2 study conditions: (1) a 20 min e-learning intervention focused on the fundamentals of the flags approach to clinical judgement-making regarding risk of future pain-related disability; compared with a (2) wait-list control group on judgement accuracy and weighting (ie, primary outcomes); flags approach knowledge, attitudes and beliefs towards pain, judgement speed and empathy (ie, secondary outcomes). Participants will be assessed at preintervention and postintervention. Ethics and dissemination The study will be performed in agreement with the Declaration of Helsinki and is approved by the National University of Ireland Galway Research Ethics Committee. The results of the trial will be published according to the

  2. Acupuncture as analgesia for non-emergent acute non-specific neck pain, ankle sprain and primary headache in an emergency department setting: a protocol for a parallel group, randomised, controlled pilot trial

    PubMed Central

    Kim, Kun Hyung; Ryu, Ji Ho; Park, Maeng Real; Kim, Yong In; Min, Mun Ki; Park, Yong Myeon; Kim, Yu Ri; Noh, Seung Hee; Kang, Min Joo; Kim, Young Jun; Kim, Jae Kyu; Lee, Byung Ryul; Choi, Jun Yong; Yang, Gi Young

    2014-01-01

    Introduction This study aims to assess the feasibility of acupuncture as an add-on intervention for patients with non-emergent acute musculoskeletal pain and primary headache in an emergency department (ED) setting. Methods and analysis A total of 40 patients who present to the ED and are diagnosed to have acute non-specific neck pain, ankle sprain or primary headache will be recruited by ED physicians. An intravenous or intramuscular injection of analgesics will be provided as the initial standard pain control intervention for all patients. Patients who still have moderate to severe pain after the 30 min of initial standard ED management will be considered eligible. These patients will be allocated in equal proportions to acupuncture plus standard ED management or to standard ED management alone based on computer-generated random numbers concealed in opaque, sealed, sequentially numbered envelopes. A 30 min session of acupuncture treatment with manual and/or electrical stimulation will be provided by qualified Korean medicine doctors. All patients will receive additional ED management at the ED physician's discretion and based on each patient's response to the allocated intervention. The primary outcome will be pain reduction measured at discharge from the ED by an unblinded assessor. Adverse events in both groups will be documented. Other outcomes will include the patient-reported overall improvement, disability due to neck pain (only for neck-pain patients), the treatment response rate, the use of other healthcare resources and the patients’ perceived effectiveness of the acupuncture treatment. A follow-up telephone interview will be conducted by a blinded assessor 72±12 h after ED discharge. Ethics and dissemination Written informed consent will be obtained from all participants. The study has been approved by the Institutional Review Boards (IRBs). The results of this study will guide a full-scale randomised trial of acupuncture in an ED context

  3. Study protocol of effectiveness of a biopsychosocial multidisciplinary intervention in the evolution of non-speficic sub-acute low back pain in the working population: cluster randomised trial

    PubMed Central

    2010-01-01

    Background Non-specific low back pain is a common cause for consultation with the general practitioner, generating increased health and social costs. This study will analyse the effectiveness of a multidisciplinary intervention to reduce disability, severity of pain, anxiety and depression, to improve quality of life and to reduce the incidence of chronic low back pain in the working population with non-specific low back pain, compared to usual clinical care. Methods/Design A Cluster randomised clinical trial will be conducted in 38 Primary Health Care Centres located in Barcelona, Spain and its surrounding areas. The centres are randomly allocated to the multidisciplinary intervention or to usual clinical care. Patients between 18 and 65 years old (n = 932; 466 per arm) and with a diagnostic of a non-specific sub-acute low back pain are included. Patients in the intervention group are receiving the recommendations of clinical practice guidelines, in addition to a biopsychosocial multidisciplinary intervention consisting of group educational sessions lasting a total of 10 hours. The main outcome is change in the score in the Roland Morris disability questionnaire at three months after onset of pain. Other outcomes are severity of pain, quality of life, duration of current non-specific low back pain episode, work sick leave and duration, Fear Avoidance Beliefs and Goldberg Questionnaires. Outcomes will be assessed at baseline, 3, 6 and 12 months. Analysis will be by intention to treat. The intervention effect will be assessed through the standard error of measurement and the effect-size. Responsiveness of each scale will be evaluated by standardised response mean and receiver-operating characteristic method. Recovery according to the patient will be used as an external criterion. A multilevel regression will be performed on repeated measures. The time until the current episode of low back pain takes to subside will be analysed by Cox regression. Discussion We hope

  4. Effectiveness of off-the-shelf footwear in reducing foot pain in Australian Department of Veterans’ Affairs recipients not eligible for medical grade footwear: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Foot pain is highly prevalent in older people, and in many cases is associated with wearing inadequate footwear. In Australia, the Department of Veterans’ Affairs (DVA) covers the costs of medical grade footwear for veterans who have severe foot deformity. However, there is a high demand for footwear by veterans with foot pain who do not meet this eligibility criterion. Therefore, this article describes the design of a randomized controlled trial to evaluate the effectiveness of low cost, off-the-shelf footwear in reducing foot pain in DVA recipients who are currently not eligible for medical grade footwear. Methods One hundred and twenty DVA clients with disabling foot pain residing in Melbourne, Australia, who are not eligible for medical grade footwear will be recruited from the DVA database, and will be randomly allocated to an intervention group or a ‘usual care’ control group. The intervention group will continue to receive their usual DVA-subsidized podiatry care in addition to being provided with low-cost, supportive footwear (Dr Comfort®, Vasyli Medical, Labrador, Queensland, Australia). The control group will also continue to receive DVA-subsidized podiatry care, but will not be provided with the footwear until the completion of the study. The primary outcome measure will be pain subscale on the Foot Health Status Questionnaire (FHSQ), measured at baseline and 4, 8, 12 and 16 weeks. Secondary outcome measures measured at baseline and 16 weeks will include the function subscale of the FHSQ, the Manchester Foot Pain and Disability Index, the number of DVA podiatry treatments required during the study period, general health-related quality of life (using the Short Form 12® Version 2.0), the number of falls experienced during the follow-up period, the Timed Up and Go test, the presence of hyperkeratotic lesions (corns and calluses), the number of participants using co-interventions to relieve foot pain, and participants’ perception of

  5. The Effect of Milnacipran on Pain in Rheumatoid Arthritis Patients with Widespread Pain: A Randomized Blinded Crossover Trial

    PubMed Central

    Lee, Yvonne C.; Massarotti, Elena; Edwards, Robert R.; Lu, Bing; Liu, ChihChin; Lo, Yuanyu; Wohlfahrt, Alyssa; Kim, Nancy D.; Clauw, Daniel J.; Solomon, Daniel H.

    2015-01-01

    Objective Clinical trials have shown that serotonin norepinephrine reuptake inhibitors, such as milnacipran, decrease pain in non-inflammatory pain conditions like fibromyalgia and osteoarthritis. We examined the effect of milnacipran on self-reported pain intensity and experimental pain sensitivity among rheumatoid arthritis (RA) patients with widespread pain and stable RA disease activity. Methods In this double-blind, crossover study, RA patients with widespread pain, on a stable treatment regimen, were randomized (via a random number generator) to receive milnacipran 50 mg twice daily or placebo for 6 weeks, followed by a 3-week washout and crossed over to the other arm for the remaining 6 weeks. The primary outcome was change in average pain intensity, assessed by the Brief Pain Inventory short form. The sample size was calculated to detect a 30% improvement in pain with power = 0.80 and alpha = 0.05. Results Of the 43 randomized subjects, 41 received study drug, and 32 completed the 15-week study per protocol. On a 0–10 scale, average pain intensity decreased by 0.39 (95% CI −1.27, 0.49; P = 0.37) more points during 6 weeks of milnacipran treatment compared to placebo. In the subgroup of subjects with swollen joint count ≤ 1, average pain intensity decreased by 1.14 (95% CI −2.26, −0.01; P= 0.04) more points during 6 weeks of milnacipran compared to placebo. Common adverse events included nausea (26.8%) and loss of appetite (9.7%). Conclusion Compared to placebo, milnacipran did not improve overall, self-reported pain intensity among subjects with widespread pain taking stable RA medications. Trial registration: ClinicalTrials.gov NCT01207453 PMID:26628607

  6. Mindfulness-based stress reduction (MBSR) as sole intervention for non-somatisation chronic non-cancer pain (CNCP): protocol for a systematic review and meta-analysis of randomised controlled trials

    PubMed Central

    Leung, Lawrence; Han, Han; Martin, Mary

    2015-01-01

    Introduction Chronic non-cancer pain (CNCP) affects up to 50% of the world's population. It impacts negatively on quality of life; entailing high costs on our medical systems, and translates to economic burden due to work loss. Aetiology of CNCP is complex and multifactorial, embracing the somatosensory, cognitive and affective domains. Opioid analgesia and other invasive interventions are often inadequate for clinical management of CNCP. Recently, mindfulness-based stress reduction (MBSR) has become a popular therapy for various medical conditions, including CNCP. However, studies reported varying efficacies, and relevant systematic reviews have included clinical trials with inherent heterogeneity either in study conditions or types of interventions used. Our study aims to provide an updated and more critical evaluation of the efficacy of MBSR as the intervention for non-somatisation CNCP. Methods and analysis A systematic review with meta-analysis of randomised controlled trials published in English will be performed in accordance with the Preferred Reporting Items for Systematic reviews and Meta-analyses (PRISMA) guidelines and the Cochrane Collaboration format. MEDLINE, EMBASE, PsychINFO, and the Cochrane Central Register of Controlled Trials Intervention, will be searched independently by reviewers using defined MeSH terms. Studies with full texts using MBSR as the main intervention on patients with non-somatising CNCP will be included. Outcome measures include pain scores and disability assessment scales. Continuous data will be meta-analysed using the RevMan 5 Review Manager programme. Primary analysis will adopt the random effects model in view of heterogeneity between trials. The standardised mean difference will be expressed as the effect size with 95% CIs. Forest plots, funnel plots, the I2 statistic and the Cochrane Risks of Bias Assessment table will be included. Ethics and dissemination No ethics approval is deemed necessary. Results of this study

  7. A nurse-initiated pain protocol in the ED improves pain treatment in patients with acute musculoskeletal pain.

    PubMed

    Pierik, Jorien G J; Berben, Sivera A; IJzerman, Maarten J; Gaakeer, Menno I; van Eenennaam, Fred L; van Vugt, Arie B; Doggen, Carine J M

    2016-07-01

    While acute musculoskeletal pain is a frequent complaint, its management is often neglected. An implementation of a nurse-initiated pain protocol based on the algorithm of a Dutch pain management guideline in the emergency department might improve this. A pre-post intervention study was performed as part of the prospective PROTACT follow-up study. During the pre- (15 months, n = 504) and post-period (6 months, n = 156) patients' self-reported pain intensity and pain treatment were registered. Analgesic provision in patients with moderate to severe pain (NRS ≥4) improved from 46.8% to 68.0%. Over 10% of the patients refused analgesics, resulting into an actual analgesic administration increase from 36.3% to 46.1%. Median time to analgesic decreased from 10 to 7 min (P < 0.05), whereas time to opioids decreased from 37 to 15 min (P < 0.01). Mean pain relief significantly increased to 1.56 NRS-points, in patients who received analgesic treatment even up to 2.02 points. The protocol appeared to lead to an increase in analgesic administration, shorter time to analgesics and a higher clinically relevant pain relief. Despite improvements, suffering moderate to severe pain at ED discharge was still common. Protocol adherence needs to be studied in order to optimize pain management. PMID:26968352

  8. Contributions of myofascial pain in diagnosis and treatment of shoulder pain. A randomized control trial

    PubMed Central

    Perez-Palomares, Sara; Oliván-Blázquez, Bárbara; Arnal-Burró, Ana Mª; Mayoral-Del Moral, Orlando; Gaspar-Calvo, Elena; de-la-Torre-Beldarraín, Mª Luisa; López-Lapeña, Elena; Pérez-Benito, Marina; Ara-Loriente, Victoria; Romo-Calvo, Laura

    2009-01-01

    Background Rotator cuff tendinopathy and subacromial impingement syndrome present complex patomechanical situations, frequent difficulties in clinical diagnosis and lack of effectiveness in treatment. Based on clinical experience, we have therefore considered the existence of another pathological entity as the possible origin of pain and dysfunction. The hypothesis of this study is to relate subacromial impingement syndrome (SIS) with myofascial pain syndrome (MPS), since myofascial trigger points (MTrPs) cause pain, functional limitation, lack of coordination and alterations in quality of movement, even prior to a tendinopathy. MTrPs can coexist with any degenerative subacromial condition. If they are not taken into consideration, they could perpetuate and aggravate the problem, hindering diagnosis and making the applied treatments ineffective. The aims and methods of this study are related with providing evidence of the relationship that may exist between this condition and MPS in the diagnosis and treatment of rotator cuff tendonitis and/or SIS. Method/design A descriptive transversal study will be made to find the correlation between the diagnosis of SIS and rotator cuff tendonitis, positive provocation test responses, the existence of active MTrPs and the results obtained with ultrasonography (US) and Magnetic Renonance Imaging (MRI). A randomized double blinded clinical trial will be carried out in experimental conditions: A Protocolized treatment based on active and passive joint repositioning, stabilization exercises, stretching of the periarticular shoulder muscles and postural reeducation. B. The previously described protocolized treatment, with the addition of dry needling applied to active MTrPs with the purpose of isolating the efficacy of dry needling in treatment. Discussion This study aims to provide a new vision of shoulder pain, from the perspective of MPS. This syndrome can, by itself, account for shoulder pain and dysfunction, although it can

  9. Study protocol of cost-effectiveness and cost-utility of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trial

    PubMed Central

    2011-01-01

    Background Low back pain (LBP), with high incidence and prevalence rate, is one of the most common reasons to consult the health system and is responsible for a significant amount of sick leave, leading to high health and social costs. The objective of the study is to assess the cost-effectiveness and cost-utility analysis of a multidisciplinary biopsychosocial educational group intervention (MBEGI) of non-specific sub-acute LBP in comparison with the usual care in the working population recruited in primary healthcare centres. Methods/design The study design is a cost-effectiveness and cost-utility analysis of a MBEGI in comparison with the usual care of non-specific sub-acute LBP. Measures on effectiveness and costs of both interventions will be obtained from a cluster randomised controlled clinical trial carried out in 38 Catalan primary health care centres, enrolling 932 patients between 18 and 65 years old with a diagnosis of non-specific sub-acute LBP. Effectiveness measures are: pharmaceutical treatments, work sick leave (% and duration in days), Roland Morris disability, McGill pain intensity, Fear Avoidance Beliefs (FAB) and Golberg Questionnaires. Utility measures will be calculated from the SF-12. The analysis will be performed from a social perspective. The temporal horizon is at 3 months (change to chronic LBP) and 12 months (evaluate the outcomes at long term). Assessment of outcomes will be blinded and will follow the intention-to-treat principle. Discussion We hope to demonstrate the cost-effectiveness and cost-utility of MBEGI, see an improvement in the patients' quality of life, achieve a reduction in the duration of episodes and the chronicity of non-specific low back pain, and be able to report a decrease in the social costs. If the intervention is cost-effectiveness and cost-utility, it could be applied to Primary Health Care Centres. Trial registration ISRCTN: ISRCTN58719694 PMID:21859489

  10. Advances in clinical research methodology for pain clinical trials.

    PubMed

    Farrar, John T

    2010-11-01

    Pain is a ubiquitous phenomenon, but the experience of pain varies considerably from person to person. Advances in understanding of the growing number of pathophysiologic mechanisms that underlie the generation of pain and the influence of the brain on the experience of pain led to the investigation of numerous compounds for treating pain. Improved knowledge of the subjective nature of pain, the variations in the measurement of pain, the mind-body placebo effect and the impact of differences in the conduct of a clinical trial on the outcome have changed approaches to design and implement studies. Careful consideration of how these concepts affect the choice of study population, the randomization and blinding process, the measurement and collection of data, and the analysis and interpretation of results should improve the quality of clinical trials for potential pain therapies.

  11. Single- or multiple-session viscosupplementation protocols for temporomandibular joint degenerative disorders: a randomized clinical trial.

    PubMed

    Guarda-Nardini, L; Rossi, A; Arboretti, R; Bonnini, S; Stellini, E; Manfredini, D

    2015-07-01

    The aim of the study was to compare the effectiveness of two single-session protocols, either adopting high- (protocol A) or medium-molecular weight hyaluronic acid (protocol B), with the reference five-session protocol of temporomandibular joint (TMJ) lavage plus viscosupplementation (protocol C) in the management of chronic TMJ degenerative disorders. A randomized clinical trial (RCT) with ten participants per treatment group was designed, with multiple observation points, ending at 6 months after treatment. Pain levels on a 10-point VAS scale were selected as the primary outcome variable to rate treatment effectiveness, along with a number of secondary outcome parameters. Findings showed that Group C patients had the highest decrease in pain levels. Nonparametric permutation analyses revealed that the global effect of treatment was significantly different between the three protocols (P = 0·024). Pairwise comparisons showed that the differences of treatment effect between the two single-session interventions were negligible (global P-value = 0·93). On the contrary, the five-session protocol was significantly superior to both single-session protocols (global P-values ranging from 0·003 to 0·012). In conclusion, in a population of age-, sex-, and psychosocial aspects-matched study groups, the standard of reference five-session protocol proved to be superior at 6 months as far as the decrease in pain levels was concerned, whilst there were no differences between the two single-session interventions. The absence of differences in treatment effect as for some other secondary clinical outcome variables may suggest that there is further space for future investigations attempting to reduce the number of multiple interventions for TMJ viscosupplementation.

  12. Sublingual Buprenorphine/Naloxone for Chronic Pain in At-Risk Patients: Development and Pilot Test of a Clinical Protocol

    PubMed Central

    Rosenblum, Andrew; Cruciani, Ricardo A.; Strain, Eric C; Cleland, Charles M.; Joseph, Herman; Magura, Stephen; Marsch, Lisa A; McNicholas, Laura F; Savage, Seddon R; Sundaram, Arun; Portenoy, Russell K.

    2013-01-01

    Objective Sublingual buprenorphine/naloxone (Bup/Nx) is approved for addiction treatment and may be useful for pain management, particularly in opioid-treated pain patients with nonadherence behaviors. The transition of opioid-treated pain patients to buprenorphine carries the risk of precipitated withdrawal and increased pain. This study convened pain and addiction specialists to develop and pilot a clinical protocol for safe transitioning to Bup/Nx. Design The protocol was revised three times based on outside expert review and pilot study observations. The pilot was conducted with a prospective cohort of 12 patients with moderate to severe chronic pain, who were receiving long-term opioid therapy with any full μ-agonist drug, and had exhibited one or more aberrant drug-related behaviors. Patients were followed up for 3 to 6 months with the expectation that they would experience few adverse events and report lower pain severity. Results The three patients on the highest baseline opioid dose (equivalent to 303–450 mg of oral morphine) and the three on the lowest doses (≤20 mg) had early adverse events (AEs) when switched to Bup/Nx and did not complete the trial. Of the remaining six, one withdrew due to AEs; one responded well, then withdrew; and four completed a three-month trial. A mixed effects model controlling for dropouts found that average and worst pain significantly decreased after the switch to Bup/Nx (both p < .01). Conclusion Based on this experience, the protocol recommends Bup/Nx for pain only when baseline opioid doses are within bounds that reduce AEs at transition and incorporates dose flexibility to further reduce risks. This protocol warrants further testing. PMID:23264315

  13. ESCAPS study protocol: a feasibility randomised controlled trial of ‘Early electrical stimulation to the wrist extensors and wrist flexors to prevent the post-stroke complications of pain and contractures in the paretic arm’

    PubMed Central

    Fletcher-Smith, Joanna C; Walker, Dawn-Marie; Sprigg, Nikola; James, Marilyn; Walker, Marion F; Allatt, Kate; Mehta, Rajnikant; Pandyan, Anand D

    2016-01-01

    Introduction Approximately 70% of patients with stroke experience impaired arm function, which is persistent and disabling for an estimated 40%. Loss of function reduces independence in daily activities and impacts on quality of life. Muscles in those who do not recover functional movement in the stroke affected arm are at risk of atrophy and contractures, which can be established as early as 6 weeks following stroke. Pain is also common. This study aims to evaluate the feasibility of a randomised controlled trial to test the efficacy and cost-effectiveness of delivering early intensive electrical stimulation (ES) to prevent post-stroke complications in the paretic upper limb. Methods and analysis This is a feasibility randomised controlled trial (n=40) with embedded qualitative studies (patient/carer interviews and therapist focus groups) and feasibility economic evaluation. Patients will be recruited from the Stroke Unit at the Nottingham University Hospitals National Health Service (NHS) Trust within 72 h after stroke. Participants will be randomised to receive usual care or usual care and early ES to the wrist flexors and extensors for 30 min twice a day, 5 days a week for 3 months. The initial treatment(s) will be delivered by an occupational therapist or physiotherapist who will then train the patient and/or their nominated carer to self-manage subsequent treatments. Ethics and dissemination This study has been granted ethical approval by the National Research Ethics Service, East Midlands Nottingham1 Research Ethics Committee (ref: 15/EM/0006). To our knowledge, this is the first study of its kind of the early application (within 72 h post-stroke) of ES to both the wrist extensors and wrist flexors of stroke survivors with upper limb impairment. The results will inform the design of a definitive randomised controlled trial. Dissemination will include 2 peer-reviewed journal publications and presentations at national conferences. Trial

  14. Liposome bupivacaine (EXPAREL®) for extended pain relief in patients undergoing ileostomy reversal at a single institution with a fast-track discharge protocol: an IMPROVE Phase IV health economics trial

    PubMed Central

    Vogel, Jon D

    2013-01-01

    Background Postoperative opioid use following ileostomy reversal procedures contributes to postoperative ileus. We assessed the impact of a liposome bupivacaine-based, opioid-sparing multimodal analgesia regimen versus a standard opioid-based analgesia regimen on postsurgical opioid use. We also assessed health economic outcomes in patients undergoing ileostomy reversal at our institution, which employs an enhanced recovery discharge protocol. Methods In this single-center, open-label study, patients undergoing ileostomy reversal received postsurgical pain therapy via multimodal analgesia that included a single intraoperative administration of liposome bupivacaine or opioid-based patient-controlled analgesia (PCA) with intravenous morphine or hydromorphone. Rescue analgesia (intravenous [IV] opioids and/or oral opioid + acetaminophen) was available to all patients. Primary efficacy measures included postsurgical opioid use, hospital length of stay (LOS), and hospitalization costs. Secondary measures included: time to first rescue opioid use; patient satisfaction with analgesia; additional medical intervention; and opioid-related adverse events. Results Forty-three patients were enrolled and met eligibility criteria (IV opioid PCA group = 20; liposome bupivacaine-based multimodal analgesia group = 23). Postsurgical opioid use was significantly less in the multimodal analgesia group compared with the IV opioid PCA group (mean [standard deviation]: 38 mg [46 mg] versus 68 mg [47 mg]; P = 0.004). Postsurgical LOS between-group differences (median: 3.0 days versus 3.8 days) and geometric mean hospitalization costs (US $6,611 versus US$6,790) favored the multimodal analgesic group but did not achieve statistical significance. Median time to first opioid use was 1.1 hours versus 0.7 hours in the multimodal analgesia and IV opioid PCA groups, respectively; P = 0.035. Two patients in the multimodal analgesia group and one in the IV opioid PCA group experienced opioid

  15. A prospective evaluation of 2 different pain management protocols for total hip arthroplasty.

    PubMed

    Post, Zachary D; Restrepo, Camilo; Kahl, Lauren K; van de Leur, Tim; Purtill, James J; Hozack, William J

    2010-04-01

    Pain management after total hip arthroplasty has improved dramatically in the past decade. However, most protocols use opioid medications for pain control. In the current study, 100 patients were prospectively selected to receive a traditional narcotic-based patient-controlled analgesia protocol or a nonnarcotic oral protocol for pain management after primary total hip arthroplasty. Therapy programs were similar for both groups. Postoperatively, patients were followed daily for opioid use, medication adverse effects, pain control, and overall satisfaction. The nonnarcotic oral group showed lower mean pain scores during the first 24 hours after surgery. The satisfaction rate was high in both groups. Both protocols provided adequate pain control after total hip arthroplasty; the nonnarcotic pain management protocol resulted in significantly decreased opioid consumption and fewer adverse effects.

  16. Meeting pragmatism halfway: making a pragmatic clinical trial protocol.

    PubMed

    Rushforth, Alexander

    2015-11-01

    Pragmatic clinical trials (PCTs) are today an increasingly prominent means of measuring the 'effectiveness' of healthcare interventions in 'real world' clinical settings, in order to produce evidence on which to base regulatory and clinical decision-making. Although several sociological studies have shown persuasively how PCTs are co-constructed within particular healthcare systems in which they are based, they have tended to focus on relatively later stages in careers of trials. The paper contributes to literature by considering how the 'real world' of the UK National Health Service (NHS) is incorporated into the design of a research protocol. Drawing on a meeting held just prior to patient recruitment for a PCT in maternal health, the paper analyses a trial collective's efforts to purify the messy domain of NHS clinical care into the orderly confines of the protocol (Law 2004), which meant satisfying demands for both scientific and social robustness (c.f. Nowotny et al. 2001). The findings show how efforts to inscribe robustness into the PCT protocol were themselves mediated through epistemic and regulatory conventions surrounding protocols as devices in healthcare research. Finally it is argued that meetings constitute an important epistemic instrument through which to settle various emerging tensions in PCT protocol design.

  17. Protocol for the Cognitive Interventions and Nutritional Supplements (CINS) trial: A randomized controlled multicenter trial of a brief intervention (BI) versus a BI plus cognitive behavioral treatment (CBT) versus nutritional supplements for patients with long-lasting muscle and back pain

    PubMed Central

    2011-01-01

    Abstract Background Brief intervention programs are clinically beneficial, and cost efficient treatments for low back pain, when offered at 8-12 weeks, compared with treatment as usual. However, about 30% of the patients do not return to work. The European Guidelines for treatment of chronic low back pain recommends Cognitive Behavioral Therapy (CBT), but conclude that further research is needed to evaluate the effectiveness of CBT for chronic low back pain. Methods/Design The aim of the multicenter CINS trial (Cognitive Interventions and Nutritional Supplements) is to compare the effectiveness of 4 different interventions; Brief Intervention, Brief Intervention and CBT, Brief Intervention and nutritional supplements of seal oil, and Brief Intervention and nutritional supplements of soy oil. All participants will be randomly assigned to the interventions. The nutritional supplements will be tested in a double blind design. 400 patients will be recruited from a population of chronic low back pain patients that have been sick listed for 2-10 months. Four outpatient clinics, located in different parts of Norway, will participate in recruitment and treatment of the patients. The Brief Intervention is a one session cognitive, clinical examination program based on a non-injury model, where return to normal activity and work is the main goal, and is followed by two booster sessions. The CBT is a tailored treatment involving 7 sessions, following a detailed manual. The nutritional supplements consist of a dosage of 10 grams of either soy or seal oil (capsules) per day for 3 months, administered in a double blind design. All patients will be followed up with questionnaires after 3, 6 and 12 months, while sick leave data will be collected up to at least 24 months after randomization. The primary outcome of the study is sick leave and will be based on register data from the National Insurance Administration. Secondary outcomes include self-reported data on disability, pain

  18. Mebeverine for pediatric functional abdominal pain: a randomized, placebo-controlled trial.

    PubMed

    Pourmoghaddas, Zahra; Saneian, Hossein; Roohafza, Hamidreza; Gholamrezaei, Ali

    2014-01-01

    We evaluated the effectiveness of an antispasmodic, mebeverine, in the treatment of childhood functional abdominal pain (FAP). Children with FAP (n = 115, aged 6-18 years) received mebeverine (135 mg, twice daily) or placebo for 4 weeks. Response was defined as ≥ 2 point reduction in the 6-point pain scale or "no pain." Physician-rated global severity was also evaluated. Patients were followed up for 12 weeks. Eighty-seven patients completed the trial (44 with mebeverine). Per-protocol and intention-to-treat (ITT) analyses were conducted. Treatment response rate in the mebeverine and placebo groups based on per-protocol [ITT] analysis was 54.5% [40.6%] and 39.5% [30.3%] at week 4 (P = 0.117 [0.469]) and 72.7% [54.2%] and 53.4% [41.0] at week 12, respectively (P = 0.0503 [0.416]). There was no significant difference between the two groups in change of the physician-rated global severity score after 4 weeks (P = 0.723) or after 12 weeks (P = 0.870) in per-protocol analysis; the same results were obtained in ITT analysis. Mebeverine seems to be effective in the treatment of childhood FAP, but our study was not able to show its statistically significant effect over placebo. Further trials with larger sample of patients are warranted. PMID:25089264

  19. Mebeverine for Pediatric Functional Abdominal Pain: A Randomized, Placebo-Controlled Trial

    PubMed Central

    Saneian, Hossein

    2014-01-01

    We evaluated the effectiveness of an antispasmodic, mebeverine, in the treatment of childhood functional abdominal pain (FAP). Children with FAP (n = 115, aged 6–18 years) received mebeverine (135 mg, twice daily) or placebo for 4 weeks. Response was defined as ≥2 point reduction in the 6-point pain scale or “no pain.” Physician-rated global severity was also evaluated. Patients were followed up for 12 weeks. Eighty-seven patients completed the trial (44 with mebeverine). Per-protocol and intention-to-treat (ITT) analyses were conducted. Treatment response rate in the mebeverine and placebo groups based on per-protocol [ITT] analysis was 54.5% [40.6%] and 39.5% [30.3%] at week 4 (P = 0.117 [0.469]) and 72.7% [54.2%] and 53.4% [41.0] at week 12, respectively (P = 0.0503 [0.416]). There was no significant difference between the two groups in change of the physician-rated global severity score after 4 weeks (P = 0.723) or after 12 weeks (P = 0.870) in per-protocol analysis; the same results were obtained in ITT analysis. Mebeverine seems to be effective in the treatment of childhood FAP, but our study was not able to show its statistically significant effect over placebo. Further trials with larger sample of patients are warranted. PMID:25089264

  20. Automated Internet-based pain coping skills training to manage osteoarthritis pain: a randomized controlled trial.

    PubMed

    Rini, Christine; Porter, Laura S; Somers, Tamara J; McKee, Daphne C; DeVellis, Robert F; Smith, Meredith; Winkel, Gary; Ahern, David K; Goldman, Roberta; Stiller, Jamie L; Mariani, Cara; Patterson, Carol; Jordan, Joanne M; Caldwell, David S; Keefe, Francis J

    2015-05-01

    Osteoarthritis (OA) places a significant burden on worldwide public health because of the large and growing number of people affected by OA and its associated pain and disability. Pain coping skills training (PCST) is an evidence-based intervention targeting OA pain and disability. To reduce barriers that currently limit access to PCST, we developed an 8-week, automated, Internet-based PCST program called PainCOACH and evaluated its potential efficacy and acceptability in a small-scale, 2-arm randomized controlled feasibility trial. Participants were 113 men and women with clinically confirmed hip or knee OA and associated pain. They were randomized to a group completing PainCOACH or an assessment-only control group. Osteoarthritis pain, pain-related interference with functioning, pain-related anxiety, self-efficacy for pain management, and positive and negative affect were measured before intervention, midway through the intervention, and after intervention. Findings indicated high acceptability and adherence: 91% of participants randomized to complete PainCOACH finished all 8 modules over 8 to 10 weeks. Linear mixed models showed that, after treatment, women who received the PainCOACH intervention reported significantly lower pain than that in women in the control group (Cohen d = 0.33). Intervention effects could not be tested in men because of their low pain and small sample size. Additionally, both men and women demonstrated increases in self-efficacy from baseline to after intervention compared with the control group (d = 0.43). Smaller effects were observed for pain-related anxiety (d = 0.20), pain-related interference with functioning (d = 0.13), negative affect (d = 0.10), and positive affect (d = 0.24). Findings underscore the value of continuing to develop an automated Internet-based approach to disseminate this empirically supported intervention.

  1. The Interactive Relationship between Pain, Psychosis, and Agitation in People with Dementia: Results from a Cluster-Randomised Clinical Trial.

    PubMed

    Habiger, Torstein F; Flo, Elisabeth; Achterberg, Wilco P; Husebo, Bettina S

    2016-01-01

    Background. Neuropsychiatric symptoms are common in people with dementia, and pain is thought to be an important underlying factor. Pain has previously been associated with agitation, and pain treatment has been shown to ameliorate agitated behaviour. So far, the association between pain and psychosis and the effect of pain treatment on psychotic symptoms is unclear. Furthermore, the impact of opioid treatment on psychosis is not established. Aim. To investigate the efficacy of a stepwise protocol for treating pain (SPTP) on psychosis and agitation measured with the Neuropsychiatric Inventory, Nursing Home version, and to explore the impact of opioid analgesics on psychosis. Method. Secondary analyses are from a cluster-randomised controlled trial including 352 patients with advanced dementia and agitation from 18 nursing homes in Western Norway. The intervention group received pain treatment according to SPTP. Results. Pain was associated with disinhibition (adjusted OR: 1.21, 95% CI: 1.10-1.34) and irritability (adjusted OR: 1.10, 95% CI: 1.01-1.21) at baseline. Pain treatment reduced agitation (p < 0.001, df = 1; 300) and aberrant motor behaviour (p = 0.017, df = 1; 300). Psychosis was reduced in people with at least one symptom at baseline (p = 0.034, df = 1; 135). The use of opioid analgesics did not increase psychotic symptoms. Study Registration. This trial is registered with ClinicalTrials.gov (NCT01021696), Norwegian Medicines Agency, EudraCT (EudraCTnr: 2008-007490-20). PMID:27247487

  2. Botulinum Toxin Type A Injections for Cervical and Shoulder Girdle Myofascial Pain Using an Enriched Protocol Design

    PubMed Central

    Nicol, Andrea L.; Wu, Irene I.; Ferrante, F. Michael

    2014-01-01

    Background Myofascial pain syndrome is a regional condition of muscle pain and stiffness and is classically characterized by the presence of trigger points in affected musculature. Botulinum toxin type A (BoNT-A) has been shown to have antinociceptive properties and elicit sustained muscle relaxation, thereby possibly affording even greater relief than traditional strategies. Our goal in this study was to determine whether direct injection of BoNT-A into painful muscle groups is effective for cervical and shoulder girdle myofascial pain. Methods An enriched protocol design was used wherein 114 patients with cervical and shoulder girdle myofascial pain underwent injection of BoNT-A to determine their response to the drug. Fifty-four responders were then enrolled in a twelve-week, randomized, double-blind, placebo-controlled trial. Pain scales and quality of life measures were assessed at baseline and at routine follow-up visits until completion of the study after 26 weeks. Results Injection of BoNT-A into painful muscle groups improved average visual numerical pain scores in subjects who received a second dose of BoNT-A compared to placebo (p = 0.019 (0.26, 2.78)). Subjects who received a second dose of BoNT-A had a reduced number of headaches per week (p = 0.04 (0.07, 4.55)). Brief Pain Inventory interference scores for general activity and sleep were improved (p = 0.046 (0.038, 3.7) and 0.02 (0.37, 4.33), respectively) in those who received a second dose of BoNT-A. Conclusion Botulinum toxin type A injected directly into painful muscle groups improves average pain scores and certain aspects of quality of life in patients suffering from severe cervical and shoulder girdle myofascial pain. PMID:24842179

  3. Pain exposure physical therapy (PEPT) compared to conventional treatment in complex regional pain syndrome type 1: a randomised controlled trial

    PubMed Central

    Barnhoorn, Karlijn J; van de Meent, Henk; van Dongen, Robert T M; Klomp, Frank P; Groenewoud, Hans; Samwel, Han; Nijhuis-van der Sanden, Maria W G; Frölke, Jan Paul M; Staal, J Bart

    2015-01-01

    Objective To compare the effectiveness of pain exposure physical therapy (PEPT) with conventional treatment in patients with complex regional pain syndrome type 1 (CRPS-1) in a randomised controlled trial with a blinded assessor. Setting The study was conducted at a level 1 trauma centre in the Netherlands. Participants 56 adult patients with CRPS-1 participated. Three patients were lost to follow-up. Interventions Patients received either PEPT in a maximum of five treatment sessions, or conventional treatment following the Dutch multidisciplinary guideline. Measurements Outcomes were assessed at baseline and at 3, 6 and 9 months after randomisation. The primary outcome measure was the Impairment level Sum Score—Restricted Version (ISS-RV), consisting of visual analogue scale for pain (VAS-pain), McGill Pain Questionnaire, active range of motion (AROM) and skin temperature. Secondary outcome measures included Pain Disability Index (PDI); muscle strength; Short Form 36 (SF-36); disability of arm, shoulder and hand; Lower Limb Tasks Questionnaire (LLTQ); 10 m walk test; timed up-and-go test (TUG) and EuroQol-5D. Results The intention-to-treat analysis showed a clinically relevant decrease in ISS-RV (6.7 points for PEPT and 6.2 points for conventional treatment), but the between-group difference was not significant (0.96, 95% CI −1.56 to 3.48). Participants allocated to PEPT experienced a greater improvement in AROM (between-group difference 0.51, 95% CI 0.07 to 0.94; p=0.02). The per protocol analysis showed larger and significant between-group effects on ISS-RV, VAS-pain, AROM, PDI, SF-36, LLTQ and TUG. Conclusions We cannot conclude that PEPT is superior to conventional treatment for patients with CRPS-1. Further high-quality research on the effects of PEPT is warranted given the potential effects as indicated by the per protocol analysis. Trial registration numbers NCT00817128 and NTR 2090. PMID:26628523

  4. Development and validation of a screening tool to predict the risk of chronic low back pain in patients presenting with acute low back pain: a study protocol

    PubMed Central

    Traeger, Adrian; Henschke, Nicholas; Hübscher, Markus; Williams, Christopher M; Kamper, Steven J; Maher, Chris G; Moseley, G Lorimer; McAuley, James H

    2015-01-01

    Introduction Around 40% of people presenting to primary care with an episode of acute low back pain develop chronic low back pain. In order to reduce the risk of developing chronic low back pain, effective secondary prevention strategies are needed. Early identification of at-risk patients allows clinicians to make informed decisions based on prognostic profile, and researchers to select appropriate participants for secondary prevention trials. The aim of this study is to develop and validate a prognostic screening tool that identifies patients with acute low back pain in primary care who are at risk of developing chronic low back pain. This paper describes the methods and analysis plan for the development and validation of the tool. Methods/analysis The prognostic screening tool will be developed using methods recommended by the Prognosis Research Strategy (PROGRESS) Group and reported using the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD) statement. In the development stage, we will use data from 1248 patients recruited for a prospective cohort study of acute low back pain in primary care. We will construct 3 logistic regression models to predict chronic low back pain according to 3 definitions: any pain, high pain and disability at 3 months. In the validation stage, we will use data from a separate sample of 1643 patients with acute low back pain to assess the performance of each prognostic model. We will produce validation plots showing Nagelkerke R2 and Brier score (overall performance), area under the curve statistic (discrimination) and the calibration slope and intercept (calibration). Ethics and dissemination Ethical approval from the University of Sydney Ethics Committee was obtained for both of the original studies that we plan to analyse using the methods outlined in this protocol (Henschke et al, ref 11-2002/3/3144; Williams et al, ref 11638). PMID:26179647

  5. Randomized Multicenter Feasibility Trial of Myofascial Physical Therapy for Treatment of Urologic Chronic Pelvic Pain Syndrome

    PubMed Central

    FitzGerald, Mary P; Anderson, Rodney U; Potts, Jeannette; Payne, Christopher K; Peters, Kenneth M; Clemens, J Quentin; Kotarinos, Rhonda; Fraser, Laura; Cosby, Annamarie; Fortman, Carole; Neville, Cynthia; Badillo, Suzanne; Odabachian, Lisa; Sanfield, Anna; O’Dougherty, Betsy; Halle-Podell, Rick; Cen, Liyi; Chuai, Shannon; Landis, J Richard; Kusek, John W; Nyberg, Leroy M

    2010-01-01

    Objectives To determine the feasibility of conducting a randomized clinical trial designed to compare two methods of manual therapy (myofascial physical therapy (MPT) and global therapeutic massage (GTM)) among patients with urologic chronic pelvic pain syndromes. Materials and Methods Our goal was to recruit 48 subjects with chronic prostatitis/chronic pelvic pain syndrome or interstitial cystitis/painful bladder syndrome at six clinical centers. Eligible patients were randomized to either MPT or GTM and were scheduled to receive up to 10 weekly treatments, each 1 hour in duration. Criteria to assess feasibility included adherence of therapists to prescribed therapeutic protocol as determined by records of treatment, adverse events which occurred during study treatment, and rate of response to therapy as assessed by the Patient Global Response Assessment (GRA). Primary outcome analysis compared response rates between treatment arms using Mantel-Haenszel methods. Results Twenty-three (49%) men and 24 (51%) women were randomized over a six month period. Twenty-four (51%) patients were randomized to GTM, 23 (49%) to MPT; 44 (94%) patients completed the study. Therapist adherence to the treatment protocols was excellent. The GRA response rate of 57% in the MPT group was significantly higher than the rate of 21% in the GTM treatment group (p=0.03). Conclusions The goals to judge feasibility of conducting a full-scale trial of physical therapy methods were met. The preliminary findings of a beneficial effect of MPT warrants further study. PMID:19535099

  6. Strengthening of the Hip and Core Versus Knee Muscles for the Treatment of Patellofemoral Pain: A Multicenter Randomized Controlled Trial

    PubMed Central

    Ferber, Reed; Bolgla, Lori; Earl-Boehm, Jennifer E.; Emery, Carolyn; Hamstra-Wright, Karrie

    2015-01-01

    Context: Patellofemoral pain (PFP) is the most common injury in running and jumping athletes. Randomized controlled trials suggest that incorporating hip and core strengthening (HIP) with knee-focused rehabilitation (KNEE) improves PFP outcomes. However, no randomized controlled trials have, to our knowledge, directly compared HIP and KNEE programs. Objective: To compare PFP pain, function, hip- and knee-muscle strength, and core endurance between KNEE and HIP protocols after 6 weeks of rehabilitation. We hypothesized greater improvements in (1) pain and function, (2) hip strength and core endurance for patients with PFP involved in the HIP protocol, and (3) knee strength for patients involved in the KNEE protocol. Design: Randomized controlled clinical trial. Setting: Four clinical research laboratories in Calgary, Alberta; Chicago, Illinois; Milwaukee, Wisconsin; and Augusta, Georgia. Patients or Other Participants: Of 721 patients with PFP screened, 199 (27.6%) met the inclusion criteria (66 men [31.2%], 133 women [66.8%], age = 29.0 ± 7.1 years, height = 170.4 ± 9.4 cm, weight = 67.6 ± 13.5 kg). Intervention(s): Patients with PFP were randomly assigned to a 6-week KNEE or HIP protocol. Main Outcome Measure(s): Primary variables were self-reported visual analog scale and Anterior Knee Pain Scale measures, which were conducted weekly. Secondary variables were muscle strength and core endurance measured at baseline and at 6 weeks. Results: Compared with baseline, both the visual analog scale and the Anterior Knee Pain Scale improved for patients with PFP in both the HIP and KNEE protocols (P < .001), but the visual analog scale scores for those in the HIP protocol were reduced 1 week earlier than in the KNEE group. Both groups increased in strength (P < .001), but those in the HIP protocol gained more in hip-abductor (P = .01) and -extensor (P = .01) strength and posterior core endurance (P = .05) compared with the KNEE group. Conclusions: Both the HIP and KNEE

  7. Parametric trial-by-trial prediction of pain by easily available physiological measures.

    PubMed

    Geuter, Stephan; Gamer, Matthias; Onat, Selim; Büchel, Christian

    2014-05-01

    Pain is commonly assessed by subjective reports on rating scales. However, in many experimental and clinical settings, an additional, objective indicator of pain is desirable. In order to identify an objective, parametric signature of pain intensity that is predictive at the individual stimulus level across subjects, we recorded skin conductance and pupil diameter responses to heat pain stimuli of different durations and temperatures in 34 healthy subjects. The temporal profiles of trial-wise physiological responses were characterized by component scores obtained from principal component analysis. These component scores were then used as predictors in a linear regression analysis, resulting in accurate pain predictions for individual trials. Using the temporal information encoded in the principal component scores explained the data better than prediction by a single summary statistic (i.e., maximum amplitude). These results indicate that perceived pain is best reflected by the temporal dynamics of autonomic responses. Application of the regression model to an independent data set of 20 subjects resulted in a very good prediction of the pain ratings demonstrating the generalizability of the identified temporal pattern. Utilizing the readily available temporal information from skin conductance and pupil diameter responses thus allows parametric prediction of pain in human subjects.

  8. Effect of local anaesthetic infiltration on chronic postsurgical pain after total hip and knee replacement: the APEX randomised controlled trials

    PubMed Central

    Wylde, Vikki; Lenguerrand, Erik; Gooberman-Hill, Rachael; Beswick, Andrew D.; Marques, Elsa; Noble, Sian; Horwood, Jeremy; Pyke, Mark; Dieppe, Paul; Blom, Ashley W.

    2015-01-01

    Abstract Total hip replacement (THR) and total knee replacement (TKR) are usually effective at relieving pain; however, 7% to 23% of patients experience chronic postsurgical pain. These trials aimed to investigate the effect of local anaesthetic wound infiltration on pain severity at 12 months after primary THR or TKR for osteoarthritis. Between November 2009 and February 2012, 322 patients listed for THR and 316 listed for TKR were recruited into a single-centre double-blind randomised controlled trial. Participants were randomly assigned (1:1) to receive local anaesthetic infiltration and standard care or standard care alone. Participants and outcomes assessors were masked to group allocation. The primary outcome was pain severity on the WOMAC Pain Scale at 12 months after surgery. Analyses were conducted using intention-to-treat and per-protocol approaches. In the hip trial, patients in the intervention group had significantly less pain at 12 months postoperative than patients in the standard care group (differences in means: 4.74; 95% confidence interval [CI]: 0.95-8.54; P = 0.015), although the difference was not clinically significant. Post hoc analysis found that patients in the intervention group were more likely to have none to moderate pain than severe pain at 12 months than those in the standard care group (odds ratio: 10.19; 95% CI: 2.10-49.55; P = 0.004). In the knee trial, there was no strong evidence that the intervention influenced pain severity at 12 months postoperative (difference in means: 3.83; 95% CI: −0.83 to 8.49; P = 0.107). In conclusion, routine use of infiltration could be beneficial in improving long-term pain relief for some patients after THR. PMID:25659070

  9. Methods to Standardize a Multicenter Acupuncture Trial Protocol to Reduce Aromatase Inhibitor-related Joint Symptoms in Breast Cancer Patients

    PubMed Central

    Greenlee, Heather; Crew, Katherine D.; Capodice, Jillian; Awad, Danielle; Jeffres, Anne; Unger, Joseph M.; Lew, Danika L.; Hansen, Lisa K.; Meyskens, Frank L.; Wade, James L.; Hershman, Dawn L.

    2015-01-01

    Robust methods are needed to efficiently conduct large, multi-site, randomized controlled clinical trials of acupuncture protocols. SWOG S1200 is a randomized, controlled sham- and waitlist-controlled trial of a standardized acupuncture protocol treating aromatase inhibitor (AI)-associated arthralgias in early stage breast cancer patients (n=228). The primary objective is to determine whether true acupuncture administered twice weekly for 6 weeks compared to sham acupuncture or a waitlist control causes a reduction in AI-associated joint pain at 6 weeks as assessed by patient report. The study is conducted at 11 institutions across the US. The true acupuncture protocol was developed using a consensus-based process. Both the true acupuncture and sham acupuncture protocols consist of 12 sessions administered over 6 weeks, followed by 1 session per week for the remaining 6 weeks. The true acupuncture protocol uses standardized protocol points in addition to standardized acupoints tailored to a patient’s joint symptoms. The similarly standardized sham acupuncture protocol utilizes superficial needling of non-acupoints. Standardized methods were developed to train and monitor acupuncturists, including online and in-person training, study manuals, monthly phone calls, and remote quality assurance monitoring throughout the study period. Research staff was similarly trained using online and in-person training, and monthly phone calls. PMID:26100070

  10. Smoked cannabis for chronic neuropathic pain: a randomized controlled trial

    PubMed Central

    Ware, Mark A.; Wang, Tongtong; Shapiro, Stan; Robinson, Ann; Ducruet, Thierry; Huynh, Thao; Gamsa, Ann; Bennett, Gary J.; Collet, Jean-Paul

    2010-01-01

    Background Chronic neuropathic pain affects 1%–2% of the adult population and is often refractory to standard pharmacologic treatment. Patients with chronic pain have reported using smoked cannabis to relieve pain, improve sleep and improve mood. Methods Adults with post-traumatic or postsurgical neuropathic pain were randomly assigned to receive cannabis at four potencies (0%, 2.5%, 6% and 9.4% tetrahydrocannabinol) over four 14-day periods in a crossover trial. Participants inhaled a single 25-mg dose through a pipe three times daily for the first five days in each cycle, followed by a nine-day washout period. Daily average pain intensity was measured using an 11-point numeric rating scale. We recorded effects on mood, sleep and quality of life, as well as adverse events. Results We recruited 23 participants (mean age 45.4 [standard deviation 12.3] years, 12 women [52%]), of whom 21 completed the trial. The average daily pain intensity, measured on the 11-point numeric rating scale, was lower on the prespecified primary contrast of 9.4% v. 0% tetrahydrocannabinol (5.4 v. 6.1, respectively; difference = 0.7, 95% confidence interval [CI] 0.02–1.4). Preparations with intermediate potency yielded intermediate but nonsignificant degrees of relief. Participants receiving 9.4% tetrahydrocannabinol reported improved ability to fall asleep (easier, p = 0.001; faster, p < 0.001; more drowsy, p = 0.003) and improved quality of sleep (less wakefulness, p = 0.01) relative to 0% tetrahydrocannabinol. We found no differences in mood or quality of life. The most common drug-related adverse events during the period when participants received 9.4% tetrahydrocannabinol were headache, dry eyes, burning sensation in areas of neuropathic pain, dizziness, numbness and cough. Conclusion A single inhalation of 25 mg of 9.4% tetrahydrocannabinol herbal cannabis three times daily for five days reduced the intensity of pain, improved sleep and was well tolerated. Further long

  11. PACE – the first placebo controlled trial of paracetamol for acute low back pain: statistical analysis plan

    PubMed Central

    2013-01-01

    Background Paracetamol (acetaminophen) is recommended in most clinical practice guidelines as the first choice of treatment for low back pain, however there is limited evidence to support this recommendation. The PACE trial is the first placebo controlled trial of paracetamol for acute low back pain. This article describes the statistical analysis plan. Results PACE is a randomized double dummy placebo controlled trial that investigates and compares the effect of paracetamol taken in two regimens for the treatment of low back pain. The protocol has been published. The analysis plan was completed blind to study group and finalized prior to initiation of analyses. All data collected as part of the trial were reviewed, without stratification by group, and classified by baseline characteristics, process of care and trial outcomes. Trial outcomes were classified as primary and secondary outcomes. Appropriate descriptive statistics and statistical testing of between-group differences, where relevant, have been planned and described. Conclusions A standard analysis plan was developed for the results of the PACE study. This plan comprehensively describes the data captured and pre-determined statistical tests of relevant outcome measures. The plan demonstrates transparent and verifiable use of the data collected. This a priori plan will be followed to ensure rigorous standards of data analysis are strictly adhered to. Trial registration Australia and New Zealand Clinical Trials Registry ACTRN12609000966291 PMID:23937999

  12. Brain Connectivity Predicts Placebo Response across Chronic Pain Clinical Trials

    PubMed Central

    Tétreault, Pascal; Mansour, Ali; Vachon-Presseau, Etienne; Schnitzer, Thomas J.; Apkarian, A. Vania

    2016-01-01

    Placebo response in the clinical trial setting is poorly understood and alleged to be driven by statistical confounds, and its biological underpinnings are questioned. Here we identified and validated that clinical placebo response is predictable from resting-state functional magnetic-resonance-imaging (fMRI) brain connectivity. This also led to discovering a brain region predicting active drug response and demonstrating the adverse effect of active drug interfering with placebo analgesia. Chronic knee osteoarthritis (OA) pain patients (n = 56) underwent pretreatment brain scans in two clinical trials. Study 1 (n = 17) was a 2-wk single-blinded placebo pill trial. Study 2 (n = 39) was a 3-mo double-blinded randomized trial comparing placebo pill to duloxetine. Study 3, which was conducted in additional knee OA pain patients (n = 42), was observational. fMRI-derived brain connectivity maps in study 1 were contrasted between placebo responders and nonresponders and compared to healthy controls (n = 20). Study 2 validated the primary biomarker and identified a brain region predicting drug response. In both studies, approximately half of the participants exhibited analgesia with placebo treatment. In study 1, right midfrontal gyrus connectivity best identified placebo responders. In study 2, the same measure identified placebo responders (95% correct) and predicted the magnitude of placebo’s effectiveness. By subtracting away linearly modeled placebo analgesia from duloxetine response, we uncovered in 6/19 participants a tendency of duloxetine enhancing predicted placebo response, while in another 6/19, we uncovered a tendency for duloxetine to diminish it. Moreover, the approach led to discovering that right parahippocampus gyrus connectivity predicts drug analgesia after correcting for modeled placebo-related analgesia. Our evidence is consistent with clinical placebo response having biological underpinnings and shows that the method can also reveal that active

  13. Improvement in pain severity category in clinical trials of pregabalin

    PubMed Central

    Parsons, Bruce; Argoff, Charles E; Clair, Andrew; Emir, Birol

    2016-01-01

    Background Pregabalin is approved by the US Food and Drug Administration for the treatment of fibromyalgia (FM), diabetic peripheral neuropathy (DPN), postherpetic neuralgia (PHN), and neuropathic pain due to spinal cord injury (SCI). Approval was based on clinical trial data demonstrating statistically significant differences in pain scores versus placebo. However, statistically significant pain relief may not always equate to clinically meaningful pain relief. To further characterize the clinical benefit of pregabalin, this analysis examined shifts in pain severity categories in patients with FM, DPN/PHN (pooled in this analysis), and SCI treated with pregabalin. Methods Data were pooled from 23 placebo-controlled trials in patients with FM (1,623 treated with pregabalin, 937 placebo), DPN/PHN (2,867 pregabalin, 1,532 placebo), or SCI (181 pregabalin, 175 placebo). Pain scores were assessed on an 11-point numeric rating scale and categorized as mild (0 to <4), moderate (4 to <7), or severe (7 to 10). Only patients with mean score ≥4 at baseline were randomized to treatment. The percentage of patients shifting pain category from baseline to endpoint for pregabalin and placebo was analyzed using a modified ridit transformation with the Cochran–Mantel–Haenszel procedure. Results A higher proportion of patients shifted to a less severe pain category at endpoint with pregabalin compared with placebo. With flexible-dose pregabalin, the percentage of patients improving from: severe to mild (pregabalin versus placebo) was 15.8 versus 13.4 in FM patients, 36.0 versus 16.6 in DPN/PHN patients, 14.3 versus 7.7 in SCI patients; severe to moderate was 28.7 versus 28.2 in FM patients, 32.5 versus 28.2 in DPN/PHN patients, 35.7 versus 28.2 in SCI patients; and moderate to mild was 38.3 versus 26.4 in FM patients, 59.5 versus 41.4 in DPN/PHN patients, 38.6 versus 27.2 in SCI patients. Conclusion Compared with placebo, pregabalin is more often associated with clinically

  14. Neuro Emotional Technique for the treatment of trigger point sensitivity in chronic neck pain sufferers: A controlled clinical trial

    PubMed Central

    Bablis, Peter; Pollard, Henry; Bonello, Rod

    2008-01-01

    compared to a control group which received a sham protocol of NET. Chronic neck pain sufferers may benefit from NET treatment in the relief of trigger point sensitivity. Further research including long-term randomised controlled trials for the effect of NET on chronic neck pain, and other chronic pain syndromes are recommended. Trial Registration This trial has been registered and allocated the Australian Clinical Trials Registry (ACTR) number ACTRN012607000358448. The ACTR has met the requirements of the ICMJE's trials registration policy and is an ICMJE acceptable registry. PMID:18495042

  15. Selective episiotomy vs. implementation of a non episiotomy protocol: a randomized clinical trial

    PubMed Central

    2014-01-01

    Background World Health Organization (WHO) recommends that the episiotomy rate should be around 10%, which is already a reality in many European countries. Currently the use of episiotomy should be restricted and physicians are encouraged to use their clinical judgment to decide when the procedure is necessary. There is no clinical evidence corroborating any indication of episiotomy, so until the present moment it is not yet known whether episiotomy is indeed necessary in any context of obstetric practice. Objectives To compare maternal and perinatal outcomes in women undergoing a protocol of not performing episiotomy versus selective episiotomy. Methods/Design An open label randomized clinical trial will be conducted including laboring women with term pregnancy, maximum dilation of 8 cm, live fetus in cephalic vertex presentation. Women with bleeding disorders of pregnancy, indication for caesarean section and those without capacity to consent and without legal guardians will be excluded. Primary outcomes will be frequency of episiotomy, delivery duration, frequency of spontaneous lacerations and perineal trauma, frequency of instrumental delivery, postpartum blood loss, need for perineal suturing, number of sutures, Apgar scores at one and five minutes, need for neonatal resuscitation and pH in cord blood. As secondary outcomes frequency complications of perineal suturing, postpartum perineal pain, maternal satisfaction, neonatal morbidity and admission newborn in NICU will be assessed. Women will be invited to participate and those who agree will sign the consent form and will be then assigned to a protocol of not conducting episiotomy (experimental group) or to a group that episiotomy is performed selectively according to the judgment of the provider of care delivery (control Group). The present study was approved by IMIP’s Research Ethics Committee. Trial Registration Clinical Trials Register under the number and was registered in ClinicalTrials.gov under

  16. Randomized Trial of Hypnosis as a Pain and Symptom Management Strategy in Adults with Sickle Cell Disease

    PubMed Central

    Wallen, Gwenyth R; Middleton, Kimberly R; Ames, Nancy; Brooks, Alyssa T; Handel, Daniel

    2014-01-01

    Sickle cell disease (SCD) is the most common genetic disease in African-Americans, characterized by recurrent painful vaso-occlusive crises. Medical therapies for controlling or preventing crises are limited because of efficacy and/or toxicity. This is a randomized, controlled, single-crossover protocol of hypnosis for managing pain in SCD patients. Participants receive hypnosis from a trained hypnosis therapist followed by six weeks of self-hypnosis using digital media. Those in the control arm receive SCD education followed by a six-week waiting period before crossing over to the hypnosis arm of the study. Outcome measures include assessments of pain (frequency, intensity and quality), anxiety, coping strategies, sleep, depression, and health care utilization. To date, there are no published randomized, controlled trials evaluating the efficacy of hypnosis on SCD pain modulation in adults. Self-hypnosis for pain management may be helpful in modulating chronic pain, improving sleep quality, and decreasing use of narcotics in patients with SCD. TRIAL REGISTRATION ClinicalTrials.gov: NCT00393250 PMID:25520557

  17. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values.

    PubMed

    Rolke, R; Baron, R; Maier, C; Tölle, T R; Treede, R-D; Beyer, A; Binder, A; Birbaumer, N; Birklein, F; Bötefür, I C; Braune, S; Flor, H; Huge, V; Klug, R; Landwehrmeyer, G B; Magerl, W; Maihöfner, C; Rolko, C; Schaub, C; Scherens, A; Sprenger, T; Valet, M; Wasserka, B

    2006-08-01

    The nationwide multicenter trials of the German Research Network on Neuropathic Pain (DFNS) aim to characterize the somatosensory phenotype of patients with neuropathic pain. For this purpose, we have implemented a standardized quantitative sensory testing (QST) protocol giving a complete profile for one region within 30 min. To judge plus or minus signs in patients we have now established age- and gender-matched absolute and relative QST reference values from 180 healthy subjects, assessed bilaterally over face, hand and foot. We determined thermal detection and pain thresholds including a test for paradoxical heat sensations, mechanical detection thresholds to von Frey filaments and a 64 Hz tuning fork, mechanical pain thresholds to pinprick stimuli and blunt pressure, stimulus/response-functions for pinprick and dynamic mechanical allodynia, and pain summation (wind-up ratio). QST parameters were region specific and age dependent. Pain thresholds were significantly lower in women than men. Detection thresholds were generally independent of gender. Reference data were normalized to the specific group means and variances (region, age, gender) by calculating z-scores. Due to confidence limits close to the respective limits of the possible data range, heat hypoalgesia, cold hypoalgesia, and mechanical hyperesthesia can hardly be diagnosed. Nevertheless, these parameters can be used for group comparisons. Sensitivity is enhanced by side-to-side comparisons by a factor ranging from 1.1 to 2.5. Relative comparisons across body regions do not offer advantages over absolute reference values. Application of this standardized QST protocol in patients and human surrogate models will allow to infer underlying mechanisms from somatosensory phenotypes.

  18. The implementation of the serial trial intervention for pain and challenging behaviour in advanced dementia patients (STA OP!): a clustered randomized controlled trial

    PubMed Central

    2011-01-01

    Background Pain (physical discomfort) and challenging behaviour are highly prevalent in nursing home residents with dementia: at any given time 45-80% of nursing home residents are in pain and up to 80% have challenging behaviour. In the USA Christine Kovach developed the serial trial intervention (STI) and established that this protocol leads to less discomfort and fewer behavioural symptoms in moderate to severe dementia patients. The present study will provide insight into the effects of implementation of the Dutch version of the STI-protocol (STA OP!) in comparison with a control intervention, not only on behavioural symptoms, but also on pain, depression, and quality of life. This article outlines the study protocol. Methods/Design The study is a cluster randomized controlled trial in 168 older people (aged >65 years) with mild or moderate dementia living in nursing homes. The clusters, Dutch nursing homes, are randomly assigned to either the intervention condition (training and implementation of the STA OP!-protocol) or the control condition (general training focusing on challenging behaviour and pain, but without the step-wise approach). Measurements take place at baseline, after 3 months (end of the STA OP! training period) and after 6 months. Primary outcome measures are symptoms of challenging behaviour (measured with the Cohen-Mansfield Agitation Inventory (CMAI) and the Neuropsychiatric Inventory-Nursing Home version (NPI-NH)), and pain (measure with the Dutch version of the Pain Assessment Checklist for Seniors (PACSLAC-D) and the Minimum Data Set of the Resident Assessment Instrument (MDS-RAI) pain scale). Secondary outcome measures include symptoms of depression (Cornell and MDS-RAI depression scale), Quality of Live (Qualidem), changes in prescriptions of analgesics and psychotropic drugs, and the use of non-pharmacological comfort interventions (e.g. snoezelen, reminiscence therapy). Discussion The transfer from the American design to the Dutch

  19. Nonsurgical Korean Integrative Treatments for Symptomatic Lumbar Spinal Stenosis: A Three-Armed Randomized Controlled Pilot Trial Protocol.

