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Sample records for cuff disease randomised

  1. Arthroscopic treatment of rotator cuff disease.

    PubMed

    Gartsman, G M

    1995-01-01

    Rotator cuff disease represents a spectrum of tendon lesions including inflammation of an intrinsically normal tendon, tendon fibrosis, partial-thickness tears, complete tears, and cuff tear arthropathy. An in-depth analysis of the entire subject is beyond the scope of this article. This article will focus on the arthroscopic management of the spectrum of rotator cuff disease in an attempt to provide a timely summary of the present state of knowledge. Five stages of rotator cuff disease will be reviewed: stage 2 impingement, partial-thickness cuff tears, complete-thickness rotator cuff tears, irreparable rotator cuff tears, and cuff tear arthropathy. In preparing this article I have assumed that the reader is familiar with the diagnosis of rotator cuff lesions through the use of appropriate patient history, physical examination, and radiologic studies.

  2. Topical glyceryl trinitrate for rotator cuff disease.

    PubMed

    Cumpston, Miranda; Johnston, Renea V; Wengier, Lainie; Buchbinder, Rachelle

    2009-07-08

    Rotator cuff disease is a common cause of shoulder pain. Topical glyceryl trinitrate is a possible new treatment. To determine the effectiveness and safety of topical glyceryl trinitrate for rotator cuff disease. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, SPORTDiscus, PEDro, the Australian Clinical Trials Registry, Current Controlled Trials (to October 2007) and the references and citations of included studies. We included randomised controlled trials and controlled clinical trials of people with rotator cuff disease who received topical glyceryl trinitrate, alone or in combination, compared to placebo or active therapy. Two authors independently assessed risk of bias and extracted data. Three small studies, one at moderate risk of bias and two at high risk of bias, were included. Meta-analysis was precluded due to different interventions and outcome measures. Study participants also had differing durations of symptoms and data for pain and function could only be extracted from one study. One placebo-controlled trial (20 participants) tested 5 mg glyceryl trinitrate patches, used daily for three days, among participants with 'acute supraspinatus tendinitis' of less than seven days duration. Treatment resulted in reduced pain intensity (adjusted MD -3.50, 95% CI -3.96 to -3.04). Function was not measured. One trial (53 participants) compared one quarter of a 5 mg glyceryl trinitrate patch used daily for up to 24 weeks combined with rehabilitation to placebo patches and rehabilitation among participants with 'supraspinatus tendinopathy' for longer than six months. A third trial (48 participants) tested 5 mg glyceryl trinitrate patches, used daily for three days, compared to corticosteroid injection among participants with 'rotator cuff tendinitis' of less than six-weeks duration. Fifteen out of 24 participants in the glyceryl trinitrate treatment reported headache (RR 0.11, 95% CI 0.01 to 1.96). There is some

  3. Microfractures at the rotator cuff footprint: a randomised controlled study.

    PubMed

    Osti, Leonardo; Del Buono, Angelo; Maffulli, Nicola

    2013-11-01

    Microfractures at the footprint may be a potential additional source of growth factor and enhance the tendon healing at the bone-tendon junction when repairing rotator cuff tears. Fifty-seven patients who underwent shoulder arthroscopy for repair of complete rotator cuff tears were randomly divided into two groups, using a block randomisation procedure. Patients underwent microfracture at the footprint in the treatment group. The patients in the control group (n = 29) did not receive that treatment. All patients had the same post-operative rehabilitation protocol. The two groups were homogeneous. There was a significant improvement from baseline to the last minimum follow-up of two years. At three months from the index procedure, visual analogue scale (VAS), range of motion (ROM) and University of California at Los Angeles (UCLA) and Constant scores were significantly better in group 1 than in group 2 (P < .05). At the last follow-up (minimum two years), clinical and functional outcomes were further improved in both the groups but inter-group differences were not significant. No technique-related complications were recorded. Microfractures at the footprint are simple, safe, inexpensive and effective at producing less pain in the short term in patients who undergo rotator cuff repair, but at two years they do not result in significantly different outcomes, either clinically or at imaging, compared to traditional rotator cuff repair.

  4. Electrotherapy modalities for rotator cuff disease.

    PubMed

    Page, Matthew J; Green, Sally; Mrocki, Marshall A; Surace, Stephen J; Deitch, Jessica; McBain, Brodwen; Lyttle, Nicolette; Buchbinder, Rachelle

    2016-06-10

    Management of rotator cuff disease may include use of electrotherapy modalities (also known as electrophysical agents), which aim to reduce pain and improve function via an increase in energy (electrical, sound, light, or thermal) into the body. Examples include therapeutic ultrasound, low-level laser therapy (LLLT), transcutaneous electrical nerve stimulation (TENS), and pulsed electromagnetic field therapy (PEMF). These modalities are usually delivered as components of a physical therapy intervention. This review is one of a series of reviews that form an update of the Cochrane review, 'Physiotherapy interventions for shoulder pain'. To synthesise available evidence regarding the benefits and harms of electrotherapy modalities for the treatment of people with rotator cuff disease. We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 3), Ovid MEDLINE (January 1966 to March 2015), Ovid EMBASE (January 1980 to March 2015), CINAHL Plus (EBSCOhost, January 1937 to March 2015), ClinicalTrials.gov and the WHO ICTRP clinical trials registries up to March 2015, unrestricted by language, and reviewed the reference lists of review articles and retrieved trials, to identify potentially relevant trials. We included randomised controlled trials (RCTs) and quasi-randomised trials, including adults with rotator cuff disease (e.g. subacromial impingement syndrome, rotator cuff tendinitis, calcific tendinitis), and comparing any electrotherapy modality with placebo, no intervention, a different electrotherapy modality or any other intervention (e.g. glucocorticoid injection). Trials investigating whether electrotherapy modalities were more effective than placebo or no treatment, or were an effective addition to another physical therapy intervention (e.g. manual therapy or exercise) were the main comparisons of interest. Main outcomes of interest were overall pain, function, pain on motion, patient-reported global assessment of treatment success

  5. Metalloproteases and rotator cuff disease.

    PubMed

    Del Buono, Angelo; Oliva, Francesco; Longo, Umile Giuseppe; Rodeo, Scott A; Orchard, John; Denaro, Vincenzo; Maffulli, Nicola

    2012-02-01

    The molecular changes occurring in rotator cuff tears are still unknown, but much attention has been paid to better understand the role of matrix metalloproteinases (MMP) in the development of tendinopathy. These are potent enzymes that, once activated, can completely degrade all components of the connective tissue, modify the extracellular matrix (ECM), and mediatethe development of painful tendinopathy and tendon rupture. To control the local activity of activated proteinases, the same cells produce tissue inhibitors of metalloproteinases (TIMP) that bind to the enzymes and prevent degradation. The balance between the activities of MMPs and TIMPs regulates tendon remodeling, whereas an imbalance produces a collagen dis-regulation and disturbances intendons. ADAMs (a disintegrin and metalloproteinase) are cell membrane-linked enzymes with proteolytic and cell signaling functions. ADAMTSs (ADAM with thrombospondin motifs) are secreted into the circulation, and constitute a heterogenous family of proteases with both anabolic and catabolic functions. Biologic modulation of endogenous MMP activity to basal levels may reduce pathologic tissue degradation and favorably influence healing after rotator cuff repair. Further studies are needed to better define the mechanism of action, and whether these new strategies are safe and effective in larger models. Copyright © 2012 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

  6. Arthroscopic treatment of rotator cuff disease.

    PubMed

    Jarrett, Claudius D; Schmidt, Christopher C

    2011-09-01

    The goal of this article is to summarize the current concepts on rotator cuff disease with an emphasis on arthroscopic treatment. Most rotator cuff tears are the result of an ongoing attritional process. Once present, a tear is likely to gradually increase in size. Partial-thickness and subscapularis tears can both be successfully treated arthroscopically if conservative management fails. Partial tears involving greater than 50% of tendon thickness should be repaired. Articular-sided partial tears involving less than 50% of the rotator cuff can reliably be treated with debridement. A more aggressive approach should be considered for low-grade tears (<50%) if they occur on the bursal side. Biomechanical and anatomic studies have shown clear superiority with dual-row fixation compared with single-row techniques. However, current studies have yet to show clear clinical advantage with dual-row over single-row repairs. Biceps tenotomy or tenodesis can reliably provide symptomatic improvement in patients with irreparable massive tears. True pseudoparalysis of the shoulder is a contraindication to this procedure alone and other alternatives should be considered.

  7. Rotator Cuff Disease and Injury--Evaluation and Management.

    ERIC Educational Resources Information Center

    Williams, Randy

    This presentation considers the incidence, evaluation, and management of rotator cuff disease and injury. Pathogenesis, symptoms, physical findings, treatment (therapeutic and surgical), and prevention are discussed. It is noted that rotator cuff problems, common in athletes, are usually related to an error in training or lack of training. They…

  8. A randomised clinical trial evaluating the efficacy of physiotherapy after rotator cuff repair.

    PubMed

    Hayes, Kimberley; Ginn, Karen A; Walton, Judie R; Szomor, Zoltan L; Murrell, George A C

    2004-01-01

    The optimal form of rehabilitation after rotator cuff repair has yet to be determined. A randomised clinical trial was undertaken to compare outcomes for two forms of rehabilitation for this condition: individualised supervised physiotherapy treatment, and a standardised unsupervised home exercise regime. Fifty-eight volunteers with all sizes of operatively repaired rotator cuff tears were allocated randomly to one of the two treatment groups. All subjects received a standardised home exercise regime. Subjects who were randomised to the physiotherapy group received additional individualised treatment. Independent, blinded assessments of range of motion, muscle force and functional outcome measures were performed pre-operatively, and at six, 12 and 24 weeks postoperation. At six, 12 and 24 weeks post-operation, comparable outcomes were demonstrated for both rehabilitation groups. By 24 weeks post-operation, most subjects demonstrated outcomes that were consistent with a favourable recovery, regardless of rehabilitation mode. On the basis of these results, outcomes for subjects allocated to individualised physiotherapy treatment after rotator cuff repair are no better than for subjects allocated to a standardised home exercise regime.

  9. National Trends in Surgery for Rotator Cuff Disease in Korea.

    PubMed

    Jo, Young Hoon; Lee, Kwang Hyun; Kim, Sung Jae; Kim, Jaedong; Lee, Bong Gun

    2017-02-01

    The objective of this study was to investigate the national trends in rotator cuff surgery in Korea and analyze hospital type-specific trends. We analyzed a nationwide database acquired from the Korean Health Insurance Review and Assessment Service (HIRA) from 2007 to 2015. International Classification of Diseases, 10th revision (ICD-10) codes, procedure codes, and arthroscopic device code were used to identify patients who underwent surgical treatment for rotator cuff disease. A total of 383,719 cases of rotator cuff surgeries were performed from 2007 to 2015. The mean annual percentage change in the age-adjusted rate of rotator cuff surgery per population of 100,000 persons rapidly increased from 2007 to 2012 (53.3%, P < 0.001), while that between 2012 to 2015 remained steady (2.3%, P = 0.34). The proportion of arthroscopic surgery among all rotator cuff surgeries steadily rose from 89.9% in 2007 to 96.8% in 2015 (P < 0.001). In terms of hospital types, the rate of rotator cuff surgery increased to the greatest degree in hospitals with 30-100 inpatient beds, and isolated acromioplasty procedure accounted for a larger proportion of the rotator cuff surgeries in small hospitals and clinics compared to large hospitals. Overall, our findings indicate that cases of rotator cuff surgery have increased rapidly recently in Korea, of which arthroscopic surgeries account for the greatest proportion. While rotator cuff surgery is a popular procedure that is commonly performed even in small hospitals, there was a difference in the component ratio of the procedure code in accordance with hospital type.

  10. National Trends in Surgery for Rotator Cuff Disease in Korea

    PubMed Central

    2017-01-01

    The objective of this study was to investigate the national trends in rotator cuff surgery in Korea and analyze hospital type-specific trends. We analyzed a nationwide database acquired from the Korean Health Insurance Review and Assessment Service (HIRA) from 2007 to 2015. International Classification of Diseases, 10th revision (ICD-10) codes, procedure codes, and arthroscopic device code were used to identify patients who underwent surgical treatment for rotator cuff disease. A total of 383,719 cases of rotator cuff surgeries were performed from 2007 to 2015. The mean annual percentage change in the age-adjusted rate of rotator cuff surgery per population of 100,000 persons rapidly increased from 2007 to 2012 (53.3%, P < 0.001), while that between 2012 to 2015 remained steady (2.3%, P = 0.34). The proportion of arthroscopic surgery among all rotator cuff surgeries steadily rose from 89.9% in 2007 to 96.8% in 2015 (P < 0.001). In terms of hospital types, the rate of rotator cuff surgery increased to the greatest degree in hospitals with 30–100 inpatient beds, and isolated acromioplasty procedure accounted for a larger proportion of the rotator cuff surgeries in small hospitals and clinics compared to large hospitals. Overall, our findings indicate that cases of rotator cuff surgery have increased rapidly recently in Korea, of which arthroscopic surgeries account for the greatest proportion. While rotator cuff surgery is a popular procedure that is commonly performed even in small hospitals, there was a difference in the component ratio of the procedure code in accordance with hospital type. PMID:28049250

  11. Improved apparatus for predictive diagnosis of rotator cuff disease

    NASA Astrophysics Data System (ADS)

    Pillai, Anup; Hall, Brittany N.; Thigpen, Charles A.; Kwartowitz, David M.

    2014-03-01

    Rotator cuff disease impacts over 50% of the population over 60, with reports of incidence being as high as 90% within this population, causing pain and possible loss of function. The rotator cuff is composed of muscles and tendons that work in tandem to support the shoulder. Heavy use of these muscles can lead to rotator cuff tear, with the most common causes is age-related degeneration or sport injuries, both being a function of overuse. Tears ranges in severity from partial thickness tear to total rupture. Diagnostic techniques are based on physical assessment, detailed patient history, and medical imaging; primarily X-ray, MRI and ultrasonography are the chosen modalities for assessment. The final treatment technique and imaging modality; however, is chosen by the clinician is at their discretion. Ultrasound has been shown to have good accuracy for identification and measurement of full-thickness and partial-thickness rotator cuff tears. In this study, we report on the progress and improvement of our method of transduction and analysis of in situ measurement of rotator cuff biomechanics. We have improved the ability of the clinician to apply a uniform force to the underlying musculotendentious tissues while simultaneously obtaining the ultrasound image. This measurement protocol combined with region of interest (ROI) based image processing will help in developing a predictive diagnostic model for treatment of rotator cuff disease and help the clinicians choose the best treatment technique.

  12. Natural History of Rotator Cuff Disease and Implications on Management

    PubMed Central

    Hsu, Jason

    2015-01-01

    Degenerative rotator cuff disease is commonly associated with ageing and is often asymptomatic. The factors related to tear progression and pain development are just now being defined through longitudinal natural history studies. The majority of studies that follow conservatively treated painful cuff tears or asymptomatic tears that are monitored at regular intervals show slow progression of tear enlargement and muscle degeneration over time. These studies have highlighted greater risks for disease progression for certain variables, such as the presence of a full-thickness tear and involvement of the anterior aspect supraspinatus tendon. Coupling the knowledge of the natural history of degenerative cuff tear progression with variables associated with greater likelihood of successful tendon healing following surgery will allow better refinement of surgical indications for rotator cuff disease. In addition, natural history studies may better define the risks of nonoperative treatment over time. This article will review pertinent literature regarding degenerative rotator cuff disease with emphasis on variables important to defining appropriate initial treatments and refining surgical indications. PMID:26726288

  13. Comorbidities in rotator cuff disease: a case-control study.

    PubMed

    Titchener, Andrew G; White, Jonathan J E; Hinchliffe, Sally R; Tambe, Amol A; Hubbard, Richard B; Clark, David I

    2014-09-01

    Rotator cuff disease is a common condition in the general population, but relatively little is known about its associated risk factors. We have undertaken a large case-control study using The Health Improvement Network database to assess and to quantify the relative contributions of some constitutional and environmental risk factors for rotator cuff disease in the community. Our data set included 5000 patients with rotator cuff disease who were individually matched with a single control by age, sex, and general practice (primary care practice). The median age at diagnosis was 55 years (interquartile range, 44-65 years). Multivariate analysis showed that the risk factors associated with rotator cuff disease were Achilles tendinitis (odds ratio [OR] = 1.78), trigger finger (OR = 1.99), lateral epicondylitis (OR = 1.71), and carpal tunnel syndrome (OR = 1.55). Oral corticosteroid therapy (OR = 2.03), oral antidiabetic use (OR = 1.66), insulin use (OR = 1.77), and "overweight" body mass index of 25.1 to 30 (OR = 1.15) were also significantly associated. Current or previous smoking history, body mass index of greater than 30, any alcohol intake, medial epicondylitis, de Quervain syndrome, cubital tunnel syndrome, and rheumatoid arthritis were not found to be associated with rotator cuff disease. We have identified a number of comorbidities and risk factors for rotator cuff disease. These include lateral epicondylitis, carpal tunnel syndrome, trigger finger, Achilles tendinitis, oral corticosteroid use, and diabetes mellitus. The findings should alert the clinician to comorbid pathologic processes and guide future research into the etiology of this condition. Copyright © 2014 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

  14. Rotator cuff disease: opinion regarding surgical criteria and likely outcome.

    PubMed

    Thorpe, Alison; Hurworth, Mark; O'Sullivan, Peter; Mitchell, Tim; Smith, Anne

    2017-04-01

    Clinical guidelines for the management of rotator cuff disease are not clear. Surgeon surveys in the USA and UK lack agreement regarding surgical indications. Physical examination tests aid surgical decision-making but also lack robust evidence. Study aims were to evaluate: Western Australian orthopaedic surgeons' perceptions about surgical indications; utility of physical examination tests; findings at surgery predictive of outcome and surgeon opinion of a successful surgical outcome. An anonymous rotator cuff survey, previously reported by the American Academy of Orthopaedic Surgeons, was emailed to all surgeons listed with the Australian Orthopaedic Association in Western Australian. Surgeons who treated patients for rotator cuff disease during the previous 12 months were invited to complete the rotator cuff survey and five additional questions were included to capture the above criteria of interest. Within a close community of surgeons based in Western Australia (n = 23) considerable heterogeneity exists in surgical decision-making criteria. A successful surgical outcome was considered to include reduced pain levels, restoration of movement and function and gains in muscle strength. Research is required to inform robust clinical practice guidelines for rotator cuff surgery. Identification of prognostic factors for successful surgical outcome is imperative. © 2017 Royal Australasian College of Surgeons.

  15. Does cuff pressure monitoring reduce postoperative pharyngolaryngeal adverse events after LMA-ProSeal insertion? A parallel group randomised trial.

    PubMed

    Vasanth Karthik, R; Ranganathan, Priya; Kulkarni, Atul P; Sharma, Kailash S

    2014-10-01

    The incidence of postoperative pharyngolaryngeal complications after laryngeal mask airway (LMA) insertion can be as high as 50%. Over-inflation of the LMA cuff may be a causal factor. We conducted a single-centre parallel group randomised trial to determine whether maintaining LMA-ProSeal intra-cuff pressures below 60 cm H2O decreases postoperative pharyngolaryngeal complications. We recruited 120 adult patients who were scheduled to undergo elective surgery under general anaesthesia. Appropriate sized LMA-ProSeal was inserted and the cuff was inflated with air (to no more than the maximum recommended volume) until there was no audible leak. Patients were randomised to either the control group (n = 60), where the intra-cuff pressure was noted and no further action was taken, or to the pressure-monitored group (n = 60), where intra-cuff pressure was maintained below 60 cm H2O. Pharyngolaryngeal complications consisting of sore throat, dysphonia and dysphagia were assessed at 1, 2, and 24 h postoperatively. Patients, anaesthesiologists and assessors were blinded to group allocation. The primary outcome was a composite endpoint of any pharyngolaryngeal complication at any of the three time points. Secondary outcomes were the incidence of individual outcomes at each time point. The incidence of pharyngolaryngeal complications at any time point was 42% in the routine care group and 32% in the pressure-monitored group (95% CI for difference +28 to -7%, p = 0.26). There was no difference between groups for any of the secondary outcomes. Our study failed to demonstrate a statistically significant reduction in postoperative pharyngolaryngeal complications by limiting intra-cuff pressures in the LMA-Proseal.

  16. Correlation between Rotator Cuff Tears and Systemic Atherosclerotic Disease

    PubMed Central

    Donovan, Andrea; Schweitzer, Mark; Bencardino, Jenny; Petchprapa, Catherine; Cohen, Jodi; Ciavarra, Gina

    2011-01-01

    The purpose of this study was to investigate the association of aortic arch calcification, a surrogate marker of atherosclerosis, with rotator cuff tendinosis and tears given the hypothesis that decreased tendon vascularity is a contributing factor in the etiology of tendon degeneration. A retrospective review was performed to identify patients ages 50 to 90 years who had a shoulder MRI and a chest radiograph performed within 6 months of each other. Chest radiographs and shoulder MRIs from 120 patients were reviewed by two sets of observers blinded to the others' conclusions. Rotator cuff disease was classified as tendinosis, partial thickness tear, and full thickness tear. The presence or absence of aortic arch calcification was graded and compared with the MRI appearance of the rotator cuff. The tendon tear grading was positively correlated with patient age. However, the tendon tear grading on MRI was not significantly correlated with the aorta calcification scores on chest radiographs. Furthermore, there was no significant correlation between aorta calcification severity and tendon tear grading. In conclusion, rotator cuff tears did not significantly correlate with aortic calcification severity. This suggests that tendon ischemia may not be associated with the degree of macrovascular disease. PMID:22091372

  17. Effectiveness of open and arthroscopic rotator cuff repair (UKUFF): a randomised controlled trial.

    PubMed

    Carr, A; Cooper, C; Campbell, M K; Rees, J; Moser, J; Beard, D J; Fitzpatrick, R; Gray, A; Dawson, J; Murphy, J; Bruhn, H; Cooper, D; Ramsay, C

    2017-01-01

    The appropriate management for patients with a degenerative tear of the rotator cuff remains controversial, but operative treatment, particularly arthroscopic surgery, is increasingly being used. Our aim in this paper was to compare the effectiveness of arthroscopic with open repair of the rotator cuff. A total of 273 patients were recruited to a randomised comparison trial (136 to arthroscopic surgery and 137 to open surgery) from 19 teaching and general hospitals in the United Kingdom. The surgeons used their usual preferred method of repair. The Oxford Shoulder Score (OSS), two years post-operatively, was the primary outcome measure. Imaging of the shoulder was performed at one year after surgery. The trial is registered with Current Controlled Trials, ISRCTN97804283. The mean OSS improved from 26.3 (standard deviation (sd) 8.2) at baseline, to 41.7 (sd 7.9) two years post-operatively for arthroscopic surgery and from 25.0 (sd 8.0) to 41.5 (sd 7.9) for open surgery. Intention-to-treat (ITT) analysis showed no statistical difference between the groups at two years (difference in OSS score -0.76; 95% confidence interval (CI) -2.75 to 1.22; p = 0.452). The confidence interval excluded the pre-determined clinically important difference in the OSS of three points. The rate of re-tear was not significantly different between the two groups (46.4% for arthroscopic and 38.6% for open surgery; 95% CI -6.9 to 25.8; p = 0.256). Healed repairs had the most improved OSS. These findings were the same when analysed per-protocol. There is no evidence of difference in effectiveness between open and arthroscopic repair of rotator cuff tears. The rate of re-tear is high in both groups, for all sizes of tear and ages and this adversely affects the outcome. Cite this article: Bone Joint J 2017;99-B:107-15. ©2017 The British Editorial Society of Bone & Joint Surgery.

  18. Self-managed loaded exercise versus usual physiotherapy treatment for rotator cuff tendinopathy: a pilot randomised controlled trial.

    PubMed

    Littlewood, Chris; Malliaras, Peter; Mawson, Sue; May, Stephen; Walters, Stephen J

    2014-03-01

    Rotator cuff tendinopathy is a common source of shoulder pain characterised by persistent and/or recurrent problems for a proportion of sufferers. The aim of this study was to pilot the methods proposed to conduct a substantive study to evaluate the effectiveness of a self-managed loaded exercise programme versus usual physiotherapy treatment for rotator cuff tendinopathy. A single-centre pragmatic unblinded parallel group pilot randomised controlled trial. One private physiotherapy clinic, northern England. Twenty-four participants with rotator cuff tendinopathy. The intervention was a programme of self-managed loaded exercise. The control group received usual physiotherapy treatment. Baseline assessment comprised the Shoulder Pain and Disability Index (SPADI) and the Short-Form 36, repeated three months post randomisation. The recruitment target was met and the majority of participants (98%) were willing to be randomised. 100% retention was attained with all participants completing the SPADI at three months. Exercise adherence rates were excellent (90%). The mean change in SPADI score was -23.7 (95% CI -14.4 to -33.3) points for the self-managed exercise group and -19.0 (95% CI -6.0 to -31.9) points for the usual physiotherapy treatment group. The difference in three month SPADI scores was 0.1 (95% CI -16.6 to 16.9) points in favour of the usual physiotherapy treatment group. In keeping with previous research which indicates the need for further evaluation of self-managed loaded exercise for rotator cuff tendinopathy, these methods and the preliminary evaluation of outcome offer a foundation and stimulus to conduct a substantive study. Copyright © 2013 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  19. Degree of tendon degeneration and stage of rotator cuff disease.

    PubMed

    Jo, Chris Hyunchul; Shin, Won Hyoung; Park, Ji Wan; Shin, Ji Sun; Kim, Ji Eun

    2017-07-01

    While tendon degeneration has been known to be an important cause of rotator cuff disease, few studies have objectively proven the association of tendon degeneration and rotator cuff disease. The purpose of this study was to investigate changes of tendon degeneration with respect to the stage of rotator cuff disease. A total of 48 patients were included in the study: 12 with tendinopathy, 12 with a partial-thickness tear (pRCT), 12 with a full-thickness tear (fRCT), and 12 as the control. A full-thickness supraspinatus tendon sample was harvested en bloc from the middle portion between the lateral edge and the musculotendinous junction of the tendon using a biopsy punch with a diameter of 3 mm. Harvested samples were evaluated using a semi-quantitative grading scale with 7 parameters after haematoxylin and eosin staining. There was no significant difference in age, gender, symptom duration, and Kellgren-Lawrence grade between the groups except for the global fatty degeneration index. All of the seven parameters were significantly different between the groups and could be categorized as follows: early responders (fibre structure and arrangement), gradual responder (rounding of the nuclei), after-tear responders (cellularity, vascularity, and stainability), and late responder (hyalinization). The total degeneration scores were not significantly different between the control (6.08 ± 1.16) and tendinopathy (6.67 ± 1.83) (n.s.). However, the score of pRCT group (10.42 ± 1.31) was greater than that of tendinopathy (P < 0.001), and so was the score of fRCT (12.33 ± 1.15) than that of pRCT (p = 0.009). This study showed that the degeneration of supraspinatus tendon increases as the stage of rotator cuff disease progresses from tendinopathy to pRCT, and then to fRCT. The degree of degeneration of tendinopathy was not different from that of normal but aged tendons, and significant tendon degeneration began from the stage of pRCT. The clinical relevance of

  20. Clinical effectiveness and cost-effectiveness of open and arthroscopic rotator cuff repair [the UK Rotator Cuff Surgery (UKUFF) randomised trial].

    PubMed

    Carr, Andrew J; Cooper, Cushla D; Campbell, Marion K; Rees, Jonathan L; Moser, Jane; Beard, David J; Fitzpatrick, Ray; Gray, Alastair; Dawson, Jill; Murphy, Jacqueline; Bruhn, Hanne; Cooper, David; Ramsay, Craig R

    2015-10-01

    Uncertainty exists regarding the best management of patients with degenerative tears of the rotator cuff. To evaluate the clinical effectiveness and cost-effectiveness of arthroscopic and open rotator cuff repair in patients aged ≥ 50 years with degenerative rotator cuff tendon tears. Two parallel-group randomised controlled trial. Nineteen teaching and district general hospitals in the UK. Patients (n = 273) aged ≥ 50 years with degenerative rotator cuff tendon tears. Arthroscopic surgery and open rotator cuff repair, with surgeons using their usual and preferred method of arthroscopic or open repair. Follow-up was by telephone questionnaire at 2 and 8 weeks after surgery and by postal questionnaire at 8, 12 and 24 months after randomisation. The Oxford Shoulder Score (OSS) at 24 months was the primary outcome measure. Magnetic resonance imaging evaluation of the shoulder was made at 12 months after surgery to assess the integrity of the repair. The mean OSS improved from 26.3 [standard deviation (SD) 8.2] at baseline to 41.7 (SD 7.9) at 24 months for arthroscopic surgery and from 25.0 (SD 8.0) at baseline to 41.5 (SD 7.9) at 24 months for open surgery. When effect sizes are shown for the intervention, a negative sign indicates that an open procedure is favoured. For the intention-to-treat analysis, there was no statistical difference between the groups, the difference in OSS score at 24 months was -0.76 [95% confidence interval (CI) -2.75 to 1.22; p = 0.452] and the CI excluded the predetermined clinically important difference in the OSS of 3 points. There was also no statistical difference when the groups were compared per protocol (difference in OSS score -0.46, 95% CI -5.30 to 4.39; p = 0.854). The questionnaire response rate was > 86%. At 8 months, 77% of participants reported that shoulder problems were much or slightly better, and at 24 months this increased to 85%. There were no significant differences in mean cost between the arthroscopic group and

  1. A randomised controlled feasibility study investigating the use of eccentric and concentric strengthening exercises in the treatment of rotator cuff tendinopathy.

    PubMed

    Bateman, Marcus; Adams, Nicola

    2014-01-01

    To conduct a feasibility study to compare concentric and eccentric rotator cuff strengthening exercises for rotator cuff tendinopathy. A total of 11 patients with rotator cuff tendinopathy who were on the waiting list for arthroscopic subacromial decompression surgery were randomised to perform eccentric rotator cuff strengthening exercises, concentric strengthening exercises or no exercises. Patients were evaluated in terms of levels of pain and function using the Oxford Shoulder Score and a Visual Analogue Scale initially, at 4 weeks and at 8 weeks. The study design was found to be acceptable to patients and achieved a high level of 86% compliance. The drop-out rate was 0%. Two patients performing eccentric strengthening exercises improved sufficiently to cancel their planned surgery. Further research in this area is recommended. The study design was feasible and power calculations have been conducted to aid future research planning.

  2. Rotator cuff tears in young patients: a different disease than rotator cuff tears in elderly patients.

    PubMed

    Lazarides, Alexander L; Alentorn-Geli, Eduard; Choi, J H James; Stuart, Joseph J; Lo, Ian K Y; Garrigues, Grant E; Taylor, Dean C

    2015-11-01

    The purpose of this study was to conduct a systematic review of the literature to evaluate the characteristics of injury and treatment outcomes of rotator cuff tears in young patients. A systematic electronic search was performed for clinical studies evaluating rotator cuff tears in patients younger than 40 years with special emphasis on reporting of injury characteristics and treatment outcomes with a minimum 1-year follow-up. Twelve studies (involving 336 patients) met inclusion criteria. The mean age of the patients was 28 years (range, 16-40 years), with a mean follow-up of 39 months. There were 2 distinct subgroups. The majority of studies (7 of 10) showed that patients typically had a full-thickness tear with an acute traumatic etiology. However, within the subgroup of elite throwers, 5 of 6 studies demonstrated a majority of tears that were partial thickness stemming from chronic overuse. Rotator cuff repair improved pain and strength in almost all studies reporting on these parameters. Eighty-seven percent of patients reported they were satisfied. However, all studies examining elite throwers showed significant difficulty in returning to play (25%-97%). In young patients with rotator cuff tears, there are 2 primary groups. (1) A majority group with rotator cuff tears of traumatic origin responded well to both arthroscopic and open rotator cuff repair in terms of pain relief and self-reported outcomes postoperatively. These patients reported high levels of satisfaction and return to preinjury level of play. (2) A unique subpopulation composed of elite throwers had improved outcomes but suboptimal return to play. Copyright © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

  3. Evidence of genetic variations associated with rotator cuff disease.

    PubMed

    Motta, Geraldo da Rocha; Amaral, Marcus Vinícius; Rezende, Eduardo; Pitta, Rafael; Vieira, Thays Cristine dos Santos; Duarte, Maria Eugenia Leite; Vieira, Alexandre Rezende; Casado, Priscila Ladeira

    2014-02-01

    Rotator cuff disease (RCD) is a complex process influenced by a multitude of factors, and a number of gene pathways are altered in rotator cuff tears. Polymorphisms in these genes can lead to an extended tendon degeneration process, which explains why subsets of patients are more susceptible to RCD. Twenty-three single-nucleotide polymorphisms within 6 genes involved in repair and degenerative processes (DEFB1, DENND2C, ESRRB, FGF3, FGF10, and FGFR1) were investigated in 410 patients, 203 with a diagnosis of RCD and 207 presenting with absence of RCD. Exclusion criteria were patients older than 60 years and younger than 45 years with a history of trauma, rheumatoid arthritis, autoimmune syndrome, pregnancy, and use of corticosteroids. Genomic DNA was obtained from saliva samples. Genetic markers were genotyped with TaqMan real-time polymerase chain reaction. The χ(2) test compared genotypes and haplotype differences between groups. Multivariate logistic regression analyzed the significance of many covariates and the incidence of RCD. Statistical analysis revealed female sex (P = .001; odds ratio, 2.07 [1.30-3.30]) and being white (P = .002; odds ratio, 1.88 [1.21-2.90]) to be risk factors for RCD development. A significant association of haplotypes CCTTCCAG in ESRRB (P = .05), CGACG in FGF3 (P = .01), CC in DEFB1 (P = .03), and FGFR1 rs13317 (P = .02) with RCD could be observed. Also, association between FGF10 rs11750845 (P = .03) and rs1011814 (P = .01) was observed after adjustment by ethnic group and sex. Our work clearly supports the role of DEFB1, ESRRB, FGF3, FGF10, and FGFR1 genes in RCD. Identification of these variants can clarify causal pathways and provide a clue for therapeutic targets. Copyright © 2014 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

  4. Dynamic Three-Dimensional Shoulder Mri during Active Motion for Investigation of Rotator Cuff Diseases

    PubMed Central

    Tempelaere, Christine; Pierrart, Jérome; Lefèvre-Colau, Marie-Martine; Vuillemin, Valérie; Cuénod, Charles-André; Hansen, Ulrich; Mir, Olivier; Skalli, Wafa; Gregory, Thomas

    2016-01-01

    Background MRI is the standard methodology in diagnosis of rotator cuff diseases. However, many patients continue to have pain despite treatment, and MRI of a static unloaded shoulder seems insufficient for best diagnosis and treatment. This study evaluated if Dynamic MRI provides novel kinematic data that can be used to improve the understanding, diagnosis and best treatment of rotator cuff diseases. Methods Dynamic MRI provided real-time 3D image series and was used to measure changes in the width of subacromial space, superior-inferior translation and anterior-posterior translation of the humeral head relative to the glenoid during active abduction. These measures were investigated for consistency with the rotator cuff diseases classifications from standard MRI. Results The study included: 4 shoulders with massive rotator cuff tears, 5 shoulders with an isolated full-thickness supraspinatus tear, 5 shoulders with tendinopathy and 6 normal shoulders. A change in the width of subacromial space greater than 4mm differentiated between rotator cuff diseases with tendon tears (massive cuff tears and supraspinatus tear) and without tears (tendinopathy) (p = 0.012). The range of the superior-inferior translation was higher in the massive cuff tears group (6.4mm) than in normals (3.4mm) (p = 0.02). The range of the anterior-posterior translation was higher in the massive cuff tears (9.2 mm) and supraspinatus tear (9.3 mm) shoulders compared to normals (3.5mm) and tendinopathy (4.8mm) shoulders (p = 0.05). Conclusion The Dynamic MRI enabled a novel measure; ‘Looseness’, i.e. the translation of the humeral head on the glenoid during an abduction cycle. Looseness was better able at differentiating different forms of rotator cuff disease than a simple static measure of relative glenohumeral position. PMID:27434235

  5. Dynamic Three-Dimensional Shoulder Mri during Active Motion for Investigation of Rotator Cuff Diseases.

    PubMed

    Tempelaere, Christine; Pierrart, Jérome; Lefèvre-Colau, Marie-Martine; Vuillemin, Valérie; Cuénod, Charles-André; Hansen, Ulrich; Mir, Olivier; Skalli, Wafa; Gregory, Thomas

    2016-01-01

    MRI is the standard methodology in diagnosis of rotator cuff diseases. However, many patients continue to have pain despite treatment, and MRI of a static unloaded shoulder seems insufficient for best diagnosis and treatment. This study evaluated if Dynamic MRI provides novel kinematic data that can be used to improve the understanding, diagnosis and best treatment of rotator cuff diseases. Dynamic MRI provided real-time 3D image series and was used to measure changes in the width of subacromial space, superior-inferior translation and anterior-posterior translation of the humeral head relative to the glenoid during active abduction. These measures were investigated for consistency with the rotator cuff diseases classifications from standard MRI. The study included: 4 shoulders with massive rotator cuff tears, 5 shoulders with an isolated full-thickness supraspinatus tear, 5 shoulders with tendinopathy and 6 normal shoulders. A change in the width of subacromial space greater than 4mm differentiated between rotator cuff diseases with tendon tears (massive cuff tears and supraspinatus tear) and without tears (tendinopathy) (p = 0.012). The range of the superior-inferior translation was higher in the massive cuff tears group (6.4mm) than in normals (3.4mm) (p = 0.02). The range of the anterior-posterior translation was higher in the massive cuff tears (9.2 mm) and supraspinatus tear (9.3 mm) shoulders compared to normals (3.5mm) and tendinopathy (4.8mm) shoulders (p = 0.05). The Dynamic MRI enabled a novel measure; 'Looseness', i.e. the translation of the humeral head on the glenoid during an abduction cycle. Looseness was better able at differentiating different forms of rotator cuff disease than a simple static measure of relative glenohumeral position.

  6. Arthroscopic decompression not recommended in the treatment of rotator cuff tendinopathy: a final review of a randomised controlled trial at a minimum follow-up of ten years.

    PubMed

    Ketola, S; Lehtinen, J T; Arnala, I

    2017-06-01

    Rotator cuff tendinopathy has a multifactorial origin. Rejecting the mechanistic theory has also led to abandoning operative treatment at initial presentation in the first line. Physiotherapy exercise programmes are the accepted first line treatment. The aim of this study was to assess the long-term additional benefits of subacromial decompression in the treatment of rotator cuff tendinopathy. This randomised controlled trial of 140 patients (52 men, 88 women, mean age 47.1 years; 18 to 60) with rotator cuff tendinopathy extended previous work up to a maximum of 13 years. The patients were randomised into two treatment groups: arthroscopic acromioplasty and a supervised exercise treatment and a similar supervised exercise treatment alone. Self-reported pain on a visual analogue scale (VAS) was the primary outcome measure. Secondary measures were disability, working ability, pain at night, Shoulder Disability Questionnaire score and the number of painful days during the three months preceding the final assessment. A total of 90 patients (64%) returned questionnaires at a mean 12 years after randomisation. On an intention-to-treat basis, both treatment groups reached statistically significant improvement compared with the initial VAS for pain, but there was no significant difference between groups. The same was true in the secondary outcome measures. Due to group changes, the results were also analysed per protocol: operated or not. No significant differences between the groups were found. The natural history of rotator cuff tendinopathy probably plays a significant role in the results in the long-term. Even though the patients who underwent operative treatment had a stronger belief in recovery, which is likely to be surgical and the effect of placebo, the exercise group obtained similar results. In the future, an optimum exercise regime should be searched for, as the most clinically and cost-effective conservative treatment for rotator cuff tendinopathy. Cite this

  7. Is rotator cuff repair appropriate in patients older than 60 years of age? prospective, randomised trial in 103 patients with a mean four-year follow-up.

    PubMed

    Jacquot, A; Dezaly, C; Goetzmann, T; Roche, O; Sirveaux, F; Molé, D

    2014-10-01

    The objective of this randomised trial was to compare surgical rotator cuff repair to simple decompression by acromioplasty and biceps tenotomy in patients older than 60 years of age with a mean follow-up of 4 years. Tendon repair produces better functional outcomes than simple decompression and prevents progression towards cuff tear arthropathy in the longer term. Of 130 initially included patients older than 60 years of age and having rotator cuff tears deemed amenable to surgical repair, 103 (79%) were evaluated after a mean of 4 years. These patients had been randomly allocated to acromioplasty and tenotomy (AT group, n=49) or to acromioplasty, tenotomy, and tendon suture (CR group, n=54). The tear was distal in 41 patients, intermediate in 40, and retracted in 22. At last follow-up, the evaluation included the clinical Constant's Score, radiographs and, in the CR group, ultrasonography. The complication rate was 4%. The mean Constant Score was 44 preoperatively; values after 4 years were 76 overall (P=0.01), 78 in the CR group, and 73 in the AT group (P=0.01). The tendon-healing rate as assessed using ultrasonography was 63%. The Constant Score was significantly better when tendon healing was achieved (82/73, P<0.001). In the AT group, the acromio-humeral distance was significantly shorter (6.9 mm/7.8mm, P=0.03) and eccentric humeral head position was more common (44%/26%, P=0.01). Arthroscopic rotator cuff repair provides better functional outcomes than does simple decompression in patients older than 60 years and prevents cuff tear arthropathy with eccentric humeral head position in the medium term. Tendon healing is the main determinant of outcomes after rotator cuff repair. II, randomised trial. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  8. A questionnaire found disease-specific WORC index is not more responsive than SPADI and OSS in rotator cuff disease.

    PubMed

    Ekeberg, Ole M; Bautz-Holter, Erik; Keller, Anne; Tveitå, Einar K; Juel, Niels G; Brox, Jens I

    2010-05-01

    To compare responsiveness and minimal clinically important change (MCIC) for the disease-specific Western Ontario Rotator Cuff index (WORC) and the two region-specific questionnaires Shoulder Pain and Disability Index (SPADI) and Oxford Shoulder Scale (OSS) in patients with rotator cuff disease receiving corticosteroid injection therapy. One hundred twenty-one patients with rotator cuff disease. Western Ontario Rotator Cuff index, SPADI, and OSS were administered before treatment and at 2 and 6 weeks after corticosteroid injection. Responsiveness was compared between questionnaires using the standardized response mean (SRM), area under the receiver operating characteristic curve, and reliable change proportion (RCP) statistics. Minimal clinically important change estimates were reported. The differences between questionnaires were small and not consistent across the different responsiveness indices. Shoulder Pain and Disability Index was significantly more responsive than OSS measured by SRM and RCP at 2 and 6 weeks. Western Ontario Rotator Cuff index was significantly more responsive than OSS in RCP and area under receiver operating characteristic curve at 6 weeks. Shoulder Pain and Disability Index was significantly more responsive than WORC measured by RCP at 2 weeks. Minimal clinically important change was estimated to 5, 275, and 20 points for OSS, WORC, and SPADI, respectively. All questionnaires are suitable for measuring change in patients with rotator cuff disease. Disease-specific WORC index is not more responsive than the region-specific SPADI and OSS in rotator cuff disease.

  9. Genetic and familial predisposition to rotator cuff disease: a systematic review.

    PubMed

    Dabija, Dominique I; Gao, Chan; Edwards, Todd L; Kuhn, John E; Jain, Nitin B

    2017-06-01

    Rotator cuff disease is a common disorder leading to shoulder pain and loss of function. Its etiology in atraumatic cases is uncertain and is likely to extend beyond repetitive microtrauma or overuse. Our objective was to determine whether there is a genetic or familial predisposition to rotator cuff disease. A literature search of PubMed and Embase databases identified 251 citations. After review of the titles, abstracts, and full articles, 7 met our inclusion and exclusion criteria. Four studies assessed familial predisposition to rotator cuff disease. One of these demonstrated that siblings of an individual with a rotator cuff tear were more likely to develop a full-thickness tear and more likely to be symptomatic. A 5-year follow-up showed that the relative risks were increased for the siblings to have a full-thickness tear, for a tear to progress in size, and for being symptomatic. Another study demonstrated that a significantly higher number of individuals with tears had family members with a history of tears or surgery than those without tears did. The other 3 studies investigated whether a genetic predisposition to rotator cuff disease exists and found significant association of haplotypes in DEFB1, FGFR1, FGF3, ESRRB, and FGF10 and 2 single-nucleotide polymorphisms within SAP30BP and SASH1. Prior studies provide preliminary evidence for genetic and familial predisposition to rotator cuff disease. However, there is a lack of large genome-wide studies that can provide more definitive information and guide early detection of individuals at risk, prophylactic rehabilitation, and potential gene therapies and regenerative medicine interventions. Copyright © 2016 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

  10. Epidemiology of the rotator cuff tears: a new incidence related to thyroid disease

    PubMed Central

    Oliva, Francesco; Osti, Leonardo; Padulo, Johnny; Maffulli, Nicola

    2014-01-01

    Summary Background: in the last years the incidence of rotator cuff tears increased and one main cause still waiting to be clarified. Receptors for thyroid hormones in rotator cuff tendons suggest possible effects on tendons metabolism and status. We undertook a retrospective, observational cohort study of 441 patients who underwent arthroscopic and mini-open repair for non traumatic degenerative rotator cuff tears. Methods: all the patients, predominantly females (63%), were interview to assess the relationship (frequency for class age “20 yrs” and factor analysis) between lesions of the rotator cuff with the following variables: gender, thyroid disease, smoker, taking medications for diabetes, hypertension or high cholesterol; presence of associated conditions (diabetes, hypertension, hypercholesterolemia). Results: thyroid disease is highly frequently (until 63% for 60<80 yrs) in females group independent to the age. Conversely, males showed a high frequency for smoker 37<62% until 80 yrs and 50% hypercholesterolemia over 80 yrs for the clinical variable studied. Conclusions: this is the first clinical report that shown a relationship between thyroid pathologies and non-traumatic rotator cuff tear as increased risk factors. PMID:25489548

  11. Association Between Cardiovascular Disease Risk Factors and Rotator Cuff Tendinopathy: A Cross-Sectional Study.

    PubMed

    Applegate, Kara Arnold; Thiese, Matthew S; Merryweather, Andrew S; Kapellusch, Jay; Drury, David L; Wood, Eric; Kendall, Richard; Foster, James; Garg, Arun; Hegmann, Kurt T

    2017-02-01

    Recent evidence has found potential associations between cardiovascular disease (CVD) risk factors and common musculoskeletal disorders. We evaluated possible associations between risk factors and both glenohumeral joint pain and rotator cuff tendinopathy. Data from WISTAH hand study participants (n = 1226) were assessed for associations between Framingham Heart Study CVD risk factors and both health outcomes. A strong association was observed between CVD risk scores and both glenohumeral joint pain and rotator cuff tendinopathy. Peak odds ratios (ORs) of the adjusted models were 4.55 [95% confidence interval (95% CI) 1.97 to 10.31] and 5.97 (95% CI 2.12 to 16.83), respectively. The results show a dose-response trend of increasing risk. Individual risk factors were associated with both outcomes. Combined, CVD risk factors demonstrated a strong correlation with glenohumeral joint pain and an even stronger correlation with rotator cuff tendinopathy. Results suggest a potentially modifiable disease mechanism.

  12. Progressive high-load strength training compared with general low-load exercises in patients with rotator cuff tendinopathy: study protocol for a randomised controlled trial.

    PubMed

    Ingwersen, Kim G; Christensen, Robin; Sørensen, Lilli; Jørgensen, Hans Ri; Jensen, Steen Lund; Rasmussen, Sten; Søgaard, Karen; Juul-Kristensen, Birgit

    2015-01-27

    Shoulder pain is the third most common musculoskeletal disorder, often affecting people's daily living and work capacity. The most common shoulder disorder is the subacromial impingement syndrome (SIS) which, among other pathophysiological changes, is often characterised by rotator cuff tendinopathy. Exercise is often considered the primary treatment option for rotator cuff tendinopathy, but there is no consensus on which exercise strategy is the most effective. As eccentric and high-load strength training have been shown to have a positive effect on patella and Achilles tendinopathy, the aim of this trial is to compare the efficacy of progressive high-load exercises with traditional low-load exercises in patients with rotator cuff tendinopathy. The current study is a randomised, participant- and assessor-blinded, controlled multicentre trial. A total of 260 patients with rotator cuff tendinopathy will be recruited from three outpatient shoulder departments in Denmark, and randomised to either 12 weeks of progressive high-load strength training or to general low-load exercises. Patients will receive six individually guided exercise sessions with a physiotherapist and perform home-based exercises three times a week. The primary outcome measure will be change from baseline to 12 weeks in the patient-reported outcome Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. Previous studies of exercise treatment for SIS have not differentiated between subgroups of SIS and have often had methodological flaws, making it difficult to specifically design target treatment for patients diagnosed with SIS. Therefore, it was considered important to focus on a subgroup such as tendinopathy, with a specific tailored intervention strategy based on evidence from other regions of the body, and to clearly describe the intervention in a methodologically strong study. The trial was registered with Clinicaltrials.gov ( NCT01984203 ) on 31 October 2013.

  13. Imaging Algorithms for Evaluating Suspected Rotator Cuff Disease: Society of Radiologists in Ultrasound Consensus Conference Statement

    PubMed Central

    Jacobson, Jon A.; Benson, Carol B.; Bancroft, Laura W.; Bedi, Asheesh; McShane, John M.; Miller, Theodore T.; Parker, Laurence; Smith, Jay; Steinbach, Lynne S.; Teefey, Sharlene A.; Thiele, Ralf G.; Tuite, Michael J.; Wise, James N.; Yamaguchi, Ken

    2013-01-01

    The Society of Radiologists in Ultrasound convened a panel of specialists from a variety of medical disciplines to reach a consensus about the recommended imaging evaluation of painful shoulders with clinically suspected rotator cuff disease. The panel met in Chicago, Ill, on October 18 and 19, 2011, and created this consensus statement regarding the roles of radiography, ultrasonography (US), computed tomography (CT), CT arthrography, magnetic resonance (MR) imaging, and MR arthrography. The consensus panel consisted of two co-moderators, a facilitator, a statistician and health care economist, and 10 physicians who have specialty expertise in shoulder pain evaluation and/or treatment. Of the 13 physicians on the panel, nine were radiologists who were chosen to represent a broad range of skill sets in diagnostic imaging, different practice types (private and academic), and different geographical regions of the United States. Five of the radiologists routinely performed musculoskeletal US as part of their practice and four did not. There was also one representative from each of the following clinical specialties: rheumatology, physical medicine and rehabilitation, orthopedic surgery, and nonoperative sports medicine. The goal of this conference was to construct several algorithms with which to guide the imaging evaluation of suspected rotator cuff disease in patients with a native rotator cuff, patients with a repaired rotator cuff, and patients who have undergone shoulder replacement. The panel hopes that these recommendations will lead to greater uniformity in rotator cuff imaging and more cost-effective care for patients suspected of having rotator cuff abnormality. © RSNA, 2013 PMID:23401583

  14. Bone density of the greater tuberosity is decreased in rotator cuff disease with and without full-thickness tears.

    PubMed

    Waldorff, Erik I; Lindner, James; Kijek, Theresa G; Downie, Brian K; Hughes, Richard E; Carpenter, James E; Miller, Bruce S

    2011-09-01

    Despite the high prevalence of rotator cuff disease in the aging adult population, the basic mechanisms initiating the disease are not known. It is known that changes occur at both the bone and tendon after rotator cuff tears. However, no study has focused on early or "pretear" rotator cuff disease states. The purpose of this study was to compare the bone mineral density of the greater tuberosity in normal subjects with that in subjects with impingement syndrome and full-thickness rotator cuff tears. Digital anteroposterior shoulder radiographs were obtained for 3 sex- and age-matched study groups (men, 40-70 years old): normal asymptomatic shoulders (control), rotator cuff disease without full-thickness tears (impingement), and full-thickness rotator cuff tears (n = 39 per group). By use of imaging software, bone mineral densities were determined for the greater tuberosity, the greater tuberosity cortex, the greater tuberosity subcortex, and the cancellous region of the humeral head. The bone mineral density of the greater tuberosity was significantly higher for the normal control subjects compared with subjects with impingement or rotator cuff tears. No differences were found between the two groups of patients with known rotator cuff disease. The greater tuberosity cortex and greater tuberosity subcortex outcome measures were similar. Bone mineral changes are present in the greater tuberosity of shoulders with rotator cuff disease both with and without full-thickness tears. The finding of focal diminished bone mineral density of the greater tuberosity in the absence of rotator cuff tears warrants further investigation. Copyright © 2011 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

  15. Rising trends in surgery for rotator cuff disease in Western Australia.

    PubMed

    Thorpe, Alison; Hurworth, Mark; O'Sullivan, Peter; Mitchell, Tim; Smith, Anne

    2016-10-01

    Increasing rates of surgery for rotator cuff disease have been reported in the past decade in a number of countries worldwide. Rising surgery rates do not correspond with equivalent increases in shoulder pain prevalence. The aims of the study were: to investigate trends in population-adjusted surgical rates for rotator cuff disease in Western Australia (WA) from 2001 to 2013; to compare population-adjusted arthroscopic surgical trends between (i) private versus public hospital setting; (ii) sex and (iii) different age groups; and to evaluate rising health care costs associated with arthroscopic surgical rates for rotator cuff disease. Numbers and costs for surgical procedures for rotator cuff disease performed in WA were extracted from the WA Department of Health database for the 13-year period, 2001-2013. Rising surgical trends were demonstrated with arthroscopic subacromial decompression (ASAD) and arthroscopic reconstruction showing large proportional increases of 108.7 and 68.4%, respectively. Increasing trends were mostly linear across private and public hospital settings, gender groups and different age groups. The rise in consumer price index-adjusted costs for ASAD in private and public hospitals was 273.7 and 320.8%, respectively, and for arthroscopic reconstruction 220.2 and 472.5%, respectively. The substantial increase in arthroscopic surgery rates for rotator cuff disease and associated costs in WA over the period 2001-2013 is in spite of evidence that surgical outcomes are no different to exercise interventions. Conservative treatments should be recommended as an initial treatment choice, to arrest escalating health care costs. © 2016 Royal Australasian College of Surgeons.

  16. [Rotator cuff diseases in occupational medicine between occupational diseases and accidents: medical-legal considerations].

    PubMed

    Spigno, F; Galli, R; Casali, C; Lagattolla, N; De Lucchi, M

    2010-01-01

    The authors have gone through the complaints concerning all the cases of shoulder accidents at work filed by the Genoa office of the Italian Workers' National compensation Agency (INAIL) during the two years' period 2006-2007, reviewing in particular those somehow affecting rotator components. The aim of this paper is to assess the real role played by the occupational trauma in the rotator cuff tear. The data gathered so far have shown, on the one hand, a high prevalence of pre-existing inflammatory and degenerative diseases and, on the other, a rather modest influence of the trauma which, for this reason, has usually borne, as an immediate medico-legal consequence, the rejection of a cause-effect relationship between the accident and the rotator cuff lesion, without taking into any account whether the worker was likely to be affected by an occupational disease (ex table Ministerial Decree n. 81 April 9th 2008- item 78). In such cases a systematic and in-depth investigation of the occupational case history is suggested, in order to highlight the possible pre-existence of a former biomechanical overload of the upper limbs, so as to allow the physician to detect a pathology often misdiagnosed.

  17. Macroscopic and microscopic assessments of the glenohumeral and subacromial synovitis in rotator cuff disease.

    PubMed

    Jo, Chris H; Shin, Ji Sun; Kim, Ji Eun; Oh, Sohee

    2015-09-30

    Whereas synovitis is one of most common findings during arthroscopic surgery in patients with rotator cuff diseases, no study has investigated its characteristics. We propose a macroscopic assessment system for investigating the characteristics of synovitis. Fifty-four patients with a full-thickness rotator cuff tear undergoing arthroscopic rotator cuff repair with an average age of 62.5 ± 7.0 years were included. For the macroscopic assessment, 3 parameters, villous hypertrophy, hyperemia, and density, were measured and translated into grades in 3 regions-of-interest (ROI) in the glenohumeral joint and 4 ROIs in the subacromial space. For the microscopic assessments, 4 commonly used microscopic assessment systems were used. The reliability and association between the macroscopic and microscopic assessments were investigated. The inter- and intra-observer reliability of all of the macroscopic and microscopic assessments were excellent. The severity of synovitis was significantly greater in the glenohumeral joint than that in the subacromial space, 1.54 ± 0.61 versus 0.94 ± 0.56 (p < 0.001). Synovitis varied with respect to location, and was generally more severe near the tear with the macroscopic assessment system. Meanwhile, none of the microscopic assessment systems demonstrated differences between different ROIs in both the glenohumeral joint and the subacromial space. The macroscopic assessment system for synovitis in rotator cuff disease in this study showed excellent reliability. It critically described characteristics of synovitis that microscopic assessment systems could not. Therefore, this system could be a useful tool for investigating synovitis in rotator cuff disease.

  18. Shoulder activity level and progression of degenerative cuff disease.

    PubMed

    Keener, Jay D; Skelley, Nathan W; Stobbs-Cucchi, Georgia; Steger-May, Karen; Chamberlain, Aaron M; Aleem, Alex W; Brophy, Robert H

    2017-09-01

    This study prospectively examined the relationship of direct and indirect measures of shoulder activity with the risks of tear progression and pain development in subjects with an asymptomatic degenerative rotator cuff tear. A cohort of asymptomatic degenerative rotator cuff tears was prospectively monitored annually, documenting tear size progression with ultrasound imaging and potential shoulder pain development. Shoulder activity level, self-reported occupational and physical demand level, and hand dominance were compared with risks of tear enlargement and future pain development. The study monitored 346 individuals with a mean age of 62.1 years for a median duration of 4.1 years (interquartile range [IQR], 2.4-7.9 years). Tear enlargement was seen in 177 shoulders (51.2%), and pain developed in 161 shoulders (46.5%) over time. Tear presence in the dominant shoulder was associated with a greater risk of tear enlargement (hazard ratio, 1.40; P = .03) and pain development (hazard ratio, 1.63; P = .002). Shoulder activity level (P = .37) and occupational demand level (P = .62) were not predictive of tear enlargement. Occupational demand categories of manual labor (P = .047) and "in between" (P = .045) had greater risks of pain development than sedentary demands. The median shoulder activity score for shoulders that became painful was lower than for shoulders that remained asymptomatic (10.0 [IQR, 7.0-13.0] vs. 11.0 [IQR, 8.0-14.0], P = .02). Tear enlargement and pain development in asymptomatic tears are more common with involvement of the dominant shoulder. Shoulder activity level is not related to tear progression risks. Pain development is associated with a lower shoulder activity level even though patients with higher occupational demands are more likely to develop pain. Copyright © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

  19. Diagnostic value of clinical tests for degenerative rotator cuff disease in medical practice.

    PubMed

    Lasbleiz, S; Quintero, N; Ea, K; Petrover, D; Aout, M; Laredo, J D; Vicaut, E; Bardin, T; Orcel, P; Beaudreuil, J

    2014-06-01

    To assess the diagnostic value of clinical tests for degenerative rotator cuff disease (DRCD) in medical practice. Patients with DRCD were prospectively included. Eleven clinical tests of the rotator cuff have been done. One radiologist performed ultrasonography (US) of the shoulder. Results of US were expressed as normal tendon, tendinopathy or full-thickness tear (the reference). For each clinical test and each US criteria, sensitivity, specificity, negative predictive value and positive predictive value, accuracy, negative likelihood ratio (NLR) and positive likelihood ratio (PLR) were calculated. Clinical relevance was defined as PLR ≥2 and NLR ≤0.5. For 35 patients (39 shoulders), Jobe (PLR: 2.08, NLR: 0.31) and full-can (2, 0.5) test results were relevant for diagnosis of supraspinatus tears and resisted lateral rotation (2.42, 0.5) for infraspinatus tears, with weakness as response criteria. The lift-off test (8.50, 0.27) was relevant for subscapularis tears with lag sign as response criteria. Yergason's test (3.7, 0.41) was relevant for tendinopathy of the long head of the biceps with pain as a response criterion. There was no relevant clinical test for diagnosis of tendinopathy of supraspinatus, infraspinatus or subscapularis. Five of 11 clinical tests were relevant for degenerative rotator cuff disease. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  20. Radial extracorporeal shock-wave therapy in patients with chronic rotator cuff tendinitis: a prospective randomised double-blind placebo-controlled multicentre trial.

    PubMed

    Kolk, A; Yang, K G Auw; Tamminga, R; van der Hoeven, H

    2013-11-01

    The aim of this study was to determine the effect of radial extracorporeal shock-wave therapy (rESWT) on patients with chronic tendinitis of the rotator cuff. This was a randomised controlled trial in which 82 patients (mean age 47 years (24 to 67)) with chronic tendinitis diagnosed clinically were randomly allocated to a treatment group who received low-dose rESWT (three sessions at an interval 10 to 14 days, 2000 pulses, 0.11 mJ/mm(2), 8 Hz) or to a placebo group, with a follow-up of six months. The patients and the treating orthopaedic surgeon, who were both blinded to the treatment, evaluated the results. A total of 44 patients were allocated to the rESWT group and 38 patients to the placebo group. A visual analogue scale (VAS) score for pain, a Constant-Murley (CMS) score and a simple shoulder test (SST) score significantly improved in both groups at three and six months compared with baseline (all p ≤ 0.012). The mean VAS was similar in both groups at three (p = 0.43) and six months (p = 0.262). Also, the mean CMS and SST scores were similar in both groups at six months (p = 0.815 and p = 0.834, respectively). It would thus seem that low-dose rESWT does not reduce pain or improve function in patients chronic rotator cuff tendinitis compared with placebo treatment.

  1. A self-managed single exercise programme versus usual physiotherapy treatment for rotator cuff tendinopathy: a randomised controlled trial (the SELF study).

    PubMed

    Littlewood, Chris; Bateman, Marcus; Brown, Kim; Bury, Julie; Mawson, Sue; May, Stephen; Walters, Stephen J

    2016-07-01

    To evaluate the clinical effectiveness of a self-managed single exercise programme versus usual physiotherapy treatment for rotator cuff tendinopathy. Multi-centre pragmatic unblinded parallel group randomised controlled trial. UK National Health Service. Patients with a clinical diagnosis of rotator cuff tendinopathy. The intervention was a programme of self-managed exercise prescribed by a physiotherapist in relation to the most symptomatic shoulder movement. The control group received usual physiotherapy treatment. The primary outcome measure was the Shoulder Pain & Disability Index (SPADI) at three months. Secondary outcomes included the SPADI at six and twelve months. A total of 86 patients (self-managed loaded exercise n=42; usual physiotherapy n=44) were randomised. Twenty-six patients were excluded from the analysis because of lack of primary outcome data at the 3 months follow-up, leaving 60 (n=27; n=33) patients for intention to treat analysis. For the primary outcome, the mean SPADI score at three months was 32.4 (SD 20.2) for the self-managed group, and 30.7 (SD 19.7) for the usual physiotherapy treatment group; mean difference adjusted for baseline score: 3.2 (95% Confidence interval -6.0 to +12.4 P = 0.49).By six and twelve months there remained no significant difference between the groups. This study does not provide sufficient evidence of superiority of one intervention over the other in the short-, mid- or long-term and hence a self-management programme based around a single exercise appears comparable to usual physiotherapy treatment. © The Author(s) 2015.

  2. Tenotomy or tenodesis for long head biceps lesions in shoulders with reparable rotator cuff tears: a prospective randomised trial.

    PubMed

    Zhang, Qiang; Zhou, Jiaojiao; Ge, Heng'an; Cheng, Biao

    2015-02-01

    Tenotomy and tenodesis are both effective for the treatment of long head biceps lesions. The aim of this study was to compare the clinical outcomes of the two procedures in patients older than 55 years of age affected by reparable rotator cuff tears with concomitant long head biceps pathologies. Patients older than 55 years of age with long head biceps lesions and reparable rotator cuff tears were selected for this study. A total of 151 patients were randomly assigned to the tenotomy group (77 patients) or the tenodesis group (74 patients). Arthroscopic rotator cuff repair was performed in all the patients. Before surgery, physical and radiological examinations were performed; the constant score was measured as well. After the operation, the surgical time, cost, pain (VAS scores), Popeye sign, cramping pain, constant scores, satisfaction level and the elbow flexion and forearm supination strength indices were recorded. Patients were followed for an average of 24 months. No significant differences in the clinical results for the constant scores, the forearm supination and elbow flexion strength indices, Popeye sign, cramping pain and satisfaction level were found between the groups. However, tenotomy required a shorter surgical time (40.4 ± 4.0 vs. 50.4 ± 5.9 min, P < 0.001) and resulted in faster pain relief (3.1 ± 1.8 vs. 4.8 ± 1.9, P < 0.001). Both tenotomy and tenodesis are effective and equal for the treatment of long head biceps lesions. However, because tenotomy requires a shorter surgical time and results in faster pain relief, tenotomy may be more suitable for the treatment of long head biceps lesions in patients older than 55 years of age with reparable rotator cuff tears. Therapeutic studies, Level I.

  3. Towards predictive diagnosis and management of rotator cuff disease: using curvelet transform for edge detection and segmentation of tissue

    NASA Astrophysics Data System (ADS)

    Pai Raikar, Vipul; Kwartowitz, David M.

    2016-04-01

    Degradation and injury of the rotator cuff is one of the most common diseases of the shoulder among the general population. In orthopedic injuries, rotator cuff disease is only second to back pain in terms of overall reduced quality of life for patients. Clinically, this disease is managed via pain and activity assessment and diagnostic imaging using ultrasound and MRI. Ultrasound has been shown to have good accuracy for identification and measurement of rotator cuff tears. In our previous work, we have developed novel, real-time techniques to biomechanically assess the condition of the rotator cuff based on Musculoskeletal Ultrasound. Of the rotator cuff tissues, supraspinatus is the first that sees degradation and is the most commonly affected. In our work, one of the challenges lies in effectively segmenting and characterizing the supraspinatus. We are exploring the possibility of using curvelet transform for improving techniques to segment tissue in ultrasound. Curvelets have been shown to give optimal multi-scale representation of edges in images. They are designed to represent edges and singularities along curves in images which makes them an attractive proposition for use in ultrasound segmentation. In this work, we present a novel approach to the possibility of using curvelet transforms for automatic edge and feature extraction for the supraspinatus.