    PubMed

    Kim, Kiok; Shin, Kyung-Min; Lee, Jun-Hwan; Seo, Bok-Nam; Jung, So-Young; Youn, Yousuk; Lee, Sang Ho; Kim, Jaehong; Qu, Wenchun; Kim, Tae-Hun

    2016-01-01

    This is a study protocol for a pilot three-armed randomized controlled trial on nonsurgical integrative Korean medicinal treatment for symptomatic lumbar spinal stenosis (LSS). Thirty-six participants who have been diagnosed with (LSS) and recommended for spinal surgery by neurosurgeons or orthopedics and have had spinal symptoms such as severe low back pain and neurological claudication regardless of at least three months of conservative treatments will be recruited. Participants will be randomly assigned to be one of the three intervention groups, including the Mokhuri treatment program group 1 or 2 or usual care group. All treatments will be administered in inpatient units over a period of 4 weeks. The primary outcomes are 0 to 100 Visual Analogue Scales for low back pain and leg pain and the secondary outcomes are Oswestry Disability Index; EQ-5D; Roland-Morris Disability Questionnaire; Oxford Claudication Score; physical function test, including treadmill test, walking duration, and distance assessment for free leg pain; radiologic testing; and adverse events which will be assessed during the 4-week treatment period as well as after 3 and 6 months of follow-up. Then, we will assess the feasibility of the clinical trial design as well as a nonsurgical integrative treatment program. This trial is registered with CRIS registration number: KCT0001218. PMID:26941823

  20. Testing the activitystat hypothesis: a randomised controlled trial protocol

    PubMed Central

    2012-01-01

    allocation. Discussion This protocol has been specifically designed to test the activitystat hypothesis while taking into account the key conceptual and methodological considerations of testing a biologically regulated homeostatic feedback loop. Results of this study will be an important addition to the growing literature and debate concerning the possible existence of an activitystat. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12610000248066 PMID:23043381

  1. Template protocol for clinical trials investigating vaccines—Focus on safety elements☆

    PubMed Central

    Bonhoeffer, Jan; Imoukhuede, Egeruan B.; Aldrovandi, Grace; Bachtiar, Novilia S.; Chan, Eng-Soon; Chang, Soju; Chen, Robert T.; Fernandopulle, Rohini; Goldenthal, Karen L.; Heffelfinger, James D.; Hossain, Shah; Jevaji, Indira; Khamesipour, Ali; Kochhar, Sonali; Makhene, Mamodikoe; Malkin, Elissa; Nalin, David; Prevots, Rebecca; Ramasamy, Ranjan; Sellers, Sarah; Vekemans, Johan; Walker, Kenneth B.; Wilson, Pam; Wong, Virginia; Zaman, Khalequz; Heininger, Ulrich

    2015-01-01

    This document is intended as a guide to the protocol development for trials of prophylactic vaccines. The template may serve phases I–IV clinical trials protocol development to include safety relevant information as required by the regulatory authorities and as deemed useful by the investigators. This document may also be helpful for future site strengthening efforts. PMID:23499603

  2. Prevention of abdominal wound infection (PROUD trial, DRKS00000390): study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Wound infection affects a considerable portion of patients after abdominal operations, increasing health care costs and postoperative morbidity and affecting quality of life. Antibacterial coating has been suggested as an effective measure to decrease postoperative wound infections after laparotomies. The INLINE metaanalysis has recently shown the superiority of a slowly absorbable continuous suture for abdominal closure; with PDS plus® such a suture has now been made available with triclosan antibacterial coating. Methods/Design The PROUD trial is designed as a randomised, controlled, observer, surgeon and patient blinded multicenter superiority trial with two parallel groups and a primary endpoint of wound infection during 30 days after surgery. The intervention group will receive triclosan coated polydioxanone sutures, whereas the control group will receive the standard polydioxanone sutures; abdominal closure will otherwise be standardized in both groups. Statistical analysis is based on intention-to-treat population via binary logistic regression analysis, the total sample size of n = 750 is sufficient to ensure alpha = 5% and power = 80%, an interim analysis will be carried out after data of 375 patients are available. Discussion The PROUD trial will yield robust data to determine the effectiveness of antibacterial coating in one of the standard sutures for abdominal closure and potentially lead to amendment of current guidelines. The exploration of clinically objective parameters as well as quality of life holds immediate relevance for clinical management and the pragmatic trial design ensures high external validity. Trial Registration The trial protocol has been registered with the German Clinical Trials Register (DRKS00000390). PMID:22103965

  3. Diagnosis and treatment of musculoskeletal chest pain: design of a multi-purpose trial

    PubMed Central

    Stochkendahl, Mette J; Christensen, Henrik W; Vach, Werner; Høilund-Carlsen, Poul Flemming; Haghfelt, Torben; Hartvigsen, Jan

    2008-01-01

    Background Acute chest pain is a major health problem all over the western world. Active approaches are directed towards diagnosis and treatment of potentially life threatening conditions, especially acute coronary syndrome/ischemic heart disease. However, according to the literature, chest pain may also be due to a variety of extra-cardiac disorders including dysfunction of muscles and joints of the chest wall or the cervical and thoracic part of the spine. The diagnostic approaches and treatment options for this group of patients are scarce and formal clinical studies addressing the effect of various treatments are lacking. Methods/Design We present an ongoing trial on the potential usefulness of chiropractic diagnosis and treatment in patients dismissed from an acute chest pain clinic without a diagnosis of acute coronary syndrome. The aims are to determine the proportion of patients in whom chest pain may be of musculoskeletal rather than cardiac origin and to investigate the decision process of a chiropractor in diagnosing these patients; further, to examine whether chiropractic treatment can reduce pain and improve physical function when compared to advice directed towards promoting self-management, and, finally, to estimate the cost-effectiveness of these procedures. This study will include 300 patients discharged from a university hospital acute chest pain clinic without a diagnosis of acute coronary syndrome or any other obvious cardiac or non-cardiac disease. After completion of the clinic's standard cardiovascular diagnostic procedures, trial patients will be examined according to a standardized protocol including a) a self-report questionnaire; b) a semi-structured interview; c) a general health examination; and d) a specific manual examination of the muscles and joints of the neck, thoracic spine, and thorax in order to determine whether the pain is likely to be of musculoskeletal origin. To describe the patients status with regards to ischemic heart

  4. The HAART cell phone adherence trial (WelTel Kenya1): a randomized controlled trial protocol

    PubMed Central

    Lester, Richard T; Mills, Edward J; Kariri, Antony; Ritvo, Paul; Chung, Michael; Jack, William; Habyarimana, James; Karanja, Sarah; Barasa, Samson; Nguti, Rosemary; Estambale, Benson; Ngugi, Elizabeth; Ball, T Blake; Thabane, Lehana; Kimani, Joshua; Gelmon, Lawrence; Ackers, Marta; Plummer, Francis A

    2009-01-01

    Background The objectives are to compare the effectiveness of cell phone-supported SMS messaging to standard care on adherence, quality of life, retention, and mortality in a population receiving antiretroviral therapy (ART) in Nairobi, Kenya. Methods and Design A multi-site randomized controlled open-label trial. A central randomization centre provided opaque envelopes to allocate treatments. Patients initiating ART at three comprehensive care clinics in Kenya will be randomized to receive either a structured weekly SMS ('short message system' or text message) slogan (the intervention) or current standard of care support mechanisms alone (the control). Our hypothesis is that using a structured mobile phone protocol to keep in touch with patients will improve adherence to ART and other patient outcomes. Participants are evaluated at baseline, and then at six and twelve months after initiating ART. The care providers keep a weekly study log of all phone based communications with study participants. Primary outcomes are self-reported adherence to ART and suppression of HIV viral load at twelve months scheduled follow-up. Secondary outcomes are improvements in health, quality of life, social and economic factors, and retention on ART. Primary analysis is by 'intention-to-treat'. Sensitivity analysis will be used to assess per-protocol effects. Analysis of covariates will be undertaken to determine factors that contribute or deter from expected and determined outcomes. Discussion This study protocol tests whether a novel structured mobile phone intervention can positively contribute to ART management in a resource-limited setting. Trial Registration Trial Registration Number: NCT00830622 PMID:19772596

  5. Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations.

    PubMed

    Gewandter, Jennifer S; Dworkin, Robert H; Turk, Dennis C; Farrar, John T; Fillingim, Roger B; Gilron, Ian; Markman, John D; Oaklander, Anne Louise; Polydefkis, Michael J; Raja, Srinivasa N; Robinson, James P; Woolf, Clifford J; Ziegler, Dan; Ashburn, Michael A; Burke, Laurie B; Cowan, Penney; George, Steven Z; Goli, Veeraindar; Graff, Ole X; Iyengar, Smriti; Jay, Gary W; Katz, Joel; Kehlet, Henrik; Kitt, Rachel A; Kopecky, Ernest A; Malamut, Richard; McDermott, Michael P; Palmer, Pamela; Rappaport, Bob A; Rauschkolb, Christine; Steigerwald, Ilona; Tobias, Jeffrey; Walco, Gary A

    2015-07-01

    Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain. We present general design considerations for prevention trials in populations that are at relatively high risk for developing chronic pain. Specific design considerations included subject identification, timing and duration of treatment, outcomes, timing of assessment, and adjusting for risk factors in the analyses. We provide a detailed examination of 4 models of chronic pain prevention (ie, chronic postsurgical pain, postherpetic neuralgia, chronic low back pain, and painful chemotherapy-induced peripheral neuropathy). The issues discussed can, in many instances, be extrapolated to other chronic pain conditions. These examples were selected because they are representative models of primary and secondary prevention, reflect persistent pain resulting from multiple insults (ie, surgery, viral infection, injury, and toxic or noxious element exposure), and are chronically painful conditions that are treated with a range of interventions. Improvements in the design of chronic pain prevention trials could improve assay sensitivity and thus accelerate the identification of efficacious interventions. Such interventions would have the potential to reduce the prevalence of chronic pain in the population. Additionally, standardization of outcomes in prevention clinical trials will facilitate meta-analyses and systematic reviews and improve detection of preventive strategies emerging from clinical trials.

  6. Adjunctive acupuncture for pain and symptom management in the inpatient setting: Protocol for a pilot hybrid effectiveness-implementation study

    PubMed Central

    Chao, Maria T.; Chang, Alexandra; Reddy, Sanjay; Harrison, James D.; Acquah, Joseph; Toveg, Miria; Santana, Trilce; Hecht, Frederick M.

    2016-01-01

    Background Effective pain management among hospitalized patients is an important aspect of providing quality care and achieving optimal clinical outcomes and patient satisfaction. Common pharmacologic approaches for pain, though effective, have serious side effects and are not appropriate for all inpatients. Findings from randomized controlled trials (RCTs) support the efficacy of acupuncture for many symptoms relevant to inpatients including postoperative pain, cancer-related pain, nausea and vomiting, and withdrawal from narcotic use. However, the extent to which findings from RCTs translate to real-world implementation of acupuncture in typical hospital settings is unknown. Methods/Design In partnership with the launch of a clinical program offering acupuncture services to inpatients at the University of California, San Francisco’s Mount Zion Hospital, we are conducting a pilot study using a hybrid effectiveness-implementation design to: (1) assess the effectiveness of acupuncture to manage pain and other symptoms and improve patient satisfaction; and (2) evaluate the barriers and facilitators to implementing an on-going acupuncture service for inpatients. During a 2-month pre-randomization phase, we evaluated and adapted clinical scheduling and treatment protocols with acupuncturists and hospital providers and pretested study procedures including enrollment, consent, and data collection. During a 6-month randomization phase, we used a two-tiered consent process in which inpatients were first consented into a study of symptom management, randomized to be offered acupuncture, and consented for acupuncture if they accepted. We are also conducting in-depth interviews and focus groups to assess evidence, context, and facilitators of key provider and hospital administration stakeholders. Discussion Effectiveness research in ‘real-world’ practice settings is needed to inform clinical decision-making and guide implementation of evidence-based acupuncture

  7. Organisation and function of the primary motor cortex in chronic pain: protocol for a systematic review and meta-analysis

    PubMed Central

    Chang, Wei-Ju; O'Connell, Neil E; Burns, Emma; Chipchase, Lucy S; Liston, Matthew B

    2015-01-01

    Introduction Primary motor cortical (M1) adaptation in the form of altered organisation and function is hypothesised to underpin motor dysfunction observed in chronic pain. The aim of this review is to assess the evidence for altered M1 organisation and function in chronic pain. Methods and analysis Systematic review and meta-analysis. We will search electronic databases with predetermined search terms to identify relevant studies and evaluate the studies for inclusion and risks of bias. Two independent reviewers will extract data. Any disagreement will be resolved through a third reviewer. Cross-sectional or prospective studies published in English before May 2015 that investigate M1 organisation and function in chronic pain will be included if they meet the eligibility criteria. Primary outcomes will include M1 cortical excitability, spatial cortical representation, the function of inhibitory and facilitatory intracortical networks, cortical reactivity and cortical glucose metabolism. Clinical measures such as pain and disability will be included where the correlation with the primary outcomes of M1 organisation and function were investigated in the included studies. Ethics and dissemination This systematic review does not require ethical approval. The results of this review will be submitted for peer-reviewed publication regardless of outcome and will be presented at relevant conferences. Trial registration number Our systematic review protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO; registration number CRD42015014823). PMID:26621512

  8. Research design considerations for single-dose analgesic clinical trials in acute pain: IMMPACT recommendations.

    PubMed

    Cooper, Stephen A; Desjardins, Paul J; Turk, Dennis C; Dworkin, Robert H; Katz, Nathaniel P; Kehlet, Henrik; Ballantyne, Jane C; Burke, Laurie B; Carragee, Eugene; Cowan, Penney; Croll, Scott; Dionne, Raymond A; Farrar, John T; Gilron, Ian; Gordon, Debra B; Iyengar, Smriti; Jay, Gary W; Kalso, Eija A; Kerns, Robert D; McDermott, Michael P; Raja, Srinivasa N; Rappaport, Bob A; Rauschkolb, Christine; Royal, Mike A; Segerdahl, Märta; Stauffer, Joseph W; Todd, Knox H; Vanhove, Geertrui F; Wallace, Mark S; West, Christine; White, Richard E; Wu, Christopher

    2016-02-01

    This article summarizes the results of a meeting convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) on key considerations and best practices governing the design of acute pain clinical trials. We discuss the role of early phase clinical trials, including pharmacokinetic-pharmacodynamic (PK-PD) trials, and the value of including both placebo and active standards of comparison in acute pain trials. This article focuses on single-dose and short-duration trials with emphasis on the perioperative and study design factors that influence assay sensitivity. Recommendations are presented on assessment measures, study designs, and operational factors. Although most of the methodological advances have come from studies of postoperative pain after dental impaction, bunionectomy, and other surgeries, the design considerations discussed are applicable to many other acute pain studies conducted in different settings. PMID:26683233

  9. Research design considerations for single-dose analgesic clinical trials in acute pain: IMMPACT recommendations.

    PubMed

    Cooper, Stephen A; Desjardins, Paul J; Turk, Dennis C; Dworkin, Robert H; Katz, Nathaniel P; Kehlet, Henrik; Ballantyne, Jane C; Burke, Laurie B; Carragee, Eugene; Cowan, Penney; Croll, Scott; Dionne, Raymond A; Farrar, John T; Gilron, Ian; Gordon, Debra B; Iyengar, Smriti; Jay, Gary W; Kalso, Eija A; Kerns, Robert D; McDermott, Michael P; Raja, Srinivasa N; Rappaport, Bob A; Rauschkolb, Christine; Royal, Mike A; Segerdahl, Märta; Stauffer, Joseph W; Todd, Knox H; Vanhove, Geertrui F; Wallace, Mark S; West, Christine; White, Richard E; Wu, Christopher

    2016-02-01

    This article summarizes the results of a meeting convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) on key considerations and best practices governing the design of acute pain clinical trials. We discuss the role of early phase clinical trials, including pharmacokinetic-pharmacodynamic (PK-PD) trials, and the value of including both placebo and active standards of comparison in acute pain trials. This article focuses on single-dose and short-duration trials with emphasis on the perioperative and study design factors that influence assay sensitivity. Recommendations are presented on assessment measures, study designs, and operational factors. Although most of the methodological advances have come from studies of postoperative pain after dental impaction, bunionectomy, and other surgeries, the design considerations discussed are applicable to many other acute pain studies conducted in different settings.

  10. A novel Dual Probe Complex Trial Protocol for detection of concealed information.

    PubMed

    Labkovsky, Elena; Rosenfeld, J Peter

    2014-11-01

    In simply guilty (SG), countermeasure-using guilty (CM), and innocent (IN) subjects, a new concealed information test, the P300-based Dual Probe Complex Trial Protocol was tested in a mock crime scenario. It combines an oddball protocol with two stimuli (probe, irrelevant) and another with three stimuli (probe, irrelevant, target) into one trial, doubling detected mock crime information per unit time, compared to previous protocols. Probe-irrelevant amplitude differences were significant in SG and CM, but not IN subjects. On a measure from both two and three stimulus protocol parts of the Dual Probe Complex Trial Protocol trial, accuracy was 94.7% (based on a .9 bootstrap criterion). The criterion-independent area (AUC) under the receiver operating characteristic (from signal detection theory) measuring SG and CM versus IN discriminability averaged .92 (in a range of 0.5-1.0). Countermeasures enhanced irrelevant (not probe) P300s in CM groups. PMID:24981064

  11. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

    PubMed Central

    Tetzlaff, Jennifer M; Gøtzsche, Peter C; Altman, Douglas G; Mann, Howard; Berlin, Jesse A; Dickersin, Kay; Hróbjartsson, Asbjørn; Schulz, Kenneth F; Parulekar, Wendy R; Krleža-Jerić, Karmela; Laupacis, Andreas; Moher, David

    2013-01-01

    High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders. PMID:23303884

  12. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials.

    PubMed

    Chan, An-Wen; Tetzlaff, Jennifer M; Gøtzsche, Peter C; Altman, Douglas G; Mann, Howard; Berlin, Jesse A; Dickersin, Kay; Hróbjartsson, Asbjørn; Schulz, Kenneth F; Parulekar, Wendy R; Krleza-Jeric, Karmela; Laupacis, Andreas; Moher, David

    2013-01-01

    High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders. PMID:23303884

  13. Nicotine patch preloading for smoking cessation (the preloading trial): study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background The use of nicotine replacement therapy before quitting smoking is called nicotine preloading. Standard smoking cessation protocols suggest commencing nicotine replacement therapy only on the first day of quitting smoking (quit day) aiming to reduce withdrawal symptoms and craving. However, other, more successful smoking cessation pharmacotherapies are used prior to the quit day as well as after. Nicotine preloading could improve quit rates by reducing satisfaction from smoking prior to quitting and breaking the association between smoking and reward. A systematic literature review suggests that evidence for the effectiveness of preloading is inconclusive and further trials are needed. Methods/Design This is a study protocol for a multicenter, non-blinded, randomized controlled trial based in the United Kingdom, enrolling 1786 smokers who want to quit, funded by the National Institute for Health Research, Health Technology Assessment program, and sponsored by the University of Oxford. Participants will primarily be recruited through general practices and smoking cessation clinics, and randomized (1:1) either to use 21 mg nicotine patches, or not, for four weeks before quitting, whilst smoking as normal. All participants will be referred to receive standard smoking cessation service support. Follow-ups will take place at one week, four weeks, six months and 12 months after quit day. The primary outcome will be prolonged, biochemically verified six-month abstinence. Additional outcomes will include point prevalence abstinence and abstinence of four-week and 12-month duration, side effects, costs of treatment, and markers of potential mediators and moderators of the preloading effect. Discussion This large trial will add substantially to evidence on the effectiveness of nicotine preloading, but also on its cost effectiveness and potential mediators, which have not been investigated in detail previously. A range of recruitment strategies have been

  14. [Analysis on the requirements for clinical trial protocol writing of external treatment of TCM such as tuina].

    PubMed

    Gao, Shuang; Wang, Jingui; Wang, Hui

    2015-06-01

    According to Standard Protocol Items: Recommendations for Interventional Trials, Consolidated Standard of Reporting Trials 2010 Statement (CONSORT), CONSORT Extension for Non-Pharmacologic Treatment Interventions (CONSORT for NPT) and Good Clinical Practice, the detailed requirements for protocol writing, reporting, and practicing of clinical trial were classified and summarized in this article. By combining the practical situation of clinical trial of external treatment of TCM such as tuina, the requirernents for clinical trial protocol writing of external treatment of TCM were analyzed and acquired which could improve the quality of clinical trial protocol of external treatment of TCM, thus to provide references for standardized execution of TMC clinical trial and reports of research results.

  15. The Effectiveness of Individualized Acupuncture Protocols in the Treatment of Gulf War Illness: A Pragmatic Randomized Clinical Trial

    PubMed Central

    Conboy, Lisa; Gerke, Travis; Hsu, Kai-Yin; St John, Meredith; Goldstein, Marc; Schnyer, Rosa

    2016-01-01

    Background Gulf War Illness is a Complex Medical Illness characterized by multiple symptoms, including fatigue, sleep and mood disturbances, cognitive dysfunction, and musculoskeletal pain affecting veterans of the first Gulf War. No standard of care treatment exists. Methods This pragmatic Randomized Clinical Trial tested the effects of individualized acupuncture treatments offered in extant acupuncture practices in the community; practitioners had at least 5 years of experience plus additional training provided by the study. Veterans with diagnosed symptoms of Gulf War Illness were randomized to either six months of biweekly acupuncture treatments (group 1, n = 52) or 2 months of waitlist followed by weekly acupuncture treatments (group 2, n = 52). Measurements were taken at baseline, 2, 4 and 6 months. The primary outcome is the SF-36 physical component scale score (SF-36P) and the secondary outcome is the McGill Pain scale. Results Of the 104 subjects who underwent randomization, 85 completed the protocol (82%). A clinically and statistically significant average improvement of 9.4 points (p = 0.03) in the SF-36P was observed for group 1 at month 6 compared to group 2, adjusting for baseline pain. The secondary outcome of McGill pain index produced similar results; at 6 months, group 1 was estimated to experience a reduction of approximately 3.6 points (p = 0.04) compared to group 2. Conclusions Individualized acupuncture treatment of sufficient dose appears to offer significant relief of physical disability and pain for veterans with Gulf War Illness. This work was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Gulf War Illness Research Program under Award No. W81XWH-09-2-0064. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense. Trial Registration ClinicalTrials.gov NCT01305811 PMID:27031099

  16. Evaluation of pain and function after two home exercise programs in a clinical trial on women with chronic neck pain - with special emphasises on completers and responders

    PubMed Central

    2014-01-01

    Background Different types of exercises can help manage chronic neck pain. Supervised exercise interventions are widely used, but these protocols require substantial resources. The aim of this trial, which focused on adherence, was to evaluate two home exercise interventions. Methods This parallel group randomized controlled trial included 57 women randomly allocated into two groups – a strength training group (STRENGTH, 34 subjects) and a stretching group (STRETCH, 23 subjects). The interventions focused on the neck and shoulder muscles and lasted for 12 months. The STRENGTH group performed weight training and ended each session with stretching exercises. These stretching exercises constituted the entirety of the STRETCH group’s training session. Both groups were instructed to exercise three times per week. All the participants kept an exercise diary. In addition, all participants were offered support via phone and e-mail. The primary outcomes were pain intensity and function. The trial included a four- to six-month and a twelve-month follow-up. A completer in this study exercised at least 1,5 times per week during eight unbroken weeks. A responder in this study reported clinically significant improvements on pain and function. The statistical analyses used the Mann Whitney U-test, Wilcoxon signed-rank test, and X 2 test. Results At four- to six-months, the numbers of completers were 19 in the STRENGTH group and 17 in the STRETCH group. At twelve months, the corresponding numbers were 11 (STRENGTH) and 10 (STRETCH). At four- to six-months, the proportions of subjects reporting clinically important changes (STRENGTH and STRETCH) were for neck pain: 47% and 41%, shoulder pain: 47% and 47%, function: 37% and 29%. At twelve months, the corresponding numbers were for neck pain: 45% and 40%, shoulder pain: 55% and 50%, function: 55% and 20%. Conclusions No differences in the two primary outcomes between the two interventions were found, a finding that may be due to

  17. Engaging hospitalized patients in clinical care: Study protocol for a pragmatic randomized controlled trial

    PubMed Central

    Prey, Jennifer; Ryan, Beatriz; Alarcon, Irma; Qian, Min; Bakken, Suzanne; Feiner, Steven; Hripcsak, George; Polubriaginof, Fernanda; Restaino, Susan; Schnall, Rebecca; Strong, Philip; Vawdrey, David

    2016-01-01

    Background Patients who are better informed and more engaged in their health care have higher satisfaction with health care and better health outcomes. While patient engagement has been a focus in the outpatient setting, strategies to engage inpatients in their care have not been well studied. We are undertaking a study to assess how patients’ information needs during hospitalization can be addressed with health information technologies. To achieve this aim, we developed a personalized inpatient portal that allows patients to see who is on their care team, monitor their vital signs, review medications being administered, review current and historical lab and test results, confirm allergies, document pain scores and send questions and comments to inpatient care providers. The purpose of this paper is to describe the protocol for the study. Methods/design This pragmatic randomized controlled trial will enroll 426 inpatient cardiology patients at an urban academic medical center into one of three arms receiving: 1) usual care, 2) iPad with general internet access, or 3) iPad with access to the personalized inpatient portal. The primary outcome of this trial is patient engagement, which is measured through the Patient Activation Measure. To assess scalability and potential reach of the intervention, we are partnering with a West Coast community hospital to deploy the patient engagement technology in their environment with an additional 160 participants. Conclusion This study employs a pragmatic randomized control trial design to test whether a personalized inpatient portal will improve patient engagement. If the study is successful, continuing advances in mobile computing technology should make these types of interventions available in a variety of clinical care delivery settings. PMID:26795675

  18. Imperfect placebos are common in low back pain trials: a systematic review of the literature

    PubMed Central

    Kamper, S. J.; Herbert, R. D.; Maher, C. G.; McAuley, J. H.

    2008-01-01

    The placebo is an important tool to blind patients to treatment allocation and therefore minimise some sources of bias in clinical trials. However, placebos that are improperly designed or implemented may introduce bias into trials. The purpose of this systematic review was to evaluate the adequacy of placebo interventions used in low back pain trials. Electronic databases were searched systematically for randomised placebo-controlled trials of conservative interventions for low back pain. Trial selection and data extraction were performed by two reviewers independently. A total of 126 trials using over 25 different placebo interventions were included. The strategy most commonly used to enhance blinding was the provision of structurally equivalent placebos. Adequacy of blinding was assessed in only 13% of trials. In 20% of trials the placebo intervention was a potentially genuine treatment. Most trials that assessed patients’ expectations showed that the placebo generated lower expectations than the experimental intervention. Taken together, these results demonstrate that imperfect placebos are common in low back pain trials; a result suggesting that many trials provide potentially biased estimates of treatment efficacy. This finding has implications for the interpretation of published trials and the design of future trials. Implementation of strategies to facilitate blinding and balance expectations in randomised groups need a higher priority in low back pain research. Electronic supplementary material The online version of this article (doi:10.1007/s00586-008-0664-3) contains supplementary material, which is available to authorized users. PMID:18421484

  19. Randomized control trial of computer-based rehabilitation of spatial neglect syndrome: the RESPONSE trial protocol

    PubMed Central

    2014-01-01

    Background Spatial neglect is a frequent and debilitating consequence of acquired brain injury and currently has no widely accepted standard of care. While previous interventions for spatial neglect have targeted patients’ overt spatial deficits (e.g., reduced contralesional visual scanning), far fewer have directly targeted patients’ non-spatial deficits (e.g., sustained attention deficits). Considering that non-spatial deficits have shown to be highly predictive of long-term disability, we developed a novel computer based training program that targets both sustained (tonic) and moment-to-moment (phasic) aspects of non-spatial attention (Tonic and Phasic Alertness Training, TAPAT). Preliminary studies demonstrate that TAPAT is safe and effective in improving both spatial and non-spatial attention deficits in the post-acute recovery phase in neglect patients. The purpose of the current trial (referred to as the REmediation of SPatial Neglect or RESPONSE trial) is to compare TAPAT to an active control training condition, include a larger sample of patients, and assess both cognitive and functional outcomes. Methods/Design We will employ a multi-site, longitudinal, blinded randomized controlled trial (RCT) design with a target sample of 114 patients with spatial neglect. Patients will either perform, at their home, the experimental TAPAT training program or an active control computer games condition for thirty minutes/day, five days a week, over three months. Patients will be assessed on a battery of cognitive and functional outcomes on three occasions: a) immediately before training, b) within forty-eight hours post completion of total training, and c) after a three-month no-contact period post completion of total training, to assess the longevity of potential training effects. Discussion The strengths of this protocol are that it tests an innovative, in-home administered treatment that targets a fundamental deficit in neglect, employs highly sensitive computer

  20. Efficacy of treatments and pain management for trapeziometacarpal (thumb base) osteoarthritis: protocol for a systematic review

    PubMed Central

    Hamasaki, Tokiko; Lalonde, Lyne; Harris, Patrick; Bureau, Nathalie J; Gaudreault, Nathaly; Ziegler, Daniela; Choinière, Manon

    2015-01-01

    Introduction The thumb is essential for daily activities. Unfortunately, this digit is commonly affected by trapeziometacarpal osteoarthritis (TMO), handicapping a large number of individuals. TMO constitutes an increasing human and economic burden for our society whose population is ageing. Limited access to adequate treatment is among the most important obstacles to optimal TMO management. Poor understanding of TMO characteristics, lack of knowledge about evidence-based treatments, simplistic pain management plans based solely on the patient's physical condition, absence of interprofessional communication and lack of multidisciplinary treatment guidelines contribute to inadequate TMO management. On the long term, our research project aims at improving the quality of care and services offered to patients with TMO by developing a patient-centred, evidence-based multidisciplinary management clinical pathway coordinated across the healthcare system. This proposed systematic review is a prerequisite to ensuring evidence-based practices and aims to document the efficacy of all the existing modalities for TMO management. Methods and analysis The protocol of the systematic review is registered with PROSPERO and will be conducted using the guidelines Cochrane Handbook for Systematic Reviews of Interventions. We will identify studies in English and French concerning TMO treatments through searches in Cochrane Central, EMBASE, MEDLINE, PsychINFO, CINHAL, PubMed, OT Seekers, PEDRO and the grey literature. 2 reviewers will independently screen study eligibility, extract data and appraise studies using published assessment tools. Meta-analyses will be undertaken where feasible; otherwise, narrative syntheses will be carried out. The robustness of evidence will be assessed using the GRADE system. Ethics and dissemination Ethics approval is not required for this study. A comprehensive knowledge exchange and transfer plan incorporating effective strategies will be used to

  1. Acupuncture is Effective for Chronic Knee Pain: A Reanalysis of the Australian Acupuncture Trial.

    PubMed

    Yin Fan, Arthur; Zhou, Kehua; Gu, Sherman; Ming Li, Yong

    2016-03-01

    Context • In the October 2014 issue of the Journal of the American Medical Association (JAMA), Hinman et al published the results of an Australian clinical trial on acupuncture in a paper entitled "Acupuncture for Chronic Knee Pain: A Randomized Clinical Trial" (JAMA report), in which they concluded that neither acupuncture nor laser acupuncture had any greater effects than sham laser acupuncture for pain or function for patients aged 50 y and older with moderate-to-severe knee pain. That study has been criticized extensively by international scholars for its validity because serious methodological flaws existed throughout the study's design, implementation, and conclusions. Objective • The current study intended to re-examine the prior study's conclusions about the efficacy of acupuncture for chronic knee pain. Design • The current research team performed a reanalysis of relevant data from the JAMA report. Intervention • The original study included 4 groups: (1) an acupuncture group, which received needle acupuncture, inferred by the current authors to have been set up to be a positive control in the original study; (2) a laser acupuncture group, which received laser acupuncture; (3) a sham laser acupuncture group, which received sham laser acupuncture and acted as the negative controls for the laser acupuncture intervention; and (4) a control group, which received conventional care but no acupuncture or laser treatments. The study lasted 12 wk. Outcome Measures • The measures included evaluations in the following areas: (1) poststudy modifications-an evaluation of the consistency of the JAMA report with the study's intentions as identified for a grant that was originally approved and funded by the Australian National Health and Medical Research Council (NHMRC) in 2009, as indicated in the study's trial registration, and as compared with the published protocols and to the study's originally stated objectives; (2) high heterogeneity-an assessment of the

  2. Traumeel S® for pain relief following hallux valgus surgery: a randomized controlled trial

    PubMed Central

    2010-01-01

    Background In spite of recent advances in post-operative pain relief, pain following orthopedic surgery remains an ongoing challenge for clinicians. We examined whether a well known and frequently prescribed homeopathic preparation could mitigate post-operative pain. Method We performed a randomized, double blind, placebo-controlled trial to evaluate the efficacy of the homeopathic preparation Traumeel S® in minimizing post-operative pain and analgesic consumption following surgical correction of hallux valgus. Eighty consecutive patients were randomized to receive either Traumeel tablets or an indistinguishable placebo, and took primary and rescue oral analgesics as needed. Maximum numerical pain scores at rest and consumption of oral analgesics were recorded on day of surgery and for 13 days following surgery. Results Traumeel was not found superior to placebo in minimizing pain or analgesic consumption over the 14 days of the trial, however a transient reduction in the daily maximum post-operative pain score favoring the Traumeel arm was observed on the day of surgery, a finding supported by a treatment-time interaction test (p = 0.04). Conclusions Traumeel was not superior to placebo in minimizing pain or analgesic consumption over the 14 days of the trial. A transient reduction in the daily maximum post-operative pain score on the day of surgery is of questionable clinical importance. Trial Registration This study was registered at ClinicalTrials.gov. # NCT00279513 PMID:20380750

  3. Reporting of planned statistical methods in published surgical randomised trial protocols: a protocol for a methodological systematic review

    PubMed Central

    Madden, Kim; Arseneau, Erika; Evaniew, Nathan; Smith, Christopher S; Thabane, Lehana

    2016-01-01

    Introduction Poor reporting can lead to inadequate presentation of data, confusion regarding research methodology used, selective reporting of results, and other misinformation regarding health research. One of the most recent attempts to improve quality of reporting comes from the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Group, which makes recommendations for the reporting of protocols. In this report, we present a protocol for a systematic review of published surgical randomised controlled trial (RCT) protocols, with the purpose of assessing the reporting quality and completeness of the statistical aspects. Methods We will include all published protocols of randomised trials that investigate surgical interventions. We will search MEDLINE, EMBASE, and CENTRAL for relevant studies. Author pairs will independently review all titles, abstracts, and full texts identified by the literature search, and extract data using a structured data extraction form. We will extract the following: year of publication, country, sample size, description of study population, description of intervention and control, primary outcome, important methodological qualities, and quality of reporting of planned statistical methods based on the SPIRIT guidelines. Ethics and dissemination The results of this review will demonstrate the quality of statistical reporting of published surgical RCT protocols. This knowledge will inform recommendations to surgeons, researchers, journal editors and peer reviewers, and other knowledge users that focus on common deficiencies in reporting and how to rectify them. Ethics approval for this study is not required. We will disseminate the results of this review in peer-reviewed publications and conference presentations, and at a doctoral independent study of oral defence. PMID:27259528

  4. Pain Perception and Stabilometric Parameters in People With Chronic Low Back Pain After a Pilates Exercise Program: A Randomized Controlled Trial.

    PubMed

    Patti, Antonino; Bianco, Antonino; Paoli, Antonio; Messina, Giuseppe; Montalto, Maria Alessandra; Bellafiore, Marianna; Battaglia, Giuseppe; Iovane, Angelo; Palma, Antonio

    2016-01-01

    Various exercise interventions, such as Pilates exercises and traditional physical therapy methods, are employed to decrease low back pain (LBP). Nonspecific low back pain (NSLBP) is distinct from LBP, however, as the distribution of pain is restricted to the region between the costal margin and the inferior gluteal. The aim of our randomized controlled trial was to evaluate the effects of a program of Pilates exercises on pain perception and stabilometric parameters in patients with NSLBP.Thirty-eight participants were randomly allocated, using a 1:1 scheme, to either the experimental group (EG) or control group (CG). The EG completed a 14-week program of Pilates exercises, performed thrice per week under the supervision of an exercise specialist, while the CG was managed with a social program only. Measures of posturography and Oswestry Disability Index (ODI) for pain perception were obtained at baseline (T0) and after the 14 weeks of intervention (T)1.Posturography measures improved for patients in the EG, with both eyes open and eyes closed (P < 0.05). There were no statistical differences in posturography in the CG. ODI decreased significantly in both groups over the 14 weeks of the study protocol: EG, T0, 13.7 ± 5.0 compared with T1, 6.5 ± 4.0 (P < 0.001); and CG, T0, 10.7 ± 7.8 compared with T1, 8.4 ± 7.8 (P < 0.01). A greater extent of reduction in pain was achieved in the EG.The Pilates exercise program yielded improvements in pain and posturography outcomes. Our study also confirms the applicability of posturography in evaluating postural instability in patients with NSLBP. Due to our relatively small study group, future studies would be necessary to confirm our findings.

  5. Pain Perception and Stabilometric Parameters in People With Chronic Low Back Pain After a Pilates Exercise Program: A Randomized Controlled Trial.

    PubMed

    Patti, Antonino; Bianco, Antonino; Paoli, Antonio; Messina, Giuseppe; Montalto, Maria Alessandra; Bellafiore, Marianna; Battaglia, Giuseppe; Iovane, Angelo; Palma, Antonio

    2016-01-01

    Various exercise interventions, such as Pilates exercises and traditional physical therapy methods, are employed to decrease low back pain (LBP). Nonspecific low back pain (NSLBP) is distinct from LBP, however, as the distribution of pain is restricted to the region between the costal margin and the inferior gluteal. The aim of our randomized controlled trial was to evaluate the effects of a program of Pilates exercises on pain perception and stabilometric parameters in patients with NSLBP.Thirty-eight participants were randomly allocated, using a 1:1 scheme, to either the experimental group (EG) or control group (CG). The EG completed a 14-week program of Pilates exercises, performed thrice per week under the supervision of an exercise specialist, while the CG was managed with a social program only. Measures of posturography and Oswestry Disability Index (ODI) for pain perception were obtained at baseline (T0) and after the 14 weeks of intervention (T)1.Posturography measures improved for patients in the EG, with both eyes open and eyes closed (P < 0.05). There were no statistical differences in posturography in the CG. ODI decreased significantly in both groups over the 14 weeks of the study protocol: EG, T0, 13.7 ± 5.0 compared with T1, 6.5 ± 4.0 (P < 0.001); and CG, T0, 10.7 ± 7.8 compared with T1, 8.4 ± 7.8 (P < 0.01). A greater extent of reduction in pain was achieved in the EG.The Pilates exercise program yielded improvements in pain and posturography outcomes. Our study also confirms the applicability of posturography in evaluating postural instability in patients with NSLBP. Due to our relatively small study group, future studies would be necessary to confirm our findings. PMID:26765419

  6. Effect of Interlaminar Epidural Steroid Injection in Acute and Subacute Pain Due to Lumbar Disk Herniation: A Randomized Comparison of 2 Different Protocols

    PubMed Central

    Gelalis, I.D; Arnaoutoglou, E; Pakos, E.E; Politis, A.N; Rapti, M; Xenakis, T.A; Papadopoulos, G

    2009-01-01

    In order to assess the efficacy of epidural steroid injections (ESI) in acute and subacute pain due to lumbar spine disk herniation, we conducted a randomized trial, comparing 2 different protocols. Fourty patients with radicular pain due to L4-L5 and L5-S1 disc herniation were assigned to receive either 3 consecutive ESI every 24 hours through a spinal catheter (group A) or 3 consecutive ESI every 10 days with an epidural needle (group B). All patients had improved Oswestry Disabilty Index (ODI) and the Visual Analog Scale (VAS) for pain scores at 1 month of follow-up compared to baseline, while no significant differences were observed between the 2 groups. The scores for group B were statistically significant lower at 2 months of follow-up compared to those of group A. The improvement in the scores of group B was continuous since the mean scores at 2 months of follow up were lower compared to the respective scores at 1 month. Protocol B (3 consecutive ESI every 10 days) was found more effective in the treatment of subacute pain compared to Protocol A (3 consecutive ESI every 24 hours) with statistically significant differences in the ODI and VAS scores at 2 months of follow-up. PMID:20111695

  7. Research design considerations for confirmatory chronic pain clinical trials: IMMPACT recommendations.

    PubMed

    Dworkin, Robert H; Turk, Dennis C; Peirce-Sandner, Sarah; Baron, Ralf; Bellamy, Nicholas; Burke, Laurie B; Chappell, Amy; Chartier, Kevin; Cleeland, Charles S; Costello, Ann; Cowan, Penney; Dimitrova, Rozalina; Ellenberg, Susan; Farrar, John T; French, Jacqueline A; Gilron, Ian; Hertz, Sharon; Jadad, Alejandro R; Jay, Gary W; Kalliomäki, Jarkko; Katz, Nathaniel P; Kerns, Robert D; Manning, Donald C; McDermott, Michael P; McGrath, Patrick J; Narayana, Arvind; Porter, Linda; Quessy, Steve; Rappaport, Bob A; Rauschkolb, Christine; Reeve, Bryce B; Rhodes, Thomas; Sampaio, Cristina; Simpson, David M; Stauffer, Joseph W; Stucki, Gerold; Tobias, Jeffrey; White, Richard E; Witter, James

    2010-05-01

    There has been an increase in the number of chronic pain clinical trials in which the treatments being evaluated did not differ significantly from placebo in the primary efficacy analyses despite previous research suggesting that efficacy could be expected. These findings could reflect a true lack of efficacy or methodological and other aspects of these trials that compromise the demonstration of efficacy. There is substantial variability among chronic pain clinical trials with respect to important research design considerations, and identifying and addressing any methodological weaknesses would enhance the likelihood of demonstrating the analgesic effects of new interventions. An IMMPACT consensus meeting was therefore convened to identify the critical research design considerations for confirmatory chronic pain trials and to make recommendations for their conduct. We present recommendations for the major components of confirmatory chronic pain clinical trials, including participant selection, trial phases and duration, treatment groups and dosing regimens, and types of trials. Increased attention to and research on the methodological aspects of confirmatory chronic pain clinical trials has the potential to enhance their assay sensitivity and ultimately provide more meaningful evaluations of treatments for chronic pain.

  8. Electronic Clinical Trial Protocol Distribution via the World-Wide Web

    PubMed Central

    Afrin, Lawrence B.; Kuppuswamy, Valarmathi; Slater, Barbara; Stuart, Robert K.

    1997-01-01

    Clinical trials today typically are inefficient, paper-based operations. Poor community physician awareness of available trials and difficult referral mechanisms also contribute to poor accrual. The Physicians Research Network (PRN) web was developed for more efficient trial protocol distribution and eligibility inquiries. The Medical University of South Carolina's Hollings Cancer Center trials program and two community oncology practices served as a testbed. In 581 man-hours over 18 months, 147 protocols were loaded into PRN. The trials program eliminated all protocol hardcopies except the masters, reduced photocopier use 59%, and saved 1.0 full-time equivalents (FTE), but 1.0 FTE was needed to manage PRN. There were no known security breaches, downtime, or content-related problems. Therefore, PRN is a paperless, user-preferred, reliable, secure method for distributing protocols and reducing distribution errors and delays because only a single copy of each protocol is maintained. Furthermore, PRN is being extended to serve other aspects of trial operations. PMID:8988471

  9. Perineal Pain Management with Cryotherapy after Vaginal Delivery: A Randomized Clinical Trial.

    PubMed

    Morais, Ítalo; Lemos, Andréa; Katz, Leila; Melo, Lorena Fernandes Rosendo de; Maciel, Mariano Maia; Amorim, Melania Maria Ramos de

    2016-07-01

    Introduction Systematic reviews that evaluate the perineal cryotherapy to reduce pain in the vaginal postpartum are inconclusive. Purpose To evaluate clinical effectiveness of cryotherapy in the management of humanized postpartum perineal pain and vaginal edema. Methods A double-bind randomized controlled clinical trial (UTN number: U1111-1131-8433) was conducted in a hospital in Northeastern, Brazil. Women were included following humanized childbirth. All had vaginal deliveries of a single, full-term pregnancy with cephalic presentation. Exclusion criteria included previous perineal lesion, episiotomy during the current delivery, instrumental delivery, uterine curettage and postpartum hemorrhage. In the experimental group, an ice pack was applied six times on the perineum for 20 minutes, reducing the temperature between 10 and 15 ° C, then 60 minutes without exposure to cold. In the non-cryotherapy, a water bag unable to reduce the temperature to this extent was used, compliance with the same application protocol of the first group. Perineal temperature was monitored at zero, 10 and 20 minutes for application in both groups. Evaluations were made immediately before and after the applications and 24 hours after delivery spontaneous, to determine the association between variables. Results A total of 80 women were included in the study, 40 in each group. There was no significant difference in scores of perineal pain and edema between the groups with or without cryotherapy until 24 hours after childbirth. There was no difference between groups when accomplished repeated measures analysis over the 24 hours after delivery, considering the median perineal pain (p = 0.3) and edema (p = 0.9). Perineal cryotherapy did not influence the amount of analgesics used (p = 0.07) and no adverse effect was registered. Conclusion The use of cryotherapy following normal vaginal delivery within the concept of humanized minimally interventionist childbirth had no

  10. Rationale, Timeline, Study Design, and Protocol Overview of the Therapeutic Hypothermia After Pediatric Cardiac Arrest Trials

    PubMed Central

    Moler, Frank W.; Silverstein, Faye S.; Meert, Kathleen L.; Clark, Amy E.; Holubkov, Richard; Browning, Brittan; Slomine, Beth S.; Christensen, James R.; Dean, Michael

    2014-01-01

    Objective To describe the rationale, timeline, study design, and protocol overview of the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Design Multicenter randomized controlled trials. Setting Pediatric intensive care and cardiac ICUs in the United States and Canada. Patients Children from 48 hours to 18 years old, who have return of circulation after cardiac arrest, who meet trial eligibility criteria, and whose guardians provide written consent. Interventions Therapeutic hypothermia or therapeutic normothermia. Measurements and Main Results From concept inception in 2002 until trial initiation in 2009, 7 years were required to plan and operationalize the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Two National Institute of Child Health and Human Development clinical trial planning grants (R21 and R34) supported feasibility assessment and protocol development. Two clinical research networks, Pediatric Emergency Care Applied Research Network and Collaborative Pediatric Critical Care Research Network, provided infrastructure resources. Two National Heart Lung Blood Institute U01 awards provided funding to conduct separate trials of in-hospital and out-of-hospital cardiac arrest. A pilot vanguard phase that included half the clinical sites began on March 9, 2009, and this was followed by full trial funding through 2015. Conclusions Over a decade will have been required to plan, design, operationalize, and conduct the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Details described in this report, such as participation of clinical research networks and clinical trial planning grants utilization, may be of utility for individuals who are planning investigator-initiated, federally supported clinical trials. PMID:23842585

  11. UK Dermatology Clinical Trials Network’s STOP GAP trial (a multicentre trial of prednisolone versus ciclosporin for pyoderma gangrenosum): protocol for a randomised controlled trial

    PubMed Central

    2012-01-01

    Background Pyoderma gangrenosum (PG) is a rare inflammatory skin disorder characterised by painful and rapidly progressing skin ulceration. PG can be extremely difficult to treat and patients often require systemic immunosuppression. Recurrent lesions of PG are common, but the relative rarity of this condition means that there is a lack of published evidence regarding its treatment. A systematic review published in 2005 found no randomised controlled trials (RCTs) relating to the treatment of PG. Since this time, one small RCT has been published comparing infliximab to placebo, but none of the commonly used systemic treatments for PG have been formally assessed. The UK Dermatology Clinical Trials Network’s STOP GAP Trial has been designed to address this lack of trial evidence. Methods The objective is to assess whether oral ciclosporin is more effective than oral prednisolone for the treatment of PG. The trial design is a two-arm, observer-blind, parallel-group, randomised controlled trial comparing ciclosporin (4 mg/kg/day) to prednisolone (0.75 mg/kg/day). A total of 140 participants are to be recruited over a period of 4 years, from up to 50 hospitals in the UK and Eire. Primary outcome of velocity of healing at 6 weeks is assessed blinded to treatment allocation (using digital images of the ulcers). Secondary outcomes include: (i) time to healing; (ii) global assessment of improvement; (iii) PG inflammation assessment scale score; (iv) self-reported pain; (v) health-related quality of life; (vi) time to recurrence; (vii) treatment failures; (viii) adverse reactions to study medications; and (ix) cost effectiveness/utility. Patients with a clinical diagnosis of PG (excluding granulomatous PG); measurable ulceration (that is, not pustular PG); and patients aged over 18 years old who are able to give informed consent are included in the trial. Randomisation is by computer generated code using permuted blocks of randomly varying size, stratified by

  12. Comparing Breast Screening Protocols: Inserting Catch Trials Does Not Improve Sensitivity over Double Screening

    PubMed Central

    Howe, Piers D. L.

    2016-01-01

    Breast screening is an important tool for the early detection of breast cancers. However, tumours are typically present in less than 1% of mammograms. This low prevalence could cause radiologists to detect fewer tumours than they otherwise would, an issue known as the prevalence effect. The aim of our study was to investigate a novel breast screening protocol, designed to decrease the number of tumours missed by radiologists, without increasing their workload. We ran two laboratory-based experiments to assess the degree to which the novel protocol, called the catch trial (CT) protocol, resulted in greater sensitivity (d’) than the double screener protocol (DS), currently utilised in Australia. In our first experiment we found evidence that the CT protocol resulted in a criterion shift relative to the DS protocol but the evidence that sensitivity was greater in the CT protocol relative to the DS protocol was less clear. A second experiment, using more realistic stimuli that were more representative of actual tumours, also failed to find convincing evidence that sensitivity was greater in the CT protocol than in the DS protocol. This experiment instead found that both the hit rate and the false alarm rate increased in the CT protocol relative to the DS protocol. So while there was again evidence that the CT protocol induced a criterion shift, the sensitivity appeared to be approximately the same in both protocols. Our results suggest the CT protocol is unlikely to result in an improvement in sensitivity over the DS protocol, so we cannot recommend that it be trialled in a clinical setting. PMID:27723788

  13. Bedside charting of pain levels in hospitalized patients with cancer: a randomized controlled trial.

    PubMed

    Kravitz, R L; Delafield, J P; Hays, R D; Drazin, R; Conolly, M

    1996-02-01

    Despite advances in the technology of cancer pain assessment and control, cancer pain often remains undertreated even in hospital settings. To determine whether a graphical display of cancer patients' pain levels might improve their treatment, the investigators conducted a randomized controlled trial. Patients assigned to the intervention group (N = 40) had periodic pain assessments by study staff, who graphically recorded their reported pain-intensity levels on bedside wall charts. Control group patients (N = 38) had periodic pain assessments by study staff but did not have this information displayed. The results failed to show a significant beneficial effect of the intervention on pain control, sleep, cancer-related symptoms, or analgesic dosing, but confidence intervals were broad. More research is needed to improve the quality of care for inpatients with cancer-related pain. PMID:8907138

  14. Randomized trial of group cognitive behavioral therapy compared with a pain education control for low-literacy rural people with chronic pain.

    PubMed

    Thorn, Beverly E; Day, Melissa A; Burns, John; Kuhajda, Melissa C; Gaskins, Susan W; Sweeney, Kelly; McConley, Regina; Ward, L Charles; Cabbil, Chalanda

    2011-12-01

    Chronic pain is a common and costly experience. Cognitive behavioral therapies (CBT) are efficacious for an array of chronic pain conditions. However, the literature is based primarily on urban (white) samples. It is unknown whether CBT works in low-socioeconomic status (SES) minority and nonminority groups. To address this question, we conducted a randomized controlled trial within a low-SES, rural chronic pain population. Specifically, we examined the feasibility, tolerability, acceptability, and efficacy of group CBT compared with a group education intervention (EDU). We hypothesized that although both interventions would elicit short- and long-term improvement across pain-related outcomes, the cognitively-focused CBT protocol would uniquely influence pain catastrophizing. Mixed design analyses of variance were conducted on the sample of eligible participants who did not commence treatment (N=26), the intention-to-treat sample (ITT; N=83), and the completer sample (N=61). Factors associated with treatment completion were examined. Results indicated significantly more drop-outs occurred in CBT. ITT analyses showed that participants in both conditions reported significant improvement across pain-related outcomes, and a nonsignificant trend was found for depressed mood to improve more in CBT than EDU. Results of the completer analyses produced a similar pattern of findings; however, CBT produced greater gains on cognitive and affect variables than EDU. Treatment gains were maintained at 6-month follow-up (N=54). Clinical significance of the findings and the number of treatment responders is reported. Overall, these findings indicate that CBT and EDU are viable treatment options in low-SES minority and nonminority groups. Further research should target disseminating and sustaining psychosocial treatment options within underserved populations.

  15. Incidence and Predictive Factors of Pain Flare After Spine Stereotactic Body Radiation Therapy: Secondary Analysis of Phase 1/2 Trials

    SciTech Connect

    Pan, Hubert Y.; Allen, Pamela K.; Wang, Xin S.; Chang, Eric L.; Rhines, Laurence D.; Tatsui, Claudio E.; Amini, Behrang; Wang, Xin A.; Tannir, Nizar M.; Brown, Paul D.; Ghia, Amol J.

    2014-11-15

    Purpose/Objective(s): To perform a secondary analysis of institutional prospective spine stereotactic body radiation therapy (SBRT) trials to investigate posttreatment acute pain flare. Methods and Materials: Medical records for enrolled patients were reviewed. Study protocol included baseline and follow-up surveys with pain assessment by Brief Pain Inventory and documentation of pain medications. Patients were considered evaluable for pain flare if clinical note or follow-up survey was completed within 2 weeks of SBRT. Pain flare was defined as a clinical note indicating increased pain at the treated site or survey showing a 2-point increase in worst pain score, a 25% increase in analgesic intake, or the initiation of steroids. Binary logistic regression was used to determine predictive factors for pain flare occurrence. Results: Of the 210 enrolled patients, 195 (93%) were evaluable for pain flare, including 172 (88%) clinically, 135 (69%) by survey, and 112 (57%) by both methods. Of evaluable patients, 61 (31%) had undergone prior surgery, 57 (29%) had received prior radiation, and 34 (17%) took steroids during treatment, mostly for prior conditions. Pain flare was observed in 44 patients (23%). Median time to pain flare was 5 days (range, 0-20 days) after the start of treatment. On multivariate analysis, the only independent factor associated with pain flare was the number of treatment fractions (odds ratio = 0.66, P=.004). Age, sex, performance status, spine location, number of treated vertebrae, prior radiation, prior surgery, primary tumor histology, baseline pain score, and steroid use were not significant. Conclusions: Acute pain flare after spine SBRT is a relatively common event, for which patients should be counseled. Additional study is needed to determine whether prophylactic or symptomatic intervention is preferred.

  16. Pain education in pre-registration professional health courses: a protocol for a scoping review

    PubMed Central

    Thompson, Kate; Milligan, James; Johnson, Mark I; Briggs, Michelle

    2016-01-01

    Introduction Pain is a global health concern causing significant health and social problems with evidence that patients experiencing pain are receiving inadequate care. The content of pain education in pre-registration professional health courses is thought to be lacking both in the UK and internationally which is unacceptable considering the prevalence of pain. Evaluating the effect of education is complex in that the outcome (improved healthcare) is some distance from the educational approach. Best evidence medical education has been proposed as a continuum between ‘opinion-based teaching’ and ‘evidence-based teaching’. Searching for evidence to inform best practice in health education is complex. A scoping review provides a practical and comprehensive strategy to locate and synthesise literature of varied methodology including reports from a variety of sources. The aim of this article is to describe a protocol for a scoping review that will locate, map and report research, guidelines and policies for pain education in pre-registration professional health courses. The extent, range and nature of reports will be examined, and where possible titles for potential systematic review will be identified. Methods and analysis Reports will be included for review that are directly relevant to the development of the pain curriculum in pre-registration professional health courses, eg nursing, medicine, physiotherapy. The search strategy will identify reports that include [pain] AND [pre-registration education or curriculum] AND [health professionals] in the title or abstract. Two authors will independently screen retrieved studies against eligibility criteria. A numerical analysis regarding the extent, nature and distribution of reports will be given along with a narrative synthesis to describe characteristics of relevant reports. Ethics and dissemination Formal ethical approval was not required to undertake this scoping review. Findings will be published in

  17. Acupuncture for postoperative pain in laparoscopic surgery: a systematic review protocol

    PubMed Central

    Lee, Seunghoon; Park, Jimin; Kim, Jihye; Kang, Jung Won; Choi, Do-Young; Park, Sun Jin; Nam, Dongwoo; Lee, Jae-Dong

    2014-01-01

    Introduction This review aims to evaluate the effectiveness and safety of acupuncture for patients with postoperative pain after laparoscopic surgery. Methods and analysis We will search the following databases from their inception to October 2014: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Allied and Complementary Medicine Database (AMED), three Chinese databases (China National Knowledge Infrastructure (CNKI), the Chongqing VIP Chinese Science and Technology Periodical Database (VIP) and the Wanfang database), one Japanese database (Japan Science and Technology Information Aggregator, Electronic (J-STAGE)) and eight Korean databases (Korean Association of Medical Journal Edition, Korean Medical Database, Korean Studies Information Service System, National Discovery for Science Leaders, Database Periodical Information Academic, Korean National Assembly Digital Library, Oriental Medicine Advanced Searching Integrated System and Korean Traditional Knowledge Portal). All randomised controlled trials of acupuncture for postoperative pain after laparoscopic surgery will be considered for inclusion. The risk of bias and reporting quality will be assessed using the Cochrane risk of bias tool, the Consolidated Standards of Reporting Trials (CONSORT) and the revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA). The risk ratio for dichotomous data and mean difference or standard mean difference for continuous data will be calculated with 95% CIs. Dissemination The results of this review will be disseminated through peer-reviewed publication or conference presentation. Our findings will summarise the current evidence of acupuncture to treat postoperative pain after laparoscopic surgery, and may provide important guidance for acupuncture usage after laparoscopic surgery for clinicians and patients. Trial registration number

  18. Effects of yoga on chronic neck pain: a systematic review of randomized controlled trials

    PubMed Central

    Kim, Sang-Dol

    2016-01-01

    [Purpose] The aim of this study was to investigate the effectiveness of yoga in the management of chronic neck pain. [Subjects and Methods] Five electronic databases were searched to identify randomized controlled trials (RCTs) of yoga intervention on chronic neck pain. The trials were published in the English language between January 1966 and December 2015. The Cochrane Risk of Bias Tool was used to assess the quality of the trials. [Results] Three trials were identified and included in this review. A critical appraisal was performed on the trials, and the result indicated a high risk of bias. A narrative description was processed because of the small number of RCTs. Neck pain intensity and functional disability were significantly lower in the yoga groups than in the control groups. [Conclusion] Evidence from the 3 randomly controlled trials shows that yoga may be beneficial for chronic neck pain. The low-quality result of the critical appraisal and the small number of trials suggest that high-quality RCTs are required to examine further the effects of yoga intervention on chronic neck pain relief. PMID:27512290

  19. Effects of yoga on chronic neck pain: a systematic review of randomized controlled trials.

    PubMed

    Kim, Sang-Dol

    2016-07-01

    [Purpose] The aim of this study was to investigate the effectiveness of yoga in the management of chronic neck pain. [Subjects and Methods] Five electronic databases were searched to identify randomized controlled trials (RCTs) of yoga intervention on chronic neck pain. The trials were published in the English language between January 1966 and December 2015. The Cochrane Risk of Bias Tool was used to assess the quality of the trials. [Results] Three trials were identified and included in this review. A critical appraisal was performed on the trials, and the result indicated a high risk of bias. A narrative description was processed because of the small number of RCTs. Neck pain intensity and functional disability were significantly lower in the yoga groups than in the control groups. [Conclusion] Evidence from the 3 randomly controlled trials shows that yoga may be beneficial for chronic neck pain. The low-quality result of the critical appraisal and the small number of trials suggest that high-quality RCTs are required to examine further the effects of yoga intervention on chronic neck pain relief. PMID:27512290

  20. Reporting quality of stepped wedge design randomized trials: a systematic review protocol

    PubMed Central

    Thabane, Alex; Dennis, Brittany B; Gajic-Veljanoski, Olga; Paul, James; Thabane, Lehana

    2016-01-01

    Background Stepped wedge design (SWD) is a cluster randomized controlled trial (RCT) design that sequentially rolls out intervention to all clusters at varying time points. Being a relatively new design method, reporting quality has yet to be explored, and this review will seek to fill this gap in knowledge. Objectives The objectives of this review are: 1) to assess the quality of SWD trial reports based on the CONSORT guidelines or CONSORT extension to cluster RCTs; 2) to assess the completeness of reporting of SWD trial abstracts using the CONSORT extension for abstracts; 3) to assess the reporting of sample size details in SWD trial reports or protocols; 4) to assess the completeness of reporting of SWD trial protocols according to SPIRIT guidelines; 5) to assess the consistency between the trial registration information and final SWD trial reports; and 6) to assess the consistency of what is reported in the abstracts and main text of the SWD trial reports. We will also explore factors that are associated with the completeness of reporting. Methods We will search MEDLINE, EMBASE, Web of Science, CINAHL, and PsycINFO for all randomized controlled trials utilizing SWD. Details from eligible papers will be extracted in duplicate. Demographic statistics obtained from the data extraction will be analyzed to answer the primary objectives pertaining to the reporting quality of several aspects of a published paper, as well as to explore possible temporal trends and consistency between abstracts, trial registration information, and final published articles. Discussion Findings from this review will establish the reporting quality of SWD trials and inform academics and clinicians on their completeness and consistency. Results of this review will influence future trials and improve the overall quality and reporting of SWD trials. PMID:27468249

  1. Acupoint Application in Patients with Chronic Stable Angina Pectoris: Study Protocol of a Randomized, Double-Blind, Controlled Trial

    PubMed Central

    Ren, Yulan; Li, Dehua; Lv, Junling; Leng, Junyan; Zhang, Linglin; Zhang, Jie; Fan, Hailong; Liang, Fanrong

    2014-01-01

    Background. Chronic stable angina pectoris (CSAP) is a major syndrome of ischemic heart disease (IHD). CSAP manifests as chest pain or discomfort and affects patients' quality of life. Acupoint application (AP) has been reported to be effective for managing the symptoms of CSAP, but the evidence is not convincing. Therefore, we designed a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy of AP in the treatment of CSAP. Methods and Analysis. Two hundred participants with CSAP will be randomly assigned in a 1 : 1 : 1 : 1 ratio into 4 groups. All participants will receive 12 sessions of treatment in 4 weeks and the same basic treatment procedure. The participants will be visited and assessed for 12 weeks, including a 4-week screening, a 4-week treatment phase, and a 4-week follow-up phase. The primary outcome is the change in the total frequency of self-reported angina attack at 4th week compared with the baseline. The secondary outcomes include the intensity of angina pain, consumption of nitroglycerin or Suxiao Jiuxin pills, CCS angina classification, SAQ, SAS and SDS score. Ethics. The study protocol has been reviewed and approved by the Sichuan Regional Ethics Review Committee on TCM (number 2013kl-001). This trial is registered with clinicaltrials.gov NCT02029118. PMID:25250055

  2. Acupoint application in patients with chronic stable angina pectoris: study protocol of a randomized, double-blind, controlled trial.

    PubMed

    Ren, Yulan; Li, Dehua; Zheng, Hui; Lv, Junling; Leng, Junyan; Zhang, Linglin; Zhang, Jie; Fan, Hailong; Liang, Fanrong

    2014-01-01

    Background. Chronic stable angina pectoris (CSAP) is a major syndrome of ischemic heart disease (IHD). CSAP manifests as chest pain or discomfort and affects patients' quality of life. Acupoint application (AP) has been reported to be effective for managing the symptoms of CSAP, but the evidence is not convincing. Therefore, we designed a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy of AP in the treatment of CSAP. Methods and Analysis. Two hundred participants with CSAP will be randomly assigned in a 1 : 1 : 1 : 1 ratio into 4 groups. All participants will receive 12 sessions of treatment in 4 weeks and the same basic treatment procedure. The participants will be visited and assessed for 12 weeks, including a 4-week screening, a 4-week treatment phase, and a 4-week follow-up phase. The primary outcome is the change in the total frequency of self-reported angina attack at 4th week compared with the baseline. The secondary outcomes include the intensity of angina pain, consumption of nitroglycerin or Suxiao Jiuxin pills, CCS angina classification, SAQ, SAS and SDS score. Ethics. The study protocol has been reviewed and approved by the Sichuan Regional Ethics Review Committee on TCM (number 2013kl-001). This trial is registered with clinicaltrials.gov NCT02029118. PMID:25250055

  3. Access to Medications and Medical Care After Participation in HIV Clinical Trials: A Systematic Review of Trial Protocols and Informed Consent Documents

    PubMed Central

    Ciaranello, Andrea L.; Walensky, Rochelle P.; Sax, Paul E.; Chang, Yuchiao; Freedberg, Kenneth A.; Weissman, Joel S.