  4. Efficacy and cost-effectiveness of a physiotherapy program for chronic rotator cuff pathology: A protocol for a randomised, double-blind, placebo-controlled trial

    PubMed Central

    Bennell, Kim; Coburn, Sally; Wee, Elin; Green, Sally; Harris, Anthony; Forbes, Andrew; Buchbinder, Rachelle

    2007-01-01

    Background Chronic rotator cuff pathology (CRCP) is a common shoulder condition causing pain and disability. Physiotherapy is often the first line of management for CRCP yet there is little conclusive evidence to support or refute its effectiveness and no formal evaluation of its cost-effectiveness. Methods/Design This randomised, double-blind, placebo-controlled trial will involve 200 participants with CRCP recruited from medical practices, outpatient departments and the community via print and radio media. Participants will be randomly allocated to a physiotherapy or placebo group using concealed allocation stratified by treating physiotherapist. Both groups will receive 10 sessions of individual standardised treatment over 10 weeks from one of 10 project physiotherapists. For the following 12 weeks, the physiotherapy group will continue a home exercise program and the placebo group will receive no treatment. The physiotherapy program will comprise shoulder joint and spinal mobilisation, soft tissue massage, postural taping, and home exercises for scapular control, posture and rotator cuff strengthening. The placebo group will receive inactive ultrasound and gentle application of an inert gel over the shoulder region. Blinded assessment will be conducted at baseline and at 10 weeks and 22 weeks after randomisation. The primary outcome measures are self reported questionnaires including the shoulder pain and disability index (SPADI), average pain on an 11-point numeric rating scale and participant perceived global rating of change. Secondary measures include Medical Outcomes Study 36-item short form (SF-36), Assessment of Quality of Life index, numeric rating scales for shoulder pain and stiffness, participant perceived rating of change for pain, strength and stiffness, and manual muscle testing for shoulder strength using a handheld dynamometer. To evaluate cost-effectiveness, participants will record the use of all health-related treatments in a log

  5. Shoulder impairments and their association with symptomatic rotator cuff disease in breast cancer survivors.

    PubMed

    Ebaugh, David; Spinelli, Bryan; Schmitz, Kathryn H

    2011-10-01

    Over 2.6 million breast cancer survivors currently reside in the United States. While improvements in the medical management of women diagnosed with breast cancer have resulted in a 5-year survival rate of 89%, curative treatments are associated with a high prevalence of shoulder and arm morbidity, which, in turn, can negatively impact a woman's quality of life. Breast cancer survivors frequently experience shoulder and arm pain, decreased range of motion, muscle weakness, and lymphedema. These symptoms can lead to difficulties with daily activities ranging from overhead reaching and carrying objects to caring for family and returning to work. Despite health care professionals awareness of these problems, a significant number of breast cancer survivors are confronted with long-term, restricted use of their affected shoulder and upper extremity. This problem may partially be explained by: (1) an incomplete understanding of relevant impairments and diagnoses associated with shoulder/arm pain and limited upper extremity use, and (2) the limited effectiveness of current rehabilitation interventions for managing shoulder pain and decreased upper extremity function in breast cancer survivors. Because breast cancer treatment directly involves the neuromusculoskeletal tissues of the shoulder girdle, it is understandable why breast cancer survivors are likely to develop shoulder girdle muscle weakness and fatigue, decreased shoulder motion, altered shoulder girdle alignment, and lymphedema. These impairments can be associated with diagnoses such as post-mastectomy syndrome, adhesive capsulitis, myofascial dysfunction, and brachial plexopathy, all of which have been reported among breast cancer survivors. It is our belief that these impairments also put women at risk for developing symptomatic rotator cuff disease. In this paper we set forth the rationale for our belief that breast cancer treatments and subsequent impairments of shoulder girdle neuromusculoskeletal tissues

  6. Postoperative Pharyngolaryngeal Adverse Events with Laryngeal Mask Airway (LMA Supreme) in Laparoscopic Surgical Procedures with Cuff Pressure Limiting 25 cmH2O: Prospective, Blind, and Randomised Study

    PubMed Central

    Kang, Joo-Eun; Choi, Jae Won; Son, Il Soon

    2014-01-01

    To reduce the incidence of postoperative pharyngolaryngeal adverse events, laryngeal mask airway (LMA) manufacturers recommend maximum cuff pressures not exceeding 60 cmH2O. We performed a prospective randomised study, comparing efficacy and adverse events among patients undergoing laparoscopic surgical procedures who were allocated randomly into low (limiting 25 cmH2O, L group) and high (at 60 cmH2O, H group) LMA cuff pressure groups with LMA Supreme. Postoperative pharyngolaryngeal adverse events were evaluated at discharge from postanaesthetic care unit (PACU) (postoperative day 1, POD 1) and 24 hours after discharge from PACU (postoperative day 2, POD 2). All patients were well tolerated with LMA without ventilation failure. Before pneumoperitoneum, cuff volume and pressure and oropharyngeal leak pressure (OLP) showed significant differences. Postoperative sore throat at POD 2 (3 versus 12 patients) and postoperative dysphagia at POD 1 and POD 2 (0 versus 4 patients at POD 1; 0 versus 4 patients at POD 2) were significantly lower in L group, compared with H group. In conclusion, LMA with cuff pressure limiting 25 cmH2O allowed both efficacy of airway management and lower incidence of postoperative adverse events in laparoscopic surgical procedures. This clinical trial is registered with KCT0000334. PMID:24778598

  7. Postoperative pharyngolaryngeal adverse events with laryngeal mask airway (LMA Supreme) in laparoscopic surgical procedures with cuff pressure limiting 25 cmH₂O: prospective, blind, and randomised study.

    PubMed

    Kang, Joo-Eun; Oh, Chung-Sik; Choi, Jae Won; Son, Il Soon; Kim, Seong-Hyop

    2014-01-01

    To reduce the incidence of postoperative pharyngolaryngeal adverse events, laryngeal mask airway (LMA) manufacturers recommend maximum cuff pressures not exceeding 60 cmH₂O. We performed a prospective randomised study, comparing efficacy and adverse events among patients undergoing laparoscopic surgical procedures who were allocated randomly into low (limiting 25 cmH₂O, L group) and high (at 60 cmH₂O, H group) LMA cuff pressure groups with LMA Supreme. Postoperative pharyngolaryngeal adverse events were evaluated at discharge from postanaesthetic care unit (PACU) (postoperative day 1, POD 1) and 24 hours after discharge from PACU (postoperative day 2, POD 2). All patients were well tolerated with LMA without ventilation failure. Before pneumoperitoneum, cuff volume and pressure and oropharyngeal leak pressure (OLP) showed significant differences. Postoperative sore throat at POD 2 (3 versus 12 patients) and postoperative dysphagia at POD 1 and POD 2 (0 versus 4 patients at POD 1; 0 versus 4 patients at POD 2) were significantly lower in L group, compared with H group. In conclusion, LMA with cuff pressure limiting 25 cmH₂O allowed both efficacy of airway management and lower incidence of postoperative adverse events in laparoscopic surgical procedures. This clinical trial is registered with KCT0000334.

  8. Treatment of non-traumatic rotator cuff tears: A randomised controlled trial with one-year clinical results.

    PubMed

    Kukkonen, J; Joukainen, A; Lehtinen, J; Mattila, K T; Tuominen, E K J; Kauko, T; Aärimaa, V

    2014-01-01

    We have compared three different methods of treating symptomatic non-traumatic tears of the supraspinatus tendon in patients above 55 years of age. A total of 180 shoulders (173 patients) with supraspinatus tendon tears were randomly allocated into one of three groups (each of 60 shoulders); physiotherapy (group 1), acromioplasty and physiotherapy (group 2) and rotator cuff repair, acromioplasty and physiotherapy (group 3). The Constant score was assessed and followed up by an independent observer pre-operatively and at three, six and twelve months after the intervention. Of these, 167 shoulders were available for assessment at one year (follow-up rate of 92.8%). There were 55 shoulders in group 1 (24 in males and 31 in females, mean age 65 years (55 to 79)), 57 in group 2 (29 male and 28 female, mean age 65 years (55 to 79)) and 55 shoulders in group 3 (26 male and 29 female, mean age 65 years (55 to 81)). There were no between-group differences in the Constant score at final follow-up: 74.1 (sd 14.2), 77.2 (sd 13.0) and 77.9 (sd 12.1) in groups 1, 2 and 3, respectively (p = 0.34). The mean change in the Constant score was 17.0, 17.5, and 19.8, respectively (p = 0.34). These results suggest that at one-year follow-up, operative treatment is no better than conservative treatment with regard to non-traumatic supraspinatus tears, and that conservative treatment should be considered as the primary method of treatment for this condition.

  9. Neglected tropical diseases: survey and geometry of randomised evidence

    PubMed Central

    Kappagoda, Shanthi

    2012-01-01

    Objective To assess the quantity and distribution of evidence from randomised controlled trials for the treatment of the major neglected tropical diseases and to identify gaps in the evidence with network analysis. Design Systematic review and network analysis. Data sources Cochrane Central Register of Controlled Trials and PubMed from inception to 31 August 2011. Study selection Randomised controlled trials that examined treatment of 16 neglected tropical diseases or complications thereof published in English, French, Spanish, Portuguese, German, or Dutch. Results We identified 971 eligible randomised trials. Leishmaniasis (184 trials, 23 039 participants) and geohelminth infections; 160 trials, 46 887 participants) were the most studied, while dracunculiasis (nine trials, 798 participants) and Buruli ulcer (five trials, 337 participants) were least studied. Relative to its global burden of disease, lymphatic filariasis had the fewest trials and participants. Only 11% of trials were industry funded. Either a single trial or trials with fewer than 100 participants comprised the randomised evidence for first or second line treatments for Buruli ulcer, human African trypanosomiasis, American trypanosomiasis, cysticercosis, rabies, echinococcosis, New World cutaneous leishmaniasis, and each of the foodborne trematode infections. Among the 10 disease categories with more than 40 trials, five lacked sufficient head to head comparisons between first or second line treatments. Conclusions There is considerable variation in the amount of evidence from randomised controlled trials for each of the 16 major neglected tropical diseases. Even in diseases with substantial evidence, such as leishmaniasis and geohelminth infections, some recommended treatments have limited supporting data and lack head to head comparisons. PMID:23089149

  10. The role of the peripheral and central nervous systems in rotator cuff disease.

    PubMed

    Bachasson, Damien; Singh, Anshuman; Shah, Sameer B; Lane, John G; Ward, Samuel R

    2015-08-01

    Rotator cuff (RC) disease is an extremely common condition associated with shoulder pain, reduced functional capacities, and impaired quality of life. It primarily involves alterations in tendon health and mechanical properties that can ultimately lead to tendon failure. RC tendon tears induce progressive muscle changes that have a negative impact on surgical reparability of the RC tendons and clinical outcomes. At the same time, a significant base of clinical data suggests a relatively weak relationship between RC integrity and clinical presentation, emphasizing the multifactorial aspects of RC disease. This review aims to summarize the potential contribution of peripheral, spinal, and supraspinal neural factors that may (1) exacerbate structural and functional muscle changes induced by tendon tear, (2) compromise the reversal of these changes during surgery and rehabilitation, (3) contribute to pain generation and persistence of pain, (4) impair shoulder function through reduced proprioception, kinematics, and muscle recruitment, and (5) help explain interindividual differences and response to treatment. Given the current clinical and scientific interest in peripheral nerve injury in the context of RC disease and surgery, we carefully reviewed this body of literature with a particular emphasis on suprascapular neuropathy that has generated a large number of studies in the past decade. Within this process, we highlight the gaps in current knowledge and suggest research avenues for scientists and clinicians.

  11. The Role of the Peripheral and Central Nervous Systems in Rotator Cuff Disease

    PubMed Central

    Bachasson, Damien; Singh, Anshuman; Shah, Sameer; Lane, John G.; Ward, Samuel R.

    2015-01-01

    Rotator cuff (RC) disease is an extremely common condition associated with shoulder pain, reduced functional capacities and impaired quality of life. It primarily involves alterations in tendon health and mechanical properties that can ultimately lead to tendon failure. RC tendon tears induce progressive muscular changes that negatively impact surgical reparability of the RC tendons and clinical outcomes. At the same time, a significant base of clinical data suggests a relatively weak relationship between RC integrity and clinical presentation, emphasizing the multifactorial aspects of RC disease. This review aims to summarize the potential contribution of peripheral, spinal and supraspinal neural factors that may: (i) exacerbate structural and functional muscle changes induced by tendon tear, (ii) compromise the reversal of these changes during surgery and rehabilitation, (iii) contribute to pain generation and persistence of pain, iv) impair shoulder function through reduced proprioception, kinematics and muscle recruitment, and iv) help to explain interindividual differences and response to treatment. Given the current clinical and scientific interest in peripheral nerve injury in the context of RC disease and surgery, we carefully reviewed this body of literature with a particular emphasis for suprascapular neuropathy that has generated a large number of studies in the past decade. Within this process, we highlight the gaps in current knowledge and suggest research avenues for scientists and clinicians. PMID:26189809

  12. Prolotherapy for Refractory Rotator Cuff Disease: Retrospective Case-Control Study of 1-Year Follow-Up.

    PubMed

    Lee, Doo-Hyung; Kwack, Kyu-Sung; Rah, Ueon Woo; Yoon, Seung-Hyun

    2015-11-01

    To determine the efficacy of prolotherapy for refractory rotator cuff disease. Retrospective case-control study. University-affiliated tertiary care hospital. Patients with nontraumatic refractory rotator cuff disease (N=151) who were unresponsive to 3 months of aggressive conservative treatment. Of the patients, 63 received prolotherapies with 16.5% dextrose 10-ml solution (treatment group), and 63 continued conservative treatment (control group). Not applicable. Visual analog scale (VAS) score of the average shoulder pain level for the past 1 week, Shoulder Pain and Disability Index (SPADI) score, isometric strength of the shoulder abductor, active range of motion (AROM) of the shoulder, maximal tear size on ultrasonography, and number of analgesic ingestions per day. Over 1-year follow-up, 57 patients in the treatment group and 53 in the control group were analyzed. There was no significant difference between the 2 groups in age, sex, shoulder dominance, duration of symptoms, and ultrasonographic findings at pretreatment. The average number of injections in the treatment group is 4.8±1.3. Compared with the control group, VAS score, SPADI score, isometric strength of shoulder abductor, and shoulder AROM of flexion, abduction, and external rotation showed significant improvement in the treatment group. There were no adverse events. To our knowledge, this is the first study to assess the efficacy of prolotherapy in rotator cuff disease. Prolotherapy showed improvement in pain, disability, isometric strength, and shoulder AROM in patients with refractory chronic rotator cuff disease. The results suggest positive outcomes, but one should still take caution in directly interpreting it as an effective treatment option, considering the limitations of this nonrandomized retrospective study. To show the efficacy of prolotherapy, further studies on prospective randomized controlled trials will be required. Copyright © 2015 American Congress of Rehabilitation Medicine

  13. Effects of therapeutic ultrasound and exercise on pain, function, and isokinetic shoulder rotator strength of patients with rotator cuff disease

    PubMed Central

    Analan, Pınar Doruk; Leblebici, Berrin; Adam, Mehmet

    2015-01-01

    [Purpose] The aim of this prospective, double-blind, randomized, placebo-controlled study was to evaluate the effects of therapeutic continuous ultrasound (US) on patients with rotator cuff disease. [Subjects and Methods] Twenty-two patients were treated with a standard physiotherapy program consisting of a hot-pack, transcutaneous electrical nerve stimulation (TENS), exercises, and US that was supervised by the same physiotherapist. The patients were randomly assigned to either a group that received true US (n=11) or one that received sham US (n=11). [Results] There were significant differences between the pre- and post-intervention UCLA Shoulder Rating Scale and Constant-Murley Shoulder Outcome scores, VAS, and external rotation (ER) peak torque 60°/second values for both the true and sham US groups. However, the between-group differences were not statistically significant. [Conclusion] In patients with rotator cuff disease, physiotherapy interventions effectively treat the pain, improve the clinical status, and increase the muscle strength of the shoulder ER at a low constant angular velocity, with functional improvement being seen immediately after treatment. However, at the end of the intervention, the US had yielded no additional efficacy to the physiotherapy treatment regimen of the patients with rotator cuff disease. PMID:26644656

  14. Does this patient with shoulder pain have rotator cuff disease?: The Rational Clinical Examination systematic review.

    PubMed

    Hermans, Job; Luime, Jolanda J; Meuffels, Duncan E; Reijman, Max; Simel, David L; Bierma-Zeinstra, Sita M A

    2013-08-28

    Rotator cuff disease (RCD) is the most common cause of shoulder pain seen by physicians. To perform a meta-analysis to identify the most accurate clinical examination findings for RCD. Structured search in MEDLINE, EMBASE, and CINAHL from their inception through May 2013. For inclusion, a study must have met the following criteria: (1) description of history taking, physical examination, or clinical tests concerning RCD; (2) detailing of sensitivity and specificity; (3) use of a reference standard with diagnostic criteria prespecified; (4) presentation of original data, or original data could be obtained from the authors; and (5) publication in a language mastered by one of the authors (Danish, Dutch, English, French, German, Norwegian, Spanish, Swedish). Likelihood ratios (LRs) of symptoms and signs of RCD or of a tear, compared with an acceptable reference standard; quality scores assigned using the Rational Clinical Examination score and bias evaluated with the Quality Assessment of Diagnostic Accuracy Studies tool. Twenty-eight studies assessed the examination of referred patients by specialists. Only 5 studies reached Rational Clinical Examination quality scores of level 1-2. The studies with quality scores of level 1-2 included 30 to 203 shoulders with the prevalence of RCD ranging from 33% to 81%. Among pain provocation tests, a positive painful arc test result was the only finding with a positive LR greater than 2.0 for RCD (3.7 [95% CI, 1.9-7.0]), and a normal painful arc test result had the lowest negative LR (0.36 [95% CI, 0.23-0.54]). Among strength tests, a positive external rotation lag test (LR, 7.2 [95% CI, 1.7-31]) and internal rotation lag test (LR, 5.6 [95% CI, 2.6-12]) were the most accurate findings for full-thickness tears. A positive drop arm test result (LR, 3.3 [95% CI, 1.0-11]) might help identify patients with RCD. A normal internal rotation lag test result was most accurate for identifying patients without a full-thickness tear (LR, 0

  15. A systematic review of the histological and molecular changes in rotator cuff disease

    PubMed Central

    Dean, B. J. F.; Franklin, S. L.; Carr, A. J.

    2012-01-01

    Introduction The pathogenesis of rotator cuff disease (RCD) is complex and not fully understood. This systematic review set out to summarise the histological and molecular changes that occur throughout the spectrum of RCD. Methods We conducted a systematic review of the scientific literature with specific inclusion and exclusion criteria. Results A total of 101 studies met the inclusion criteria: 92 studies used human subjects exclusively, seven used animal overuse models, and the remaining two studies involved both humans and an animal overuse model. A total of 58 studies analysed supraspinatus tendon exclusively, 16 analysed subacromial bursal tissue exclusively, while the other studies analysed other tissue or varying combinations of tissue types including joint fluid and muscle. The molecular biomarkers that were altered in RCD included matrix substances, growth factors, enzymes and other proteins including certain neuropeptides. Conclusions The pathogenesis of RCD is being slowly unravelled as a result of the significant recent advances in molecular medicine. Future research aimed at further unlocking these key molecular processes will be pivotal in developing new surgical interventions both in terms of the diagnosis and treatment of RCD. PMID:23610686

  16. Maintaining endotracheal tube cuff pressure at 20 mm Hg to prevent dysphagia after anterior cervical spine surgery; protocol of a double-blind randomised controlled trial

    PubMed Central

    2013-01-01

    Background In anterior cervical spine surgery a retractor is obligatory to approach the spine. Previous studies showed an increase of endotracheal tube cuff pressure after placement of a retractor. It is known that high endotracheal tube cuff pressure increases the incidence of postoperative dysphagia, hoarseness, and sore throat. However, until now no evidence supports the fact whether adjusting the endotracheal tube cuff pressure during anterior cervical spine surgery will prevent this comorbidity. We present the design of a randomized controlled trial to determine whether adjusting endotracheal tube cuff pressure after placement of a retractor during anterior cervical spine surgery will prevent postoperative dysphagia. Methods/design 177 patients (aged 18–90 years) scheduled for anterior cervical spine surgery on 1 or more levels will be included. After intubation, endotracheal tube cuff pressure is manually inflated to 20 mm Hg in all patients. Patients will be randomized into two groups. In the control group endotracheal tube cuff pressure is not adjusted after retractor placement. In the intervention group endotracheal tube cuff pressure after retractor placement is maintained at 20 mm Hg and air is withdrawn when cuff pressure exceeds 20 mm Hg. Endotracheal tube cuff pressure is measured after intubation, before and after placement and removal of the retractor. Again air is inflated if cuff pressure sets below 20 mmHg after removal of the retractor. The primary outcome measure is postoperative dysphagia. Other outcome measures are postoperative hoarseness, postoperative sore throat, degree of dysphagia, length of hospital stay, and pneumonia. The study is a single centre double blind randomized trial in which patients and research nurses will be kept blinded for the allocated treatment during the follow-up period of 2 months. Discussion Postoperative dysphagia occurs frequently after anterior cervical spine surgery. This may be related to high

  17. Maintaining endotracheal tube cuff pressure at 20 mm Hg to prevent dysphagia after anterior cervical spine surgery; protocol of a double-blind randomised controlled trial.

    PubMed

    Arts, Mark P; Rettig, Thijs C D; de Vries, Jessica; Wolfs, Jasper F C; in't Veld, Bas A

    2013-09-25

    In anterior cervical spine surgery a retractor is obligatory to approach the spine. Previous studies showed an increase of endotracheal tube cuff pressure after placement of a retractor. It is known that high endotracheal tube cuff pressure increases the incidence of postoperative dysphagia, hoarseness, and sore throat. However, until now no evidence supports the fact whether adjusting the endotracheal tube cuff pressure during anterior cervical spine surgery will prevent this comorbidity. We present the design of a randomized controlled trial to determine whether adjusting endotracheal tube cuff pressure after placement of a retractor during anterior cervical spine surgery will prevent postoperative dysphagia. 177 patients (aged 18-90 years) scheduled for anterior cervical spine surgery on 1 or more levels will be included. After intubation, endotracheal tube cuff pressure is manually inflated to 20 mm Hg in all patients. Patients will be randomized into two groups. In the control group endotracheal tube cuff pressure is not adjusted after retractor placement. In the intervention group endotracheal tube cuff pressure after retractor placement is maintained at 20 mm Hg and air is withdrawn when cuff pressure exceeds 20 mm Hg. Endotracheal tube cuff pressure is measured after intubation, before and after placement and removal of the retractor. Again air is inflated if cuff pressure sets below 20 mmHg after removal of the retractor. The primary outcome measure is postoperative dysphagia. Other outcome measures are postoperative hoarseness, postoperative sore throat, degree of dysphagia, length of hospital stay, and pneumonia. The study is a single centre double blind randomized trial in which patients and research nurses will be kept blinded for the allocated treatment during the follow-up period of 2 months. Postoperative dysphagia occurs frequently after anterior cervical spine surgery. This may be related to high endotracheal tube cuff pressure. Whether

  18. ESRRB polymorphisms are associated with comorbidity of temporomandibular disorders and rotator cuff disease.

    PubMed

    Bonato, L L; Quinelato, V; Pinheiro, A da R; Amaral, M V G; de Souza, F N; Lobo, J C; Aguiar, D P; Augusto, L M M; Vieira, A R; Salles, J I; Cossich, V R A; Guimarães, J A M; de Gouvêa, C V D; Granjeiro, J M; Casado, P L

    2016-03-01

    Temporomandibular disorders (TMD) are associated with comorbidity. Shoulder pain is among the symptoms associated with TMD. The purpose of this study was to investigate the association between TMD and rotator cuff disease (RCD) and related genetic aspects. All subjects underwent orofacial and shoulder examinations. The control group comprised 30 subjects with no pain. Affected subjects were divided into three groups: RCD (TMD-free, n=16), TMD (RCD-free, n=13), and TMD/RCD (patients with both RCD and TMD, n=49). A total of eight single nucleotide polymorphisms in the ESRRB gene were investigated. A chemiluminescent immunoassay was used to measure estradiol levels. Surface electromyography recorded head and cervical muscle activity. The χ(2) test and Student t-test/Mann-Whitney test were used to assess the significance of nominal and continuous variables. A P-value of <0.05 was considered significant. TMD subjects were seven times more susceptible to RCD than controls. The rs1676303 TT (P=0.02) and rs6574293 GG (P=0.04) genotypes were associated with RCD and TMD, respectively. TMD/RCD subjects showed associations with rs4903399 (P=0.02), rs10132091 (P=0.02), and CTTCTTAG/CCTCTCAG (P=0.01) haplotypes and lower muscle activity. Estradiol levels were similar among groups. This study supports TMD as a risk factor for RCD. ESRRB haplotypes and low muscle activity are common biomechanical characteristics in subjects with both diseases. Copyright © 2015 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  19. [Nonoperative management of rotator cuff defects].

    PubMed

    Heers, H; Heers, G

    2007-09-01

    Rotator cuff defects are common disorders of the shoulder. Although the outcome of surgical treatment of rotator cuff tears is well documented in the literature, less is known about the efficacy of physical therapy for symptomatic rotator cuff tears. Clear therapeutic standards are still missing. This article presents the nonoperative treatment options as well as a literature review. The results of most studies show that patients with rotator cuff defects do benefit from both physical therapy and simple home exercises independent from the size of the defect. However, due to the heterogeneity of outcome measures used, it is difficult to compare the results published. There is still a need for well-planned randomised controlled studies investigating the efficacy of exercise in the management of rotator cuff tears.

  20. A systematic review and pooled analysis of the prevalence of rotator cuff disease with increasing age.

    PubMed

    Teunis, Teun; Lubberts, Bart; Reilly, Brian T; Ring, David

    2014-12-01

    Hypothesis and background: Abnormalities of the rotator cuff are more common with age, but the exact prevalence of abnormalities and the extent to which the presence of an abnormality is associated with symptoms are topics of debate. Our aim was to review the published literature to establish the prevalence of abnormalities of the rotator cuff and to determine if the prevalence of abnormalities increases with older age in 10-year intervals. In addition, we assessed prevalence in 4 separate groups: (1) asymptomatic patients, (2) general population, (3) symptomatic patients, and (4) patients after shoulder dislocation. We searched PubMed, EMBASE, and the Cochrane Library up to February 24, 2014, and included studies reporting rotator cuff abnormalities by age. Thirty studies including 6112 shoulders met our criteria. We pooled the individual patient data and calculated proportions of patients with and without abnormalities per decade (range, younger than 20 years to 80 years and older). Overall prevalence of abnormalities increased with age, from 9.7% (29 of 299) in patients aged 20 years and younger to 62% (166 of 268) in patients aged 80 years and older (P < .001) (odds ratio, 15; 95% confidence interval, 9.6-24; P < .001). There was a similar increasing prevalence of abnormalities regardless of symptoms or shoulder dislocation. The prevalence of rotator cuff abnormalities in asymptomatic people is high enough for degeneration of the rotator cuff to be considered a common aspect of normal human aging and to make it difficult to determine when an abnormality is new (e.g., after a dislocation) or is the cause of symptoms.

  1. Effect of angiogenesis-related cytokines on rotator cuff disease: the search for sensitive biomarkers of early tendon degeneration.

    PubMed

    Savitskaya, Yulia A; Izaguirre, Aldo; Sierra, Luis; Perez, Francisco; Cruz, Francisco; Villalobos, Enrique; Almazan, Arturo; Ibarra, Clemente

    2011-01-01

    Hallmarks of the pathogenesis of rotator cuff disease (RCD) include an abnormal immune response, angiogenesis, and altered variables of vascularity. Degenerative changes enhance production of pro-inflammatory, anti-inflammatory, and vascular angiogenesis-related cytokines (ARC) that play a pivotal role in the immune response to arthroscopic surgery and participate in the pathogenesis of RCD. The purpose of this study was to evaluate the ARC profile, ie, interleukin (IL): IL-1β, IL-6, IL-8, IL-10, vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF), and angiogenin (ANG), in human peripheral blood serum and correlate this with early degenerative changes in patients with RCD. Blood specimens were obtained from 200 patients with RCD and 200 patients seen in the orthopedic clinic for nonrotator cuff disorders. Angiogenesis imaging assays was performed using power Doppler ultrasound to evaluate variables of vascularity in the rotator cuff tendons. Expression of ARC was measured by commercial Bio-Plex Precision Pro Human Cytokine Assays. Baseline concentrations of IL-1β, IL-8, and VEGF was significantly higher in RCD patients than in controls. Significantly higher serum VEGF levels were found in 85% of patients with RCD, and correlated with advanced stage of disease (r = 0.75; P < 0.0005), average microvascular density (r = 0.68, P < 0.005), and visual analog score (r = 0.75, P < 0.0002) in RCD patients. ANG and IL-10 levels were significantly lower in RCD patients versus controls. IL-1β and ANG levels were significantly correlated with degenerative tendon grade in RCD patients. No difference in IL-6 and bFGF levels was observed between RCD patients and controls. Patients with degenerative changes had markedly lower ANG levels compared with controls. Power Doppler ultrasound showed high blood vessel density in patients with tendon rupture. The pathogenesis of RCD is associated with an imbalance between pro-inflammatory, anti

  2. Conservative treatment of rotator cuff injuries.

    PubMed

    Bytomski, Jeffrey R; Black, Douglass

    2006-01-01

    Across all ages and activity levels, rotator cuff injuries are one of the most common causes of shoulder pain. The anatomy and biomechanics of the shoulder guide the history and physical exam toward the appropriate treatment of rotator cuff injuries. Rotator cuff tears are rare under the age of 40 unless accompanied by acute trauma. Throwing athletes are prone to rotator cuff injury from various causes of impingement (subacromial, internal, or secondary) and flexibility deficits, strength deficits, or both along the kinetic chain. Most rotator cuff injuries may be treated conservatively by using regimens of nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections, and functional rehabilitation therapy. Injury prevention programs are essential for the long-term care of patients with rotator cuff disease, for primary prevention, and for prevention of recurrent injuries, unless a traumatically torn rotator cuff is present. Surgical management is reserved for refractory cases that have exhausted conservative measures.

  3. Multicentre randomised controlled trial to investigate the usefulness of continuous pneumatic regulation of tracheal cuff pressure for reducing ventilator-associated pneumonia in mechanically ventilated severe trauma patients: the AGATE study protocol.

    PubMed

    Marjanovic, Nicolas; Frasca, Denis; Asehnoune, Karim; Paugam, Catherine; Lasocki, Sigismond; Ichai, Carole; Lefrant, Jean-Yves; Leone, Marc; Dahyot-Fizelier, Claire; Pottecher, Julien; Falcon, Dominique; Veber, Benoit; Constantin, Jean-Michel; Seguin, Sabrina; Guénézan, Jérémy; Mimoz, Olivier

    2017-08-07

    Severe trauma represents the leading cause of mortality worldwide. While 80% of deaths occur within the first 24 hours after trauma, 20% occur later and are mainly due to healthcare-associated infections, including ventilator-associated pneumonia (VAP). Preventing underinflation of the tracheal cuff is recommended to reduce microaspiration, which plays a major role in the pathogenesis of VAP. Automatic devices facilitate the regulation of tracheal cuff pressure, and their implementation has the potential to reduce VAP. The objective of this work is to determine whether continuous regulation of tracheal cuff pressure using a pneumatic device reduces the incidence of VAP compared with intermittent control in severe trauma patients. This multicentre randomised controlled and open-label trial will include patients suffering from severe trauma who are admitted within the first 24 hours, who require invasive mechanical ventilation to longer than 48 hours. Their tracheal cuff pressure will be monitored either once every 8 hours (control group) or continuously using a pneumatic device (intervention group). The primary end point is the proportion of patients that develop VAP in the intensive care unit (ICU) at day 28. The secondary end points include the proportion of patients that develop VAP in the ICU, early (≤7 days) or late (>7 days) VAP, time until the first VAP diagnosis, the number of ventilator-free days and antibiotic-free days, the length of stay in the ICU, the proportion of patients with ventilator-associated events and that die during their ICU stay. This protocol has been approved by the ethics committee of Poitiers University Hospital, and will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results of this study will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals. Clinical Trials NCT02534974. © Article author(s) (or

  4. Education and coronary heart disease: mendelian randomisation study.

    PubMed

    Tillmann, Taavi; Vaucher, Julien; Okbay, Aysu; Pikhart, Hynek; Peasey, Anne; Kubinova, Ruzena; Pajak, Andrzej; Tamosiunas, Abdonas; Malyutina, Sofia; Hartwig, Fernando Pires; Fischer, Krista; Veronesi, Giovanni; Palmer, Tom; Bowden, Jack; Davey Smith, George; Bobak, Martin; Holmes, Michael V

    2017-08-30

    Objective To determine whether educational attainment is a causal risk factor in the development of coronary heart disease.Design Mendelian randomisation study, using genetic data as proxies for education to minimise confounding.Setting The main analysis used genetic data from two large consortia (CARDIoGRAMplusC4D and SSGAC), comprising 112 studies from predominantly high income countries. Findings from mendelian randomisation analyses were then compared against results from traditional observational studies (164 170 participants). Finally, genetic data from six additional consortia were analysed to investigate whether longer education can causally alter the common cardiovascular risk factors.Participants The main analysis was of 543 733 men and women (from CARDIoGRAMplusC4D and SSGAC), predominantly of European origin.Exposure A one standard deviation increase in the genetic predisposition towards higher education (3.6 years of additional schooling), measured by 162 genetic variants that have been previously associated with education.Main outcome measure Combined fatal and non-fatal coronary heart disease (63 746 events in CARDIoGRAMplusC4D).Results Genetic predisposition towards 3.6 years of additional education was associated with a one third lower risk of coronary heart disease (odds ratio 0.67, 95% confidence interval 0.59 to 0.77; P=3×10(-8)). This was comparable to findings from traditional observational studies (prevalence odds ratio 0.73, 0.68 to 0.78; incidence odds ratio 0.80, 0.76 to 0.83). Sensitivity analyses were consistent with a causal interpretation in which major bias from genetic pleiotropy was unlikely, although this remains an untestable possibility. Genetic predisposition towards longer education was additionally associated with less smoking, lower body mass index, and a favourable blood lipid profile.Conclusions This mendelian randomisation study found support for the hypothesis that low education is a causal risk factor in the

  5. Rotator Cuff Injuries

    MedlinePlus

    ... cuff are common. They include tendinitis, bursitis, and injuries such as tears. Rotator cuff tendons can become ... cuff depends on age, health, how severe the injury is, and how long you've had the ...

  6. Effect of Angiogenesis-Related Cytokines on Rotator Cuff Disease: The Search for Sensitive Biomarkers of Early Tendon Degeneration

    PubMed Central

    Savitskaya, Yulia A.; Izaguirre, Aldo; Sierra, Luis; Perez, Francisco; Cruz, Francisco; Villalobos, Enrique; Almazan, Arturo; Ibarra, Clemente

    2011-01-01

    Background: Hallmarks of the pathogenesis of rotator cuff disease (RCD) include an abnormal immune response, angiogenesis, and altered variables of vascularity. Degenerative changes enhance production of pro-inflammatory, anti-inflammatory, and vascular angiogenesis-related cytokines (ARC) that play a pivotal role in the immune response to arthroscopic surgery and participate in the pathogenesis of RCD. The purpose of this study was to evaluate the ARC profile, ie, interleukin (IL): IL-1β, IL-6, IL-8, IL-10, vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF), and angiogenin (ANG), in human peripheral blood serum and correlate this with early degenerative changes in patients with RCD. Methods: Blood specimens were obtained from 200 patients with RCD and 200 patients seen in the orthopedic clinic for nonrotator cuff disorders. Angiogenesis imaging assays was performed using power Doppler ultrasound to evaluate variables of vascularity in the rotator cuff tendons. Expression of ARC was measured by commercial Bio-Plex Precision Pro Human Cytokine Assays. Results: Baseline concentrations of IL-1β, IL-8, and VEGF was significantly higher in RCD patients than in controls. Significantly higher serum VEGF levels were found in 85% of patients with RCD, and correlated with advanced stage of disease (r = 0.75; P < 0.0005), average microvascular density (r = 0.68, P < 0.005), and visual analog score (r = 0.75, P < 0.0002) in RCD patients. ANG and IL-10 levels were significantly lower in RCD patients versus controls. IL-1β and ANG levels were significantly correlated with degenerative tendon grade in RCD patients. No difference in IL-6 and bFGF levels was observed between RCD patients and controls. Patients with degenerative changes had markedly lower ANG levels compared with controls. Power Doppler ultrasound showed high blood vessel density in patients with tendon rupture. Conclusion: The pathogenesis of RCD is associated with an imbalance

  7. Relation Between Subacromial Bursitis on Ultrasonography and Efficacy of Subacromial Corticosteroid Injection in Rotator Cuff Disease: A Prospective Comparison Study.

    PubMed

    Lee, Doo-Hyung; Hong, Ji Yeon; Lee, Michael Young; Kwack, Kyu-Sung; Yoon, Seung-Hyun

    2017-05-01

    To evaluate the correlations between subacromial bursitis (bursal thickening and effusion) on ultrasonography and its response to subacromial corticosteroid injection in patients with rotator cuff disease. Prospective, longitudinal comparison study. University-affiliated tertiary care hospital. Patients with rotator cuff disease (N=69) were classified into 3 groups based on ultrasonographic findings; (1) normative bursa group (group 1, n=23): bursa and effusion thickness <1mm; (2) bursa thickening group (group 2, n=22): bursa thickness >2mm and effusion thickness <1mm; and (3) bursa effusion group (group 3, n=24): bursa thickness <1mm and effusion thickness >2mm. A single subacromial injection with 20mg of triamcinolone acetonide. Visual analog scale (VAS) of shoulder pain, Shoulder Disability Questionnaire (SDQ), angles of active shoulder range of motion (flexion, abduction, external rotation, and internal rotation), and bursa and effusion thickness at pre- and posttreatment at week 8. There were no significant differences between the 3 groups in demographic characteristics pretreatment. Groups 2 and 3 showed a significant difference compared with group 1 in changes on the VAS and abduction; group 3 showed a significant difference compared with group 1 in changes of the SDQ, internal rotation, and external rotation; and all groups showed significant differences when compared with each other (groups 1 and 3, 2 and 3, and 1 and 2) in changes of thickness. A patient with ultrasonographic observation of subacromial bursitis, instead of normative bursa, can expect better outcome with subacromial corticosteroid injection. Therefore, we recommend a careful selection of patients using ultrasonography prior to injection. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  8. Rehabilitation after Rotator Cuff Repair

    PubMed Central

    Nikolaidou, Ourania; Migkou, Stefania; Karampalis, Christos

    2017-01-01

    Background: Rotator cuff tears are a very common condition that is often incapacitating. Whether non-surgical or surgical, successful management of rotator cuff disease is dependent on appropriate rehabilitation. If conservative management is insufficient, surgical repair is often indicated. Postsurgical outcomes for patients having had rotator cuff repair can be quite good. A successful outcome is much dependent on surgical technique as it is on rehabilitation. Numerous rehabilitation protocols for the management of rotator cuff disease are based primarily on clinical experience and expert opinion. This article describes the different rehabilitation protocols that aim to protect the repair in the immediate postoperative period, minimize postoperative stiffness and muscle atrophy. Methods: A review of currently available literature on rehabilitation after arthroscopic rotator cuff tear repair was performed to illustrate the available evidence behind various postoperative treatment modalities. Results: There were no statistically significant differences between a conservative and an accelerated rehabilitation protocol . Early passive range of motion (ROM) following arthroscopic cuff repair is thought to decrease postoperative stiffness and improve functionality. However, early aggressive rehabilitation may compromise repair integrity. Conclusion: The currently available literature did not identify any significant differences in functional outcomes and relative risks of re-tears between delayed and early motion in patients undergoing arthroscopic rotator cuff repairs. A gentle rehabilitation protocol with limits in range of motion and exercise times after arthroscopic rotator cuff repair would be better for tendon healing without taking any substantial risks. A close communication between the surgeon, the patient and the physical therapy team is important and should continue throughout the whole recovery process. PMID:28400883

  9. Rehabilitation after Rotator Cuff Repair.

    PubMed

    Nikolaidou, Ourania; Migkou, Stefania; Karampalis, Christos

    2017-01-01

    Rotator cuff tears are a very common condition that is often incapacitating. Whether non-surgical or surgical, successful management of rotator cuff disease is dependent on appropriate rehabilitation. If conservative management is insufficient, surgical repair is often indicated. Postsurgical outcomes for patients having had rotator cuff repair can be quite good. A successful outcome is much dependent on surgical technique as it is on rehabilitation. Numerous rehabilitation protocols for the management of rotator cuff disease are based primarily on clinical experience and expert opinion. This article describes the different rehabilitation protocols that aim to protect the repair in the immediate postoperative period, minimize postoperative stiffness and muscle atrophy. A review of currently available literature on rehabilitation after arthroscopic rotator cuff tear repair was performed to illustrate the available evidence behind various postoperative treatment modalities. There were no statistically significant differences between a conservative and an accelerated rehabilitation protocol . Early passive range of motion (ROM) following arthroscopic cuff repair is thought to decrease postoperative stiffness and improve functionality. However, early aggressive rehabilitation may compromise repair integrity. The currently available literature did not identify any significant differences in functional outcomes and relative risks of re-tears between delayed and early motion in patients undergoing arthroscopic rotator cuff repairs. A gentle rehabilitation protocol with limits in range of motion and exercise times after arthroscopic rotator cuff repair would be better for tendon healing without taking any substantial risks. A close communication between the surgeon, the patient and the physical therapy team is important and should continue throughout the whole recovery process.

  10. [Transanal endorectal pull-through with short muscular cuff in the treatment of Hirschsprung disease. Preliminary study with 37 patients].

    PubMed

    Rintala, R J; Wester, T

    2003-10-01

    Totally transanal operation for classic Hirschsprung's disease has gained increasing popularity during the last few years. The procedure leaves no scars, is associated with less postoperative pain and discomfort and shortens hospital stay. The most commonly used technique for transanal pull-through is long endorectal dissection leaving a long muscular cuff, which is usually split posteriorly. We present our preliminary results following transanal endorectal operation with a short unsplit muscular cuff. Thirty-seven patients underwent short-cuff transanal endorectal operation for Hirchsprung's disease between years 2000 and 2002. Patients' hospital records were analysed retrospectively. The collected data included age at the operation, associated conditions, hospital stay and time to full enteral feeds, occurrence of pre- and postoperative enterocolitis and preoperative stoma, operative complications, need for postoperative anal dilatations, postoperative perianal skin problems and preliminary data on bowel function. The median age at operation was 5 months (range 0-60 months), 13 patients were operated in the neonatal period. Six patients had Down's syndrome, 1 had cartilage-hair hypoplasia and one Ondine's syndrome. Six patients had preoperative enterocolitis. Thirteen patients had undergone levelling stoma formation for unremitting obstruction or enterocolitis, two of these had a long segment aganglionosis. The proximal ganglionic stoma was concomitantly pulled-through and anastomosed to the anus in all 13 patients with a stoma. Complications related to surgery occurred in 3 patients, 2 had prolapse of the pulled-through bowel (reduced immediately without later sequels) and 1 infection in the stoma closure wound. Median postoperative hospital stay was 4 days (range 2-21 days) and median time to full enteral feeds 3 (range 1-14) days. The median follow-up time was 6 months (range 1-22 months). Postoperative enterocolitis occurred in 1 patient, further 3 patients

  11. Crohn's disease management after intestinal resection: a randomised trial.

    PubMed

    De Cruz, Peter; Kamm, Michael A; Hamilton, Amy L; Ritchie, Kathryn J; Krejany, Efrosinia O; Gorelik, Alexandra; Liew, Danny; Prideaux, Lani; Lawrance, Ian C; Andrews, Jane M; Bampton, Peter A; Gibson, Peter R; Sparrow, Miles; Leong, Rupert W; Florin, Timothy H; Gearry, Richard B; Radford-Smith, Graham; Macrae, Finlay A; Debinski, Henry; Selby, Warwick; Kronborg, Ian; Johnston, Michael J; Woods, Rodney; Elliott, P Ross; Bell, Sally J; Brown, Steven J; Connell, William R; Desmond, Paul V

    2015-04-11

    Most patients with Crohn's disease need an intestinal resection, but a majority will subsequently experience disease recurrence and require further surgery. This study aimed to identify the optimal strategy to prevent postoperative disease recurrence. In this randomised trial, consecutive patients from 17 centres in Australia and New Zealand undergoing intestinal resection of all macroscopic Crohn's disease, with an endoscopically accessible anastomosis, received 3 months of metronidazole therapy. Patients at high risk of recurrence also received a thiopurine, or adalimumab if they were intolerant to thiopurines. Patients were randomly assigned to parallel groups: colonoscopy at 6 months (active care) or no colonoscopy (standard care). We used computer-generated block randomisation to allocate patients in each centre to active or standard care in a 2:1 ratio. For endoscopic recurrence (Rutgeerts score ≥i2) at 6 months, patients stepped-up to thiopurine, fortnightly adalimumab with thiopurine, or weekly adalimumab. The primary endpoint was endoscopic recurrence at 18 months. Patients and treating physicians were aware of the patient's study group and treatment, but central reading of the endoscopic findings was undertaken blind to the study group and treatment. Analysis included all patients who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, number NCT00989560. Between Oct 13, 2009, and Sept 28, 2011, 174 (83% high risk across both active and standard care groups) patients were enrolled and received at least one dose of study drug. Of 122 patients in the active care group, 47 (39%) stepped-up treatment. At 18 months, endoscopic recurrence occurred in 60 (49%) patients in the active care group and 35 (67%) patients in the standard care group (p=0.03). Complete mucosal normality was maintained in 27 (22%) of 122 patients in the active care group versus four (8%) in the standard care group (p=0.03). In the active care arm

  12. Ultrasound-guided myofascial trigger point injection into brachialis muscle for rotator cuff disease patients with upper arm pain: a pilot study.

    PubMed

    Suh, Mi Ri; Chang, Won Hyuk; Choi, Hyo Seon; Lee, Sang Chul

    2014-10-01

    To assess the efficacy of trigger point injection into brachialis muscle for rotator cuff disease patients with upper arm pain. A prospective, randomized, and single-blinded clinical pilot trial was performed at university rehabilitation hospital. Twenty-one patients clinically diagnosed with rotator cuff disease suspected of having brachialis myofascial pain syndrome (MPS) were randomly allocated into two groups. Effect of ultrasound (US)-guided trigger point injection (n=11) and oral non-steroidal anti-inflammatory drug (NSAID) (n=10) was compared by visual analog scale (VAS). US-guided trigger point injection of brachialis muscle resulted in excellent outcome compared to the oral NSAID group. Mean VAS scores decreased significantly after 2 weeks of treatment compared to the baseline in both groups (7.3 vs. 4.5 in the injection group and 7.4 vs. 5.9 in the oral group). The decrease of the VAS score caused by injection (ДVAS=-2.8) was significantly larger than caused by oral NSAID (ДVAS=-1.5) (p<0.05). In patients with rotator cuff disease, US-guided trigger point injection of the brachialis muscle is safe and effective for both diagnosis and treatment when the cause of pain is suspected to be originated from the muscle.

  13. Ultrasound-Guided Myofascial Trigger Point Injection Into Brachialis Muscle for Rotator Cuff Disease Patients With Upper Arm Pain: A Pilot Study

    PubMed Central

    Suh, Mi Ri; Chang, Won Hyuk; Choi, Hyo Seon

    2014-01-01

    Objective To assess the efficacy of trigger point injection into brachialis muscle for rotator cuff disease patients with upper arm pain. Methods A prospective, randomized, and single-blinded clinical pilot trial was performed at university rehabilitation hospital. Twenty-one patients clinically diagnosed with rotator cuff disease suspected of having brachialis myofascial pain syndrome (MPS) were randomly allocated into two groups. Effect of ultrasound (US)-guided trigger point injection (n=11) and oral non-steroidal anti-inflammatory drug (NSAID) (n=10) was compared by visual analog scale (VAS). Results US-guided trigger point injection of brachialis muscle resulted in excellent outcome compared to the oral NSAID group. Mean VAS scores decreased significantly after 2 weeks of treatment compared to the baseline in both groups (7.3 vs. 4.5 in the injection group and 7.4 vs. 5.9 in the oral group). The decrease of the VAS score caused by injection (ДVAS=-2.8) was significantly larger than caused by oral NSAID (ДVAS=-1.5) (p<0.05). Conclusion In patients with rotator cuff disease, US-guided trigger point injection of the brachialis muscle is safe and effective for both diagnosis and treatment when the cause of pain is suspected to be originated from the muscle. PMID:25379497

  14. Partial Thickness Rotator Cuff Tears: Current Concepts

    PubMed Central

    Matthewson, Graeme; Beach, Cara J.; Nelson, Atiba A.; Woodmass, Jarret M.; Ono, Yohei; Boorman, Richard S.; Lo, Ian K. Y.; Thornton, Gail M.

    2015-01-01

    Partial thickness rotator cuff tears are a common cause of pain in the adult shoulder. Despite their high prevalence, the diagnosis and treatment of partial thickness rotator cuff tears remains controversial. While recent studies have helped to elucidate the anatomy and natural history of disease progression, the optimal treatment, both nonoperative and operative, is unclear. Although the advent of arthroscopy has improved the accuracy of the diagnosis of partial thickness rotator cuff tears, the number of surgical techniques used to repair these tears has also increased. While multiple repair techniques have been described, there is currently no significant clinical evidence supporting more complex surgical techniques over standard rotator cuff repair. Further research is required to determine the clinical indications for surgical and nonsurgical management, when formal rotator cuff repair is specifically indicated and when biologic adjunctive therapy may be utilized. PMID:26171251

  15. National Trends in Rotator Cuff Repair

    PubMed Central

    Colvin, Alexis Chiang; Egorova, Natalia; Harrison, Alicia K.; Moskowitz, Alan; Flatow, Evan L.

    2012-01-01

    Background: Recent publications suggest that arthroscopic and open rotator cuff repairs have had comparable clinical results, although each technique has distinct advantages and disadvantages. National hospital and ambulatory surgery databases were reviewed to identify practice patterns for rotator cuff repair. Methods: The rates of medical visits for rotator cuff pathology, and the rates of open and arthroscopic rotator cuff repair, were examined for the years 1996 and 2006 in the United States. The national incidence of rotator cuff repairs and related data were obtained from inpatient (National Hospital Discharge Survey, NHDS) and ambulatory surgery (National Survey of Ambulatory Surgery, NSAS) databases. These databases were queried with use of International Classification of Diseases, Ninth Revision (ICD-9) procedure codes for arthroscopic (ICD-9 codes 83.63 and 80.21) and open (code 83.63 without code 80.21) rotator cuff repair. We also examined where the surgery was performed (inpatient versus ambulatory surgery center) and characteristics of the patients, including age, sex, and comorbidities. Results: The unadjusted volume of all rotator cuff repairs increased 141% in the decade from 1996 to 2006. The unadjusted number of arthroscopic procedures increased by 600% while open repairs increased by only 34% during this time interval. There was a significant shift from inpatient to outpatient surgery (p < 0.001). Conclusions: The increase in national rates of rotator cuff repair over the last decade has been dramatic, particularly for arthroscopic assisted repair. PMID:22298054

  16. Comparison of effects of ProSeal LMA™ laryngeal mask airway cuff inflation with air, oxygen, air:oxygen mixture and oxygen:nitrous oxide mixture in adults: A randomised, double-blind study

    PubMed Central

    Sharma, Mona; Sinha, Renu; Trikha, Anjan; Ramachandran, Rashmi; Chandralekha, C

    2016-01-01

    Background and Aims: Laryngeal mask airway (LMA) cuff pressure increases when the air is used for the cuff inflation during oxygen: nitrous oxide (O2:N2O) anaesthesia, which may lead to various problems. We compared the effects of different gases for ProSeal LMA™ (PLMA) cuff inflation in adult patients for various parameters. Methods: A total of 120 patients were randomly allocated to four groups, according to composition of gases used to inflate the PLMA cuff to achieve 40 cmH2 O cuff pressure, air (Group A), 50% O2 :air (Group OA), 50% O2:N2O (Group ON) and 100% O2 (Group O). Cuff pressure, cuff volume and ventilator parameters were monitored intraoperatively. Pharyngolaryngeal parameters were assessed at 1, 2 and 24 h postoperatively. Statistical analysis was performed using ANOVA, Fisher's exact test and step-wise logistic regression. Results: Cuff pressure significantly increased at 10, 15 and 30 min in Group A, OA and O from initial pressure. Cuff pressure decreased at 5 min in Group ON (36.6 ± 3.5 cmH2 O) (P = 0.42). PLMA cuff volume increased in Group A, OA, O, but decreased in Group ON (6.16 ± 2.8 ml [P < 0.001], 4.7 ± 3.8 ml [P < 0.001], 1.4 ± 3.19 ml [P = 0.023] and − 1.7 ± 4.9 ml [P = 0.064], respectively), from basal levels. Ventilatory parameters were comparable in all four groups. There was no significant association between sore throat and cuff pressure, with odds ratio 1.002. Conclusion: Cuff inflation with 50% O2:N2O mixture provided more stable cuff pressure in comparison to air, O2 :air, 100% O2 during O2:N2O anaesthesia. Ventilatory parameters did not change with variation in PLMA cuff pressure. Post-operative sore throat had no correlation with cuff pressure. PMID:27601739

  17. Composition of Muscle Fiber Types in Rat Rotator Cuff Muscles.

    PubMed

    Rui, Yongjun; Pan, Feng; Mi, Jingyi

    2016-10-01

    The rat is a suitable model to study human rotator cuff pathology owing to the similarities in morphological anatomy structure. However, few studies have reported the composition muscle fiber types of rotator cuff muscles in the rat. In this study, the myosin heavy chain (MyHC) isoforms were stained by immunofluorescence to show the muscle fiber types composition and distribution in rotator cuff muscles of the rat. It was found that rotator cuff muscles in the rat were of mixed fiber type composition. The majority of rotator cuff fibers labeled positively for MyHCII. Moreover, the rat rotator cuff muscles contained hybrid fibers. So, compared with human rotator cuff muscles composed partly of slow-twitch fibers, the majority of fast-twitch fibers in rat rotator cuff muscles should be considered when the rat model study focus on the pathological process of rotator cuff muscles after injury. Gaining greater insight into muscle fiber types in rotator cuff muscles of the rat may contribute to elucidate the mechanism of pathological change in rotator cuff muscles-related diseases. Anat Rec, 299:1397-1401, 2016. © 2016 Wiley Periodicals, Inc.

  18. Plasma urate concentration and risk of coronary heart disease: a Mendelian randomisation analysis.

    PubMed

    White, Jon; Sofat, Reecha; Hemani, Gibran; Shah, Tina; Engmann, Jorgen; Dale, Caroline; Shah, Sonia; Kruger, Felix A; Giambartolomei, Claudia; Swerdlow, Daniel I; Palmer, Tom; McLachlan, Stela; Langenberg, Claudia; Zabaneh, Delilah; Lovering, Ruth; Cavadino, Alana; Jefferis, Barbara; Finan, Chris; Wong, Andrew; Amuzu, Antoinette; Ong, Ken; Gaunt, Tom R; Warren, Helen; Davies, Teri-Louise; Drenos, Fotios; Cooper, Jackie; Ebrahim, Shah; Lawlor, Debbie A; Talmud, Philippa J; Humphries, Steve E; Power, Christine; Hypponen, Elina; Richards, Marcus; Hardy, Rebecca; Kuh, Diana; Wareham, Nicholas; Ben-Shlomo, Yoav; Day, Ian N; Whincup, Peter; Morris, Richard; Strachan, Mark W J; Price, Jacqueline; Kumari, Meena; Kivimaki, Mika; Plagnol, Vincent; Whittaker, John C; Smith, George Davey; Dudbridge, Frank; Casas, Juan P; Holmes, Michael V; Hingorani, Aroon D

    2016-04-01

    Increased circulating plasma urate concentration is associated with an increased risk of coronary heart disease, but the extent of any causative effect of urate on risk of coronary heart disease is still unclear. In this study, we aimed to clarify any causal role of urate on coronary heart disease risk using Mendelian randomisation analysis. We first did a fixed-effects meta-analysis of the observational association of plasma urate and risk of coronary heart disease. We then used a conventional Mendelian randomisation approach to investigate the causal relevance using a genetic instrument based on 31 urate-associated single nucleotide polymorphisms (SNPs). To account for potential pleiotropic associations of certain SNPs with risk factors other than urate, we additionally did both a multivariable Mendelian randomisation analysis, in which the genetic associations of SNPs with systolic and diastolic blood pressure, HDL cholesterol, and triglycerides were included as covariates, and an Egger Mendelian randomisation (MR-Egger) analysis to estimate a causal effect accounting for unmeasured pleiotropy. In the meta-analysis of 17 prospective observational studies (166 486 individuals; 9784 coronary heart disease events) a 1 SD higher urate concentration was associated with an odds ratio (OR) for coronary heart disease of 1·07 (95% CI 1·04-1·10). The corresponding OR estimates from the conventional, multivariable adjusted, and Egger Mendelian randomisation analysis (58 studies; 198 598 individuals; 65 877 events) were 1·18 (95% CI 1·08-1·29), 1·10 (1·00-1·22), and 1·05 (0·92-1·20), respectively, per 1 SD increment in plasma urate. Conventional and multivariate Mendelian randomisation analysis implicates a causal role for urate in the development of coronary heart disease, but these estimates might be inflated by hidden pleiotropy. Egger Mendelian randomisation analysis, which accounts for pleiotropy but has less statistical power, suggests there might be

  19. Plasma urate concentration and risk of coronary heart disease: a Mendelian randomisation analysis

    PubMed Central

    White, Jon; Sofat, Reecha; Hemani, Gibran; Shah, Tina; Engmann, Jorgen; Dale, Caroline; Shah, Sonia; Kruger, Felix A; Giambartolomei, Claudia; Swerdlow, Daniel I; Palmer, Tom; McLachlan, Stela; Langenberg, Claudia; Zabaneh, Delilah; Lovering, Ruth; Cavadino, Alana; Jefferis, Barbara; Finan, Chris; Wong, Andrew; Amuzu, Antoinette; Ong, Ken; Gaunt, Tom R; Warren, Helen; Davies, Teri-Louise; Drenos, Fotios; Cooper, Jackie; Ebrahim, Shah; Lawlor, Debbie A; Talmud, Philippa J; Humphries, Steve E; Power, Christine; Hypponen, Elina; Richards, Marcus; Hardy, Rebecca; Kuh, Diana; Wareham, Nicholas; Ben-Shlomo, Yoav; Day, Ian N; Whincup, Peter; Morris, Richard; Strachan, Mark W J; Price, Jacqueline; Kumari, Meena; Kivimaki, Mika; Plagnol, Vincent; Whittaker, John C; Smith, George Davey; Dudbridge, Frank; Casas, Juan P; Holmes, Michael V; Hingorani, Aroon D

    2016-01-01

    Summary Background Increased circulating plasma urate concentration is associated with an increased risk of coronary heart disease, but the extent of any causative effect of urate on risk of coronary heart disease is still unclear. In this study, we aimed to clarify any causal role of urate on coronary heart disease risk using Mendelian randomisation analysis. Methods We first did a fixed-effects meta-analysis of the observational association of plasma urate and risk of coronary heart disease. We then used a conventional Mendelian randomisation approach to investigate the causal relevance using a genetic instrument based on 31 urate-associated single nucleotide polymorphisms (SNPs). To account for potential pleiotropic associations of certain SNPs with risk factors other than urate, we additionally did both a multivariable Mendelian randomisation analysis, in which the genetic associations of SNPs with systolic and diastolic blood pressure, HDL cholesterol, and triglycerides were included as covariates, and an Egger Mendelian randomisation (MR-Egger) analysis to estimate a causal effect accounting for unmeasured pleiotropy. Findings In the meta-analysis of 17 prospective observational studies (166 486 individuals; 9784 coronary heart disease events) a 1 SD higher urate concentration was associated with an odds ratio (OR) for coronary heart disease of 1·07 (95% CI 1·04–1·10). The corresponding OR estimates from the conventional, multivariable adjusted, and Egger Mendelian randomisation analysis (58 studies; 198 598 individuals; 65 877 events) were 1·18 (95% CI 1·08–1·29), 1·10 (1·00–1·22), and 1·05 (0·92–1·20), respectively, per 1 SD increment in plasma urate. Interpretation Conventional and multivariate Mendelian randomisation analysis implicates a causal role for urate in the development of coronary heart disease, but these estimates might be inflated by hidden pleiotropy. Egger Mendelian randomisation analysis, which accounts for

  20. A Systematic Review of the Psychometric Properties of Patient-Reported Outcome Instruments for Use in Patients With Rotator Cuff Disease.

    PubMed

    Huang, Hsiaomin; Grant, John A; Miller, Bruce S; Mirza, Faisal M; Gagnier, Joel J

    2015-10-01

    Many patient-reported outcome instruments (or questionnaires) have been developed for use in patients with rotator cuff disease. Before an instrument is implemented, its psychometric properties should be carefully assessed, and the methodological quality of papers that investigate a psychometric component of an instrument must be carefully evaluated. Together, the psychometric evidence and the methodological quality can then be used to arrive at an estimate of an instrument's quality. To identify patient-reported outcome instruments used in patients with rotator cuff disease and to critically appraise and summarize their psychometric properties to guide researchers and clinicians in using high-quality patient-reported outcome instruments in this population. Systematic review. Systematic literature searches were performed to find English-language articles concerning the development or evaluation of a psychometric property of a patient-reported outcome instrument for use in patients with rotator cuff disease. Methodological quality and psychometric evidence were critically appraised and summarized through 2 standardized sets of criteria. A total of 1881 articles evaluating 39 instruments were found per the search strategy, of which 73 articles evaluating 16 instruments were included in this study. The Constant-Murley score, the DASH (Disability of the Arm, Shoulder, and Hand), and the Shoulder Pain and Disability Index were the 3 most frequently evaluated instruments. In contrast, the psychometric properties of the Korean Shoulder Scoring System, Shoulder Activity Level, Subjective Shoulder Value, and Western Ontario Osteoarthritis Shoulder index were evaluated by only 1 study each. The Western Ontario Rotator Cuff Index was found to have the best overall quality of psychometric properties per the established criteria, with positive evidence found in internal consistency, reliability, content validity, hypothesis testing, and responsiveness. The DASH, Shoulder Pain

  1. Association between randomised trial evidence and global burden of disease: cross sectional study (Epidemiological Study of Randomized Trials—ESORT)

    PubMed Central

    Odutayo, Ayodele; Hsiao, Allan J; Shakir, Mubeen; Hopewell, Sally; Rahimi, Kazem; Altman, Douglas G

    2015-01-01

    Objectives To determine whether an association exists between the number of published randomised controlled trials and the global burden of disease, whether certain diseases are under-investigated relative to their burden, and whether the relation between the output of randomised trials and global burden of disease can be explained by the relative disease burden in high and low income regions. Design Cross sectional investigation. Study sample All primary reports of randomised trials published in December 2012 and indexed in PubMed by 17 November 2013. Main outcome measures Number of trials conducted and number of participants randomised for each of 239 different diseases or injuries; variation in each outcome explainable by total disability adjusted life years (a measure of the overall burden of each disease) and the ratio of disability adjusted life years in low income to high income regions (a measure of whether a disease is more likely to affect people living in high income regions) quantified using multivariable regression. Results 4190 abstracts were reviewed and 1351 primary randomised trials identified, of which 1097 could be classified using the global burden of disease taxonomy. Total disability adjusted life years was poorly associated with number of randomised trials and number of participants randomised in univariable analysis (Spearman’s r=0.35 and 0.33, respectively), although it was a significant predictor in the univariable and multivariable models (P<0.001). Diseases for which the burden was predominantly located in low income regions had sevenfold fewer trials per million disability adjusted life years than diseases predominantly located in high income regions. However, only 26% of the variation in number of trials among diseases could be explained by total disability adjusted life years and the ratio of disability adjusted life years in low income regions to high income regions. Many high income type diseases (for example, neck pain

  2. Are degenerative rotator cuff disorders a cause of shoulder pain? Comparison of prevalence of degenerative rotator cuff disease to prevalence of nontraumatic shoulder pain through three systematic and critical reviews.

    PubMed

    Vincent, Karl; Leboeuf-Yde, Charlotte; Gagey, Olivier

    2017-05-01

    The role of degeneration is not well understood for rotator cuff pain. If age-related degenerative changes would be the cause of symptoms, degeneration would precede or concur with self-reported pain. We performed 3 systematic literature reviews. Our objectives were to determine the prevalence estimates for rotator cuff partial or complete tears (1) in cadavers and (2) in the general population and (3) to estimate the incidence/prevalence of self-reported nontraumatic shoulder pain in the general population in order to compare their respective age-related profiles. We searched PubMed and ScienceDirect, including 2015, for cadaveric studies and transverse and longitudinal studies of the general population reporting the incidence/prevalence of rotator cuff disorders or nontraumatic shoulder pain, or both, according to age. The review process followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Results were interpreted visually. We found 6 cadaveric studies, 2 studies from the general population reporting complete tears, and 10 articles on nontraumatic shoulder pain in the general population that met our criteria. The profiles of degeneration vs. pain were very similar in early years. Although degenerative rotators cuff lesions increased gradually after 50 years, the incidence/prevalence of nontraumatic shoulder pain decreased after 65 years. The profile of age-related degenerative rotator cuff disorders fails to correlate systematically with self-reported nontraumatic shoulder pain, particularly in older age; thus, it appears that degeneration should not be considered the primary source of the pain. Physical activity may play an important role in the production of the pain, a theory that warrants further study. Copyright © 2017. Published by Elsevier Inc.

  3. Randomised, double-blind, placebo-controlled trial of fructo-oligosaccharides in active Crohn's disease.

    PubMed

    Benjamin, Jane L; Hedin, Charlotte R H; Koutsoumpas, Andreas; Ng, Siew C; McCarthy, Neil E; Hart, Ailsa L; Kamm, Michael A; Sanderson, Jeremy D; Knight, Stella C; Forbes, Alastair; Stagg, Andrew J; Whelan, Kevin; Lindsay, James O

    2011-07-01

    The commensal intestinal microbiota drive the inflammation associated with Crohn's disease. However, bacteria such as bifidobacteria and Faecalibacterium prausnitzii appear to be immunoregulatory. In healthy subjects the intestinal microbiota are influenced by prebiotic carbohydrates such as fructo-oligosaccharides (FOS). Preliminary data suggest that FOS increase faecal bifidobacteria, induce immunoregulatory dendritic cell (DC) responses and reduce disease activity in patients with Crohn's disease. To assess the impact of FOS in patients with active Crohn's disease using an adequately powered randomised double-blind placebo-controlled trial with predefined clinical, microbiological and immunological end points. Patients with active Crohn's disease were randomised to 15 g/day FOS or non-prebiotic placebo for 4 weeks. The primary end point was clinical response at week 4 (fall in Crohn's Disease Activity Index of ≥ 70 points) in the intention-to-treat (ITT) population. 103 patients were randomised to receive FOS (n = 54) or placebo (n = 49). More patients receiving FOS (14 (26%) vs 4 (8%); p = 0.018) withdrew before the 4-week end point. There was no significant difference in the number of patients achieving a clinical response between the FOS and placebo groups in the ITT analysis (12 (22%) vs 19 (39%), p = 0.067). Patients receiving FOS had reduced proportions of interleukin (IL)-6-positive lamina propria DC and increased DC staining of IL-10 (p < 0.05) but no change in IL-12p40 production. There were no significant differences in the faecal concentration of bifidobacteria and F prausnitzii between the groups at baseline or after the 4-week intervention. An adequately powered placebo-controlled trial of FOS showed no clinical benefit in patients with active Crohn's disease, despite impacting on DC function. ISRCTN50422530.

  4. Rotator cuff problems

    MedlinePlus

    Miller RH III, Azar FM, Throckmorton TW. Shoulder and elbow injuries. In: Canale ST, Beaty JH, eds. ... Krishnan SG. Rotator cuff and impingement lesions. In: Miller MD, Thompson SR, eds. DeLee and Drez's Orthopaedic ...

  5. Rotator cuff repair - slideshow

    MedlinePlus

    ... presentations/100229.htm Rotator cuff repair - series—Normal anatomy To use the sharing features on this page, ... Bethesda, MD 20894 U.S. Department of Health and Human Services National Institutes of Health Page last updated: ...

  6. Rotator cuff injuries.

    PubMed

    Crusher, R H

    2000-07-01

    Different types of rotator cuff injuries frequently present to Accident and Emergency departments and minor injury units but can be difficult to differentiate clinically. This brief case study describes the examination and diagnosis of related shoulder injuries, specifically rotator cuff tears/disruption and calcifying supraspinatus tendinitis. The relevant anatomy and current therapies for these injuries is also discussed to enable the emergency nurse practitioner to have a greater understanding of the theory surrounding their diagnosis and treatments.

  7. Rotator cuff tendinopathy.

    PubMed

    Lewis, J S

    2009-04-01

    A review was conducted to synthesise the available research literature on the pathogenesis of rotator cuff tendinopathy. Musculoskeletal disorders of the shoulder are extremely common, with reports of prevalence ranging from one in three people experiencing shoulder pain at some stage of their lives to approximately half the population experiencing at least one episode of shoulder pain annually. Pathology of the soft tissues of the shoulder, including the musculotendinous rotator cuff and subacromial bursa, is a principal cause of pain and suffering. The pathoaetiology of rotator cuff failure is multifactorial and results from a combination of intrinsic, extrinsic and environmental factors. The specialised morphology of the rotator cuff, together with the effects of stress shielding, may contribute to the development of rotator cuff tendinopathy. Profound changes within the subacromial bursa are strongly related to the pathology and resulting symptoms. A considerable body of research is necessary to more fully understand the aetiology and pathohistology of rotator cuff tendinopathy and its relationship with bursal pathology. Once this knowledge exists more effective management will become available.