    2009-01-01

    Background Expectations regarding receipt of medications and medical care after clinical trials conclude may inform decisions about trial participation. We describe the frequency with which these posttrial services are described in the protocols and informed consent forms (ICFs) of antiretroviral drug (ARV) trials. Method We systematically reviewed protocols and ICFs from Phase 3 and 4 antiretroviral trials in adults (≥12 years) from 1987 to 2006. Pharmaceutical industry-sponsored trials were selected from US Food and Drug Administration (FDA) documentation and Clinicaltrials.gov. Trials administered by the AIDS Clinical Trials Group (ACTG) were selected from the ACTG online registry. ACTG- and industry-provided protocols and ICFs were reviewed in full. The primary outcome was any mention of posttrial services, defined as any text regarding posttrial medications or medical care. Results Complete trial documents were available for 31 (48%) of 65 trials meeting inclusion criteria. Documents from 14 trials (45%) mentioned any posttrial service: 12 (39%) mentioned medications, and 5 (16%) mentioned medical care. Payment for trial participation (74%) and for care for trial-related injury (94%) were mentioned more often than were posttrial services. Conclusions Posttrial medications or medical care was mentioned in the trial documents of <50% of reviewed antiretroviral trials. Improved efforts are needed to clearly describe posttrial services in clinical trial protocols and ICFs. and ICFs. PMID:19362992

  4. Effectiveness of Self-Hypnosis on the Relief of Experimental Dental Pain: A Randomized Trial.

    PubMed

    Wolf, Thomas Gerhard; Wolf, Dominik; Below, Dagna; d'Hoedt, Bernd; Willershausen, Brita; Daubländer, Monika

    2016-01-01

    This randomized, controlled clinical trial evaluates the effectiveness of self-hypnosis on pain perception. Pain thresholds were measured, and a targeted, standardized pain stimulus was created by electrical stimulation of the dental pulp of an upper anterior tooth. Pain stimulus was rated by a visual analogue scale (VAS). The pain threshold under self-hypnosis was higher (57.1 ± 17.1) than without hypnotic intervention (39.5 ± 11.8) (p < .001). Pain was rated lower on the VAS with self-hypnosis (4.0 ± 3.8) than in the basal condition without self-hypnosis (7.1 ± 2.7) (p < .001). Self-hypnosis can be used in clinical practice as an adjunct to the gold standard of local anesthesia for pain management, as well as an alternative in individual cases. PMID:26894422

  5. Personalised Hip Therapy: development of a non-operative protocol to treat femoroacetabular impingement syndrome in the FASHIoN randomised controlled trial

    PubMed Central

    Wall, Peter DH; Dickenson, Edward J; Robinson, David; Hughes, Ivor; Realpe, Alba; Hobson, Rachel; Griffin, Damian R; Foster, Nadine E

    2016-01-01

    Introduction Femoroacetabular impingement (FAI) syndrome is increasingly recognised as a cause of hip pain. As part of the design of a randomised controlled trial (RCT) of arthroscopic surgery for FAI syndrome, we developed a protocol for non-operative care and evaluated its feasibility. Methods In phase one, we developed a protocol for non-operative care for FAI in the UK National Health Service (NHS), through a process of systematic review and consensus gathering. In phase two, the protocol was tested in an internal pilot RCT for protocol adherence and adverse events. Results The final protocol, called Personalised Hip Therapy (PHT), consists of four core components led by physiotherapists: detailed patient assessment, education and advice, help with pain relief and an exercise-based programme that is individualised, supervised and progressed over time. PHT is delivered over 12–26 weeks in 6–10 physiotherapist-patient contacts, supplemented by a home exercise programme. In the pilot RCT, 42 patients were recruited and 21 randomised to PHT. Review of treatment case report forms, completed by physiotherapists, showed that 13 patients (62%) received treatment that had closely followed the PHT protocol. 13 patients reported some muscle soreness at 6 weeks, but there were no serious adverse events. Conclusion PHT provides a structure for the non-operative care of FAI and offers guidance to clinicians and researchers in an evolving area with limited evidence. PHT was deliverable within the National Health Service, is safe, and now forms the comparator to arthroscopic surgery in the UK FASHIoN trial (ISRCTN64081839). Trial registration number ISRCTN 09754699. PMID:27629405

  6. Effectiveness of phototherapy incorporated into an exercise program for osteoarthritis of the knee: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Osteoarthritis is a chronic disease with a multifactor etiology involving changes in bone alignment, cartilage, and other structures necessary to joint stability. There is a need to investigate therapeutic resources that combine different wavelengths as well as different light sources (low-level laser therapy and light-emitting diode therapy) in the same apparatus for the treatment of osteoarthritis. The aim of the proposed study is to analyze the effect of the incorporation of phototherapy into a therapeutic exercise program for individuals with osteoarthritis of the knee. Methods/Design A double-blind, controlled, randomized clinical trial will be conducted involving patients with osteoarthritis of the knee. Evaluations will be performed using functional questionnaires before and after the treatment protocols, in a reserved room with only the evaluator and participant present, and no time constraints placed on the answers or evaluations. The following functional tests will also be performed: stabilometry (balance assessment), dynamometry (muscle strength of gluteus medius and quadriceps), algometry (pain threshold), fleximeter (range of motion), timed up-and-go test (functional mobility), and the functional reach test. The participants will then be allocated to three groups through a randomization process using opaque envelopes: exercise program, exercise program + phototherapy, or exercise program + placebo phototherapy, all of which will last for eight weeks. Discussion The purpose of this randomized clinical trial is to analyze the effect of the incorporation of phototherapy into a therapeutic exercise program for osteoarthritis of the knee. The study will support the practice based on evidence to the use of phototherapy in individuals with a diagnosis of osteoarthritis of the knee. Data will be published after the study is completed. Trial registration The protocol for this study has been submitted to Clinical Trials, registration number

  7. Surgical Trial in Lobar Intracerebral Haemorrhage (STICH II) Protocol

    PubMed Central

    2011-01-01

    Background Within the spectrum of spontaneous intracerebral haemorrhage there are some patients with large or space occupying haemorrhage who require surgery for neurological deterioration and others with small haematomas who should be managed conservatively. There is equipoise about the management of patients between these two extremes. In particular there is some evidence that patients with lobar haematomas and no intraventricular haemorrhage might benefit from haematoma evacuation. The STICH II study will establish whether a policy of earlier surgical evacuation of the haematoma in selected patients will improve outcome compared to a policy of initial conservative treatment. Methods/Design an international multicentre randomised parallel group trial. Only patients for whom the treating neurosurgeon is in equipoise about the benefits of early craniotomy compared to initial conservative treatment are eligible. All patients must have a CT scan confirming spontaneous lobar intracerebral haemorrhage (≤1 cm from the cortex surface of the brain and 10-100 ml in volume). Any clotting or coagulation problems must be corrected and randomisation must take place within 48 hours of ictus. With 600 patients, the study will be able to demonstrate a 12% benefit from surgery (2p < 0.05) with 80% power. Stratified randomisation is undertaken using a central 24 hour randomisation service accessed by telephone or web. Patients randomised to early surgery should have the operation within 12 hours. Information about the status (Glasgow Coma Score and focal signs) of all patients through the first five days of their trial progress is also collected in addition to another CT scan at about five days (+/- 2 days). Outcome is measured at six months via a postal questionnaire to the patient. Primary outcome is death or severe disability defined using a prognosis based 8 point Glasgow Outcome Scale. Secondary outcomes include: Mortality, Rankin, Barthel, EuroQol, and Survival. Trial

  8. Measuring practitioner/therapist effects in randomised trials of low back pain and neck pain interventions in primary care settings.

    PubMed

    Lewis, Martyn; Morley, Stephen; van der Windt, Danielle A W M; Hay, Elaine; Jellema, Petra; Dziedzic, Krysia; Main, Chris J

    2010-11-01

    In psychological health treatment studies it has been shown that differences between therapists account for some of the non-specific effect of treatment but this phenomenon has not so far systematically been investigated in musculoskeletal disorders. In this study we evaluated and compared the size and potential influence of the 'practitioner effect' (or 'therapist effect') in three randomised treatment trials of low back pain and neck pain patients in primary care. We calculated the proportion of variance in outcomes attributable to differences across practitioners, i.e. the practitioner-variance partition coefficient (p-vpc). As measures of outcome, we focused on self-reported disability as the primary outcome, but we also investigated assessed psychological outcomes. The p-vpc for the disability measures ranged from 2.6% to 7.1% across trials and time points (post treatment and follow up). Estimates differed between treatment subgroups within trials; being highest in treatment subgroups assigned to psychosocial-based interventions. A 'practitioner effect' does exist and is more pronounced in treatments involving greater psychosocial emphasis. This has implications for both practice and research in this clinical area. It highlights the importance of patient-practitioner interactions, and the need to address practitioner effects in designing and analysing outcome studies in low back pain and neck pain in primary care.

  9. Chronic pain self-management for older adults: a randomized controlled trial [ISRCTN11899548

    PubMed Central

    Ersek, Mary; Turner, Judith A; Cain, Kevin C; Kemp, Carol A

    2004-01-01

    Background Chronic pain is a common and frequently disabling problem in older adults. Clinical guidelines emphasize the need to use multimodal therapies to manage persistent pain in this population. Pain self-management training is a multimodal therapy that has been found to be effective in young to middle-aged adult samples. This training includes education about pain as well as instruction and practice in several management techniques, including relaxation, physical exercise, modification of negative thoughts, and goal setting. Few studies have examined the effectiveness of this therapy in older adult samples. Methods/Design This is a randomized, controlled trial to assess the effectiveness of a pain self-management training group intervention, as compared with an education-only control condition. Participants are recruited from retirement communities in the Pacific Northwest of the United States and must be 65 years or older and experience persistent, noncancer pain that limits their activities. The primary outcome is physical disability, as measured by the Roland-Morris Disability Questionnaire. Secondary outcomes are depression (Geriatric Depression Scale), pain intensity (Brief Pain Inventory), and pain-related interference with activities (Brief Pain Inventory). Randomization occurs by facility to minimize cross-contamination between groups. The target sample size is 273 enrolled, which assuming a 20% attrition rate at 12 months, will provide us with 84% power to detect a moderate effect size of .50 for the primary outcome. Discussion Few studies have investigated the effects of multimodal pain self-management training among older adults. This randomized controlled trial is designed to assess the efficacy of a pain self-management program that incorporates physical and psychosocial pain coping skills among adults in the mid-old to old-old range. PMID:15285783

  10. Effects of Massage Therapy and Occlusal Splint Usage on Quality of Life and Pain in Individuals with Sleep Bruxism: A Randomized Controlled Trial

    PubMed Central

    Gomes, Cid Andre Fidelis de Paula; El-Hage, Yasmin; Amaral, Ana Paula; Herpich, Carolina Marciela; Politti, Fabiano; Kalil-Bussadori, Sandra; Gonzalez, Tabajara de Oliveira; Biasotto-Gonzalez, Daniela Aparecida

    2015-01-01

    Purpose: The aim of the present study was to investigate the effects of massage therapy on the masticatory muscles and occlusal splint usage on quality of life and pain in individuals with sleep bruxism. Method: A randomized, controlled, blinded, clinical trial was conducted involving 78 volunteers aged 18 to 40 years with sleep bruxism. Quality of life and pain assessments were performed. Results: Significant differences (p < 0.05) were found on the physical functioning, general health state, vitality, role emotional and mental health subscales. A large effect size was found for all treatment protocols with regard to pain. The largest effect was found in the combined treatment group. Conclusions: The findings of the present study reveal that the occlusal splint usage alone led to improvements in components of quality of life among individuals with sleep bruxism. Moreover, both treatments (occlusal splint usage and massage therapy on the masticatory muscles) led to a reduction in pain. PMID:26733760

  11. The relationship between Clinical Trial Network protocol involvement and quality of substance use disorder (SUD) treatment

    PubMed Central

    Abraham, Amanda J.; Knudsen, Hannah K.; Roman, Paul M.

    2013-01-01

    The National Institute on Drug Abuse’s Clinical Trials Network (CTN) is a practice-based research network that partners academic researchers with community based substance use disorder (SUD) treatment programs designed primarily to conduct effectiveness trials of promising interventions. A secondary goal of the CTN is to widely disseminate results of these trials and thus improve the quality of SUD treatment in the US. Drawing on data from 156 CTN programs, this study examines the association between involvement in CTN protocols and overall treatment quality measured by a comprehensive index of 35 treatment services. Negative binomial regression models show that treatment programs that participated in a greater number of CTN protocols had significantly higher levels of treatment quality, an association that held after controlling for key organizational characteristics. These findings contribute to the growing body of research on the role of practice-based research networks in promoting health care quality. PMID:24080073

  12. Targeting Temporomandibular Disorder Pain Treatment to Hormonal Fluctuations: A Randomized Clinical Trial

    PubMed Central

    Turner, Judith A.; Mancl, Lloyd; Huggins, Kimberly Hanson; Sherman, Jeffrey J.; Lentz, Gretchen; LeResche, Linda

    2011-01-01

    Mounting evidence supports the importance of hormonal fluctuations in temporomandibular disorder (TMD) pain among women. Stabilizing influential hormones or having a plan and skills for coping with hormonally-related increases in TMD pain therefore may be beneficial for women with TMD pain. This randomized clinical trial evaluated the short- and long-term efficacy of three interventions for women with TMD pain: (1) dental hygienist-delivered pain self-management training (SMT; n = 59); (2) the same dental hygienist-delivered pain self-management training, but with a focus on menstrual cycle-related changes in pain and other symptoms (targeted SMT, or TSMT; n = 55); and (3) continuous oral contraceptive therapy (6 month trial), aimed at stabilizing hormones believed to be influential in TMD pain (COCT; n = 57). Study participants completed outcome (pain, activity interference, depression) and process (pain beliefs, catastrophizing, coping effectiveness) measures before randomization, and 6 and 12 months later. Intent-to-treat analyses supported the benefits of the SMT and TSMT interventions relative to COCT. Targeting the self-management treatment to menstrual cycle-related symptoms did not increase the treatment’s efficacy. The benefits of the self-management interventions relative to COCT for pain and activity interference were statistically significant at 12 months, but not at 6 months, whereas the benefits for the process measures generally were apparent at both timepoints. COCT was associated with multiple adverse events (none serious). The study provides further support for long-term benefits of a safe, low intensity (two in-person sessions and six brief telephone contacts), dental hygienist-delivered self-management treatment for TMD pain. PMID:21680092

  13. Smoked medicinal cannabis for neuropathic pain in HIV: a randomized, crossover clinical trial.

    PubMed

    Ellis, Ronald J; Toperoff, Will; Vaida, Florin; van den Brande, Geoffrey; Gonzales, James; Gouaux, Ben; Bentley, Heather; Atkinson, J Hampton

    2009-02-01

    Despite management with opioids and other pain modifying therapies, neuropathic pain continues to reduce the quality of life and daily functioning in HIV-infected individuals. Cannabinoid receptors in the central and peripheral nervous systems have been shown to modulate pain perception. We conducted a clinical trial to assess the impact of smoked cannabis on neuropathic pain in HIV. This was a phase II, double-blind, placebo-controlled, crossover trial of analgesia with smoked cannabis in HIV-associated distal sensory predominant polyneuropathy (DSPN). Eligible subjects had neuropathic pain refractory to at least two previous analgesic classes; they continued on their prestudy analgesic regimens throughout the trial. Regulatory considerations dictated that subjects smoke under direct observation in a hospital setting. Treatments were placebo and active cannabis ranging in potency between 1 and 8% Delta-9-tetrahydrocannabinol, four times daily for 5 consecutive days during each of 2 treatment weeks, separated by a 2-week washout. The primary outcome was change in pain intensity as measured by the Descriptor Differential Scale (DDS) from a pretreatment baseline to the end of each treatment week. Secondary measures included assessments of mood and daily functioning. Of 127 volunteers screened, 34 eligible subjects enrolled and 28 completed both cannabis and placebo treatments. Among the completers, pain relief was greater with cannabis than placebo (median difference in DDS pain intensity change, 3.3 points, effect size=0.60; p=0.016). The proportions of subjects achieving at least 30% pain relief with cannabis versus placebo were 0.46 (95%CI 0.28, 0.65) and 0.18 (0.03, 0.32). Mood and daily functioning improved to a similar extent during both treatment periods. Although most side effects were mild and self-limited, two subjects experienced treatment-limiting toxicities. Smoked cannabis was generally well tolerated and effective when added to concomitant analgesic

  14. Smoked medicinal cannabis for neuropathic pain in HIV: a randomized, crossover clinical trial.

    PubMed

    Ellis, Ronald J; Toperoff, Will; Vaida, Florin; van den Brande, Geoffrey; Gonzales, James; Gouaux, Ben; Bentley, Heather; Atkinson, J Hampton

    2009-02-01

    Despite management with opioids and other pain modifying therapies, neuropathic pain continues to reduce the quality of life and daily functioning in HIV-infected individuals. Cannabinoid receptors in the central and peripheral nervous systems have been shown to modulate pain perception. We conducted a clinical trial to assess the impact of smoked cannabis on neuropathic pain in HIV. This was a phase II, double-blind, placebo-controlled, crossover trial of analgesia with smoked cannabis in HIV-associated distal sensory predominant polyneuropathy (DSPN). Eligible subjects had neuropathic pain refractory to at least two previous analgesic classes; they continued on their prestudy analgesic regimens throughout the trial. Regulatory considerations dictated that subjects smoke under direct observation in a hospital setting. Treatments were placebo and active cannabis ranging in potency between 1 and 8% Delta-9-tetrahydrocannabinol, four times daily for 5 consecutive days during each of 2 treatment weeks, separated by a 2-week washout. The primary outcome was change in pain intensity as measured by the Descriptor Differential Scale (DDS) from a pretreatment baseline to the end of each treatment week. Secondary measures included assessments of mood and daily functioning. Of 127 volunteers screened, 34 eligible subjects enrolled and 28 completed both cannabis and placebo treatments. Among the completers, pain relief was greater with cannabis than placebo (median difference in DDS pain intensity change, 3.3 points, effect size=0.60; p=0.016). The proportions of subjects achieving at least 30% pain relief with cannabis versus placebo were 0.46 (95%CI 0.28, 0.65) and 0.18 (0.03, 0.32). Mood and daily functioning improved to a similar extent during both treatment periods. Although most side effects were mild and self-limited, two subjects experienced treatment-limiting toxicities. Smoked cannabis was generally well tolerated and effective when added to concomitant analgesic

  15. Radiofrequency ablation for chronic low back pain: A systematic review of randomized controlled trials

    PubMed Central

    Leggett, Laura E; Soril, Lesley JJ; Lorenzetti, Diane L; Noseworthy, Tom; Steadman, Rodney; Tiwana, Simrandeep; Clement, Fiona

    2014-01-01

    BACKGROUND: Radiofrequency ablation (RFA), a procedure using heat to interrupt pain signals in spinal nerves, is an emerging treatment option for chronic low back pain. Its clinical efficacy has not yet been established. OBJECTIVE: To determine the efficacy of RFA for chronic low back pain associated with lumbar facet joints, sacroiliac joints, discogenic low back pain and the coccyx. METHODS: A systematic review was conducted. Medline, EMBASE, PubMed, SPORTDiscus, CINAHL and the Cochrane Library were searched up to August 2013. Abstracts and full-text articles were reviewed in duplicate. Included articles were sham-controlled randomized controlled trials (RCTs), assessed the efficacy of RFA, reported at least one month of follow-up and included participants who had experienced back pain for at least three months. Data were extracted in duplicate and quality was assessed using the Cochrane Risk of Bias tool. Due to heterogeneity, as well as a lack of reported mean differences and SDs, meta-analysis was not possible using these data. RESULTS: The present systematic review retrieved 1063 abstracts. Eleven sham-controlled RCTs were included: three studies involving discogenic back pain; six studies involving lumbar facet joint pain; and two studies involving sacroiliac joint pain. No studies were identified assessing the coccyx. The evidence supports RFA as an efficacious treatment for lumbar facet joint and sacroiliac joint pain, with five of six and both of the RCTs demonstrating statistically significant pain reductions, respectively. The evidence supporting RFA for the treatment of discogenic pain is mixed. CONCLUSIONS: While the majority of the studies focusing on lumbar facet joints and sacroiliac joints suggest that RFA significantly reduces pain in short-term follow-up, the evidence base for discogenic low back pain is mixed. There is no RCT evidence for RFA for the coccyx. Future studies should examine the clinical significance of the achieved pain reduction

  16. Influence of three Ni–Ti cleaning and shaping files on postinstrumentation endodontic pain: A triple-blinded, randomized, controlled trial

    PubMed Central

    Krithikadatta, Jogikalmat; Sekar, Vadhana; Sudharsan, Paramanantham; Velumurugan, Natanasabapathy

    2016-01-01

    Aim: This randomized, controlled trial evaluated the incidence of postinstrumentation pain on using two different rotary Ni–Ti and one reciprocating Ni–Ti cleaning and shaping systems. Materials and Methods: Asfter sample size estimation, a total of 152 patients were randomized to three groups (Group WO [WaveOne], Group PU [ProTaper Universal], and Group Mt [Mtwo]). Selection of patients was based on root curvature, periapical lesion, vitality, gender, and diagnosis of the patient. A similar clinical protocol was followed and endodontic treatment was performed. Pre- and post-instrumentation pain scores (2, 4, 6, 8, 12, 36, and 48 h) were recorded using visual analog scale score. Kruskal–Wallis test was done for overall comparison of the groups. Bonferroni-corrected Mann–Whitney test was done for pair-wise comparisons and Friedman test was done to compare pain between time points in each file system (P < 0.05). Results: All preinstrumentation pain values were higher than postinstrumentation pain values (P < 0.05). At 48 h, patients in Group WO experienced more pain compared to the other two groups. Pain scores of nonvital teeth were significantly higher when compared to vital teeth. Among nonvital teeth, patients in Group WO had early onset of pain at 6 h and lasted till 48 h, whereas pain started at 12 h and lasted till 36 and 48 h for Group Mt and Group PU, respectively. Conclusion: Patients treated with WaveOne files experienced more pain when compared to the other files. Nonvital teeth experienced more pain compared to vital teeth. Group Mt had the lowest postinstrumentation pain. PMID:27563177

  17. The Efficacy of Thermotherapy and Cryotherapy on Pain Relief in Patients with Acute Low Back Pain, A Clinical Trial Study

    PubMed Central

    Dehghan, Morteza

    2014-01-01

    Introduction: Acute low back pain is one of the most common health problems especially in industrialized countries where 75 per cent of the population develop it at least once during their life. This study examined the efficacy of thermotherapy and cryotherapy, alongside a routine pharmacologic treatment, on pain relief in patients with acute low back pain referring an orthopedic clinic in Shahrekord, Iran. Materials and Methods: This clinical trial study was conducted on 87 patients randomly assigned to three (thermotherapy and cryotherapy as intervention, and naproxen as control) groups of 29 each. The first (thermotherapy) group underwent treatment with hot water bag and naproxen, the second (cryotherapy) group was treated with ice and naproxen, and the naproxen group was only treated with naproxen, all for one week. All patients were examined on 0, 3rd, 8th, and 15th day after the first visit and the data gathered by McGill Pain Questionnaire. The data were analyzed by SPSS software using paired t-test, ANOVA, and chi-square. Results: In this study, mean age of the patients was 34.48 (20–50) years and 51.72 per cent were female. Thermotherapy patients reported significantly less pain compared to cryotherapy and control (p≤0.05). In thermotherapy and cryotherapy groups, mean pain in the first visit was 12.70±3.7 and 12.06±2.6, and on the 15th day after intervention 0.75±0.37 and 2.20±2.12, respectively. Conclusion: The results indicated that the application of thermo–therapy and cryotherapy accompanied with a pharmacologic treatment could relieve pain in the patients with acute low back pain. PMID:25386469

  18. Analyzing multiple endpoints in clinical trials of pain treatments: IMMPACT recommendations. Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials.

    PubMed

    Turk, Dennis C; Dworkin, Robert H; McDermott, Michael P; Bellamy, Nicholas; Burke, Laurie B; Chandler, Julie M; Cleeland, Charles S; Cowan, Penney; Dimitrova, Rozalina; Farrar, John T; Hertz, Sharon; Heyse, Joseph F; Iyengar, Smriti; Jadad, Alejandro R; Jay, Gary W; Jermano, John A; Katz, Nathaniel P; Manning, Donald C; Martin, Susan; Max, Mitchell B; McGrath, Patrick; McQuay, Henry J; Quessy, Steve; Rappaport, Bob A; Revicki, Dennis A; Rothman, Margaret; Stauffer, Joseph W; Svensson, Ola; White, Richard E; Witter, James

    2008-10-31

    The increasing complexity of randomized clinical trials and the practice of obtaining a wide variety of measurements from study participants have made the consideration of multiple endpoints a critically important issue in the design, analysis, and interpretation of clinical trials. Failure to consider important outcomes can limit the validity and utility of clinical trials; specifying multiple endpoints for the evaluation of treatment efficacy, however, can increase the rate of false positive conclusions about the efficacy of a treatment. We describe the use of multiple endpoints in the design, analysis, and interpretation of pain clinical trials, and review available strategies and methods for addressing multiplicity. To decrease the probability of a Type I error (i.e., the likelihood of obtaining statistically significant results by chance) in pain clinical trials, the use of gatekeeping procedures and other methods that correct for multiple analyses is recommended when a single primary endpoint does not adequately reflect the overall benefits of treatment. We emphasize the importance of specifying in advance the outcomes and clinical decision rule that will serve as the basis for determining that a treatment is efficacious and the methods that will be used to control the overall Type I error rate. PMID:18706763

  19. Lessons Learned From Nocebo Effects in Clinical Trials for Pain Conditions and Neurodegenerative Disorders.

    PubMed

    Amanzio, Martina; Palermo, Sara; Skyt, Ina; Vase, Lene

    2016-10-01

    It has been demonstrated that patients in the placebo arm of a clinical trial may experience adverse events (AEs), which may lead to nonadherence and dropout. However, so far, it is unknown to which extent this phenomenon is observed consistently across different diseases such as pain and neurodegenerative disorders.The current review shows for the first time that different diseases share a common risk for patients in terms of a negative outcome: a large percentage of placebo-treated patients experience AEs in pain conditions (up to 59%) and neurodegenerative disorders (up to 66%). In addition, the rate of patients who discontinue because of AEs is up to 10% and 11% in pain conditions and neurodegenerative disorders, respectively.We highlight methodological shortcomings with the aim of suggesting how the detection and reporting of AEs can be improved in future trials. The insights from the current review should be taken into consideration when designing clinical trials to tailor individualized treatments. PMID:27580494

  20. Equal Improvement in Men and Women in the Treatment of Urologic Chronic Pelvic Pain Syndrome Using a Multi-modal Protocol with an Internal Myofascial Trigger Point Wand.

    PubMed

    Anderson, Rodney U; Wise, David; Sawyer, Tim; Nathanson, Brian H; Nevin Smith, J

    2016-06-01

    Both men and women require treatment for urologic chronic pelvic pain syndromes (UCPPS), which includes interstitial cystitis/painful bladder syndrome, pelvic floor dysfunction, and chronic prostatitis/chronic pelvic pain syndrome. However, it is unknown if men and women respond differently to a protocol that includes specific physical therapy self-treatment using an internal trigger point wand and training in paradoxical relaxation. We performed a retrospective analysis by gender in a single arm, open label, single center clinical trial designed to evaluate the safety and effectiveness of a protocol for the treatment of UCPPS from October, 2008 to May, 2011. 314 adult men (79.9 %) and 79 (20.1 %) women met inclusion criteria. The median duration of symptoms was 60 months. The protocol required an initial 6-day clinic for training followed by a 6-month self-treatment period. The treatment included self-administered pelvic floor trigger point release with an internal trigger point device for physical therapy along with paradoxical relaxation training. Notable gender differences in prior treatments were observed. Men had a lower median [Interquartile Range] NIH-CPSI score at baseline than women (27 [21, 31] vs. 29 [22, 33], p = 0.04). Using a 1-10 scale with 10 = Most Severe, the median reduction in trigger point sensitivity was 3 units for both men and women after 6 months therapy (p = 0.74). A modified Intention to Treat analysis and a multivariate regression analysis found similar results. We conclude that men and women have similar, significant reductions in trigger point sensitivity with this protocol. PMID:26721470

  1. Equal Improvement in Men and Women in the Treatment of Urologic Chronic Pelvic Pain Syndrome Using a Multi-modal Protocol with an Internal Myofascial Trigger Point Wand.

    PubMed

    Anderson, Rodney U; Wise, David; Sawyer, Tim; Nathanson, Brian H; Nevin Smith, J

    2016-06-01

    Both men and women require treatment for urologic chronic pelvic pain syndromes (UCPPS), which includes interstitial cystitis/painful bladder syndrome, pelvic floor dysfunction, and chronic prostatitis/chronic pelvic pain syndrome. However, it is unknown if men and women respond differently to a protocol that includes specific physical therapy self-treatment using an internal trigger point wand and training in paradoxical relaxation. We performed a retrospective analysis by gender in a single arm, open label, single center clinical trial designed to evaluate the safety and effectiveness of a protocol for the treatment of UCPPS from October, 2008 to May, 2011. 314 adult men (79.9 %) and 79 (20.1 %) women met inclusion criteria. The median duration of symptoms was 60 months. The protocol required an initial 6-day clinic for training followed by a 6-month self-treatment period. The treatment included self-administered pelvic floor trigger point release with an internal trigger point device for physical therapy along with paradoxical relaxation training. Notable gender differences in prior treatments were observed. Men had a lower median [Interquartile Range] NIH-CPSI score at baseline than women (27 [21, 31] vs. 29 [22, 33], p = 0.04). Using a 1-10 scale with 10 = Most Severe, the median reduction in trigger point sensitivity was 3 units for both men and women after 6 months therapy (p = 0.74). A modified Intention to Treat analysis and a multivariate regression analysis found similar results. We conclude that men and women have similar, significant reductions in trigger point sensitivity with this protocol.

  2. Considerations for improving assay sensitivity in chronic pain clinical trials: IMMPACT recommendations.

    PubMed

    Dworkin, Robert H; Turk, Dennis C; Peirce-Sandner, Sarah; Burke, Laurie B; Farrar, John T; Gilron, Ian; Jensen, Mark P; Katz, Nathaniel P; Raja, Srinivasa N; Rappaport, Bob A; Rowbotham, Michael C; Backonja, Misha-Miroslav; Baron, Ralf; Bellamy, Nicholas; Bhagwagar, Zubin; Costello, Ann; Cowan, Penney; Fang, Weikai Christopher; Hertz, Sharon; Jay, Gary W; Junor, Roderick; Kerns, Robert D; Kerwin, Rosemary; Kopecky, Ernest A; Lissin, Dmitri; Malamut, Richard; Markman, John D; McDermott, Michael P; Munera, Catherine; Porter, Linda; Rauschkolb, Christine; Rice, Andrew S C; Sampaio, Cristina; Skljarevski, Vladimir; Sommerville, Kenneth; Stacey, Brett R; Steigerwald, Ilona; Tobias, Jeffrey; Trentacosti, Ann Marie; Wasan, Ajay D; Wells, George A; Williams, Jim; Witter, James; Ziegler, Dan

    2012-06-01

    A number of pharmacologic treatments examined in recent randomized clinical trials (RCTs) have failed to show statistically significant superiority to placebo in conditions in which their efficacy had previously been demonstrated. Assuming the validity of previous evidence of efficacy and the comparability of the patients and outcome measures in these studies, such results may be a consequence of limitations in the ability of these RCTs to demonstrate the benefits of efficacious analgesic treatments vs placebo ("assay sensitivity"). Efforts to improve the assay sensitivity of analgesic trials could reduce the rate of falsely negative trials of efficacious medications and improve the efficiency of analgesic drug development. Therefore, an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials consensus meeting was convened in which the assay sensitivity of chronic pain trials was reviewed and discussed. On the basis of this meeting and subsequent discussions, the authors recommend consideration of a number of patient, study design, study site, and outcome measurement factors that have the potential to affect the assay sensitivity of RCTs of chronic pain treatments. Increased attention to and research on methodological aspects of clinical trials and their relationships with assay sensitivity have the potential to provide the foundation for an evidence-based approach to the design of analgesic clinical trials and expedite the identification of analgesic treatments with improved efficacy and safety.

  3. Extinction memory in the crab Chasmagnathus: recovery protocols and effects of multi-trial extinction training.

    PubMed

    Hepp, Yanil; Pérez-Cuesta, Luis María; Maldonado, Héctor; Pedreira, María Eugenia

    2010-05-01

    A decline in the frequency or intensity of a conditioned behavior following the withdrawal of the reinforcement is called experimental extinction. However, the experimental manipulation necessary to trigger memory reconsolidation or extinction is to expose the animal to the conditioned stimulus in the absence of reinforcement. Recovery protocols were used to reveal which of these two processes was developed. By using the crab contextual memory model (a visual danger stimulus associated with the training context), we investigated the dynamics of extinction memory in Chasmagnathus. Here, we reveal the presence of three recovery protocols that restore the original memory: the old memory comes back 4 days after the extinction training, or when a weak training is administered later, or once the VDS is presented in a novel context 24 h after the extinction session. Another objective was to evaluate whether the administration of multi-trial extinction training could trigger an extinction memory in Chasmagnathus. The results evince that the extinction memory appears only when the total re-exposure time is around 90 min independently of the number of trials employed to accumulate it. Thus, it is feasible that the mechanisms described for the case of the extinction memory acquired through a single training trial are valid for multi-trial extinction protocols. Finally, these results are in agreement with those reports obtained with models phylogenetically far apart from the crab. Behind this attempt is the idea that in the domain of studies on memory, some principles of behavior organization and basic mechanisms have universal validity.

  4. Effects of Natural Sounds on Pain: A Randomized Controlled Trial with Patients Receiving Mechanical Ventilation Support.

    PubMed

    Saadatmand, Vahid; Rejeh, Nahid; Heravi-Karimooi, Majideh; Tadrisi, Sayed Davood; Vaismoradi, Mojtaba; Jordan, Sue

    2015-08-01

    Nonpharmacologic pain management in patients receiving mechanical ventilation support in critical care units is under investigated. Natural sounds may help reduce the potentially harmful effects of anxiety and pain in hospitalized patients. The aim of this study was to examine the effect of pleasant, natural sounds on self-reported pain in patients receiving mechanical ventilation support, using a pragmatic parallel-arm, randomized controlled trial. The study was conducted in a general adult intensive care unit of a high-turnover teaching hospital, in Tehran, Iran. Between October 2011 and June 2012, we recruited 60 patients receiving mechanical ventilation support to the intervention (n = 30) and control arms (n = 30) of a pragmatic parallel-group, randomized controlled trial. Participants in both arms wore headphones for 90 minutes. Those in the intervention arm heard pleasant, natural sounds, whereas those in the control arm heard nothing. Outcome measures included the self-reported visual analog scale for pain at baseline; 30, 60, and 90 minutes into the intervention; and 30 minutes post-intervention. All patients approached agreed to participate. The trial arms were similar at baseline. Pain scores in the intervention arm fell and were significantly lower than in the control arm at each time point (p < .05). Administration of pleasant, natural sounds via headphones is a simple, safe, nonpharmacologic nursing intervention that may be used to allay pain for up to 120 minutes in patients receiving mechanical ventilation support.

  5. Randomized control trial of topical clonidine for treatment of painful diabetic neuropathy

    PubMed Central

    Campbell, Claudia M.; Kipnes, Mark S.; Stouch, Bruce C.; Brady, Kerrie L.; Kelly, Margaret; Schmidt, William K.; Petersen, Karin L.; Rowbotham, Michael C.; Campbell, James N.

    2012-01-01

    A length-dependent neuropathy with pain in the feet is a common complication of diabetes (painful diabetic neuropathy, PDN). It was hypothesized that pain may arise from sensitized-hyperactive cutaneous nociceptors, and that this abnormal signaling may be reduced by topical administration of the α2-adrenergic agonist, clonidine, to the painful area. This was a randomized, double-blind, placebo-controlled, parallel-group, multi-center trial. Nociceptor function was measured by determining the painfulness of 0.1% topical capsaicin applied to the pre-tibial area of each subject for 30 minutes during screening. Subjects were then randomized to receive 0.1% topical clonidine gel (n=89) or placebo gel (n=90) applied t.i.d. to their feet for 12 weeks. The difference in foot pain at week 12 in relation to baseline, rated on a 0-10 numerical pain rating scale (NPRS), was compared between groups. Baseline NPRS was imputed for missing data for subjects who terminated the study early. The subjects treated with clonidine showed a trend toward decreased foot pain compared to the placebo-treated group (the primary endpoint; p=0.07). In subjects who felt any level of pain to capsaicin, clonidine was superior to placebo (p<0.05). In subjects with a capsaicin pain rating ≥2 (0-10, NPRS), the mean decrease in foot pain was 2.6 for active compared to 1.4 for placebo (p=0.01). Topical clonidine gel significantly reduces the level of foot pain in PDN subjects with functional (and possibly sensitized) nociceptors in the affected skin as revealed by testing with topical capsaicin. Screening for cutaneous nociceptor function may help distinguish candidates for topical therapy for neuropathic pain. PMID:22683276

  6. Rationale, design and methods of the Study of Work and Pain (SWAP): a cluster randomised controlled trial testing the addition of a vocational advice service to best current primary care for patients with musculoskeletal pain (ISRCTN 52269669)

    PubMed Central

    2014-01-01

    Background Musculoskeletal pain is a major contributor to short and long term work absence. Patients seek care from their general practitioner (GP) and yet GPs often feel ill-equipped to deal with work issues. Providing a vocational case management service in primary care, to support patients with musculoskeletal problems to remain at or return to work, is one potential solution but requires robust evaluation to test clinical and cost-effectiveness. Methods/Design This protocol describes a cluster randomised controlled trial, with linked qualitative interviews, to investigate the effect of introducing a vocational advice service into general practice, to provide a structured approach to managing work related issues in primary care patients with musculoskeletal pain who are absent from work or struggling to remain in work. General practices (n = 6) will be randomised to offer best current care or best current care plus a vocational advice service. Adults of working age who are absent from or struggling to remain in work due to a musculoskeletal pain problem will be invited to participate and 330 participants will be recruited. Data collection will be through patient completed questionnaires at baseline, 4 and 12 months. The primary outcome is self-reported work absence at 4 months. Incremental cost-utility analysis will be undertaken to calculate the cost per additional QALY gained and incremental net benefits. A linked interview study will explore the experiences of the vocational advice service from the perspectives of GPs, nurse practitioners (NPs), patients and vocational advisors. Discussion This paper presents the rationale, design, and methods of the Study of Work And Pain (SWAP) trial. The results of this trial will provide evidence to inform primary care practice and guide the development of services to provide support for musculoskeletal pain patients with work-related issues. Trial registration Current Controlled Trials ISRCTN52269669. PMID:25012813

  7. Effects of tai chi program on neuromuscular function for patients with knee osteoarthritis: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Knee osteoarthritis (OA) is a major cause of disability as well as a burden on healthcare resources. Tai chi has been proposed as an alternative and complementary treatment for the management of knee osteoarthritis, but there appears to be no consensus on its usefulness. This study aims to develop an innovative tai chi rehabilitation program (ITCRP) for patients with knee OA, and to investigate the effect of ITCRP intervention on a range of outcomes including pain, function, balance, neuromuscular response, and biomechanics in knee OA. Methods/Design We will conduct a prospective, single-blind, randomized controlled trial of 140 individuals with symptomatic knee OA. Patients will be randomly assigned into either an ITCRP group or a control group. The ITCRP group will participate in tai chi two or three times a week for 6 months. The control group will receive health education. After the 6-month intervention period, there will be a 6-month follow-up period with no active intervention in either group. The primary and secondary outcomes will be assessed at baseline, 6 months, and 12 months. Primary outcome measures will be a visual analog scale for pain, the Western Ontario and McMaster Universities Osteoarthritis Index,and the Lequesne Knee Score. The secondary outcome measures will include the Berg balance scale, knee and ankle proprioception, neuromuscular response, and 3D functional biomechanics. Furthermore, adverse events will be recorded and analyzed. If any participants withdraw from the trial, intention-to-treat analysiswill be performed. Discussion Important features of this trial include the randomization procedures, large sample size, and a standardized protocol for ITCRP for knee OA. This study aims to determine the feasibility of ITCRP for knee OA and provide data on the effects of ITCRP. Hence, our results will be useful for patients with knee OA as well as for medical staff and healthcare decision makers. Trial registration Chinese

  8. Effect of pretreatment diclofenac sodium on postendodontic pain: A randomised controlled trial

    PubMed Central

    Metri, Malasiddappa; Hegde, Swaroop; Bhandi, Shilpa

    2016-01-01

    Introduction: Effective management of endodontic pain represents a continuing challenge. Many of the dental professionals are facing significant problems associated with postendodontic pain. Hence, the postendodontic pain has to be prevented at its primary stage without waiting for its occurrence. This trial was carried out to evaluate the use of a preoperative, single oral dose of diclofenac sodium for the prevention and control of postendodontic pain. Materials and Methods: Fifty patients were randomly assigned to two groups, placebo and diclofenac sodium (100 mg). The medications were administered 30 min before the start of standard endodontic treatment. Postoperative pain was assessed after 6, 12, and 24 h by using a visual analog scale. Results: Postendodontic pain showed a statistically significant difference between both groups at 6 and 12 h (P < 0.05) and there was no significant difference at 24 h. Conclusion: Postendodontic pain was substantially reduced by preoperative administration of single oral dose of diclofenac sodium. It is thus possible to conclude that these favorable results might help to prevent postendodontic pain, especially in patients with a low pain threshold. PMID:26957785

  9. Development of a dynamic quality assurance testing protocol for multisite clinical trial DCE-CT accreditation

    SciTech Connect

    Driscoll, B.; Keller, H.; Jaffray, D.; Coolens, C.

    2013-08-15

    Purpose: Credentialing can have an impact on whether or not a clinical trial produces useful quality data that is comparable between various institutions and scanners. With the recent increase of dynamic contrast enhanced-computed tomography (DCE-CT) usage as a companion biomarker in clinical trials, effective quality assurance, and control methods are required to ensure there is minimal deviation in the results between different scanners and protocols at various institutions. This paper attempts to address this problem by utilizing a dynamic flow imaging phantom to develop and evaluate a DCE-CT quality assurance (QA) protocol.Methods: A previously designed flow phantom, capable of producing predictable and reproducible time concentration curves from contrast injection was fully validated and then utilized to design a DCE-CT QA protocol. The QA protocol involved a set of quantitative metrics including injected and total mass error, as well as goodness of fit comparison to the known truth concentration curves. An additional region of interest (ROI) sensitivity analysis was also developed to provide additional details on intrascanner variability and determine appropriate ROI sizes for quantitative analysis. Both the QA protocol and ROI sensitivity analysis were utilized to test variations in DCE-CT results using different imaging parameters (tube voltage and current) as well as alternate reconstruction methods and imaging techniques. The developed QA protocol and ROI sensitivity analysis was then applied at three institutions that were part of clinical trial involving DCE-CT and results were compared.Results: The inherent specificity of robustness of the phantom was determined through calculation of the total intraday variability and determined to be less than 2.2 ± 1.1% (total calculated output contrast mass error) with a goodness of fit (R{sup 2}) of greater than 0.99 ± 0.0035 (n= 10). The DCE-CT QA protocol was capable of detecting significant deviations from

  10. Cohort protocol paper: The Pain and Opioids In Treatment (POINT) study

    PubMed Central

    2014-01-01

    Background Internationally, there is concern about the increased prescribing of pharmaceutical opioids for chronic non-cancer pain (CNCP). In part, this is related to limited knowledge about the long-term benefits and outcomes of opioid use for CNCP. There has also been increased injection of some pharmaceutical opioids by people who inject drugs, and for some patients, the development of problematic and/or dependent use. To date, much of the research on the use of pharmaceutical opioids among people with CNCP, have been clinical trials that have excluded patients with complex needs, and have been of limited duration (i.e. fewer than 12 weeks). The Pain and Opioids In Treatment (POINT) study is unique study that aims to: 1) examine patterns of opioid use in a cohort of patients prescribed opioids for CNCP; 2) examine demographic and clinical predictors of adverse events, including opioid abuse or dependence, medication diversion, other drug use, and overdose; and 3) identify factors predicting poor pain relief and other outcomes. Methods/Design The POINT cohort comprises around 1,500 people across Australia prescribed pharmaceutical opioids for CNCP. Participants will be followed-up at four time points over a two year period. POINT will collect information on demographics, physical and medication use history, pain, mental health, drug and alcohol use, non-adherence, medication diversion, sleep, and quality of life. Data linkage will provide information on medications and services from Medicare (Australia’s national health care scheme). Data on those who receive opioid substitution therapy, and on mortality, will be linked. Discussion This study will rigorously examine prescription opioid use among CNCP patients, and examine its relationship to important health outcomes. The extent to which opioids for chronic pain is associated with pain reduction, quality of life, mental and physical health, aberrant medication behavior and substance use disorders will be

  11. Systematic evaluation of patient-reported outcome (PRO) protocol content and reporting in UK cancer clinical trials: the EPiC study protocol

    PubMed Central

    Ahmed, Khaled; Kyte, Derek; Keeley, Thomas; Efficace, Fabio; Armes, Jo; Brown, Julia M; Calman, Lynn; Copland, Chris; Gavin, Anna; Glaser, Adam; Greenfield, Diana M; Lanceley, Anne; Taylor, Rachel; Velikova, Galina; Brundage, Michael; Mercieca-Bebber, Rebecca; King, Madeleine T

    2016-01-01

    Introduction Emerging evidence suggests that patient-reported outcome (PRO)-specific information may be omitted in trial protocols and that PRO results are poorly reported, limiting the use of PRO data to inform cancer care. This study aims to evaluate the standards of PRO-specific content in UK cancer trial protocols and their arising publications and to highlight examples of best-practice PRO protocol content and reporting where they occur. The objective of this study is to determine if these early findings are generalisable to UK cancer trials, and if so, how best we can bring about future improvements in clinical trials methodology to enhance the way PROs are assessed, managed and reported. Hypothesis: Trials in which the primary end point is based on a PRO will have more complete PRO protocol and publication components than trials in which PROs are secondary end points. Methods and analysis Completed National Institute for Health Research (NIHR) Portfolio Cancer clinical trials (all cancer specialities/age-groups) will be included if they contain a primary/secondary PRO end point. The NIHR portfolio includes cancer trials, supported by a range of funders, adjudged as high-quality clinical research studies. The sample will be drawn from studies completed between 31 December 2000 and 1 March 2014 (n=1141) to allow sufficient time for completion of the final trial report and publication. Two reviewers will then review the protocols and arising publications of included trials to: (1) determine the completeness of their PRO-specific protocol content; (2) determine the proportion and completeness of PRO reporting in UK Cancer trials and (3) model factors associated with PRO protocol and reporting completeness and with PRO reporting proportion. Ethics and dissemination The study was approved by the ethics committee at University of Birmingham (ERN_15-0311). Trial findings will be disseminated via presentations at local, national and international conferences, peer

  12. Multi-level assessment protocol (MAP) for adoption in multi-site clinical trials

    PubMed Central

    Guydish, J.; Manser, S.T.; Jessup, M.; Tajima, B.; Sears, C.; Montini, T.

    2010-01-01

    The National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) is intended to test promising drug abuse treatment models in multi-site clinical trials, and to support adoption of new interventions into clinical practice. Using qualitative research methods we asked: How might the technology of multi-site clinical trials be modified to better support adoption of tested interventions? A total of 42 participants, representing 8 organizational levels ranging from clinic staff to clinical trial leaders, were interviewed about their role in the clinical trial, its interactions with clinics, and intervention adoption. Among eight clinics participating in the clinical trial, we found adoption of the tested intervention in one clinic only. In analysis of interview data we identified four conceptual themes which are likely to affect adoption and may be informative in future multi-site clinical trials. We offer the conclusion that planning for adoption in the early stages of protocol development will better serve the aim of integrating new interventions into practice. PMID:20890376

  13. Written pain neuroscience education in fibromyalgia: a multicenter randomized controlled trial.

    PubMed

    van Ittersum, Miriam W; van Wilgen, C Paul; van der Schans, Cees P; Lambrecht, Luc; Groothoff, Johan W; Nijs, Jo

    2014-11-01

    Mounting evidence supports the use of face-to-face pain neuroscience education for the treatment of chronic pain patients. This study aimed at examining whether written education about pain neuroscience improves illness perceptions, catastrophizing, and health status in patients with fibromyalgia. A double-blind, multicenter randomized controlled clinical trial with 6-month follow-up was conducted. Patients with FM (n = 114) that consented to participate were randomly allocated to receive either written pain neuroscience education or written relaxation training. Written pain neuroscience education comprised of a booklet with pain neuroscience education plus a telephone call to clarify any difficulties; the relaxation group received a booklet with relaxation education and a telephone call. The revised illness perception questionnaire, Pain Catastrophizing Scale, and fibromyalgia impact questionnaire were used as outcome measures. Both patients and assessors were blinded. Repeated-measures analyses with last observation carried forward principle were performed. Cohen's d effect sizes (ES) were calculated for all within-group changes and between-group differences. The results reveal that written pain neuroscience education does not change the impact of FM on daily life, catastrophizing, or perceived symptoms of patients with FM. Compared with written relaxation training, written pain neuroscience education improved beliefs in a chronic timeline of FM (P = 0.03; ES = 0.50), but it does not impact upon other domains of illness perceptions. Compared with written relaxation training, written pain neuroscience education slightly improved illness perceptions of patients with FM, but it did not impart clinically meaningful effects on pain, catastrophizing, or the impact of FM on daily life. Face-to-face sessions of pain neuroscience education are required to change inappropriate cognitions and perceived health in patients with FM.

  14. Cognitive behavioral therapy for orthodontic pain control: a randomized trial.

    PubMed

    Wang, J; Jian, F; Chen, J; Ye, N S; Huang, Y H; Wang, S; Huang, R H; Pei, J; Liu, P; Zhang, L; Zhao, Z H; Chen, Q M; Lai, W L; Lin, Y F

    2012-06-01

    The objective of this study was to evaluate the efficacy of cognitive behavioral therapy intervention for patients who experienced pain during orthodontic treatment. The baseline characteristics were assessed via questionnaires and oral examinations. Four hundred and fifty eligible individuals were recruited and randomized by computer-generated block randomization into three groups: cognitive behavioral therapy intervention (n = 150), ibuprofen intervention (n = 150), and no intervention (control; n = 150). Primary outcomes were the change from baseline in pain intensity measured with 100-mm Visual Analog Scale (VAS) scores at 1, 2, 3, 7, 14, and 30 days after initial archwire placement. Outcomes assessment was blinded and followed the intention-to-treat principle. One hundred forty-three (95.30%), 145 (96.70%), and 141 (94.00%) individuals in the cognitive behavioral therapy, the ibuprofen, and the control groups, respectively, completed the one-month follow-up evaluations. Those in the cognitive behavioral therapy group showed a greater decrease in mean VAS scores than did those in the control group over the previous five time-points (p < 0.001). Cognitive behavioral therapy was shown to be effective in pain control during the initial stage of orthodontic treatment. The study registration number was ChiCTR-TRC-00000556.

  15. Evolution of the lipid trial protocol of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.

    PubMed

    Ginsberg, Henry N; Bonds, Denise E; Lovato, Laura C; Crouse, John R; Elam, Marshall B; Linz, Peter E; O'connor, Patrick J; Leiter, Lawrence A; Weiss, Daniel; Lipkin, Edward; Fleg, Jerome L

    2007-06-18

    The Action to Control Cardiovascular Risk in Diabetes (ACCORD) lipid trial aims to test whether a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin) plus a fibrate is more efficacious in reducing cardiovascular events than a statin plus placebo in patients with type 2 diabetes mellitus with defined glycemic control. This is a blinded component in a 5,518-patient subset of the ACCORD cohort. These participants were randomized to either be (1) treated with simvastatin (titrated to 40 mg/day if necessary to achieve a goal low-density lipoprotein [LDL] cholesterol level of <2.59 mmol/L [100 mg/dL]) plus placebo or (2) treated to the same goal LDL cholesterol level with the statin plus active fenofibrate 160 mg/day or its bioequivalent (or 54 mg/day if the estimated glomerular filtration rate ranges from 30 to <50 mL/min per 1.73 m2). Setting an upper limit of LDL cholesterol qualifying for randomization excluded patients who would not likely achieve the LDL cholesterol goal. Recruitment for ACCORD began in January 2001, and follow-up is scheduled to end in June 2009. Since recruitment began, several clinical trials and consensus statements have been published that led to changes in the details of the lipid treatment algorithm and protocol. This report describes the design of the lipid protocol and modifications to the protocol during the course of the study in response to and in anticipation of these developments. The current protocol is designed to provide an ethically justifiable test of combined statin plus fibrate treatment consistent with the highest level of safety and lipid treatment standards of care.

  16. Memantine before Mastectomy Prevents Post-Surgery Pain: A Randomized, Blinded Clinical Trial in Surgical Patients

    PubMed Central

    Morel, Véronique; Joly, Dominique; Villatte, Christine; Dubray, Claude; Durando, Xavier; Daulhac, Laurence; Coudert, Catherine; Roux, Delphine; Pereira, Bruno; Pickering, Gisèle

    2016-01-01

    Background Neuropathic pain following surgical treatment for breast cancer with or without chemotherapy is a clinical burden and patients frequently report cognitive, emotional and quality of life impairment. A preclinical study recently showed that memantine administered before surgery may prevent neuropathic pain development and cognitive dysfunction. With a translational approach, a clinical trial has been carried out to evaluate whether memantine administered before and after mastectomy could prevent the development of neuropathic pain, the impairment of cognition and quality of life. Method A randomized, pilot clinical trial included 40 women undergoing mastectomy in the Oncology Department, University Hospital, Clermont-Ferrand, France. Memantine (5 to 20 mg/day; n = 20) or placebo (n = 20) was administered for four weeks starting two weeks before surgery. The primary endpoint was pain intensity measured on a (0–10) numerical rating scale at three months post-mastectomy. Results Data analyses were performed using mixed models and the tests were two-sided, with a type I error set at α = 0.05. Compared with placebo, patients receiving memantine showed at three months a significant difference in post-mastectomy pain intensity, less rescue analgesia and a better emotional state. An improvement of pain symptoms induced by cancer chemotherapy was also reported. Conclusions This study shows for the first time the beneficial effect of memantine to prevent post-mastectomy pain development and to diminish chemotherapy-induced pain symptoms. The lesser analgesic consumption and better well-being of patients for at least six months after treatment suggests that memantine could be an interesting therapeutic option to diminish the burden of breast cancer therapy. Trial Registration Clinicaltrials.gov NCT01536314 PMID:27050431

  17. The Cessation in Pregnancy Incentives Trial (CPIT): study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Seventy percent of women in Scotland have at least one baby, making pregnancy an opportunity to help most young women quit smoking before their own health is irreparably compromised. By quitting during pregnancy their infants will be protected from miscarriage and still birth as well as low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. In the UK, the NICE guidelines: ‘How to stop smoking in pregnancy and following childbirth’ (June 2010) highlighted that little evidence exists in the literature to confirm the efficacy of financial incentives to help pregnant smokers to quit. Its first research recommendation was to determine: Within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? Design and methods This study is a phase II exploratory individually randomized controlled trial comparing standard care for pregnant smokers with standard care plus the additional offer of financial voucher incentives to engage with specialist cessation services and/or to quit smoking during pregnancy. Participants (n = 600) will be pregnant smokers identified at maternity booking who, when contacted by specialist cessation services, agree to having their details passed to the NHS Smokefree Pregnancy Study Helpline to discuss the trial. The NHS Smokefree Pregnancy Study Helpline will be responsible for telephone consent and follow-up in late pregnancy. The primary outcome will be self reported smoking in late pregnancy verified by cotinine measurement. An economic evaluation will refine cost data collection and assess potential cost-effectiveness while qualitative research interviews with clients and health professionals will assess the level of acceptance of this form of incentive payment. The research questions are: What is the likely therapeutic efficacy? Are incentives potentially cost-effective? Is individual randomization an efficient trial design without

  18. Identifying important outcome domains for chronic pain clinical trials: an IMMPACT survey of people with pain.

    PubMed

    Turk, Dennis C; Dworkin, Robert H; Revicki, Dennis; Harding, Gale; Burke, Laurie B; Cella, David; Cleeland, Charles S; Cowan, Penney; Farrar, John T; Hertz, Sharon; Max, Mitchell B; Rappaport, Bob A

    2008-07-15

    This two-phase study was conducted to identify relevant domains of patient-reported outcomes from the perspective of people who experience chronic pain. In Phase 1, focus groups were conducted to generate a pool of patient outcome-related domains and their components. The results of the focus groups identified 19 aspects of their lives that were significantly impacted by the presence of their symptoms and for which improvements were important criteria they would use in evaluating the effectiveness of any treatment. Phase 2 was conducted to examine the importance and relevance of domains identified from a much larger and diverse sample of people with chronic pain. A survey was developed and posted on the American Chronic Pain Association website. Participants were asked to rate the importance of each item or domain identified by the focus groups on a scale of 0 to10 (i.e., 0="not at all important" and 10="extremely important"). The survey was completed by 959 individuals. The results indicate that all 19 aspects of daily life derived from the focus groups were considered important with a majority of respondents indicating a score of 8 or greater. In addition to pain reduction, the most important aspects were enjoyment of life, emotional well-being, fatigue, weakness, and sleep-related problems. Chronic pain clearly impacts health-related quality of life. The results of the two phases of the study indicate that people with chronic pain consider functioning and well-being as important areas affected by the presence of symptoms and as appropriate targets of treatment. These multiple outcomes should be considered when evaluating the efficacy and effectiveness of chronic pain treatments.

  19. Intravenous Ibuprofen for Treatment of Post-Operative Pain: A Multicenter, Double Blind, Placebo-Controlled, Randomized Clinical Trial

    PubMed Central

    Escontrela Rodriguez, Blanca; Planas Roca, Antonio; Martínez Ruiz, Alberto

    2016-01-01

    Background Non-steroidal anti-inflammatory drugs are often used as components of multimodal therapy for postoperative pain management, but their use is currently limited by its side effects. The specific objective of this study was to evaluate the efficacy and safety of a new formulation of intravenous (IV) ibuprofen for the management of postoperative pain in a European population. Methods and Findings A total of 206 patients from both abdominal and orthopedic surgery, were randomly assigned in 1:1 ratio to receive 800 mg IV-ibuprofen or placebo every 6 hours; all patients had morphine access through a patient controlled analgesia pump. The primary outcome measure was median morphine consumption within the first 24 hours following surgery. The mean±SEM of morphine requirements was reduced from 29,8±5,25 mg to 14,22±3,23 mg (p = 0,015) and resulted in a decrease in pain at rest (p = 0,02) measured by Visual Analog Scale (VAS) from mean±SEM 3.34±0,35 to 0.86±0.24, and also in pain during movement (p = 0,02) from 4.32±0,36 to 1.90±0,30 in the ibuprofen treatment arm; while in the placebo group VAS score at rest ranged from 4.68±0,40 to 2.12±0,42 and during movement from 5.66±0,42 to 3.38±0,44. Similar treatment-emergent adverse events occurred across both study groups and there was no difference in the overall incidence of these events. Conclusions Perioperative administration of IV-Ibuprofen 800 mg every 6 hours in abdominal surgery patient’s decreases morphine requirements and pain score. Furthermore IV-Ibuprofen was safe and well tolerate. Consequently we consider appropriate that protocols for management of postoperative pain include IV-Ibuprofen 800 mg every 6 hours as an option to offer patients an analgesic benefit while reducing the potentially risks associated with morphine consumption. Trial Registration EU Clinical Trials Register 2011-005007-33 PMID:27152748

  20. The ethics of a clinical trial when the protocol clashes with international guidelines.

    PubMed

    Lan, N T N; Thu, N T N; Duc, N H; Lan, N N; Lien, T T X; Dung, N H; Taburet, A-M; Laureillard, D; Borand, L; Quillet, C; Lagarde, D; Pym, A; Connolly, C; Lienhardt, C; Rekacewicz, C; Harries, A D

    2013-06-21

    Due to their nature and complexity, clinical trials often take some time to launch after the protocol has been designed and ethics approval obtained. During this time, there may be changes in international treatment guidelines and recommendations that result in a conflict between study protocol and recommended international best practice. Here, we describe the situation that arose in a pharmacokinetic study on the use of two different doses of rifabutin in patients with human immunodeficiency virus-associated tuberculosis who initiated antiretroviral therapy (ART) with a lopinavir-ritonavir-based regimen in South Africa and Viet Nam. The study protocol specified that ART should be started 10 weeks after the start of anti-tuberculosis treatment. The study in South Africa was approved in June 2008, went ahead as scheduled and was completed in August 2010. The study in Viet Nam was approved in October 2008 and was started in June 2010. A few weeks later, the World Health Organization released their 2010 guidelines for adult ART; one of its strong recommendations (with moderate quality of evidence) was that ART should be started 2-8 weeks after the start of anti-tuberculosis treatment. Emerging scientific evidence also supported this recommendation. The investigators felt that the Viet Nam study protocol was in conflict with recommended international best practice, and the trial was stopped in October 2010. An amended study protocol in which ART was started at 2 weeks was developed and implemented. The ethics issues around this decision and the need to change the study protocol are discussed in this article.

  1. Effectiveness of dry needling for chronic nonspecific neck pain: a randomized, single-blinded, clinical trial.

    PubMed

    Cerezo-Téllez, Ester; Torres-Lacomba, María; Fuentes-Gallardo, Isabel; Perez-Muñoz, Milagros; Mayoral-Del-Moral, Orlando; Lluch-Girbés, Enrique; Prieto-Valiente, Luis; Falla, Deborah

    2016-09-01

    Chronic neck pain attributed to a myofascial pain syndrome is characterized by the presence of muscle contractures referred to as myofascial trigger points. In this randomized, parallel-group, blinded, controlled clinical trial, we examined the effectiveness of deep dry needling (DDN) of myofascial trigger points in people with chronic nonspecific neck pain. The study was conducted at a public Primary Health Care Centre in Madrid, Spain, from January 2010 to December 2014. A total of 130 participants with nonspecific neck pain presenting with active myofascial trigger points in their cervical muscles were included. These participants were randomly allocated to receive: DDN plus stretching (n = 65) or stretching only (control group [n = 65]). Four sessions of treatment were applied over 2 weeks with a 6-month follow-up after treatment. Pain intensity, mechanical hyperalgesia, neck active range of motion, neck muscle strength, and perceived neck disability were measured at baseline, after 2 sessions of intervention, after the intervention period, and 15, 30, 90, and 180 days after the intervention. Significant and clinically relevant differences were found in favour of dry needling in all the outcomes (all P < 0.001) at both short and long follow-ups. Deep dry needling and passive stretching is more effective than passive stretching alone in people with nonspecific neck pain. The results support the use of DDN in the management of myofascial pain syndrome in people with chronic nonspecific neck pain. PMID:27537209

  2. Honey Versus Diphenhydramine for Post-Tonsillectomy Pain Relief in Pediatric Cases: A Randomized Clinical Trial

    PubMed Central

    Amani, Soroush; Kheiri, Soleyman

    2015-01-01

    Introduction: Tonsillectomy is one of the most common surgeries done worldwide and often the first one a child sustains. Pain relief after tonsillectomy is helpful for oral feeding after surgery. Acetaminophen and diphenhydramine have been conventionally used for reducing pain. This study was conducted to compare the effect of honey and diphehydramine on pain relief after tonsillectomy. Materials and Methods: For this randomized clinical trial study, 120 patients of 5 to 12 years undergoing tonsillectomy were recruited. The patients were divided into four groups randomly. After tonsillectomy and beginning of eating, Group A took 5cc honey alone every hour, Group B was given 5 cc 50% honey (mixed with water) every hour, group C was treated with 1mg/kg diphenhydramine every 6 hours and group D was observed without any intervention. In all patients, severity of the pain was evaluated by ocher questionnaire at recovery, and 3, 6, 12 and 24 hours after surgery. The data were analyzed using ANOVA and the repeated measures ANOVA (SPSS version 17). Results: The repeated ANOVA showed a significant decreasing trend of pain scores during the study for both pain scales (p <0.05), but the rate of trend was similar between the four groups (p > 0.05). No statistically significant difference in pain was detected among the groups. Conclusion: Although honey can help the pain decrease, more research is supported for confirmation of this effect. PMID:25954673

  3. Oral glucose for pain relief during examination for retinopathy of prematurity: a masked randomized clinical trial

    PubMed Central

    da Costa, Marlene Coelho; Eckert, Gabriela Unchalo; Fortes, Bárbara Gastal Borges; Filho, João Borges Fortes; Silveira, Rita C.; Procianoy, Renato S

    2013-01-01

    OBJECTIVE: Ophthalmologic examination for retinopathy of prematurity is a painful procedure. Pharmacological and non-pharmacological interventions have been proposed to reduce pain during eye examinations. This study aims to evaluate the analgesic effect of 25% glucose using a validated pain scale during the first eye examination for retinopathy of prematurity in preterm infants with birth weight ≤1,500 g and/or gestational age ≤32 weeks. METHODS: A masked, randomized clinical trial for one dose of 1 ml of oral 25% glucose solution 2 minutes before the first ophthalmologic examination for retinopathy of prematurity was conducted between March 2008 and April 2010. The results were compared to those of a control group that did not receive oral glucose solution. Pain was evaluated using a Neonatal Infant Pain Scale immediately before and immediately after the ophthalmologic examination in both groups. Clinicaltrials.gov: NCT00648687 RESULTS: One hundred and twenty-four patients who were examined for the first time for retinopathy of prematurity were included. Seventy were included in the intervention group and 54 in the control group. The number of patients with pain immediately before the procedure was similar in both groups. The number of patients with pain after ophthalmologic examination was 15.7% in the intervention group and 68.5% in the control group (p<0.001). CONCLUSIONS: One ml of oral 25% glucose solution given 2 minutes before an ophthalmologic examination for retinopathy of prematurity was an effective measure for pain relief. PMID:23525316

  4. Effectiveness of dry needling for chronic nonspecific neck pain: a randomized, single-blinded, clinical trial.

    PubMed

    Cerezo-Téllez, Ester; Torres-Lacomba, María; Fuentes-Gallardo, Isabel; Perez-Muñoz, Milagros; Mayoral-Del-Moral, Orlando; Lluch-Girbés, Enrique; Prieto-Valiente, Luis; Falla, Deborah

    2016-09-01

    Chronic neck pain attributed to a myofascial pain syndrome is characterized by the presence of muscle contractures referred to as myofascial trigger points. In this randomized, parallel-group, blinded, controlled clinical trial, we examined the effectiveness of deep dry needling (DDN) of myofascial trigger points in people with chronic nonspecific neck pain. The study was conducted at a public Primary Health Care Centre in Madrid, Spain, from January 2010 to December 2014. A total of 130 participants with nonspecific neck pain presenting with active myofascial trigger points in their cervical muscles were included. These participants were randomly allocated to receive: DDN plus stretching (n = 65) or stretching only (control group [n = 65]). Four sessions of treatment were applied over 2 weeks with a 6-month follow-up after treatment. Pain intensity, mechanical hyperalgesia, neck active range of motion, neck muscle strength, and perceived neck disability were measured at baseline, after 2 sessions of intervention, after the intervention period, and 15, 30, 90, and 180 days after the intervention. Significant and clinically relevant differences were found in favour of dry needling in all the outcomes (all P < 0.001) at both short and long follow-ups. Deep dry needling and passive stretching is more effective than passive stretching alone in people with nonspecific neck pain. The results support the use of DDN in the management of myofascial pain syndrome in people with chronic nonspecific neck pain.