  8. Validation of the western ontario rotator cuff index in patients with arthroscopic rotator cuff repair: A study protocol

    PubMed Central

    2011-01-01

    Background Arthroscopic rotator cuff repair is described as being a successful procedure. These results are often derived from clinical general shoulder examinations, which are then classified as 'excellent', 'good', 'fair' or 'poor'. However, the cut-off points for these classifications vary and sometimes modified scores are used. Arthroscopic rotator cuff repair is performed to improve quality of life. Therefore, disease specific health-related quality of life patient-administered questionnaires are needed. The WORC is a quality of life questionnaire designed for patients with disorders of the rotator cuff. The score is validated for rotator cuff disease, but not for rotator cuff repair specifically. The aim of this study is to investigate reliability, validity and responsiveness of WORC in patients undergoing arthroscopic rotator cuff repair. Methods/Design An approved translation of the WORC into Dutch is used. In this prospective study three groups of patients are used: 1. Arthroscopic rotator cuff repair; 2. Disorders of the rotator cuff without rupture; 3. Shoulder instability. The WORC, SF-36 and the Constant Score are obtained twice before therapy is started to measure reliability and validity. Responsiveness is tested by obtaining the same tests after therapy. PMID:21453470

  9. The factors affecting stiffness occurring with rotator cuff tear.

    PubMed

    Seo, Seung-Suk; Choi, Jang-Seuk; An, Ki-Chan; Kim, Jung-Han; Kim, Sang-Bum

    2012-03-01

    Stiffness after a rotator cuff tear is common, and it affects postoperative prognosis. This study aims to define the factors affecting stiffness that accompanies rotator cuff tear. From June 2002 to May 2009 (84 months), 143 patients underwent arthroscopic rotator cuff repair. Of these, 119 were enrolled as subjects in this study. Preoperative range of motion was measured in all patients. Stiffness of the shoulder was defined as restriction of active and passive motion of 100° of elevation or less, less than 50% of external rotation, and internal rotation only to the sacrum. Factors that can affect stiffness were evaluated, including the type, size, and direction of rotator cuff; duration of symptoms; gender; age; presence of accompanying medical disease; degenerative factors (Goutallier classification); and presence of trauma. Retrospective analysis was conducted accordingly. A statistically significantly higher degree of stiffness was seen for full-thickness tears than for partial-thickness tears (P = .0187). Between 2 groups that were divided by direction of rotator cuff tear, posterosuperior cuff tears showed a statistically significantly higher prevalence of stiffness (P = .0415). Patients with trauma had a statistically higher prevalence of stiffness (P = .0264). The other factors did not show significant differences. In patients with rotator cuff tear, the type and direction of rotator cuff tear and the presence of trauma seem to increase the limitation of preoperative joint range of motion. Copyright © 2012 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

  10. Rotator Cuff Injuries - Multiple Languages

    MedlinePlus

    ... Are Here: Home → Multiple Languages → All Health Topics → Rotator Cuff Injuries URL of this page: https://medlineplus.gov/ ... V W XYZ List of All Topics All Rotator Cuff Injuries - Multiple Languages To use the sharing features ...

  11. Deep brain stimulation in early stage Parkinson's disease: operative experience from a prospective randomised clinical trial.

    PubMed

    Kahn, Elyne; D'Haese, Pierre-Francois; Dawant, Benoit; Allen, Laura; Kao, Chris; Charles, P David; Konrad, Peter

    2012-02-01

    Recent evidence suggests that deep brain stimulation of the subthalamic nucleus (STN-DBS) may have a disease modifying effect in early Parkinson's disease (PD). A randomised, prospective study is underway to determine whether STN-DBS in early PD is safe and tolerable. 15 of 30 early PD patients were randomised to receive STN-DBS implants in an institutional review board approved protocol. Operative technique, location of DBS leads and perioperative adverse events are reported. Active contact used for stimulation in these patients was compared with 47 advanced PD patients undergoing an identical procedure by the same surgeon. 14 of the 15 patients did not sustain any long term (>3 months) complications from the surgery. One subject suffered a stroke resulting in mild cognitive changes and slight right arm and face weakness. The average optimal contact used in symptomatic treatment of early PD patients was: anterior -1.1±1.7 mm, lateral 10.7±1.7 mm and superior -3.3±2.5 mm (anterior and posterior commissure coordinates). This location is statistically no different (0.77 mm, p>0.05) than the optimal contact used in the treatment of 47 advanced PD patients. The perioperative adverse events in this trial of subjects with early stage PD are comparable with those reported for STN-DBS in advanced PD. The active contact position used in early PD is not significantly different from that used in late stage disease. This is the first report of the operative experience from a randomised, surgical versus best medical therapy trial for the early treatment of PD.

  12. Clinical features of patients diagnosed with degenerative rotator cuff tendon disease: a 6-month prospective-definitive clinical study from turkey.

    PubMed

    Koca, Tuba Tülay; Arslan, Aydın; Özdemir, Filiz; Acet, Günseli

    2017-08-01

    [Purpose] In rotator cuff tendon disease (RCTD), anamnesis is as important as clinical findings and anatomic/radio diagnostic examination. This study aimed to investigate the clinical features of patients diagnosed with RCTD using clinical and radiological methods between March 2015 and August 2015 at Malatya Research and Training Hospital Physical Medicine and Rehabilitation department. [Subjects and Methods] The study included 178 patients who were diagnosed with RCTD (128 females and 50 males). A questionnaire comprising 33 questions was given to each patient. [Results] Eighty-eight of the patients (49.9%) had an involvement on their right side, eighty-four (47.1%) had an involvement on their left side, and 6 had bilateral involvement. Mean visual analog scale (VAS) score was found to be statistically significant in favor of female patients. A statistically significant correlation was found between educational status and VAS. The body mass index (BMI) of the female patients was found to be higher than that of the male patients. Statistically significant correlation between doing risky work and gender showed that males were at a higher risk. [Conclusion] RCDT is more seen in people who have high BMI and are at their 50s. Pain complaint and BMI were found higher in female patients. DM, thyroid and cardiac diseases were seen more in the patients who are diagnosed with RCTD relative to the healthy population.

  13. Intense focused ultrasound stimulation of the rotator cuff: evaluation of the source of pain in rotator cuff tears and tendinopathy.

    PubMed

    Gellhorn, Alfred C; Gillenwater, Cody; Mourad, Pierre D

    2015-09-01

    The objective of this preliminary study was to evaluate the ability of individual 0.1-s long pulses of intense focused ultrasound (iFU) emitted with a carrier frequency of 2 MHz to evoke diagnostic sensations when applied to patients whose shoulders have rotator cuff tears or tendinopathy. Patients were adults with painful shoulders and clinical and imaging findings consistent with rotator cuff disease. iFU stimulation of the shoulder was performed using B-mode ultrasound coupled with a focused ultrasound transducer that allowed image-guided delivery of precisely localized pulses of energy to different anatomic areas around the rotator cuff. The main outcome measure was iFU spatial average-temporal average intensity (I_SATA), and location required to elicit sensation. In control patients, iFU produced no sensation throughout the range of stimulation intensities (≤2000 W/cm(2) I_SATA). In patients with rotator cuff disease, iFU was able to induce sensation in the tendons of the rotator cuff, the subacromial bursa, and the subchondral bone in patients with chronic shoulder pain and rotator cuff disease, with an average ± standard deviation intensity equaling 680 ± 281 W/cm(2) I_SATA. This result suggests a primary role for these tissues in the pathogenesis of shoulder pain related to rotator cuff tendinopathy.

  14. Rotator Cuff Injuries.

    ERIC Educational Resources Information Center

    Connors, G. Patrick

    Many baseball players suffer from shoulder injuries related to the rotator cuff muscles. These injuries may be classified as muscular strain, tendonitis or tenosynovitis, and impingement syndrome. Treatment varies from simple rest to surgery, so it is important to be seen by a physician as soon as possible. In order to prevent these injuries, the…

  15. Rotator Cuff Injuries.

    ERIC Educational Resources Information Center

    Connors, G. Patrick

    Many baseball players suffer from shoulder injuries related to the rotator cuff muscles. These injuries may be classified as muscular strain, tendonitis or tenosynovitis, and impingement syndrome. Treatment varies from simple rest to surgery, so it is important to be seen by a physician as soon as possible. In order to prevent these injuries, the…

  16. Outcome of physiotherapy after surgery for cervical disc disease: a prospective randomised multi-centre trial

    PubMed Central

    2014-01-01

    Background Many patients with cervical disc disease require leave from work, due to long-lasting, complex symptoms, including chronic pain and reduced levels of physical and psychological function. Surgery on a few segmental levels might be expected to resolve disc-specific pain and reduce neurological deficits, but not the non-specific neck pain and the frequent illness. No study has investigated whether post-surgery physiotherapy might improve the outcome of surgery. The main purpose of this study was to evaluate whether a well-structured rehabilitation programme might add benefit to the customary post-surgical treatment for cervical disc disease, with respect to function, disability, work capability, and cost effectiveness. Methods/Design This study was designed as a prospective, randomised, controlled, multi-centre study. An independent, blinded investigator will compare two alternatives of rehabilitation. We will include 200 patients of working age, with cervical disc disease confirmed by clinical findings and symptoms of cervical nerve root compression. After providing informed consent, study participants will be randomised to one of two alternative physiotherapy regimes; (A) customary treatment (information and advice on a specialist clinic); or (B) customary treatment plus active physiotherapy. Physiotherapy will follow a standardised, structured programme of neck-specific exercises combined with a behavioural approach. All patients will be evaluated both clinically and subjectively (with questionnaires) before surgery and at 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery. The main outcome variable will be neck-specific disability. Cost-effectiveness will also be calculated. Discussion We anticipate that the results of this study will provide evidence to support physiotherapeutic rehabilitation applied after surgery for cervical radiculopathy due to cervical disc disease. Trial registration ClinicalTrials.gov identifier: NCT01547611

  17. Effectiveness of job rotation for preventing work-related musculoskeletal diseases: a cluster randomised controlled trial.

    PubMed

    Comper, Maria Luiza Caires; Dennerlein, Jack Tigh; Evangelista, Gabriela Dos Santos; Rodrigues da Silva, Patricia; Padula, Rosimeire Simprini

    2017-08-01

    Job rotation is an organisational strategy widely used on assembly lines in manufacturing industries to mitigate workers' exposure so as to prevent musculoskeletal disorders. This study aimed to evaluate the effectiveness of job rotation for reducing working hours lost due to sick leave resulting from musculoskeletal diseases. The design consisted of a 1-year cluster randomised controlled trial with a blinded assessor. Production sectors of the textile industry were randomised to intervention and control groups. Both groups received ergonomic training. The intervention group performed a job rotation programme. The primary outcome measure was number of working hours lost due to sick leave as a result of musculoskeletal disease (ICD-10). The secondary outcome measures were musculoskeletal symptoms (Yes/No), risk factors for musculoskeletal diseases (0-10), psychosocial factors and fatigue (0-100), general health (0-100), and productivity (0-10). All secondary outcomes were measured at baseline and 12-month follow-up. At the 12-month follow-up, both groups showed an increase in the number of working hours lost due to sick leave for musculoskeletal disease. There was no significant difference between the job rotation intervention group (mean deviation -5.6 hours, 95% CI -25.0 to 13.8) at the 12-month follow-up and the control group. There were no significant differences between groups for the secondary outcomes (p>0.05). The job rotation programme was not effective in reducing the number of working hours lost due to sick leave, decreasing the prevalence of musculoskeletal symptoms, or improving perception of musculoskeletal pain and workplace risk factors, psychosocial risk factors and productivity. NCT01979731. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  18. Fistula Plug in Fistulising Ano-Perineal Crohn's Disease: a Randomised Controlled Trial.

    PubMed

    Senéjoux, A; Siproudhis, L; Abramowitz, L; Munoz-Bongrand, N; Desseaux, K; Bouguen, G; Bourreille, A; Dewit, O; Stefanescu, C; Vernier, G; Louis, E; Grimaud, J C; Godart, B; Savoye, G; Hebuterne, X; Bauer, P; Nachury, M; Laharie, D; Chevret, S; Bouhnik, Y

    2016-02-01

    Anal fistula plug [AFP] is a bioabsorbable bioprosthesis used in ano-perineal fistula treatment. We aimed to assess efficacy and safety of AFP in fistulising ano-perineal Crohn's disease [FAP-CD]. In a multicentre, open-label, randomised controlled trial we compared seton removal alone [control group] with AFP insertion [AFP group] in 106 Crohn's disease patients with non- or mildly active disease having at least one ano-perineal fistula tract drained for more than 1 month. Patients with abscess [collection ≥ 3mm on magnetic resonance imaging or recto-vaginal fistulas were excluded. Randomisation was stratified in simple or complex fistulas according to AGA classification. Primary end point was fistula closure at Week 12. In all, 54 patients were randomised to AFP group [control group 52]. Median fistula duration was 23 [10-53] months. Median Crohn's Disease Activity Index at baseline was 81 [45-135]. Fistula closure at Week 12 was achieved in 31.5% patients in the AFP group and in 23.1 % in the control group (relative risk [RR] stratified on AGA classification: 1.31; 95% confidence interval: 0.59-4.02; p = 0.19). No interaction in treatment effect with complexity stratum was found; 33.3% of patients with complex fistula and 30.8% of patients with simple fistula closed the tracts after AFP, as compared with 15.4% and 25.6% in controls, respectively [RR of success = 2.17 in complex fistula vs RR = 1.20 in simple fistula; p = 0.45]. Concerning safety, at Week 12, 17 patients developed at least one adverse event in the AFP group vs 8 in the controls [p = 0.07]. AFP is not more effective than seton removal alone to achieve FAP-CD closure. Copyright © 2015 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  19. Randomised clinical trial: the safety and tolerability of Trichuris suis ova in patients with Crohn's disease.

    PubMed

    Sandborn, W J; Elliott, D E; Weinstock, J; Summers, R W; Landry-Wheeler, A; Silver, N; Harnett, M D; Hanauer, S B

    2013-08-01

    Recent evidence suggests that embryonated eggs of the porcine whipworm Trichuris suis ova (TSO) may be an effective treatment for inflammatory bowel disease (IBD). To assess the safety and tolerability of TSO following a single dose in patients with Crohn's disease. This was a sequential dose-escalation (500, 2500 and 7500 viable embryonated TSO), randomised, double-blind, placebo-controlled study to evaluate the safety of a single dose of oral suspension TSO in patients with Crohn's disease. Twelve patients were randomised into each of three cohorts. Patients were assessed 1, 3, 5, 7, 9, 11 and 14 days following dosing (via a telephone call and diary symptom collection through 14 days postdose) for adverse events, changes to concomitant medications and gastrointestinal (GI) signs and symptoms. Patients were again assessed at Months 1, 2 and 6. Eighteen males and 18 females were enrolled, ages 20 to 54 years. All patients were dosed and completed the initial 2-month follow-up period (five patients did not attend their 6-month study visit). GI disorders were reported with the highest frequency; 7 (25.9%) TSO-treated patients and 3 (33.3%) placebo-treated patients. No dose-dependent relationship was observed, with 3 (33.3%) placebo, 4 (44.4%) TSO 500, 0 (0.0%) TSO 2500 and 3 (33.3%) TSO 7500 patients experiencing at least one GI event, and no clinically meaningful changes in GI signs and symptoms. A single dose of Trichuris suis ova up to 7500 ova was well tolerated and did not result in short- or long-term treatment-related side effects. Clinicaltrials.gov NCT01576461. © 2013 John Wiley & Sons Ltd.

  20. Low LDL cholesterol, PCSK9 and HMGCR genetic variation, and risk of Alzheimer's disease and Parkinson's disease: Mendelian randomisation study.

    PubMed

    Benn, Marianne; Nordestgaard, Børge G; Frikke-Schmidt, Ruth; Tybjærg-Hansen, Anne

    2017-04-24

    Objective To test the hypothesis that low density lipoprotein (LDL) cholesterol due to genetic variation in the genes responsible for LDL cholesterol metabolism and biosynthesis(PCSK9 and 3-hydroxy-3-methylglutaryl-CoA reductase (HMGCR), respectively) is associated with a high risk of Alzheimer's disease, vascular dementia, any dementia, and Parkinson's disease in the general population.Design Mendelian randomisation study.Setting Copenhagen General Population Study and Copenhagen City Heart Study.Participants 111 194 individuals from the Danish general population.Main outcome measures Risk of Alzheimer's disease, vascular dementia, all dementia, and Parkinson's disease.Results In observational analyses, the multifactorially adjusted hazard ratio for Parkinson's disease in participants with an LDL cholesterol level <1.8 mmol/L versus ≥4.0 mmol/L was 1.70 (95% confidence interval 1.03 to 2.79), whereas the corresponding hazard ratios for Alzheimer's disease, vascular dementia, or any dementia did not differ from 1.0. PCSK9 and HMGCR variants combined were associated with a 9.3% lower LDL cholesterol level. In genetic, causal analyses adjusted for age, sex, and year of birth, the risk ratios for a lifelong 1 mmol/L lower LDL cholesterol level were 0.57 (0.27 to 1.17) for Alzheimer's disease, 0.81 (0.34 to 1.89) for vascular dementia, 0.66 (0.34 to 1.26) for any dementia, and 1.02 (0.26 to 4.00) for Parkinson's disease. Summary level data from the International Genomics of Alzheimer's Project using Egger Mendelian randomisation analysis gave a risk ratio for Alzheimer's disease of 0.24 (0.02 to 2.79) for 26 PCSK9 and HMGCR variants, and of 0.64 (0.52 to 0.79) for 380 variants of LDL cholesterol level lowering.Conclusion Low LDL cholesterol levels due to PCSK9 and HMGCR variants had no causal effect on high risk of Alzheimer's disease, vascular dementia, any dementia, or Parkinson's disease; however, low LDL cholesterol levels may have a causal effect in

  1. Regenerative Medicine in Rotator Cuff Injuries

    PubMed Central

    Randelli, Pietro; Ragone, Vincenza; Menon, Alessandra; Cabitza, Paolo; Banfi, Giuseppe

    2014-01-01

    Rotator cuff injuries are a common source of shoulder pathology and result in an important decrease in quality of patient life. Given the frequency of these injuries, as well as the relatively poor result of surgical intervention, it is not surprising that new and innovative strategies like tissue engineering have become more appealing. Tissue-engineering strategies involve the use of cells and/or bioactive factors to promote tendon regeneration via natural processes. The ability of numerous growth factors to affect tendon healing has been extensively analyzed in vitro and in animal models, showing promising results. Platelet-rich plasma (PRP) is a whole blood fraction which contains several growth factors. Controlled clinical studies using different autologous PRP formulations have provided controversial results. However, favourable structural healing rates have been observed for surgical repair of small and medium rotator cuff tears. Cell-based approaches have also been suggested to enhance tendon healing. Bone marrow is a well known source of mesenchymal stem cells (MSCs). Recently, ex vivo human studies have isolated and cultured distinct populations of MSCs from rotator cuff tendons, long head of the biceps tendon, subacromial bursa, and glenohumeral synovia. Stem cells therapies represent a novel frontier in the management of rotator cuff disease that required further basic and clinical research. PMID:25184132

  2. Mendelian Randomisation study of the influence of eGFR on coronary heart disease

    PubMed Central

    Charoen, Pimphen; Nitsch, Dorothea; Engmann, Jorgen; Shah, Tina; White, Jonathan; Zabaneh, Delilah; Jefferis, Barbara; Wannamethee, Goya; Whincup, Peter; Mulick Cassidy, Amy; Gaunt, Tom; Day, Ian; McLachlan, Stela; Price, Jacqueline; Kumari, Meena; Kivimaki, Mika; Brunner, Eric; Langenberg, Claudia; Ben-Shlomo, Yoav; Hingorani, Aroon; Whittaker, John; Pablo Casas, Juan; Dudbridge, Frank; Dale, Caroline; Finan, Chris; Wong, Andrew; Ong, Ken; Drenos, Fotios; Cooper, Jackie; Sofat, Reecha; Schmidt, Floriaan; Lawlor, Debbie A.; Talmud, Philippa J.; Humphries, Steve E.; Hardy, Rebecca; Kuh, Diana; Wareham, Nicholas; Morris, Richard; Plagno, Vincent

    2016-01-01

    Impaired kidney function, as measured by reduced estimated glomerular filtration rate (eGFR), has been associated with increased risk of coronary heart disease (CHD) in observational studies, but it is unclear whether this association is causal or the result of confounding or reverse causation. In this study we applied Mendelian randomisation analysis using 17 genetic variants previously associated with eGFR to investigate the causal role of kidney function on CHD. We used 13,145 participants from the UCL-LSHTM-Edinburgh-Bristol (UCLEB) Consortium and 194,427 participants from the Coronary ARtery DIsease Genome-wide Replication and Meta-analysis plus Coronary Artery Disease (CARDIoGRAMplusC4D) consortium. We observed significant association of an unweighted gene score with CHD risk (odds ratio = 0.983 per additional eGFR-increasing allele, 95% CI = 0.970–0.996, p = 0.008). However, using weights calculated from UCLEB, the gene score was not associated with disease risk (p = 0.11). These conflicting results could be explained by a single SNP, rs653178, which was not associated with eGFR in the UCLEB sample, but has known pleiotropic effects that prevent us from drawing a causal conclusion. The observational association between low eGFR and increased CHD risk was not explained by potential confounders, and there was no evidence of reverse causation, therefore leaving the remaining unexplained association as an open question. PMID:27338949

  3. A pragmatic, multicentre, randomised controlled trial comparing stapled haemorrhoidopexy to traditional excisional surgery for haemorrhoidal disease (eTHoS): study protocol for a randomised controlled trial.

    PubMed

    Watson, Angus J M; Bruhn, Hanne; MacLeod, Kathleen; McDonald, Alison; McPherson, Gladys; Kilonzo, Mary; Norrie, John; Loudon, Malcolm A; McCormack, Kirsty; Buckley, Brian; Brown, Steven; Curran, Finlay; Jayne, David; Rajagopal, Ramesh; Cook, Jonathan A

    2014-11-11

    Current interventions for haemorrhoidal disease include traditional haemorrhoidectomy (TH) and stapled haemorrhoidopexy (SH) surgery. However, uncertainty remains as to how they compare from a clinical, quality of life (QoL) and economic perspective. The study is therefore designed to determine whether SH is more effective and more cost-effective, compared with TH. eTHoS (either Traditional Haemorrhoidectomy or Stapled Haemorrhoidopexy for Haemorrhoidal Disease) is a pragmatic, multicentre, randomised controlled trial. Currently, 29 secondary care centres are open to recruitment. Patients, aged 18 year or older, with circumferential haemorrhoids grade II to IV, are eligible to take part. The primary clinical and economic outcomes are QoL profile (area under the curve derived from the EuroQol Group's 5 Dimension Health Status Questionnaire (EQ-5D) at all assessment points) and incremental cost per quality adjusted life year (QALY) based on the responses to the EQ-5D at 24 months. The secondary outcomes include a comparison of the SF-36 scores, pain and symptoms sub-domains, disease recurrence, complication rates and direct and indirect costs to the National Health Service (NHS). A sample size of n =338 per group has been calculated to provide 90% power to detect a difference in the mean area under the curve (AUC) of 0.25 standard deviations derived from EQ-5D score measurements, with a two-sided significance level of 5%. Allowing for non-response, 400 participants will be randomised per group. Randomisation will utilise a minimisation algorithm that incorporates centre, grade of haemorrhoidal disease, baseline EQ-5D score and gender. Blinding of participants and outcome assessors is not attempted. This is one of the largest trials of its kind. In the United Kingdom alone, 29,000 operations for haemorrhoidal disease are done annually. The trial is therefore designed to give robust evidence on which clinicians and health service managers can base management decisions

  4. Epidemiology, genetics and biological factors of rotator cuff tears.

    PubMed

    Longo, Umile Giuseppe; Berton, Alessandra; Papapietro, Nicola; Maffulli, Nicola; Denaro, Vincenzo

    2012-01-01

    Rotator cuff disease is among the most common musculoskeletal disorders with high direct and indirect costs in industrialized countries. Not all rotator cuff tears are symptomatic. Genetics has recently been investigated as a factor involved in the pathogenesis of rotator cuff pathology. Genetic factors seem to be involved in symptom presentation and tear progression. As rotator cuff disease is multifactorial, no single gene is directly involved in the pathology. Phenotypic expression of genetic susceptibility manifests at the level of ultrastructure of the tendon. Predisposing genes may also operate through apoptosis and regenerative capacity. Studies on cellular and molecular biology are more numerous, but still incomplete, and recently have focussed on the role of apoptosis in tendinopathy, analyzing its key mediators and cellular changes. Oxidative stress is responsible for reduction of collagen synthesis. Biological investigations have identified recently new risk factors. Preliminary reports introduced the possible role of glucose as a risk factor for rotator cuff tear. Further studies are required to fully clarify the genetic and biological factors involved in rotator cuff tears. Copyright © 2012 S. Karger AG, Basel.

  5. WITHDRAWN: Interventions for tears of the rotator cuff in adults.

    PubMed

    Ejnisman, Benno; Andreoli, Carlos V; Soares, Bernardo; Peccin, Maria Stella; Abdalla, Rene J; Faloppa, Flávio; Cohen, Moisés

    2009-01-21

    Tears of the rotator cuff tendons, which surround the joints of the shoulder, are one of the most common causes of pain and disability in the upper extremity. To review the efficacy and safety of common interventions for tears of the rotator cuff in adults. We searched the Cochrane Bone, Joint and Muscle Trauma Group specialised trail register (July 2002), the Cochrane Controlled Trials Register (The Cochrane Library issue 2, 2002), MEDLINE (1966 to December 2001), EMBASE (1974 to December 2001), Biological Abstracts (1980 to December 2001), LILACS (1982 to December 2001), CINAHL (November 1982 to December 2001), Science Citation Index and reference lists of articles. We also contacted authors and handsearched conference proceedings focusing on shoulder conditions. Randomised or quasi-randomised clinical trials involving tears of the rotator cuff were the focus of this review. All trials involving conservative interventions or surgery were included (non-steroidal anti-inflammatory drugs, intra-articular or subacromial glucocorticosteroid injection, oral glucocorticosteroid treatment, physiotherapy, and open or arthroscopic surgery). Two reviewers independently assessed suitability for inclusion, methodological quality and extracted data. Dichotomous data were presented as relative risks (RR) and 95% confidence intervals (CI), using the fixed effects model. Eight trials involving 455 people were included and 393 patients analysed. Trials were grouped in eight categories of conservative or surgical treatment. The median quality score of all trials combined was 16 out of a possible 24 points, with a range of 12-18. In general, included trials differed on diagnostic criteria for rotator cuff tear, there was no uniformity in reported outcome measures, and data which could be summarised were rarely reported. Only results from two studies comparing open repair to arthroscopic debridement could be pooled. There is weak evidence for the superiority of open repair of rotator

  6. Interventions for tears of the rotator cuff in adults.

    PubMed

    Ejnisman, B; Andreoli, C V; Soares, B G O; Fallopa, F; Peccin, M S; Abdalla, R J; Cohen, M

    2004-01-01

    Tears of the rotator cuff tendons, which surround the joints of the shoulder, are one of the most common causes of pain and disability in the upper extremity. To review the efficacy and safety of common interventions for tears of the rotator cuff in adults. We searched the Cochrane Musculoskeletal Injuries Group specialised trail register (July 2002), the Cochrane Controlled Trials Register (The Cochrane Library issue 2, 2002), MEDLINE (1966 to December 2001), EMBASE (1974 to December 2001), Biological Abstracts (1980 to December 2001), LILACS (1982 to December 2001), CINAHL (November 1982 to December 2001), Science Citation Index and reference lists of articles. We also contacted authors and handsearched conference proceedings focusing on shoulder conditions. Randomised or quasi-randomised clinical trials involving tears of the rotator cuff were the focus of this review. All trials involving conservative interventions or surgery were included (non-steroidal anti-inflammatory drugs, intra-articular or subacromial glucocorticosteroid injection, oral glucocorticosteroid treatment, physiotherapy, and open or arthroscopic surgery). Two reviewers independently assessed suitability for inclusion, methodological quality and extracted data. Dichotomous data were presented as relative risks (RR) and 95% confidence intervals (CI), using the fixed effects model. Eight trials involving 455 people were included and 393 patients analysed. Trials were grouped in eight categories of conservative or surgical treatment. The median quality score of all trials combined was 16 out of a possible 24 points, with a range of 12-18. In general, included trials differed on diagnostic criteria for rotator cuff tear, there was no uniformity in reported outcome measures, and data which could be summarised were rarely reported. Only results from two studies comparing open repair to arthroscopic debridement could be pooled. There is weak evidence for the superiority of open repair of rotator cuff

  7. Early combined immunosuppression for the management of Crohn's disease (REACT): a cluster randomised controlled trial.

    PubMed

    Khanna, Reena; Bressler, Brian; Levesque, Barrett G; Zou, Guangyong; Stitt, Larry W; Greenberg, Gordon R; Panaccione, Remo; Bitton, Alain; Paré, Pierre; Vermeire, Séverine; D'Haens, Geert; MacIntosh, Donald; Sandborn, William J; Donner, Allan; Vandervoort, Margaret K; Morris, Joan C; Feagan, Brian G

    2015-11-07

    Conventional management of Crohn's disease features incremental use of therapies. However, early combined immunosuppression (ECI), with a TNF antagonist and antimetabolite might be a more effective strategy. We compared the efficacy of ECI with that of conventional management for treatment of Crohn's disease. In this open-label cluster randomised controlled trial (Randomised Evaluation of an Algorithm for Crohn's Treatment, REACT), we included community gastroenterology practices from Belgium and Canada that were willing to be assigned to either of the study groups, participate in all aspects of the study, and provide data on up to 60 patients with Crohn's disease. These practices were randomly assigned (1:1) to either ECI or conventional management. The computer-generated randomisation was minimised by country and practice size. Up to 60 consecutive adult patients were assessed within practices. Patients who were aged 18 years or older; documented to have Crohn's disease; able to speak or understand English, French, or Dutch; able to access a telephone; and able to provide written informed consent were followed up for 2 years. The primary outcome was the proportion of patients in corticosteroid-free remission (Harvey-Bradshaw Index score ≤ 4) at 12 months at the practice level. This trial is registered with ClinicalTrials.gov, number NCT01030809. This study took place between March 15, 2010, and Oct 1, 2013. Of the 60 practices screened, 41 were randomly assigned to either ECI (n=22) or conventional management (n=19). Two practices (one in each group) discontinued because of insufficient resources. 921 (85%) of the 1084 patients at ECI practices and 806 (90%) of 898 patients at conventional management practices completed 12 months follow-up and were included in an intention-to-treat analysis. The 12 month practice-level remission rates were similar at ECI and conventional management practices (66·0% [SD 14·0] and 61·9% [16·9]; adjusted difference 2·5%, 95

  8. Factorial randomised controlled trial of glucocorticoids and combination disease modifying drugs in early rheumatoid arthritis.

    PubMed

    Choy, E H S; Smith, C M; Farewell, V; Walker, D; Hassell, A; Chau, L; Scott, D L

    2008-05-01

    Treating early active rheumatoid arthritis (RA) with disease modifying antirheumatic drug (DMARD) monotherapy achieves incomplete outcomes and intensive treatment seems preferable. As the relative benefits of combining two DMARDs, one DMARD with glucocorticoids and two DMARDs with glucocorticoids are uncertain we defined them in a factorial trial. A 2-year randomised double-blind factorial trial in patients with RA within 2 years of diagnosis treated with methotrexate studied the benefits of added ciclosporin, 9 months intensive prednisolone or both (triple therapy). The primary outcome was the number of patients with new erosions. Secondary outcomes included Larsen's x-ray scores, disability, quality of life and adverse events. 1391 patients were screened and 467 randomised. Over 2 years 132 (28%) changed therapy and 88 (19%) were lost to follow-up. The number of patients with new erosions was reduced by nearly half by adding ciclosporin or prednisolone (p = 0.01 and 0.03); both treatments reduced increases in Larsen's x-ray scores by over 2 units (p = 0.008 and 0.003). A further reduction in erosive damage was seen with combined use of both treatments. Their effects on erosive damage appeared independent. Triple therapy reduced disability and improved quality of life compared with methotrexate; ciclosporin and prednisolone acted synergistically. More patients withdrew because of adverse events with triple therapy, without an increase in serious adverse effects. This study confirms the existence of a "window of opportunity" in early RA, when intensive combination therapy produces sustained benefits on damage and disability. Although methotrexate-prednisolone combinations reduce erosive damage, the synergistic effect of two DMARDs is needed to improve quality of life.

  9. Arm exercise training in chronic obstructive pulmonary disease: a randomised controlled trial.

    PubMed

    McKeough, Zoe J; Bye, Peter T P; Alison, Jennifer A

    2012-08-01

    The aim of this study was to compare the effects of arm endurance training, arm strength training, a combination of arm endurance and strength training, and no arm training on endurance arm exercise capacity. A randomised controlled trial was undertaken with chronic obstructive pulmonary disease subjects randomised into one of four groups to complete 8 weeks of training: (a) arm endurance training (endurance group) consisting of supported and unsupported arm exercises, (b) arm strength training (strength group) using weight machines, (c) a combination of arm endurance and arm strength training (combined group), or (d) no arm training (control group). The primary outcome measurement was endurance arm exercise capacity measured by an endurance arm crank test. Secondary outcomes included functional arm exercise capacity measured by the incremental unsupported arm exercise test and health-related quality of life. A total of 52 subjects were recruited and 38 (73%) completed the study. When comparing the arm endurance group to the control group, there was a significant increase in endurance time of 6 min (95% CI 2-10, p < 0.01) following the interventions. When comparing the combined group to each of the control, endurance and strength groups, there was a significantly greater reduction in dyspnoea and rate of perceived exertion at the end of the functional arm exercise test for the combined group following the interventions. The mode of training to be favoured to increase endurance arm exercise capacity is arm endurance training. However, combined arm endurance and strength training may also be very useful to reduce the symptoms during everyday arm tasks.

  10. 2D.08: COMPARISON OF CENTRAL HEMODYNAMIC INDICES FOR PREDICTING THE PRESENCE AND SEVERITY OF CORONARY ARTERY DISEASE USING A BRACHIAL CUFF-BASED OSCILLOMETRIC DEVICE.

    PubMed

    Nakagomi, A; Okada, S; Shoji, T; Kobayashi, Y

    2015-06-01

    Various indices of central hemodynamics, such as aortic pulsatility, pulse pressure amplification (PPA) and augmentation index, have been proposed as novel predictors for coronary artery disease (CAD). However, it remains unknown which parameter is most appropriate for risk estimation. The aim of this study was to compare the predictive value of these indices using an easy-to-use, brachial cuff-based oscillometric device. Consecutive 139 patients undergoing elective coronary angiography were enrolled in this study. Augmentation index adjusted to 75 beats/min (Aix@75), brachial and aortic BP indices were measured with Mobil-O-Graph®. We defined fractional pulse pressure (FPP) as pulse pressure (PP) per mean BP and PPA as brachial PP minus aortic PP. Significant CAD was defined as having more than 50% stenosis in major coronary arteries, and the severity was evaluated with Gensini score. Compared with no CAD patients, CAD patients showed significantly higher PPs and FPPs (brachial PP 48.4 ± 15.5 vs 55.0 ± 16.2mmHg, aortic PP 51.7 ± 19.4 vs 62.2 ± 19.9mmHg, brachial FPP 0.42 ± 0.09 vs 0.49 ± 0.11, aortic FPP 0.46 ± 0.13 vs 0.57 ± 0.14; all p < 0.05) and lower PPA (-3.3 ± 8.7 vs -7.2 ± 7.8; p < 0.05). Other indices including Aix@75 did not differ significantly. Logistic regression analysis revealed aortic PP, brachial FPP, aortic FPP and PPA each correlated with the presence of CAD after adjustment for potential confounders (odds ratio (OR) [95% confidence interval]: aortic PP per 10 mmHg OR = 1.50 [1.08-2.08], brachial FPP per 0.1 OR = 2.26 [1.30-3.94], aortic FPP per 0.1 OR = 2.15 [1.35-3.42], PPA per 1 mmHg OR = 0.93 [0.87-0.99], respectively). However, when aortic FPP plus either aortic PP, brachial FPP, or PPA were included in the model, only aortic FPP remained significant. These indices were all associated with the severity of CAD expressed as Gensini score (correlation coefficient

  11. Special report: Occlusive cuff controller

    NASA Technical Reports Server (NTRS)

    Baker, J. T.

    1975-01-01

    A mechanical occlusive cuff controller suitable for blood flow experiments in space shuttle flights is described. The device requires 115 volt ac power and a pressurized gas source. Two occluding cuff pressures (30 and 50 mmHg) are selectable by a switch on the front panel. A screw driver adjustment allows accurate cuff pressurization levels for under or oversized limbs. Two pressurization cycles (20 second and 2 minutes) can be selected by a front panel switch. Adjustment of the timing cycles is also available through the front panel. A pushbutton hand switch allows remote start of the cuff inflation cycle. A stop/reset switch permits early termination of the cycle and disabling of the controller to prevent inadvertent reactivation. Pressure in the cuff is monitored by a differential aneroid barometer. In addition, an electrocardiogram trigger circuit permits the initiation of the pressurization cycle by an externally supplied ECG cycle.

  12. Rolling cuff flexible bellows

    DOEpatents

    Lambert, Donald R.

    1985-01-01

    A flexible connector apparatus used to join two stiff non-deformable members, such as piping. The apparatus is provided with one or more flexible sections or assemblies each utilizing a bellows of a rolling cuff type connected between two ridge members, with the bellows being supported by a back-up ring, such that only the curved end sections of the bellows are unsupported. Thus, the bellows can be considered as being of a tube-shaped configuration and thus have high pressure resistance. The components of the flexible apparatus are sealed or welded one to another such that it is fluid tight.

  13. The evidence of benefits of exercise training in interstitial lung disease: a randomised controlled trial.

    PubMed

    Dowman, Leona M; McDonald, Christine F; Hill, Catherine J; Lee, Annemarie L; Barker, Kathryn; Boote, Claire; Glaspole, Ian; Goh, Nicole S L; Southcott, Anne M; Burge, Angela T; Gillies, Rebecca; Martin, Alicia; Holland, Anne E

    2017-07-01

    Uncertainty exists regarding the clinical relevance of exercise training across the range of interstitial lung diseases (ILDs). To establish the impact of exercise training in patients with ILDs of differing aetiology and severity. 142 participants with ILD (61 idiopathic pulmonary fibrosis (IPF), 22 asbestosis, 23 connective tissue disease-related ILD (CTD-ILD) and 36 with other aetiologies) were randomised to either 8 weeks of supervised exercise training or usual care. Six-minute walk distance (6MWD), Chronic Respiratory Disease Questionnaire (CRDQ), St George Respiratory Questionnaire IPF-specific version (SGRQ-I) and modified Medical Research Council dyspnoea score were measured at baseline, 9 weeks and 6 months. Exercise training significantly increased 6MWD (25 m, 95% CI 2 to 47 m) and health-related quality of life (CRDQ and SGRQ-I) in people with ILD. Larger improvements in 6MWD, CRDQ, SGRQ-I and dyspnoea occurred in asbestosis and IPF compared with CTD-ILD, but with few significant differences between subgroups. Benefits declined at 6 months except in CTD-ILD. Lower baseline 6MWD and worse baseline symptoms were associated with greater benefit in 6MWD and symptoms following training. Greater gains were seen in those whose exercise prescription was successfully progressed according to the protocol. At 6 months, sustained improvements in 6MWD and symptoms were associated with better baseline lung function and less pulmonary hypertension. Exercise training is effective in patients across the range of ILDs, with clinically meaningful benefits in asbestosis and IPF. Successful exercise progression maximises improvements and sustained treatment effects favour those with milder disease. Results, ACTRN12611000416998. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  14. Comparison between surgery and physiotherapy in the treatment of small and medium-sized tears of the rotator cuff: A randomised controlled study of 103 patients with one-year follow-up.

    PubMed

    Moosmayer, S; Lund, G; Seljom, U; Svege, I; Hennig, T; Tariq, R; Smith, H-J

    2010-01-01

    In order to compare the outcome from surgical repair and physiotherapy, 103 patients with symptomatic small and medium-sized tears of the rotator cuff were randomly allocated to one of the two approaches. The primary outcome measure was the Constant score, and secondary outcome measures included the self-report section of the American Shoulder and Elbow Surgeons score, the Short Form 36 Health Survey and subscores for shoulder movement, pain, strength and patient satisfaction. Scores were taken at baseline and after six and 12 months by a blinded assessor. Nine patients (18%) with insufficient benefit from physiotherapy after at least 15 treatment sessions underwent secondary surgical treatment. Analysis of between-group differences showed better results for the surgery group on the Constant scale (difference 13.0 points, p - 0.002), on the American Shoulder and Elbow surgeons scale (difference 16.1 points, p < 0.0005), for pain-free abduction (difference 28.8 degrees , p = 0.003) and for reduction in pain (difference on a visual analogue scale -1.7 cm, p < 0.0005).

  15. Telehealth for patients at high risk of cardiovascular disease: pragmatic randomised controlled trial

    PubMed Central

    O’Cathain, Alicia; Thomas, Clare; Edwards, Louisa; Gaunt, Daisy; Dixon, Padraig; Hollinghurst, Sandra; Nicholl, Jon; Large, Shirley; Yardley, Lucy; Fahey, Tom; Foster, Alexis; Garner, Katy; Horspool, Kimberley; Man, Mei-See; Rogers, Anne; Pope, Catherine; Montgomery, Alan A

    2016-01-01

    Objective To assess whether non-clinical staff can effectively manage people at high risk of cardiovascular disease using digital health technologies. Design Pragmatic, multicentre, randomised controlled trial. Setting 42 general practices in three areas of England. Participants Between 3 December 2012 and 23 July 2013 we recruited 641 adults aged 40 to 74 years with a 10 year cardiovascular disease risk of 20% or more, no previous cardiovascular event, at least one modifiable risk factor (systolic blood pressure ≥140 mm Hg, body mass index ≥30, current smoker), and access to a telephone, the internet, and email. Participants were individually allocated to intervention (n=325) or control (n=316) groups using automated randomisation stratified by site, minimised by practice and baseline risk score. Interventions Intervention was the Healthlines service (alongside usual care), comprising regular telephone calls from trained lay health advisors following scripts generated by interactive software. Advisors facilitated self management by supporting participants to use online resources to reduce risk factors, and sought to optimise drug use, improve treatment adherence, and encourage healthier lifestyles. The control group comprised usual care alone. Main outcome measures The primary outcome was the proportion of participants responding to treatment, defined as maintaining or reducing their cardiovascular risk after 12 months. Outcomes were collected six and 12 months after randomisation and analysed masked. Participants were not masked. Results 50% (148/295) of participants in the intervention group responded to treatment compared with 43% (124/291) in the control group (adjusted odds ratio 1.3, 95% confidence interval 1.0 to 1.9; number needed to treat=13); a difference possibly due to chance (P=0.08). The intervention was associated with reductions in blood pressure (difference in mean systolic −2.7 mm Hg (95% confidence interval −4.7 to −0.6 mm Hg

  16. The Societal and Economic Value of Rotator Cuff Repair

    PubMed Central

    Mather, Richard C.; Koenig, Lane; Acevedo, Daniel; Dall, Timothy M.; Gallo, Paul; Romeo, Anthony; Tongue, John; Williams, Gerald

    2013-01-01

    Background: Although rotator cuff disease is a common musculoskeletal problem in the United States, the impact of this condition on earnings, missed workdays, and disability payments is largely unknown. This study examines the value of surgical treatment for full-thickness rotator cuff tears from a societal perspective. Methods: A Markov decision model was constructed to estimate lifetime direct and indirect costs associated with surgical and continued nonoperative treatment for symptomatic full-thickness rotator cuff tears. All patients were assumed to have been unresponsive to one six-week trial of nonoperative treatment prior to entering the model. Model assumptions were obtained from the literature and data analysis. We obtained estimates of indirect costs using national survey data and patient-reported outcomes. Four indirect costs were modeled: probability of employment, household income, missed workdays, and disability payments. Direct cost estimates were based on average Medicare reimbursements with adjustments to an all-payer population. Effectiveness was expressed in quality-adjusted life years (QALYs). Results: The age-weighted mean total societal savings from rotator cuff repair compared with nonoperative treatment was $13,771 over a patient’s lifetime. Savings ranged from $77,662 for patients who are thirty to thirty-nine years old to a net cost to society of $11,997 for those who are seventy to seventy-nine years old. In addition, surgical treatment results in an average improvement of 0.62 QALY. Societal savings were highly sensitive to age, with savings being positive at the age of sixty-one years and younger. The estimated lifetime societal savings of the approximately 250,000 rotator cuff repairs performed in the U.S. each year was $3.44 billion. Conclusions: Rotator cuff repair for full-thickness tears produces net societal cost savings for patients under the age of sixty-one years and greater QALYs for all patients. Rotator cuff repair is cost

  17. Falls and mobility in Parkinson's disease: protocol for a randomised controlled clinical trial

    PubMed Central

    2011-01-01

    Background Although physical therapy and falls prevention education are argued to reduce falls and disability in people with idiopathic Parkinson's disease, this has not yet been confirmed with a large scale randomised controlled clinical trial. The study will investigate the effects on falls, mobility and quality of life of (i) movement strategy training combined with falls prevention education, (ii) progressive resistance strength training combined with falls prevention education, (iii) a generic life-skills social program (control group). Methods/Design People with idiopathic Parkinson's disease who live at home will be recruited and randomly allocated to one of three groups. Each person shall receive therapy in an out-patient setting in groups of 3-4. Each group shall be scheduled to meet once per week for 2 hours for 8 consecutive weeks. All participants will also have a structured 2 hour home practice program for each week during the 8 week intervention phase. Assessments will occur before therapy, after the 8 week therapy program, and at 3 and 12 months after the intervention. A falls calendar will be kept by each participant for 12 months after outpatient therapy. Consistent with the recommendations of the Prevention of Falls Network Europe group, three falls variables will be used as the primary outcome measures: the number of fallers, the number of multiple fallers and the falls rate. In addition to quantifying falls, we shall measure mobility, activity limitations and quality of life as secondary outcomes. Discussion This study has the potential to determine whether outpatient movement strategy training combined with falls prevention education or progressive resistance strength training combined with falls prevention education are effective for reducing falls and improving mobility and life quality in people with Parkinson's disease who live at home. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12606000344594 PMID

  18. TCH346 as a neuroprotective drug in Parkinson's disease: a double-blind, randomised, controlled trial.

    PubMed

    Olanow, C Warren; Schapira, Anthony H V; LeWitt, Peter A; Kieburtz, Karl; Sauer, Dirk; Olivieri, Gianfranco; Pohlmann, Harald; Hubble, Jean

    2006-12-01

    There is an important unmet medical need in Parkinson's disease for a neuroprotective treatment that slows or stops disease progression. TCH346 is a potent anti-apoptotic drug that protects against loss of dopaminergic neurons in laboratory models. Our aim was to assess TCH346 as a neuroprotective drug in patients with Parkinson's disease. Patients presenting at 45 international movement disorder clinics with early untreated Parkinson's disease were assessed as part of this parallel-group, double-blind, randomised controlled trial. 301 eligible patients were randomly assigned 12-18 months' treatment with TCH346 at a daily dose of 0.5 mg (n=78), 2.5 mg (n=79), or 10 mg (n=73), or placebo (n=71), followed by a 4 week washout period. The primary outcome measure was time to development of a disability requiring dopaminergic treatment. Secondary outcome measures were the annual rate of change in the unified Parkinson's disease rating scale (UPDRS) and the PDQ-39, a measure of quality of life. Analyses were by intention-to-treat. This study is pending registration with . 255 patients completed the study. TCH346 did not differ from placebo for any of the study outcomes. Treatment was needed in 26 (34%) patients in the TCH346 0.5 mg group, 30 (38%) in the TCH346 2.5 mg group, 24 (33%) in the TCH346 10 mg group, and 23 (32%) in the placebo group. There were no significant differences between groups. There were no differences between groups in the annual change in the UPDRS or PDQ-39 either. Few patients withdrew because of adverse events and none was judged to be related to the study intervention. TCH346 did not show evidence of a neuroprotective effect. The discrepancy between the preclinical promise of TCH346 and the clinical outcome could have arisen because of the use of laboratory models that do not accurately reflect the pathogenesis of Parkinson's disease, the doses of study drug used, insensitive clinical endpoints, and the patient population selected for study.

  19. Characteristics of randomised trials on diseases in the digestive system registered in ClinicalTrials.gov: a retrospective analysis.

    PubMed

    Wildt, Signe; Krag, Aleksander; Gluud, Liselotte

    2011-01-01

    Objectives To evaluate the adequacy of reporting of protocols for randomised trials on diseases of the digestive system registered in http://ClinicalTrials.gov and the consistency between primary outcomes, secondary outcomes and sample size specified in http://ClinicalTrials.gov and published trials. Methods Randomised phase III trials on adult patients with gastrointestinal diseases registered before January 2009 in http://ClinicalTrials.gov were eligible for inclusion. From http://ClinicalTrials.gov all data elements in the database required by the International Committee of Medical Journal Editors (ICMJE) member journals were extracted. The subsequent publications for registered trials were identified. For published trials, data concerning publication date, primary and secondary endpoint, sample size, and whether the journal adhered to ICMJE principles were extracted. Differences between primary and secondary outcomes, sample size and sample size calculations data in http://ClinicalTrials.gov and in the published paper were registered. Results 105 trials were evaluated. 66 trials (63%) were published. 30% of trials were registered incorrectly after their completion date. Several data elements of the required ICMJE data list were not filled in, with missing data in 22% and 11%, respectively, of cases concerning the primary outcome measure and sample size. In 26% of the published papers, data on sample size calculations were missing and discrepancies between sample size reporting in http://ClinicalTrials.gov and published trials existed. Conclusion The quality of registration of randomised controlled trials still needs improvement.

  20. Predicting rotator cuff tears using data mining and Bayesian likelihood ratios.

    PubMed

    Lu, Hsueh-Yi; Huang, Chen-Yuan; Su, Chwen-Tzeng; Lin, Chen-Chiang

    2014-01-01

    Rotator cuff tear is a common cause of shoulder diseases. Correct diagnosis of rotator cuff tears can save patients from further invasive, costly and painful tests. This study used predictive data mining and Bayesian theory to improve the accuracy of diagnosing rotator cuff tears by clinical examination alone. In this retrospective study, 169 patients who had a preliminary diagnosis of rotator cuff tear on the basis of clinical evaluation followed by confirmatory MRI between 2007 and 2011 were identified. MRI was used as a reference standard to classify rotator cuff tears. The predictor variable was the clinical assessment results, which consisted of 16 attributes. This study employed 2 data mining methods (ANN and the decision tree) and a statistical method (logistic regression) to classify the rotator cuff diagnosis into "tear" and "no tear" groups. Likelihood ratio and Bayesian theory were applied to estimate the probability of rotator cuff tears based on the results of the prediction models. Our proposed data mining procedures outperformed the classic statistical method. The correction rate, sensitivity, specificity and area under the ROC curve of predicting a rotator cuff tear were statistical better in the ANN and decision tree models compared to logistic regression. Based on likelihood ratios derived from our prediction models, Fagan's nomogram could be constructed to assess the probability of a patient who has a rotator cuff tear using a pretest probability and a prediction result (tear or no tear). Our predictive data mining models, combined with likelihood ratios and Bayesian theory, appear to be good tools to classify rotator cuff tears as well as determine the probability of the presence of the disease to enhance diagnostic decision making for rotator cuff tears.

  1. Predicting Rotator Cuff Tears Using Data Mining and Bayesian Likelihood Ratios

    PubMed Central

    Lu, Hsueh-Yi; Huang, Chen-Yuan; Su, Chwen-Tzeng; Lin, Chen-Chiang

    2014-01-01

    Objectives Rotator cuff tear is a common cause of shoulder diseases. Correct diagnosis of rotator cuff tears can save patients from further invasive, costly and painful tests. This study used predictive data mining and Bayesian theory to improve the accuracy of diagnosing rotator cuff tears by clinical examination alone. Methods In this retrospective study, 169 patients who had a preliminary diagnosis of rotator cuff tear on the basis of clinical evaluation followed by confirmatory MRI between 2007 and 2011 were identified. MRI was used as a reference standard to classify rotator cuff tears. The predictor variable was the clinical assessment results, which consisted of 16 attributes. This study employed 2 data mining methods (ANN and the decision tree) and a statistical method (logistic regression) to classify the rotator cuff diagnosis into “tear” and “no tear” groups. Likelihood ratio and Bayesian theory were applied to estimate the probability of rotator cuff tears based on the results of the prediction models. Results Our proposed data mining procedures outperformed the classic statistical method. The correction rate, sensitivity, specificity and area under the ROC curve of predicting a rotator cuff tear were statistical better in the ANN and decision tree models compared to logistic regression. Based on likelihood ratios derived from our prediction models, Fagan's nomogram could be constructed to assess the probability of a patient who has a rotator cuff tear using a pretest probability and a prediction result (tear or no tear). Conclusions Our predictive data mining models, combined with likelihood ratios and Bayesian theory, appear to be good tools to classify rotator cuff tears as well as determine the probability of the presence of the disease to enhance diagnostic decision making for rotator cuff tears. PMID:24733553

  2. A Scoping Review of Economic Evaluations Alongside Randomised Controlled Trials of Home Monitoring in Chronic Disease Management.

    PubMed

    Kidholm, Kristian; Kristensen, Mie Borch Dahl

    2017-09-04

    Many countries have considered telemedicine and home monitoring of patients as a solution to the demographic challenges that health-care systems face. However, reviews of economic evaluations of telemedicine have identified methodological problems in many studies as they do not comply with guidelines. The aim of this study was to examine economic evaluations alongside randomised controlled trials of home monitoring in chronic disease management and hereby to explore the resources included in the programme costs, the types of health-care utilisation that change as a result of home monitoring and discuss the value of economic evaluation alongside randomised controlled trials of home monitoring on the basis of the studies identified. A scoping review of economic evaluations of home monitoring of patients with chronic disease based on randomised controlled trials and including information on the programme costs and the costs of equipment was carried out based on a Medline (PubMed) search. Nine studies met the inclusion criteria. All studies include both costs of equipment and use of staff, but there is large variation in the types of equipment and types of tasks for the staff included in the costs. Equipment costs constituted 16-73% of the total programme costs. In six of the nine studies, home monitoring resulted in a reduction in primary care or emergency contacts. However, in total, home monitoring resulted in increased average costs per patient in six studies and reduced costs in three of the nine studies. The review is limited by the small number of studies found and the restriction to randomised controlled trials, which can be problematic in this area due to lack of blinding of patients and healthcare professionals and the difficulty of implementing organisational changes in hospital departments for the limited period of a trial. Furthermore, our results may be based on assessments of older telemedicine interventions.

  3. Doxycycline in Creutzfeldt-Jakob disease: a phase 2, randomised, double-blind, placebo-controlled trial.

    PubMed

    Haïk, Stéphane; Marcon, Gabriella; Mallet, Alain; Tettamanti, Mauro; Welaratne, Arlette; Giaccone, Giorgio; Azimi, Shohreh; Pietrini, Vladimiro; Fabreguettes, Jean-Roch; Imperiale, Daniele; Cesaro, Pierre; Buffa, Carlo; Aucan, Christophe; Lucca, Ugo; Peckeu, Laurène; Suardi, Silvia; Tranchant, Christine; Zerr, Inga; Houillier, Caroline; Redaelli, Veronica; Vespignani, Hervé; Campanella, Angela; Sellal, François; Krasnianski, Anna; Seilhean, Danielle; Heinemann, Uta; Sedel, Frédéric; Canovi, Mara; Gobbi, Marco; Di Fede, Giuseppe; Laplanche, Jean-Louis; Pocchiari, Maurizio; Salmona, Mario; Forloni, Gianluigi; Brandel, Jean-Philippe; Tagliavini, Fabrizio

    2014-02-01

    Creutzfeldt-Jakob disease (CJD) is a fatal, untreatable prion encephalopathy. Previous studies showed that doxycycline is effective in in-vitro and in-vivo models of disease, and patients with CJD who received compassionate treatment with doxycycline showed increased survival time compared with historical series. We therefore did a randomised, double-blind study of doxycycline versus placebo in CJD. We recruited patients older than 18 years old who had a diagnosis of definite or probable sporadic CJD or genetic forms of the disease via Italian reference centres and the French national referral system. Patients were randomly assigned (ratio 1:1) to receive oral doxycycline (100 mg daily) or placebo under double-blind conditions from the day of randomisation to death. Centralised randomisation was done independently of enrolment or evaluation of patients using a minimisation method in Italy and a simple randomisation in France. Participants, caregivers, and clinicians were masked to group assignment. The primary efficacy variable was the survival time from randomisation. Interim analyses were planned to detect a significant effect of treatment as early as possible. This trial is registered with EudraCT, 2006-001858-27 for the Italian study and 2007-005553-34 for the French study. From April 12, 2007, to Aug 19, 2010, in Italy, and from Jan 30, 2009, to Jan 10, 2012, in France, 121 patients with CJD were enrolled in the study, 62 of whom were randomly assigned to the treatment group and 59 to the placebo group. The first interim analysis showed absence of superiority of doxycycline compared with placebo, and the trial was stopped for futility. Efficacy analyses did not show significant differences between patients treated with doxycycline and placebo with regard to survival times (HR 1.1, 95% CI 0.8-1.7, p=0.50). Serious adverse events were judged not to be related to treatment, whereas a relation was deemed probable or possible for five non-serious adverse events

  4. Association between alcohol and cardiovascular disease: Mendelian randomisation analysis based on individual participant data

    PubMed Central

    Holmes, Michael V; Dale, Caroline E; Zuccolo, Luisa; Silverwood, Richard J; Guo, Yiran; Ye, Zheng; Prieto-Merino, David; Dehghan, Abbas; Trompet, Stella; Wong, Andrew; Cavadino, Alana; Drogan, Dagmar; Padmanabhan, Sandosh; Yesupriya, Ajay; Leusink, Maarten; Sundstrom, Johan; Hubacek, Jaroslav A; Pikhart, Hynek; Swerdlow, Daniel I; Panayiotou, Andrie G; Borinskaya, Svetlana A; Finan, Chris; Shah, Sonia; Kuchenbaecker, Karoline B; Shah, Tina; Engmann, Jorgen; Folkersen, Lasse; Eriksson, Per; Ricceri, Fulvio; Melander, Olle; Sacerdote, Carlotta; Gamble, Dale M; Rayaprolu, Sruti; Ross, Owen A; McLachlan, Stela; Vikhireva, Olga; Sluijs, Ivonne; Scott, Robert A; Adamkova, Vera; Flicker, Leon; van Bockxmeer, Frank M; Power, Christine; Marques-Vidal, Pedro; Meade, Tom; Marmot, Michael G; Ferro, Jose M; Paulos-Pinheiro, Sofia; Humphries, Steve E; Talmud, Philippa J; Leach, Irene Mateo; Verweij, Niek; Linneberg, Allan; Skaaby, Tea; Doevendans, Pieter A; Cramer, Maarten J; van der Harst, Pim; Klungel, Olaf H; Dowling, Nicole F; Dominiczak, Anna F; Kumari, Meena; Nicolaides, Andrew N; Weikert, Cornelia; Boeing, Heiner; Ebrahim, Shah; Gaunt, Tom R; Price, Jackie F; Lannfelt, Lars; Peasey, Anne; Kubinova, Ruzena; Pajak, Andrzej; Malyutina, Sofia; Voevoda, Mikhail I; Tamosiunas, Abdonas; Maitland-van der Zee, Anke H; Norman, Paul E; Hankey, Graeme J; Bergmann, Manuela M; Hofman, Albert; Franco, Oscar H; Cooper, Jackie; Palmen, Jutta; Spiering, Wilko; de Jong, Pim A; Kuh, Diana; Hardy, Rebecca; Uitterlinden, Andre G; Ikram, M Arfan; Ford, Ian; Hyppönen, Elina; Almeida, Osvaldo P; Wareham, Nicholas J; Khaw, Kay-Tee; Hamsten, Anders; Husemoen, Lise Lotte N; Tjønneland, Anne; Tolstrup, Janne S; Rimm, Eric; Beulens, Joline W J; Verschuren, W M Monique; Onland-Moret, N Charlotte; Hofker, Marten H; Wannamethee, S Goya; Whincup, Peter H; Morris, Richard; Vicente, Astrid M; Watkins, Hugh; Farrall, Martin; Jukema, J Wouter; Meschia, James; Cupples, L Adrienne; Sharp, Stephen J; Fornage, Myriam; Kooperberg, Charles; LaCroix, Andrea Z; Dai, James Y; Lanktree, Matthew B; Siscovick, David S; Jorgenson, Eric; Spring, Bonnie; Coresh, Josef; Buxbaum, Sarah G; Schreiner, Pamela J; Ellison, R Curtis; Tsai, Michael Y; Patel, Sanjay R; Redline, Susan; Johnson, Andrew D; Hoogeveen, Ron C; Hakonarson, Hakon; Rotter, Jerome I; Boerwinkle, Eric; de Bakker, Paul I W; Kivimaki, Mika; Asselbergs, Folkert W; Sattar, Naveed; Lawlor, Debbie A; Whittaker, John; Davey Smith, George; Mukamal, Kenneth; Psaty, Bruce M; Wilson, James G; Lange, Leslie A; Hamidovic, Ajna; Hingorani, Aroon D; Nordestgaard, Børge G; Bobak, Martin; Leon, David A; Langenberg, Claudia; Palmer, Tom M; Reiner, Alex P; Keating, Brendan J; Dudbridge, Frank

    2014-01-01

    Objective To use the rs1229984 variant in the alcohol dehydrogenase 1B gene (ADH1B) as an instrument to investigate the causal role of alcohol in cardiovascular disease. Design Mendelian randomisation meta-analysis of 56 epidemiological studies. Participants 261 991 individuals of European descent, including 20 259 coronary heart disease cases and 10 164 stroke events. Data were available on ADH1B rs1229984 variant, alcohol phenotypes, and cardiovascular biomarkers. Main outcome measures Odds ratio for coronary heart disease and stroke associated with the ADH1B variant in all individuals and by categories of alcohol consumption. Results Carriers of the A-allele of ADH1B rs1229984 consumed 17.2% fewer units of alcohol per week (95% confidence interval 15.6% to 18.9%), had a lower prevalence of binge drinking (odds ratio 0.78 (95% CI 0.73 to 0.84)), and had higher abstention (odds ratio 1.27 (1.21 to 1.34)) than non-carriers. Rs1229984 A-allele carriers had lower systolic blood pressure (−0.88 (−1.19 to −0.56) mm Hg), interleukin-6 levels (−5.2% (−7.8 to −2.4%)), waist circumference (−0.3 (−0.6 to −0.1) cm), and body mass index (−0.17 (−0.24 to −0.10) kg/m2). Rs1229984 A-allele carriers had lower odds of coronary heart disease (odds ratio 0.90 (0.84 to 0.96)). The protective association of the ADH1B rs1229984 A-allele variant remained the same across all categories of alcohol consumption (P=0.83 for heterogeneity). Although no association of rs1229984 was identified with the combined subtypes of stroke, carriers of the A-allele had lower odds of ischaemic stroke (odds ratio 0.83 (0.72 to 0.95)). Conclusions Individuals with a genetic variant associated with non-drinking and lower alcohol consumption had a more favourable cardiovascular profile and a reduced risk of coronary heart disease than those without the genetic variant. This suggests that reduction of alcohol consumption, even for light to moderate drinkers, is beneficial for

  5. Top-down Infliximab Study in Kids with Crohn's disease (TISKids): an international multicentre randomised controlled trial

    PubMed Central

    Cozijnsen, M A; van Pieterson, M; Samsom, J N; Escher, J C; de Ridder, L

    2016-01-01

    Introduction Crohn's disease (CD) is a chronic inflammatory disease predominantly affecting the gastrointestinal tract. CD usually requires lifelong medication and is accompanied by severe complications, such as fistulae and strictures, resulting in surgery. Infliximab (IFX) is very effective for treating paediatric patients with CD, but is currently only registered for therapy refractory patients—the so-called step-up strategy. We hypothesise that using IFX first-line, that is, top-down, will give more mucosal healing, fewer relapses, less complications, need for surgery and hospitalisation. Methods and analysis This international multicentre open-label randomised controlled trial includes children, aged 3–17 years, with new-onset, untreated CD with moderate-to-severe disease activity (weighted Paediatric Crohn's Disease Activity Index (wPCDAI)>40). Eligible patients will be randomised to top-down or step-up treatment. Top-down treatment consists of 5 IFX infusions combined with azathioprine (AZA). After these 5 infusions, patients will continue AZA. Patients randomised to step-up will receive standard induction treatment, either oral prednisolone or exclusive enteral nutrition, combined with AZA as maintenance treatment. The primary outcome is clinical remission (wPCDAI<12.5) at 52 weeks without need for additional CD-related therapy or surgery. Total follow-up is 5 years. Secondary outcomes include clinical disease activity, mucosal healing by endoscopy (at week 10 and optionally week 52), faecal calprotectin, growth, quality of life, medication use and adverse events. Ethics and dissemination Conducted according to the Declaration of Helsinki and Good Clinical Practice. Medical-ethical approval will be obtained for each site. Trial registration number NCT02517684; Pre-results. PMID:28090335

  6. Relationship of ABO Blood Type on Rotator Cuff Tears.

    PubMed

    Lee, Doo-Hyung; Lee, Han-Dong; Yoon, Seung-Hyun

    2015-11-01

    ABO blood groups are associated with various diseases. A relationship between Achilles tendon ruptures and blood type O has been reported, although its pathogenesis was not clear. To the best of our knowledge, there is no published study describing the relationship between blood type and rotator cuff tendon tears. To determine whether patients with rotator cuff tear had a greater prevalence of blood type O than those without rotator cuff tear. A cross-sectional study. Research hospital outpatient evaluation. A total of 316 subjects with shoulder pain were included and divided into "tear" and "no-tear" groups according to ultrasonographic examination. ABO blood group, gender, dominant arm, smoking history, trauma history, and age were compared between the 2 groups and the odds ratios of these factors were evaluated by logistic regression. The tear group (38.6%) had more instances of blood type O than the healthy population (27.2%; P = .002). The adjusted odds ratio for rotator cuff tear for blood type O to non-O was 2.38 (95% confidence interval 1.28-4.42). The odds ratios for rotator cuff tears for smoking, major trauma history, minor trauma history, and age were 2.08, 3.11, 2.29, and 1.06, respectively. Patients with rotator cuff tears were more likely to have blood type O. The odds ratios of factors for rotator cuff tears were high in the following order: major trauma history, blood type O, minor trauma history, and age. Copyright © 2015 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

  7. Pramipexole in patients with early Parkinson's disease (PROUD): a randomised delayed-start trial.

    PubMed

    Schapira, Anthony H V; McDermott, Michael P; Barone, Paolo; Comella, Cynthia L; Albrecht, Stefan; Hsu, Helen H; Massey, Daniel H; Mizuno, Yoshikuni; Poewe, Werner; Rascol, Olivier; Marek, Kenneth

    2013-08-01

    In models of dopaminergic neuronal loss, the dopamine agonist pramipexole has exhibited neuroprotective properties. The Pramipexole On Underlying Disease (PROUD) study was designed to identify whether early versus delayed pramipexole initiation has clinical and neuroimaging benefits in patients with Parkinson's disease (PD). Between May 24, 2006, and April 22, 2009, at 98 centres, we recruited patients with PD diagnosed within 2 years and aged 30-79 years. We randomly assigned eligible patients (ratio 1:1), by a centralised, computerised randomisation schedule, to receive double-blind either placebo or pramipexole (1·5 mg a day) and followed them up for 15 months. At 9 months, or as early as 6 months if considered necessary, placebo recipients were assigned to pramipexole. In a neuroimaging substudy, striatal dopamine-transporter binding was assessed by SPECT. All patients, investigators, and independent raters were masked to study treatment. The primary endpoint was the 15-month change from baseline in total score on the unified Parkinson's disease rating scale (UPDRS). This trial is registered with ClinicalTrials.gov, number NCT00321854. Of 535 patients, 261 were randomly assigned to receive pramipexole and 274 to receive placebo. At 15 months (n=411), adjusted mean change in UPDRS total score showed no significant difference between early and delayed pramipexole (-0·4 points, 95% CI -2·2 to 1·4, p=0·65). 62 patients in the early pramipexole group and 61 patients in the delayed pramipexole group were included in the neuroimaging substudy, for which the adjusted mean 15-month change in striatal (123)I-FP-CIT binding was -15·1% (SE 2·1) for early and -14·6% (2·0) for delayed pramipexole (difference -0·5 percentage points, 95% CI -5·4 to 4·4, p=0·84). Overall, 180 (81%) of patients given early pramipexole and 179 (84%) patients given delayed pramipexole reported adverse events (most frequently nausea), and 22 (10%) patients in the early pramipexole

  8. Pramipexole in patients with early Parkinson's disease (PROUD): a randomised delayed-start trial

    PubMed Central

    Schapira, Anthony HV; McDermott, Michael P; Barone, Paolo; Comella, Cynthia L; Albrecht, Stefan; Hsu, Helen H; Massey, Daniel H; Mizuno, Yoshikuni; Poewe, Werner; Rascol, Olivier; Marek, Kenneth