  5. Sensitivity to Change of Patient‐Preference Measures for Pain in Patients With Knee Osteoarthritis: Data From Two Trials

    PubMed Central

    Callaghan, Michael J.; O'Neill, Terence W.; Forsythe, Laura M.; Lunt, Mark; Felson, David T.

    2016-01-01

    Objective In osteoarthritis (OA) clinical trials, a pain measure that is most sensitive to change is considered optimal. We compared sensitivity to change of patient‐reported pain outcomes, including a patient‐preference measure (where the patient nominates an activity that aggravates their pain). Methods We used data from 2 trials of patients with confirmed (American College of Rheumatology criteria) knee OA: a trial of brace treatment for patellofemoral OA, and a trial of intraarticular steroids in knee OA. Both trials reported an improvement in pain following treatment. Participants rated pain on a 100‐mm visual analog scale (VAS), in the activity that caused them the most knee pain (VASNA), as well as completing questions on overall knee pain and the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores were also calculated from the KOOS. Standardized changes in each outcome were generated between treatment and control after 6 weeks intervention in the BRACE trial, and 1–2 weeks following intervention in the steroid trial. Results The VASNA produced standardized changes following treatment that were at least as large as other pain outcomes. In the BRACE trial, the between‐groups standardized change with the VASNA was −0.63, compared with the KOOS pain subscale change of −0.33, and pain in the last week VAS change of −0.56. In the steroid study, within‐group change following treatment in the VASNA was −0.60, compared to the last week VAS change of −0.51, and KOOS pain subscale change of −0.58. Conclusion Pain on nominated activity appears to be at least as, and in some cases more, sensitive to change than the KOOS/WOMAC questionnaire. PMID:26713415

  6. Sexual assault resistance education for university women: study protocol for a randomized controlled trial (SARE trial)

    PubMed Central

    2013-01-01

    Background More than one in six women will be sexually assaulted in their lifetimes, most by men they know. The situation on university campuses is even more startling, with as many as 1 in 4 female students being victims of rape or attempted rape. The associated physical and mental health effects are extensive and the social and economic costs are staggering. The aim of this randomized controlled trial is to determine whether a novel, small-group sexual assault resistance education program can reduce the incidence of sexual assault among university-attending women, when compared to current university practice of providing informational brochures. Methods/Design The trial will evaluate a theoretically and empirically sound four-unit, 12-hour education program that has been demonstrated in pilot studies to have short-term efficacy. Three of the four units provide information, skills, and practice aimed at decreasing the time needed for women to assess situations with elevated risk of acquaintance sexual assault as dangerous and to take action, reducing emotional obstacles to taking action, and increasing the use of the most effective methods of verbal and physical self-defense. The fourth unit focuses on facilitating a stronger positive sexuality from which women may resist sexual coercion by male intimates more successfully. The trial will extend the pilot evaluations by expanding the participant pool and examining the long term efficacy of the program. A total of 1716 first-year female students (age 17 to 24 years) from three Canadian universities will be enrolled. The primary outcome is completed sexual assault, measured by The Sexual Experiences Survey - Short Form Victimization instrument. Secondary outcomes include changes in knowledge, attitudes, and skills related to the process of sexual assault resistance. Outcomes will be measured at baseline, 1 week, 6, 12, 18, and 24 months. Discussion The results of the trial will be used to produce a maximally

  7. Telemonitoring and Protocolized Case Management for Hypertensive Community-Dwelling Seniors With Diabetes: Protocol of the TECHNOMED Randomized Controlled Trial

    PubMed Central

    McAlister, Finlay Aleck; Wood, Peter William; Boulanger, Pierre; Fradette, Miriam; Klarenbach, Scott; Edwards, Alun L; Holroyd-Leduc, Jayna M; Alagiakrishnan, Kannayiram; Rabi, Doreen; Majumdar, Sumit Ranjan

    2016-01-01

    Background Diabetes and hypertension are devastating, deadly, and costly conditions that are very common in seniors. Controlling hypertension in seniors with diabetes dramatically reduces hypertension-related complications. However, blood pressure (BP) must be lowered carefully because seniors are also susceptible to low BP and attendant harms. Achieving “optimal BP control” (ie, avoiding both undertreatment and overtreatment) is the ultimate therapeutic goal in such patients. Regular BP monitoring is required to achieve this goal. BP monitoring at home is cheap, convenient, widely used, and guideline endorsed. However, major barriers prevent proper use. These may be overcome through use of BP telemonitoring—the secure teletransmission of BP readings to a health portal, where BP data are summarized for provider and patient use, with or without protocolized case management. Objective To examine the incremental effectiveness, safety, cost-effectiveness, usability, and acceptability of home BP telemonitoring, used with or without protocolized case management, compared with “enhanced usual care” in community-dwelling seniors with diabetes and hypertension. Methods A 300-patient, 3-arm, pragmatic randomized controlled trial with blinded outcome ascertainment will be performed in seniors with diabetes and hypertension living independently in seniors’ residences in greater Edmonton. Consenting patients will be randomized to usual care, home BP telemonitoring alone, or home BP telemonitoring plus protocolized pharmacist case management. Usual care subjects will receive a home BP monitor but neither they nor their providers will have access to teletransmitted data. In both telemonitored arms, providers will receive telemonitored BP data summaries. In the case management arm, pharmacist case managers will be responsible for reviewing teletransmitted data and initiating guideline-concordant and protocolized changes in BP management. Results Outcomes will be

  8. Coping with Pain in the Motivational Context of Values: Comparison between an Acceptance-Based and a Cognitive Control-Based Protocol

    ERIC Educational Resources Information Center

    Paez-Blarrina, Marisa; Luciano, Carmen; Gutierrez-Martinez, Olga; Valdivia, Sonsoles; Rodriguez-Valverde, Miguel; Ortega, Jose

    2008-01-01

    This study compares the effect of an acceptance-based protocol (ACT) and a cognitive control-based (CONT) protocol on three measures of pain coping: tolerance, self-report, and believability. Specific methodological controls were employed to further isolate the role of the value of participating in a pain task, compared to previous investigations…

  9. Surgical trial in traumatic intracerebral hemorrhage (STITCH(Trauma)): study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Intracranial hemorrhage occurs in over 60% of severe head injuries in one of three types: extradural (EDH); subdural (SDH); and intraparenchymal (TICH). Prompt surgical removal of significant SDH and EDH is established and widely accepted. However, TICH is more common and is found in more than 40% of severe head injuries. It is associated with a worse outcome but the role for surgical removal remains undefined. Surgical practice in the treatment of TICHs differs widely around the world. The aim of early surgery in TICH removal is to prevent secondary brain injury. There have been trials of surgery for spontaneous ICH (including the STICH II trial), but none so far of surgery for TICH. Methods/Design The UK National Institutes of Health Research has funded STITCH(Trauma) to determine whether a policy of early surgery in patients with TICH improves outcome compared to a policy of initial conservative treatment. It will include a health economics component and carry out a subgroup analysis of patients undergoing invasive monitoring. This is an international multicenter pragmatic randomized controlled trial. Patients are eligible if: they are within 48 h of injury; they have evidence of TICH on CT scan with a confluent volume of attenuation significantly raised above that of the background white and grey matter that has a total volume >10 mL; and their treating neurosurgeon is in equipoise. Patients will be ineligible if they have: a significant surface hematoma (EDH or SDH) requiring surgery; a hemorrhage/contusion located in the cerebellum; three or more separate hematomas fulfilling inclusion criteria; or severe pre-existing physical or mental disability or severe co-morbidity which would lead to poor outcome even if the patient made a full recovery from the head injury. Patients will be randomized via an independent service. Patients randomized to surgery receive surgery within 12 h. Both groups will be monitored according to standard neurosurgical

  10. Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials

    PubMed Central

    Kasenda, Benjamin; von Elm, Erik; You, John J.; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J.; Stegert, Mihaela; Olu, Kelechi K.; Tikkinen, Kari A. O.; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M.; Mertz, Dominik; Akl, Elie A.; Bassler, Dirk; Busse, Jason W.; Nordmann, Alain; Gloy, Viktoria; Ebrahim, Shanil; Schandelmaier, Stefan; Sun, Xin; Vandvik, Per O.; Johnston, Bradley C.; Walter, Martin A.; Burnand, Bernard; Hemkens, Lars G.; Bucher, Heiner C.; Guyatt, Gordon H.; Briel, Matthias

    2016-01-01

    Background Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i) the existence and types of publication agreements in trial protocols, (ii) the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii) the frequency of co-authorship by industry employees. Methods and Findings We used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5%) mentioned an agreement regarding publication of results. Of these 456, 393 (86.2%) documented an industry partner’s right to disapprove or at least review proposed manuscripts; 39 (8.6%) agreements were without constraints of publication. The remaining 24 (5.3%) protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0%) trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]). Of 71 agreements reported in publications, 52 (73.2%) were concordant with those documented in the protocol. In 14 of 37 (37.8%) publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements. Conclusions Publication agreements constraining academic authors’ independence are common. Journal articles seldom report on

  11. Effect of exercise-based management on multidirectional instability of the glenohumeral joint: a pilot randomised controlled trial protocol

    PubMed Central

    Warby, Sarah A; Ford, Jon J; Hahne, Andrew J; Watson, Lyn; Balster, Simon; Lenssen, Ross; Pizzari, Tania

    2016-01-01

    Introduction The most commonly recommended treatment for multidirectional instability (MDI) of the shoulder is exercise. Despite this recommendation, there is limited evidence to support the effectiveness of exercise. The aim of this paper is to describe a pilot randomised controlled trial comparing the effectiveness of 2 exercise programmes on outcomes of participants with MDI. Methods and analysis Consenting participants between 12 and 35 years, with non-traumatic MDI will be randomly allocated to participate in either the Rockwood Instability programme or the Watson MDI programme. Both programmes involve 1 consultation per week for 12 weeks with a physiotherapist to prescribe and progress a home exercise programme. Outcomes will be assessed at baseline, 6, 12, 24 and 52 weeks. Primary outcome measures include the Melbourne Instability Shoulder Score and Western Ontario Shoulder Index. Secondary outcomes include scapular coordinates, scapular upward rotation angles, muscle strength, symptomatic onset, limiting factor and angle of limiting factor in abduction range, incidence of complete glenohumeral joint dislocation, global rating of change, satisfaction scores, the Orebro Musculoskeletal Pain Questionnaire, adverse events and compliance with the home exercise programme. Data will be analysed on intention-to-treat principles and a per protocol basis. Discussion This trial will evaluate whether there are differences in outcomes between the Rockwood and the Watson MDI programmes for participants with MDI. Ethics and dissemination Participant confidentiality will be maintained with publication of results. Ethics approval: Faculty of Health Sciences (FHEC12/201). Trial registration number ACTRN12613001240730; Pre-results. PMID:27619831

  12. Nitrates and bone turnover (NABT) - trial to select the best nitrate preparation: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    will use the ‘multiple comparisons with the best’ approach for data analyses, as this strategy allows practical considerations of ease of use and tolerability to guide selection of the preparation for future studies. Discussion Data from this protocol will be used to develop a randomized, controlled trial of nitrates to prevent osteoporotic fractures. Trial registration ClinicalTrials.gov Identifier: NCT01387672. Controlled-Trials.com: ISRCTN08860742. PMID:24010992

  13. Study protocol of a randomised controlled trial of intranasal ketamine compared with intranasal fentanyl for analgesia in children with suspected, isolated extremity fractures in the paediatric emergency department

    PubMed Central

    Reynolds, Stacy L; Studnek, Jonathan R; Bryant, Kathleen; VanderHave, Kelly; Grossman, Eric; Moore, Charity G; Young, James; Hogg, Melanie; Runyon, Michael S

    2016-01-01

    Introduction Fentanyl is the most widely studied intranasal (IN) analgesic in children. IN subdissociative (INSD) ketamine may offer a safe and efficacious alternative to IN fentanyl and may decrease overall opioid use during the emergency department (ED) stay. This study examines the feasibility of a larger, multicentre clinical trial comparing the safety and efficacy of INSD ketamine to IN fentanyl and the potential role for INSD ketamine in reducing total opioid medication usage. Methods and analysis This double-blind, randomised controlled, pilot trial will compare INSD ketamine (1 mg/kg) to IN fentanyl (1.5 μg/kg) for analgesia in 80 children aged 4–17 years with acute pain from a suspected, single extremity fracture. The primary safety outcome for this pilot trial will be the frequency of cumulative side effects and adverse events at 60 min after drug administration. The primary efficacy outcome will be exploratory and will be the mean reduction of pain scale scores at 20 min. The study is not powered to examine efficacy. Secondary outcome measures will include the total dose of opioid pain medication in morphine equivalents/kg/hour (excluding study drug) required during the ED stay, number and reason for screen failures, time to consent, and the number and type of protocol deviations. Patients may receive up to 2 doses of study drug. Ethics and dissemination This study was approved by the US Food and Drug Administration, the local institutional review board and the study data safety monitoring board. This study data will be submitted for publication regardless of results and will be used to establish feasibility for a multicentre, non-inferiority trial. Trial registration number NCT02521415. PMID:27609854

  14. PACE - The first placebo controlled trial of paracetamol for acute low back pain: design of a randomised controlled trial

    PubMed Central

    2010-01-01

    Background Clinical practice guidelines recommend that the initial treatment of acute low back pain (LBP) should consist of advice to stay active and regular simple analgesics such as paracetamol 4 g daily. Despite this recommendation in all international LBP guidelines there are no placebo controlled trials assessing the efficacy of paracetamol for LBP at any dose or dose regimen. This study aims to determine whether 4 g of paracetamol daily (in divided doses) results in a more rapid recovery from acute LBP than placebo. A secondary aim is to determine if ingesting paracetamol in a time-contingent manner is more effective than paracetamol taken when required (PRN) for recovery from acute LBP. Methods/Design The study is a randomised double dummy placebo controlled trial. 1650 care seeking people with significant acute LBP will be recruited. All participants will receive advice to stay active and will be randomised to 1 of 3 treatment groups: time-contingent paracetamol dose regimen (plus placebo PRN paracetamol), PRN paracetamol (plus placebo time-contingent paracetamol) or a double placebo study arm. The primary outcome will be time (days) to recovery from pain recorded in a daily pain diary. Other outcomes will be pain intensity, disability, function, global perceived effect and sleep quality, captured at baseline and at weeks 1, 2, 4 and 12 by an assessor blind to treatment allocation. An economic analysis will be conducted to determine the cost-effectiveness of treatment from the health sector and societal perspectives. Discussion The successful completion of the trial will provide the first high quality evidence on the effectiveness of the use of paracetamol, a guideline endorsed treatment for acute LBP. Trail registration ACTRN12609000966291. PMID:20650012

  15. Parecoxib increases muscle pain threshold and relieves shoulder pain after gynecologic laparoscopy: a randomized controlled trial

    PubMed Central

    Zhang, Hufei; Liu, Xinhe; Jiang, Hongye; Liu, Zimeng; Zhang, Xu-Yu; Xie, Hong-Zhe

    2016-01-01

    Objectives Postlaparoscopic shoulder pain (PLSP) remains a common problem after laparoscopies. The aim of this study was to investigate the correlation between pressure pain threshold (PPT) of different muscles and PLSP after gynecologic laparoscopy, and to explore the effect of parecoxib, a cyclooxygenase-2 inhibitor, on the changes of PPT. Materials and methods The patients were randomly allocated into two groups; group P and group C. In group P, parecoxib 40 mg was intravenously infused at 30 minutes before surgery and 8 and 20 hours after surgery. In group C, normal saline was infused at the corresponding time point. PPT assessment was performed 1 day before surgery and at postoperative 24 hours by using a pressure algometer at bilateral shoulder muscles (levator scapulae and supraspinatus) and forearm (flexor carpi ulnaris). Meanwhile, bilateral shoulder pain was evaluated through visual analog scale score at 24 hours after surgery. Results Preoperative PPT level of the shoulder, but not of the forearm, was significantly and negatively correlated with the intensity of ipsilateral PLSP. In group C, PPT levels of shoulder muscles, but not of forearm muscles, decreased after laparoscopy at postoperative 24 hours. The use of parecoxib significantly improved the decline of PPT levels of bilateral shoulder muscles (all P<0.01). Meanwhile, parecoxib reduced the incidence of PLSP (group P: 45% vs group C: 83.3%; odds ratio: 0.164; 95% confidence interval: 0.07–0.382; P<0.001) and the intensity of bilateral shoulder pain (both P<0.01). Conclusion Preoperative PPT levels of shoulder muscles are closely associated with the severity of shoulder pain after gynecologic laparoscopy. PPT levels of shoulder muscles, but not of forearm muscles, significantly decreased after surgery. Parecoxib improved the decrease of PPT and relieved PLSP.

  16. Parecoxib increases muscle pain threshold and relieves shoulder pain after gynecologic laparoscopy: a randomized controlled trial

    PubMed Central

    Zhang, Hufei; Liu, Xinhe; Jiang, Hongye; Liu, Zimeng; Zhang, Xu-Yu; Xie, Hong-Zhe

    2016-01-01

    Objectives Postlaparoscopic shoulder pain (PLSP) remains a common problem after laparoscopies. The aim of this study was to investigate the correlation between pressure pain threshold (PPT) of different muscles and PLSP after gynecologic laparoscopy, and to explore the effect of parecoxib, a cyclooxygenase-2 inhibitor, on the changes of PPT. Materials and methods The patients were randomly allocated into two groups; group P and group C. In group P, parecoxib 40 mg was intravenously infused at 30 minutes before surgery and 8 and 20 hours after surgery. In group C, normal saline was infused at the corresponding time point. PPT assessment was performed 1 day before surgery and at postoperative 24 hours by using a pressure algometer at bilateral shoulder muscles (levator scapulae and supraspinatus) and forearm (flexor carpi ulnaris). Meanwhile, bilateral shoulder pain was evaluated through visual analog scale score at 24 hours after surgery. Results Preoperative PPT level of the shoulder, but not of the forearm, was significantly and negatively correlated with the intensity of ipsilateral PLSP. In group C, PPT levels of shoulder muscles, but not of forearm muscles, decreased after laparoscopy at postoperative 24 hours. The use of parecoxib significantly improved the decline of PPT levels of bilateral shoulder muscles (all P<0.01). Meanwhile, parecoxib reduced the incidence of PLSP (group P: 45% vs group C: 83.3%; odds ratio: 0.164; 95% confidence interval: 0.07–0.382; P<0.001) and the intensity of bilateral shoulder pain (both P<0.01). Conclusion Preoperative PPT levels of shoulder muscles are closely associated with the severity of shoulder pain after gynecologic laparoscopy. PPT levels of shoulder muscles, but not of forearm muscles, significantly decreased after surgery. Parecoxib improved the decrease of PPT and relieved PLSP. PMID:27695359

  17. Protocol for the Locomotor Experience Applied Post-stroke (LEAPS) trial: a randomized controlled trial

    PubMed Central

    Duncan, Pamela W; Sullivan, Katherine J; Behrman, Andrea L; Azen, Stanley P; Wu, Samuel S; Nadeau, Stephen E; Dobkin, Bruce H; Rose, Dorian K; Tilson, Julie K

    2007-01-01

    Background Locomotor training using body weight support and a treadmill as a therapeutic modality for rehabilitation of walking post-stroke is being rapidly adopted into clinical practice. There is an urgent need for a well-designed trial to determine the effectiveness of this intervention. The objective of the Locomotor Experience Applied Post-Stroke (LEAPS) trial is to determine if there is a difference in the proportion of participants who recover walking ability at one year post-stroke when randomized to a specialized locomotor training program (LTP), conducted at 2- or 6-months post-stroke, or those randomized to a home based non-specific, low intensity exercise intervention (HEP) provided 2 months post-stroke. We will determine if the timing of LTP delivery affects gait speed at 1 year and whether initial impairment severity interacts with the timing of LTP. The effect of number of treatment sessions will be determined by changes in gait speed taken pre-treatment and post-12, -24, and -36 sessions. Methods/Design We will recruit 400 adults with moderate or severe walking limitations within 30 days of stroke onset. At two months post stroke, participants are stratified by locomotor impairment severity as determined by overground walking speed and randomly assigned to one of three groups: (a) LTP-Early; (b) LTP-Late or (c) Home Exercise Program -Early. The LTP program includes body weight support on a treadmill and overground training. The LTP and HEP interventions are delivered for 36 sessions over 12 weeks. Primary outcome measure include successful walking recovery defined as the achievement of a 0.4 m/s gait speed or greater by persons with initial severe gait impairment or the achievement of a 0.8 m/s gait speed or greater by persons with initial moderate gait impairment. LEAPS is powered to detect a 20% difference in the proportion of participants achieving successful locomotor recovery between the LTP groups and the HEP group, and a 0.1 m/s mean

  18. Amiloride Clinical Trial In Optic Neuritis (ACTION) protocol: a randomised, double blind, placebo controlled trial

    PubMed Central

    McKee, Justin B; Elston, John; Evangelou, Nikos; Gerry, Stephen; Fugger, Lars; Kennard, Christopher; Kong, Yazhuo; Palace, Jacqueline; Craner, Matthew

    2015-01-01

    Introduction Neurodegeneration is a widely accepted contributor to the development of long-term disability in multiple sclerosis (MS). While current therapies in MS predominantly target inflammation and reduce relapse rate they have been less effective at preventing long-term disability. The identification and evaluation of effective neuroprotective therapies within a trial paradigm are key unmet needs. Emerging evidence supports amiloride, a licenced diuretic, as a neuroprotective agent in MS through acid sensing ion channel blockade. Optic neuritis (ON) is a common manifestation of MS with correlates of inflammation and neurodegeneration measurable within the visual pathways. Amiloride Clinical Trial In Optic Neuritis (ACTION) will utilise a multimodal approach to assess the neuroprotective efficacy of amiloride in acute ON. Methods and analysis 46 patients will be recruited within 28 days from onset of ON visual symptoms and randomised on a 1:1 basis to placebo or amiloride 10 mg daily. Double-blinded treatment groups will be balanced for age, sex and visual loss severity by a random-deterministic minimisation algorithm. The primary objective is to demonstrate that amiloride is neuroprotective in ON as assessed by scanning laser polarimetry of the peripapillary retinal nerve fibre layer (RNFL) thickness at 6 months in the affected eye compared to the unaffected eye at baseline. RNFL in combination with further retinal measures will also be assessed by optical coherence tomography. Secondary outcome measures on brain MRI will include cortical volume, diffusion-weighted imaging, resting state functional MRI, MR spectroscopy and magnetisation transfer ratio. In addition, high and low contrast visual acuity, visual fields, colour vision and electrophysiology will be assessed alongside quality of life measures. Ethics and dissemination Ethical approval was given by the south central Oxford B research ethics committee (REC reference: 13/SC/0022). The findings

  19. Krill Oil Improves Mild Knee Joint Pain: A Randomized Control Trial

    PubMed Central

    Fukushima, Minoru; Sakuraba, Keishoku; Sawaki, Keisuke; Sekigawa, Kazuaki

    2016-01-01

    Background Krill oil is an edible oil extracted from krill, a small red-colored crustacean found in the Antarctic Ocean. The administration of krill oil is reported to mitigate inflammation in patients with cardiac disease, rheumatoid arthritis, or osteoarthritis. However, the effect of krill oil on mild knee pain has not yet been determined. Objective To assess the effect of krill oil on mild knee pain. Design A randomized, double-blind, parallel-group, placebo-controlled trial of fifty adults (38–85 years old) with mild knee pain attending the Fukushima Orthopedic Clinic (Tochigi, Japan) between September 2014 and March 2015. Interventions Participants were randomized to receive 2 g per day of either krill oil or an identical placebo for 30 days. Outcomes The primary outcome was improvement in subjective symptoms of knee pain as assessed by the Japanese Knee Osteoarthritis Measure (JKOM) and Japanese Orthopaedic Association score (JOA). Secondary outcomes included blood and urine biochemical parameters. Results Both the placebo and krill oil groups showed significant improvements in the questions in the JKOM and JOA questionnaires after administration. After the intervention, krill oil group showed more improvements than placebo group in two questions regarding the pain and stiffness in knees in JKOM. Controlling for age, sex, weight, and smoking and drinking habits, krill oil significantly mitigated knee pain in sleeping (P < 0.001), standing (P < 0.001) and the range of motion of both right and left knees (both P = 0.011) compared to placebo. Krill oil administration raised plasma EPA (P = 0.048) and EPA/AA ratio (P = 0.003). Conclusion This study indicates that krill oil administration (2 g/day, 30 days) improved the subjective symptoms of knee pain in adults with mild knee pain. Trial registration UMIN-CTR; ID UMIN000014413 PMID:27701428

  20. Ketorolac for Pain Control With Intrauterine Device Placement: A Randomized Controlled Trial

    PubMed Central

    Ngo, Lynn L.; Ward, Kristy K.; Mody, Sheila K.

    2015-01-01

    Objective To evaluate intramuscular ketorolac compared to placebo saline injection for pain control with intrauterine device (IUD) placement. Methods We conducted a randomized, double-blind, placebo controlled trial between July 2012 and March 2014. Patients received ketorolac 30mg or placebo saline intramuscular injection 30 minutes prior to IUD placement. The primary outcome was pain with IUD placement on a 10cm visual analog scale (VAS). Sample size was calculated to provide 80% power to show a 2.0cm difference (α=0.05) in the primary outcome. Secondary outcomes included pain with study drug injection, speculum insertion, tenaculum placement, uterine sounding, and at 5 and 15 minutes after IUD placement. Results A total of 67 women participated in the study, 33 in the ketorolac arm and 34 in the placebo arm. There were no differences in baseline demographics including age, BMI, and race. There were no differences in median pain scores for IUD placement in the placebo versus ketorolac groups (5.2cm vs 3.6cm, p=0.99). There was a decrease in median pain scores at 5 minutes (2.2cm vs 0.3cm, p=<0.001) and 15 minutes (1.6cm vs 0.1cm, p=<0.001) after IUD placement but no difference for all other time points. Nulliparous participants (n=16, 8 per arm) had a decrease in pain scores with IUD placement (8.1cm vs 5.4cm, p=0.02). In this study, 22% of participants in the placebo group and 18% in the ketorolac group reported injection pain was as painful as IUD placement. Conclusions Ketorolac does not reduce pain with IUD placement but does reduce pain at 5 and 15 minutes after placement. PMID:26241253

  1. Nutritional route in oesophageal resection trial II (NUTRIENT II): study protocol for a multicentre open-label randomised controlled trial

    PubMed Central

    Berkelmans, Gijs H K; Wilts, Bas J W; Kouwenhoven, Ewout A; Kumagai, Koshi; Nilsson, Magnus; Weijs, Teus J; Nieuwenhuijzen, Grard A P; van Det, Marc J; Luyer, Misha D P

    2016-01-01

    Introduction Early start of an oral diet is safe and beneficial in most types of gastrointestinal surgery and is a crucial part of fast track or enhanced recovery protocols. However, the feasibility and safety of oral intake directly following oesophagectomy remain unclear. The aim of this study is to investigate the effects of early versus delayed start of oral intake on postoperative recovery following oesophagectomy. Methods and analysis This is an open-label multicentre randomised controlled trial. Patients undergoing elective minimally invasive or hybrid oesophagectomy for cancer are eligible. Further inclusion criteria are intrathoracic anastomosis, written informed consent and age 18 years or older. Inability for oral intake, inability to place a feeding jejunostomy, inability to provide written consent, swallowing disorder, achalasia, Karnofsky Performance Status <80 and malnutrition are exclusion criteria. Patients will be randomised using online randomisation software. The intervention group (direct oral feeding) will receive a liquid oral diet for 2 weeks with gradually expanding daily maximums. The control group (delayed oral feeding) will receive enteral feeding via a jejunostomy during 5 days and then start the same liquid oral diet. The primary outcome measure is functional recovery. Secondary outcome measures are 30-day surgical complications; nutritional status; need for artificial nutrition; need for additional interventions; health-related quality of life. We aim to recruit 148 patients. Statistical analysis will be performed according to an intention to treat principle. Results are presented as risk ratios with corresponding 95% CIs. A two-tailed p<0.05 is considered statistically significant. Ethics and dissemination Our study protocol has received ethical approval from the Medical research Ethics Committees United (MEC-U). This study is conducted according to the principles of Good Clinical Practice. Verbal and written informed consent is

  2. Acupuncture for acute stroke: study protocol for a multicenter, randomized, controlled trial

    PubMed Central

    2014-01-01

    Background Acupuncture has been widely used as a treatment for stroke in China for more than 3,000 years. However, previous research has not yet shown that acupuncture is effective as a stroke treatment. We report a protocol for a multicenter, randomized, controlled, and outcome assessor-blind trial to evaluate the efficacy and safety of acupuncture on acute ischemic stroke. Methods/Design In a prospective trial involving three hospitals in the Zhejiang Province (China) 250 patients with a recent (less than 1 week previous) episode of ischemic stroke will be included. Patients will be randomized into two groups: an acupuncture group given scalp acupuncture and electroacupuncture, and a control group given no acupuncture. Eighteen treatment sessions will be performed over a three-week period. The primary outcome will be measured by changes in the National Institutes of Health Stroke Scale score at the one, three, and four-week follow-up. Secondary outcome measures will be: 1) the Fugl-Meyer assessment scale for motor function; 2) the mini-mental state examination and Montreal cognitive assessment for cognitive function; 3) the video-fluoroscopic swallowing study for swallowing ability; and 4) the incidence of adverse events. Discussion This trial is expected to clarify whether or not acupuncture is effective for acute stroke. It will also show if acupuncture can improve motor, cognitive, or swallowing function. Trial registration Chinese Clinical Trial Registry ChiCTR-TRC-12001971. PMID:24908241

  3. Relationship of opioid analgesic protocols to assessed pain and length of stay in the pediatric postanesthesia unit following tonsillectomy.

    PubMed

    Smith, Jana; Newcomb, Patricia; Sundberg, Erin; Shaffer, Paul

    2009-04-01

    After tonsillectomy and adenoidectomy in children, postoperative pain management is an essential, yet often challenging, task. In addition to discomfort, lack of pain management can lead to delays in oral intake of patients, resulting in extended stays and increased costs. At one North Texas pediatric facility, postoperative coblation tonsillectomy and adenoidectomy pain management orders include the as-needed use of both intravenous fentanyl and intravenous morphine. Both drugs are effective and both have potential side effects that might prolong the recovery period. Nurses in the postanesthesia care unit retrospectively compared a fentanyl and morphine regimen with a morphine-only regimen to determine whether either protocol made a difference in length-of-stay or pain relief. Analysis of available data revealed no statistically significant differences in length of stay between the groups and trivial differences thought to be clinically irrelevant on other variables.

  4. Consensus recommendations for a standardized Brain Tumor Imaging Protocol in clinical trials

    PubMed Central

    Ellingson, Benjamin M.; Bendszus, Martin; Boxerman, Jerrold; Barboriak, Daniel; Erickson, Bradley J.; Smits, Marion; Nelson, Sarah J.; Gerstner, Elizabeth; Alexander, Brian; Goldmacher, Gregory; Wick, Wolfgang; Vogelbaum, Michael; Weller, Michael; Galanis, Evanthia; Kalpathy-Cramer, Jayashree; Shankar, Lalitha; Jacobs, Paula; Pope, Whitney B.; Yang, Dewen; Chung, Caroline; Knopp, Michael V.; Cha, Soonme; van den Bent, Martin J.; Chang, Susan; Al Yung, W.K.; Cloughesy, Timothy F.; Wen, Patrick Y.; Gilbert, Mark R.

    2015-01-01

    A recent joint meeting was held on January 30, 2014, with the US Food and Drug Administration (FDA), National Cancer Institute (NCI), clinical scientists, imaging experts, pharmaceutical and biotech companies, clinical trials cooperative groups, and patient advocate groups to discuss imaging endpoints for clinical trials in glioblastoma. This workshop developed a set of priorities and action items including the creation of a standardized MRI protocol for multicenter studies. The current document outlines consensus recommendations for a standardized Brain Tumor Imaging Protocol (BTIP), along with the scientific and practical justifications for these recommendations, resulting from a series of discussions between various experts involved in aspects of neuro-oncology neuroimaging for clinical trials. The minimum recommended sequences include: (i) parameter-matched precontrast and postcontrast inversion recovery-prepared, isotropic 3D T1-weighted gradient-recalled echo; (ii) axial 2D T2-weighted turbo spin-echo acquired after contrast injection and before postcontrast 3D T1-weighted images to control timing of images after contrast administration; (iii) precontrast, axial 2D T2-weighted fluid-attenuated inversion recovery; and (iv) precontrast, axial 2D, 3-directional diffusion-weighted images. Recommended ranges of sequence parameters are provided for both 1.5 T and 3 T MR systems. PMID:26250565

  5. Quality Assessment of Randomized Control Trials Applied Psychotherapy for Chronic Pains in Iran: A Systematic Review of Domestic Trials

    PubMed Central

    Faizi, Fakhrudin; Tavallaee, Abbas; Rahimi, Aboulfazl; Saburi, Amin; Saghafinia, Masoud

    2014-01-01

    Context: Keeping in mind the burden of psychotherapy can play a crucial role concerning chronic pain (CP). Psychotherapy techniques are widely used to relief Chronic Pain (CP) worldwide. Appling psychotherapy needs to consider both individual and popular cultures. In addition to international requirements; nation-wide legitimacy should be regarded too. Psychological methods have provided a lot of articles in Iran, but they were neglected by the reviewers because the documents only have abstracts in English. The current study aimed to assess all Farsi Randomized Control Trials (RCTs) addressing psychotherapy to relieve chronic pains. Evidence Acquisition: Six nation-wide medical databases were investigated in 2012 using the keyword chronic pain in the Abstracts, systematically. Appling PICO question format (patient problem or population, intervention, comparison, and outcomes) all the interventional studies were reviewed for eligibility. Retrieving full text (in Farsi) and making the articles indistinguishable, two native reviewers assessed the quality of the articles independently using Jadad scale. Results: Inclusion criteria met 1542 abstracts. After refining and excluding, seventeen experimental studies were retrieved and evaluated. Mean quality score of Jadad was 1.53 ± 1.37 (median = 1.0). Cognitive Behavior Therapy (CBT) was the dominant approach (11 out of 17) and the majority (6 out of 17 studies) of the treated cases was Low Back Pain (LBP). Patient-therapist gender adjustment has clearly reported in most of the studies, based on the requirements. Conclusions: Cognitive Behavior Therapy was more effective than the other psychotherapy approaches relieving chronic pain in the studies. Well-designed studies and comprehensive clarification of the studies demonstrating groups, intervention, follow-up and drop outs can improve the quality of the RCTs. PMID:25593723

  6. Barriers to primary care clinician adherence to clinical guidelines for the management of low back pain: protocol of a systematic review and meta-synthesis of qualitative studies

    PubMed Central

    Slade, Susan C; Kent, Peter; Bucknall, Tracey; Molloy, Elizabeth; Patel, Shilpa; Buchbinder, Rachelle

    2015-01-01

    Introduction Low back pain is the highest ranked condition contributing to years lived with disability, and is a significant economic and societal burden. Evidence-based clinical practice guidelines are designed to improve quality of care and reduce practice variation by providing graded recommendations based on the best available evidence. Studies of low back pain guideline implementation have shown no or modest effects at changing clinical practice. Objectives To identify enablers and barriers to adherence to clinical practice guidelines for the management of low back pain. Methods and analysis A systematic review and meta-synthesis of qualitative studies that will be conducted and reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statement guidelines. Eight databases will be searched using a priori inclusion/exclusion criteria. Two independent reviewers will conduct a structured review and meta-synthesis, and a third reviewer will arbitrate where there is disagreement. This protocol has been registered on PROSPERO 2014. Ethics and dissemination Ethical approval is not required. The systematic review will be published in a peer-reviewed journal. The review will also be disseminated electronically, in print and at conferences. Updates of the review will be conducted to inform and guide healthcare translation into practice. Trial registration number PROSPERO 2014:CRD42014012961. Available from http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42014012961 PMID:25900462

  7. Manual therapy for the management of pain and limited range of motion in subjects with signs and symptoms of temporomandibular disorder: a systematic review of randomised controlled trials.

    PubMed

    Calixtre, L B; Moreira, R F C; Franchini, G H; Alburquerque-Sendín, F; Oliveira, A B

    2015-11-01

    There is a lack of knowledge about the effectiveness of manual therapy (MT) on subjects with temporomandibular disorders (TMD). The aim of this systematic review is to synthetise evidence regarding the isolated effect of MT in improving maximum mouth opening (MMO) and pain in subjects with signs and symptoms of TMD. MEDLINE(®) , Cochrane, Web of Science, SciELO and EMBASE(™) electronic databases were consulted, searching for randomised controlled trials applying MT for TMD compared to other intervention, no intervention or placebo. Two authors independently extracted data, PEDro scale was used to assess risk of bias, and GRADE (Grading of Recommendations Assessment, Development and Evaluation) was applied to synthetise overall quality of the body of evidence. Treatment effect size was calculated for pain, MMO and pressure pain threshold (PPT). Eight trials were included, seven of high methodological quality. Myofascial release and massage techniques applied on the masticatory muscles are more effective than control (low to moderate evidence) but as effective as toxin botulinum injections (moderate evidence). Upper cervical spine thrust manipulation or mobilisation techniques are more effective than control (low to high evidence), while thoracic manipulations are not. There is moderate-to-high evidence that MT techniques protocols are effective. The methodological heterogeneity across trials protocols frequently contributed to decrease quality of evidence. In conclusion, there is widely varying evidence that MT improves pain, MMO and PPT in subjects with TMD signs and symptoms, depending on the technique. Further studies should consider using standardised evaluations and better study designs to strengthen clinical relevance.

  8. Manual therapy for the management of pain and limited range of motion in subjects with signs and symptoms of temporomandibular disorder: a systematic review of randomised controlled trials.

    PubMed

    Calixtre, L B; Moreira, R F C; Franchini, G H; Alburquerque-Sendín, F; Oliveira, A B

    2015-11-01

    There is a lack of knowledge about the effectiveness of manual therapy (MT) on subjects with temporomandibular disorders (TMD). The aim of this systematic review is to synthetise evidence regarding the isolated effect of MT in improving maximum mouth opening (MMO) and pain in subjects with signs and symptoms of TMD. MEDLINE(®) , Cochrane, Web of Science, SciELO and EMBASE(™) electronic databases were consulted, searching for randomised controlled trials applying MT for TMD compared to other intervention, no intervention or placebo. Two authors independently extracted data, PEDro scale was used to assess risk of bias, and GRADE (Grading of Recommendations Assessment, Development and Evaluation) was applied to synthetise overall quality of the body of evidence. Treatment effect size was calculated for pain, MMO and pressure pain threshold (PPT). Eight trials were included, seven of high methodological quality. Myofascial release and massage techniques applied on the masticatory muscles are more effective than control (low to moderate evidence) but as effective as toxin botulinum injections (moderate evidence). Upper cervical spine thrust manipulation or mobilisation techniques are more effective than control (low to high evidence), while thoracic manipulations are not. There is moderate-to-high evidence that MT techniques protocols are effective. The methodological heterogeneity across trials protocols frequently contributed to decrease quality of evidence. In conclusion, there is widely varying evidence that MT improves pain, MMO and PPT in subjects with TMD signs and symptoms, depending on the technique. Further studies should consider using standardised evaluations and better study designs to strengthen clinical relevance. PMID:26059857

  9. Trial protocol for a randomised controlled trial of red cell washing for the attenuation of transfusion-associated organ injury in cardiac surgery: the REDWASH trial

    PubMed Central

    Murphy, G J; Verheyden, V; Wozniak, M; Sullo, N; Dott, W; Bhudia, S; Bittar, N; Morris, T; Ring, A; Tebbatt, A; Kumar, T

    2016-01-01

    Introduction It has been suggested that removal of proinflammatory substances that accumulate in stored donor red cells by mechanical cell washing may attenuate inflammation and organ injury in transfused cardiac surgery patients. This trial will test the hypotheses that the severity of the postoperative inflammatory response will be less and postoperative recovery faster if patients undergoing cardiac surgery receive washed red cells compared with standard care (unwashed red cells). Methods and analysis Adult (≥16 years) cardiac surgery patients identified at being at increased risk for receiving large volume red cell transfusions at 1 of 3 UK cardiac centres will be randomly allocated in a 1:1 ratio to either red cell washing or standard care. The primary outcome is serum interleukin-8 measured at 5 postsurgery time points up to 96 h. Secondary outcomes will include measures of inflammation, organ injury and volumes of blood transfused and cost-effectiveness. Allocation concealment, internet-based randomisation stratified by operation type and recruiting centre, and blinding of outcome assessors will reduce the risk of bias. The trial will test the superiority of red cell washing versus standard care. A sample size of 170 patients was chosen in order to detect a small-to-moderate target difference, with 80% power and 5% significance (2-tailed). Ethics and dissemination The trial protocol was approved by a UK ethics committee (reference 12/EM/0475). The trial findings will be disseminated in scientific journals and meetings. Trial registration number ISRCTN 27076315. PMID:26977309

  10. Physical Exam and Self-Reported Pain Outcomes from a Randomized Trial on Chronic Cervicogenic Headache

    PubMed Central

    Vavrek, Darcy; Haas, Mitchell; Peterson, Dave

    2010-01-01

    Objective Objective clinical measures for use as surrogate markers of cervicogenic headache (CGH) pain have not been established. In this analysis, we investigate relationships between objective physical exam (PE) measures with self-reported CGH outcomes. Methods This is an exploratory analysis of data generated by attention control PE from an open-label randomized clinical trial. Forty of 80 subjects were randomized to 8 treatments (spinal manipulative therapy or light massage control) and 8 PE over 8 weeks. The remaining subjects received no PE. PE included motion palpation of the cervical and upper thoracic regions, active cervical range of motion (ROM) and associated pain, and algometric pain threshold evaluated over articular pillars. Self-reported outcomes included CGH and neck pain and disability, number of CGH headaches, and related disability days. Associations between PE and self-reported outcomes were evaluated using generalized linear models, adjusting for socio-demographic differences and study group. Results At baseline, number of CGH and disability days were strongly associated with cervical active ROM (p <.001 to .037). Neck pain and disability were strongly associated with ROM-elicited pain (p <.001 to .035) but not later in the study. After the final treatment, pain thresholds were strongly associated with week 12 neck pain and disability and CGH disability and disability days (p =<.001 to .048). Conclusions Cervical ROM was most associated with the baseline headache experience. However, 4 weeks after treatment, algometric pain thresholds were most associated. No one PE measure remained associated with the self-reported headache outcomes over time. PMID:20605552

  11. Traumatic Brain Injury in Latin America: Lifespan Analysis Randomized Control Trial Protocol

    PubMed Central

    Chesnut, Randall M.; Temkin, Nancy; Carney, Nancy; Dikmen, Sureyya; Pridgeon, Jim; Barber, Jason; Celix, Juanita M.; Chaddock, Kelley; Cherner, Marianna; Hendrix, Terence; Lujan, Silvia; Machamer, Joan; Petroni, Gustavo; Rondina, Carlos; Videtta, Walter

    2012-01-01

    Background Although in the developed world the intracranial pressure (ICP) monitor is considered “standard of care” for patients with severe traumatic brain injury (TBI), its usefulness to direct treatment decisions has never been tested rigorously. Objective The primary focus is to conduct a high quality randomized, controlled trial to determine if ICP monitoring used to direct TBI treatment improves patient outcomes. By providing education, equipment, and structure, the project will enhance the research capacity of the collaborating investigators and will foster the collaborations established during earlier studies (add refs to papers from earlier studies). Methods Study centers were selected that routinely treated ICP based on clinical examination and CT imaging using internal protocols. We randomize patients to either an ICP Monitor Group or an Imaging and Clinical Examination Group. Treatment decisions for the ICP Monitor Group are guided by ICP monitoring, based on established guidelines. Treatment decisions for the Imaging and Clinical Examination Group are made using a single protocol derived from those previously being used at those centers. Expected Outcomes There are two study hypotheses: 1) Patients with severe TBI whose acute care treatment is managed using ICP monitors will have improved outcomes and 2) incorporating ICP monitoring into the care of patients with severe TBI will minimize complications and decrease length of ICU stay. Discussion This clinical trial tests the effectiveness of a management protocol based on technology considered pivotal to brain trauma treatment in the developed world - the ICP monitor. A randomized controlled trial of ICP monitoring has never been performed - a critical gap in the evidence base that supports the role of ICP monitoring in TBI care. As such, the results of this RCT will have global implications regardless of the level of development of the trauma system. PMID:22986600

  12. A Randomized Placebo-Controlled Trial of Duloxetine for Central Pain in Multiple Sclerosis

    PubMed Central

    Slee, April

    2015-01-01

    Background: Pain is common in multiple sclerosis (MS). Duloxetine has a potential therapeutic role in treating MS-related pain. Methods: Thirty-eight MS patients were randomized 1:1 to receive duloxetine (n = 18) or matched placebo (n = 20). The dosing regimen was 30 mg daily for 1 week, then 60 mg daily for 5 weeks. The primary outcome measure was change in worst pain for week 6 relative to baseline recorded on a daily pain diary. Results: Of 38 randomized patients, 14 (78%) patients randomized to duloxetine and 18 (90%) randomized to placebo completed treatment per protocol. These participants had an average age of 55.5 years, 25% were male, and 66% had relapsing-remitting MS (RRMS). Baseline characteristics were similar. Discontinuations were due primarily to drug intolerance. Among those who completed treatment, worst pain at 6 weeks was reduced by 29% (±20%) for duloxetine versus 12% (±18%) for placebo (P = .016). Average daily pain at 6 weeks was reduced by 39% (±29%) in the duloxetine group compared to 10% (±18.8%) in the placebo group (P = .002). There were no significant changes (week 6 vs. baseline) or between-group differences for subject global impression, Beck Depression Inventory, 36-item Short Form Health Status Survey (SF-36), or sleep quality score. Conclusions: Fewer patients could tolerate duloxetine compared to placebo. Among patients who completed 6 weeks of treatment, there were significant reductions in average and worst daily pain scores with duloxetine compared to placebo. This study suggests that duloxetine has a direct pain-relieving effect in MS. PMID:25892978

  13. Total ankle replacement versus arthrodesis (TARVA): protocol for a multicentre randomised controlled trial

    PubMed Central

    Goldberg, Andrew J; Zaidi, Razi; Thomson, Claire; Doré, Caroline J; Cro, Suzie; Round, Jeff; Molloy, Andrew; Davies, Mark; Karski, Michael; Kim, Louise; Cooke, Paul

    2016-01-01

    Introduction Total ankle replacement (TAR) or ankle arthrodesis (fusion) is the main surgical treatments for end-stage ankle osteoarthritis (OA). The popularity of ankle replacement is increasing while ankle fusion rates remain static. Both treatments have efficacy but to date all studies comparing the 2 have been observational without randomisation, and there are no published guidelines as to the most appropriate management. The TAR versus arthrodesis (TARVA) trial aims to compare the clinical and cost-effectiveness of TAR against ankle arthrodesis in the treatment of end-stage ankle OA in patients aged 50–85 years. Methods and analysis TARVA is a multicentre randomised controlled trial that will randomise 328 patients aged 50–85 years with end-stage ankle arthritis. The 2 arms of the study will be TAR or ankle arthrodesis with 164 patients in each group. Up to 16 UK centres will participate. Patients will have clinical assessments and complete questionnaires before their operation and at 6, 12, 26 and 52 weeks after surgery. The primary clinical outcome of the study is a validated patient-reported outcome measure, the Manchester Oxford foot questionnaire, captured preoperatively and 12 months after surgery. Secondary outcomes include quality-of-life scores, complications, revision, reoperation and a health economic analysis. Ethics and dissemination The protocol has been approved by the National Research Ethics Service Committee (London, Bloomsbury 14/LO/0807). This manuscript is based on V.5.0 of the protocol. The trial findings will be disseminated through peer-reviewed publications and conference presentations. Trial registration number NCT02128555. PMID:27601503

  14. A randomised controlled trial of acceptance and commitment therapy (ACT) for psychosis: study protocol

    PubMed Central

    2014-01-01

    Background Cognitive behavior therapy for psychosis has been a prominent intervention in the psychological treatment of psychosis. It is, however, a challenging therapy to deliver and, in the context of increasingly rigorous trials, recent reviews have tempered initial enthusiasm about its effectiveness in improving clinical outcomes. Acceptance and commitment therapy shows promise as a briefer, more easily implemented therapy but has not yet been rigorously evaluated in the context of psychosis. The purpose of this trial is to evaluate whether Acceptance and Commitment Therapy could reduce the distress and disability associated with psychotic symptoms in a sample of community-residing patients with chronic medication-resistant symptoms. Methods/Design This is a single (rater)-blind multi-centre randomised controlled trial comparing Acceptance and Commitment Therapy with an active comparison condition, Befriending. Eligible participants have current residual hallucinations or delusions with associated distress or disability which have been present continuously over the past six months despite therapeutic doses of antipsychotic medication. Following baseline assessment, participants are randomly allocated to treatment condition with blinded, post-treatment assessments conducted at the end of treatment and at 6 months follow-up. The primary outcome is overall mental state as measured using the Positive and Negative Syndrome Scale. Secondary outcomes include preoccupation, conviction, distress and disruption to life associated with symptoms as measured by the Psychotic Symptom Rating Scales, as well as social functioning and service utilisation. The main analyses will be by intention-to-treat using mixed-model repeated measures with non-parametric methods employed if required. The model of change underpinning ACT will be tested using mediation analyses. Discussion This protocol describes the first randomised controlled trial of Acceptance and commitment therapy in

  15. Efficacy of tart cherry juice in reducing muscle pain during running: a randomized controlled trial

    PubMed Central

    2010-01-01

    Background Long distance running causes acute muscle damage resulting in inflammation and decreased force production. Endurance athletes use NSAIDs during competition to prevent or reduce pain, which carries the risk of adverse effects. Tart cherries, rich in antioxidant and anti-inflammatory properties, may have a protective effect to reduce muscle damage and pain during strenuous exercise. This study aimed to assess the effects of tart cherry juice as compared to a placebo cherry drink on pain among runners in a long distance relay race. Methods The design was a randomized, double blind, placebo controlled trial. Fifty-four healthy runners (36 male, 18 female; 35.8 ± 9.6 yrs) ran an average of 26.3 ± 2.5 km over a 24 hour period. Participants ingested 355 mL bottles of tart cherry juice or placebo cherry drink twice daily for 7 days prior to the event and on the day of the race. Participants assessed level of pain on a standard 100 mm Visual Analog Scale (VAS) at baseline, before the race, and after the race. Results While both groups reported increased pain after the race, the cherry juice group reported a significantly smaller increase in pain (12 ± 18 mm) compared to the placebo group (37 ± 20 mm) (p < .001). Participants in the cherry juice group were more willing to use the drink in the future (p < 0.001) and reported higher satisfaction with the pain reduction they attributed to the drink (p < 0.001). Conclusions Ingesting tart cherry juice for 7 days prior to and during a strenuous running event can minimize post-run muscle pain. PMID:20459662

  16. Can pain be managed through the Internet? A systematic review of randomized controlled trials.

    PubMed

    Bender, Jacqueline L; Radhakrishnan, Arun; Diorio, Caroline; Englesakis, Marina; Jadad, Alejandro R

    2011-08-01

    Given the increasing penetration and health care related use of the Internet, we examined the evidence on the impact of Internet-based interventions on pain. A search of Medline, CINAHL, PsycINFO, and the Cochrane Library was conducted for literature published from 1990 to 2010 describing randomized controlled trials that assessed the effects of Internet-based interventions on patients with pain of any kind. Of 6724 citations, 17 articles were included. The studies evaluated the effects of interventions that provided cognitive and behavioral therapy, moderated peer support programs, or clinical visit preparation or follow-up support on 2503 people in pain. Six studies (35.3%) received scores associated with high quality. Most cognitive and behavioral therapy studies showed an improvement in pain (n=7, 77.8%), activity limitation (n=4, 57.1%) and costs associated with treatment (n=3, 100%), whereas effects on depression (n=2, 28.6%) and anxiety (n=2, 50%) were less consistent. There was limited (n=2 from same research group) but promising evidence that Internet-based peer support programs can lead to improvements in pain intensity, activity limitation, health distress and self-efficacy; limited (n=4 from same research group) but promising evidence that social networking programs can reduce pain in children and adolescents; and insufficient evidence on Internet-based clinical support interventions. Internet-based interventions seem promising for people in pain, but it is still unknown what types of patients benefit most. More well-designed studies with diverse patient groups, active control conditions, and a better description of withdrawals are needed to strengthen the evidence concerning the impact of Internet-based interventions on people in pain.

  17. Does paracetamol (acetaminophen) reduce the pain of osteoarthritis?: a meta-analysis of randomised controlled trials

    PubMed Central

    Zhang, W; Jones, A; Doherty, M

    2004-01-01

    Design: Systematic review and meta-analysis of randomised controlled trials (RCTs). Data sources: Medline, Embase, Scientific Citation Index, CINAHL, Cochrane Library, and conference abstracts in the past 2 years from the British Society for Rheumatology, the European League Against Rheumatism, the American College of Rheumatology, and the Osteoarthritis Research Society International. Subjects: 10 RCTs including 1712 patients with either symptomatic OA of the knee (6 trials) or hip/knee (3 trials) or multiple joints (1 trial). Main outcome measures: (a) effect size (ES) for pain, stiffness, and functional scores from baseline to end point; (b) rate ratio (RR) and number needed to treat for clinical response rate and patient preference for treatment. Results: Paracetamol was effective in relieving pain due to OA (ES = 0.21, 95% confidence interval (CI) 0.02 to 0.41). Non-steroidal anti-inflammatory drugs (NSAIDs) were better than paracetamol for pain relief (ES = 0.20, 95% CI 0.10 to 0.30). Clinical response rate was higher with NSAIDs than with paracetamol (RR = 1.24, 95% CI 1.08 to 1.41), and the number of patients who preferred NSAIDs was more than twice the number of those preferring paracetamol (RR = 2.46, 95% CI 1.51 to 4.12). NSAIDs were associated with more frequent gastrointestinal discomfort than paracetamol (RR = 1.35, 95% CI 1.05 to 1.75). Conclusion: Paracetamol is an effective agent for pain relief due to OA. Although safer, it is less effective than NSAIDs. For safety reasons paracetamol should be the first line treatment, with NSAIDs reserved for those who do not respond. PMID:15020311

  18. Acupuncture with manual and electrical stimulation for labour pain: a longitudinal randomised controlled trial

    PubMed Central

    2014-01-01

    Background Acupuncture is commonly used to reduce pain during labour despite contradictory results. The aim of this study is to evaluate the effectiveness of acupuncture with manual stimulation and acupuncture with combined manual and electrical stimulation (electro-acupuncture) compared with standard care in reducing labour pain. Our hypothesis was that both acupuncture stimulation techniques were more effective than standard care, and that electro-acupuncture was most effective. Methods A longitudinal randomised controlled trial. The recruitment of participants took place at the admission to the labour ward between November 2008 and October 2011 at two Swedish hospitals . 303 nulliparous women with normal pregnancies were randomised to: 40 minutes of manual acupuncture (MA), electro-acupuncture (EA), or standard care without acupuncture (SC). Primary outcome: labour pain, assessed by Visual Analogue Scale (VAS). Secondary outcomes: relaxation, use of obstetric pain relief during labour and post-partum assessments of labour pain. The sample size calculation was based on the primary outcome and a difference of 15 mm on VAS was regarded as clinically relevant, this gave 101 in each group, including a total of 303 women. Results Mean estimated pain scores on VAS (SC: 69.0, MA: 66.4 and EA: 68.5), adjusted for: treatment, age, education, and time from baseline, with no interactions did not differ between the groups (SC vs MA: mean difference 2.6, 95% confidence interval [CI] -1.7-6.9 and SC vs EA: mean difference 0.6 [95% CI] -3.6-4.8). Fewer number of women in the EA group used epidural analgesia (46%) than women in the MA group (61%) and SC group (70%) (EA vs SC: odds ratio [OR] 0.35; [95% CI] 0.19-0.67). Conclusions Acupuncture does not reduce women’s experience of labour pain, neither with manual stimulation nor with combined manual and electrical stimulation. However, fewer women in the EA group used epidural analgesia thus indicating that the effect of

  19. Randomized trial for answers to clinical questions: Evaluating a pre-appraised versus a MEDLINE search protocol

    PubMed Central

    Patel, Manesh R.; Schardt, Connie M.; Sanders, Linda L.; Keitz, Sheri A.

    2006-01-01

    Objective: The paper compares the speed, validity, and applicability of two different protocols for searching the primary medical literature. Design: A randomized trial involving medicine residents was performed. Setting: An inpatient general medicine rotation was used. Participants: Thirty-two internal medicine residents were block randomized into four groups of eight. Main Outcome Measures: Success rate of each search protocol was measured by perceived search time, number of questions answered, and proportion of articles that were applicable and valid. Results: Residents randomized to the MEDLINE-first (protocol A) group searched 120 questions, and residents randomized to the MEDLINE-last (protocol B) searched 133 questions. In protocol A, 104 answers (86.7%) and, in protocol B, 117 answers (88%) were found to clinical questions. In protocol A, residents reported that 26 (25.2%) of the answers were obtained quickly or rated as “fast” (<5 minutes) as opposed to 55 (51.9%) in protocol B, (P = 0.0004). A subset of questions and articles (n = 79) were reviewed by faculty who found that both protocols identified similar numbers of answer articles that addressed the questions and were felt to be valid using critical appraisal criteria. Conclusion: For resident-generated clinical questions, both protocols produced a similarly high percentage of applicable and valid articles. The MEDLINE-last search protocol was perceived to be faster. However, in the MEDLINE-last protocol, a significant portion of questions (23%) still required searching MEDLINE to find an answer. PMID:17082828

  20. Music and 25% glucose pain relief for the premature infant: a randomized clinical trial 1

    PubMed Central

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

    2014-01-01

    OBJECTIVE: 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. METHOD: 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. RESULTS: 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. CONCLUSION: neonatal variables are associated with pain in premature infants. Brazilian Registry of Clinical Trials: UTN: U1111-1123-4821. PMID:25493677

  1. Supporting Policy In health with Research: an Intervention Trial (SPIRIT)—protocol for a stepped wedge trial

    PubMed Central

    2014-01-01

    Introduction Governments in different countries have committed to better use of evidence from research in policy. Although many programmes are directed at assisting agencies to better use research, there have been few tests of the effectiveness of such programmes. This paper describes the protocol for SPIRIT (Supporting Policy In health with Research: an Intervention Trial), a trial designed to test the effectiveness of a multifaceted programme to build organisational capacity for the use of research evidence in policy and programme development. The primary aim is to determine whether SPIRIT results in an increase in the extent to which research and research expertise is sought, appraised, generated and used in the development of specific policy products produced by health policy agencies. Methods and analysis A stepped wedge cluster randomised trial involving six health policy agencies located in Sydney, Australia. Policy agencies are the unit of randomisation and intervention. Agencies were randomly allocated to one of three start dates (steps) to receive the 1-year intervention programme, underpinned by an action framework. The SPIRIT intervention is tailored to suit the interests and needs of each agency and includes audit, feedback and goal setting; a leadership programme; staff training; the opportunity to test systems to assist in the use of research in policies; and exchange with researchers. Outcome measures will be collected at each agency every 6 months for 30 months (starting at the beginning of step 1). Ethics and dissemination Ethics approval was granted by the University of Western Sydney Human Research and Ethics Committee HREC Approval H8855. The findings of this study will be disseminated broadly through peer-reviewed publications and presentations at conferences and used to inform future strategies. PMID:24989620

  2. The "Healthy Habits, Healthy Girls" randomized controlled trial for girls: study design, protocol, and baseline results.

    PubMed

    Leme, Ana Carolina Barco; Philippi, Sonia Tucunduva

    2015-07-01

    The purpose of this article is to describe the study design, protocol, and baseline results of the "Healthy Habits, Healthy Girls" program. The intervention is being evaluated through a randomized controlled trial in 10 public schools in the city of São Paulo, Brazil. Data on the following variables were collected and assessed at baseline and will be reevaluated at 7 and 12 months: body mass index, waist circumference, dietary intake, nutrition, physical activity, social cognitive mediators, physical activity level, sedentary behaviors, self-rated physical status, and overall self-esteem. According to the baseline results, 32.4% and 23.4% of girls were overweight in the intervention and control groups, respectively, and in both groups a higher percentage failed to meet daily recommendations for moderate and vigorous physical activity and maximum screen time (TV, computer, mobile devices). There were no significant differences between the groups for most of the variables, except age (p = 0.000) and waist circumference (p = 0.014). The study showed a gap in the Brazilian literature on protocols for randomized controlled trials to prevent obesity among youth. The current study may thus be an important initial contribution to the field. PMID:26248094

  3. The "Healthy Habits, Healthy Girls" randomized controlled trial for girls: study design, protocol, and baseline results.

    PubMed

    Leme, Ana Carolina Barco; Philippi, Sonia Tucunduva

    2015-07-01

    The purpose of this article is to describe the study design, protocol, and baseline results of the "Healthy Habits, Healthy Girls" program. The intervention is being evaluated through a randomized controlled trial in 10 public schools in the city of São Paulo, Brazil. Data on the following variables were collected and assessed at baseline and will be reevaluated at 7 and 12 months: body mass index, waist circumference, dietary intake, nutrition, physical activity, social cognitive mediators, physical activity level, sedentary behaviors, self-rated physical status, and overall self-esteem. According to the baseline results, 32.4% and 23.4% of girls were overweight in the intervention and control groups, respectively, and in both groups a higher percentage failed to meet daily recommendations for moderate and vigorous physical activity and maximum screen time (TV, computer, mobile devices). There were no significant differences between the groups for most of the variables, except age (p = 0.000) and waist circumference (p = 0.014). The study showed a gap in the Brazilian literature on protocols for randomized controlled trials to prevent obesity among youth. The current study may thus be an important initial contribution to the field.