    2013-01-01

    Summary Background In models of dopaminergic neuronal loss, the dopamine agonist pramipexole has exhibited neuroprotective properties. The Pramipexole On Underlying Disease (PROUD) study was designed to identify whether early versus delayed pramipexole initiation has clinical and neuroimaging benefits in patients with Parkinson's disease (PD). Methods Between May 24, 2006, and April 22, 2009, at 98 centres, we recruited patients with PD diagnosed within 2 years and aged 30–79 years. We randomly assigned eligible patients (ratio 1:1), by a centralised, computerised randomisation schedule, to receive double-blind either placebo or pramipexole (1·5 mg a day) and followed them up for 15 months. At 9 months, or as early as 6 months if considered necessary, placebo recipients were assigned to pramipexole. In a neuroimaging substudy, striatal dopamine-transporter binding was assessed by SPECT. All patients, investigators, and independent raters were masked to study treatment. The primary endpoint was the 15-month change from baseline in total score on the unified Parkinson's disease rating scale (UPDRS). This trial is registered with ClinicalTrials.gov, number NCT00321854. Findings Of 535 patients, 261 were randomly assigned to receive pramipexole and 274 to receive placebo. At 15 months (n=411), adjusted mean change in UPDRS total score showed no significant difference between early and delayed pramipexole (−0·4 points, 95% CI −2·2 to 1·4, p=0·65). 62 patients in the early pramipexole group and 61 patients in the delayed pramipexole group were included in the neuroimaging substudy, for which the adjusted mean 15-month change in striatal 123I-FP-CIT binding was −15·1% (SE 2·1) for early and −14·6% (2·0) for delayed pramipexole (difference −0·5 percentage points, 95% CI −5·4 to 4·4, p=0·84). Overall, 180 (81%) of patients given early pramipexole and 179 (84%) patients given delayed pramipexole reported adverse events (most frequently nausea), and

  9. Efficacy of occupational therapy for patients with Parkinson's disease: a randomised controlled trial.

    PubMed

    Sturkenboom, Ingrid H W M; Graff, Maud J L; Hendriks, Jan C M; Veenhuizen, Yvonne; Munneke, Marten; Bloem, Bastiaan R; Nijhuis-van der Sanden, Maria W

    2014-06-01

    There is insufficient evidence to support use of occupational therapy interventions for patients with Parkinson's disease. We aimed to assess the efficacy of occupational therapy in improving daily activities of patients with Parkinson's disease. We did a multicentre, assessor-masked, randomised controlled clinical trial in ten hospitals in nine Dutch regional networks of specialised health-care professionals (ParkinsonNet), with assessment at 3 months and 6 months. Patients with Parkinson's disease with self-reported difficulties in daily activities were included, along with their primary caregivers. Patients were randomly assigned (2:1) to the intervention or control group by a computer-generated minimisation algorithm. The intervention consisted of 10 weeks of home-based occupational therapy according to national practice guidelines; control individuals received usual care with no occupational therapy. The primary outcome was self-perceived performance in daily activities at 3 months, assessed with the Canadian Occupational Performance Measure (score 1-10). Data were analysed using linear mixed models for repeated measures (intention-to-treat principle). Assessors monitored safety by asking patients about any unusual health events during the preceding 3 months. This trial is registered with ClinicalTrials.gov, NCT01336127. Between April 14, 2011, and Nov 2, 2012, 191 patients were randomly assigned to the intervention group (n=124) or the control group (n=67). 117 (94%) of 124 patients in the intervention group and 63 (94%) of 67 in the control group had a participating caregiver. At baseline, the median score on the Canadian Occupational Performance Measure was 4·3 (IQR 3·5-5·0) in the intervention group and 4·4 (3·8-5·0) in the control group. At 3 months, these scores were 5·8 (5·0-6·4) and 4·6 (4·6-6·6), respectively. The adjusted mean difference in score between groups at 3 months was in favour of the intervention group (1·2; 95% CI 0·8-1·6; p

  10. Randomised controlled trial of a lay-led self-management programme for Bangladeshi patients with chronic disease

    PubMed Central

    Griffiths, Chris; Motlib, Justhna; Azad, Abdul; Ramsay, Jean; Eldridge, Sandra; Feder, Gene; Khanam, Rowshan; Munni, Rafia; Garrett, Myra; Turner, Andy; Barlow, Julia

    2005-01-01

    Background Reducing the impact of chronic disease in minority ethnic groups is an important public health challenge. Lay-led education may overcome cultural and language barriers that limit the effectiveness of professionally–led programmes. We report the first randomised trial of a lay-led self-management programme — the Chronic Disease Self-Management Programme (CDSMP) (Expert Patient Programme) — in a south Asian group. Aim To determine the effectiveness of a culturally-adapted lay–led self-management programme for Bangladeshi adults with chronic disease. Design of study Randomised controlled trial. Setting Tower Hamlets, east London. Method We recruited Bangladeshi adults with diabetes, cardiovascular disease, respiratory disease or arthritis from general practices and randomised them to the CDSMP or waiting-list control. Self-efficacy (primary outcome), self-management behaviour, communication with clinician, depression scores, and healthcare use were assessed by blinded interviewer-administered questionnaires in Sylheti before randomisation and 4 months later. Results Of the 1363 people invited, 476 (34%) agreed to take part and 92% (439/476) of participants were followed up. The programme improved self-efficacy (difference: 0.67, 95% confidence interval [CI] = 0.08 to 1.25) and self-management behaviour (0.53; 95% CI = 0.01 to 1.06). In the 51% (121/238) of intervention participants attending three or more of the 6-weekly education sessions the programme led to greater improvements in self-efficacy (1.47; 95% CI = 0.50 to 1.82) and self-management behaviour (1.16; 95% CI = 0.50 to 1.82), and reduced HADS depression scores (0.64; 95% CI = 0.07 to 1.22). Communication and healthcare use were not significantly different between groups. The programme cost £123 (€181) per participant. Conclusion A culturally-adapted CDSMP improves self-efficacy and self-care behaviour in Bangladeshi patients with chronic disease. Effects on health status were marginal

  11. Home screening for sexually transmitted diseases in high‐risk young women: randomised controlled trial

    PubMed Central

    Cook, Robert L; Østergaard, Lars; Hillier, Sharon L; Murray, Pamela J; Chang, Chung‐Chou H; Comer, Diane M; Ness, Roberta B

    2007-01-01

    Objective Home screening tests could eliminate several barriers to testing sexually transmitted diseases (STDs). Aim To determine whether offering repeated home screening tests would increase the rate of testing for chlamydia and gonorrhoea in a high‐risk sample of young women. Methods In this randomised controlled trial, 403 young women (mean age 18.9 years, 70% black) with a recent STD or with STD‐related risk factors were enrolled. Participants were recruited from clinics and high‐prevalence neighbourhoods and then randomly assigned to receive either a home testing kit or an invitation to attend a medical clinic for testing at 6, 12 and 18 months after enrollment. Over 80% of women were followed for 2 years. The trial is registered with ClinicalTrials.gov, number NCT 00177437. Results Of 197 women in the intervention group, 140 (71%) returned at least one home test and 25 of 249 (10%) home tests were positive. Women who received home screening tests completed significantly more STD tests overall (1.94 vs 1.41 tests per woman‐year, p<0.001) and more STD tests in the absence of symptoms (1.18 vs 0.75 tests per woman‐year, p<0.001). More women in the intervention group completed at least one test when asymptomatic (162 (82.2%) vs 117 (61.3%), p<0.001). The intervention was most effective among women recruited outside medical clinics. There was no significant difference in the overall rate of STDs detected. Conclusions Home screening significantly increased the utilisation of chlamydia and gonorrhoea testing in this sample of high‐risk young women, and thus represents a feasible strategy to facilitate STD testing in young women. PMID:17301105

  12. Alternative vs. conventional treatment given on-demand for gastroesophageal reflux disease: a randomised controlled trial

    PubMed Central

    Farup, Per G; Heibert, Mathis; Høeg, Victor

    2009-01-01

    Background Alternative treatments are commonly used for various disorders and often taken on-demand. On-demand treatment of gastroesophageal reflux disease (GERD) with pharmaceutical products is an established, cost-effective strategy. Comparisons between alternative medicine and pharmaceutical products are rare. The aim of this trial was to compare on-demand treatment with a pectin-based, raft-forming, natural, anti-reflux agent (PRA) with that of esomeprazole 20 mg (Eso20) in patients with mild/moderate GERD. Methods Patients with mild/moderate GERD were randomised to a six weeks' on-demand treatment with PRA or Eso20 in a pragmatic, open, multicentre trial. Overall satisfaction with treatment, satisfactory relief on a weekly basis, reflux symptoms, and treatment preferences were noted. Results Seventy-seven patients were included in the analyses. Eso20 was significantly superior to PRA for proportion of overall satisfied patients (92% and 58% respectively; p = 0.001), reduction of symptoms (mean symptom scores at the end 5.9 and 8.0 respectively; p = 0.019), proportion of weeks of satisfactory relief (89% and 62% respectively; p = 0.008) and proportion preferring continuation with the same treatment (85% and 42% respectively; p < 0.001). Older patients were more satisfied than younger, and patients preferring on-demand treatment had lower symptom scores at inclusion than those preferring regular treatment. Conclusion On-demand treatment with esomeprazole 20 mg was clearly superior to the pectin-based raft-forming agent. Most patients preferred on-demand treatment to regular treatment. Those preferring regular therapy had significantly more symptoms at inclusion. Trial registration ClinicalTrials.gov: NCT00184522. PMID:19236727

  13. Alternative vs. conventional treatment given on-demand for gastroesophageal reflux disease: a randomised controlled trial.

    PubMed

    Farup, Per G; Heibert, Mathis; Høeg, Victor

    2009-02-24

    Alternative treatments are commonly used for various disorders and often taken on-demand. On-demand treatment of gastroesophageal reflux disease (GERD) with pharmaceutical products is an established, cost-effective strategy. Comparisons between alternative medicine and pharmaceutical products are rare. The aim of this trial was to compare on-demand treatment with a pectin-based, raft-forming, natural, anti-reflux agent (PRA) with that of esomeprazole 20 mg (Eso20) in patients with mild/moderate GERD. Patients with mild/moderate GERD were randomised to a six weeks' on-demand treatment with PRA or Eso20 in a pragmatic, open, multicentre trial. Overall satisfaction with treatment, satisfactory relief on a weekly basis, reflux symptoms, and treatment preferences were noted. Seventy-seven patients were included in the analyses. Eso20 was significantly superior to PRA for proportion of overall satisfied patients (92% and 58% respectively; p = 0.001), reduction of symptoms (mean symptom scores at the end 5.9 and 8.0 respectively; p = 0.019), proportion of weeks of satisfactory relief (89% and 62% respectively; p = 0.008) and proportion preferring continuation with the same treatment (85% and 42% respectively; p < 0.001). Older patients were more satisfied than younger, and patients preferring on-demand treatment had lower symptom scores at inclusion than those preferring regular treatment. On-demand treatment with esomeprazole 20 mg was clearly superior to the pectin-based raft-forming agent. Most patients preferred on-demand treatment to regular treatment. Those preferring regular therapy had significantly more symptoms at inclusion.

  14. Singing teaching as a therapy for chronic respiratory disease - a randomised controlled trial and qualitative evaluation

    PubMed Central

    2010-01-01

    Background Despite optimal pharmacological therapy and pulmonary rehabilitation, patients with COPD continue to be breathless. There is a need to develop additional strategies to alleviate symptoms. Learning to sing requires control of breathing and posture and might have benefits that translate into daily life. Methods To test this hypothesis we performed a randomised controlled trial, comparing a six week course of twice weekly singing classes to usual care, in 28 COPD patients. The experience of singing was assessed in a qualitative fashion, through interviews with a psychologist. In addition, we surveyed patients with chronic respiratory conditions who participated in a series of open singing workshops. Results In the RCT, the physical component score of the SF36 improved in the singers (n = 15) compared to the controls (n = 13); +7.5(14.6) vs. -3.8(8.4) p = 0.02. Singers also had a significant fall in HAD anxiety score; -1.1(2.7) vs. +0.8(1.7) p = 0.03. Singing did not improve single breath counting, breath hold time or shuttle walk distance. In the qualitative element, 8 patients from the singing group were interviewed. Positive effects on physical sensation, general well-being, community/social support and achievement/efficacy emerged as common themes. 150 participants in open workshops completed a questionnaire. 96% rated the workshops as "very enjoyable" and 98% thought the workshop had taught them something about breathing in a different way. 81% of attendees felt a "marked physical difference" after the workshop. Conclusion Singing classes can improve quality of life measures and anxiety and are viewed as a very positive experience by patients with respiratory disease; no adverse consequences of participation were observed. Trial Registration Current Controlled Trials - ISRCTN17544114. PMID:20682030

  15. Effects of exercise training on sleep apnoea in patients with coronary artery disease: a randomised trial.

    PubMed

    Mendelson, Monique; Lyons, Owen D; Yadollahi, Azadeh; Inami, Toru; Oh, Paul; Bradley, T Douglas

    2016-07-01

    Overnight fluid shift from the legs to the neck and lungs may contribute to the pathogenesis of obstructive sleep apnoea (OSA) and central sleep apnoea (CSA). We hypothesised that exercise training will decrease the severity of OSA and CSA in patients with coronary artery disease (CAD) by decreasing daytime leg fluid accumulation and overnight rostral fluid shift.Patients with CAD and OSA or CSA (apnoea-hypopnoea index >15 events per h) were randomised to 4 weeks of aerobic exercise training or to a control group. Polysomnography, with measurement of leg, thoracic and neck fluid volumes and upper-airway cross-sectional area (UA-XSA) before and after sleep, was performed at baseline and follow-up.17 patients per group completed the study. Apnoea-hypopnoea index decreased significantly more in the exercise group than in the control group (31.1±12.9 to 20.5±9.4 versus 28.1±13.5 to 27.0±15.1 events per h, p=0.047), in association with a greater reduction in the overnight change in leg fluid volume (579±222 to 466±163 versus 453±164 to 434±141 mL, p=0.04) and by a significantly greater increase in the overnight change in UA-XSA in the exercise group (p=0.04).In patients with CAD and sleep apnoea, exercise training decreases sleep apnoea severity via attenuation of overnight fluid shift and an increase in UA-XSA.

  16. Randomised field trial to evaluate serological response after foot-and-mouth disease vaccination in Turkey

    PubMed Central

    Knight-Jones, T.J.D.; Bulut, A.N.; Gubbins, S.; Stärk, K.D.C.; Pfeiffer, D.U.; Sumption, K.J.; Paton, D.J.

    2015-01-01

    Despite years of biannual mass vaccination of cattle, foot-and-mouth disease (FMD) remains uncontrolled in Anatolian Turkey. To evaluate protection after mass vaccination we measured post-vaccination antibodies in a cohort of cattle (serotypes O, A and Asia-1). To obtain results reflecting typical field protection, participants were randomly sampled from across Central and Western Turkey after routine vaccination. Giving two-doses one month apart is recommended when cattle are first vaccinated against FMD. However, due to cost and logistics, this is not routinely performed in Turkey, and elsewhere. Nested within the cohort, we conducted a randomised trial comparing post-vaccination antibodies after a single-dose versus a two-dose primary vaccination course. Four to five months after vaccination, only a third of single-vaccinated cattle had antibody levels above a threshold associated with protection. A third never reached this threshold, even at peak response one month after vaccination. It was not until animals had received three vaccine doses in their lifetime, vaccinating every six months, that most (64% to 86% depending on serotype) maintained antibody levels above this threshold. By this time cattle would be >20 months old with almost half the population below this age. Consequently, many vaccinated animals will be unprotected for much of the year. Compared to a single-dose, a primary vaccination course of two-doses greatly improved the level and duration of immunity. We concluded that the FMD vaccination programme in Anatolian Turkey did not produce the high levels of immunity required. Higher potency vaccines are now used throughout Turkey, with a two-dose primary course in certain areas. Monitoring post-vaccination serology is an important component of evaluation for FMD vaccination programmes. However, consideration must be given to which antigens are present in the test, the vaccine and the field virus. Differences between these antigens affect the

  17. Randomised field trial to evaluate serological response after foot-and-mouth disease vaccination in Turkey.

    PubMed

    Knight-Jones, T J D; Bulut, A N; Gubbins, S; Stärk, K D C; Pfeiffer, D U; Sumption, K J; Paton, D J

    2015-02-04

    Despite years of biannual mass vaccination of cattle, foot-and-mouth disease (FMD) remains uncontrolled in Anatolian Turkey. To evaluate protection after mass vaccination we measured post-vaccination antibodies in a cohort of cattle (serotypes O, A and Asia-1). To obtain results reflecting typical field protection, participants were randomly sampled from across Central and Western Turkey after routine vaccination. Giving two-doses one month apart is recommended when cattle are first vaccinated against FMD. However, due to cost and logistics, this is not routinely performed in Turkey, and elsewhere. Nested within the cohort, we conducted a randomised trial comparing post-vaccination antibodies after a single-dose versus a two-dose primary vaccination course. Four to five months after vaccination, only a third of single-vaccinated cattle had antibody levels above a threshold associated with protection. A third never reached this threshold, even at peak response one month after vaccination. It was not until animals had received three vaccine doses in their lifetime, vaccinating every six months, that most (64% to 86% depending on serotype) maintained antibody levels above this threshold. By this time cattle would be >20 months old with almost half the population below this age. Consequently, many vaccinated animals will be unprotected for much of the year. Compared to a single-dose, a primary vaccination course of two-doses greatly improved the level and duration of immunity. We concluded that the FMD vaccination programme in Anatolian Turkey did not produce the high levels of immunity required. Higher potency vaccines are now used throughout Turkey, with a two-dose primary course in certain areas. Monitoring post-vaccination serology is an important component of evaluation for FMD vaccination programmes. However, consideration must be given to which antigens are present in the test, the vaccine and the field virus. Differences between these antigens affect the

  18. Gene expression profiles of changes underlying different-sized human rotator cuff tendon tears.

    PubMed

    Chaudhury, Salma; Xia, Zhidao; Thakkar, Dipti; Hakimi, Osnat; Carr, Andrew J

    2016-10-01

    Progressive cellular and extracellular matrix (ECM) changes related to age and disease severity have been demonstrated in rotator cuff tendon tears. Larger rotator cuff tears demonstrate structural abnormalities that potentially adversely influence healing potential. This study aimed to gain greater insight into the relationship of pathologic changes to tear size by analyzing gene expression profiles from normal rotator cuff tendons, small rotator cuff tears, and large rotator cuff tears. We analyzed gene expression profiles of 28 human rotator cuff tendons using microarrays representing the entire genome; 11 large and 5 small torn rotator cuff tendon specimens were obtained intraoperatively from tear edges, which we compared with 12 age-matched normal controls. We performed real-time polymerase chain reaction and immunohistochemistry for validation. Torn rotator cuff tendons demonstrated upregulation of a number of key genes, such as matrix metalloproteinase 3, 10, 12, 13, 15, 21, and 25; a disintegrin and metalloproteinase (ADAM) 12, 15, and 22; and aggrecan. Amyloid was downregulated in all tears. Small tears displayed upregulation of bone morphogenetic protein 5. Chemokines and cytokines that may play a role in chemotaxis were altered; interleukins 3, 10, 13, and 15 were upregulated in tears, whereas interleukins 1, 8, 11, 18, and 27 were downregulated. The gene expression profiles of normal controls and small and large rotator cuff tear groups differ significantly. Extracellular matrix remodeling genes were found to contribute to rotator cuff tear pathogenesis. Rotator cuff tears displayed upregulation of a number of matrix metalloproteinase (3, 10, 12, 13, 15, 21, and 25), a disintegrin and metalloproteinase (ADAM 12, 15, and 22) genes, and downregulation of some interleukins (1, 8, and 27), which play important roles in chemotaxis. These gene products may potentially have a role as biomarkers of failure of healing or therapeutic targets to improve tendon

  19. The impact of virtual admission on self-efficacy in patients with chronic obstructive pulmonary disease - a randomised clinical trial.

    PubMed

    Emme, Christina; Mortensen, Erik L; Rydahl-Hansen, Susan; Østergaard, Birte; Svarre Jakobsen, Anna; Schou, Lone; Phanareth, Klaus

    2014-11-01

    To investigate how virtual admission during acute exacerbation influences self-efficacy in patients with chronic obstructive pulmonary disease, compared with conventional hospital admission. Telemedicine solutions have been highlighted as a possible way to increase self-efficacy in patients with chronic diseases, such as chronic obstructive pulmonary disease. However, little is known about how telemedicine-based virtual admission as a replacement of hospital admission during acute exacerbation affects chronic obstructive pulmonary disease patients' self-efficacy. This study was a nonblinded, randomised clinical multicentre trial. The study was a substudy to The Virtual Hospital, investigating the feasibility and safety of telemedicine-based treatment at home for patients with acute exacerbation of chronic obstructive pulmonary disease. Participants were consecutively randomised to virtual admission or conventional hospital admission. Data from 50 patients were analysed. Self-efficacy was assessed at baseline, three days after discharge, and also six weeks and three months after discharge, using the Danish version of 'The chronic obstructive pulmonary disease self-efficacy scale'. Intergroup comparison showed no significant differences between the two groups at baseline, three days after discharge, six weeks after discharge or three months after discharge. Furthermore, intragroup comparison did not reveal significant differences in the chronic obstructive pulmonary disease self-efficacy scale mean sum score within the two groups. The results of the study suggest that there is no difference between self-efficacy in chronic obstructive pulmonary disease patients undergoing virtual admission, compared with conventional hospital admission. However, the anticipated sample size could not be reached, which prompts caution regarding interpretation of the findings. This study provides new insight into how virtual admission affects chronic obstructive pulmonary disease

  20. Pioglitazone in early Parkinson's disease: a phase 2, multicentre, double-blind, randomised trial

    PubMed Central

    2015-01-01

    Summary Background A systematic assessment of potential disease-modifying compounds for Parkinson's disease concluded that pioglitazone could hold promise for the treatment of patients with this disease. We assessed the effect of pioglitazone on the progression of Parkinson's disease in a multicentre, double-blind, placebo-controlled, futility clinical trial. Methods Participants with the diagnosis of early Parkinson's disease on a stable regimen of 1 mg/day rasagiline or 10 mg/day selegiline were randomly assigned (1:1:1) to 15 mg/day pioglitazone, 45 mg/day pioglitazone, or placebo. Investigators were masked to the treatment assignment. Only the statistical centre and the central pharmacy knew the treatment name associated with the randomisation number. The primary outcome was the change in the total Unified Parkinson's Disease Rating Scale (UPDRS) score between the baseline and 44 weeks, analysed by intention to treat. The primary null hypothesis for each dose group was that the mean change in UPDRS was 3 points less than the mean change in the placebo group. The alternative hypothesis (of futility) was that pioglitazone is not meaningfully different from placebo. We rejected the null if there was significant evidence of futility at the one-sided alpha level of 0.10. The study is registered at ClinicalTrials.gov, number NCT01280123. Findings 210 patients from 35 sites in the USA were enrolled between May 10, 2011, and July 31, 2013. The primary analysis included 72 patients in the 15 mg group, 67 in the 45 mg group, and 71 in the placebo group. The mean total UPDRS change at 44 weeks was 4.42 (95% CI 2.55–6.28) for 15 mg pioglitazone, 5.13 (95% CI 3.17–7.08) for 45 mg pioglitazone, and 6.25 (95% CI 4.35–8.15) for placebo (higher change scores are worse). The mean difference between the 15 mg and placebo groups was −1.83 (80% CI −3.56 to −0.10) and the null hypothesis could not be rejected (p=0.19). The mean difference between the 45 mg and placebo

  1. Systematic review of randomised controlled trials of multiple risk factor interventions for preventing coronary heart disease.

    PubMed Central

    Ebrahim, S.; Smith, G. D.

    1997-01-01

    OBJECTIVE: To assess the effectiveness of multiple risk factor intervention in reducing cardiovascular risk factors, total mortality, and mortality from coronary heart disease among adults. DESIGN: Systematic review and meta-analysis of randomised controlled trials in workforces and in primary care in which subjects were randomly allocated to more than one of six interventions (stopping smoking, exercise, dietary advice, weight control, antihypertensive drugs, and cholesterol lowering drugs) and followed up for at least six months. SUBJECTS: Adults aged 17-73 years, 903000 person years of observation were included in nine trials with clinical event outcomes and 303000 person years in five trials with risk factor outcomes alone. MAIN OUTCOME MEASURES: Changes in systolic and diastolic blood pressure, smoking rates, blood cholesterol concentrations, total mortality, and mortality from coronary heart disease. RESULTS: Net decreases in systolic and diastolic blood pressure, smoking prevalence, and blood cholesterol were 4.2 mm Hg (SE 0.19 mm Hg), 2.7 mm Hg (0.09 mm Hg), 4.2% (0.3%), and 0.14 mmol/l (0.01 mmol/l) respectively. In the nine trials with clinical event end points the pooled odds ratios for total and coronary heart disease mortality were 0.97 (95% confidence interval 0.92 to 1.02) and 0.96 (0.88 to 1.04) respectively. Statistical heterogeneity between the studies with respect to changes in mortality and risk factors was due to trials focusing on hypertensive participants and those using considerable amounts of drug treatment, with only these trials showing significant reductions in mortality. CONCLUSIONS: The pooled effects of multiple risk factor intervention on mortality were insignificant and a small, but potentially important, benefit of treatment (about a 10% reduction in mortality) may have been missed. Changes in risk factors were modest, were related to the amount of pharmacological treatment used, and in some cases may have been overestimated

  2. The effect of diabetes, hyperlipidemia, and statins on the development of rotator cuff disease: a nationwide, 11-year, longitudinal, population-based follow-up study.

    PubMed

    Lin, Tony Tung-Liang; Lin, Ching-Heng; Chang, Chia-Li; Chi, Chun-Han; Chang, Shin-Tsu; Sheu, Wayne Huey-Herng

    2015-09-01

    The intrinsic risk factors of rotator cuff disease (RCD) include degeneration, inflammation, oxidative stress, and circulation impairment. Both diabetes and hyperlipidemia are thought to increase these risk factors and therefore potentially enhance RCD development. However, few studies, and few longitudinal follow-up studies in particular, exist to prove this. Both diabetes and hyperlipidemia can increase a patient's risk of developing RCD. Cohort study; Level of evidence, 3. A total of 498,678 participants, including 28,391 diagnosed with diabetes and 25,621 with hyperlipidemia in the year 2000, were followed for an 11-year period. Multivariate Cox proportional hazards models were used to explore the effect of (1) diabetes, (2) hyperlipidemia, (3) diabetes with/without insulin use, and (4) hyperlipidemia with/without statin use on the development of RCD. In the subgroup of patients with hyperlipidemia, multivariate Cox proportional hazards models were also performed to explore the relationship between statin use and RCD development. During an 11-year follow-up period, 26,664 patients developed RCD. The crude hazard ratio (HR) for RCD in patients with diabetes as compared with those without diabetes was 2.11 (95% CI, 2.02-2.20; P < .0001). The crude HR for RCD in patients with hyperlipidemia as compared with those without hyperlipidemia was 2.00 (95% CI, 1.92-2.08; P < .0001). Multivariate Cox proportional hazards analysis revealed that, in addition to older age and female sex, both diabetes and hyperlipidemia increased the risk of RCD (diabetes: HR, 1.47 [95% CI, 1.41-1.54]; P < .0001) (hyperlipidemia: HR, 1.48 [95% CI, 1.42-1.55]; P < .0001). An elevated risk still existed in patients with diabetes with/without insulin use (diabetes with insulin use: HR, 1.43 [95% CI, 1.35-1.51]; P < .0001) (diabetes without insulin use: HR, 1.64 [95% CI, 1.53-1.75]; P < .0001). An increased risk also existed in patients with hyperlipidemia with/without statin use (hyperlipidemia

  3. Effectiveness of integrated disease management for primary care chronic obstructive pulmonary disease patients: results of cluster randomised trial.

    PubMed

    Kruis, Annemarije L; Boland, Melinde R S; Assendelft, Willem J J; Gussekloo, Jacobijn; Tsiachristas, Apostolos; Stijnen, Theo; Blom, Coert; Sont, Jacob K; Rutten-van Mölken, Maureen P H M; Chavannes, Niels H

    2014-09-10

    To investigate the long term effectiveness of integrated disease management delivered in primary care on quality of life in patients with chronic obstructive pulmonary disease (COPD) compared with usual care. 24 month, multicentre, pragmatic cluster randomised controlled trial 40 general practices in the western part of the Netherlands Patients with COPD according to GOLD (Global Initiative for COPD) criteria. Exclusion criteria were terminal illness, cognitive impairment, alcohol or drug misuse, and inability to fill in Dutch questionnaires. Practices were included if they were willing to create a multidisciplinary COPD team. General practitioners, practice nurses, and specialised physiotherapists in the intervention group received a two day training course on incorporating integrated disease management in practice, including early recognition of exacerbations and self management, smoking cessation, physiotherapeutic reactivation, optimal diagnosis, and drug adherence. Additionally, the course served as a network platform and collaborating healthcare providers designed an individual practice plan to integrate integrated disease management into daily practice. The control group continued usual care (based on international guidelines). The primary outcome was difference in health status at 12 months, measured by the Clinical COPD Questionnaire (CCQ); quality of life, Medical Research Council dyspnoea, exacerbation related outcomes, self management, physical activity, and level of integrated care (PACIC) were also assessed as secondary outcomes. Of a total of 1086 patients from 40 clusters, 20 practices (554 patients) were randomly assigned to the intervention group and 20 clusters (532 patients) to the usual care group. No difference was seen between groups in the CCQ at 12 months (mean difference -0.01, 95% confidence interval -0.10 to 0.08; P=0.8). After 12 months, no differences were seen in secondary outcomes between groups, except for the PACIC domain "follow

  4. Effectiveness of integrated disease management for primary care chronic obstructive pulmonary disease patients: results of cluster randomised trial

    PubMed Central

    Boland, Melinde R S; Assendelft, Willem J J; Gussekloo, Jacobijn; Tsiachristas, Apostolos; Stijnen, Theo; Blom, Coert; Sont, Jacob K; Rutten-van Mölken, Maureen P H M; Chavannes, Niels H

    2014-01-01

    Objective To investigate the long term effectiveness of integrated disease management delivered in primary care on quality of life in patients with chronic obstructive pulmonary disease (COPD) compared with usual care. Design 24 month, multicentre, pragmatic cluster randomised controlled trial Setting 40 general practices in the western part of the Netherlands Participants Patients with COPD according to GOLD (Global Initiative for COPD) criteria. Exclusion criteria were terminal illness, cognitive impairment, alcohol or drug misuse, and inability to fill in Dutch questionnaires. Practices were included if they were willing to create a multidisciplinary COPD team. Intervention General practitioners, practice nurses, and specialised physiotherapists in the intervention group received a two day training course on incorporating integrated disease management in practice, including early recognition of exacerbations and self management, smoking cessation, physiotherapeutic reactivation, optimal diagnosis, and drug adherence. Additionally, the course served as a network platform and collaborating healthcare providers designed an individual practice plan to integrate integrated disease management into daily practice. The control group continued usual care (based on international guidelines). Main outcome measures The primary outcome was difference in health status at 12 months, measured by the Clinical COPD Questionnaire (CCQ); quality of life, Medical Research Council dyspnoea, exacerbation related outcomes, self management, physical activity, and level of integrated care (PACIC) were also assessed as secondary outcomes. Results Of a total of 1086 patients from 40 clusters, 20 practices (554 patients) were randomly assigned to the intervention group and 20 clusters (532 patients) to the usual care group. No difference was seen between groups in the CCQ at 12 months (mean difference –0.01, 95% confidence interval –0.10 to 0.08; P=0.8). After 12 months, no differences

  5. Exercise for rotator cuff tendinopathy: a systematic review.

    PubMed

    Littlewood, Chris; Ashton, Jon; Chance-Larsen, Ken; May, Stephen; Sturrock, Ben

    2012-06-01

    Shoulder pain due to rotator cuff tendinopathy is a common problem. Exercise is one intervention used to address this problem but conclusions from previous reviews have been mixed. To systematically review the effectiveness of exercise, incorporating loaded exercise (against gravity or resistance), for rotator cuff tendinopathy. An electronic search of AMED, CiNAHL, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PEDro and SPORTDiscus was undertaken from their inception to November 2010 and supplemented by hand searching related articles and contact with topic experts. Randomised controlled trials evaluating the effectiveness of exercise, incorporating loaded exercise, in participants with rotator cuff tendinopathy. Included studies were appraised for risk of bias using the tool developed by the Cochrane Back review Group. Due to heterogeneity of studies, a narrative synthesis was undertaken based upon levels of evidence. Five articles detailing four studies were included, all of which were regarded as presenting a low risk of bias. Overall, the literature was supportive of the use of exercise in terms of pain and functional disability. The results should be regarded with some degree of caution due to limitations associated with the studies including lack of blinding, no intervention control groups and limitations of the outcome measures used. CONCLUSION AND IMPLICATIONS OF KEY FINDINGS: The available literature is supportive of the use of exercise but due to the paucity of research and associated limitations further study is indicated. Copyright © 2011 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  6. Rotator cuff tear: physical examination and conservative treatment.

    PubMed

    Itoi, Eiji

    2013-03-01

    Rotator cuff tear is one of the most common shoulder diseases. It is interesting that some rotator cuff tears are symptomatic, whereas others are asymptomatic. Pain is the most common symptom of patients with a tear. Even in patients with an asymptomatic tear, it may become symptomatic with an increase in tear size. Physical examination is extremely important to evaluate the presence, location, and extent of a tear. It also helps us to understand the mechanism of pain. Conservative treatment often works. Patients with well-preserved function of the supraspinatus and infraspinatus are the best candidates for conservative treatment. After a successful conservative treatment, the symptom once disappeared may come back again. This recurrence of symptoms is related to tear expansion. Those with high risk of tear expansion and those with less functional rotator cuff muscles are less likely to respond to conservative treatment. They may need a surgical treatment.

  7. Use of cuff tear arthroplasty head prosthesis for rotator cuff arthropathy treatment in elderly patients with comorbidities

    PubMed Central

    Carvalho, Cassiano Diniz; Andreoli, Carlos Vicente; Pochini, Alberto de Castro; Ejnisman, Benno

    2016-01-01

    ABSTRACT Objective To evaluate the clinical and functional behavior of patients undergoing cuff tear arthroplasty at different stages of the disease. Methods Cuff tear arthroplasty hemiarthroplasties were performed in 34 patients with rotator cuff arthropathy and associated comorbidities, classified according to Seebauer. The mean age was 76.3 years, and the sample comprised 23 females (67.6%) and 11 males (32.4%). The mean follow-up period was 21.7 months, and evaluations were performed using the Visual Analog Scale for pain and the Constant scale. Results There were no statistically significant differences in the mean reduction in the Visual Analog Scale or in the Constant scale increase between the female and male groups. The variation between the pre- and postoperative Visual Analog Scale and Constant scale evaluations was significant. There was also no statistically significant difference between the Seebauer classification groups regarding the mean Visual Analog Scale reduction, or the mean Constant scale increase. Conclusion Cuff tear arthroplasty shoulder hemiarthroplasty is a good option for rotator cuff arthropathy in patients with comorbidities. PMID:28076600

  8. Cuff extrusion in peritoneal dialysis: single-centre experience with the cuff-shaving procedure in five patients over a 4-year period.