  4. Management of persistent postconcussion symptoms in youth: a randomised control trial protocol

    PubMed Central

    Reed, Nick; Greenspoon, Dayna; Iverson, Grant L; DeMatteo, Carol; Fait, Philippe; Gauvin-Lepage, Jérôme; Hunt, Anne; Gagnon, Isabelle J

    2015-01-01

    Introduction Current management of concussion consists of early education, rest until symptom free, with gradual return to school and physical activity protocols. Although this management strategy is effective for most youth who sustain a concussion, it is not an appropriate strategy for youth with persistent postconcussion symptoms. Prolonged rest and periods of restricted activity may place youth at risk for secondary issues and contribute to the chronicity of postconcussion symptoms. The purpose of this study is to evaluate the efficacy of an active rehabilitation protocol for youth who are slow to recover from concussion. It is hypothesised that an active rehabilitation intervention can reduce persistent postconcussion symptoms, improve function and facilitate return to activity. This article describes the research protocol. Methods and analysis This is a randomised clinical trial with blinded outcome measurement. Participants will be recruited and randomly assigned to 1 of 2 treatment groups, an active rehabilitation intervention or a standard care education group. Both groups will receive standard care education. However, the active rehabilitation group will participate in an additional low-intensity exercise programme consisting of aerobic, coordination and visualisation exercises. Both the active rehabilitation and the standard care education interventions will be 6 weeks in duration. The primary outcome measure is postconcussion symptoms. Secondary outcome measures include functional recovery (cognitive, motor, psychosocial and emotional functioning) and return to activity. Outcome measures will be administered preintervention and postintervention. The primary outcome measure will also be repeated 2 weeks into the intervention period. Ethics and dissemination This study has been approved by the Holland Bloorview Kids Rehabilitation Hospital research ethics board (REB # 13-459). The findings from this study will be shared with the general public, sport

  5. Well-Loved Music Robustly Relieves Pain: A Randomized, Controlled Trial

    PubMed Central

    Hsieh, Christine; Kong, Jian; Kirsch, Irving; Edwards, Robert R.; Jensen, Karin B.; Kaptchuk, Ted J.; Gollub, Randy L.

    2014-01-01

    Music has pain-relieving effects, but its mechanisms remain unclear. We sought to verify previously studied analgesic components and further elucidate the underpinnings of music analgesia. Using a well-characterized conditioning-enhanced placebo model, we examined whether boosting expectations would enhance or interfere with analgesia from strongly preferred music. A two-session experiment was performed with 48 healthy, pain experiment-naïve participants. In a first cohort, 36 were randomized into 3 treatment groups, including music enhanced with positive expectancy, non-musical sound enhanced with positive expectancy, and no expectancy enhancement. A separate replication cohort of 12 participants received only expectancy-enhanced music following the main experiment to verify the results of expectancy-manipulation on music. Primary outcome measures included the change in subjective pain ratings to calibrated experimental noxious heat stimuli, as well as changes in treatment expectations. Without conditioning, expectations were strongly in favor of music compared to non-musical sound. While measured expectations were enhanced by conditioning, this failed to affect either music or sound analgesia significantly. Strongly preferred music on its own was as pain relieving as conditioning-enhanced strongly preferred music, and more analgesic than enhanced sound. Our results demonstrate the pain-relieving power of personal music even over enhanced expectations. Trial Information Clinicaltrials.gov NCT01835275. PMID:25211164

  6. Paraspinous Lidocaine Injection for Chronic Nonspecific Low Back Pain: A Randomized Controlled Clinical Trial

    PubMed Central

    Imamura, Marta; Imamura, Satiko Tomikawa; Targino, Rosa Alves; Morales-Quezada, León; Onoda Tomikawa, Luis C.; Onoda Tomikawa, Luis G.; Alfieri, Fabio M.; Filippo, Thais R.; da Rocha, Ivan D.; Neto, Raul Bolliger; Fregni, Felipe; Battistella, Linamara Rizzo

    2016-01-01

    In this large, sham-controlled, randomized trial, we examined the efficacy of the combination of standard treatment and paraspinous lidocaine injection compared with standard therapy alone in subjects with chronic low back pain. There is little research-based evidence for the routine clinical use of paraspinous lidocaine injection for low back pain. A total of 378 subjects with nonspecific chronic low back pain were randomized to 3 groups: paraspinous lidocaine injection, analgesics, and exercises (group 1, LID-INJ); sham paraspinous lidocaine injection, analgesics, and exercises (group 2, SH-INJ); and analgesics and exercises (group 3, STD-TTR). A blinded rater assessed the study outcomes at 3 time points: baseline, after treatment, and after 3 months of follow-up. There were increased frequency of pain responses and better low back functional scores in the LID-INJ group compared with the SH-INJ and STD-TTR groups. These effects remained at the 3-month follow-up but differed between all 3 groups. There were significant changes in pain threshold immediately after treatment, supporting the effects of this intervention in reducing central sensitization. Paraspinous lidocaine injection therapy is not associated with a higher risk of adverse effects compared with conventional treatment and sham injection. Its effects on hyperalgesia might correlate with changes in central sensitization. PMID:26828801

  7. Traditional Chinese Medications for Knee Osteoarthritis Pain: A Meta-Analysis of Randomized Controlled Trials.

    PubMed

    Chen, Bo; Zhan, Hongsheng; Marszalek, Jolanta; Chung, Mei; Lin, Xun; Zhang, Min; Pang, Jian; Wang, Chenchen

    2016-01-01

    Traditional Chinese medication (TCM) has analgesic and anti-inflammatory effects in patients with knee osteoarthritis (OA). We conducted the first systematic review of the best quantitative and qualitative evidence currently available in order to evaluate the effectiveness of TCM in relieving pain in knee OA. A comprehensive literature search was conducted using three English and four Chinese biomedical databases from their inception through March 1, 2015. We included randomized controlled trials of TCM for knee OA with intervention durations of at least two weeks. The effects of TCM on pain and other clinical symptoms were measured with the visual analog scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The total effectiveness rate, which was used to assess overall pain, physical performance and wellness, was also measured. Two researchers independently extracted data on study design, population characteristics, duration, intervention, outcomes, risk of bias, and primary results. We performed a random-effects meta-analysis when appropriate. We also explored factors that could explain the heterogeneity by conducting subgroup and meta-regression analyses. Twenty-three studies, totaling 2362 subjects, met the eligibility criteria. Treatments were formulated with an average of 8 Chinese herbs and were prescribed based on the traditional Chinese diagnostic method of syndrome differentiation. The mean treatment duration was seven weeks, with oral administration occurring one to three times a day. Compared with non-steroidal anti-inflammatory drugs and intra-articular hyaluronate injections, 18 of the studies showed significantly improved VAS pain scores (Mean Difference [MD] [Formula: see text] 0.56; 95% confidence interval [CI], 0.18 to 0.94; [Formula: see text]), six of the studies showed significantly improved WOMAC pain subscale scores (MD [Formula: see text] 2.23; 95% CI, 0.56 to 3.91; [Formula: see text]), and 16 of the trials

  8. Traditional Chinese Medications for Knee Osteoarthritis Pain: A Meta-Analysis of Randomized Controlled Trials.

    PubMed

    Chen, Bo; Zhan, Hongsheng; Marszalek, Jolanta; Chung, Mei; Lin, Xun; Zhang, Min; Pang, Jian; Wang, Chenchen

    2016-01-01

    Traditional Chinese medication (TCM) has analgesic and anti-inflammatory effects in patients with knee osteoarthritis (OA). We conducted the first systematic review of the best quantitative and qualitative evidence currently available in order to evaluate the effectiveness of TCM in relieving pain in knee OA. A comprehensive literature search was conducted using three English and four Chinese biomedical databases from their inception through March 1, 2015. We included randomized controlled trials of TCM for knee OA with intervention durations of at least two weeks. The effects of TCM on pain and other clinical symptoms were measured with the visual analog scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The total effectiveness rate, which was used to assess overall pain, physical performance and wellness, was also measured. Two researchers independently extracted data on study design, population characteristics, duration, intervention, outcomes, risk of bias, and primary results. We performed a random-effects meta-analysis when appropriate. We also explored factors that could explain the heterogeneity by conducting subgroup and meta-regression analyses. Twenty-three studies, totaling 2362 subjects, met the eligibility criteria. Treatments were formulated with an average of 8 Chinese herbs and were prescribed based on the traditional Chinese diagnostic method of syndrome differentiation. The mean treatment duration was seven weeks, with oral administration occurring one to three times a day. Compared with non-steroidal anti-inflammatory drugs and intra-articular hyaluronate injections, 18 of the studies showed significantly improved VAS pain scores (Mean Difference [MD] [Formula: see text] 0.56; 95% confidence interval [CI], 0.18 to 0.94; [Formula: see text]), six of the studies showed significantly improved WOMAC pain subscale scores (MD [Formula: see text] 2.23; 95% CI, 0.56 to 3.91; [Formula: see text]), and 16 of the trials

  9. Interreality for the management and training of psychological stress: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Psychological stress occurs when an individual perceives that environmental demands tax or exceed his or her adaptive capacity. Its association with severe health and emotional diseases, points out the necessity to find new efficient strategies to treat it. Moreover, psychological stress is a very personal problem and requires training focused on the specific needs of individuals. To overcome the above limitations, the INTERSTRESS project suggests the adoption of a new paradigm for e-health - Interreality - that integrates contextualized assessment and treatment within a hybrid environment, bridging the physical and the virtual worlds. According to this premise, the aim of this study is to investigate the advantages of using advanced technologies, in combination with cognitive behavioral therapy (CBT), based on a protocol for reducing psychological stress. Methods/Design The study is designed as a randomized controlled trial. It includes three groups of approximately 50 subjects each who suffer from psychological stress: (1) the experimental group, (2) the control group, (3) the waiting list group. Participants included in the experimental group will receive a treatment based on cognitive behavioral techniques combined with virtual reality, biofeedback and mobile phone, while the control group will receive traditional stress management CBT-based training, without the use of new technologies. The wait-list group will be reassessed and compared with the two other groups five weeks after the initial evaluation. After the reassessment, the wait-list patients will randomly receive one of the two other treatments. Psychometric and physiological outcomes will serve as quantitative dependent variables, while subjective reports of participants will be used as the qualitative dependent variable. Discussion What we would like to show with the present trial is that bridging virtual experiences, used to learn coping skills and emotional regulation, with real

  10. Vitamin D Supplementation for Nonspecific Musculoskeletal Pain in Non-Western Immigrants: A Randomized Controlled Trial

    PubMed Central

    Schreuder, Ferdinand; Bernsen, Roos M. D.; van der Wouden, Johannes C.

    2012-01-01

    PURPOSE Many non-Western immigrants report musculoskeletal pains that are hard to treat. We studied the effect of high-dose vitamin D3 on nonspecific persistent musculoskeletal complaints in vitamin D–deficient non-Western immigrants and assessed correlation of pain patterns with benefit. METHODS We conducted a semi-crossover randomized controlled trial between February 2008 and February 2010 in primary care in 84 non-Western immigrants visiting their general practitioner for nonspecific musculoskeletal pain. At baseline, patients were randomized to placebo or vitamin D (150,000 IU vitamin D3 orally); at week 6, patients in the original vitamin D group were randomized a second time to receive vitamin D (again) or to switch to placebo, whereas patients in the original placebo group were all switched to vitamin D. The main outcome was self-assessed change in pain after the first 6 weeks. RESULTS Patients in the vitamin D group were significantly more likely than their counterparts in the placebo group to report pain relief 6 weeks after treatment (34.9% vs 19.5%, P = .04). The former were also more likely to report an improved ability to walk stairs (21.0% vs 8.4%, P = .008). Pain pattern was not correlated with the success of treatment. In a nonsignificant trend, patients receiving vitamin D over 12 weeks were more likely to have an improvement than patients receiving it over 6 weeks. CONCLUSIONS There is a small positive effect 6 weeks after high-dose vitamin D3 on persistent nonspecific musculoskeletal pain. Future research should focus on longer follow-up, higher supplementation doses, and mental health. PMID:23149532

  11. Randomized trial of epidural vs. subcutaneous catheters for managing pain after modified Nuss in adults

    PubMed Central

    Temkit, M’hamed; Ewais, MennatAllah M.; Luckritz, Todd C.; Stearns, Joshua D.; Craner, Ryan C.; Gaitan, Brantley D.; Ramakrishna, Harish; Thunberg, Christopher A.; Weis, Ricardo A.; Myers, Kelly M.; Merritt, Marianne V.; Rosenfeld, David M.

    2016-01-01

    Background Minimally invasive repair of pectus excavatum (MIRPE) is now performed in adults. Managing adult patients’ pain postoperatively has been challenging due to increased chest wall rigidity and the pressure required for supporting the elevated sternum. The optimal pain management regimen has not been determined. We designed this prospective, randomized trial to compare postoperative pain management and outcomes between thoracic epidural analgesia (TEA) and bilateral subcutaneous infusion pump catheters (On-Q). Methods Patients undergoing MIRPE (modified Nuss) underwent random assignment to TEA or On-Q group. Both groups received intravenous, patient-controlled opioid analgesia, with concomitant delivery of local anesthetic. Primary outcomes were length of stay (LOS), opioid use, and pain scores. Results Of 85 randomly assigned patients, 68 completed the study [52 men, 76.5%; mean (range) age, 32.2 (20.0–58.0) years; Haller index, 5.9 (range, 3.0-26.7)]. The groups were equally matched for preoperative variables; however, the On-Q arm had more patients (60.3%). No significant differences were found between groups in mean daily pain scores (P=0.52), morphine-equivalent opioid usage (P=0.28), or hospital stay 3.5 vs. 3.3 days (TEA vs. On-Q; P=0.55). Thirteen patients randomized to TEA refused the epidural and withdrew from the study because they perceived greater benefit of the On-Q system. Conclusions Postoperative pain management in adults after MIRPE can be difficult. Both continuous local anesthetic delivery by TEA and On-Q catheters with concomitant, intravenous, patient-controlled anesthesia maintained acceptable analgesia with a reasonable LOS. In our cohort, there was preference for the On-Q system for pain management. PMID:27621865

  12. Comparison of indomethacin suppository and lidocaine cream on post-episiotomy pain: A randomized trial

    PubMed Central

    Delaram, Masoumeh; Dadkhah, Narges-Khaton; Jafarzadeh, Loabat

    2015-01-01

    Background: One of the most important problems after episiotomy is perineal pain which is more severe on the first day of postpartum period. The aim of this study was to compare the analgesic effects of indomethacin suppository and lidocaine cream in the management of post-episiotomy pain. Materials and Methods: In a randomized, controlled trial, 60 primiparous women who had mediolateral episiotomy received 50 mg indomethacin suppository (n = 30) or 2% lidocaine cream (n = 30) in the postpartum period in Hajar Hospital in Shahrekord (Iran). The mean severity of post-episiotomy pain was assessed with the first complaint and at 6, 12, and 24 h after the delivery, and compared in the two groups. The visual analog scale (VAS) was used for pain recording and data were analyzed with independent-samples t-test, χ2, and Fisher's exact tests, and significance was defined as P < 0.05. Results: With the first complaint of pain, the mean intensity of pain was 4.9 (1.9) in the indomethacin group and 4.9 (1.8) in the lidocaine group, and the difference was not significant (P = 0.25). Six hours after birth, it was 3.3 (1.3) in the indomethacin group and 3.2 (1.9) in the lidocaine group, and there was not a significant difference between the two groups (P = 0.90). No significant difference was found between the two groups at 12 h after birth [2.3 (1.7) vs 2.5 (1.7); P = 0.59]. Also, the difference was not significant at 24 h after birth [1.5 (1.3) vs 1.8 (1.3); P = 0.31]. Conclusions: It was concluded from the study that indomethacin suppository and lidocaine cream have similar efficacy on episiotomy pain relief on the first day of postpartum period. PMID:26257799

  13. Randomized trial of epidural vs. subcutaneous catheters for managing pain after modified Nuss in adults

    PubMed Central

    Temkit, M’hamed; Ewais, MennatAllah M.; Luckritz, Todd C.; Stearns, Joshua D.; Craner, Ryan C.; Gaitan, Brantley D.; Ramakrishna, Harish; Thunberg, Christopher A.; Weis, Ricardo A.; Myers, Kelly M.; Merritt, Marianne V.; Rosenfeld, David M.

    2016-01-01

    Background Minimally invasive repair of pectus excavatum (MIRPE) is now performed in adults. Managing adult patients’ pain postoperatively has been challenging due to increased chest wall rigidity and the pressure required for supporting the elevated sternum. The optimal pain management regimen has not been determined. We designed this prospective, randomized trial to compare postoperative pain management and outcomes between thoracic epidural analgesia (TEA) and bilateral subcutaneous infusion pump catheters (On-Q). Methods Patients undergoing MIRPE (modified Nuss) underwent random assignment to TEA or On-Q group. Both groups received intravenous, patient-controlled opioid analgesia, with concomitant delivery of local anesthetic. Primary outcomes were length of stay (LOS), opioid use, and pain scores. Results Of 85 randomly assigned patients, 68 completed the study [52 men, 76.5%; mean (range) age, 32.2 (20.0–58.0) years; Haller index, 5.9 (range, 3.0-26.7)]. The groups were equally matched for preoperative variables; however, the On-Q arm had more patients (60.3%). No significant differences were found between groups in mean daily pain scores (P=0.52), morphine-equivalent opioid usage (P=0.28), or hospital stay 3.5 vs. 3.3 days (TEA vs. On-Q; P=0.55). Thirteen patients randomized to TEA refused the epidural and withdrew from the study because they perceived greater benefit of the On-Q system. Conclusions Postoperative pain management in adults after MIRPE can be difficult. Both continuous local anesthetic delivery by TEA and On-Q catheters with concomitant, intravenous, patient-controlled anesthesia maintained acceptable analgesia with a reasonable LOS. In our cohort, there was preference for the On-Q system for pain management.

  14. The effect of two phototherapy protocols on pain control in orthodontic procedure--a preliminary clinical study.

    PubMed

    Esper, Maria Angela Lacerda Rangel; Nicolau, Renata Amadei; Arisawa, Emília Angela Lo Schiavo

    2011-09-01

    Phototherapy with low-level coherent light (laser) has been reported as an analgesic and anti-inflammatory as well as having a positive effect in tissue repair in orthodontics. However, there are few clinical studies using low-level LED therapy (non-coherent light). The aim of the present study was to analyze the pain symptoms after orthodontic tooth movement associated with and not associated with coherent and non-coherent phototherapy. Fifty-five volunteers (mean age = 24.1 ± 8.1 years) were randomly divided into four groups: G1 (control), G2 (placebo), G3 (protocol 1: laser, InGaAlP, 660 nm, 4 J/cm(2), 0.03 W, 25 s), G4 (protocol 2: LED, GaAlAs, 640 nm with 40 nm full-bandwidth at half-maximum, 4 J/cm(2), 0.10 W, 70 s). Separators were used to induce orthodontic pain and the volunteers pain levels were scored with the visual analog scale (VAS) after the separator placement, after the therapy (placebo, laser, or LED), and after 2, 24, 48, 72, 96, and 120 h. The laser group did not have statistically significant results in the reduction of pain level compared to the LED group. The LED group had a significant reduction in pain levels between 2 and 120 h compared to the control and the laser groups. The LED therapy showed a significant reduction in pain sensitivity (an average of 56%), after the orthodontic tooth movement when compared to the control group.

  15. Mortality Reduction in Septic Shock by Plasma Adsorption (ROMPA): a protocol for a randomised clinical trial

    PubMed Central

    Colomina-Climent, Francisco; Giménez-Esparza, Carola; Portillo-Requena, Cristina; Allegue-Gallego, José Manuel; Galindo-Martínez, María; Mollà-Jiménez, Cristina; Antón-Pascual, José Luis; Rodríguez-Serra, Manuel; Martín-Ruíz, José Luis; Fernández-Arroyo, Pablo Juan; Blasco-Císcar, Eugenia María; Cánovas-Robles, José; Herrera-Murillo, Miguel; González-Hernández, Enrique; Sánchez-Morán, Fernando; Solera-Suárez, Manuel; Torres-Tortajada, Jesús; Nuñez-Martínez, José María; Martín-Langerwerf, David; Herrero-Gutiérrez, Eugenio; Sebastián-Muñoz, Isabel; Palazón-Bru, Antonio; Gil-Guillén, Vicente Francisco

    2016-01-01

    Introduction There is a lack of evidence in the efficacy of the coupled plasma filtration adsorption (CPFA) to reduce the mortality rate in septic shock. To fill this gap, we have designed the ROMPA study (Mortality Reduction in Septic Shock by Plasma Adsorption) to confirm whether treatment with an adequate dose of treated plasma by CPFA could confer a clinical benefit. Methods and analysis Our study is a multicentric randomised clinical trial with a 28-day and 90-day follow-up and allocation ratio 1:1. Its aim is to clarify whether the application of high doses of CPFA (treated plasma ≥0.20 L/kg/day) in the first 3 days after randomisation, in addition to the current clinical practice, is able to reduce hospital mortality in patients with septic shock in intensive care units (ICUs) at 28 and 90 days after initiation of the therapy. The study will be performed in 10 ICUs in the Southeast of Spain which follow the same protocol in this disease (based on the Surviving Sepsis Campaign). Our trial is designed to be able to demonstrate an absolute mortality reduction of 20% (α=0.05; 1−β=0.8; n=190(95×2)). The severity of the process, ensuring the recruitment of patients with a high probability of death (50% in the control group), will be achieved through an adequate stratification by using both severity scores and classical definitions of severe sepsis/septic shock and dynamic parameters. Our centres are fully aware of the many pitfalls associated with previous medical device trials. Trying to reduce these problems, we have developed a training programme to improve the CPFA use (especially clotting problems). Ethics and dissemination The protocol was approved by the Ethics Committees of all the participant centres. The findings of the trial will be disseminated through peer-reviewed journals, as well as national and international conference presentations. Trial registration number NCT02357433; Pre-results. PMID:27406647

  16. Efficacy of metacognitive therapy for prolonged grief disorder: protocol for a randomised controlled trial

    PubMed Central

    Wenn, Jenine; O'Connor, Moira; Breen, Lauren J; Kane, Robert T; Rees, Clare S

    2015-01-01

    Introduction Studies of effective psychotherapy for individuals suffering from the effects of prolonged grief disorder (PGD) are scarce. This paper describes the protocol for an evaluation of a metacognitive therapy programme designed specifically for PGD, to reduce the psychological distress and loss of functioning resulting from bereavement. Methods and analysis The proposed trial comprises three phases. Phase 1 consists of a review of the literature and semistructured interviews with key members of the target population to inform the development of a metacognitive therapy programme for Prolonged Grief. Phase 2 involves a randomised controlled trial to implement and evaluate the programme. Male and female adults (N=34) will be randomly assigned to either a wait list or an intervention group. Measures of PGD, anxiety, depression, rumination, metacognitions and quality of life will be taken pretreatment and posttreatment and at the 3-month and 6-month follow-up. The generalised linear mixed model will be used to assess treatment efficacy. Phase 3 will test the social validity of the programme. Discussion This study is the first empirical investigation of the efficacy of a targeted metacognitive treatment programme for PGD. A focus on identifying and changing the metacognitive mechanisms underpinning the development and maintenance of prolonged grief is likely to be beneficial to theory and practice. Ethics Ethics approval was obtained from Curtin University Human Research Ethics Committee (Approval number HR 41/2013.) Trial registration number ACTRN12613001270707. PMID:26646828

  17. Immediate and short-term pain relief by acute sciatic nerve press: a randomized controlled trial

    PubMed Central

    He, Jiman; Wu, Bin; Zhang, Wenlong; Ten, Guangping

    2007-01-01

    Background Despite much research, an immediately available, instantly effective and harmless pain relief technique has not been discovered. This study describes a new manipulation: a "2-minute sciatic nerve press", for rapid short-term relief of pain brought on by various dental and renal diseases. Methods This randomized, single-blind, placebo-controlled trial ran in three hospitals in Anhui Province, China, with an enrollment of 66 out of 111 solicited patients aged 16 to 74 years. Patients were recruited sequentially, by specific participating physicians at their clinic visits to three independent hospitals. The diseases in enrolled dental patients included dental caries, periodontal diseases and dental trauma. Renal diseases in recruits included kidney infections, stones and some other conditions. Patients were randomly assigned to receive the "2-minute sciatic nerve press" or the "placebo press". For the "2-minute sciatic nerve press", pressure was applied simultaneously to the sciatic nerves at the back of the thighs, using the fists while patients lay prone. For the "placebo press", pressure was applied simultaneously to a parallel spot on the front of the thighs, using the fists while patients lay supine. Each fist applied a pressure of 11 to 20 kg for 2 minutes, after which, patients arose to rate pain. Results The "2-minute sciatic nerve press" produced greater pain relief than the "placebo press". Within the first 10 minutes after sciatic pressure, immediate pain relief ratings averaged 66.4% (p < 0.001) for the dental patients, versus pain relief of 20% for the placebo press, and, 52.2% (p < 0.01) for the renal patients, versus relief of 14% for the placebo press, in median. The method worked excellently for dental caries and periodontal diseases, but poorly for dental trauma. Forty percent of renal patients with renal colic did not report any pain relief after the treatment. Conclusion Two minutes of pressure on both sciatic nerves can produce

  18. How is radiating leg pain defined in randomized controlled trials of conservative treatments in primary care? A systematic review.

    PubMed

    Lin, C-W C; Verwoerd, A J H; Maher, C G; Verhagen, A P; Pinto, R Z; Luijsterburg, P A J; Hancock, M J

    2014-04-01

    Many terms exist to describe radiating leg pain or symptoms associated with back pain (e.g., sciatica or radiculopathy) and it appears that these terms are used inconsistently. We examined the terms used to describe, and the eligibility criteria used to define, radiating leg pain in randomized controlled trials of conservative treatments, and evaluated how the eligibility criteria compared to an international pain taxonomy. Eligible studies were identified from two systematic reviews and an updated search of their search strategy. Studies were included if they recruited adults with radiating leg pain associated with back pain. Two independent reviewers screened the studies and extracted data. Studies were grouped according to the terms used to describe radiating leg pain. Thirty-one of the seventy-seven included studies used multiple terms to describe radiating leg pain; the most commonly used terms were sciatica (60 studies) and disc herniation (19 studies). Most studies that used the term sciatica included pain distribution in the eligibility criteria, but studies were inconsistent in including signs (e.g., neurological deficits) and imaging findings. Similarly, studies that used other terms to describe radiating leg pain used inconsistent eligibility criteria between studies and to the pain taxonomy, except that positive imaging findings were required for almost all studies that used disc herniation to describe radiating leg pain. In view of the varying terms to describe, and eligibility criteria to define, radiating leg pain, consensus needs to be reached for each of communication and comparison between studies.

  19. Randomized Clinical Trial of an Emergency Department Observation Syncope Protocol vs. Routine Inpatient Admission

    PubMed Central

    Sun, Benjamin C.; McCreath, Heather; Liang, Li-Jung; Bohan, Stephen; Baugh, Christopher; Ragsdale, Luna; Henderson, Sean O.; Clark, Carol; Bastani, Aveh; Keeler, Emmett; An, Ruopeng; Mangione, Carol M.

    2013-01-01

    Study Hypothesis Older adults are frequently hospitalized from the emergency department (ED) after an episode of unexplained syncope. Current admission patterns are costly with little evidence of benefit. We hypothesized that an Emergency Department Observation Syncope Protocol would reduce resource use without adversely affecting patient-oriented outcomes. Methods This randomized trial at five EDs compared an ED observation syncope protocol to inpatient admission for intermediate-risk adults (≥50 years) presenting with syncope or near-syncope. Primary outcomes included inpatient admission rate and length-of-stay. Secondary outcomes included 30-day and 6-month serious outcomes after hospital discharge, index and 30-day hospital costs, 30-day quality-of-life scores, and 30-day patient satisfaction. Results Study staff randomized 124 patients. Observation resulted in a lower inpatient admission rate (15% vs. 92%, 95%CI Difference: −88%, −66%) and shorter hospital length-of-stay (29 vs. 47 hours, 95%CI Difference: −28, −8). Serious outcome rates after hospital discharge were similar for observation vs. admission at 30-days (3% vs. 0%, 95%CI Difference: −1%, 8%) and 6-months (8% vs. 10%, 95%CI Difference: −13%, 9%). Index hospital costs in the observation group were $629 (95%CI Difference: −$1376, −$56) lower than in the admission group. There were no differences in 30-day quality-of-life scores or in patient satisfaction. Conclusions An ED observation syncope protocol reduced the primary outcomes of admission rate and hospital length-of-stay. Analyses of secondary outcomes suggest reduction in index hospital costs with no difference in safety events, quality-of-life, or patient satisfaction. Our findings suggest that an ED observation syncope protocol can be replicated and safely reduce resource use. PMID:24239341

  20. Magnetic Resonance–Guided Focused Ultrasound for Patients With Painful Bone Metastases: Phase III Trial Results

    PubMed Central

    Ghanouni, Pejman; Kanaev, Sergey V.; Iozeffi, Dmitri; Gianfelice, David; Fennessy, Fiona Mary; Kuten, Abraham; Meyer, Joshua E.; LeBlang, Suzanne D.; Roberts, Ann; Choi, Junsung; Larner, James M.; Napoli, Alessandro; Turkevich, Vladimir G.; Inbar, Yael; Tempany, Clare Mary C.; Pfeffer, Raphael M.

    2014-01-01

    Background Pain due to bone metastases is a common cause of cancer-related morbidity, with few options available for patients refractory to medical therapies and who do not respond to radiation therapy. This study assessed the safety and efficacy of magnetic resonance-guided focused ultrasound surgery (MRgFUS), a noninvasive method of thermal tissue ablation for palliation of pain due to bone metastases. Methods Patients with painful bone metastases were randomly assigned 3:1 to receive MRgFUS sonication or placebo. The primary endpoint was improvement in self-reported pain score without increase of pain medication 3 months after treatment and was analyzed by Fisher’s exact test. Components of the response composite, Numerical Rating Scale for pain (NRS) and morphine equivalent daily dose intake, were analyzed by t test and Wilcoxon rank-sum test, respectively. Brief Pain Inventory (BPI-QoL), a measure of functional interference of pain on quality of life, was compared between MRgFUS and placebo by t test. Statistical tests were two-sided. Results One hundred forty-seven subjects were enrolled, with 112 and 35 randomly assigned to MRgFUS and placebo treatments, respectively. Response rate for the primary endpoint was 64.3% in the MRgFUS arm and 20.0% in the placebo arm (P < .001). MRgFUS was also superior to placebo at 3 months on the secondary endpoints assessing worst score NRS (P < .001) and the BPI-QoL (P < .001). The most common treatment-related adverse event (AE) was sonication pain, which occurred in 32.1% of MRgFUS patients. Two patients had pathological fractures, one patient had third-degree skin burn, and one patient suffered from neuropathy. Overall 60.3% of all AEs resolved on the treatment day. Conclusions This multicenter phase III trial demonstrated that MRgFUS is a safe and effective, noninvasive treatment for alleviating pain resulting from bone metastases in patients that have failed standard treatments. PMID:24760791

  1. A multicenter randomized controlled trial of intravenous magnesium for sickle cell pain crisis in children.

    PubMed

    Brousseau, David C; Scott, J Paul; Badaki-Makun, Oluwakemi; Darbari, Deepika S; Chumpitazi, Corrie E; Airewele, Gladstone E; Ellison, Angela M; Smith-Whitley, Kim; Mahajan, Prashant; Sarnaik, Sharada A; Casper, T Charles; Cook, Lawrence J; Dean, J Michael; Leonard, Julie; Hulbert, Monica L; Powell, Elizabeth C; Liem, Robert I; Hickey, Robert; Krishnamurti, Lakshmanan; Hillery, Cheryl A; Nimmer, Mark; Panepinto, Julie A

    2015-10-01

    Magnesium, a vasodilator, anti-inflammatory, and pain reliever, could alter the pathophysiology of sickle cell pain crises. We hypothesized that intravenous magnesium would shorten length of stay, decrease opioid use, and improve health-related quality of life (HRQL) for pediatric patients hospitalized with sickle cell pain crises. The Magnesium for Children in Crisis (MAGiC) study was a randomized, double-blind, placebo-controlled trial of intravenous magnesium vs normal saline placebo conducted at 8 sites within the Pediatric Emergency Care Applied Research Network (PECARN). Children 4 to 21 years old with hemoglobin SS or Sβ(0) thalassemia requiring hospitalization for pain were eligible. Children received 40 mg/kg of magnesium or placebo every 8 hours for up to 6 doses plus standard therapy. The primary outcome was length of stay in hours from the time of first study drug infusion, compared using a Van Elteren test. Secondary outcomes included opioid use and HRQL. Of 208 children enrolled, 204 received the study drug (101 magnesium, 103 placebo). Between-group demographics and prerandomization treatment were similar. The median interquartile range (IQR) length of stay was 56.0 (27.0-109.0) hours for magnesium vs 47.0 (24.0-99.0) hours for placebo (P = .24). Magnesium patients received 1.46 mg/kg morphine equivalents vs 1.28 mg/kg for placebo (P = .12). Changes in HRQL before discharge and 1 week after discharge were similar (P > .05 for all comparisons). The addition of intravenous magnesium did not shorten length of stay, reduce opioid use, or improve quality of life in children hospitalized for sickle cell pain crisis. This trial was registered at www.clinicaltrials.gov as #NCT01197417.

  2. A multicenter randomized controlled trial of intravenous magnesium for sickle cell pain crisis in children

    PubMed Central

    Scott, J. Paul; Badaki-Makun, Oluwakemi; Darbari, Deepika S.; Chumpitazi, Corrie E.; Airewele, Gladstone E.; Ellison, Angela M.; Smith-Whitley, Kim; Mahajan, Prashant; Sarnaik, Sharada A.; Casper, T. Charles; Cook, Lawrence J.; Dean, J. Michael; Leonard, Julie; Hulbert, Monica L.; Powell, Elizabeth C.; Liem, Robert I.; Hickey, Robert; Krishnamurti, Lakshmanan; Hillery, Cheryl A.; Nimmer, Mark; Panepinto, Julie A.

    2015-01-01

    Magnesium, a vasodilator, anti-inflammatory, and pain reliever, could alter the pathophysiology of sickle cell pain crises. We hypothesized that intravenous magnesium would shorten length of stay, decrease opioid use, and improve health-related quality of life (HRQL) for pediatric patients hospitalized with sickle cell pain crises. The Magnesium for Children in Crisis (MAGiC) study was a randomized, double-blind, placebo-controlled trial of intravenous magnesium vs normal saline placebo conducted at 8 sites within the Pediatric Emergency Care Applied Research Network (PECARN). Children 4 to 21 years old with hemoglobin SS or Sβ0 thalassemia requiring hospitalization for pain were eligible. Children received 40 mg/kg of magnesium or placebo every 8 hours for up to 6 doses plus standard therapy. The primary outcome was length of stay in hours from the time of first study drug infusion, compared using a Van Elteren test. Secondary outcomes included opioid use and HRQL. Of 208 children enrolled, 204 received the study drug (101 magnesium, 103 placebo). Between-group demographics and prerandomization treatment were similar. The median interquartile range (IQR) length of stay was 56.0 (27.0-109.0) hours for magnesium vs 47.0 (24.0-99.0) hours for placebo (P = .24). Magnesium patients received 1.46 mg/kg morphine equivalents vs 1.28 mg/kg for placebo (P = .12). Changes in HRQL before discharge and 1 week after discharge were similar (P > .05 for all comparisons). The addition of intravenous magnesium did not shorten length of stay, reduce opioid use, or improve quality of life in children hospitalized for sickle cell pain crisis. This trial was registered at www.clinicaltrials.gov as #NCT01197417. PMID:26232172

  3. Hyperbaric Oxygen in Lower Limb Trauma (HOLLT); protocol for a randomised controlled trial

    PubMed Central

    Millar, Ian L; McGinnes, Rosemary A; Williamson, Owen; Lind, Folke; Jansson, Karl-Åke; Hajek, Michal; Smart, David; Fernandes, Tiago; Miller, Russell; Myles, Paul; Cameron, Peter

    2015-01-01

    Introduction Open fractures with significant soft tissue injury are associated with high rates of complications, such as non-union, infection, chronic pain and disability. Complications often require further inpatient care, and in many cases, multiple operations and prolonged rehabilitation. Use of hyperbaric oxygen therapy as an adjunct to standard orthopaedic trauma care has the potential to reduce the complications of musculoskeletal injury and thus improve outcomes. Two previous randomised trials have suggested some positive effect, but neither functional measures nor long-term outcomes were reported. Methods and analysis An international, multicentre, randomised, open-label, clinical trial. Patients with trauma with an acute open fracture of the tibia with severe soft tissue injury (Gustilo grade 3) and high risk of injury-related complications were recruited from participating major trauma hospitals with hyperbaric facilities. Patients were enrolled with the expectation of commencing 12 sessions of hyperbaric oxygen therapy within 48 h of injury. The primary outcome measure is the incidence of acute complications of the open fracture wound at 14 days. Other short-term outcome measures include amputation, need for fasciotomy, time until wound closure, breakdown of closed wounds, time until definitive orthopaedic fixation, number of operative procedures, intensive care stay and hospital stay. Long-term follow-up will continue for 2 years postinjury. Ethics and dissemination Ethics approval was given by The Alfred Health Human Ethics Committee (206/04) and the Monash University Human Research Ethics Committee (CF07/4208). Approval was also obtained from the institutional research ethics committee at each participating site. This study will make a significant contribution to the trauma literature and should answer the question of whether hyperbaric oxygen therapy can significantly improve outcomes in severe lower limb trauma. Collective study results will

  4. The promise of lung master protocol for squamous cell carcinoma: one trial to rule them all, one trial to find them…?

    PubMed Central

    Russell, Prudence Anne

    2015-01-01

    The recently initiated lung master protocol (Lung-MAP) trial provides hope that the successes of targeted molecular therapy in lung adenocarcinoma can be extended to squamous cell carcinoma (SCC). It also is a template for rapid translation of clinical research through regulatory approval to clinical practice. This is vital in cancers with multiple possible oncogenic genomic aberrations, for which clinical trials would be too costly and impractical to conduct for individual targets making up less than 10% of cases. PMID:26488015

  5. Subgroups of musculoskeletal pain patients and their psychobiological patterns – The LOGIN study protocol

    PubMed Central

    2012-01-01

    Background Pain conditions of the musculoskeletal system are very common and have tremendous socioeconomic impact. Despite its high prevalence, musculoskeletal pain remains poorly understood and predominantly non-specifically and insufficiently treated. The group of chronic musculoskeletal pain patients is supposed to be heterogeneous, due to a multitude of mechanisms involved in chronic pain. Psychological variables, psychophysiological processes, and neuroendocrine alterations are expected to be involved. Thus far, studies on musculoskeletal pain have predominantly focused on the general aspects of pain processing, thus neglecting the heterogeneity of patients with musculoskeletal pain. Consequently, there is a need for studies that comprise a multitude of mechanisms that are potentially involved in the chronicity and spread of pain. This need might foster research and facilitate a better pathophysiological understanding of the condition, thereby promoting the development of specific mechanism-based treatments for chronic pain. Therefore, the objectives of this study are as follows: 1) identify and describe subgroups of patients with musculoskeletal pain with regard to clinical manifestations (including mental co-morbidity) and 2) investigate whether distinct sensory profiles or 3) distinct plasma levels of pain-related parameters due to different underlying mechanisms can be distinguished in various subgroups of pain patients. Methods/Design We will examine a population-based chronic pain sample (n = 100), a clinical tertiary care sample (n = 100) and pain-free patients with depression or post-traumatic stress disorder and pain-free healthy controls (each n = 30, respectively). The samples will be pain localisation matched by sex and age to the population-based sample. Patients will undergo physical examination and thorough assessments of mental co-morbidity (including psychological trauma), perceptual and central sensitisation (quantitative sensory

  6. A randomised, controlled trial of a dietary intervention for adults with major depression (the “SMILES” trial): study protocol

    PubMed Central

    2013-01-01

    Background Despite increased investment in its recognition and treatment, depression remains a substantial health and economic burden worldwide. Current treatment strategies generally focus on biological and psychological pathways, largely neglecting the role of lifestyle. There is emerging evidence to suggest that diet and nutrition play an important role in the risk, and the genesis, of depression. However, there are limited data regarding the therapeutic impact of dietary changes on existing mental illness. Using a randomised controlled trial design, we aim to investigate the efficacy and cost-efficacy of a dietary program for the treatment of Major Depressive Episodes (MDE). Methods/Design One hundred and seventy six eligible participants suffering from current MDE are being randomised into a dietary intervention group or a social support group. Depression status is assessed using the Montgomery–Åsberg Depression Rating Scale (MADRS) and Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (Non Patient Edition) (SCID-I/NP). The intervention consists of 7 individual nutrition consulting sessions (of approximately 60 minutes), delivered by an Accredited Practising Dietitian (APD). Sessions commence within one week of baseline assessment. The intervention focuses on advocating a healthy diet based on the Australian Dietary Guidelines and the Dietary Guidelines for Adults in Greece. The control condition comprises a befriending protocol using the same visit schedule and length as the diet intervention. The study is being conducted at two locations in Victoria, Australia (a metropolitan and regional centre). Data collection occurs at baseline (pre-intervention), 3-months (post-intervention) and 6– months. The primary endpoint is MADRS scores at 3 months. A cost consequences analysis will determine the economic value of the intervention. Discussion If efficacious, this program could provide an alternative or adjunct treatment

  7. Dezocine for Preventing Postoperative Pain: A Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Wang, Min; Yu, LiNa; Yan, M.

    2015-01-01

    Background Dezocine is considered to be an alternative medication for managing postoperative pain. The aim of this study was to assess the efficacy and safety of this drug in this regard. Methods Medline, EMBASE and the Cochrane Central Register of Control Trials (CENTRAL) were searched to identify all randomized controlled trials (RCTs) that compare dezocine with placebo or dezocine with morphine on postoperative pain. The data were extracted and pooled using Mantel-Haenszel random effects model. Heterogeneity was tested using the I2 statistic with values >50% and Chi2 test with P ≤ 0.05 indicating obvious heterogeneity between the studies. Results Seven trials evaluating 665 patients were included. The number of patients with at least 50% pain relief was increased (N = 234; RR 3.04, 95% CI 2.27 to 4.08) and physician (N = 465; RR 2.84, 95% CI 1.66 to 4.84) and patient satisfaction (N = 390; RR 2.81, 95% CI 1.85 to 4.26) were improved following the administration of dezocine compared with the placebo. The effects of dezocine were similar to those of morphine in terms of the number of patients reporting at least 50% pain relief within 2–6 h after surgery (N = 235; RR 1.29, 95% CI 1.15 to 1.46) and physician (N = 234; RR 1.18, 95% CI 0.93 to 1.49) and patient (N = 158; RR 1.33, 95% CI 0.93 to 1.92) satisfaction. While, the number of patients with at least 50% pain relief within 0–1 h after surgery increased following dezocine compared with morphine treatment (N = 79; RR 1.45, 95% CI 1.18 to 1.77). There was no difference in the incidence of postoperative nausea and vomiting (PONV) following dezocine treatment compared with the placebo (N = 391; RR 1.06, 95% CI 0.42 to 2.68) or morphine treatment (N = 235; RR 0.65, 95% CI 0.14 to 2.93). Conclusion Dezocine is a promising analgesic for preventing postoperative pain, but further studies are required to evaluate its safety. PMID:26287536

  8. Effect of Reiki Therapy on Pain and Anxiety in Adults: An In-Depth Literature Review of Randomized Trials with Effect Size Calculations

    PubMed Central

    Thrane, Susan; Cohen, Susan M.

    2013-01-01

    Objective To calculate the effect of Reiki therapy for pain and anxiety in randomized clinical trials. Data Sources A systematic search of PubMed, ProQuest, Cochrane, PsychInfo, CINAHL, Web of Science, Global Health, and Medline databases was conducted using the search terms pain, anxiety, and Reiki. The Center for Reiki Research was also examined for articles. Study Selection Studies that used randomization and a control or usual care group, used Reiki therapy in one arm of the study, published in 2000 or later in peer-reviewed journals in English, and measured pain or anxiety were included. Results After removing duplicates, 49 articles were examined and 12 articles received full review. Seven studies met the inclusion criteria: four articles studied cancer patients; one examined post-surgical patients; and two analyzed community dwelling older adults. Effect sizes were calculated for all studies using Cohen’s d statistic. Effect sizes for within group differences ranged from d=0.24 for decrease in anxiety in women undergoing breast biopsy to d=2.08 for decreased pain in community dwelling adults. The between group differences ranged from d=0.32 for decrease of pain in a Reiki versus rest intervention for cancer patients to d=4.5 for decrease in pain in community dwelling adults. Conclusions While the number of studies is limited, based on the size Cohen’s d statistics calculated in this review, there is evidence to suggest that Reiki therapy may be effective for pain and anxiety. Continued research using Reiki therapy with larger sample sizes, consistently randomized groups, and standardized treatment protocols is recommended. PMID:24582620

  9. Effect of Reiki therapy on pain and anxiety in adults: an in-depth literature review of randomized trials with effect size calculations.

    PubMed

    Thrane, Susan; Cohen, Susan M

    2014-12-01

    The objective of this study was to calculate the effect of Reiki therapy for pain and anxiety in randomized clinical trials. A systematic search of PubMed, ProQuest, Cochrane, PsychInfo, CINAHL, Web of Science, Global Health, and Medline databases was conducted using the search terms pain, anxiety, and Reiki. The Center for Reiki Research also was examined for articles. Studies that used randomization and a control or usual care group, used Reiki therapy in one arm of the study, were published in 2000 or later in peer-reviewed journals in English, and measured pain or anxiety were included. After removing duplicates, 49 articles were examined and 12 articles received full review. Seven studies met the inclusion criteria: four articles studied cancer patients, one examined post-surgical patients, and two analyzed community dwelling older adults. Effect sizes were calculated for all studies using Cohen's d statistic. Effect sizes for within group differences ranged from d = 0.24 for decrease in anxiety in women undergoing breast biopsy to d = 2.08 for decreased pain in community dwelling adults. The between group differences ranged from d = 0.32 for decrease of pain in a Reiki versus rest intervention for cancer patients to d = 4.5 for decrease in pain in community dwelling adults. Although the number of studies is limited, based on the size Cohen's d statistics calculated in this review, there is evidence to suggest that Reiki therapy may be effective for pain and anxiety. Continued research using Reiki therapy with larger sample sizes, consistently randomized groups, and standardized treatment protocols is recommended. PMID:24582620

  10. Efficacy of Low-Level Laser Therapy in Relieving Nipple Pain in Breastfeeding Women: A Triple-Blind, Randomized, Controlled Trial.

    PubMed

    Coca, Kelly Pereira; Marcacine, Karla Oliveira; Gamba, Mônica Antar; Corrêa, Luciana; Aranha, Ana Cecília Corrêa; Abrão, Ana Cristina Freitas de Vilhena

    2016-08-01

    Pain accruing from nipple lesions caused by inadequate latching by the baby is a common complaint among breastfeeding women and an important obstacle to successful breastfeeding. Nipple pain occurs during the first days after delivery and is considered one of the main causes for early weaning. To investigate the efficacy of low-level laser therapy as a treatment for nipple pain due to breastfeeding. A triple-blind, randomized, clinical study. A university-affiliated hospital in São Paulo, Brazil. Fifty-nine women with nipple lesions at the time of their admission. Thirty women (intervention group) received three sessions of laser therapy (InGaAIP laser, 660 nanometer, 40 milliwatts of power, 5 Joules per square centimeter of energy density for 5 seconds each, total energy = 0.6 Joules) in the region of the nipples at three different points in time (0 hour, 24 hours, and 48 hours after diagnosis of nipple lesion). Twenty-nine women with similar clinical conditions were randomly assigned to the control group. Self-reported pain was recorded before and after laser therapy using a visual analogue scale. The intervention group experienced a decrease of 2.0 centimeters in intensity of pain (p = .016) 24 hours after the first intervention and also presented lower levels of pain compared with the control group. Low-level laser therapy was considered effective for treating nipple lesions in breastfeeding women with pain, providing relief and prolonging exclusive breastfeeding. More clinical trials with different laser dosimetry and parameters are necessary to optimize laser therapy protocols for breastfeeding women. PMID:27363734

  11. Rehabilitation for the management of knee osteoarthritis using comprehensive traditional Chinese medicine in community health centers: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background It is becoming increasingly necessary for community health centers to make rehabilitation services available to patients with osteoarthritis of the knee. However, for a number of reasons, including a lack of expertise, the small size of community health centers and the availability of only simple medical equipment, conventional rehabilitation therapy has not been widely used in China. Consequently, most patients with knee osteoarthritis seek treatment in high-grade hospitals. However, many patients cannot manage the techniques that they were taught in the hospital. Methods such as acupuncture, tuina, Chinese medical herb fumigation-washing and t’ai chi are easy to do and have been reported to have curative effects in those with knee osteoarthritis. To date, there have been no randomized controlled trials validating comprehensive traditional Chinese medicine for the rehabilitation of knee osteoarthritis in a community health center. Furthermore, there is no standard rehabilitation protocol using traditional Chinese medicine for knee osteoarthritis. The aim of the current study is to develop a comprehensive rehabilitation protocol using traditional Chinese medicine for the management of knee osteoarthritis in a community health center. Method/design This will be a randomized controlled clinical trial with blinded assessment. There will be a 4-week intervention utilizing rehabilitation protocols from traditional Chinese medicine and conventional therapy. Follow-up will be conducted for a period of 12 weeks. A total of 722 participants with knee osteoarthritis will be recruited. Participants will be randomly divided into two groups: experimental and control. Primary outcomes will include range of motion, girth measurement, the visual analogue scale, and results from the manual muscle, six-minute walking and stair-climbing tests. Secondary outcomes will include average daily consumption of pain medication, ability to perform daily tasks and health

  12. A randomised controlled trial linking mental health inpatients to community smoking cessation supports: A study protocol

    PubMed Central

    2011-01-01

    Background Mental health inpatients smoke at higher rates than the general population and are disproportionately affected by tobacco dependence. Despite the advent of smoke free policies within mental health hospitals, limited systems are in place to support a cessation attempt post hospitalisation, and international evidence suggests that most smokers return to pre-admission smoking levels following discharge. This protocol describes a randomised controlled trial that will test the feasibility, acceptability and efficacy of linking inpatient smoking care with ongoing community cessation support for smokers with a mental illness. Methods/Design This study will be conducted as a randomised controlled trial. 200 smokers with an acute mental illness will be recruited from a large inpatient mental health facility. Participants will complete a baseline survey and will be randomised to either a multimodal smoking cessation intervention or provided with hospital smoking care only. Randomisation will be stratified by diagnosis (psychotic, non-psychotic). Intervention participants will be provided with a brief motivational interview in the inpatient setting and options of ongoing smoking cessation support post discharge: nicotine replacement therapy (NRT); referral to Quitline; smoking cessation groups; and fortnightly telephone support. Outcome data, including cigarettes smoked per day, quit attempts, and self-reported 7-day point prevalence abstinence (validated by exhaled carbon monoxide), will be collected via blind interview at one week, two months, four months and six months post discharge. Process information will also be collected, including the use of cessation supports and cost of the intervention. Discussion This study will provide comprehensive data on the potential of an integrated, multimodal smoking cessation intervention for persons with an acute mental illness, linking inpatient with community cessation support. Trial Registration Australian and New Zealand

  13. Trajectories of change during a randomized controlled trial of internet-delivered psychological treatment for adolescent chronic pain: how does change in pain and function relate?

    PubMed

    Palermo, Tonya M; Law, Emily F; Zhou, Chuan; Holley, Amy Lewandowski; Logan, Deirdre; Tai, Gabrielle

    2015-04-01

    Although pain and function improve at immediate posttreatment for youth receiving cognitive behavioral therapy for chronic pain, limited data are available to understand changes that youth make during psychological treatment. We sought to characterize distinct trajectory patterns of change in pain and function to understand the temporal association of these changes during internet-delivered cognitive behavioral therapy (CBT). Weekly repeated assessments of pain and function were conducted during 8 weeks of treatment among 135 adolescents, aged 11 to 17 years, with chronic pain who were randomized to the cognitive behavioral intervention arm of an ongoing trial of internet-delivered CBT (Web-based management of adolescent pain; Web-MAP2). Using random-effects growth mixture models, we characterized pain and functional disability trajectories finding distinct trajectory groups indicating patterns of both linear and quadratic effects. Trajectories of change showed that some patients' pain and functional disability were improving, others worsened or changed minimally. Paired t tests compared the within-subject relative change rate in pain and function demonstrating similar change range for pain and function during the treatment period. There was no support for improvements in either pain or function to precede changes in the other domain. Findings may be useful in informing future studies of psychosocial treatments for pediatric chronic pain to consider how to target treatment strategies to distinct patient response profiles. This may lead to the development of intervention strategies that can both more effectively target children's pain and function during treatment and lead to sustained changes after treatment.

  14. Effects of the Web Behavior Change Program for Activity and Multimodal Pain Rehabilitation: Randomized Controlled Trial

    PubMed Central

    Michaelson, Peter; Gard, Gunvor; Eriksson, Margareta K

    2016-01-01

    Background Web-based interventions with a focus on behavior change have been used for pain management, but studies of Web-based interventions integrated in clinical practice are lacking. To emphasize the development of cognitive skills and behavior, and to increase activity and self-care in rehabilitation, the Web Behavior Change Program for Activity (Web-BCPA) was developed and added to multimodal pain rehabilitation (MMR). Objective The objective of our study was to evaluate the effects of MMR in combination with the Web-BCPA compared with MMR among persons with persistent musculoskeletal pain in primary health care on pain intensity, self-efficacy, and copying, as part of a larger collection of data. Web-BCPA adherence and feasibility, as well as treatment satisfaction, were also investigated. Methods A total of 109 participants, mean age 43 (SD 11) years, with persistent pain in the back, neck, shoulder, and/or generalized pain were recruited to a randomized controlled trial with two intervention arms: (1) MMR+WEB (n=60) and (2) MMR (n=49). Participants in the MMR+WEB group self-guided through the eight modules of the Web-BCPA: pain, activity, behavior, stress and thoughts, sleep and negative thoughts, communication and self-esteem, solutions, and maintenance and progress. Data were collected with a questionnaire at baseline and at 4 and 12 months. Outcome measures were pain intensity (Visual Analog Scale), self-efficacy to control pain and to control other symptoms (Arthritis Self-Efficacy Scale), general self-efficacy (General Self-Efficacy Scale), and coping (two-item Coping Strategies Questionnaire; CSQ). Web-BCPA adherence was measured as minutes spent in the program. Satisfaction and Web-BCPA feasibility were assessed by a set of items. Results Of 109 participants, 99 received the allocated intervention (MMR+WEB: n=55; MMR: n=44); 88 of 99 (82%) completed the baseline and follow-up questionnaires. Intention-to-treat analyses were performed with a sample

  15. Changes in Knee Biomechanics After a Hip-Abductor Strengthening Protocol for Runners With Patellofemoral Pain Syndrome

    PubMed Central

    Ferber, Reed; Kendall, Karen D.; Farr, Lindsay

    2011-01-01

    Abstract Context: Very few authors have investigated the relationship between hip-abductor muscle strength and frontal-plane knee mechanics during running. Objective: To investigate this relationship using a 3-week hip-abductor muscle-strengthening program to identify changes in strength, pain, and biomechanics in runners with patellofemoral pain syndrome (PFPS). Design: Cohort study. Setting: University-based clinical research laboratory. Patients or Other Participants: Fifteen individuals (5 men, 10 women) with PFPS and 10 individuals without PFPS (4 men, 6 women) participated. Intervention(s): The patients with PFPS completed a 3-week hip-abductor strengthening protocol; control participants did not. Main Outcome Measure(s): The dependent variables of interest were maximal isometric hip-abductor muscle strength, 2-dimensional peak knee genu valgum angle, and stride-to-stride knee-joint variability. All measures were recorded at baseline and 3 weeks later. Between-groups differences were compared using repeated-measures analyses of variance. Results: At baseline, the PFPS group exhibited reduced strength, no difference in peak genu valgum angle, and increased stride-to-stride knee-joint variability compared with the control group. After the 3-week protocol, the PFPS group demonstrated increased strength, less pain, no change in peak genu valgum angle, and reduced stride-to-stride knee-joint variability compared with baseline. Conclusions: A 3-week hip-abductor muscle-strengthening protocol was effective in increasing muscle strength and decreasing pain and stride-to-stride knee-joint variability in individuals with PFPS. However, concomitant changes in peak knee genu valgum angle were not observed. PMID:21391799

  16. Nordic Walking and chronic low back pain: design of a randomized clinical trial

    PubMed Central

    Morsø, Lars; Hartvigsen, Jan; Puggaard, Lis; Manniche, Claus

    2006-01-01

    results available at this point. Discussion This study will investigate the effect of Nordic Walking on pain and function in a population of people with chronic LBP. Trial Registration registration # NCT00209820 PMID:17014731

  17. EFFECT OF THERAPEUTIC TOUCH ON PAIN RELATED PARAMETERS IN PATIENTS WITH CANCER: A RANDOMIZED CLINICAL TRIAL

    PubMed Central

    Tabatabaee, Amir; Tafreshi, Mansoureh Zagheri; Rassouli, Maryam; Aledavood, Seyed Amir; AlaviMajd, Hamid; Farahmand, Seyed Kazem

    2016-01-01

    Introduction: In patients with cancer, pain may influence their life style, and feeling of satisfaction and comfort, leading to fatigue, and cause impairment of their quality of life, personal relationships, sleep and daily activities. The aim of this study was to evaluate the effect of therapeutic touch (TT) on pain related parameters of in patients with cancer. Methods: In a randomized clinical trial a total of 90 male patients referring to Specialized Oncology Hospital in Mashhad, were conveniently selected and randomly divided into three intervention, placebo, and control groups. The intervention consisted of TT in 7 sessions for a 4-week period. The data were collected using a demographic questionnaire along with the Brief Pain Inventory, which were then analyzed and compared using Kruskal-Wallis and Mann-Whitney tests. Results: By comparing scores parameters of pain scales (general activity, mood, walking ability, relations with other people and sleep) in the three groups, there was no significant difference at the beginning of the first session. However, a significant difference was observed at the end of TT sessions between the three groups (p= 0.001). Furthermore, the groups were compared two-by-two by using Mann-Whitney test and Bonferroni correction, and the result indicated significant differences between the two intervention and placebo groups as well as between the two intervention and control groups. Conclusion: The results of the study showed that TT had a positive impact on the positive management of pain related parameters in cancer patients. Therefore, TT is suggested to be used by healthcare providers as a complementary method for managing pain and its parameters. PMID:27482166

  18. Randomized controlled trial of an educational booklet for patients presenting with back pain in general practice.

    PubMed

    Roland, M; Dixon, M

    1989-06-01

    A randomized controlled trial was used to evaluate an educational booklet on back pain for patients presenting to five group practices during one calendar year. The booklet had no immediate effect on consultations for back pain, but in the period from two weeks to one year after presentation significantly fewer patients in the group receiving the booklet consulted with back pain (35.6%) than in the control group (42.2%) (P less than 0.05). There were no significant differences between the booklet and control groups in certified absence from work owing to back pain. Referral to hospital, referral to physiotherapy, admissions to hospital and laminectomies were all less common in the booklet group. The reduction in the combined referral rate to physiotherapy and hospital, and the reduction in laminectomy rate almost reached statistical significance at the 5% level. In replying to a questionnaire sent one year after entry to the study 94.1% of respondents in the booklet group said that they had read the book, 84.0% said that they found it useful, and 68.0% said that they still had a copy. Scores on a 15-item test of knowledge about back pain were significantly higher in the group of patients who had received the booklet than in the control group. The results suggest that the booklet had some effect in altering both the knowledge and behaviour of patients with back pain. The provision of an educational booklet was a method of giving information which was appreciated by both patients and doctors.

  19. Comparison of two doses of ketoprofen to treat pain: a double-blind, randomized, noninferiority trial.

    PubMed

    Riou, Bruno; Plaisance, Patrick; Lecomte, François; Soulat, Louis; Orcel, Philippe; Mazoit, Jean-Xavier

    2014-02-01

    The aim of our study was to compare the efficacy and safety of two doses of ketoprofen (200 mg vs. 300 mg/day) in ambulatory emergency patients with pain related to traumatic and nontraumatic bone and joint diseases. We tested the hypothesis that the efficacy of the lower dose was not lower than that of the higher dose in a double-blind, randomized, noninferiority trial. Patients included in the study were aged 18-65 years with closed benign trauma of the motor system or acute noninfectious rheumatologic conditions, with a resting pain intensity ≥3/10 on a numeric pain scale (NPS), requiring ketoprofen for 5 days. The main end-point was based on two efficacy co-criteria: (i) mean change from baseline of resting pain intensity at the end of the day over 5 days and (ii) total intake of concomitant analgesics. We included 409 patients: 200 in the 200-mg group and 209 in the 300-mg group. The mean change in pain intensity at rest (difference between groups: 0.0, 95% CI -0.4 to 0.4; P = 1.00) and in analgesic consumption (difference between groups: -0.6, 95% CI -1.9 to 0.6; P = 0.33) was not significantly different between the two groups, and the differences were lower than the predefined inferiority margins (0.5 and 1.5, respectively), thus demonstrating noninferiority. No significant difference was noted in the incidence of adverse events (21% vs. 20%, P = 0.71). The efficacy of the 200-mg daily dose of ketoprofen in relieving pain in emergency cases was not inferior to that of the 300-mg dose.

  20. Massage Therapy Protocol for Post–Anterior Cruciate Ligament Reconstruction Patellofemoral Pain Syndrome: A Case Report

    PubMed Central

    Zalta, Jennifer

    2008-01-01

    Background: The intent of the present study was to determine the effectiveness of massage therapy in the rehabilitation of post–anterior cruciate ligament reconstruction patellofemoral pain syndrome. The primary complications following surgical repair of the anterior cruciate ligament—classified as patellofemoral pain syndrome—are hamstring flexion contracture and quadriceps weakness, leading to patellofemoral dysfunction and retropatellar pain. Methods: Treatment included lymphatic drainage, myofascial release, neuromuscular techniques including trigger point release, muscle energy techniques and cross-fiber friction. Orthopedic physical assessment tests were used to chart changes in patellofemoral function and changes in range of motion in the knee during the course of the massage interventions. Subjective reporting on pain level and function were also documented. Results: A decrease in pain level, hamstring flexion contracture and lateral tracking of the patella were documented. Conclusion: Massage therapy was determined to be an effective complementary therapy in the treatment of patellofemoral pain syndrome. PMID:21589717

  1. Oral administration of morphine versus ibuprofen to manage postfracture pain in children: a randomized trial

    PubMed Central

    Poonai, Naveen; Bhullar, Gina; Lin, Kangrui; Papini, Adam; Mainprize, David; Howard, Jocelyn; Teefy, John; Bale, Michelle; Langford, Cindy; Lim, Rodrick; Stitt, Larry; Rieder, Michael J.; Ali, Samina

    2014-01-01

    for outpatient pain management in children with uncomplicated fractures. Trial registration: ClinicalTrials.gov, no. NCT01690780. PMID:25349008

  2. Acceptance and Commitment Therapy for anxious children and adolescents: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Anxiety disorders affect approximately 10% to 20% of young people, can be enduring if left untreated, and have been associated with psychopathology in later life. Despite this, there is a paucity of empirical research to assist clinicians in determining appropriate treatment options. We describe a protocol for a randomized controlled trial in which we will examine the effectiveness of a group-based Acceptance and Commitment Therapy program for children and adolescents with a primary diagnosis of anxiety disorder. For the adolescent participants we will also evaluate the elements of the intervention that act as mechanisms for change. Methods/design We will recruit 150 young people (90 children and 60 adolescents) diagnosed with an anxiety disorder and their parent or caregiver. After completion of baseline assessment, participants will be randomized to one of three conditions (Acceptance and Commitment Therapy, Cognitive Behavior Therapy or waitlist control). Those in the Acceptance and Commitment Therapy and Cognitive Behavior Therapy groups will receive 10 × 1.5 hour weekly group-therapy sessions using a manualized treatment program, in accordance with the relevant therapy, to be delivered by psychologists. Controls will receive the Cognitive Behavior Therapy program after 10 weeks waitlisted. Repeated measures will be taken immediately post-therapy and at three months after therapy cessation. Discussion To the best of our knowledge, this study will be the largest trial of Acceptance and Commitment Therapy in the treatment of children and young people to date. It will provide comprehensive data on the use of Acceptance and Commitment Therapy for anxiety disorders and will offer evidence for mechanisms involved in the process of change. Furthermore, additional data will be obtained for the use of Cognitive Behavior Therapy in this population and this research will illustrate the comparative effectiveness of these two interventions, which are currently

  3. Increasing girls’ physical activity during an organised youth sport basketball program: a randomised controlled trial protocol

    PubMed Central

    2014-01-01

    Background Participation in organised youth sports (OYS) has been recommended as an opportunity to increase young peoples’ moderate-to-vigorous physical activity (MVPA) levels. Participants, however, spend a considerable proportion of time during OYS inactive. The purpose of this study, therefore, was to investigate whether coaches who attended coach education sessions (where education on increasing MVPA and decreasing inactivity during training was delivered) can increase players’ MVPA during training sessions over a 5-day basketball program compared to coaches who did not receive coach education sessions. Methods/design A convenience sample of 80 female players and 8 coaches were recruited into the UWS School Holiday Basketball Program in Greater Western Sydney, Australia. A two-arm, parallel-group randomised controlled trial was employed to investigate whether coaches who attended 2 coach education sessions (compared with a no-treatment control) can increase their players’ MVPA during training sessions over a 5-day basketball program. Objectively measured physical activity, directly observed lesson context and leader behaviour, player motivation, players’ perceived autonomy support, and coaching information (regarding training session planning, estimations on player physical activity and lesson context during training, perceived ability to modify training sessions, perceived importance of physical activity during training, intention to increase physical activity/reduce inactivity, and likelihood of increasing physical activity/reducing inactivity) were assessed at baseline (day 1) and at follow-up (day 5). Linear mixed models will be used to analyse between arm differences in changes from baseline to follow-up on all outcomes. Discussion The current trial protocol describes, to our knowledge, the first trial conducted in an OYS context to investigate the efficacy of an intervention, relative to a control, in increasing MVPA. This study’s findings will

  4. A Fully Automated Diabetes Prevention Program, Alive-PD: Program Design and Randomized Controlled Trial Protocol

    PubMed Central

    Azar, Kristen MJ; Block, Torin J; Romanelli, Robert J; Carpenter, Heather; Hopkins, Donald; Palaniappan, Latha; Block, Clifford H

    2015-01-01

    Background In the United States, 86 million adults have pre-diabetes. Evidence-based interventions that are both cost effective and widely scalable are needed to prevent diabetes. Objective Our goal was to develop a fully automated diabetes prevention program and determine its effectiveness in a randomized controlled trial. Methods Subjects with verified pre-diabetes were recruited to participate in a trial of the effectiveness of Alive-PD, a newly developed, 1-year, fully automated behavior change program delivered by email and Web. The program involves weekly tailored goal-setting, team-based and individual challenges, gamification, and other opportunities for interaction. An accompanying mobile phone app supports goal-setting and activity planning. For the trial, participants were randomized by computer algorithm to start the program immediately or after a 6-month delay. The primary outcome measures are change in HbA1c and fasting glucose from baseline to 6 months. The secondary outcome measures are change in HbA1c, glucose, lipids, body mass index (BMI), weight, waist circumference, and blood pressure at 3, 6, 9, and 12 months. Randomization and delivery of the intervention are independent of clinic staff, who are blinded to treatment assignment. Outcomes will be evaluated for the intention-to-treat and per-protocol populations. Results A total of 340 subjects with pre-diabetes were randomized to the intervention (n=164) or delayed-entry control group (n=176). Baseline characteristics were as follows: mean age 55 (SD 8.9); mean BMI 31.1 (SD 4.3); male 68.5%; mean fasting glucose 109.9 (SD 8.4) mg/dL; and mean HbA1c 5.6 (SD 0.3)%. Data collection and analysis are in progress. We hypothesize that participants in the intervention group will achieve statistically significant reductions in fasting glucose and HbA1c as compared to the control group at 6 months post baseline. Conclusions The randomized trial will provide rigorous evidence regarding the efficacy of

  5. Efficacy of composite versus ceramic inlays and onlays: study protocol for the CECOIA randomized controlled trial

    PubMed Central

    2013-01-01

    Background Dental caries is a common disease and affects many adults worldwide. Inlay or onlay restoration is widely used to treat the resulting tooth substance loss. Two esthetic materials can be used to manufacture an inlay/onlay restoration of the tooth: ceramic or composite. Here, we present the protocol of a multicenter randomized controlled trial (RCT) comparing the clinical efficacy of both materials for tooth restoration. Other objectives are analysis of overall quality, wear, restoration survival and prognosis. Methods The CEramic and COmposite Inlays Assessment (CECOIA) trial is an open-label, parallel-group, multicenter RCT involving two hospitals and five private practices. In all, 400 patients will be included. Inclusion criteria are adults who need an inlay/onlay restoration for one tooth (that can be isolated with use of a dental dam and has at least one intact cusp), can tolerate restorative procedures and do not have severe bruxism, periodontal or carious disease or poor oral hygiene. The decayed tissue will be evicted, the cavity will be prepared for receiving an inlay/onlay and the patient will be randomized by use of a centralized web-based interface to receive: 1) a ceramic or 2) composite inlay or onlay. Treatment allocation will be balanced (1:1). The inlay/onlay will be adhesively luted. Follow-up will be for 2 years and may be extended; two independent examiners will perform the evaluations. The primary outcome measure will be the score obtained with use of the consensus instrument of the Fédération Dentaire Internationale (FDI) World Dental Federation. Secondary outcomes include this instrument’s items, inlay/onlay wear, overall quality and survival of the inlay/onlay. Data will be analyzed by a statistician blinded to treatments and an adjusted ordinal logistic regression model will be used to compare the efficacy of both materials. Discussion For clinicians, the CECOIA trial results may help with evidence-based recommendations

  6. Dual sensory loss: development of a dual sensory loss protocol and design of a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Dual sensory loss (DSL) has a negative impact on health and wellbeing and its prevalence is expected to increase due to demographic aging. However, specialized care or rehabilitation programs for DSL are scarce. Until now, low vision rehabilitation does not sufficiently target concurrent impairments in vision and hearing. This study aims to 1) develop a DSL protocol (for occupational therapists working in low vision rehabilitation) which focuses on optimal use of the senses and teaches DSL patients and their communication partners to use effective communication strategies, and 2) describe the multicenter parallel randomized controlled trial (RCT) designed to test the effectiveness and cost-effectiveness of the DSL protocol. Methods/design To develop a DSL protocol, literature was reviewed and content was discussed with professionals in eye/ear care (interviews/focus groups) and DSL patients (interviews). A pilot study was conducted to test and confirm the DSL protocol. In addition, a two-armed international multi-center RCT will evaluate the effectiveness and cost-effectiveness of the DSL protocol compared to waiting list controls, in 124 patients in low vision rehabilitation centers in the Netherlands and Belgium. Discussion This study provides a treatment protocol for rehabilitation of DSL within low vision rehabilitation, which aims to be a valuable addition to the general low vision rehabilitation care. Trial registration Netherlands Trial Register (NTR) identifier: NTR2843 PMID:23941667

  7. Non-invasive interactive neurostimulation (InterX ™) reduces acute pain in patients following total knee replacement surgery: a randomised, controlled trial

    PubMed Central

    2011-01-01

    Background Adequate post-operative pain relief following total knee replacement (TKR) is very important to optimal post-operative recovery. Faster mobilisation and rehabilitation ultimately results in optimum recovery outcomes, but pain is often the limiting factor. This study evaluates the potential clinical benefit of the InterX neurostimulation device on pain reduction and rehabilitative outcome. Methods A clinical trial under the Hywel Dda Clinical Audit Committee to validate the clinical benefit of Non-invasive Interactive Neurostimulation (NIN) therapy using the InterX device was performed in patients undergoing TKR. 61 patients were randomised to treatment groups in blocks of two from the Theatre Operation List. The control group received the standard hospital course of pain medication and rehabilitation twice daily for 3 post-op days. The experimental group received 8 sessions of NIN therapy over 3 post-op days in addition to the standard course received by the Control group. Pain and range of motion were collected as the primary study measures. Results Sixty one subjects were enrolled and randomised, but 2 subjects (one/group) were excluded due to missing data at Baseline/Final; one subject in the InterX group was excluded due to pre-existing rheumatoid pain conditions confounding the analysis. The experimental group pre- to post-session Verbal Rating Scale for pain (VRS) showed that NIN therapy consistently reduced the pain scores by a mean of 2.3 points (SE 0.11). The NIN pre-treatment score at Final was used for the primary ANCOVA comparison, demonstrating a significantly greater cumulative treatment effect of a mean 2.2 (SE 0.49) points pain reduction (p = 0.002). Control subjects only experienced a mean 0.34 (SE 0.49) point decrease in pain. Ninety degrees ROM was required to discharge the patient and this was attained as an average despite the greater Baseline deficit in the InterX group. Eight control patients and three experimental patients did not

  8. Standardized Patient Walkthroughs in the National Drug Abuse Treatment Clinical Trials Network: Common Challenges to Protocol Implementation

    PubMed Central

    Fussell, Holly; Kunkel, Lynn E.; McCarty, Dennis; Lewy, Colleen S.

    2012-01-01

    Background Training research staff to implement clinical trials occurring in community-based addiction treatment programs presents unique challenges. Standardized patient walkthroughs of study procedures may enhance training and protocol implementation. Objectives Examine and discuss cross-site and cross-study challenges of participant screening and data collection procedures identified during standardized patient walkthroughs of multi-site clinical trials. Method Actors portrayed clients and “walked through” study procedures with protocol research staff. The study completed 57 walkthroughs during implementation of 4 clinical trials. Results Observers and walkthrough participants identified three areas of concern (consent procedures, screening and assessment processes, and protocol implementation) and made suggestions for resolving the concerns. Conclusions and Scientific Significance Standardized patient walkthroughs capture issues with study procedures previously unidentified with didactic training or unscripted rehearsals. Clinical trials within the National Drug Abuse Treatment Clinical Trials Network are conducted in addiction treatment centers that vary on multiple dimensions. Based on walkthrough observations, the national protocol team and local site leadership modify standardized operating procedures and resolve cross-site problems prior to recruiting study participants. The standardized patient walkthrough improves consistency across study sites and reduces potential site variation in study outcomes. PMID:21854287

  9. Reduction of pain thresholds in fibromyalgia after very low-intensity magnetic stimulation: A double-blinded, randomized placebo-controlled clinical trial

    PubMed Central

    Maestú, Ceferino; Blanco, Manuel; Nevado, Angel; Romero, Julia; Rodríguez-Rubio, Patricia; Galindo, Javier; Lorite, Juan Bautista; de las Morenas, Francisco; Fernández-Argüelles, Pedro

    2013-01-01

    BACKGROUND: Exposure to electromagnetic fields has been reported to have analgesic and antinociceptive effects in several organisms. OBJECTIVE: To test the effect of very low-intensity transcranial magnetic stimulation on symptoms associated with fibromyalgia syndrome. METHODS: A double-blinded, placebo-controlled clinical trial was performed in the Sagrado Corazón Hospital, Seville, Spain. Female fibromyalgia patients (22 to 50 years of age) were randomly assigned to either a stimulation group or a sham group. The stimulation group (n=28) was stimulated using 8 Hz pulsed magnetic fields of very low intensity, while the sham group (n=26) underwent the same protocol without stimulation. Pressure pain thresholds before and after stimulation were determined using an algometer during the eight consecutive weekly sessions of the trial. In addition, blood serotonin levels were measured and patients completed questionnaires to monitor symptom evolution. RESULTS: A repeated-measures ANOVA indicated statistically significant improvement in the stimulation group compared with the control group with respect to somatosensory pain thresholds, ability to perform daily activities, perceived chronic pain and sleep quality. While improvement in pain thresholds was apparent after the first stimulation session, improvement in the other three measures occurred after the sixth week. No significant between-group differences were observed in scores of depression, fatigue, severity of headaches or serotonin levels. No adverse side effects were reported in any of the patients. CONCLUSIONS: Very low-intensity magnetic stimulation may represent a safe and effective treatment for chronic pain and other symptoms associated with fibromyalgia. PMID:24308025

  10. Pain phenotype as a predictor for drug response in painful polyneuropathy-a retrospective analysis of data from controlled clinical trials.

    PubMed

    Holbech, Jakob V; Bach, Flemming W; Finnerup, Nanna B; Jensen, Troels S; Sindrup, Søren H

    2016-06-01

    The drugs available for treatment of neuropathic pain have somewhat disappointing efficacy with many patients left with limited or no effect. Individualized treatment based on phenotype according to presumed underlying pain mechanism(s) has been proposed to improve outcomes. We report a retrospective analysis of phenotype-specific effects of several neuropathic pain drugs, which were studied in a series of crossover, placebo-controlled, clinical trials. The data originate from 7 trials with similar design and outcome recordings, which all had a thorough baseline registration of symptoms, signs, and quantitative sensory testing. The latter was used to phenotype patients into subgroups reflecting presumed pain mechanisms. There were a total of 361 patient records distributed over treatments with 4 antidepressants and 4 anticonvulsants. Five of the drugs reduced total pain significantly compared with placebo. Only a few phenotype-specific differences in total pain reduction were found within the investigated drugs. Thus, imipramine reduced total pain 1.84 (CI: 0.02-3.67) and pregabalin 0.81 (CI: -0.67 to 2.29) in patients with than without gain of sensory function. Pregabalin showed a better effect in patients with preserved large fiber function with a mean difference in total pain reduction 1.31 (CI: 0.15-2.47). No phenotype-specific effects were found for venlafaxine, escitalopram, oxcarbazepine, valproic acid, levetiracetam, or St. John's wort. Thus, this post hoc analysis of 8 drugs with mainly nonselective actions on neuropathic pain mechanisms found limited usefulness of sensory phenotyping in pain as the basis for individualized treatment. PMID:27007067

  11. Exercise Programme in Endometrial Cancer; Protocol of the Feasibility and Acceptability Survivorship Trial (EPEC-FAST)

    PubMed Central

    Smits, Anke; Lopes, Alberto; Das, Nagindra; Bekkers, Ruud; Massuger, Leon; Galaal, Khadra

    2015-01-01

    Introduction Obesity has been associated with impaired quality of life and poorer outcomes in endometrial cancer survivors. Lifestyle interventions promoting exercise and weight reduction have been proposed for survivorship care. However, studies evaluating exercise programmes for endometrial cancer survivors are lacking. Purpose The objective of this study is to evaluate the feasibility of an individualised exercise intervention for endometrial cancer survivors to improve quality of life. Methods and analysis This is a feasibility study in which women will undergo a 10-week exercise programme with a personal trainer. The study population comprises women with confirmed diagnosis of endometrial cancer, who have completed surgical treatment with curative intent, and are aged 18 years or older. The study will take place at the Royal Cornwall Hospital Trust, UK. Feasibility will be evaluated in terms of recruitment, adherence and compliance to the programme. Secondary outcomes are quality of life, psychological distress, fatigue, pain and complication rates. In addition, the acceptability of the programme will be assessed. Ethics and dissemination Ethical approval was obtained through the Exeter NRES Committee. The study results will be used to optimise the intervention content, and may serve as the foundation for a larger definitive trial. Results will be disseminated through peer-review journals, congresses, relevant clinical groups and presented on the Trust's website. Trial registration number: NCT02367950; pre-results. PMID:26674498

  12. Systematic review of clinical trials of cervical manipulation: control group procedures and pain outcomes

    PubMed Central

    2011-01-01

    Objective To characterize the types of control procedures used in controlled clinical trials of cervical spine manipulation and to evaluate the outcomes obtained by subjects in control groups so as to improve the quality of future clinical trials Methods A search of relevant clinical trials was performed in PubMed 1966-May 2010 with the following key words: "Chiropractic"[Mesh] OR "Manipulation, Spinal"[Mesh]) AND "Clinical Trial "[Publication Type]. Reference lists from these trials were searched for any additional trials. The reference lists of two prior studies, one review and one original study were also searched. Accepted reports were then rated for quality by 2 reviewers using the PEDro scale. Studies achieving a score of >50% were included for data extraction and analysis. Intra-group change scores on pain outcomes were obtained. For determining clinically important outcomes, a threshold of 20% improvement was used where continuous data were available; otherwise, an effect size of 0.30 was employed Results The PubMed search yielded 753 citations of which 13 were selected. Eight (8) other studies were identified by reviewing two systematic reviews and through reference searches. All studies scored >50% on the PEDro scale. There were 9 multi-session studies and 12 single-session studies. The most commonly used control procedure was "manual contact/no thrust". Four (4) studies used a placebo-control (patient blinded). For two of these studies with VAS data, the average change reported was 4.5 mm. For the other control procedures, variable results were obtained. No clinically important changes were reported in 57% of the paired comparisons, while, in 43% of these, changes which would be considered clinically important were obtained in the control groups. Only 15% of trials reported on post-intervention group registration. Conclusions Most control procedures in cervical manipulation trials result in small clinical changes, although larger changes are observed in

  13. Guided imagery in people with fibromyalgia: a randomized controlled trial of effects on pain, functional status and self-efficacy.

    PubMed

    Verkaik, Renate; Busch, Martine; Koeneman, Trees; van den Berg, Rianny; Spreeuwenberg, Peter; Francke, Anneke L

    2014-05-01

    Studies on the effects of guided imagery in patients with fibromyalgia show varying results. This randomized controlled trial (n = 65) aims to give more insight into the effects on pain, functional status, and self-efficacy. Daily pain was assessed with a pain diary using a Visual Analogue Scale. Functional status and self-efficacy were measured at pretest, posttest, and follow-up using the Fibromyalgia Impact Questionnaire and the Chronic Pain Self-Efficacy Scale. No effects of guided imagery could be established. Explanations for the diverging results between studies might be found in the content of the exercises, length of the intervention period, and background of participants. PMID:23520350

  14. Comparative trial of rectal indomethacin and cryoanalgesia for control of early postthoracotomy pain.

    PubMed

    Keenan, D J; Cave, K; Langdon, L; Lea, R E

    1983-11-01

    A randomised double blind trial was carried out over the first two days after thoracotomy to compare the analgesic effects of rectal indomethacin 100 mg administered eight hourly, cryoanalgesia, and a combination of both of these with the effects of conventional intramuscular opiate analgesia. Pain scores were significantly reduced with both rectal indomethacin alone and cryoanalgesia alone; these treatments had an additive effect when used in combination. Pain on movement was significantly increased, and indomethacin was more effective in reducing this than cryoanalgesia. Groups receiving either indomethacin alone or the combination treatment required significantly less opiate on the first day and exhibited improved peak flow values over the first two days. It is concluded that rectal indomethacin, in this dosage, can provide good, safe analgesia after thoracotomy with minimum administrative difficulty. When used as an adjunct to cryoanalgesia it has an additive effect. There are many potential uses for this drug in other branches of surgery. PMID:6416399

  15. Comparative trial of rectal indomethacin and cryoanalgesia for control of early postthoracotomy pain.

    PubMed Central

    Keenan, D J; Cave, K; Langdon, L; Lea, R E

    1983-01-01

    A randomised double blind trial was carried out over the first two days after thoracotomy to compare the analgesic effects of rectal indomethacin 100 mg administered eight hourly, cryoanalgesia, and a combination of both of these with the effects of conventional intramuscular opiate analgesia. Pain scores were significantly reduced with both rectal indomethacin alone and cryoanalgesia alone; these treatments had an additive effect when used in combination. Pain on movement was significantly increased, and indomethacin was more effective in reducing this than cryoanalgesia. Groups receiving either indomethacin alone or the combination treatment required significantly less opiate on the first day and exhibited improved peak flow values over the first two days. It is concluded that rectal indomethacin, in this dosage, can provide good, safe analgesia after thoracotomy with minimum administrative difficulty. When used as an adjunct to cryoanalgesia it has an additive effect. There are many potential uses for this drug in other branches of surgery. PMID:6416399

  16. Work-related outcomes in randomised placebo-controlled pain trials: a systematic review and meta-analysis

    PubMed Central

    2014-01-01

    Background Chronic painful conditions have an important influence on the ability to work. Work-related outcomes, however, are not commonly reported in publications on trials investigating the treatment of chronic painful conditions. We aim to provide an overview of the reporting of work-related outcomes in such trials and investigate the relationship between work-related outcomes and pain outcomes. Methods We conducted a systematic literature search in PubMed with the aim of identifying randomised placebo-controlled clinical trials investigating treatments for chronic painful conditions or rheumatic diseases that also reported on work-related outcomes. Methodological study quality was assessed with the Oxford Quality Scale (OQS). Meta-analyses were conducted for the outcomes of interference with work and number of patients with at least 30% reduction in pain intensity (30% pain responders). The correlation between work-related and pain outcomes was investigated with regression analyses. Results We included 31 publications reporting on 27 datasets from randomised placebo-controlled trials (with a total of 11,434 study participants) conducted in chronic painful or rheumatic diseases and reporting on work-related outcomes. These 31 publications make up only about 0.2% of all publications on randomised placebo-controlled trials in such conditions. The methodological quality of the included studies was high; only nine studies scored less than four (out of a maximum five) points on the OQS. Sixteen different work-related outcomes were reported on in the studies. Of 25 studies testing for the statistical significance of changes in work-related outcomes over the course of the trials, 14 (56%) reported a significant improvement; the others reported non-significant changes. Eight studies reported data on both interference with work and 30% pain responders: meta-analyses demonstrated similar, statistically significant improvements in both these outcomes with active therapy

  17. A randomized clinical trial of the effectiveness of mechanical traction for sub-groups of patients with low back pain: study methods and rationale

    PubMed Central

    2010-01-01

    Background Patients with signs of nerve root irritation represent a sub-group of those with low back pain who are at increased risk of persistent symptoms and progression to costly and invasive management strategies including surgery. A period of non-surgical management is recommended for most patients, but there is little evidence to guide non-surgical decision-making. We conducted a preliminary study examining the effectiveness of a treatment protocol of mechanical traction with extension-oriented activities for patients with low back pain and signs of nerve root irritation. The results suggested this approach may be effective, particularly in a more specific sub-group of patients. The aim of this study will be to examine the effectiveness of treatment that includes traction for patients with low back pain and signs of nerve root irritation, and within the pre-defined sub-group. Methods/Design The study will recruit 120 patients with low back pain and signs of nerve root irritation. Patients will be randomized to receive an extension-oriented treatment approach, with or without the addition of mechanical traction. Randomization will be stratified based on the presence of the pre-defined sub-grouping criteria. All patients will receive 12 physical therapy treatment sessions over 6 weeks. Follow-up assessments will occur after 6 weeks, 6 months, and 1 year. The primary outcome will be disability measured with a modified Oswestry questionnaire. Secondary outcomes will include self-reports of low back and leg pain intensity, quality of life, global rating of improvement, additional healthcare utilization, and work absence. Statistical analysis will be based on intention to treat principles and will use linear mixed model analysis to compare treatment groups, and examine the interaction between treatment and sub-grouping status. Discussion This trial will provide a methodologically rigorous evaluation of the effectiveness of using traction for patients with low back

  18. A pilot randomized controlled trial comparing the efficacy of exercise, spinal manipulation, and neuro emotional technique for the treatment of pregnancy-related low back pain

    PubMed Central

    2012-01-01

    Background This pilot randomized controlled trial evaluated the feasibility of conducting a full scale study and compared the efficacy of exercise, spinal manipulation, and a mind-body therapy called Neuro Emotional Technique for the treatment of pregnancy-related low back pain, a common morbidity of pregnancy. Methods Healthy pregnant women with low back pain of insidious onset were eligible to enroll in the study at any point in their pregnancy. Once enrolled, they remained in the study until they had their babies. Women were randomly allocated into one of three treatment groups using opaque envelopes. The treatment schedule paralleled the prenatal care schedule and women received individualized intervention. Our null hypothesis was that spinal manipulation and Neuro Emotional Technique would perform no better than exercise in enhancing function and decreasing pain. Our primary outcome measure was the Roland Morris Disability Questionnaire and our secondary outcome measure was the Numeric Pain Rating Scale. Intention to treat analysis was conducted. For the primary analysis, regression was conducted to compare groups on the outcome measure scores. In a secondary responder analysis, difference in proportions of participants in attaining 30% and 50% improvement were calculated. Feasibility factors for conducting a future larger trial were also evaluated such as recruitment, compliance to study protocols, cost, and adverse events. Results Fifty-seven participants were randomized into the exercise (n = 22), spinal manipulation (n = 15), and Neuro Emotional Technique (n = 20) treatment arms. At least 50% of participants in each treatment group experienced clinically meaningful improvement in symptoms for the Roland Morris Disability Questionnaire. At least 50% of the exercise and spinal manipulation participants also experienced clinically meaningful improvement for the Numeric Pain Rating Scale. There were no clinically meaningful or statistically

  19. Effectiveness of physical activity in reducing pain in patients with fibromyalgia: a blinded randomized clinical trial.

    PubMed

    Kayo, Andrea Harumi; Peccin, Maria Stella; Sanches, Carla Munhoz; Trevisani, Virgínia Fernandes Moça

    2012-08-01

    The purpose of this study was to evaluate and compare the effectiveness of muscle-strengthening exercises (MS) and a walking program (WA) in reducing pain in patients with fibromyalgia. Ninety women, 30-55 years of age, diagnosed with fibromyalgia according to the American College of Rheumatology 1990 criteria, were randomized into 3 groups: WA Group, MS Group, and control group. Pain (visual analog scale) was evaluated as the primary outcome. Physical functioning (Fibromyalgia Impact Questionnaire, FIQ), health-related quality of life (Short-Form 36 Health Survey, SF-36), and use of medication were evaluated as secondary outcomes. Assessments were performed at baseline, 8, 16, and 28 weeks. Intention-to-treat and efficacy analyses were conducted. Sixty-eight patients completed the treatment protocol. All 3 groups showed improvement after the 16-week treatment compared to baseline. At the 28-week follow-up, pain reduction was similar for the WA and MS groups (P = 0.39), but different from the control group (P = 0.01). At the end of the treatment, 80% of subjects in the control group took pain medication, but only 46.7% in the WA and 41.4% in the MS groups. Mean FIQ total scores were lower for the WA and MS groups (P = 0.96) compared with the control group (P < 0.01). Patients in the WA and MS groups reported higher scores (better health status) than controls in almost all SF-36 subscales. MS was as effective as WA in reducing pain regarding all study variables; however, symptoms management during the follow-up period was more efficient in the WA group.

  20. Expose or protect? A randomized controlled trial of exposure in vivo vs pain-contingent treatment as usual in patients with complex regional pain syndrome type 1.

    PubMed

    den Hollander, Marlies; Goossens, Mariëlle; de Jong, Jeroen; Ruijgrok, Joop; Oosterhof, Jan; Onghena, Patrick; Smeets, Rob; Vlaeyen, Johan W S

    2016-10-01

    Complex regional pain syndrome type I (CRPS-I) highly affects patients' ability to perform daily life activities. Pain-related fear might be a key target to reduce disability in chronic pain. Current treatments aiming at reducing pain show little improvements on pain and disability, whereas novel exposure-based treatments targeting pain-related fears have shown to be promising. We conducted a randomized controlled trial (N = 46) comparing exposure in vivo (EXP) with pain-contingent treatment as usual (TAU), for CRPS-I patients with at least moderate levels of pain-related fear. Primary outcome is self-reported disability, for upper and lower extremity, respectively. Secondary outcomes are self-reported pain-intensity, pain-catastrophizing, perceived harmfulness of physical activity, and health-related quality of life. Pretreatment to posttreatment and pretreatment to 6-month follow-up change scores were tested using randomization-based inference. EXP was superior to TAU in reducing upper extremity disability from pretreatment to posttreatment (between-group difference, 1.082; 95% confidence interval [CI], 0.563-1.601; P < 0.001) and from pretreatment to 6-month follow-up (1.303; 95% CI, 0.917-1.690; P < 0.001). EXP was superior in reducing lower extremity disability from pretreatment to 6-month follow-up (3.624; 95% CI, 0.467-6.781; P = 0.02), but not from pretreatment to posttreatment (3.055; 95% CI, -0.018 to 6.128; P = 0.054). All secondary outcomes significantly favored EXP pretreatment to posttreatment, as well as pretreatment to 6-month follow-up. Exposure to daily activities shows to be more effective than a protective pain-contingent TAU in reducing self-reported disability in daily life of CRPS-I patients with at least moderate levels of pain-related fear.

  1. Effects of Qishe Pill, a compound traditional Chinese herbal medicine, on cervical radiculopathy: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Neck pain is a common symptom in most patients suffering from cervical radiculopathy. However, some conservative treatments are limited by their modest effectiveness. On the other hand, surgical intervention for cervical disc disorders is indicated when symptoms are refractory to conservative treatments and neurological symptoms are progressive. Many patients use complementary and alternative medicine, including traditional Chinese medicine, to address their symptoms. The purpose of the present study is to examine the efficacy and safety of Qishe Pill, a compound traditional Chinese herbal medicine, for neck pain in patients with cervical radiculopathy. Methods/design A multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of the Qishe Pill is proposed. The study will include 240 patients from five sites across China and diagnosed with cervical radiculopathy, according to the following inclusion criteria: age 18 to 65 with pain or stiffness in the neck for at least 2 weeks (neck disability index score 25 or more) and accompanying arm pain that radiates distally from the elbow. Qualified participants will be randomly allocated into two groups: Qishe Pill group and placebo group. The prescription of the trial medications (Qishe Pill/placebo) are 3.75 g each twice a day for 28 consecutive days. The primary outcome is pain severity. Secondary outcomes are functional status, patient satisfaction, and adverse events as reported in the trial. Discussion Qishe Pill is composed of processed Radix Astragali, Muscone, Szechuan Lovage Rhizome, Radix Stephaniae Tetrandrae, Ovientvine, and Calculus Bovis Artifactus. According to modern research and preparation standards, Qishe Pill is developed to improve on the various symptoms of cervical radiculopathy, especially for neck pain. As it has a potential benefit in treating patients with neck pain, we designed a double-blind, prospective, randomized-controlled trial and

  2. [Development of clinical trial education program for pharmaceutical science students through small group discussion and role-playing using protocol].

    PubMed

    Imakyure, Osamu; Shuto, Hideki; Nishikawa, Fumi; Hagiwara, Yoshifuka; Inoue, Sachiko; Koyanagi, Taeko; Hirakawa, Masaaki; Kataoka, Yasufumi

    2010-08-01

    The acquirement of basic knowledge of clinical trials and professional attitude in their practices is a general instructional objective in the Model Core Curriculum for Pharmaceutical Education. Unfortunately, the previous program of clinical trial education was not effective in the acquirement of a professional attitude in their practices. Then, we developed the new clinical trial education program using protocol through small group discussion (SGD) and roll-playing. Our program consists of 7 steps of practical training. In step 1, the students find some problems after presentation of the protocol including case and prescription. In step 2, they analyse the extracted problems and share the information obtained in SGD. In steps 3 and 5, five clinical case scenarios are presented to the students and they discuss which case is suitable for entry to the clinical trial or which case corresponds to the discontinuance criteria in the present designed protocol. In steps 4 and 6, the roll-playing is performed by teachers and students as doctors and clinical research coordinators (CRC) respectively. Further, we conducted a trial practice based on this program for the students. In the student's self-evaluation into five grades, the average score of the skill acquisition level in each step was 3.8-4.7 grade. Our clinical trial education program could be effective in educating the candidates for CRC or clinical pharmacists.

  3. Study protocol for a randomised controlled trial of electronic cigarettes versus nicotine patch for smoking cessation

    PubMed Central

    2013-01-01

    Background Electronic cigarettes (e-cigarettes or electronic nicotine delivery systems [ENDS]) are electrically powered devices generally similar in appearance to a cigarette that deliver a propylene glycol and/or glycerol mist to the airway of users when drawing on the mouthpiece. Nicotine and other substances such as flavourings may be included in the fluid vaporised by the device. People report using e-cigarettes to help quit smoking and studies of their effects on tobacco withdrawal and craving suggest good potential as smoking cessation aids. However, to date there have been no adequately powered randomised trials investigating their cessation efficacy or safety. This paper outlines the protocol for this study. Methods/design Design: Parallel group, 3-arm, randomised controlled trial. Participants: People aged ≥18 years resident in Auckland, New Zealand (NZ) who want to quit smoking. Intervention: Stratified blocked randomisation to allocate participants to either Elusion™ e-cigarettes with nicotine cartridges (16 mg) or with placebo cartridges (i.e. no nicotine), or to nicotine patch (21 mg) alone. Participants randomised to the e-cigarette groups will be told to use them ad libitum for one week before and 12 weeks after quit day, while participants randomised to patches will be told to use them daily for the same period. All participants will be offered behavioural support to quit from the NZ Quitline. Primary outcome: Biochemically verified (exhaled carbon monoxide) continuous abstinence at six months after quit day. Sample size: 657 people (292 in both the nicotine e-cigarette and nicotine patch groups and 73 in the placebo e-cigarettes group) will provide 80% power at p = 0.05 to detect an absolute difference of 10% in abstinence between the nicotine e-cigarette and nicotine patch groups, and 15% between the nicotine and placebo e-cigarette groups. Discussion This trial will inform international debate and policy on the regulation and

  4. Hemiablative Focal Low Dose Rate Brachytherapy: A Phase II Trial Protocol

    PubMed Central

    Bucci, Joseph; Chin, Yaw Sinn; Malouf, David; Howie, Andrew; Enari, Komiti Ese

    2016-01-01

    trial (RCT). Conclusions This protocol is designed to show feasibility in delivering hemigland focal therapy with seed BT. It may answer crucial questions and obtain data which will enable downstream decisions on focal low dose rate (LDR) prostate BT. ClinicalTrial Clinicaltrial.gov NCT02643511; https://www.clinicaltrials.gov/ct2/show/NCT02643511 (Archived by Webcite at http://www.webcitation.org/6ghLCzIhY) PMID:27296781

  5. Early intervention for adolescents with Patellofemoral Pain Syndrome - a pragmatic cluster randomised controlled trial

    PubMed Central

    2012-01-01

    Background Self-reported knee pain is highly prevalent among adolescents. As much as 50% of the non-specific knee pain may be attributed to Patellofemoral Pain Syndrome (PFPS). In the short term, exercise therapy appears to have a better effect than patient education consisting of written information and general advice on exercise or compared with placebo treatment. But the long-term effect of exercise therapy compared with patient education is conflicting. The purpose of this study is to examine the short- and long-term effectiveness of patient education compared with patient education and multimodal physiotherapy applied at a very early stage of the condition among adolescents. Methods/Design This study is a single blind pragmatic cluster randomised controlled trial. Four upper secondary schools have been invited to participate in the study (approximately 2500 students, aged 15-19 years). Students are asked to answer an online questionnaire regarding musculoskeletal pain. The students who report knee pain are contacted by telephone and offered a clinical examination by a rheumatologist. Subjects who fit the inclusion criteria and are diagnosed with PFPS are invited to participate in the study. A minimum of 102 students with PFPS are then cluster-randomised into two intervention groups based on which school they attend. Both intervention groups receive written information and education. In addition to patient education, one group receives multimodal physiotherapy consisting primarily of neuromuscular training of the muscles around the foot, knee and hip and home exercises. The students with PFPS fill out self-reported questionnaires at baseline, 3, 6, 12 and 24 months after inclusion in the study. The primary outcome measure is perception of recovery measured on a 7-point Likert scale ranging from "completely recovered" to "worse than ever" at 12 months. Discussion This study is designed to investigate the effectiveness of patient education compared with patient

  6. Computerised cognitive behaviour therapy for depression in adolescents: study protocol for a feasibility randomised controlled trial

    PubMed Central

    Wright, Barry; Tindall, Lucy; Littlewood, Elizabeth; Adamson, Joy; Allgar, Victoria; Bennett, Sophie; Gilbody, Simon; Verduyn, Chrissie; Alderson-Day, Ben; Dyson, Lisa; Trépel, Dominic; Ali, Shehzad

    2014-01-01

    dissemination The current trial protocol received a favourable ethical opinion from Leeds (West) Research and Ethics Committee. (Reference: 10/H1307/137). Trial registration number ISRCTN31219579. PMID:25361841

  7. Osteopathic manipulative treatment for low back pain: a systematic review and meta-analysis of randomized controlled trials

    PubMed Central

    Licciardone, John C; Brimhall, Angela K; King, Linda N

    2005-01-01

    Background Osteopathic manipulative treatment (OMT) is a distinctive modality commonly used by osteopathic physicians to complement their conventional treatment of musculoskeletal disorders. Previous reviews and meta-analyses of spinal manipulation for low back pain have not specifically addressed OMT and generally have focused on spinal manipulation as an alternative to conventional treatment. The purpose of this study was to assess the efficacy of OMT as a complementary treatment for low back pain. Methods Computerized bibliographic searches of MEDLINE, EMBASE, MANTIS, OSTMED, and the Cochrane Central Register of Controlled Trials were supplemented with additional database and manual searches of the literature. Six trials, involving eight OMT vs control treatment comparisons, were included because they were randomized controlled trials of OMT that involved blinded assessment of low back pain in ambulatory settings. Data on trial methodology, OMT and control treatments, and low back pain outcomes were abstracted by two independent reviewers. Effect sizes were computed using Cohen's d statistic and meta-analysis results were weighted by the inverse variance of individual comparisons. In addition to the overall meta-analysis, stratified meta-analyses were performed according to control treatment, country where the trial was conducted, and duration of follow-up. Sensitivity analyses were performed for both the overall and stratified meta-analyses. Results Overall, OMT significantly reduced low back pain (effect size, -0.30; 95% confidence interval, -0.47 – -0.13; P = .001). Stratified analyses demonstrated significant pain reductions in trials of OMT vs active treatment or placebo control and OMT vs no treatment control. There were significant pain reductions with OMT regardless of whether trials were performed in the United Kingdom or the United States. Significant pain reductions were also observed during short-, intermediate-, and long-term follow-up. Conclusion

  8. Implementation of RCGP guidelines for acute low back pain: a cluster randomised controlled trial.

    PubMed Central

    Dey, Paola; Simpson, Carl W R; Collins, Stuart I; Hodgson, G; Dowrick, Christopher F; Simison, A J M; Rose, M J

    2004-01-01

    BACKGROUND: The Royal College of General Practitioners (RCGP) has produced guidelines for the management of acute low back pain in primary care. AIM: To investigate the impact on patient management of an educational strategy to promote these guidelines among general practitioners (GPs). DESIGN OF STUDY: Group randomised controlled trial, using the health centre as the unit of randomisation. SETTING: Primary care teams in north-west England. METHOD: Twenty-four health centres were randomly allocated to an intervention or control arm. Practices in the intervention arm were offered outreach visits to promote national guidelines on acute low back pain, as well as access to fast-track physiotherapy and to a triage service for patients with persistent symptoms. RESULTS: Twenty-four centres were randomised. Two thousand, one hundred and eighty-seven eligible patients presented with acute low back pain during the study period: 1049 in the intervention group and 1138 in the control group. There were no significant differences between study groups in the proportion of patients who were referred for X-ray, issued with a sickness certificate, prescribed opioids or muscle relaxants, or who were referred to secondary care, but significantly more patients in the intervention group were referred to physiotherapy or the back pain unit (difference in proportion = 12.2%, 95% confidence interval [CI] = 2.8% to 21.6%). CONCLUSION: The management of patients presenting with low back pain to primary care was mostly unchanged by an outreach educational strategy to promote greater adherence to RCGP guidelines among GPs. An increase in referral to physiotherapy or educational programmes followed the provision of a triage service. PMID:14965404

  9. Transcutaneous pulsed radiofrequency treatment for patients with shoulder pain booked for surgery: a double-blind, randomized controlled trial.

    PubMed

    Taverner, Murray; Loughnan, Terence

    2014-02-01

    Shoulder pain is the third most common musculoskeletal problem and accounts for 5% of general practitioner consultations. Although many treatments are described, there is no consensus on optimal treatment and up to 40% of patients still have pain 12 months after initially seeking help for pain. Previously, the effect of transcutaneous pulsed radiofrequency treatment (TCPRFT) was evaluated in a retrospective audit that showed good pain relief for a mean 395 days and justified this randomized sham controlled trial. In this study, 51 patients entered into a randomized double-blinded, placebo controlled study of TCPRFT. Patients were assessed at 4 and 12 weeks by a blinded observer and compared with baseline. We observed sustained reductions in pain at night, pain with activity, and functional improvement at 4 and 12 weeks with active but not sham TCPRFT. The 25 subjects who received active treatment showed statistically significant reductions of 24/100 in pain at night and 20/100 of pain with activity at 4 weeks and 18/100 and 19/100, respectively, at 12 weeks from baseline. Statistically significant lower Brief Pain Inventory pain and function scores (4 and 12 weeks), improved pain self-efficacy (4 weeks), Oxford Shoulder scores (12 weeks), and internal rotation (12 weeks) were seen. Pain at both rest and shoulder elevation were not improved by active treatment. No complications were seen. This study of a simple, low risk, outpatient treatment confirms the findings of our earlier study of TCPRFT for knee pain and shoulder pain audit that transcutaneous pulsed radiofrequency treatment may help some people with painful shoulders.

  10. Steroid Injection and Nonsteroidal Anti-inflammatory Agents for Shoulder Pain: A PRISMA Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    PubMed

    Sun, Yaying; Chen, Jiwu; Li, Hong; Jiang, Jia; Chen, Shiyi

    2015-12-01

    Advantages and possible risks associated with steroid injection compared with nonsteroidal anti-inflammatory drugs (NSAIDs) for shoulder pain are not fully understood. To compare the efficiency and safety of steroid injection versus NSAIDs for patients with shoulder pain. PubMed, Embase, and the Cochrane Library were searched through July 2015. Study eligibility criteria, participants, and interventions: randomized controlled trials (RCTs) that assessed steroid injection versus NSAIDs for patients with shoulder pain. Study appraisal and synthesis methods: predefined primary efficacy outcome was functional improvement; and secondary efficacy outcomes included pain relief and complications. Relative risks (RRs) and standardized mean differences (SMDs) with 95% confidence intervals (CIs) were calculated using a random-effects model accounting for clinical heterogeneity. Eight RCTs involving 465 participants were included in the meta-analysis. Five trials compared steroid injection with oral NSAIDs, and 3 compared steroids injection with NSAIDs injection. Compared with steroid injection, oral NSAIDs were less effective in 4 or 6 weeks for functional improvement (SMD 0.61; 95% CI, 0.08-1.14; P = 0.01), while there was no significant difference in pain relief (SMD 0.45; 95% CI, -0.50-1.40; P < 0.00001) or complication rate (RR 1.10; 95% CI, 0.26-4.58; P = 0.29). Meta-analysis was not performed for NSAIDs injection due to considerable heterogeneity. Conflicting results were observed in favor of either steroid or NSAIDs injection. Not all diseases that can lead to shoulder pain were included, detailed intervention protocols were inconsistent across studies, and some estimated data were input into comparison while some data were lost, which could exert an influence on pooled results. Steroid injection, compared with oral NSAIDs, provides slightly more improvement in shoulder function without superiority in pain relief or risk of complications at 4 to 6 weeks

  11. Performance of research ethics committees in Spain. A prospective study of 100 applications for clinical trial protocols on medicines.

    PubMed Central

    Dal-Ré, R; Espada, J; Ortega, R

    1999-01-01

    OBJECTIVES: To review the characteristics and performance of research ethics committees in Spain in the evaluation of multicentre clinical trial drug protocols. DESIGN: A prospective study of 100 applications. SETTING: Forty-one committees reviewing clinical trial protocols, involving 50 hospitals in 25 cities. MAIN MEASURES: Protocol-related features, characteristics of research ethics committees and evaluation dynamics. RESULTS: The 100 applications involved 15 protocols (of which 12 were multinational) with 12 drugs. Committees met monthly (except one). They had a mean number of 12 members, requested a mean of six complete dossiers and nine additional copies of the protocol with a mean deadline of 14 days before the meeting. All applications were approved except three (two of the three were open-label long-term safety trials rejected by the same committee), which were approved by the other committees involved. The mean time from submission to approval was 64 days. The mean time from submission to arrival of the approval document at our offices was 85 days. Twenty-five committees raised queries for 38 of the 97 finally approved applications. Impact of evaluation fee, number of members, queries raised and experience of committees on timings were not statistically significant. CONCLUSION: Obtaining ethical approval is time-consuming. There is much diversity in the research ethics committees' performance. A remarkable delay (> 20 days) exists between the decision and the arrival of the written approval, suggesting administrative or organisational problems. PMID:10390685

  12. The ENHANCES study—Enhancing Head and Neck Cancer patients’ Experiences of Survivorship: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Few cancers pose greater challenges than head and neck (H&N) cancer. Residual effects following treatment include body image changes, pain, fatigue and difficulties with appetite, swallowing and speech. Depression is a common comorbidity. There is limited evidence about ways to assist patients to achieve optimal adjustment after completion of treatment. In this study, we aim to examine the effectiveness and feasibility of a model of survivorship care to improve the quality of life of patients who have completed treatment for H&N cancer. Methods/Design This is a preliminary study in which 120 patients will be recruited. A prospective randomised controlled trial of the H&N Cancer Survivor Self-management Care Plan (HNCP) involving pre- and post-intervention assessments will be used. Consecutive patients who have completed a defined treatment protocol for H&N cancer will be recruited from two large cancer services and randomly allocated to one of three study arms: (1) usual care, (2) information in the form of a written resource or (3) the HNCP delivered by an oncology nurse who has participated in manual-based training and skill development in patient self-management support. The trained nurses will meet patients in a face-to-face interview lasting up to 60 minutes to develop an individualised HNCP, based on principles of chronic disease self-management. Participants will be assessed at baseline, 3 and 6 months. The primary outcome measure is quality of life. The secondary outcome measures include mood, self-efficacy and health-care utilisation. The feasibility of implementing this intervention in routine clinical care will be assessed through semistructured interviews with participating nurses, managers and administrators. Interviews with patients who received the HNCP will explore their perceptions of the HNCP, including factors that assisted them in achieving behavioural change. Discussion In this study, we aim to improve the quality of life of a

  13. Randomized controlled trials in industrial low back pain relating to return to work. Part 2. Discogenic low back pain.

    PubMed

    Scheer, S J; Radack, K L; O'Brien, D R

    1996-11-01

    The purpose of this review was to determine the efficacy of treatments for discogenic low back pain (LBP) by examining all randomized controlled trials (RCTs) of discogenic LBP published in the English language literature between 1975 and 1993 with "return to work" (RTW) as the end point. From more than 4,000 LBP citations, nearly 600 articles were initially reviewed; 35 studies met our selection criteria. Twenty-two studies were discussed in Part 1 (Acute Interventions) or will be discussed in Part 3 (Chronic Interventions). In this review, of 13 RCTs assessing interventions for LBP with sciatica, 9 were appropriate for their focus on, and radiologic confirmation of, discogenic LBP. The treatments assessed included chemonucleolysis, surgical discectomy, and epidural steroid injection. A 26-point system to assess the quality of methodologic rigor was used for each article. Our literature survey found a need for additional studies comparing surgery, conservative care, epidural steroids, traction, and other approaches to determine their individual effects for RTW after discogenic disease. PMID:8931535

  14. Teleconsultation in children with abdominal pain: a comparison of physician triage recommendations and an established paediatric telephone triage protocol

    PubMed Central

    2013-01-01

    Background Quality assessment and continuous quality feedback to the staff is crucial for safety and efficiency of teleconsultation and triage. This study evaluates whether it is feasible to use an already existing telephone triage protocol to assess the appropriateness of point-of-care and time-to-treat recommendations after teleconsultations. Methods Based on electronic patient records, we retrospectively compared the point-of-care and time-to-treat recommendations of the paediatric telephone triage protocol with the actual recommendations of trained physicians for children with abdominal pain, following a teleconsultation. Results In 59 of 96 cases (61%) these recommendations were congruent with the paediatric telephone protocol. Discrepancies were either of organizational nature, due to factors such as local referral policies or gatekeeping insurance models, or of medical origin, such as milder than usual symptoms or clear diagnosis of a minor ailment. Conclusions A paediatric telephone triage protocol may be applicable in healthcare systems other than the one in which it has been developed, if triage rules are adapted to match the organisational aspects of the local healthcare system. PMID:24079719

  15. Exercise program for prevention of groin pain in football players: a cluster-randomized trial.

    PubMed

    Hölmich, P; Larsen, K; Krogsgaard, K; Gluud, C

    2010-12-01

    Groin injuries cause major problems in sports and particularly in football. Exercise is effective in treating adductor-related groin pain, but no trials have been published regarding the specific prevention of groin pain or prevention specifically targeting overuse injuries in sport using exercise programs. We performed a cluster-randomized trial including 55 football clubs representing 1211 players. The clubs were randomized to an exercise program aimed at preventing groin injuries (n=27) or to a control group training as usual (n=28). The intervention program consisted of six exercises including strengthening (concentric and eccentric), coordination, and core stability exercises for the muscles related to the pelvis. Physiotherapists assigned to each club registered all groin injuries. Twenty-two clubs in each group completed the study, represented by 977 players. There was no significant effect of the intervention (HR=0.69, 95% CI 0.40-1.19). The risk of a groin injury was reduced by 31%, but this reduction was not significant. A univariate analysis showed that having had a previous groin injury almost doubles the risk of developing a new groin injury and playing at a higher level almost triples the risk of developing a groin injury. PMID:19883386

  16. Mesotherapy versus Systemic Therapy in the Treatment of Acute Low Back Pain: A Randomized Trial

    PubMed Central

    Costantino, Cosimo; Marangio, Emilio; Coruzzi, Gabriella

    2011-01-01

    Pharmacological therapy of back pain with analgesics and anti-inflammatory drugs is frequently associated with adverse effects, particularly in the elderly. Aim of this study was to compare mesotherapic versus conventional systemic administration of nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids in patients with acute low back pain. Eighty-four patients were randomized to receive anti-inflammatory therapy according to the following protocols: (a) mesotherapy group received the 1st and 4th day 2% lidocaine (1 mL) + ketoprofen 160 mg (1 mL) + methylprednisolone 40 mg (1 mL), then on 7th, 10th, and 13th day, 2% lidocaine (1 mL) + ketoprofen 160 mg (1 mL) + methylprednisolone 20 mg (1 mL) (b) conventional therapy group received ketoprofen 80 mg × 2/die and esomeprazole 20 mg/die orally for 12 days, methylprednisolone 40 mg/die intramuscularly for 4 days, followed by methylprednisolone 20 mg/die for 3 days, and thereafter, methylprednisolone 20 mg/die at alternate days. Pain intensity and functional disability were assessed at baseline (T0), at the end of treatment (T1), and 6 months thereafter (T2) by using visual analogic scale (VAS) and Roland-Morris disability questionnaire (RMDQ). In both groups, VAS and RMDQ values were significantly reduced at the end of drug treatment and after 6 months, in comparison with baseline. No significant differences were found between the two groups. This suggests that mesotherapy may be a valid alternative to conventional therapy in the treatment of acute low back pain with corticosteroids and NSAIDs. PMID:20953425

  17. Osteopathic Manipulative Treatment of Back Pain and Related Symptoms during Pregnancy: A Randomized Controlled Trial

    PubMed Central

    LICCIARDONE, John C.; BUCHANAN, Steve; HENSEL, Kendi L.; KING, Hollis H.; FULDA, Kimberly G.; STOLL, Scott T.

    2009-01-01

    Objective: To study osteopathic manipulative treatment (OMT) of back pain and related symptoms during the third trimester of pregnancy. Study design: A randomized, placebo-controlled trial was conducted to compare usual obstetrical care (UOBC) and OMT (UOBC+OMT), UOBC and sham ultrasound treatment (UOBC+SUT), and UOBC only. Outcomes included average pain levels and the Roland Morris-Disability Questionnaire (RMDQ) to assess back-specific functioning. Results: Intention-to-treat analyses included 144 subjects. The RMDQ scores worsened during pregnancy; however, back-specific functioning deteriorated significantly less in the UOBC+OMT group (effect size, 0.72; 95% CI, 0.31-1.14; P=.001 vs. UOBC only; and effect size, 0.35; 95% CI, −0.06-0.76; P=.09 vs. UOBC+SUT). During pregnancy, back pain decreased in the UOBC+OMT group, remained unchanged in the UOBC+SUT group, and increased in the UOBC only group, although no between-group difference achieved statistical significance. Conclusion: Osteopathic manipulative treatment slows or halts the deterioration of back-specific functioning during the third trimester of pregnancy. PMID:19766977

  18. Exposure-Based Cognitive Behavior Therapy for Children with Abdominal Pain: A Pilot Trial

    PubMed Central

    Olén, Ola; Bonnert, Marianne; Hedman, Erik; Serlachius, Eva; Ljótsson, Brjánn

    2016-01-01

    Background Children with pain-related functional gastrointestinal disorders (P-FGIDs) have an increased risk for school absenteeism, depression, anxiety and low quality of life. Exposure-based cognitive behavior therapy (CBT) has shown large treatment effects in adults with irritable bowel syndrome, but has not been tested for children 8–12 years with P-FGIDs. Aim The aim of this trial was to test the feasibility, acceptability and potential efficacy of a newly developed exposure-based CBT for children with P-FGIDs. Method The children (n = 20) with a P-FGID, were referred by their treating physicians. The participants received 10 weekly sessions of exposure-based CBT and were assessed at pre-treatment, post-treatment and 6-month follow-up. Results Children improved significantly on the primary outcome measure pain intensity at post (Cohen’s d = 0.40, p = 0.049) and at 6-month follow-up (Cohen’s d = 0.85, p = 0.004). Improvements were also seen in pain frequency, gastrointestinal symptoms, quality of life, depression, anxiety, school absenteeism and somatic symptoms. Improvements were maintained or further increased at 6-month follow-up. The children engaged in the exposures and were satisfied with the treatment. Conclusions Exposure-based CBT for children with P-FGIDs is feasible, acceptable and potentially efficacious. PMID:27736943

  19. The effects of acupressure on labor pains during child birth: randomized clinical trial 1

    PubMed Central

    Mafetoni, Reginaldo Roque; Shimo, Antonieta Keiko Kakuda

    2016-01-01

    ABSTRACT Objective: to analyze the effects of acupressure on the sanyinjiao point for pregnant women in labor at public maternity wards. Method: single-blind controlled clinical trial, randomly done employing a pragmatic profile. We selected 156 pregnant women in their ≥ 37 week/s, who had cervical dilations of ≥ 4 cm and with two or more contractions in 10 minutes. The pregnant women were randomly divided into three groups at a university hospital in the suburbs of Sao Paulo, Brazil, in order to receive either acupressure treatment, a placebo or participate as part of a control group. The acupressure was applied on the sanyinjiao point during the contractions for 20 minutes. Then the intensity of the pain was evaluated using the Visual Analogue Scale (VAS). Results: The averages for the pain measured using the VAS were not different for the three groups that were a part of the study (p-value=0.0929), however they were less in the acupressure groups immediately after receiving the treatment (p-value=<0.0001). This was also the case where the treatment lasted for 1 hour (p-value=0.0001). This was the case in comparison with placebo and control groups. Conclusion: the use of acupressure on the sanyinjiao point is a useful way to alleviate pain in a non-invasive manner. It can improve the quality of care given to pregnant women in labor. Register: RBR-9mhs8r. PMID:27508910

  20. Ear Acupuncture Therapy for Masticatory Myofascial and Temporomandibular Pain: A Controlled Clinical Trial

    PubMed Central

    Ferreira, Luciano Ambrosio; Grossmann, Eduardo; Januzzi, Eduardo; Gonçalves, Rafael Tardin Rosa Ferraz; Mares, Fernando Antonio Guedes; de Paula, Marcos Vinicius Queiroz; Carvalho, Antonio Carlos Pires

    2015-01-01

    Ear acupuncture works by reducing painful sensations with analgesic effect through microsystem therapy and has been demonstrated to be as effective as conventional therapies in the control of facial pain. This clinical trial aimed to evaluate the adjuvant action of auricular acupuncture through an observation of the evolution of temporomandibular and masticatory myofascial symptoms in two groups defined by the therapies elected: auricular acupuncture associated with occlusal splint (study) and the use of the occlusal splint plate alone (control). We have selected 20 patients, who were randomly allocated into two groups of ten individuals. Symptoms were evaluated in five different moments, every seven days. We analyzed the orofacial muscle and joint palpation in order to measure the intensity of the experienced pain. Both groups showed a statistically significant decrease in muscle and joint symptoms (p < 0.05). However, comparisons between the groups showed an expressive and significant reduction of symptomatology in the study group (p < 0.05) already on the first week of therapy. According to the results, to the methodological criteria developed and statistical analysis applied, the conclusion is that auricular acupuncture therapy has synergistic action on conventional occlusal splint treatment. It was demonstrated to be effective in the reduction of symptoms in the short term. PMID:26351510

  1. Whole Body Vibration Exercise Protocol versus a Standard Exercise Protocol after ACL Reconstruction: A Clinical Randomized Controlled Trial with Short Term Follow-Up

    PubMed Central

    Berschin, Gereon; Sommer, Björn; Behrens, Antje; Sommer, Hans-Martin

    2014-01-01

    The suitability and effectiveness of whole body vibration (WBV) exercise in rehabilitation after injury of the anterior cruciate ligament (ACL) was studied using a specially designed WBV protocol. We wanted to test the hypothesis if WBV leads to superior short term results regarding neuromuscular performance (strength and coordination) and would be less time consuming than a current standard muscle strengthening protocol. In this prospective randomized controlled clinical trial, forty patients who tore their ACL and underwent subsequent ligament reconstruction were enrolled. Patients were randomized to the whole body vibration (n=20) or standard rehabilitation exercise protocol (n=20). Both protocols started in the 2nd week after surgery. Isometric and isokinetic strength measurements, clinical assessment, Lysholm score, neuromuscular performance were conducted weeks 2, 5, 8 and 11 after surgery. Time spent for rehabilitation exercise was reduced to less than a half in the WBV group. There were no statistically significant differences in terms of clinical assessment, Lysholm score, isokinetic and isometric strength. The WBV group displayed significant better results in the stability test. In conclusion, preliminary data indicate that our whole body vibration muscle exercise protocol seems to be a good alternative to a standard exercise program in ACL-rehabilitation. Despite of its significant reduced time requirement it is at least equally effective compared to a standard rehabilitation protocol. Key points In this prospective randomized controlled clinical trial, we tested the hypothesis if WBV leads to superior short term results regarding neuromuscular performance (strength and coordination) and would be less time consuming than a current standard muscle strengthening protocol in forty patients who underwent ACL reconstruction. Time spent for rehabilitation exercise was reduced to less than a half in the WBV group as compared to the standard exercise group. Both

  2. Hypnosis as a treatment of chronic widespread pain in general practice: A randomized controlled pilot trial

    PubMed Central

    Grøndahl, Jan Robert; Rosvold, Elin Olaug

    2008-01-01

    Background Hypnosis treatment in general practice is a rather new concept. This pilot study was performed to evaluate the effect of a standardized hypnosis treatment used in general practice for patients with chronic widespread pain (CWP). Methods The study was designed as a randomized control group-controlled study. Sixteen patients were randomized into a treatment group or a control group, each constituting eight patients. Seven patients in the treatment group completed the schedule. After the control period, five of the patients in the control group also received treatment, making a total of 12 patients having completed the treatment sessions. The intervention group went through a standardized hypnosis treatment with ten consecutive therapeutic sessions once a week, each lasting for about 30 minutes, focusing on ego-strengthening, relaxation, releasing muscular tension and increasing self-efficacy. A questionnaire was developed in order to calibrate the symptoms before and after the 10 weeks period, and the results were interpolated into a scale from 0 to 100, increasing numbers representing increasing suffering. Data were analyzed by means of T-tests. Results The treatment group improved from their symptoms, (change from 62.5 to 55.4), while the control group deteriorated, (change from 37.2 to 45.1), (p = 0,045). The 12 patients who completed the treatment showed a mean improvement from 51.5 to 41.6. (p = 0,046). One year later the corresponding result was 41.3, indicating a persisting improvement. Conclusion The study indicates that hypnosis treatment may have a positive effect on pain and quality of life for patients with chronic muscular pain. Considering the limited number of patients, more studies should be conducted to confirm the results. Trial Registration The study was registered in ClinicalTrials.gov and released 27.08.07 Reg nr NCT00521807 Approval Number: 05032001. PMID:18801190

  3. A quality control program within a clinical trial Consortium for PCR protocols to detect Plasmodium species.

    PubMed

    Taylor, Steve M; Mayor, Alfredo; Mombo-Ngoma, Ghyslain; Kenguele, Hilaire M; Ouédraogo, Smaïla; Ndam, Nicaise Tuikue; Mkali, Happy; Mwangoka, Grace; Valecha, Neena; Singh, Jai Prakash Narayan; Clark, Martha A; Verweij, Jaco J; Adegnika, Ayola Akim; Severini, Carlo; Menegon, Michela; Macete, Eusebio; Menendez, Clara; Cisteró, Pau; Njie, Fanta; Affara, Muna; Otieno, Kephas; Kariuki, Simon; ter Kuile, Feiko O; Meshnick, Steven R

    2014-06-01

    Malaria parasite infections that are only detectable by molecular methods are highly prevalent and represent a potential transmission reservoir. The methods used to detect these infections are not standardized, and their operating characteristics are often unknown. We designed a proficiency panel of Plasmodium spp. in order to compare the accuracy of parasite detection of molecular protocols used by labs in a clinical trial consortium. Ten dried blood spots (DBSs) were assembled that contained P. falciparum, P. vivax, P. malariae, and P. ovale; DBSs contained either a single species or a species mixed with P. falciparum. DBS panels were tested in 9 participating laboratories in a masked fashion. Of 90 tests, 68 (75.6%) were correct; there were 20 false-negative results and 2 false positives. The detection rate was 77.8% (49/63) for P. falciparum, 91.7% (11/12) for P. vivax, 83.3% (10/12) for P. malariae, and 70% (7/10) for P. ovale. Most false-negative P. falciparum results were from samples with an estimated ≤ 5 parasites per μl of blood. Between labs, accuracy ranged from 100% to 50%. In one lab, the inability to detect species in mixed-species infections prompted a redesign and improvement of the assay. Most PCR-based protocols were able to detect P. falciparum and P. vivax at higher densities, but these assays may not reliably detect parasites in samples with low P. falciparum densities. Accordingly, formal quality assurance for PCR should be employed whenever this method is used for diagnosis or surveillance. Such efforts will be important if PCR is to be widely employed to assist malaria elimination efforts.

  4. The efficacy of the addition of the Pilates method over a minimal intervention in the treatment of chronic nonspecific low back pain: a study protocol of a randomized controlled trial☆

    PubMed Central

    Miyamoto, Gisela C.; Costa, Leonardo O.P.; Galvanin, Thalissa; Cabral, Cristina M.N.

    2011-01-01

    Objective There is little high-quality evidence on the efficacy of the Pilates-based exercises for the treatment of chronic nonspecific low back pain. Therefore, the objective of this paper is to present a study protocol to investigate the efficacy of adding Pilates-based exercises to a minimum intervention in patients with chronic non-specific low back pain. Methods This randomized controlled trial will recruit 86 patients of both sexes, aged between 18 and 60 years, with chronic non-specific low back pain. The participants will be randomly allocated into 2 treatment groups: the Booklet Group, which will receive a booklet with postural orientations, and the Pilates Group, which will receive the same booklet in addition to a Pilates-based exercises program. The general and specific functional capacities of the patient, kinesiophobia, pain intensity, and the global perceived effect will be evaluated by a blinded assessor before randomization and at 6 weeks and 6 months after randomization. In addition, the expectations of the participants and their confidence in the treatment will be evaluated before the randomization and after the first treatment session, respectively. Conclusions It is hoped that the results of this study will provide high-quality evidence on the usefulness of Pilates-based exercises in the treatment of chronic non-specific low back pain. PMID:22654682

  5. A systematic review of controlled clinical trials on the prevention of back pain in industry.

    PubMed Central

    van Poppel, M N; Koes, B W; Smid, T; Bouter, L M

    1997-01-01

    OBJECTIVE: To assess the effectiveness of lumbar supports, education, and exercise in the prevention of back pain in industry. METHODS: A computerised search for controlled clinical trials was conducted. A criteria list was used to assess the methodological quality of the studies. The available evidence for the effectiveness of the interventions was graded with a rating system for the level of evidence. Effect sizes of individual studies were combined if the studies were sufficiently similar. RESULTS: 11 studies were identified for the review. The methodological quality of all studies was low, with a maximum score of three out of seven for internal validity. There was no evidence for the effectiveness of lumbar supports due to contradictory outcomes of the studies. Five of the six studies on education reported no effect. Thus there is limited evidence that education does not help to prevent back pain. All three studies on exercise reported a positive result, indicating limited evidence for the effectiveness of exercise. The combined effect size for exercise was 0.53, which is a medium sized effect. CONCLUSIONS: Although widely used, there is little evaluative research on the preventive measures studied here. The review showed that there is limited evidence that exercise has some effect in the prevention of back pain and that education is not effective. No conclusive evidence was found for or against the effectiveness of lumbar supports. Research of higher methodological quality is needed before firm conclusions on the effectiveness of lumbar supports, education, and exercise in the prevention of back pain in industry can be drawn. PMID:9470890

  6. Protocol of plain radiographs, hip ultrasound, and triple phase bone scans in the evaluation of the painful pediatric hip

    SciTech Connect

    Alexander, J.E.; Seibert, J.J.; Aronson, J.; Williamson, S.L.; Glasier, C.M.; Rodgers, A.B.; Corbitt, S.L.

    1988-04-01

    A useful protocol for the evaluation of hip pain in the pediatric patient, using a combination of plain radiographs, hip ultrasound (US), and triple phase radionuclide bone scans is presented. Patients with hip pain were initially evaluated by plain radiographs of the pelvis and hips. If no diagnosis was reached, the hips were studied for effusions by real-time hip ultrasonography. If an effusion was present, the joint was aspirated for diagnosis. If no effusion was present by US or if no diagnosis was reached by aspiration, triple phase radionuclide bone scans were performed. Fifty patients were evaluated by this prospective protocol, and the diagnosis was reached in 48 of the 50 cases (10 by plain radiographs, 16 by US, and aspiration of the joint, and 22 by triple phase bone scans). Hip effusions were found in 20 patients by US, with no false positives or false negatives. Previous studies for detecting effusions by US have emphasized absolute measurements of the capsular width, but we report a typical appearance of the hip capsule when fluid is present (a bulging convex capsule). When no effusion is present, the capsule is concave and parallels the long axis of the femoral neck.

  7. [Chest pain units. Organization and protocol for the diagnosis of acute coronary syndromes].

    PubMed

    Bayón Fernández, Julián; Alegría Ezquerra, Eduardo; Bosch Genover, Xavier; Cabadés O'Callaghan, Adolfo; Iglesias Gárriz, Ignacio; Jiménez Nácher, José Julio; Malpartida De Torres, Félix; Sanz Romero, Ginés

    2002-02-01

    The two main goals of chest pain units are the early, accurate diagnosis of acute coronary syndromes and the rapid, efficient recognition of low-risk patients who do not need hospital admission. Many clinical, practical, and economic reasons support the establishment of such units. Patients with chest pain account for a substantial proportion of emergency room turnover and their care is still far from optimal: 8% of patients sent home are later diagnosed of acute coronary syndrome and 60% of admissions for chest pain eventually prove to have been unnecessary.We present a systematic approach to create and manage a chest pain unit employing specialists headed by a cardiologist. The unit may be functional or located in a separate area of the emergency room. Initial triage is based on the clinical characteristics, the ECG and biomarkers of myocardial infarct. Risk stratification in the second phase selects patients to be admitted to the chest pain unit for 6-12 h. Finally, we propose treadmill testing before discharge to rule out the presence of acute myocardial ischemia or damage in patients with negative biomarkers and non-diagnostic serial ECGs.

  8. Femoral nerve block Intervention in Neck of Femur fracture (FINOF): study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Hip fractures are very painful leading to lengthy hospital stays. Conventional methods of treating pain are limited. Non-steroidal anti-inflammatories are relatively contraindicated and opioids have significant side effects.Regional anaesthesia holds promise but results from these techniques are inconsistent. Trials to date have been inconclusive with regard to which blocks to use and for how long. Interpatient variability remains a problem. Methods/Design This is a single centre study conducted at Queen’s Medical Centre, Nottingham; a large regional trauma centre in England. It is a pragmatic, parallel arm, randomized controlled trial. Sample size will be 150 participants (75 in each group). Randomization will be web-based, using computer generated concealed tables (service provided by Nottingham University Clinical Trials Unit). There is no blinding. Intervention will be a femoral nerve block (0.5 mls/kg 0.25% levo-bupivacaine) followed by ropivacaine (0.2% 5 ml/hr−1) infused via a femoral nerve catheter until 48 hours post-surgery. The control group will receive standard care. Participants will be aged over 70 years, cognitively intact (abbreviated mental score of seven or more), able to provide informed consent, and admitted directly through the Emergency Department from their place of residence. Primary outcomes will be cumulative ambulation score (from day 1 to 3 postoperatively) and cumulative dynamic pain scores (day 1 to 3 postoperatively). Secondary outcomes will be cumulative dynamic pain score preoperatively, cumulative side effects, cumulative calorific and protein intake, EUROQOL EQ-5D score, length of stay, and rehabilitation outcome (measured by mobility score). Discussion Many studies have shown the effectiveness of regional blockade in neck of femur fractures, but the techniques used have varied. This study aims to identify whether early and continuous femoral nerve block can be effective in relieving pain and enhancing mobilization.Trial

  9. Alternative Physical Therapy Protocol Using a Cycle Ergometer During Hospital Rehabilitation of Coronary Artery Bypass Grafting: a Clinical Trial

    PubMed Central

    Trevisan, Margarete Diprat; Lopes, Diene Gomes Colvara; de Mello, Renato Gorga Bandeira; Macagnan, Fabrício Edler; Kessler, Adriana

    2015-01-01

    OBJECTIVE To compare the efficacy of a cycle ergometer-based exercise program to a standard protocol on the increment of the maximum distance walked during the six-minute walk test in the postoperative rehabilitation of patients submitted to coronary artery bypass grafting. METHODS A controlled clinical trial pilot, blinded to the outcome, enrolled subjects who underwent coronary artery bypass grafting in a hospital from Southern Brazil. Subjects were designated for the standard physical rehabilitation protocol or to an alternative cycle ergometer-based protocol through simple random sampling. The primary outcome was the difference in the maximum distance walked in the six-minute walk test before and after the allocated intervention. RESULTS Twenty-four patients were included in the analysis, 10 in the standard protocol and 14 in the alternative protocol group. There was an increment in the maximum distance walked in both groups, and borderline superiority in the intervention group comparing to the control group (312.2 vs. 249.7; P=0.06). CONCLUSION There was an increase in the maximum distance walked in the alternative protocol compared to the standard protocol. Thus, it is postulated that the use of a cycle ergometer can be included in physical rehabilitation in the hospital phase of postoperative coronary artery bypass grafting. However, randomized studies with larger sample size should be conducted to assess the significance of these findings. PMID:26934400

  10. Advice for the management of low back pain: a systematic review of randomised controlled trials.

    PubMed

    Liddle, S Dianne; Gracey, Jacqueline H; Baxter, G David

    2007-11-01

    To synthesise the evidence relating to the effectiveness of advice, the relevance of its content and frequency, and to compare the advice being offered to acute, subacute and chronic low back pain (LBP) patients. A systematic review of Randomised Controlled Trials (RCTs) using advice, either alone or with another intervention. The QUOROM guidelines and the Cochrane Collaboration Back Review Group Guidelines for Systematic Reviews were followed throughout: methodological assessment identified RCTs of 'high' or 'medium' methodological quality, based on their inclusion of at least 50% of the specified internal validity criteria. Outcome measures were analysed based on five recommended core outcome domains; pain, work disability, back-specific function, generic health status and satisfaction with care. Relevant RCTs (n=56) were scored for methodological quality; 39 RCTs involving 7347 patients qualified for inclusion, based upon their methodological quality. Advice as an adjunct to exercise was most effective for improving pain, back-specific function and work disability in chronic LBP but, for acute LBP, was no more effective for improving these outcomes than simple advice to stay active. Advice as part of a back school was most effective for improving back-specific function in subacute LBP; these trials generally demonstrated long-term positive results. Advice as an adjunct to exercise was the most common form of treatment for acute and chronic LBP; advice as part of a back school was most commonly used for subacute LBP. Fifteen percent of acute LBP trials had a positive outcome, compared to 86% and 74% of subacute and chronic LBP trials respectively. A wide variety of outcome measures were used, making valid comparisons between treatment outcomes difficult. The advice provided to patients with LBP within RCTs varied considerably depending on symptom duration. The findings of this review have important implications for clinical practice, and for the design of further

  11. Study protocol title: a prospective cohort study of low back pain

    PubMed Central

    2013-01-01

    Background Few prospective cohort studies of workplace low back pain (LBP) with quantified job physical exposure have been performed. There are few prospective epidemiological studies for LBP occupational risk factors and reported data generally have few adjustments for many personal and psychosocial factors. Methods/design A multi-center prospective cohort study has been incepted to quantify risk factors for LBP and potentially develop improved methods for designing and analyzing jobs. Due to the subjectivity of LBP, six measures of LBP are captured: 1) any LBP, 2) LBP ≥ 5/10 pain rating, 3) LBP with medication use, 4) LBP with healthcare provider visits, 5) LBP necessitating modified work duties and 6) LBP with lost work time. Workers have thus far been enrolled from 30 different employment settings in 4 diverse US states and performed widely varying work. At baseline, workers undergo laptop-administered questionnaires, structured interviews, and two standardized physical examinations to ascertain demographics, medical history, psychosocial factors, hobbies and physical activities, and current musculoskeletal disorders. All workers’ jobs are individually measured for physical factors and are videotaped. Workers are followed monthly for the development of low back pain. Changes in jobs necessitate re-measure and re-videotaping of job physical factors. The lifetime cumulative incidence of low back pain will also include those with a past history of low back pain. Incident cases will exclude prevalent cases at baseline. Statistical methods planned include survival analyses and logistic regression. Discussion Data analysis of a prospective cohort study of low back pain is underway and has successfully enrolled over 800 workers to date. PMID:23497211

  12. Unified Protocol for Transdiagnostic Treatment of Emotional Disorders: A Randomized Controlled Trial

    PubMed Central

    Farchione, Todd J.; Fairholme, Christopher P.; Ellard, Kristen K.; Boisseau, Christina L.; Thompson-Hollands, Johanna; Carl, Jenna R.; Gallagher, Matthew W.; Barlow, David H.

    2012-01-01

    This study further evaluates the efficacy of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP). A diagnostically heterogeneous clinical sample of 37 patients with a principal anxiety disorder diagnosis was enrolled in a randomized controlled trial (RCT) involving up to 18 sessions of treatment and a 6-month follow-up period. Patients were randomly assigned to receive either immediate treatment with the UP (n=26) or delayed treatment, following a 16-week wait-list control period (WLC; n= 11). The UP resulted in significant improvement on measures of clinical severity, general symptoms of depression and anxiety, levels of negative and positive affect, and a measure of symptom interference in daily functioning across diagnoses. In comparison, participants in the WLC condition exhibited little to no change following the 16-week wait-list period. The effects of UP treatment were maintained over the 6-month follow-up period. Results from this RCT provide additional evidence for the efficacy of the UP in the treatment of anxiety and comorbid depressive disorders, and provide additional support for a transdiagnostic approach to the treatment of emotional disorders. PMID:22697453

  13. Unified protocol for transdiagnostic treatment of emotional disorders: a randomized controlled trial.

    PubMed

    Farchione, Todd J; Fairholme, Christopher P; Ellard, Kristen K; Boisseau, Christina L; Thompson-Hollands, Johanna; Carl, Jenna R; Gallagher, Matthew W; Barlow, David H

    2012-09-01

    This study further evaluates the efficacy of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP). A diagnostically heterogeneous clinical sample of 37 patients with a principal anxiety disorder diagnosis was enrolled in a randomized controlled trial (RCT) involving up to 18 sessions of treatment and a 6-month follow-up period. Patients were randomly assigned to receive either immediate treatment with the UP (n=26) or delayed treatment, following a 16-week wait-list control period (WLC; n=11). The UP resulted in significant improvement on measures of clinical severity, general symptoms of depression and anxiety, levels of negative and positive affect, and a measure of symptom interference in daily functioning across diagnoses. In comparison, participants in the WLC condition exhibited little to no change following the 16-week wait-list period. The effects of UP treatment were maintained over the 6-month follow-up period. Results from this RCT provide additional evidence for the efficacy of the UP in the treatment of anxiety and comorbid depressive disorders, and provide additional support for a transdiagnostic approach to the treatment of emotional disorders.

  14. Impact of parent-directed education on parental use of pain treatments during routine infant vaccinations: a cluster randomized trial.

    PubMed

    Taddio, Anna; Parikh, Chaitya; Yoon, Eugene W; Sgro, Michael; Singh, Harvinder; Habtom, Erita; Ilersich, Andrew F; Pillai Riddell, Rebecca; Shah, Vibhuti

    2015-01-01

    Educating parents about ways to minimize pain during routine infant vaccine injections at the point of care may positively impact on pain management practices. The objective of this cluster randomized trial was to determine the impact of educating parents about pain in outpatient pediatric clinics on their use of pain treatments during routine infant vaccinations. Four hospital-based pediatric clinics were randomized to intervention or control groups. Parents of 2- to 4-month-old infants attending the intervention clinics reviewed a pamphlet and a video about vaccination pain management on the day of vaccination, whereas those in the control clinics did not. Parent use of specific pain treatments (breastfeeding, sugar water, topical anesthetics, and/or holding of infants) on the education day and at subsequent routine vaccinations 2 months later was the primary outcome. Altogether, 160 parent-infant dyads (80 per group) participated between November 2012 and February 2014; follow-up data were available for 126 (79%). Demographics did not differ between groups (P > 0.05). On the education day and at follow-up vaccinations, use of pain interventions during vaccinations was higher in the intervention group (80% vs 26% and 68% vs 32%, respectively; P < 0.001 for both analyses). Educating parents about pain management in a hospital outpatient setting leads to higher use of pain interventions during routine infant vaccinations.

  15. Manipulative therapy and/or NSAIDs for acute low back pain: design of a randomized controlled trial [ACTRN012605000036617

    PubMed Central

    Hancock, Mark J; Maher, Christopher G; Latimer, Jane; McLachlan, Andrew J; Cooper, Chris W; Day, Richard O; Spindler, Megan F; McAuley, James H

    2005-01-01

    Background Acute low back pain is a common condition resulting in pain and disability. Current national and international guidelines advocate general practitioner care including advice and paracetamol (4 g daily in otherwise well adults) as the first line of care for people with acute low back pain. Non-steroidal anti-inflammatory drugs (NSAIDs) and spinal manipulative therapy (SMT) are advocated in many guidelines as second line management options for patients with acute low back pain who are not recovering. No studies have explored the role of NSAIDs and/or SMT in addition to first line management for acute low back pain. The primary aim of this study is to investigate if NSAIDs and/or SMT in addition to general practitioner advice and paracetamol results in shorter recovery times for patients with acute low back pain. The secondary aims of the study are to evaluate whether the addition of SMT and/or NSAIDs influences pain, disability and global perceived effect at 1, 2, 4 and 12 weeks after onset of therapy for patients with significant acute low back pain. Methods/design This paper presents the rationale and design of a randomised controlled trial examining the addition of NSAIDs and/or SMT in 240 people who present to their general practitioner with significant acute low back pain. PMID:16280089

  16. Acupuncture for musculoskeletal pain: A meta-analysis and meta-regression of sham-controlled randomized clinical trials

    PubMed Central

    Yuan, Qi-ling; Wang, Peng; Liu, Liang; Sun, Fu; Cai, Yong-song; Wu, Wen-tao; Ye, Mao-lin; Ma, Jiang-tao; Xu, Bang-bang; Zhang, Yin-gang

    2016-01-01

    The aims of this systematic review were to study the analgesic effect of real acupuncture and to explore whether sham acupuncture (SA) type is related to the estimated effect of real acupuncture for musculoskeletal pain. Five databases were searched. The outcome was pain or disability immediately (≤1 week) following an intervention. Standardized mean differences (SMDs) with 95% confidence intervals were calculated. Meta-regression was used to explore possible sources of heterogeneity. Sixty-three studies (6382 individuals) were included. Eight condition types were included. The pooled effect size was moderate for pain relief (59 trials, 4980 individuals, SMD −0.61, 95% CI −0.76 to −0.47; P < 0.001) and large for disability improvement (31 trials, 4876 individuals, −0.77, −1.05 to −0.49; P < 0.001). In a univariate meta-regression model, sham needle location and/or depth could explain most or all heterogeneities for some conditions (e.g., shoulder pain, low back pain, osteoarthritis, myofascial pain, and fibromyalgia); however, the interactions between subgroups via these covariates were not significant (P < 0.05). Our review provided low-quality evidence that real acupuncture has a moderate effect (approximate 12-point reduction on the 100-mm visual analogue scale) on musculoskeletal pain. SA type did not appear to be related to the estimated effect of real acupuncture. PMID:27471137

  17. The Effect of Virtual Reality on Pain in Primiparity Women during Episiotomy Repair: A Randomize Clinical Trial

    PubMed Central

    JahaniShoorab, Nahid; Ebrahimzadeh Zagami, Samira; Nahvi, Ali; Mazluom, Seyed Reza; Golmakani, Nahid; Talebi, Mahdi; Pabarja, Ferial

    2015-01-01

    Background Pain is one of the side effects of episiotomy. The virtual reality (VR) is a non-pharmacological method for pain relief. The purpose of this study was to determine the effect of using video glasses on pain reduction in primiparity women during episiotomy repair. Methods This clinical trial was conducted on 30 primiparous parturient women having labor at Omolbanin Hospital (Mashhad, Iran) during May-July 2012. Samples during episiotomy repair were randomly divided into two equal groups. The intervention group received the usual treatment with VR (video glasses and local infiltration 5 ml solution of lidocaine 2%) and the control group only received local infiltration (5 ml solution of lidocaine 2%). Pain was measured using the Numeric Pain Rating Scale (0-100 scale) before, during and after the episiotomy repair. Data were analyzed using Fisher’s exact test, Chi-square, Mann-Whitney and repeated measures ANOVA tests by SPSS 11.5 software. Results There were statistically significant differences between the pain score during episiotomy repair in both groups (P=0.038). Conclusion Virtual reality is an effective complementary non-pharmacological method to reduce pain during episiotomy repair. Trial Registration Number: IRCT138811063185N1. PMID:25999621

  18. Short-Term Effect of Laser Acupuncture on Lower Back Pain: A Randomized, Placebo-Controlled, Double-Blind Trial

    PubMed Central

    Shin, Jae-Young; Ku, Boncho; Kim, Jaeuk U.; Lee, Yu Jung; Kang, Jae Hui; Heo, Hyun; Choi, Hyo-Joon; Lee, Jun-Hwan

    2015-01-01

    Purpose. This trial was performed to investigate the efficacy of laser acupuncture for the alleviation of lower back pain. Methods. This was a randomized, placebo-controlled, double-blind trial. Fifty-six participants were randomly assigned to either the laser acupuncture group (n = 28) or the sham laser acupuncture group (n = 28). Participants in both groups received three treatment sessions over the course of one week. Thirteen acupuncture points were selected. The visual analogue scale for pain, pressure pain threshold, Patient Global Impression of Change, and Euro-Quality-of-Life Five Dimensions questionnaire (Korean version) were used to evaluate the effect of laser acupuncture treatment on lower back pain. Results. There were no significant differences in any outcome between the two groups, although the participants in both groups showed a significant improvement in each assessed parameter relative to the baseline values. Conclusion. Although there was no significant difference in outcomes between the two groups, the results suggest that laser acupuncture can provide effective pain alleviation and can be considered an option for relief from lower back pain. Further studies using long-term intervention, a larger sample size, and rigorous methodology are required to clarify the effect of laser acupuncture on lower back pain. PMID:26516333

  19. Acupuncture for musculoskeletal pain: A meta-analysis and meta-regression of sham-controlled randomized clinical trials.

    PubMed

    Yuan, Qi-Ling; Wang, Peng; Liu, Liang; Sun, Fu; Cai, Yong-Song; Wu, Wen-Tao; Ye, Mao-Lin; Ma, Jiang-Tao; Xu, Bang-Bang; Zhang, Yin-Gang

    2016-01-01

    The aims of this systematic review were to study the analgesic effect of real acupuncture and to explore whether sham acupuncture (SA) type is related to the estimated effect of real acupuncture for musculoskeletal pain. Five databases were searched. The outcome was pain or disability immediately (≤1 week) following an intervention. Standardized mean differences (SMDs) with 95% confidence intervals were calculated. Meta-regression was used to explore possible sources of heterogeneity. Sixty-three studies (6382 individuals) were included. Eight condition types were included. The pooled effect size was moderate for pain relief (59 trials, 4980 individuals, SMD -0.61, 95% CI -0.76 to -0.47; P < 0.001) and large for disability improvement (31 trials, 4876 individuals, -0.77, -1.05 to -0.49; P < 0.001). In a univariate meta-regression model, sham needle location and/or depth could explain most or all heterogeneities for some conditions (e.g., shoulder pain, low back pain, osteoarthritis, myofascial pain, and fibromyalgia); however, the interactions between subgroups via these covariates were not significant (P < 0.05). Our review provided low-quality evidence that real acupuncture has a moderate effect (approximate 12-point reduction on the 100-mm visual analogue scale) on musculoskeletal pain. SA type did not appear to be related to the estimated effect of real acupuncture. PMID:27471137

  20. The neurophysiological effects of dry needling in patients with upper trapezius myofascial trigger points: study protocol of a controlled clinical trial

    PubMed Central

    Abbaszadeh-Amirdehi, Maryam; Ansari, Noureddin Nakhostin; Naghdi, Soofia; Olyaei, Gholamreza; Nourbakhsh, Mohammad Reza

    2013-01-01

    Introduction Dry needling (DN) is an effective method for the treatment of myofascial trigger points (MTrPs). There is no report on the neurophysiological effects of DN in patients with MTrPs. The aim of the present study will be to assess the immediate neurophysiological efficacy of deep DN in patients with upper trapezius MTrPs. Methods and analysis A prospective, controlled clinical trial was designed to include patients with upper trapezius MTrPs and volunteered healthy participants to receive one session of DN. The primary outcome measures are neuromuscular junction response and sympathetic skin response. The secondary outcomes are pain intensity and pressure pain threshold. Data will be collected at baseline and immediately after intervention. Ethics and dissemination This study protocol has been approved by the Research Council, School of Rehabilitation and the Ethics Committee of Tehran University of Medical Sciences. The results of the study will be disseminated in a peer-reviewed journal and presented at international congresses. PMID:23793673

  1. Reporting of IMMPACT-recommended core outcome domains among trials assessing opioids for chronic non-cancer pain.

    PubMed

    Mulla, Sohail M; Maqbool, Amna; Sivananthan, Laxsanaa; Lopes, Luciane C; Schandelmaier, Stefan; Kamaleldin, Mostafa; Hsu, Sandy; Riva, John J; Vandvik, Per Olav; Tsoi, Ludwig; Lam, Tommy; Ebrahim, Shanil; Johnston, Bradley C; Olivieri, Lori; Montoya, Luis; Kunz, Regina; Scheidecker, Anne; Buckley, D Norman; Sessler, Daniel I; Guyatt, Gordon H; Busse, Jason W

    2015-09-01

    The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) has recommended that trialists evaluating treatments for chronic pain should consider reporting 9 patient-important outcome domains. We examined the extent to which clinical trials evaluating the effect of opioids for chronic non-cancer pain (CNCP) report outcome domains recommended by IMMPACT. We systematically searched electronic databases for English-language studies that randomized patients with CNCP to receive an opioid or a non-opioid control. In duplicate and independently, reviewers established the eligibility of each identified study and recorded all reported outcome domains from eligible trials. We conducted a priori regression analyses to explore factors that may be associated with IMMPACT-recommended outcome domains. Among 156 eligible trials, reporting of IMMPACT-recommended outcome domains was highly variable, ranging from 99% for pain to 7% for interpersonal functioning. Recently published trials were more likely to report the effect of treatment on physical functioning, emotional functioning, role functioning, sleep and fatigue, and participant disposition. Trials for which the corresponding author was from North America were more likely to report treatment effects on physical functioning and participant ratings of improvement and satisfaction with treatment. Trials published in higher impact journals were more likely to report treatment effects on emotional function, but less likely to report participant ratings of improvement and satisfaction with treatment. Most IMMPACT domains showed an increased rate of reporting over time, although many patient-important outcome domains remained unreported by over half of all trials evaluating the effects of opioids for CNCP.

  2. Pain biology education and exercise classes compared to pain biology education alone for individuals with chronic low back pain: a pilot randomised controlled trial.

    PubMed

    Ryan, Cormac G; Gray, Heather G; Newton, Mary; Granat, Malcolm H

    2010-08-01

    The aim of this single-blind pilot RCT was to investigate the effect of pain biology education and group exercise classes compared to pain biology education alone for individuals with chronic low back pain (CLBP). Participants with CLBP were randomised to a pain biology education and group exercise classes group (EDEX) [n = 20] or a pain biology education only group (ED) [n = 18]. The primary outcome was pain (0-100 numerical rating scale), and self-reported function assessed using the Roland Morris Disability Questionnaire, measured at pre-intervention, post-intervention and three month follow up. Secondary outcome measures were pain self-efficacy, pain related fear, physical performance testing and free-living activity monitoring. Using a linear mixed model analysis, there was a statistically significant interaction effect between time and intervention for both pain (F[2,49] = 3.975, p < 0.05) and pain self-efficacy (F[2,51] = 4.011, p < 0.05) with more favourable results for the ED group. The effects levelled off at the three month follow up point. In the short term, pain biology education alone was more effective for pain and pain self-efficacy than a combination of pain biology education and group exercise classes. This pilot study highlights the need to investigate the combined effects of different interventions.

  3. Ultramicronized palmitoylethanolamide in spinal cord injury neuropathic pain: a randomized, double-blind, placebo-controlled trial.

    PubMed

    Andresen, Sven R; Bing, Jette; Hansen, Rikke M; Biering-Sørensen, Fin; Johannesen, Inger L; Hagen, Ellen Merete; Rice, Andrew S C; Nielsen, Jørgen F; Bach, Flemming W; Finnerup, Nanna B

    2016-09-01

    Neuropathic pain and spasticity after spinal cord injury (SCI) represent significant problems. Palmitoylethanolamide (PEA), a fatty acid amide that is produced in many cells in the body, is thought to potentiate the action of endocannabinoids and to reduce pain and inflammation. This randomized, double-blind, placebo-controlled, parallel multicenter study was performed to investigate the effect of ultramicronized PEA (PEA-um) as add-on therapy on neuropathic pain in individuals with SCI. A pain diary was completed and questionnaires were completed before and after the 12-week treatment with either placebo or PEA-um. The primary outcome measure was the change in mean neuropathic pain intensity from the 1-week baseline period to the last week of treatment measured on a numeric rating scale ranging from 0 to 10. The primary efficacy analysis was the intention to treat (baseline observation carried forward). Secondary outcomes included a per protocol analysis and effects on spasticity, evoked pain, sleep problems, anxiety, depression, and global impression of change. We randomized 73 individuals with neuropathic pain due to SCI, of which 5 had a major protocol violation, and thus 68 were included in the primary analysis. There was no difference in mean pain intensity between PEA-um and placebo treatment (P = 0.46, mean reductions in pain scores 0.4 (-0.1 to 0.9) vs 0.7 (0.2-1.2); difference of means 0.3 (-0.4 to 0.9)). There was also no effect of PEA-um as add-on therapy on spasticity, insomnia, or psychological functioning. PEA was not associated with more adverse effects than placebo. PMID:27227691

  4. Current Postoperative Pain Management Protocols Contribute to the Opioid Epidemic in the United States.

    PubMed

    Kelly, Michael A

    2015-10-01

    There is growing concern about the emergence of an "opioid epidemic" in the United States, where the abuse of opioids has had a devastating impact on public health and safety. Around 250 million prescriptions for pain medication are now written each year in this country, and 46 people die from an overdose of a prescription pain medication every day. A very strong correlation has been shown to exist between therapeutic exposure to opioid analgesics and the abuse of those drugs. In addition, opioid-related adverse events are a leading cause of preventable harm in hospitals and, as a result, these events have become a focus of attention for the Joint Commission, which has issued a Sentinel Event Alert on the safe use of opioids. A variety of government organizations and expert groups, such as the American Society of Anesthesiologists Task Force on Acute Pain Management, now recommend multimodal analgesia and weighing the benefits and risks of systemic opioids. The Joint Commission also has recommended that strategies for pain management include a patient-centered approach that takes into consideration the accompanying risks and benefits--including the potential risk of dependency, addiction, and abuse.

  5. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis

    PubMed Central

    Schroll, Jeppe Bennekou; Penninga, Elisabeth I.; Gøtzsche, Peter C.

    2016-01-01

    Background Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs) from the European Medicines Agency through the Freedom of Information Act. The CSRs describe the results of studies conducted as part of the application for marketing authorisation for the slimming pill orlistat. The purpose of this study was to study how adverse events were summarised and reported in study protocols, CSRs, and published papers of orlistat trials. Methods and Findings We received the CSRs from seven randomised placebo controlled orlistat trials (4,225 participants) submitted by Roche. The CSRs consisted of 8,716 pages and included protocols. Two researchers independently extracted data on adverse events from protocols and CSRs. Corresponding published papers were identified on PubMed and adverse event data were extracted from this source as well. All three sources were compared. Individual adverse events from one trial were summed and compared to the totals in the summary report. None of the protocols or CSRs contained instructions for investigators on how to question participants about adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were “bothersome,” a condition that was not specified in the protocol for two of the trials. Serious adverse events were assessed for relationship to the drug by the sponsor, and all adverse events were coded by the sponsor using a glossary that could be updated by the sponsor. The criteria for withdrawal due to adverse events were in one case related to efficacy (high fasting glucose led to withdrawal), which meant that one trial had more withdrawals due to adverse events in the placebo group. Finally, only between 3% and 33% of the total number of investigator-reported adverse events from the trials were reported in the publications because of post hoc

  6. The Impact of Massage Therapy on Function in Pain Populations—A Systematic Review and Meta-Analysis of Randomized Controlled Trials: Part III, Surgical Pain Populations

    PubMed Central

    Crawford, Cindy; Paat, Charmagne F.; Price, Ashley; Xenakis, Lea; Zhang, Weimin

    2016-01-01

    Objective. Pain is multi-dimensional and may be better addressed through a holistic, biopsychosocial approach. Massage therapy is commonly practiced among patients seeking pain management; however, its efficacy is unclear. This systematic review and meta-analysis is the first to rigorously assess the quality of the evidence for massage therapy’s efficacy in treating pain, function-related, and health-related quality of life outcomes in surgical pain populations. Methods. Key databases were searched from inception through February 2014. Eligible randomized controlled trials were assessed for methodological quality using SIGN 50 Checklist. Meta-analysis was applied at the outcome level. A professionally diverse steering committee interpreted the results to develop recommendations. Results. Twelve high quality and four low quality studies were included in the review. Results indicate massage therapy is effective for treating pain [standardized mean difference (SMD) = −0.79] and anxiety (SMD = −0.57) compared to active comparators. Conclusion. Based on the available evidence, weak recommendations are suggested for massage therapy, compared to active comparators for reducing pain intensity/severity and anxiety in patients undergoing surgical procedures. This review also discusses massage therapy safety, challenges within this research field, how to address identified research gaps, and next steps for future research. PMID:27165970

  7. A Randomized Non-inferiority Trial of Condensed Protocols for Genetic Risk Disclosure of Alzheimer’s Disease

    PubMed Central

    Green, Robert C.; Christensen, Kurt D.; Cupples, L. Adrienne; Relkin, Norman R.; Whitehouse, Peter J.; Royal, Charmaine D. M.; Obisesan, Thomas O.; Cook-Deegan, Robert; Linnenbringer, Erin P.; Butson, Melissa Barber; Fasaye, Grace-Ann; Levinson, Elana; Roberts, J. Scott

    2015-01-01

    Background Conventional multi-session genetic counseling is currently recommended when disclosing APOE genotype for risk of Alzheimer’s disease (AD) in cognitively normal individuals. Objective To evaluate the safety of brief disclosure protocols for disclosing APOE genotype for risk of Alzheimer’s disease (AD). Methods A randomized, multicenter non-inferiority trial was conducted at 4 sites. Participants were asymptomatic adults having a first-degree relative with AD. A standard disclosure protocol by genetic counselors (SP-GC) was compared to condensed protocols, with disclosures by genetic counselors (CP-GC) and by physicians (CP-MD). Pre-planned co-primary outcomes were anxiety and depression scales 12 months after disclosure. Results 343 adults (mean age 58.3, range 33–86 years, 71% female, 23% African American) were randomly assigned to the SP-GC protocol (n= 115), CP-GC protocol (n=116) or CP-MD protocol (n=112). Mean post-disclosure scores on all outcomes were well below cut-offs for clinical concern across protocols. Comparing CP-GC to SP-GC, the 97.5% upper confidence limits at 12 months after disclosure on co-primary outcomes of anxiety and depression ranged from a difference of 1.2 to 2.0 in means (all p<0.001 on non-inferiority tests), establishing non-inferiority for condensed protocols. Results were similar between European Americans and African Americans. Conclusions These data support the safety of condensed protocols for APOE disclosure for those free of severe anxiety or depression who are actively seeking such information. PMID:25499536

  8. Mobile-Web App to Self-Manage Low Back Pain: Randomized Controlled Trial

    PubMed Central

    Irvine, A Blair; Russell, Holly; Manocchia, Michael; Mino, David E; Cox Glassen, Terri; Morgan, Rebecca; Gau, Jeff M; Ary, Dennis V

    2015-01-01

    patient activation, constructs of the Theory of Planned Behavior, and attitudes toward pain. Conclusions This research demonstrated that a theoretically based stand-alone mobile-Web intervention that tailors content to users’ preferences and interests can be an effective tool in self-management of low back pain. When viewed from the RE-AIM perspective (ie, reach, efficacy/effectiveness, adoption, implementation fidelity, and maintenance), this study supports the notion that there is considerable value in this type of intervention as a potentially cost-effective tool that can reach large numbers of people. The results are promising considering that the FitBack intervention was neither supported by professional caregivers nor integrated within a health promotion campaign, which might have provided additional support for participants. Still, more research is needed on how self-guided mobile-Web interventions will be used over time and to understand factors associated with continuing user engagement. Trial Registration Clinicaltrials.gov NCT01950091; http://clinicaltrials.gov/ct2/show/NCT01950091 (Archived by WebCite at http://www.webcitation.org/6TwZucX77). PMID:25565416

  9. Retracted: Postoperative pain after irrigation with Vibringe versus a conventional needle: a randomized controlled trial.

    PubMed

    Bilgili, D; Yilmaz, S; Dumani, A; Yoldas, O

    2016-08-01

    The following article from International Endodontic Journal, 'Postoperative pain after irrigation with Vibringe versus a conventional needle: a randomized controlled trial' by D. Bilgili, S. Yilmaz, A. Dumani & O. Yoldas, published online on 29 February 2016 in Wiley Online Library (wileyonlinelibrary.com), has been retracted by agreement between the authors, the Journal Editor in Chief, Prof. Paul Dummer, and John Wiley & Sons Ltd. The retraction has been agreed because the corresponding author did not contact the first author who carried out the work before alterations to the article were made prior to submission. This damages the integrity of the work and there are additional concerns over the number of patients and the accuracy of the results and conclusions. PMID:26855328

  10. The clinical relevance of axillary reverse mapping (ARM): study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Axillary lymph node dissection (ALND) in patients with breast cancer has the potential to induce side-effects, including upper-limb lymphedema. Axillary reverse mapping (ARM) is a technique that enables discrimination of the lymphatic drainage of the breast from that of the upper limb in the axillary lymph node (LN) basin. If lymphedema is caused by removing these lymphatics and nodes in the upper limb, the possibility of identifying these lymphatics would enable surgeons to preserve them. The aim of this study is to determine the clinical relevance of selective axillary LN and lymphatic preservation by means of ARM. To minimize the risk of overlooking tumor-positive ARM nodes and the associated risk of undertreatment, we will only include patients with a tumor-positive sentinel lymph node (SLN). Patients who are candidates for ALND because of a proven positive axillary LN at clinical examination can be included in a registration study. Methods/design The study will enroll 280 patients diagnosed with SLN biopsy-proven metastasis of invasive breast cancer with an indication for a completion ALND. Patients will be randomized to undergo standard ALND or an ALND in which the ARM nodes and their corresponding lymphatics will be left in situ. Primary outcome is the presence of axillary surgery-related lymphedema at 6, 12, and 24 months post-operatively, measured by the water-displacement method. Secondary outcome measures include pain, paresthesia, numbness, and loss of shoulder mobility, quality of life, and axillary recurrence risk. Discussion The benefit of ALND in patients with a positive SLN is a subject of debate. For many patients, an ALND will remain the treatment of choice. This multicenter randomized trial will provide evidence of whether or not axillary LN preservation by means of ARM decreases the side-effects of an ALND. Enrolment of patients will start in April 2013 in five breast-cancer centers in the Netherlands, and is expected to conclude by

  11. Back Pain

    MedlinePlus

    ... Back Pain Find a Clinical Trial Journal Articles Back Pain March 2015 Handout on Health: Back Pain This publication is for people who have back ... to discuss them with your doctor. What Is Back Pain? Back pain is an all-too-familiar problem ...

  12. Preoperative Gabapentin to Prevent Postoperative Shoulder Pain After Laparoscopic Ovarian Cystectomy: A Randomized Clinical Trial

    PubMed Central

    Valadan, Mehrnaz; Banifatemi, Sakineh; Yousefshahi, Fardin

    2015-01-01

    Background: Patients undergoing gynecology laparoscopy frequently experience shoulder pain as a common postoperative complication. Considering diaphragm stimulation in its pathophysiology, there are some advice to prevent or control this special form of referral pain. Objectives: The current study aimed to assess the prophylactic effect of preoperative administration of oral gabapentin to prevent Post Laparoscopic Shoulder Pain (PLSP) after laparoscopic ovarian cystectomy. Patients and Methods: In a randomized, double blind, placebo controlled trial 40 female patients who were candidates to have elective laparoscopic ovarian cystectomy, received uniformed capsules containing gabapentin 600 mg or placebo 30 minutes before anesthesia induction. All patients had the American Society of Anesthesiologists (ASA) Physical Status of I-II and none had pervious abdominal surgery. Thereafter, the presence of side effects and PLSP and its severity was assessed by Visual Analog Scale (VAS) in the beginning of surgery and 2, 6, 12 hours after the surgery. Results: Comparing the gabapentin (n = 20) and placebo (n = 20) groups, basic characteristics including age (P = 0.446), Body Mass Index (BMI) (P = 0.876), pregnancy history (P = 0.660), and surgery time (P = 0.232) were statistically similar. PLSP occurrence was less frequent in the gabapentin group (45%) compared with the placebo group (75%) (P = 0.053), while In gabapentin group the VAS scores were lower in 2(P = 0.004), 6 (P = 0.132), and 12 (P = 0.036) hours, post operatively. Conclusions: Prophylactic gabapentin administration could be considered as an effective and safe intervention to reduce occurrence and severity of PLSP after gynecologic laparoscopic cystectomy. PMID:26705527

  13. Acupuncture in patients with acute low back pain: a multicentre randomised controlled clinical trial.

    PubMed

    Vas, Jorge; Aranda, José Manuel; Modesto, Manuela; Benítez-Parejo, Nicolás; Herrera, Antonia; Martínez-Barquín, Dulce María; Aguilar, Inmaculada; Sánchez-Araujo, Max; Rivas-Ruiz, Francisco

    2012-09-01

    Reviews of the efficacy of acupuncture as a treatment for acute low back pain have concluded that there is insufficient evidence for its efficacy and that more research is needed to evaluate it. A multicentre randomized controlled trial was conducted at 4 primary-care centres in Spain to evaluate the effects of acupuncture in patients with acute nonspecific low back pain in the context of primary care. A total of 275 patients with nonspecific acute low back pain (diagnosed by their general practitioner) were recruited and assigned randomly to 4 different groups: conventional treatment either alone or complemented by 5 sessions over a 2-week period of true acupuncture, sham acupuncture, or placebo acupuncture per patient. Patients were treated from February 2006 to January 2008. The primary outcome was the reduction in Roland Morris Disability Questionnaire scores of 35% or more after 2weeks' treatment. The patients in the 3 types of acupuncture groups were blinded to the treatments, but those who received conventional treatment alone were not. In the analysis adjusted for the total sample (true acupuncture relative risk 5.04, 95% confidence interval 2.24-11.32; sham acupuncture relative risk 5.02, 95% confidence interval 2.26-11.16; placebo acupuncture relative risk 2.57 95% confidence interval 1.21-5.46), as well as for the subsample of occupationally active patients, all 3 modalities of acupuncture were better than conventional treatment alone, but there was no difference among the 3 acupuncture modalities, which implies that true acupuncture is not better than sham or placebo acupuncture. PMID:22770838

  14. Predictors of the placebo analgesia response in randomized controlled trials of chronic pain: a meta-analysis of the individual data from nine industrially sponsored trials.

    PubMed

    Vase, Lene; Vollert, Jan; Finnerup, Nanna B; Miao, Xiaopeng; Atkinson, Gary; Marshall, Scott; Nemeth, Robert; Lange, Bernd; Liss, Charlie; Price, Donald D; Maier, Christoph; Jensen, Troels S; Segerdahl, Märta

    2015-09-01

    A large number of analgesics have failed to prove superiority over placebo in randomized controlled trials (RCTs), and as this has been related to increasing placebo responses, there is currently an interest in specifying predictors of the placebo response. The literature on placebo mechanisms suggests that factors related to patients' expectations of treatment efficacy are pivotal for the placebo response. Also, general characteristics of RCTs have been suggested to influence the placebo response. Yet, only few meta-analyses have directly tested these hypotheses. Placebo data from 9 industrially sponsored, randomized, double-blind, placebo-controlled, multicenter phase III trials in 2017 adult patients suffering from chronic painful osteoarthritis (hip or knee) or low back pain were included. The primary outcome was pain intensity. Based on previous studies, we chose 3 expectancy-related primary predictors: type of active medication, randomization ratio, and number of planned face-to-face visits. In addition, explorative analyses tested whether RCT and patients' characteristics predicted the placebo response. Opioid trials, a high number of planned face-to-face visits, and randomization ratio predicted the magnitude of the placebo response, thereby supporting the expectancy hypothesis. Exploratory models with baseline pain intensity, age, washout length, and discontinuation because of adverse events accounted for approximately 10% of the variability in the placebo response. Based on these results and previous mechanisms studies, we think that patients' perception of treatment allocation and expectations toward treatment efficacy could potently predict outcomes of RCTs.

  15. A commercialized dietary supplement alleviates joint pain in community adults: a double-blind, placebo-controlled community trial

    PubMed Central

    2013-01-01

    % versus ↓12%, respectively, interaction effect P = 0.081). Patterns of change in SF-36, systemic inflammation biomarkers, and the 6-minute walk test did not differ significantly between groups during the 8-week study Conclusions Results from this randomized, double blind, placebo-controlled community trial support the use of the Instaflex™ dietary supplement in alleviating joint pain severity in middle-aged and older adults, with mitigation of difficulty performing daily activities most apparent in subjects with knee pain. Trial registration ClinicalTrials.gov Identifier: NCT01956500 PMID:24274358

  16. A Randomized Double-Blind Placebo-Controlled Trial of Lactobacillus reuteri for Chronic Functional Abdominal Pain in Children

    PubMed Central

    Eftekhari, Kambiz; Vahedi, Zahra; Kamali Aghdam, Mojtaba; Noemi Diaz, Diana

    2015-01-01

    Background: Functional abdominal pain (FAP) is one of the most common diseases, and large percentages of children suffer from it. Objectives: The purpose of the study was to evaluate the effect of Lactobacillus reuteri in treatment of children with functional abdominal pain. Patients and Methods: This study was a randomized double-blind placebo-controlled trial. Children aged 4 to 16 years with chronic functional abdominal pain (based on Rome III criteria) were enrolled in the study. They were randomly divided into two groups, one receiving probiotic and the other placebo. Results: Forty children received probiotic and forty others placebo. There were no significant differences in age, weight, sex, location of pain, associated symptoms, frequency and intensity of pain between the groups. The severity and frequency of abdominal pain in the first month compared to baseline was significantly less and at the end of the second month, there was no significant difference between both groups compared to the end of the first month. Conclusions: This study showed that the severity of pain was significantly reduced in both groups. There was no significant difference in pain scores between them. The effect of probiotic and placebo can probably be attributed to psychological effect of the drugs. PMID:26635937

  17. EXERCISE in pediatric autologous stem cell transplant patients: a randomized controlled trial protocol

    PubMed Central

    2012-01-01

    Background Hematopoietic stem cell transplantation is an intensive therapy used to improve survivorship and cure various oncologic diseases. However, this therapy is associated with high mortality rates and numerous negative side-effects. The recovery of the immune system is a special concern and plays a key role in the success of this treatment. In healthy populations it is known that exercise plays an important role in immune system regulation, but little is known about the role of exercise in the hematological and immunological recovery of children undergoing hematopoietic stem cell transplant. The primary objective of this randomized-controlled trial (RCT) is to study the effect of an exercise program (in- and outpatient) on immune cell recovery in patients undergoing an autologous stem cell transplantation. The secondary objective is to determine if an exercise intervention diminishes the usual deterioration in quality of life, physical fitness, and the acquisition of a sedentary lifestyle. Methods This RCT has received approval from The Conjoint Health Research Ethics Board (CHREB) of the University of Calgary (Ethics ID # E-24476). Twenty-four participants treated for a malignancy with autologous stem cell transplant (5 to 18 years) in the Alberta Children’s Hospital will be randomly assigned to an exercise or control group. The exercise group will participate in a two-phase exercise intervention (in- and outpatient) from hospitalization until 10 weeks after discharge. The exercise program includes strength, flexibility and aerobic exercise. During the inpatient phase this program will be performed 5 times/week and will be supervised. The outpatient phase will combine a supervised session with two home-based exercise sessions with the use of the Wii device. The control group will follow the standard protocol without any specific exercise program. A range of outcomes, including quantitative and functional recovery of immune system, cytokine levels in

  18. Intensive lifestyle intervention improves physical function among obese adults with knee pain: Findings from the Look AHEAD trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Lifestyle interventions causing weight loss or improved physical fitness in obese individuals may lead to improved physical function. This study involved participants in the Action for Health in Diabetes (Look AHEAD) trial who reported knee pain at baseline (n = 2,203). The purposes of this study we...

  19. Intensive lifestyle intervention improves physical function among obese adults with knee pain: Findings from the Look AHEAD Trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Lifestyle interventions have resulted in weight loss or improved physical fitness among individuals with obesity, which may lead to improved physical function. This prospective investigation involved participants in the Action for Health in Diabetes (Look AHEAD) trial who reported knee pain at basel...

  20. A Randomized Controlled Trial on the Effect of Needle Gauge on the Pain and Anxiety Experienced during Radial Arterial Puncture

    PubMed Central

    Molano, Luis-Carlos; Viacroze, Catherine; Benhamou, Daniel

    2015-01-01

    Background Arterial punctures for assessment of arterial blood-gases can be a painful procedure. Lidocaine can be used to reduce pain prior to needle insertion but it is not a widely accepted practice. The purpose of this study was to determine whether a large size needle induces more pain compared to a smaller size needle for radial arterial puncture and to assess the anxiety associated with radial arterial punctures. Methods We conducted a prospective, double-blind, randomized, controlled, monocentric study including all outpatients who had a planned assessment of arterial blood gas analysis. Patients were randomized to have the arterial puncture performed with a 23 or a 25 G needle. The main judgement criteria was pain during arterial puncture. Visual analogue scale for pain (VAS-P) and visual analogue scale for anxiety (VAS-A) were used to assess pain and anxiety during radial arterial puncture. Results Two hundred consecutive patients were randomized. The 25 G needle was as painful as the 23 G needle (6.63 mm [0–19 mm] vs. 5.21 mm [0–18.49 mm], respectively, p = 0.527). Time for arterial puncture was longer with the 25 G needle than with the 23 G needle (42 s [35–55 s] vs. 33 s [24.5–35 s], respectively, p = 0.002). There was a correlation between the level of anxiety prior to the arterial puncture and the pain experienced by the patients (p: 0.369, p<0.0001). There was a correlation between the pain experienced by patients and the anxiety experienced in anticipation of another arterial puncture (p: 0.5124, p<0.0001). Conclusions The use of 23 G needle allows quicker arterial sampling and is not associated with increased pain and symptoms. Anxiety was correlated with the pain experienced by patients during arterial punctures. Trial Registration Clinicaltrials.gov: NCT02320916 PMID:26407017

  1. Reduction Of Chronic Musculoskeletal Pain With Cranial Laser Reflex Technique (CLRT): A Randomized Controlled Trial Using Pressure Algometry

    SciTech Connect

    Wise, Nicholas A. D.C.

    2010-05-31

    Cranial Laser Reflex Technique (CLRT) is a novel method involving a brief low level laser stimulation of specific cranial reflex points to reduce musculoskeletal pain. Objective: The objective of the study was to compare the immediate effects of CLRT with a sham treatment on chronic musculoskeletal pain using pressure algometry in a double-blinded randomized controlled trial. Methods: Fifty-seven (57) volunteers with various musculoskeletal pains gave informed consent and were randomly allocated to either the CLRT treatment or sham group. Painful trigger points and/or tender spinal joints were found in each patient. Using a digital algometer, the pain/pressure threshold (PPT) was determined and a pain rating was given using a numerical pain scale from 0-10. CLRT or a sham treatment was performed with a 50 mW, 840 nm laser, for a maximum of 20 seconds to the each cranial reflex. The initial pressure (PPT) was immediately delivered to the same spot, and the pain rated again. Results: There was a statistically significant difference in pain scores between CLRT and sham groups immediately following treatment. Improvement was reported in 95% of the treatment group, with 59% reporting an improvement of 2 points or greater. The average change in pain scores in the treatment group was 2.6 points (p 0.000) versus negligible change (p= 0.4) for the control group. Conclusion: The results show that CLRT is effective at immediately reducing chronic musculoskeletal pain. Further studies are needed with additional outcome measures to.

  2. Reduction Of Chronic Musculoskeletal Pain With Cranial Laser Reflex Technique (CLRT): A Randomized Controlled Trial Using Pressure Algometry

    NASA Astrophysics Data System (ADS)

    Wise, Nicholas A.

    2010-05-01

    Cranial Laser Reflex Technique (CLRT) is a novel method involving a brief low level laser stimulation of specific cranial reflex points to reduce musculoskeletal pain. Objective: The objective of the study was to compare the immediate effects of CLRT with a sham treatment on chronic musculoskeletal pain using pressure algometry in a double-blinded randomized controlled trial. Methods: Fifty-seven (57) volunteers with various musculoskeletal pains gave informed consent and were randomly allocated to either the CLRT treatment or sham group. Painful trigger points and/or tender spinal joints were found in each patient. Using a digital algometer, the pain/pressure threshold (PPT) was determined and a pain rating was given using a numerical pain scale from 0-10. CLRT or a sham treatment was performed with a 50 mW, 840 nm laser, for a maximum of 20 seconds to the each cranial reflex. The initial pressure (PPT) was immediately delivered to the same spot, and the pain rated again. Results: There was a statistically significant difference in pain scores between CLRT and sham groups immediately following treatment. Improvement was reported in 95% of the treatment group, with 59% reporting an improvement of 2 points or greater. The average change in pain scores in the treatment group was 2.6 points (p = 0.000) versus negligible change (p= 0.4) for the control group. Conclusion: The results show that CLRT is effective at immediately reducing chronic musculoskeletal pain. Further studies are needed with additional outcome measures to.

  3. Study protocol for the evaluation of an Infant Simulator based program delivered in schools: a pragmatic cluster randomised controlled trial

    PubMed Central

    2010-01-01

    Background This paper presents the study protocol for a pragmatic randomised controlled trial to evaluate the impact of a school based program developed to prevent teenage pregnancy. The program includes students taking care of an Infant Simulator; despite growing popularity and an increasing global presence of such programs, there is no published evidence of their long-term impact. The aim of this trial is to evaluate the Virtual Infant Parenting (VIP) program by investigating pre-conceptual health and risk behaviours, teen pregnancy and the resultant birth outcomes, early child health and maternal health. Methods and Design Fifty-seven schools (86% of 66 eligible secondary schools) in Perth, Australia were recruited to the clustered (by school) randomised trial, with even randomisation to the intervention and control arms. Between 2003 and 2006, the VIP program was administered to 1,267 participants in the intervention schools, while 1,567 participants in the non-intervention schools received standard curriculum. Participants were all female and aged between 13-15 years upon recruitment. Pre and post-intervention questionnaires measured short-term impact and participants are now being followed through their teenage years via data linkage to hospital medical records, abortion clinics and education records. Participants who have a live birth are interviewed by face-to-face interview. Kaplan-Meier survival analysis and proportional hazards regression will test for differences in pregnancy, birth and abortion rates during the teenage years between the study arms. Discussion This protocol paper provides a detailed overview of the trial design as well as initial results in the form of participant flow. The authors describe the intervention and its delivery within the natural school setting and discuss the practical issues in the conduct of the trial, including recruitment. The trial is pragmatic and will directly inform those who provide Infant Simulator based programs

  4. Acupuncture for Acute Postoperative Pain after Back Surgery: A Systematic Review and Meta-analysis of Randomized Controlled Trials

    PubMed Central

    Cho, Young-Hun; Kim, Chang-Kyu; Heo, Kwang-Ho; Lee, Myeong Soo; Ha, In-Hyuk; Son, Dong Wuk; Choi, Byung Kwan; Song, Geun-Sung; Shin, Byung-Cheul

    2015-01-01

    Objectives Acupuncture is commonly used as a complimentary treatment for pain management. However, there has been no systematic review summarizing the current evidence concerning the effectiveness of acupuncture for acute postoperative pain after back surgery. This systematic review aimed at evaluating the effectiveness of acupuncture treatment for acute postoperative pain (≤1 week) after back surgery. Methods We searched 15 electronic databases without language restrictions. Two reviewers independently assessed studies for eligibility and extracted data, outcomes, and risk of bias. Random effect meta-analyses and subgroup analyses were performed. Results Five trials, including 3 of high quality, met our inclusion criteria. The meta-analysis showed positive results for acupuncture treatment of pain after surgery in terms of the visual analogue scale (VAS) for pain intensity 24 hours after surgery, when compared to sham acupuncture (standard mean difference −0.67 (−1.04 to −0.31), P = 0.0003), whereas the other meta-analysis did not show a positive effect of acupuncture on 24-hour opiate demands when compared to sham acupuncture (standard mean difference −0.23 (−0.58 to 0.13), P = 0.21). Conclusion Our systematic review finds encouraging but limited evidence for the effectiveness of acupuncture treatment for acute postoperative pain after back surgery. Further rigorously designed clinical trials are required. PMID:24766648

  5. Oropharyngeal dysphagia, free water protocol and quality of life: an update from a prospective clinical trial.

    PubMed

    Karagiannis, Martha; Karagiannis, Tom C

    2014-01-01

    Oropharyngeal dysphagia, typically associated with older adults, represents a spectrum of swallowing disorders with potentially serious complications and a negative impact on quality of life. A major complication of dysphagia is caused by aspiration, predominantly of thin liquids, which may cause aspiration pneumonia. Given that thin liquids are typically aspirated, the conventional therapy involves altering the diet to one consisting of modified solid consistencies and thickened fluids. While it is well known that this approach is appropriate for aspiration, it does represent difficulties with compliancy and quality of life. We have undertaken a relatively large scale clinical trial to investigate the relationships between the effects of free access to water and the development of aspiration, aspects of hydration and issues related to quality in people with dysphagia. Along with clinical observations and findings from others we have previously stratified people with dysphagia, namely those that are immobile or who have low mobility and severe degenerative neurological dysfunction, at highest risk of developing aspiration pneumonia following intake of water. In the present study, we have extended our previous clinical results. Our findings indicate that following purposeful selection of people with dysphagia with their own mobility and relatively healthy cognitive function, free access to water did not result in aspiration pneumonia, improved measures of hydration and in particular, significantly increased quality of life when compared to a diet consisting of thickened fluids only. Overall, we conclude that in people with good mobility and cognitive ability, there is no need to deviate from the Frazier Rehabilitation Centre free water protocol, which allows for the provision of water to people with dysphagia with strict guidelines particularly in relation to good physical ability.

  6. A randomized controlled clinical trial of SPA -- the Seattle Protocol for Activity in older adults

    PubMed Central

    Teri, Linda; McCurry, Susan M.; Logsdon, Rebecca G.; Gibbons, Laura E.; Buchner, David M.; Larson, Eric B.

    2012-01-01

    OBJECTIVES Evaluate the efficacy of a physical activity program (Seattle Protocol for Activity: SPA) for low-exercising older adults, compared to educational health promotion program (HP), combination treatment (SPA+HP), and routine medical care control conditions (RMC). DESIGN Single-blinded, randomized controlled trial with 2 × 2 factorial design. SETTING: November 2001 to September 2004, in community centers in King County, Washington. PARTICIPANTS 273 community-residing, cognitively intact older adults (mean age, 79.2 y; 62% women). INTERVENTIONS SPA (in-class exercises with assistance setting weekly home exercise goals), and HP (information about age-appropriate topics relevant to enhancing health), with randomization to four conditions: SPA only (n = 69), HP only (n = 73), SPA+HP (n = 67), and RMC control (n = 64). Active treatment participants attended nine group classes over three months, followed by five booster sessions over one year. MAIN OUTCOME MEASURES Self-rated health (SF-36) and depression (GDS). Secondary ratings of physical performance, treatment adherence, and self-rated health and affective function were also collected. RESULTS At 3-months, participants in SPA exercised more and had significantly better self-reported health, strength, and general well-being (p<.05) than participants in HP or RMC. Over 18 months, SPA participants maintained health and physical function benefits, and had continued to exercise more than non-SPA participants. SPA+HP was not significantly better than SPA alone. Better adherence was associated with better outcomes. CONCLUSION Older adults participating in low levels of regular exercise can establish and maintain a home-based exercise program that yields immediate and long-term physical and affective benefits. PMID:21718259

  7. The Use of Wet Cupping for Persistent Nonspecific Low Back Pain: Randomized Controlled Clinical Trial

    PubMed Central

    AlBedah, Abdullah; Elolemy, Ahmed; Hussein, Asim A.; AlQaed, Meshari; Al Mudaiheem, Abdullah; Abutalib, Raid A.; Bazaid, Faisal Mohamed; Bafail, Ahmad Saeed; Essa, AboBakr; Bakrain, Mohammed Yahia

    2015-01-01

    Abstract Objectives: To evaluate the effectiveness and safety of wet cupping therapy as a single treatment for persistent nonspecific low back pain (PNSLBP). Design: Randomized controlled trial comparing wet cupping versus no treatment in PNSLBP. Setting: Outpatient clinic in three secondary care hospitals in Saudi Arabia. Patients: Eighty eligible participants with PNSLBP for at least 3 months were randomly allocated to an intervention group (n=40) or to a control group (n=40). Interventions: Six wet cupping sessions within 2 weeks, each of which were done at two bladder meridian (BL) acupuncture points among BL23, BL24, and BL25. Only acetaminophen was allowed as a rescue treatment in both groups. Outcome measures: The Numeric Rating Scale (NRS), McGill Present Pain Intensity (PPI), and Oswestry Disability Questionnaire (ODQ) were used as outcome measures. Numbers of acetaminophen tablets taken were compared at 4 weeks from baseline. Adverse events were recorded. Results: At the end of the intervention, statistically significant differences in the three outcome measures favoring the wet cupping group compared with the control group were seen: NRS score, 29.2 (95% confidence interval [CI], 24.6–33.8) versus 57.9 (95% CI, 53.3–62.6), respectively; PPI score, 1.17 (95% CI, 0.96–1.4) versus 2.3 (95% CI, 2.1– 2.7); and ODQ score, 19.6 (95% CI, 16.5–22.7) versus 35.4 (95% CI, 32.3–38.5) (p=0.0001). This improvement continued for another 2 weeks after the end of the intervention. Acetaminophen was used less in the wet cupping group, but this difference was not statistically significant. No adverse events were reported. Conclusions: Wet cupping is potentially effective in reducing pain and improving disability associated with PNSLBP at least for 2 weeks after the end of the wet cupping period. Placebo-controlled trials are needed. PMID:26069973

  8. A systematic review of randomized controlled trials on exercise parameters in the treatment of patellofemoral pain: what works?

    PubMed Central

    Harvie, Daniel; O’Leary, Timothy; Kumar, Saravana

    2011-01-01

    Purpose There is research evidence which supports the effectiveness of exercise in reducing pain and increasing function in patients with patellofemoral pain syndrome. However, what is unclear are the parameters underpinning this intervention. This has led to uncertainty when operationalizing exercises for patients with patellofemoral pain syndrome in clinical practice. The aim of this review was to evaluate the parameters of exercise programs reported in primary research, to provide clinicians with evidence-based recommendations for exercise prescription for patellofemoral pain. Methods A systematic review of randomized controlled trials was undertaken. Only trials that identified exercise to be effective in treating patellofemoral pain were included. Appropriate databases and reference lists were searched using established keywords. Data relating to common exercise parameters such as the type of exercise, length, and frequency of intervention, intensity, repetitions, sets, and specific technique were extracted, along with details of co-interventions that may have been used. Results A total of ten randomized controlled trials were included in this review and from these trials 14 interventions arms were evaluated. All 14 interventions focused on active exercises, all but two of which also included a passive stretching component. The current body of evidence demonstrates positive results with exercise interventions such as knee extension, squats, stationary cycling, static quadriceps, active straight leg raise, leg press, and step-up and down exercises for patients with patellofemoral pain syndrome. A progressive regime of daily exercises of two to four sets of ten or more repetitions over an intervention period of 6 weeks or more, combined with exercises to address flexibility of the lower limb musculature was commonly used. Conclusion Currently, the primary research on this topic supports the use of closed kinetic chain, strengthening exercises for musculature of

  9. Bone pain from granulocyte colony stimulating factor: does clinical trial sponsorship by a pharmaceutical company influence its reporting?

    PubMed

    Aldairy, Y; Nguyen, P L; Jatoi, A

    2011-01-01

    It is alleged that pharmaceutical companies sometimes unfairly present clinical trial results. To our knowledge, studies have not explored whether such alleged unfair reporting also occurs in the testing of palliative care agents in cancer patients, a particularly vulnerable group. Therefore, a systematic search was conducted to retrieve all published, prospective clinical trials that used granulocyte colony stimulating factor starting in 2003. Because granulocyte colony stimulating factor can cause severe bone pain - a concerning but historically under-reported symptom in cancer patients - this symptom was assessed to determine whether differences in reporting occurred based on pharmaceutical company-sponsorship. A total of 239 published clinical trials met the present study's eligibility criteria and were retrievable. Within this entire group of studies, 65 (27%) were pharmaceutical company-sponsored, and only 31 (13%) reported on bone pain. However, pharmaceutical company-sponsored trials reported on bone pain at a higher rate compared with other studies: 23% versus 9% (P= 0.005), and this conclusion did not change after adjusting for dose, use of the slow release formulation and year of publication. The reporting of adverse events from cancer symptom control and palliative care interventions should be improved - especially in trials not sponsored by pharmaceutical companies.

  10. A randomized, controlled trial of osteopathic manipulative treatment for acute low back pain in active duty military personnel

    PubMed Central

    Cruser, des Anges; Maurer, Douglas; Hensel, Kendi; Brown, Sarah K; White, Kathryn; Stoll, Scott T

    2012-01-01

    Objective Acute low back pain (ALBP) may limit mobility and impose functional limitations in active duty military personnel. Although some manual therapies have been reported effective for ALBP in military personnel, there have been no published randomized controlled trials (RCTs) of osteopathic manipulative treatment (OMT) in the military. Furthermore, current military ALBP guidelines do not specifically include OMT. Methods This RCT examined the efficacy of OMT in relieving ALBP and improving functioning in military personnel at Fort Lewis, Washington. Sixty-three male and female soldiers ages 18 to 35 were randomly assigned to a group receiving OMT plus usual care or a group receiving usual care only (UCO). Results The primary outcome measures were pain on the quadruple visual analog scale, and functioning on the Roland Morris Disability Questionnaire. Outcomes were measured immediately preceding each of four treatment sessions and at four weeks post-trial. Intention to treat analysis found significantly greater post-trial improvement in ‘Pain Now’ for OMT compared to UCO (P = 0·026). Furthermore, the OMT group reported less ‘Pain Now’ and ‘Pain Typical’ at all visits (P = 0·025 and P = 0·020 respectively). Osteopathic manipulative treatment subjects also tended to achieve a clinically meaningful improvement from baseline on ‘Pain at Best’ sooner than the UCO subjects. With similar baseline expectations, OMT subjects reported significantly greater satisfaction with treatment and overall self-reported improvement (P<0·01). Conclusion This study supports the effectiveness of OMT in reducing ALBP pain in active duty military personnel. PMID:23372389

  11. Gabapentin for the Management of Chronic Pelvic Pain in Women (GaPP1): A Pilot Randomised Controlled Trial

    PubMed Central

    Lewis, Steff C.; Bhattacharya, Siladitya; Wu, Olivia; Vincent, Katy; Jack, Stuart A.; Critchley, Hilary O. D.; Porter, Maureen A.; Cranley, Denise; Wilson, John A.; Horne, Andrew W.

    2016-01-01

    Chronic pelvic pain (CPP) affects 2.1–24% of women. Frequently, no underlying pathology is identified, and the pain is difficult to manage. Gabapentin is prescribed for CPP despite no robust evidence of efficacy. We performed a pilot trial in two UK centres to inform the planning of a future multicentre RCT to evaluate gabapentin in CPP management. Our primary objective was to determine levels of participant recruitment and retention. Secondary objectives included estimating potential effectiveness, acceptability to participants of trial methodology, and cost-effectiveness of gabapentin. Women with CPP and no obvious pelvic pathology were assigned to an increasing regimen of gabapentin (300-2700mg daily) or placebo. We calculated the proportion of eligible women randomised, and of randomised participants who were followed up to six months. The analyses by treatment group were by intention-to-treat. Interviews were conducted to evaluate women’s experiences of the trial. A probabilistic decision analytical model was used to estimate cost-effectiveness. Between September 2012–2013, 47 women (34% of those eligible) were randomised (22 to gabapentin, 25 to placebo), and 25 (53%) completed six-month follow-up. Participants on gabapentin had less pain (BPI difference 1.72 points, 95% CI:0.07–3.36), and an improvement in mood (HADS difference 4.35 points, 95% CI:1.97–6.73) at six months than those allocated placebo. The majority of participants described their trial experience favorably. At the UK threshold for willingness-to-pay, the probabilities of gabapentin or no treatment being cost-effective are similar. A pilot trial assessing gabapentin for CPP was feasible, but uncertainty remains, highlighting the need for a large definitive trial. Trial registration Controlled-Trials.com ISRCTN45178534 PMID:27070434

  12. Acupuncture for lateral epicondylitis (tennis elbow): study protocol for a randomized, practitioner-assessor blinded, controlled pilot clinical trial

    PubMed Central

    2013-01-01

    Background Lateral epicondylitis is the most frequent cause of pain around the elbow joint. It causes pain in the region of the elbow joint and results in dysfunction of the elbow and deterioration of the quality of life. The purpose of this study is to compare the effects of ipsilateral acupuncture, contralateral acupuncture and sham acupuncture on lateral epicondylitis. Methods/design Forty-five subjects with lateral epicondylitis will be randomized into three groups: the ipsilateral acupuncture group, contralateral acupuncture group and the sham acupuncture group. The inclusion criteria will be as follows: (1) age between 19 and 65 years with pain due to one-sided lateral epicondylitis that persisted for at least four weeks, (2) with tenderness on pressure limited to regions around the elbow joint, (3) complaining of pain during resistive extension of the middle finger or the wrist, (4) with average pain of NRS 4 or higher during the last one week at a screening visit and (5) voluntarily agree to this study and sign a written consent. Acupuncture treatment will be given 10 times in total for 4 weeks to all groups. Follow up observations will be conducted after the completion of the treatment, 8 weeks and 12 weeks after the random assignment. Ipsilateral acupuncture group and contralateral acupuncture group will receive acupuncture on LI4, TE5, LI10, LI11, LU5, LI12 and two Ashi points. The sham acupuncture group will receive treatment on acupuncture points not related to the lateral epicondylitis using a non-invasive method. The needles will be maintained for 20 minutes. The primary outcome will be differences in the visual analogue scale (VAS) for elbow pain between the groups. The secondary outcome will be differences in patient-rated tennis elbow evaluation (PRTEE), pain-free/maximum grip strength (Dynamometer), pressure pain threshold, clinically relevant improvement, patient global assessment, and the EQ-5D. The data will be analyzed with the paired t

  13. [Hypnosis and self-hypnosis administered and taught by nurses for relief of chronic pain: a controlled clinical trial].

    PubMed

    Buchser, E

    1999-02-01

    In this controlled clinical trial hypnosis and self-hypnosis were evaluated when used as an adjuvant treatment to instrumental and pharmacological management of chronic pain. The study took place in a hospital specialized in the treatment of outpatients suffering from chronic pain. Hypnosis and self-hypnosis were administered and taught by nurses who had been trained just recently for this very purpose. Under the conditions of the study it was not possible to measure an effect of hypnosis on pain despite some subjective feeling of usefulness. However, it should be taken into account that this form of adjuvant therapy was used for the first time in that hospital for the purpose of the study and, therefore, took place in an artificial setting. It could well be that the same therapy administered in the proper therapeutic environment of a specialized institution could show beneficial effects on pain. PMID:10077717

  14. [Hypnosis and self-hypnosis administered and taught by nurses for relief of chronic pain: a controlled clinical trial].

    PubMed

    Buchser, E

    1999-02-01

    In this controlled clinical trial hypnosis and self-hypnosis were evaluated when used as an adjuvant treatment to instrumental and pharmacological management of chronic pain. The study took place in a hospital specialized in the treatment of outpatients suffering from chronic pain. Hypnosis and self-hypnosis were administered and taught by nurses who had been trained just recently for this very purpose. Under the conditions of the study it was not possible to measure an effect of hypnosis on pain despite some subjective feeling of usefulness. However, it should be taken into account that this form of adjuvant therapy was used for the first time in that hospital for the purpose of the study and, therefore, took place in an artificial setting. It could well be that the same therapy administered in the proper therapeutic environment of a specialized institution could show beneficial effects on pain.

  15. A feasibility trial of a cognitive-behavioural symptom management program for chronic pelvic pain for men with refractory chronic prostatitis/chronic pelvic pain syndrome

    PubMed Central

    Tripp, Dean A; Nickel, J. Curtis; Katz, Laura

    2011-01-01

    Background: Our objective was to determine the feasibility of a cognitive behavioural symptom management program for the acute improvement of psychosocial risk factors of diminished quality of life (QoL) in men suffering from chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Materials and Methods: We assessed CP/CPPS symptoms and impact (i.e., chronic prostatitis symptom index [CPSI] pain, urinary, QoL domains), psychosocial risk factors were assessed at baseline and weekly for 8 weeks. We included the following psychosocial risk factors: catastrophizing (Pain Catastrophizing Scale, PCS), mood (Center for Epidemiological Studies in Depression Scale, CES-D), social support (Multidimensional Scale of Perceived Social Support, MSPSS) and general pain (McGill Pain Questionnaire). Patient sessions dispute and replace pessimistic thinking with health-focused thinking and behaviour. Results: Eleven men completed the psychosocial management program (mean age = 51.3, standard deviaton [SD] = 12.49). Mean CPSI baseline total score was 25.2 (SD = 10.21). Repeated measures ANOVAs showed the program was associated with significant linear reductions for pain (p = 0.051), disability (p= 0.020) and catastrophizing (p = 0.005), but no changes in depressive symptoms or social support. The CPSI baseline scores compared to follow-up scores (n = 8) were significantly reduced (p = 0.007), with CPSI pain (p = 0.015) and QoL impact (p = 0.013) reduced, but not for urinary scores. Correlations between change scores at the baseline and at 8 weeks for CPSI and psychosocial risk factors indicated that reductions in catastrophizing were most strongly associated with score reductions for the CPSI; these reductions, however, were not significant. Conclusions: The psychosocial management program targets and significantly reduces several empirically supported psychosocial risk factors associated with poorer CP/CPPS outcomes. Psychosocial management for CP/CPPS is feasible, but requires a

  16. The Impact of Massage Therapy on Function in Pain Populations—A Systematic Review and Meta-Analysis of Randomized Controlled Trials: Part II, Cancer Pain Populations

    PubMed Central

    Crawford, Cindy; Paat, Charmagne F.; Price, Ashley; Xenakis, Lea; Zhang, Weimin

    2016-01-01

    Purpose. Pain is multi-dimensional and may be better addressed through a holistic, biopsychosocial approach. Massage therapy is commonly practiced among patients seeking pain management; however, its efficacy is unclear. This systematic review and meta-analysis is the first to rigorously assess the quality of massage therapy research and evidence for its efficacy in treating pain, function-related and health-related quality of life in cancer populations. Methods. Key databases were searched from inception through February 2014. Eligible randomized controlled trials were assessed for methodological quality using the SIGN 50 Checklist. Meta-analysis was applied at the outcome level. A diverse steering committee interpreted the results to develop recommendations. Results. Twelve high quality and four low quality studies were subsequently included in the review. Results demonstrate massage therapy is effective for treating pain compared to no treatment [standardized mean difference (SMD)  = −.20] and active (SMD = −0.55) comparators. Compared to active comparators, massage therapy was also found to be beneficial for treating fatigue (SMD = −1.06) and anxiety (SMD = −1.24). Conclusion. Based on the evidence, weak recommendations are suggested for massage therapy, compared to an active comparator, for the treatment of pain, fatigue, and anxiety. No recommendations were suggested for massage therapy compared to no treatment or sham control based on the available literature to date. This review addresses massage therapy safety, research challenges, how to address identified research gaps, and necessary next steps for implementing massage therapy as a viable pain management option for cancer pain populations. PMID:27165967

  17. Effects of strength vs aerobic exercise on pain severity in adults with fibromyalgia: a randomized equivalence trial.

    PubMed

    Hooten, W Michael; Qu, Wenchun; Townsend, Cynthia O; Judd, Jeffrey W

    2012-04-01

    Strength training and aerobic exercise have beneficial effects on pain in adults with fibromyalgia. However, the equivalence of strengthening and aerobic exercise has not been reported. The primary aim of this randomized equivalence trial involving patients with fibromyalgia admitted to an interdisciplinary pain treatment program was to test the hypothesis that strengthening (n=36) and aerobic (n=36) exercise have equivalent effects (95% confidence interval within an equivalence margin ± 8) on pain, as measured by the pain severity subscale of the Multidimensional Pain Inventory. Secondary aims included determining the effects of strengthening and aerobic exercise on peak Vo(2) uptake, leg strength, and pressure pain thresholds. In an intent-to-treat analysis, the mean (± standard deviation) pain severity scores for the strength and aerobic groups at study completion were 34.4 ± 11.5 and 37.6 ± 11.9, respectively. The group difference was -3.2 (95% confidence interval, -8.7 to 2.3), which was within the equivalence margin of Δ8. Significant improvements in pain severity (P<.001), peak Vo(2) (P<.001), strength (P<.001), and pain thresholds (P<.001) were observed from baseline to week 3 in the intent-to-treat analysis; however, patients in the aerobic group (mean change 2.0 ± 2.6 mL/kg/min) experienced greater gains (P<.013) in peak Vo(2) compared to the strength group (mean change 0.4 ± 2.6 mL/kg/min). Knowledge of the equivalence and physiological effects of exercise have important clinical implications that could allow practitioners to target exercise recommendations on the basis of comorbid medical conditions or patient preference for a particular type of exercise. This study found that strength and aerobic exercise had equivalent effects on reducing pain severity among patients with fibromyalgia.

  18. Once-yearly zoledronic acid and days of disability, bed rest, and back pain: randomized, controlled HORIZON Pivotal Fracture Trial.

    PubMed

    Cauley, Jane A; Black, Dennis; Boonen, Steven; Cummings, Steven R; Mesenbrink, Peter; Palermo, Lisa; Man, Zulema; Hadji, Peyman; Reid, Ian R

    2011-05-01

    The objective of this study was to determine the effect of once-yearly zoledronic acid on the number of days of back pain and the number of days of disability (ie, limited activity and bed rest) owing to back pain or fracture in postmenopausal women with osteoporosis. This was a multicenter, randomized, double-blind, placebo-controlled trial in 240 clinical centers in 27 countries. Participants included 7736 postmenopausal women with osteoporosis. Patients were randomized to receive either a single 15-minute intravenous infusion of zoledronic acid (5 mg) or placebo at baseline, 12 months, and 24 months. The main outcome measures were self-reported number of days with back pain and the number of days of limited activity and bed rest owing to back pain or a fracture, and this was assessed every 3 months over a 3-year period. Our results show that although the incidence of back pain was high in both randomized groups, women randomized to zoledronic acid experienced, on average, 18 fewer days of back pain compared with placebo over the course of the trial (p = .0092). The back pain among women randomized to zoledronic acid versus placebo resulted in 11 fewer days of limited activity (p = .0017). In Cox proportional-hazards models, women randomized to zoledronic acid were about 6% less likely to experience 7 or more days of back pain [relative risk (RR) = 0.94, 95% confidence interval (CI) 0.90-0.99] or limited activity owing to back pain (RR = 0.94, 95% CI 0.87-1.00). Women randomized to zoledronic acid were significantly less likely to experience 7 or more bed-rest days owing to a fracture (RR = 0.58, 95% CI 0.47-0.72) and 7 or more limited-activity days owing to a fracture (RR = 0.67, 95% CI 0.58-0.78). Reductions in back pain with zoledronic acid were independent of incident fracture. Our conclusion is that in women with postmenopausal osteoporosis, a once-yearly infusion with zoledronic acid over a 3-year period significantly reduced the

  19. Evaluation of effect of low-level laser therapy on adolescents with temporomandibular disorder: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background A number of problems involving the temporomandibular joint (TMJ) and associated structures can lead to temporomandibular disorder (TMD). The aim of the proposed study is to assess the effect of low-level laser therapy on occlusal contacts, mandibular movements, electromyography activity in the muscles of mastication and pain in adolescents with TMD. Methods/Design A randomized, controlled, double-blind, clinical trial will be carried out involving 85 male and female adolescents between 15 and 18 years of age. The research diagnostic criteria for TMD will be used to assess all individuals who agree to participate. All participants will be submitted to a clinical examination and electromyographic analysis of the masseter muscles and anterior bundle of the temporal muscles bilaterally, to determine TMD. Based on the clinical findings, the participants will be classified as having or not having TMD. Those with TMD will be divided into four groups, three of which will receive low-level laser therapy and one of which will receive a placebo treatment. The treatments will involve the TMJ region alone, the masseter and temporal muscles alone, or both these regions together. The data will be submitted to descriptive statistical analysis. The chi-square test and Fisher’s exact test will be used to determine associations among the categorical variables. The Student’s t test and analysis of variance will be used for the comparison of mean electromyographic signals. Pearson’s correlation coefficients will be calculated for the analysis of correlations among the continuous variables. Trial registration The protocol for this study has been submitted to Clinical Trials – registration number (NCT01846000). PMID:23876095

  20. Japanese POEMS syndrome with Thalidomide (J-POST) Trial: study protocol for a phase II/III multicentre, randomised, double-blind, placebo-controlled trial

    PubMed Central

    Katayama, Kanako; Misawa, Sonoko; Sato, Yasunori; Sobue, Gen; Yabe, Ichiro; Watanabe, Osamu; Nishizawa, Masatoyo; Kusunoki, Susumu; Kikuchi, Seiji; Nakashima, Ichiro; Ikeda, Shu-ichi; Kohara, Nobuo; Kanda, Takashi; Kira, Jun-ichi; Hanaoka, Hideki; Kuwabara, Satoshi

    2015-01-01

    Introduction Polyneuropathy, organomegaly, endocrinopathy, M-protein and skin changes (POEMS) syndrome is a fatal systemic disorder associated with plasma cell dyscrasia and the overproduction of the vascular endothelial growth factor (VEGF). Recently, the prognosis of POEMS was substantially improved by introduction of therapeutic intervention for myeloma. However, no randomised clinical trial has been performed because of the rarity and severity of the disease. Methods and analysis The Japanese POEMS syndrome with Thalidomide (J-POST) Trial is a phase II/III multicentre, double-blinded, randomised, controlled trial that aims to evaluate the efficacy and safety of a 24-week treatment with thalidomide in POEMS syndrome, with an additional 48-week open-label safety study. Adults with POEMS syndrome who have no indication for transplantation are assessed for eligibility at 12 tertiary neurology centres in Japan. Patients who satisfy the eligibility criteria are randomised (1:1) to receive thalidomide (100–300 mg daily) plus dexamethasone (12 mg/m2 on days 1–4 of a 28-day cycle) or placebo plus dexamethasone. Both treatments were administered for 24 weeks (six cycles; randomised comparative study period). Patients who complete the randomised study period or show subacute deterioration during the randomised period participate in the subsequent 48-week open-label safety study (long-term safety period). The primary end point of the study is the reduction rate of serum VEGF levels at 24 weeks. Ethics and dissemination The protocol was approved by the Institutional Review Board of each hospital. The trial was notified and registered at the Pharmaceutical and Medical Devices Agency, Japan (No. 22-1716). The J-POST Trial is currently ongoing and is due to finish in August 2015. The findings of this trial will be disseminated through peer-reviewed publications and conference presentations and will also be disseminated to participants. Trial registration number

  1. The Prevention of Delirium and Complications Associated with Surgical Treatments (PODCAST) study: protocol for an international multicentre randomised controlled trial

    PubMed Central

    Avidan, Michael S; Fritz, Bradley A; Maybrier, Hannah R; Muench, Maxwell R; Escallier, Krisztina E; Chen, Yulong; Ben Abdallah, Arbi; Veselis, Robert A; Hudetz, Judith A; Pagel, Paul S; Noh, Gyujeong; Pryor, Kane; Kaiser, Heiko; Arya, Virendra Kumar; Pong, Ryan; Jacobsohn, Eric; Grocott, Hilary P; Choi, Stephen; Downey, Robert J; Inouye, Sharon K; Mashour, George A

    2014-01-01

    Introduction Postoperative delirium is one of the most common complications of major surgery, affecting 10–70% of surgical patients 60 years and older. Delirium is an acute change in cognition that manifests as poor attention and illogical thinking and is associated with longer intensive care unit (ICU) and hospital stay, long-lasting cognitive deterioration and increased mortality. Ketamine has been used as an anaesthetic drug for over 50 years and has an established safety record. Recent research suggests that, in addition to preventing acute postoperative pain, a subanaesthetic dose of intraoperative ketamine could decrease the incidence of postoperative delirium as well as other neurological and psychiatric outcomes. However, these proposed benefits of ketamine have not been tested in a large clinical trial. Methods The Prevention of Delirium and Complications Associated with Surgical Treatments (PODCAST) study is an international, multicentre, randomised controlled trial. 600 cardiac and major non-cardiac surgery patients will be randomised to receive ketamine (0.5 or 1 mg/kg) or placebo following anaesthetic induction and prior to surgical incision. For the primary outcome, blinded observers will assess delirium on the day of surgery (postoperative day 0) and twice daily from postoperative days 1–3 using the Confusion Assessment Method or the Confusion Assessment Method for the ICU. For the secondary outcomes, blinded observers will estimate pain using the Behavioral Pain Scale or the Behavioral Pain Scale for Non-Intubated Patients and patient self-report. Ethics and dissemination The PODCAST trial has been approved by the ethics boards of five participating institutions; approval is ongoing at other sites. Recruitment began in February 2014 and will continue until the end of 2016. Dissemination plans include presentations at scientific conferences, scientific publications, stakeholder engagement and popular media. Registration details The study is

  2. Acupuncture, counselling or usual care for depression and comorbid pain: secondary analysis of a randomised controlled trial

    PubMed Central

    Hopton, A; MacPherson, H; Keding, A; Morley, S

    2014-01-01

    Background Depression with comorbid pain is associated with a poor response to various treatments. The objective in this secondary analysis was to determine whether patients reporting pain have different depression and pain outcomes over time in response to acupuncture, counselling or usual care. Methods Self-reported ratings of depression and pain from 755 patients in a pragmatic randomised controlled trial of acupuncture (302) or counselling (302) compared to usual care alone (151) are described and analysed using a series of regression models and analysis of covariance. Patient-reported outcomes of Patient Health Questionnaire (PHQ)-9 for depression, SF36 bodily pain and EQ-5D, all at baseline, 3, 6, 9 and 12 months. Results At baseline, 755 patients reported EQ-5D pain categories; 384 (50.9%) reported moderate-to-extreme pain. Controlling for baseline depression, a linear regression model showed that the presence of pain at baseline was associated with poorer depression outcomes at 3 months mean difference=−1.16, (95% CI 0.12 to 2.2). Participants with moderate-to-extreme pain at baseline did better at 3 months if they received acupuncture (mean reduction in Patient Health Questionnaire 9 (PHQ-9) from baseline=6.0, 95% CI 5.0 to 7.1 and a mean reduction in SF-36 bodily pain=11.2, (95% CI 7.1 to 15.2) compared to improvements for those who received counselling (4.3, 95% CI 3.3 to 5.4; 7.6, 95% CI 3.6 to 11.6) or usual care (2.7, 95% CI 1.50 to 4.0: 7.2, 95% CI 2.3 to 12.1). In comparison, no notable differences were seen between treatment arms within the no pain comparator group. Conclusions Patients with depression and pain at baseline recovered less well from treatment over 3 months than those with depression and no pain. Reductions in both depression and pain were most marked in the acupuncture group, followed by the counselling group and then the usual care group. PMID:24793257

  3. Tachikawa project for prevention of posttraumatic stress disorder with polyunsaturated fatty acid (TPOP): study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Preclinical and clinical studies suggest that supplementation with omega-3 fatty acids after trauma might reduce subsequent posttraumatic stress disorder (PTSD). To date, we have shown in an open trial that PTSD symptoms in critically injured patients can be reduced by taking omega-3 fatty acids, hypothesized to stimulate hippocampal neurogenesis. The primary aim of the present randomized controlled trial is to examine the efficacy of omega-3 fatty acid supplementation in the secondary prevention of PTSD following accidental injury, as compared with placebo. This paper describes the rationale and protocol of this trial. Methods/design The Tachikawa Project for Prevention of Posttraumatic Stress Disorder with Polyunsaturated Fatty Acid (TPOP) is a double-blinded, parallel group, randomized controlled trial to assess whether omega-3 fatty acid supplementation can prevent PTSD symptoms among accident-injured patients consecutively admitted to an intensive care unit. We plan to recruit accident-injured patients and follow them prospectively for 12 weeks. Enrolled patients will be randomized to either the omega-3 fatty acid supplement group (1,470 mg docosahexaenoic acid and 147 mg eicosapentaenoic acid daily) or placebo group. Primary outcome is score on the Clinician-Administered PTSD Scale (CAPS). We will need to randomize 140 injured patients to have 90% power to detect a 10-point difference in mean CAPS scores with omega-3 fatty acid supplementation compared with placebo. Secondary measures are diagnosis of PTSD and major depressive disorder, depressive symptoms, physiologic response in the experiment using script-driven imagery and acoustic stimulation, serum brain-derived neurotrophic factor, health-related quality of life, resilience, and aggression. Analyses will be by intent to treat. The trial was initiated on December 13 2008, with 104 subjects randomized by November 30 2012. Discussion This study promises to be the first trial to provide a novel

  4. The Clinical Effects of Aromatherapy Massage on Reducing Pain for the Cancer Patients: Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Chen, Ting-Hao; Tung, Tao-Hsin; Chen, Pei-Shih; Wang, Shu-Hui; Chao, Chuang-Min; Hsiung, Nan-Hsing; Chi, Ching-Chi

    2016-01-01

    Purpose. Aromatherapy massage is an alternative treatment in reducing the pain of the cancer patients. This study was to investigate whether aromatherapy massage could improve the pain of the cancer patients. Methods. We searched PubMed and Cochrane Library for relevant randomized controlled trials without language limitations between 1 January 1990 and 31 July 2015 with a priori defined inclusion and exclusion criteria. The search terms included aromatherapy, essential oil, pain, ache, cancer, tumor, and carcinoma. There were 7 studies which met the selection criteria and 3 studies were eventually included among 63 eligible publications. Results. This meta-analysis included three randomized controlled trials with a total of 278 participants (135 participants in the massage with essential oil group and 143 participants in the control (usual care) group). Compared with the control group, the massage with essential oil group had nonsignificant effect on reducing the pain (standardized mean difference = 0.01; 95% CI [−0.23,0.24]). Conclusion. Aromatherapy massage does not appear to reduce pain of the cancer patients. Further rigorous studies should be conducted with more objective measures. PMID:26884799

  5. The Clinical Effects of Aromatherapy Massage on Reducing Pain for the Cancer Patients: Meta-Analysis of Randomized Controlled Trials.

    PubMed

    Chen, Ting-Hao; Tung, Tao-Hsin; Chen, Pei-Shih; Wang, Shu-Hui; Chao, Chuang-Min; Hsiung, Nan-Hsing; Chi, Ching-Chi

    2016-01-01

    Purpose. Aromatherapy massage is an alternative treatment in reducing the pain of the cancer patients. This study was to investigate whether aromatherapy massage could improve the pain of the cancer patients. Methods. We searched PubMed and Cochrane Library for relevant randomized controlled trials without language limitations between 1 January 1990 and 31 July 2015 with a priori defined inclusion and exclusion criteria. The search terms included aromatherapy, essential oil, pain, ache, cancer, tumor, and carcinoma. There were 7 studies which met the selection criteria and 3 studies were eventually included among 63 eligible publications. Results. This meta-analysis included three randomized controlled trials with a total of 278 participants (135 participants in the massage with essential oil group and 143 participants in the control (usual care) group). Compared with the control group, the massage with essential oil group had nonsignificant effect on reducing the pain (standardized mean difference = 0.01; 95% CI [-0.23,0.24]). Conclusion. Aromatherapy massage does not appear to reduce pain of the cancer patients. Further rigorous studies should be conducted with more objective measures. PMID:26884799

  6. Efficacy of Continuous S(+)-Ketamine Infusion for Postoperative Pain Control: A Randomized Placebo-Controlled Trial

    PubMed Central

    Miziara, Luiz Eduardo de Paula Gomes; Simoni, Ricardo Francisco; Esteves, Luís Otávio; Cangiani, Luis Henrique; Grillo-Filho, Gil Fernando Ribeiro; Paula, Anderson Garcia Lima e

    2016-01-01

    Aim. A double-blind, randomized, placebo-controlled trial was designed to evaluate the efficacy of continuous intraoperative infusion of S(+)-ketamine under intravenous anesthesia with target-controlled infusion of remifentanil and propofol for postoperative pain control. Methods. Forty-eight patients undergoing laparoscopic cholecystectomy were assigned to receive continuous S(+)-ketamine infusion at a rate of 0.3 mg·kg−1·h−1 (n = 24, intervention group) or an equivalent volume of saline at the same rate (n = 24, placebo group). The same target-controlled intravenous anesthesia was induced in both groups. Pain was assessed using a 0 to 10 verbal numeric rating scale during the first 12 postoperative hours. Pain scores and morphine consumption were recorded in the postanesthesia care unit (PACU) and at 4 and 12 hours after surgery. Results. Pain scores were lower in the intervention group at all time points. Morphine consumption did not differ significantly between groups during PACU stay, but it was significantly lower in the intervention group at each time point after PACU discharge (P = 0.0061). At 12 hours after surgery, cumulative morphine consumption was also lower in the intervention group (5.200 ± 2.707) than in the placebo group (7.525 ± 1.872). Conclusions. Continuous S(+)-ketamine infusion during laparoscopic cholecystectomy under target-controlled intravenous anesthesia provided better postoperative pain control than placebo, reducing morphine requirement. Trial Registration. This trial is registered with ClinicalTrials.gov NCT02421913. PMID:26949390

  7. Improving adherence to web-based cessation programs: a randomized controlled trial study protocol

    PubMed Central

    2013-01-01

    Background Reducing smoking prevalence is a public health priority that can save more lives and money than almost any other known preventive intervention. Internet interventions have the potential for enormous public health impact given their broad reach and effectiveness. However, most users engage only minimally with even the best designed websites, diminishing their impact due to an insufficient ‘dose’. Two approaches to improve adherence to Internet cessation programs are integrating smokers into an online social network and providing free nicotine replacement therapy (NRT). Active participation in online communities is associated with higher rates of cessation. Integrating smokers into an online social network can increase support and may also increase utilization of cessation tools and NRT. Removing barriers to NRT may increase uptake and adherence, and may also increase use of online cessation tools as smokers look for information and support while quitting. The combination of both strategies may exert the most powerful effects on adherence compared to either strategy alone. Methods/Design This study compares the efficacy of a smoking cessation website (WEB) alone and in conjunction with free NRT and a social network (SN) protocol designed to integrate participants into the online community. Using a 2 (SN, no SN) x 2 (NRT, no NRT) randomized, controlled factorial design with repeated measures at baseline, 3 months, and 9 months, this study will recruit N = 4,000 new members of an internet cessation program and randomize them to: 1) WEB, 2) WEB + SN, 3) WEB + NRT, or 4) WEB + SN + NRT. Hypotheses are that all interventions will outperform WEB and that WEB + SN + NRT will outperform WEB + NRT and WEB + SN on 30-day point prevalence abstinence at 9 months. Exploratory analyses will examine theory-driven hypotheses about the mediators and moderators of outcome. Discussion Addressing adherence in internet cessation programs is critical and timely to leverage

  8. Percutaneous Radiofrequency Ablation of Painful Osseous Metastases: A Multi-center American College of Radiology Imaging Network Trial

    PubMed Central

    Dupuy, Damian E.; Liu, Dawei; Hartfeil, Donna; Hanna, Lucy; Blume, Jeffrey D.; Ahrar, Kamran; Lopez, Robert; Safran, Howard; DiPetrillo, Thomas

    2009-01-01

    Background To determine if radiofrequency ablation (RFA) can safely reduce pain from osseous metastatic disease. Methods A single arm prospective trial in patients with a single painful bone metastasis with unremitting pain of at least a score above 50 on a pain scale of 0–100. Percutaneous CT guided RFA of the bone metastasis to temperatures above 60 degrees Celsius was performed. Endpoints were the toxicity and pain effects of RFA before and at 2 weeks, one and three months after RFA. Results 55 patients completed RFA. Grade 3 toxicities occurred in 3 of 55 patients (5%). RFA reduced pain at 1- and 3-month for all pain assessment measures. The average increase in pain relief from pre-RFA to 1-month follow-up is 26.27 (95% CI, 17.65 to 34.89, P<0.0001) and the increase from pre-RFA to 3-month follow-up is 16.38 (95% CI, 3.37 to 29.39, P=0.02). The average decrease in pain intensity from pre-RFA to 1-month follow-up was 26.9 (P<0.0001) and 14.2 for 3-month follow-up (P=0.02). The odds of being in lower pain severity at 1-month follow-up is 14.03 (95% CI, 2.33 to 25.73, P<0.0001) times higher than that at pre-RFA, and the odds at 3-month follow-up is 8.00 (95% CI, 0.85 to 15.15, P<0.001) times higher than that at pre-RFA. The average increase in mood from pre-RFA to 1-month follow-up was 19.9 (P<0.0001) and 14.9 for 3-month follow-up (P=0.005). Conclusion This cooperative group trial strongly suggests that RFA can safely palliate pain from bone metastases. PMID:20041484

  9. Efficacy of non-steroidal anti-inflammatory drugs for low back pain: a systematic review of randomised clinical trials

    PubMed Central

    Koes, B.; Scholten, R.; Mens, J.; Bouter, L.

    1997-01-01

    PURPOSE—To assess the efficacy of non-steroidal anti-inflammatory drugs (NSAIDs) for low back pain.
DATA SOURCES—Computer aided search of published randomised clinical trials and assessment of the methods of the studies.
STUDY SELECTION—26 randomised clinical trials evaluating NSAIDs for low back pain were identified.
DATA EXTRACTION—Score for quality (maximum = 100 points) of the methods based on four categories: study population; interventions; effect measurement; data presentation and analysis. Determination of success rate per study group and evaluation of different contrasts. Statistical pooling of placebo controlled trials in similar patient groups and using similar outcome measures.
RESULTS—The methods scores of the trials ranged from 27 to 83 points. NSAIDs were compared with placebo treatment in 10 studies. The pooled odds ratio in four trials comparing NSAIDs with placebo after one week was 0.53 (95% confidence intervals 0.32 to 0.89) using the fixed effect model, indicating a significant effect in favour of NSAIDs compared with placebo. In nine studies NSAIDs were compared with other (drug) therapies. Of these, only two studies reported better results of NSAIDs compared with paracetamol with and without dextropropoxyphene. In the other trials NSAIDs were not better than the reference treatment. In 11 studies different NSAIDs were compared, of which seven studies reported no differences in effect.
CONCLUSIONS—There are flaws in the design of most studies. The pooled odds ratio must be interpreted with caution because the trials at issue, including the high quality trials, did not use identical outcome measures. The results of the 26 randomised trials that have been carried out to date, suggest that NSAIDs might be effective for short-term symptomatic relief in patients with uncomplicated low back pain, but are less effective or ineffective in patients with low back pain with sciatica and patients with sciatica with nerve

  10. Long-Term Effects of Neonatal Morphine Infusion on Pain Sensitivity: Follow-Up of a Randomized Controlled Trial.

    PubMed

    Valkenburg, Abraham J; van den Bosch, Gerbrich E; de Graaf, Joke; van Lingen, Richard A; Weisglas-Kuperus, Nynke; van Rosmalen, Joost; Groot Jebbink, Liesbeth J M; Tibboel, Dick; van Dijk, Monique

    2015-09-01

    Short-term and long-term effects of neonatal pain and its analgesic treatment have been topics of translational research over the years. This study aimed to identify the long-term effects of continuous morphine infusion in the neonatal period on thermal pain sensitivity, the incidence of chronic pain, and neurological functioning. Eighty-nine of the 150 participants of a neonatal randomized controlled trial on continuous morphine infusion versus placebo during mechanical ventilation underwent quantitative sensory testing and neurological examination at the age of 8 or 9 years. Forty-three children from the morphine group and 46 children from the placebo group participated in this follow-up study. Thermal detection and pain thresholds were compared with data from 28 healthy controls. Multivariate analyses revealed no statistically significant differences in thermal detection thresholds and pain thresholds between the morphine and placebo groups. The incidence of chronic pain was comparable between both groups. The neurological examination was normal in 29 (76%) of the children in the morphine group and 25 (61%) of the children in the control group (P = .14). We found that neonatal continuous morphine infusion (10 μg/kg/h) has no adverse effects on thermal detection and pain thresholds, the incidence of chronic pain, or overall neurological functioning 8 to 9 years later. Perspective: This unique long-term follow-up study shows that neonatal continuous morphine infusion (10 μg/kg/h) has no long-term adverse effects on thermal detection and pain thresholds or overall neurological functioning. These findings will help clinicians to find the most adequate and safe analgesic dosing regimens for neonates and infants.

  11. The relaxation exercise and social support trial-resst: study protocol for a randomized community based trial

    PubMed Central

    2011-01-01

    Background Studies suggests a possible link between vaginal discharge and common mental distress, as well as highlight the implications of the subjective burden of disease and its link with mental health. Methods/Design This is a community-based intervention trial that aims to evaluate the impact of a psycho-social intervention on medically unexplained vaginal discharge (MUVD) in a group of married, low-income Lebanese women, aged 18-49, and suffering from low to moderate levels of anxiety and/or depression. The intervention consisted of 12 sessions of structured social support, problem solving techniques, group discussions and trainer-supervised relaxation exercises (twice per week over six weeks). Women were recruited from Hey el Selloum, a southern disadvantaged suburb of Beirut, Lebanon, during an open recruitment campaign. The primary outcome was self-reported MUVD, upon ruling out reproductive tract infections (RTIs), through lab analysis. Anxiety and/or depression symptoms were the secondary outcomes for this trial. These were assessed using an Arabic validated version of the Hopkins Symptoms Checklist-25 (HSCL-25). Assessments were done at baseline and six months using face-to face interviews, pelvic examinations and laboratory tests. Women were randomized into either intervention or control group. Intent to treat analysis will be used. Discussion The results will indicate whether the proposed psychosocial intervention was effective in reducing MUVD (possibly mediated by common mental distress). Trial Registration The trial is registered at the Wellcome Trust Registry, ISRCTN assigned: ISRCTN: ISRCTN98441241 PMID:21864414

  12. Stopping randomized trials early for benefit: a protocol of the Study Of Trial Policy Of Interim Truncation-2 (STOPIT-2)

    PubMed Central

    Briel, Matthias; Lane, Melanie; Montori, Victor M; Bassler, Dirk; Glasziou, Paul; Malaga, German; Akl, Elie A; Ferreira-Gonzalez, Ignacio; Alonso-Coello, Pablo; Urrutia, Gerard; Kunz, Regina; Culebro, Carolina Ruiz; da Silva, Suzana Alves; Flynn, David N; Elamin, Mohamed B; Strahm, Brigitte; Murad, M Hassan; Djulbegovic, Benjamin; Adhikari, Neill KJ; Mills, Edward J; Gwadry-Sridhar, Femida; Kirpalani, Haresh; Soares, Heloisa P; Elnour, Nisrin O Abu; You, John J; Karanicolas, Paul J; Bucher, Heiner C; Lampropulos, Julianna F; Nordmann, Alain J; Burns, Karen EA; Mulla, Sohail M; Raatz, Heike; Sood, Amit; Kaur, Jagdeep; Bankhead, Clare R; Mullan, Rebecca J; Nerenberg, Kara A; Vandvik, Per Olav; Coto-Yglesias, Fernando; Schünemann, Holger; Tuche, Fabio; Chrispim, Pedro Paulo M; Cook, Deborah J; Lutz, Kristina; Ribic, Christine M; Vale, Noah; Erwin, Patricia J; Perera, Rafael; Zhou, Qi; Heels-Ansdell, Diane; Ramsay, Tim; Walter, Stephen D; Guyatt, Gordon H

    2009-01-01

    Background Randomized clinical trials (RCTs) stopped early for benefit often receive great attention and affect clinical practice, but pose interpretational challenges for clinicians, researchers, and policy makers. Because the decision to stop the trial may arise from catching the treatment effect at a random high, truncated RCTs (tRCTs) may overestimate the true treatment effect. The Study Of Trial Policy Of Interim Truncation (STOPIT-1), which systematically reviewed the epidemiology and reporting quality of tRCTs, found that such trials are becoming more common, but that reporting of stopping rules and decisions were often deficient. Most importantly, treatment effects were often implausibly large and inversely related to the number of the events accrued. The aim of STOPIT-2 is to determine the magnitude and determinants of possible bias introduced by stopping RCTs early for benefit. Methods/Design We will use sensitive strategies to search for systematic reviews addressing the same clinical question as each of the tRCTs identified in STOPIT-1 and in a subsequent literature search. We will check all RCTs included in each systematic review to determine their similarity to the index tRCT in terms of participants, interventions, and outcome definition, and conduct new meta-analyses addressing the outcome that led to early termination of the tRCT. For each pair of tRCT and systematic review of corresponding non-tRCTs we will estimate the ratio of relative risks, and hence estimate the degree of bias. We will use hierarchical multivariable regression to determine the factors associated with the magnitude of this ratio. Factors explored will include the presence and quality of a stopping rule, the methodological quality of the trials, and the number of total events that had occurred at the time of truncation. Finally, we will evaluate whether Bayesian methods using conservative informative priors to "regress to the mean" overoptimistic tRCTs can correct observed

  13. Canadian Optically-guided approach for Oral Lesions Surgical (COOLS) trial: study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Oral cancer is a major health problem worldwide. The 5-year survival rate ranges from 30-60%, and has remained unchanged in the past few decades. This is mainly due to late diagnosis and high recurrence of the disease. Of the patients who receive treatment, up to one third suffer from a recurrence or a second primary tumor. It is apparent that one major cause of disease recurrence is clinically unrecognized field changes which extend beyond the visible tumor boundary. We have previously developed an approach using fluorescence visualization (FV) technology to improve the recognition of the field at risk surrounding a visible oral cancer that needs to be removed and preliminary results have shown a significant reduction in recurrence rates. Method/Design This paper describes the study design of a randomized, multi-centre, double blind, controlled surgical trial, the COOLS trial. Nine institutions across Canada will recruit a total of 400 patients with oral severe dysplasia or carcinoma in situ (N = 160) and invasive squamous cell carcinoma (N = 240). Patients will be stratified by participating institution and histology grade and randomized equally into FV-guided surgery (experimental arm) or white light-guided surgery (control arm). The primary endpoint is a composite of recurrence at or 1 cm within the previous surgery site with 1) the same or higher grade histology compared to the initial diagnosis (i.e., the diagnosis used for randomization); or 2) further treatment due to the presence of severe dysplasia or higher degree of change at follow-up. This is the first randomized, multi-centre trial to validate the effectiveness of the FV-guided surgery. Discussion In this paper we described the strategies, novelty, and challenges of this unique trial involving a surgical approach guided by the FV technology. The success of the trial requires training, coordination, and quality assurance across multiple sites within Canada. The COOLS trial, an example of

  14. Ringing Up about Breastfeeding: a randomised controlled trial exploring early telephone peer support for breastfeeding (RUBY) – trial protocol

    PubMed Central

    2014-01-01

    Background The risks of not breastfeeding for mother and infant are well established, yet in Australia, although most women initiate breastfeeding many discontinue breastfeeding altogether and few women exclusively breastfeed to six months as recommended by the World Health Organization and Australian health authorities. We aim to determine whether proactive telephone peer support during the postnatal period increases the proportion of infants who are breastfed at six months, replicating a trial previously found to be effective in Canada. Design/Methods A two arm randomised controlled trial will be conducted, recruiting primiparous women who have recently given birth to a live baby, are proficient in English and are breastfeeding or intending to breastfeed. Women will be recruited in the postnatal wards of three hospitals in Melbourne, Australia and will be randomised to peer support or to ‘usual’ care. All women recruited to the trial will receive usual hospital postnatal care and infant feeding support. For the intervention group, peers will make two telephone calls within the first ten days postpartum, then weekly telephone calls until week twelve, with continued contact until six months postpartum. Primary aim: to determine whether postnatal telephone peer support increases the proportion of infants who are breastfed for at least six months. Hypothesis: that telephone peer support in the postnatal period will increase the proportion of infants receiving any breast milk at six months by 10% compared with usual care (from 46% to 56%). Outcome data will be analysed by intention to treat. A supplementary multivariate analysis will be undertaken if there are any baseline differences in the characteristics of women in the two groups which might be associated with the primary outcomes. Discussion The costs and health burdens of not breastfeeding fall disproportionately and increasingly on disadvantaged groups. We have therefore deliberately chosen trial sites

  15. Influences of Deqi on Immediate Analgesia Effect of Needling SP6 (Sanyinjiao) in Patients with Primary Dysmenorrhea in Cold and Dampness Stagnation Pattern: Study Protocol for a Randomized Controlled Trial

    PubMed Central

    Liu, Yu-qi; Zhang, Peng; Xie, Jie-ping; Ma, Liang-xiao; Yuan, Hong-wen; Li, Jing; Lin, Chi; Wang, Pei; Yang, Guo-yan; Zhu, Jiang

    2015-01-01

    Deqi, according to traditional Chinese medicine, is a specific needle sensation during the retention of needles at certain acupoints and is considered to be necessary to produce therapeutic effects from acupuncture. Although some modern researches have showed that Deqi is essential for producing acupuncture analgesia and anesthesia, the data are not enough. It is a paper of a multicenter, randomized controlled study protocol, to evaluate the influences of Deqi on acupuncture SP6 in Cold and Dampness Stagnation pattern primary dysmenorrhea patients, in terms of reducing pain and anxiety, and to find out the relationship between Deqi and the temperature changes at SP6 (Sanyinjiao) and CV4 (Guanyuan). The results of this trial will be helpful to explain the role of Deqi in acupuncture analgesia and may provide a new objective index for measuring Deqi in the future study. This trial is registered with ChiCTR-TRC-13003086. PMID:26294921

  16. An iontophoretic fentanyl patient-activated analgesic delivery system for postoperative pain: a double-blind, placebo-controlled trial.

    PubMed

    Viscusi, Eugene R; Reynolds, Lowell; Tait, Stacy; Melson, Timothy; Atkinson, Linda E

    2006-01-01

    An iontophoretic fentanyl HCl patient-activated transdermal system (fentanyl HCl PATS) is under development for the treatment of acute postoperative pain. The fentanyl HCl PATS is a needle-free, credit card-sized, preprogrammed system that is applied to the patient's upper outer arm or chest. The fentanyl HCl PATS was demonstrated to be superior to placebo in a previous trial; however, the randomization scheme used and the lack of control of entry pain level may have contributed to the lack of robust findings. We compared the fentanyl HCl PATS with placebo for acute postoperative pain management in a larger trial that addressed the limitations of the previous study. Adult patients admitted to the postanesthesia care unit after major surgery were titrated to comfort with opioids and randomized 1:1 to receive the fentanyl HCl PATS 40 microg or placebo for 24 hours. Supplemental IV fentanyl was available to patients upon request in both treatment groups for the first 3 hours after enrollment. The primary efficacy end-point was the percentage of patients who discontinued participation in the study because of inadequate analgesia. Pain intensity scores, patient global assessments (PGA), and investigator global assessments (IGA) were collected. Four-hundred-eighty-four patients (PATS, n = 244; placebo, n = 240) were enrolled. Fewer patients receiving the fentanyl HCl PATS discontinued because of inadequate analgesia compared with placebo (28.7% versus 60.0%; P < 0.0001). Mean last pain intensity scores were 3.5 and 5.4 for the fentanyl HCl PATS and placebo groups, respectively. Patients (73.4%, PGA) and investigators (72.1%, IGA) considered the fentanyl HCl PATS a good or excellent method of pain control. Treatment-related adverse events were similar between groups. This study demonstrated the superiority of the iontophoretic fentanyl HCl PATS over placebo for acute postoperative pain management. PMID:16368828

  17. A new analgesic method, two-minute sciatic nerve press, for immediate pain relief: a randomized trial

    PubMed Central

    He, Jiman; Wu, Bin; Jiang, Xianrong; Zhang, Fenglin; Zhao, Tao; Zhang, Wenlon

    2008-01-01

    Background Current analgesics have drawbacks such as delays in acquisition, lag-times for effect, and side effects. We recently presented a preliminary report of a new analgesic method involving a two-minute sciatic nerve press, which resulted in immediate short-term relief of pain associated with dental and renal diseases. The present study investigated whether this technique was effective for pain associated with other disease types, and whether the relief was effective for up to one hour. Methods This randomized, placebo-controlled, parallel-group trial was conducted in four hospitals in Anhui Province, China. Patients with pain were sequentially recruited by participating physicians during clinic visits, and 135 patients aged 15 – 80 years were enrolled. Dental disease patients included those with acute pulpitis and periapical abscesses. Renal disease patients included those with kidney infections and/or stones. Tumor patients included those with nose, breast, stomach and liver cancers, while Emergency Room patients had various pathologies. Patients were randomly assigned to receive a "sciatic nerve press" in which pressure was applied simultaneously to the sciatic nerves at the back of both thighs, or a "placebo press" in which pressure was applied to a parallel region on the front of the thighs. Each fist applied a pressure of 11 – 20 kg for 2 minutes. Patients rated their level of pain before and after the procedure. Results The "sciatic nerve press" produced immediate relief of pain in all patient groups. Emergency patients reported a 43.5% reduction in pain (p < 0.001). Significant pain relief for dental, renal and tumor patients lasted for 60 minutes (p < 0.001). The peak pain relief occurred at the 10 – 20th minutes, and the relief decreased 47% by the 60th minutes. Conclusion Two minutes of pressure on both sciatic nerves produced immediate significant short-term conduction analgesia. This technique is a convenient, safe and powerful method for

  18. The EARN-Health Trial: protocol for a randomised controlled trial to identify health effects of a financial savings programme among low-income US adults

    PubMed Central

    Basu, Sanjay; Hamad, Rita; White, Justin S; Modrek, Sepideh; Rehkopf, David H; Cullen, Mark R

    2015-01-01

    Introduction A theory within the social epidemiology field is that financial stress related to having inadequate financial savings may contribute to psychological stress, poor mental health and poor health-related behaviours among low-income US adults. Our objective is to test whether an intervention that encourages financial savings among low-income US adults improves health behaviours and mental health. Methods and analysis A parallel group two-arm controlled superiority trial will be performed in which 700 participants will be randomised to the intervention or a wait list. The intervention arm will be provided an online Individual Development Account (IDA) for 6 months, during which participants receive a $5 incentive (£3.2, €4.5) for every month they save $20 in their account (£12.8, €18), and an additional $5 if they save $20 for two consecutive months. Both groups will be provided links to standard online financial counselling materials. Online surveys in months 0 (prior to randomisation), 6 and 12 (6 months postintervention) will assess self-reported health behaviours and mental health among participants in both arms. The surveys items were tested previously in the US Centers for Disease Control and Prevention national health interviews and related health studies, including self-reported overall health, health-related quality of life, alcohol and tobacco use, depression symptoms, financial stress, optimism and locus of control, and spending and savings behaviours. Trial data will be analysed on an intent-to-treat basis. Ethics and dissemination This protocol was approved by the Institutional Review Board of Stanford University (Protocol ID: 30641). The findings of the trial will be disseminated through peer-reviewed publication. Trial registration number Identifier NCT02185612; Pre-results. PMID:26443663

  19. A comprehensive review of clinical trials on the efficacy and safety of drugs for the treatment of low back pain.

    PubMed

    Schnitzer, Thomas J; Ferraro, Aimee; Hunsche, Elke; Kong, Sheldon X

    2004-07-01

    A systematic review involving 50 randomized controlled trials (4,863 patients) published since 1980 was undertaken with the objective of assessing efficacy and safety of low back pain (LBP) medications. The methodological quality of each trial was evaluated based on a standardized system. Quality scores ranged from 26 to 82 points on a 100-point scale (from 0 to 100), indicating an overall moderate quality of the trials reviewed. Limited evidence was found regarding the effectiveness of drug treatments for LBP and current studies focused on short-term usage of the therapies. Available evidence supported the effectiveness of non-selective nonsteroidal anti-inflammatory drugs (NSAIDs) in acute and chronic LBP, of muscle relaxants in acute LBP, and of antidepressants in chronic LBP; safety results were heterogeneous. More rigorously designed trials should be implemented to establish comparative efficacy and safety of drugs used to treat chronic and acute LBP. PMID:15223086

  20. Analysis of longitudinal trials with protocol deviation: a framework for relevant, accessible assumptions, and inference via multiple imputation.

    PubMed

    Carpenter, James R; Roger, James H; Kenward, Michael G

    2013-01-01

    Protocol deviations, for example, due to early withdrawal and noncompliance, are unavoidable in clinical trials. Such deviations often result in missing data. Additional assumptions are then needed for the analysis, and these cannot be definitively verified from the data at hand. Thus, as recognized by recent regulatory guidelines and reports, clarity about these assumptions and their implications is vital for both the primary analysis and framing relevant sensitivity analysis. This article focuses on clinical trials with longitudinal quantitative outcome data. For the target population, we define two estimands, the de jure estimand, "does the treatment work under the best case scenario," and the de facto estimand, "what would be the effect seen in practice." We then carefully define the concept of a deviation from the protocol relevant to the estimand, or for short a deviation. Each patient's postrandomization data can then be divided into predeviation data and postdeviation data. We set out an accessible framework for contextually appropriate assumptions relevant to de facto and de jure estimands, that is, assumptions about the joint distribution of pre- and postdeviation data relevant to the clinical question at hand. We then show how, under these assumptions, multiple imputation provides a practical approach to estimation and inference. We illustrate with data from a longitudinal clinical trial in patients with chronic asthma. PMID:24138436

  1. Protocol to evaluate the impact of yoga supplementation on cognitive function in schizophrenia: a randomised controlled trial

    PubMed Central

    Bhatia, Triptish; Mazumdar, Sati; Mishra, Nagendra Narayan; Gur, Raquel E.; Gur, Ruben C.; Nimgaonkar, Vishwajit Laxmikant; Deshpande, Smita Neelkanth

    2015-01-01

    Background Schizophrenia (SZ) is a chronic illness that is treated symptomatically. Cognitive dysfunction is a core feature of SZ that is relatively intractable to pharmacotherapy. Yoga can improve cognitive function among healthy individuals. A recent open trial indicated significant benefits of yoga training (YT) in conjunction with conventional pharmacotherapy among patients with SZ. Aims To describe the protocol for an ongoing randomised controlled trial designed to test whether the reported beneficial effects of YT on cognitive function among SZ patients can be replicated. Secondarily, the effects of YT on daily functioning living skills are evaluated. Methods Consenting patients with SZ receive routine clinical treatment and are randomised to adjunctive YT, adjunctive physical exercise (PE) or treatment as usual (proposed N = 234 total, N = 78 in each group). The trial involves YT or PE 5 days a week and lasts 3 weeks. Participants are evaluated thrice over 6 months. Cognitive functions measured by Trail Making Test, University of Pennsylvania Neurocognitive Computerised Battery were primary outcome measures while clinical severity and daily functioning measured by Independent Living Skills Survey were secondary outcome measures. Results A total of 309 participants have been randomised as of 31 August 2013, which exceeded beyond 294 proposed after attrition. Once participants begin YT or PE they generally complete the protocol. No injuries have been reported. Conclusions Short term YT is feasible and acceptable to Indian SZ patients. If beneficial effects of YT are detected, it will provide a novel adjunctive cognitive remediation strategy for SZ patients. PMID:25241756

  2. Study protocol for a controlled trial of Strengths Model Case Management in mental health services in Hong Kong

    PubMed Central

    Tsoi, Wing-See Emily; Tse, Samson; Fukui, Sadaaki; Jones, Steven

    2015-01-01

    Introduction Although strengths-based models are popular within recovery-oriented approaches, there is still a lack of conclusive research to guide how they should be implemented. A recent meta-analysis confirmed the lack of clarity in how this perspective is operationalised and that fidelity monitoring during the implementation process is lacking. Hence, there is a clear need to evaluate the feasibility of delivering and evaluating a clearly operationalised strengths-based intervention that incorporates fidelity checks to inform more definitive research. This protocol therefore describes a controlled trial of Strengths Model Case Management (SMCM), a complex intervention, for people with severe mental illnesses in Hong Kong. This trial follows the guidelines of the Medical Research Council as a phase 2 trial. Hence, it is a pilot study that tests the feasibility and effectiveness of the model. Methods and analysis This is a 9-month controlled trial that uses the Kansas Model. Participants and a matched control group are recruited on a voluntary basis, after screening for eligibility. Effectiveness of the SMCM will be measured through outcome measures taken at baseline, the mid-point and at the end of the trial. Outcomes for service users include personal recovery, hope, subjective well-being, psychiatric symptoms, perceived level of recovery features within the organisation, therapeutic alliance and achievement of recovery goals. Outcomes for care workers will include job burnout, organisational features of recovery and perceived supervisory support. With a 2×3 analysis of variance design and a moderate intervention effect (Cohen's d=0.50), a total of 86 participants will be needed for a statistical power of 0.80. Ethics and dissemination Ethical approval has been obtained from the Human Research Ethics Committee for Non-Clinical Faculties at The University of Hong Kong (HRECNCF: EA140913). Trial registration number Australian New Zealand Clinical Trial Registry

  3. Gabapentin for the Management of Chronic Pelvic Pain in Women (GaPP1): A Pilot Randomised Controlled Trial.

    PubMed

    Lewis, Steff C; Bhattacharya, Siladitya; Wu, Olivia; Vincent, Katy; Jack, Stuart A; Critchley, Hilary O D; Porter, Maureen A; Cranley, Denise; Wilson, John A; Horne, Andrew W

    2016-01-01

    Chronic pelvic pain (CPP) affects 2.1-24% of women. Frequently, no underlying pathology is identified, and the pain is difficult to manage. Gabapentin is prescribed for CPP despite no robust evidence of efficacy. We performed a pilot trial in two UK centres to inform the planning of a future multicentre RCT to evaluate gabapentin in CPP management. Our primary objective was to determine levels of participant recruitment and retention. Secondary objectives included estimating potential effectiveness, acceptability to participants of trial methodology, and cost-effectiveness of gabapentin. Women with CPP and no obvious pelvic pathology were assigned to an increasing regimen of gabapentin (300-2700 mg daily) or placebo. We calculated the proportion of eligible women randomised, and of randomised participants who were followed up to six months. The analyses by treatment group were by intention-to-treat. Interviews were conducted to evaluate women's experiences of the trial. A probabilistic decision analytical model was used to estimate cost-effectiveness. Between September 2012-2013, 47 women (34% of those eligible) were randomised (22 to gabapentin, 25 to placebo), and 25 (53%) completed six-month follow-up. Participants on gabapentin had less pain (BPI difference 1.72 points, 95% CI:0.07-3.36), and an improvement in mood (HADS difference 4.35 points, 95% CI:1.97-6.73) at six months than those allocated placebo. The majority of participants described their trial experience favorably. At the UK threshold for willingness-to-pay, the probabilities of gabapentin or no treatment being cost-effective are similar. A pilot trial assessing gabapentin for CPP was feasible, but uncertainty remains, highlighting the need for a large definitive trial.

  4. Comparison of Single Visit Post Endodontic Pain Using Mtwo Rotary and Hand K-File Instruments: A Randomized Clinical Trial

    PubMed Central

    Kashefinejad, Mohamad; Harandi, Azade; Bijani, Ali

    2016-01-01

    Objectives: Pain is an unpleasant outcome of endodontic treatment that can be unbearable to patients. Instrumentation techniques may affect the frequency and intensity of post-endodontic pain. This study aimed to compare single visit post endodontic pain using Mtwo (NiTi) rotary and hand K-file instruments. Materials and Methods: In this randomized controlled trial, 60 teeth with symptomatic irreversible pulpitis in 53 patients were selected and randomly assigned into two groups of 30 teeth. In group A, the root canals were prepared with Mtwo (NiTi) rotary instruments. In group B, the root canals were prepared with hand K-file instruments. Pain assessment was implemented using visual analog scale (VAS) at four, eight, 12 and 24 hours after treatment. The acquired data were analyzed using chi-square, Mann-Whitney U and Student’s t-test (P<0.05). Results: Patients treated with rotary instruments experienced significantly less post-endodontic pain than those treated with hand instruments (P<0.001). Conclusions: The use of Mtwo (NiTi) rotary instruments in root canal preparation contributed to lower incidence of postoperative pain than hand K-files. PMID:27536323

  5. The Effects of Kangaroo Mother Care and Swaddling on Venipuncture Pain in Premature Neonates: A Randomized Clinical Trial

    PubMed Central

    Dezhdar, Shahin; Jahanpour, Faezeh; Firouz Bakht, Saeedeh; Ostovar, Afshin

    2016-01-01

    Background Hospitalized premature babies often undergo various painful procedures. Kangaroo mother care (KMC) and swaddling are two pain reduction methods. Objectives This study was undertaken to compare the effects of swaddling and KMC on pain during venous sampling in premature neonates. Patients and Methods This study was performed as a randomized clinical trial on 90 premature neonates. The neonates were divided into three groups using a random allocation block. The three groups were group A (swaddling), group B (KMC), and group C (control). In all three groups, the heart rate and arterial oxygen saturation were measured and recorded in time intervals of 30 seconds before, during, and 30, 60, 90, and 120 seconds after blood sampling. The neonate’s face was video recorded and assessed using the premature infant pain profile (PIPP) at time intervals of 30 seconds. The data was analyzed using the t-test, chi-square test, Repeated Measure analysis of variance (ANOVA), Kruskal-Wallis, Post-hoc, and Bonferroni test. Results The findings revealed that pain was reduced to a great extent in the swaddling and KMC methods compared to the control group. However, there was no significant difference between KMC and swaddling (P ≥ 0.05). Conclusions The results of this study indicate that there is no meaningful difference between swaddling and KMC on physiological indexes and pain in neonates. Therefore, the swaddling method may be a good substitute for KMC. PMID:27274399

  6. Tai Chi for Chronic Pain Conditions: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

    PubMed

    Kong, Ling Jun; Lauche, Romy; Klose, Petra; Bu, Jiang Hui; Yang, Xiao Cun; Guo, Chao Qing; Dobos, Gustav; Cheng, Ying Wu

    2016-04-29

    Several studies reported that Tai Chi showed potential effects for chronic pain, but its role remains controversial. This review assessed the evidence regarding the effects of Tai Chi for chronic pain conditions. 18 randomized controlled trials were included in our review. The aggregated results have indicated that Tai Chi showed positive evidence on immediate relief of chronic pain from osteoarthritis (standardized mean difference [SMD], -0.54; 95% confidence intervals [CI], -0.77 to -0.30; P < 0.05). The valid duration of Tai Chi practice for osteoarthritis may be more than 5 weeks. And there were some beneficial evidences regarding the effects of Tai Chi on immediate relief of chronic pain from low back pain (SMD, -0.81; 95% CI, -1.11 to -0.52; P < 0.05) and osteoporosis (SMD, -0.83; 95% CI, -1.37 to -0.28; P = 0.003). Therefore, clinicians may consider Tai Chi as a viable complementary and alternative medicine for chronic pain conditions.

  7. Tai Chi for Chronic Pain Conditions: A Systematic Review and Meta-analysis of Randomized Controlled Trials

    PubMed Central

    Kong, Ling Jun; Lauche, Romy; Klose, Petra; Bu, Jiang Hui; Yang, Xiao Cun; Guo, Chao Qing; Dobos, Gustav; Cheng, Ying Wu

    2016-01-01

    Several studies reported that Tai Chi showed potential effects for chronic pain, but its role remains controversial. This review assessed the evidence regarding the effects of Tai Chi for chronic pain conditions. 18 randomized controlled trials were included in our review. The aggregated results have indicated that Tai Chi showed positive evidence on immediate relief of chronic pain from osteoarthritis (standardized mean difference [SMD], −0.54; 95% confidence intervals [CI], −0.77 to −0.30; P < 0.05). The valid duration of Tai Chi practice for osteoarthritis may be more than 5 weeks. And there were some beneficial evidences regarding the effects of Tai Chi on immediate relief of chronic pain from low back pain (SMD, −0.81; 95% CI, −1.11 to −0.52; P < 0.05) and osteoporosis (SMD, −0.83; 95% CI, −1.37 to −0.28; P = 0.003). Therefore, clinicians may consider Tai Chi as a viable complementary and alternative medicine for chronic pain conditions. PMID:27125299

  8. Sativex successfully treats neuropathic pain characterised by allodynia: a randomised, double-blind, placebo-controlled clinical trial.

    PubMed

    Nurmikko, Turo J; Serpell, Mick G; Hoggart, Barbara; Toomey, Peter J; Morlion, Bart J; Haines, Derek

    2007-12-15

    Cannabinoids are known to have analgesic properties. We evaluated the effect of oro-mucosal sativex, (THC: CBD), an endocannabinoid system modulator, on pain and allodynia, in 125 patients with neuropathic pain of peripheral origin in a five-week, randomised, double-blind, placebo-controlled, parallel design trial. Patients remained on their existing stable analgesia. A self-titrating regimen was used to optimise drug administration. Sixty-three patients were randomised to receive sativex and 62 placebo. The mean reduction in pain intensity scores (primary outcome measure) was greater in patients receiving sativex than placebo (mean adjusted scores -1.48 points vs. -0.52 points on a 0-10 Numerical Rating Scale (p=0.004; 95% CI: -1.59, -0.32). Improvements in Neuropathic Pain Scale composite score (p=0.007), sleep NRS (p=0.001), dynamic allodynia (p=0.042), punctate allodynia (p=0.021), Pain Disability Index (p=0.003) and Patient's Global Impression of Change (p<0.001) were similarly greater on sativex vs. placebo. Sedative and gastrointestinal side effects were reported more commonly by patients on active medication. Of all participants, 18% on sativex and 3% on placebo withdrew during the study. An open-label extension study showed that the initial pain relief was maintained without dose escalation or toxicity for 52 weeks. PMID:17997224

  9. Menstrual pain and quality of life in women with primary dysmenorrhea: Rationale, design, and interventions of a randomized controlled trial of effects of a treadmill-based exercise intervention.

    PubMed

    Kannan, Priya; Chapple, Cathy M; Miller, Dawn; Claydon, Leica S; Baxter, G David

    2015-05-01

    Dysmenorrhea in the absence of pelvic abnormality is termed primary dysmenorrhea (PD). The health burden and social and economic costs of PD are high as it is reported to be the leading cause of recurrent absenteeism from school or work in adolescent girls and young adults. The belief that exercise works for relieving symptoms in women with PD is based on anecdotal evidence and non-experimental studies. There is very limited evidence from randomized controlled trials (RCTs) to support the use of exercise to reduce the intensity of menstrual pain. The objective of this study is to evaluate the effectiveness of exercise to reduce intensity of pain and improve quality of life in women with PD. We describe the study design of a single-blind (assessor), prospective, two-arm RCT, and the participant characteristics of the 70 women recruited in the age-group 18 to 43 years. The primary outcome of the study is pain intensity. The secondary outcomes of the study are quality of life, functional limitation, sleep, global improvement with treatment, and protocol adherence. The outcomes assessments are done at first menstrual period (baseline, Week 0), 2nd menstrual period (Week 4) and at two additional time points (Week 16 and Week 28) during the trial. The results of the study will provide physiotherapists, medical practitioners, and researchers as well as the women who have PD with new insights, knowledge, and evidence about the use of exercise to manage pain in women with PD. PMID:25839713

  10. A randomised controlle