    PubMed

    Debowski, Jedrzej A; Wærp, Cora; Kjellevold, Stig A; Abedini, Sadollah

    2017-02-01

    Catheter-related infections in peritoneal dialysis (PD) remain a significant complication, and some patients with recurrent exit-site (ESI) and/or tunnel infections may experience external cuff extrusion. In these cases, cuff-shaving has been described as a possible course of treatment. During a 4-year period, there were 44 patients with PD at our department; all received double-cuffed Tenckhoff catheters. Six (13%) never started on PD. Five (13%) of the 38 active PD patients experienced cuff extrusion. Causes of end-stage renal disease (ESRD) were diabetic nephropathy (n = 1), toxic nephropathy (n = 1), hypertensive nephrosclerosis (n = 1), systemic disease (n = 1) and one with unknown cause. PD catheters were inserted by the Department of Surgery and our patients waited a mean of 3.71 weeks (0.57-7.86) from catheter insertion to PD start. Patients were followed up by monthly and even fortnightly during infections. Our cohort experienced two (1-5) ESIs per patient prior to cuff extrusion. Cultures showed growth of Staphylococcus aureus and the patients received dicloxacillin orally 500 mg qid for 3-4 weeks. Of the 38 active PD patients, 5 (13%) developed cuff extrusion with an incidence of 0.20 episodes/patient/year, manifesting on average at 32 weeks (17.3-40.6), due to repeated ESI in four patients and substantial weight loss in one patient. All five underwent cuff-shaving and the ESIs resolved completely in 80% of the cases assisted by supplemental treatment with mupirocin and/or dicloxacillin. There were no complications to the cuff-shaving procedure itself. None of the five patients experienced new ESIs after cuff-shaving had been performed. Cuff-shaving reduces the rate of recurring ESIs. The procedure is safe, if performed correctly, and poses no risk to the patient or the catheter.

  9. Dietary Advanced Glycation End Products and Risk Factors for Chronic Disease: A Systematic Review of Randomised Controlled Trials

    PubMed Central

    Clarke, Rachel E.; Dordevic, Aimee L.; Tan, Sih Min; Ryan, Lisa; Coughlan, Melinda T.

    2016-01-01

    Dietary advanced glycation end-products (AGEs) form during heating and processing of food products and are widely prevalent in the modern Western diet. Recent systematic reviews indicate that consumption of dietary AGEs may promote inflammation, oxidative stress and insulin resistance. Experimental evidence indicates that dietary AGEs may also induce renal damage, however, this outcome has not been considered in previous systematic reviews. The purpose of this review was to examine the effect of consumption of a high AGE diet on biomarkers of chronic disease, including chronic kidney disease (CKD), in human randomized controlled trials (RCTs). Six databases (SCOPUS, CINHAL, EMBASE, Medline, Biological abstracts and Web of Science) were searched for randomised controlled dietary trials that compared high AGE intake to low AGE intake in adults with and without obesity, diabetes or CKD. Twelve dietary AGE interventions were identified with a total of 293 participants. A high AGE diet increased circulating tumour necrosis factor-alpha and AGEs in all populations. A high AGE diet increased 8-isoprostanes in healthy adults, and vascular cell adhesion molecule-1 (VCAM-1) in patients with diabetes. Markers of CKD were not widely assessed. The evidence presented indicates that a high AGE diet may contribute to risk factors associated with chronic disease, such as inflammation and oxidative stress, however, due to a lack of high quality randomised trials, more research is required. PMID:26938557

  10. Rotator Cuff and Shoulder Conditioning Program

    MedlinePlus

    ... Cuff and Shoulder Conditioning Program Stretching Exercises 1. Pendulum_________________________________________________________________________ Repetitions Main muscles worked: Deltoids, supraspinatus, infraspinatus, subscapularis ...

  11. 21 CFR 882.5275 - Nerve cuff.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Nerve cuff. 882.5275 Section 882.5275 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5275 Nerve cuff. (a) Identification. A nerve cuff...

  12. 21 CFR 882.5275 - Nerve cuff.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Nerve cuff. 882.5275 Section 882.5275 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5275 Nerve cuff. (a) Identification. A nerve cuff...

  13. 21 CFR 882.5275 - Nerve cuff.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Nerve cuff. 882.5275 Section 882.5275 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5275 Nerve cuff. (a) Identification. A nerve cuff...

  14. 21 CFR 882.5275 - Nerve cuff.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nerve cuff. 882.5275 Section 882.5275 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5275 Nerve cuff. (a) Identification. A nerve cuff...

  15. 21 CFR 882.5275 - Nerve cuff.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Nerve cuff. 882.5275 Section 882.5275 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5275 Nerve cuff. (a) Identification. A nerve cuff...

  16. Endotracheal Tube Cuff Pressure Following Intubation

    DTIC Science & Technology

    2005-09-08

    inflated ETT cuff. This method may lead to erroneous cuff pressures. Fernandez, Blanch, Mancebo, Bonsoms, and Artigas studied the accuracy of...Laryngologica, 345, suppl: 1-71. 10. Fernandez, R., Blanch, L., Mancebo, J., Bonsoms, N., Artigas , A. (1990). Endotracheal tube cuff pressure assessment

  17. Autologous blood products in rotator cuff repair.

    PubMed

    Mei-Dan, Omer; Carmont, Michael R

    2012-01-01

    We review the management of rotator cuff tears, the mechanism of action of autologous blood products, principally platelet-rich plasma, and the current evidence for effective use of platelet-rich plasma, particularly in relation to the shoulder and chronic rotator cuff tears, for biological augmentation of rotator cuff repair.

  18. 21 CFR 868.5760 - Cuff spreader.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Cuff spreader. 868.5760 Section 868.5760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5760 Cuff spreader. (a) Identification. A cuff spreader is...

  19. 21 CFR 868.5760 - Cuff spreader.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Cuff spreader. 868.5760 Section 868.5760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5760 Cuff spreader. (a) Identification. A cuff spreader is...

  20. The Completeness of Intervention Descriptions in Randomised Trials of Supervised Exercise Training in Peripheral Arterial Disease.

    PubMed

    Tew, Garry A; Brabyn, Sally; Cook, Liz; Peckham, Emily

    2016-01-01

    Research supports the use of supervised exercise training as a primary therapy for improving the functional status of people with peripheral arterial disease (PAD). Several reviews have focused on reporting the outcomes of exercise interventions, but none have critically examined the quality of intervention reporting. Adequate reporting of the exercise protocols used in randomised controlled trials (RCTs) is central to interpreting study findings and translating effective interventions into practice. The purpose of this review was to evaluate the completeness of intervention descriptions in RCTs of supervised exercise training in people with PAD. A systematic search strategy was used to identify relevant trials published until June 2015. Intervention description completeness in the main trial publication was assessed using the Template for Intervention Description and Replication checklist. Missing intervention details were then sought from additional published material and by emailing authors. Fifty-eight trials were included, reporting on 76 interventions. Within publications, none of the interventions were sufficiently described for all of the items required for replication; this increased to 24 (32%) after contacting authors. Although programme duration, and session frequency and duration were well-reported in publications, complete descriptions of the equipment used, intervention provider, and number of participants per session were missing for three quarters or more of interventions (missing for 75%, 93% and 80% of interventions, respectively). Furthermore, 20%, 24% and 26% of interventions were not sufficiently described for the mode of exercise, intensity of exercise, and tailoring/progression, respectively. Information on intervention adherence/fidelity was also frequently missing: attendance rates were adequately described for 29 (38%) interventions, whereas sufficient detail about the intensity of exercise performed was presented for only 8 (11

  1. The Completeness of Intervention Descriptions in Randomised Trials of Supervised Exercise Training in Peripheral Arterial Disease

    PubMed Central

    Tew, Garry A.; Brabyn, Sally; Cook, Liz; Peckham, Emily

    2016-01-01

    Research supports the use of supervised exercise training as a primary therapy for improving the functional status of people with peripheral arterial disease (PAD). Several reviews have focused on reporting the outcomes of exercise interventions, but none have critically examined the quality of intervention reporting. Adequate reporting of the exercise protocols used in randomised controlled trials (RCTs) is central to interpreting study findings and translating effective interventions into practice. The purpose of this review was to evaluate the completeness of intervention descriptions in RCTs of supervised exercise training in people with PAD. A systematic search strategy was used to identify relevant trials published until June 2015. Intervention description completeness in the main trial publication was assessed using the Template for Intervention Description and Replication checklist. Missing intervention details were then sought from additional published material and by emailing authors. Fifty-eight trials were included, reporting on 76 interventions. Within publications, none of the interventions were sufficiently described for all of the items required for replication; this increased to 24 (32%) after contacting authors. Although programme duration, and session frequency and duration were well-reported in publications, complete descriptions of the equipment used, intervention provider, and number of participants per session were missing for three quarters or more of interventions (missing for 75%, 93% and 80% of interventions, respectively). Furthermore, 20%, 24% and 26% of interventions were not sufficiently described for the mode of exercise, intensity of exercise, and tailoring/progression, respectively. Information on intervention adherence/fidelity was also frequently missing: attendance rates were adequately described for 29 (38%) interventions, whereas sufficient detail about the intensity of exercise performed was presented for only 8 (11

  2. Development of a self-managed loaded exercise programme for rotator cuff tendinopathy.

    PubMed

    Littlewood, Chris; Malliaras, Peter; Mawson, Sue; May, Stephen; Walters, Stephen

    2013-12-01

    This paper describes a self-managed loaded exercise programme which has been designed to address the pain and disability associated with rotator cuff tendinopathy. The intervention has been developed with reference to current self-management theory and with reference to the emerging benefit of loaded exercise for tendinopathy. This self-managed loaded exercise programme is being evaluated within the mixed methods SELF study (ISRCTN 84709751) which includes a pragmatic randomised controlled trial conducted within the UK National Health Service.

  3. Response shift of the Western Ontario Rotator Cuff index in patients undergoing arthroscopic rotator cuff repair.

    PubMed

    Hollman, Freek; Wessel, Ronald N; Wolterbeek, Nienke

    2016-12-01

    This study determined the response shift in patients undergoing rotator cuff repair using the Western Ontario Rotator Cuff index (WORC), a disease-specific quality of life questionnaire. We hypothesized there would be a response shift with a positive recalibration (overestimated their preoperative disability) on the WORC and increases over time. The study prospectively included 36 patients undergoing arthroscopic rotator cuff repair. At baseline, 3 months (T1), and 1 year (T2) after surgery the WORC, EuroQol (EQ)-5D-3L, and the patient's level of satisfaction after surgery were scored. To evaluate the response shift, patients also completed the WORC at 3 months (Pre-T1) and 1 year (Pre-T2) as how they perceived themselves to have been before surgery. The result on Pre-T1 and Pre-T2 results revealed that patients retrospectively rated their overall WORC score comparable with the baseline WORC score (Pre-T0; T0 = 40.5 ± 18.4, Pre-T1 = 45.0 ± 22.7, Pre-T2 = 34.3 ± 21.3). No response shift was observed on all domains except a negative recalibrated response shift for emotional disability on T1 (P = .04). No significant group-level response shift was observed using the WORC, except for the subdomain emotional disability at 3 months after arthroscopic rotator cuff repair. With the absence of any shift in patient's perception on the self-administered quality of life-related WORC questionnaire, this study suggests one could retrospectively reliably conduct group-level preoperative baseline information on quality of life up to 1 year after surgery. Copyright © 2016 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

  4. What do standard radiography and clinical examination tell about the shoulder with cuff tear arthropathy?

    PubMed Central

    2011-01-01

    Background This study evaluates the preoperative conventional anteroposterior radiography and clinical testing in non-operated patients with cuff tear arthropathy. It analyses the radiological findings in relation to the status of the rotator cuff and clinical status as also the clinical testing in relation to the rotator cuff quality. The aim of the study is to define the usefulness of radiography and clinical examination in cuff tear arthropathy. Methods This study analyses the preoperative radiological (AP-view, (Artro-)CT-scan or MRI-scan) and clinical characteristics (Constant-Murley-score plus active and passive mobility testing) and the peroperative findings in a cohort of 307 patients. These patients were part of a multicenter, retrospective, consecutive study of the French Orthopaedic Society (SOFCOT-2006). All patients had no surgical antecedents and were all treated with prosthetic shoulder surgery for a painful irreparable cuff tear arthropathy (reverse-(84%) or hemi-(8%) or double cup-bipolar prosthesis (8%)). Results A positive significancy could be found for the relationship between clinical testing and the rotator cuff quality; between acromiohumeral distance and posterior rotator cuff quality; between femoralization and posterior rotator cuff quality. Conclusion A conventional antero-posterior radiograph can not provide any predictive information on the clinical status of the patient. The subscapular muscle can be well tested by the press belly test and the teres minor muscle can be well tested by the hornblower' sign and by the exorotation lag signs. The upward migration index and the presence of femoralization are good indicators for the evaluation of the posterior rotator cuff. An inferior coracoid tip positioning suggests rotator cuff disease. PMID:21208449

  5. Functional outcomes after bilateral arthroscopic rotator cuff repair.

    PubMed

    Aleem, Alexander W; Syed, Usman Ali M; Wascher, Jocelyn; Zoga, Adam C; Close, Koby; Abboud, Joseph A; Cohen, Steven B

    2016-10-01

    Arthroscopic repair of rotator cuff tears is a common procedure performed by orthopedic surgeons. There is a well-known incidence of up to 35% of bilateral rotator cuff tear disease in patients who have a known unilateral tear. The majority of the literature focuses on outcomes after unilateral surgery. The purpose of this study was to determine if there are clinical differences in shoulders of patients who underwent staged bilateral rotator cuff repairs during their lifetime. A retrospective review of all patients who underwent staged bilateral arthroscopic rotator cuff surgery at our institution was performed. All patients had at least 2 years of follow-up. Clinical outcome scores including the American Shoulder and Elbow Surgeons (ASES), Single Assessment Numeric Evaluation, and Rowe measures were obtained. A subset of patients returned for clinical and ultrasound evaluation performed by an independent fellowship-trained musculoskeletal radiologist. Overall, 110 shoulders in 55 patients, representing 68% of all eligible patients, participated. No clinical or statistical difference was found in any outcome measure. ASES scores averaged 86.5 (36.7-100) in the dominant shoulder compared with 89.6 (23.3-100) in the nondominant shoulder (P = .42). Ultrasound was available on 34 shoulders and showed complete healing rate of 88%. The shoulders with retearing of the rotator cuff (12%) demonstrated clinically relevant lower ASES scores (72.5) compared with shoulders with confirmed healed repairs (86.2; P = .2). Patients who undergo staged bilateral rotator cuff repair can expect to have similarly good clinical outcomes regardless of hand dominance or chronologic incidence with excellent healing rates in both shoulders. Copyright © 2016 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

  6. Proximal Biceps Tendon and Rotator Cuff Tears.

    PubMed

    Virk, Mandeep S; Cole, Brian J

    2016-01-01

    The long head of biceps tendon (LHBT) is frequently involved in rotator cuff tears and can cause anterior shoulder pain. Tendon hypertrophy, hourglass contracture, delamination, tears, and tendon instability in the bicipital groove are common macroscopic pathologic findings affecting the LHBT in the presence of rotator cuff tears. Failure to address LHBT disorders in the setting of rotator cuff tear can result in persistent shoulder pain and poor satisfaction after rotator cuff repair. Tenotomy or tenodesis of the LHBT are effective options for relieving pain arising from the LHBT in the setting of reparable and selected irreparable rotator cuff tears.

  7. Surgery or conservative treatment for rotator cuff tear: a meta-analysis.

    PubMed

    Ryösä, Anssi; Laimi, Katri; Äärimaa, Ville; Lehtimäki, Kaisa; Kukkonen, Juha; Saltychev, Mikhail

    2017-07-01

    Comparative evidence on treating rotator cuff tear is inconclusive. The objective of this review was to evaluate the evidence on effectiveness of tendon repair in reducing pain and improving function of the shoulder when compared with conservative treatment of symptomatic rotator cuff tear. Search on CENTRAL, MEDLINE, EMBASE, CINAHL, Web of Science and Pedro databases. Randomised controlled trials (RCT) comparing surgery and conservative treatment of rotator cuff tear. Study selection and extraction based on the Cochrane Handbook for Systematic reviews of Interventions. Random effects meta-analysis. Three identified RCTs involved 252 participants (123 cases and 129 controls). The risk of bias was considered low for all three RCTs. For Constant score, statistically insignificant effect size was 5.6 (95% CI -0.41 to 11.62) points in 1-year follow up favouring surgery and below the level of minimal clinically important difference. The respective difference in pain reduction was -0.93 (95% CI -1.65 to -0.21) cm on a 0-10 pain visual analogue scale favouring surgery. The difference was statistically significant (p = 0.012) in 1-year follow up but below the level of minimal clinically important difference. There is limited evidence that surgery is not more effective in treating rotator cuff tear than conservative treatment alone. Thus, a conservative approach is advocated as the initial treatment modality. Implications for Rehabilitation There is limited evidence that surgery is not more effective in treating rotator cuff tear than conservative treatment alone. There was no clinically significant difference between surgery and active physiotherapy in 1-year follow-up in improving Constant score or reducing pain caused by rotator cuff tear. As physiotherapy is less proneness to complications and less expensive than surgery, a conservative approach is advocated as the initial treatment modality to rotator cuff tears.

  8. Exercise therapy for functional capacity in chronic diseases: an overview of meta-analyses of randomised controlled trials.

    PubMed

    Pasanen, Tero; Tolvanen, Samppa; Heinonen, Ari; Kujala, Urho M

    2017-10-01

    To summarise all meta-analyses of randomised controlled trials that have evaluated the effects of exercise therapy on functional capacity in patients with chronic diseases. Umbrella review of meta-analyses of randomised controlled trials. We systematically searched the CENTRAL, CINAHL, DARE, Medline, OTSeeker, PEDro, SPORTDiscus, ProQuest Nursing & Allied Health Database, Web of Science, Scopus, OpenGrey and BMC Proceedings from database inception to 1 September 2016. We included meta-analyses that compared the effects of exercise therapy with no treatment or usual care in adults with non-communicable chronic diseases and included outcomes related to functional capacity. We excluded meta-analyses with less than 100 patients. Eighty-five meta-analyses with 22 different chronic diseases were included. The exercise interventions resulted in statistically significant (p<0.05) improvements for 126 of 146 (86%) functional capacity outcomes, compared with the control group. The standardised mean differences were small in 64 (44%), moderate in 54 (37%) and large in 28 (19%) of the 146 functional capacity outcomes. The results were similar for aerobic exercise, resistance training, and aerobic and resistance training combined. There were no significant differences in serious adverse effects between the intervention and control groups in any of the meta-analyses. Exercise therapy appears to be a safe way to improve functional capacity and reduce disability in individuals with chronic disease. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  9. Tofacitinib for induction and maintenance therapy of Crohn's disease: results of two phase IIb randomised placebo-controlled trials.

    PubMed

    Panés, Julian; Sandborn, William J; Schreiber, Stefan; Sands, Bruce E; Vermeire, Séverine; D'Haens, Geert; Panaccione, Remo; Higgins, Peter D R; Colombel, Jean-Frederic; Feagan, Brian G; Chan, Gary; Moscariello, Michele; Wang, Wenjin; Niezychowski, Wojciech; Marren, Amy; Healey, Paul; Maller, Eric

    2017-06-01

    Tofacitinib is an oral, small-molecule Janus kinase inhibitor that is being investigated for IBD. We evaluated the efficacy and safety of tofacitinib for induction and maintenance treatment in patients with moderate-to-severe Crohn's disease (CD). We conducted two randomised, double-blind, placebo-controlled, multicentre phase IIb studies. Adult patients with moderate-to-severe CD were randomised to receive induction treatment with placebo, tofacitinib 5 or 10 mg twice daily for 8 weeks. Those achieving clinical response-100 or remission were re-randomised to maintenance treatment with placebo, tofacitinib 5 or 10 mg twice daily for 26 weeks. Primary endpoints were clinical remission at the end of the induction study, and clinical response-100 or remission at the end of the maintenance study. 180/280 patients randomised in the induction study were enrolled in the maintenance study. At week 8 of induction, the proportion of patients with clinical remission was 43.5% and 43.0% with 5 and 10 mg twice daily, respectively, compared with 36.7% in the placebo group (p=0.325 and 0.392 for 5 and 10 mg twice daily vs placebo). At week 26 of maintenance, the proportion of patients with clinical response-100 or remission was 55.8% with tofacitinib 10 mg twice daily compared with 39.5% with tofacitinib 5 mg twice daily and 38.1% with placebo (p=0.130 for 10 mg twice daily vs placebo). Compared with placebo, the change in C-reactive protein from baseline was statistically significant (p<0.0001) with 10 mg twice daily after both induction and maintenance treatments. Primary efficacy endpoints were not significantly different from placebo, although there was evidence of a minor treatment effect. No new safety signals were observed for tofacitinib. NCT01393626 and NCT01393899. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  10. Epidemiology, natural history, and indications for treatment of rotator cuff tears.

    PubMed

    Tashjian, Robert Z

    2012-10-01

    The etiology of rotator cuff disease is likely multifactorial, including age-related degeneration and microtrauma and macrotrauma. The incidence of rotator cuff tears increases with aging with more than half of individuals in their 80s having a rotator cuff tear. Smoking, hypercholesterolemia, and genetics have all been shown to influence the development of rotator cuff tearing. Substantial full-thickness rotator cuff tears, in general, progress and enlarge with time. Pain, or worsening pain, usually signals tear progression in both asymptomatic and symptomatic tears and should warrant further investigation if the tear is treated conservatively. Larger (>1-1.5 cm) symptomatic full-thickness cuff tears have a high rate of tear progression and, therefore, should be considered for earlier surgical repair in younger patients if the tear is reparable and there is limited muscle degeneration to avoid irreversible changes to the cuff, including tear enlargement and degenerative muscle changes. Smaller symptomatic full-thickness tears have been shown to have a slower rate of progression, similar to partial-thickness tears, and can be considered for initial nonoperative treatment due to the limited risk for rapid tear progression. In both small full-thickness tears and partial-thickness tears, increasing pain should alert physicians to obtain further imaging as it can signal tear progression. Natural history data, along with information on factors affecting healing after rotator cuff repair, can help guide surgeons in making appropriate decisions regarding the treatment of rotator cuff tears. The management of rotator cuff tears should be considered in the context of the risks and benefits of operative versus nonoperative treatment. Tear size and acuity, the presence of irreparable changes to the rotator cuff or glenohumeral joint, and patient age should all be considered in making this decision. Initial nonoperative care can be safely undertaken in older patients (>70

  11. Rotator cuff rehabilitation: current theories and practice.

    PubMed

    Osborne, Jeffrey D; Gowda, Ashok L; Wiater, Brett; Wiater, J Michael

    2016-01-01

    A fully functioning, painless shoulder joint is essential to maintain a healthy, normal quality of life. Disease of the rotator cuff tendons (RCTs) is a common issue that affects the population, increasing with age, and can lead to significant disability and social and health costs. RCT injuries can affect younger, healthy patients and the elderly alike, and may be the result of trauma or occur as a result of chronic degeneration. They can be acutely painful, limited to certain activities or completely asymptomatic and incidental findings. A wide variety of treatment options exists ranging from conservative local and systemic pain modalities, to surgical fixation. Regardless of management ultimately chosen, physiotherapy of the RCT, rotator cuff muscles and surrounding shoulder girdle plays an essential role in proper treatment. Length of treatment, types of therapy and timing may vary if therapy is definitive care or part of a postoperative protocol. Allowing time for adequate RCT healing must always be considered when implementing ROM and strengthening after surgery. With current rehabilitation methods, patients with all spectrums of RCT pathology can improve their function, pain and quality of life. This manuscript reviews current theories and practice involving rehabilitation for RCT injuries.

  12. The Role of Acromioplasty for Management of Rotator Cuff Problems: Where Is the Evidence?

    PubMed Central

    Shi, Lewis L.; Edwards, T. Bradley

    2012-01-01

    The incidence of acromioplasty has increased dramatically in recent decades, but its role in rotator cuff surgery has been debated. Neer popularized the extrinsic theory of rotator cuff pathology, where mechanical compression of the coracoacromial arch leads to tearing of the rotator cuff. Under this theory, acromioplasty is advocated to modify acromial morphology as an essential part of rotator cuff surgery. Proponents of the intrinsic theory suggest rotator cuff tendons undergo degeneration through aging and overuse, and that bursectomy alone without acromioplasty is sufficient. There exist cadaveric studies, expert opinions, and numerous case series espousing both sides of the argument. Recently, however, numerous high-quality prospective randomized controlled trials have been published examining the role of acromioplasty. They have similar study design and randomization protocols, including groups of arthroscopic rotator cuff repair with bursectomy and acromioplasty versus isolated bursectomy. The results have been consistent across all studies, with no difference in the outcomes of the acromioplasty and isolated bursectomy groups. Current evidence does not support the routine use of acromioplasty in the treatment of rotator cuff disease. PMID:23316375

  13. Acromion Index in Korean Population and Its Relationship with Rotator Cuff Tears.

    PubMed

    Kum, Dong Ho; Kim, Jun Ho; Park, Keun Min; Lee, Eun Su; Park, Yong Bok; Yoo, Jae Chul

    2017-06-01

    Among the many causes of rotator cuff tears, scapular morphology is associated with the accelerating degenerative process of the rotator cuff. Acromion index (AI) was previously introduced and compared in two populations. We enrolled 100 Korean patients diagnosed with full-thickness rotator cuff tears by magnetic resonance imaging and intraoperative arthroscopic findings between January and December 2013. Another 100 Korean patients with an intact rotator cuff tendon identified on magnetic resonance imaging and other shoulder diseases, such as frozen shoulder and instability, were enrolled as controls. We retrospectively compared these 100 rotator cuff tear patients (mean age, 63 years) and 100 controls (mean age, 51 years) in this study. Two independent orthopedic surgeons assessed the AI on radiographs. We performed an interobserver reliability test of the AI assessment, and then compared the AI between two groups. The measurement of the AI showed excellent reliability (intraclass correlation coefficient, 0.82). The mean AI in the rotator cuff tear group was 0.68 and it was significantly different between groups (p<0.001, 95% confidence interval). The AI was not related to tear size. Our study showed that the AI was an effective predictive factor for rotator cuff tears in a Korean population.

  14. Arthroscopic Rotator Cuff Repair: Indication and Technique.

    PubMed

    Gilotra, Mohit; O'Brien, Michael J; Savoie, Felix H

    2016-01-01

    Shoulder arthroscopy and rotator cuff repair techniques are frequently used by most practicing orthopaedic surgeons. A thorough patient history and physical examination can often confirm the presence of a rotator cuff tear, and imaging can be used to evaluate the extent of the injury. The indication for rotator cuff repair is a painful shoulder refractory to nonsurgical management. Arthroscopic techniques, including capsular and coracohumeral ligament releases to decrease tension on the repair, facilitate successful rotator cuff repair. Biomechanically, a double-row transosseous-equivalent rotator cuff repair provides excellent results for medium-size rotator cuff tears. Larger, retracted rotator cuff tears may be better repaired with oblique convergence sutures and a medial single-row rotator cuff repair. The biology of healing, the preservation of blood supply, and the trephination of the bony healing bed are essential parts of all rotator cuff repair procedures. Protection of the rotator cuff repair with an abduction sling for 4 to 8 weeks postoperatively and the delay of active motion until early healing has occurred will improve outcomes.

  15. Interface Pressure Behavior During Painful Cuff Algometry.

    PubMed

    Manafi Khanian, Bahram; Arendt-Nielsen, Lars; Kjær Petersen, Kristian; Samani, Afshin; Graven-Nielsen, Thomas

    2016-05-01

    Cuff algometry is used for the psychophysical assessment of deep-tissue pain sensitivity. The cuff pressure homogeneity may affect the pain sensitivity assessment and potentially be improved by alternative cuff designs optimizing the pressure distribution. The aim of this study was to investigate the relationship between pain sensitivity, inflation pressure, and distribution of interface pressure between the skin and cuff during stimulation with a conventional air tourniquet and a novel tourniquet including a water tube interfacing the air cuff with the skin. Air and water cuff stimulations were applied separately on the right lower leg of 12 subjects until the tolerance pain threshold. The inflation pressure was controlled and recorded by a computer-control program, while the interface pressure distribution was measured by a flexible pressure sensor mat located between the cuff and skin. The mean interface pressure across the entire stimulation surface was not significantly different from inflating pressure during air-cuff algometry. For the water cuff there was a significant reduction in the mean interface pressure compared with the inflating pressure at both the detection and tolerance pain levels (P < 0.002). The interface pressure distribution of the water cuff around the limb was significantly more homogeneous compared with the air cuff (P < 0.03). This homogeneity showed a significant correlation with pain sensitivity (P < 0.008). Cuff systems with a liquid medium optimize the homogeneity of the interface pressure distribution. However, the deviation of the interface pressure from the inflating pressure is crucial as it counteracts the effects of pressure homogeneity on pain sensitivity in water-cuff algometry. © 2016 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  16. The Biomechanical Role of Scaffolds in Augmented Rotator Cuff Tendon Repairs

    DTIC Science & Technology

    2012-01-01

    ultimate load (56%-76%) of rotator cuff repairs in a human cadaver model.20 X-Repair augmentation also altered the mode of repair failure: failure by...amore clinically relevant repair and loading conditions in a human cadaver model: full-thickness supraspinatus tendon repairs (with and without...Andreychik D, Ahmad S. Determinants of outcome in the treatment of rotator cuff disease . Clin Orthop Rel Res 1994;308:90-7. 6. Bishop J, Klepps S, Lo IK

  17. Delaminated rotator cuff tear: extension of delamination and cuff integrity after arthroscopic rotator cuff repair.

    PubMed

    Gwak, Heui-Chul; Kim, Chang-Wan; Kim, Jung-Han; Choo, Hye-Jeung; Sagong, Seung-Yeob; Shin, John

    2015-05-01

    The purpose of this study was to evaluate the extension of delamination and the cuff integrity after arthroscopic repair of delaminated rotator cuff tears. Sixty-five patients with delaminated rotator cuff tears were retrospectively reviewed. The delaminated tears were divided into full-thickness delaminated tears and partial-thickness delaminated tears. To evaluate the medial extension, we calculated the coronal size of the delaminated portion. To evaluate the posterior extension, we checked the tendon involved. Cuff integrity was evaluated by computed tomography arthrography. The mean medial extension in the full-thickness and partial-thickness delaminated tears was 18.1 ± 6.0 mm and 22.7 ± 6.3 mm, respectively (P = .0084). The posterior extension into the supraspinatus and the infraspinatus was 36.9% and 32.3%, respectively, in the full-thickness delaminated tears, and it was 27.7% and 3.1%, respectively, in the partial-thickness delaminated tears (P = .0043). With regard to cuff integrity, 35 cases of anatomic healing, 10 cases of partial healing defects, and 17 cases of retear were detected. Among the patients with retear and partial healing of the defect, all the partially healed defects showed delamination. Three retear patients showed delamination, and 14 retear patients did not show delamination; the difference was statistically significant (P = .0001). The full-thickness delaminated tears showed less medial extension and more posterior extension than the partial-thickness delaminated tears. Delamination did not develop in retear patients, but delamination was common in the patients with partially healed defects. Copyright © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

  18. Randomised, controlled trial of N-acetylcysteine for treatment of acute exacerbations of chronic obstructive pulmonary disease [ISRCTN21676344

    PubMed Central

    Black, Peter N; Morgan-Day, Althea; McMillan, Tracey E; Poole, Phillippa J; Young, Robert P

    2004-01-01

    Background Prophylactic treatment with N-acetylcysteine (NAC) for 3 months or more is associated with a reduction in the frequency of exacerbations of chronic obstructive pulmonary disease (COPD). This raises the question of whether treatment with NAC during an acute exacerbation will hasten recovery from the exacerbation. Methods We have examined this in a randomised, double-blind, placebo controlled trial. Subjects, admitted to hospital with an acute exacerbation of COPD, were randomised within 24 h of admission to treatment with NAC 600 mg b.d. (n = 25) or matching placebo (n = 25). Treatment continued for 7 days or until discharge (whichever occurred first). To be eligible subjects had to be ≥ 50 years, have an FEV1 ≤ 60% predicted, FEV1/VC ≤ 70% and ≥ 10 pack year smoking history. Subjects with asthma, heart failure, pneumonia and other respiratory diseases were excluded. All subjects received concurrent treatment with prednisone 40 mg/day, nebulised salbutamol 5 mg q.i.d and where appropriate antibiotics. FEV1, VC, SaO2 and breathlessness were measured 2 hours after a dose of nebulised salbutamol, at the same time each day. Breathlessness was measured on a seven point Likert scale. Results At baseline FEV1 (% predicted) was 22% in the NAC group and 24% in the control group. There was no difference between the groups in the rate of change of FEV1, VC, SaO2 or breathlessness. Nor did the groups differ in the median length of stay in hospital (6 days for both groups). Conclusions Addition of NAC to treatment with corticosteroids and bronchodilators does not modify the outcome in acute exacerbations of COPD. PMID:15581425

  19. Evaluation and treatment of rotator cuff tears.

    PubMed

    Lansdown, Drew A; Feeley, Brian T

    2012-05-01

    Rotator cuff injuries are common problems and a frequent reason for patients to present to primary care physicians. These injuries are seen more frequently now with the aging population. These muscles allow for movement of the arm in overhead activities and controlled movements through space. A thorough physical examination can lead to the diagnosis of rotator cuff pathology. Radiographic imaging may offer some insight into the underlying pathology, and magnetic resonance imaging provides for excellent visualization of the rotator cuff. Many rotator cuff tears, especially partial tears, will symptomatically improve with conservative management. Surgical treatment may offer improved pain relief and function in those patients for whom nonoperative care is insufficient. In cases in which rotator cuff repair is not possible, the reverse total shoulder arthroplasty is a possibility. New technologies are also under investigation that allow for biological augmentation of rotator cuff tears.

  20. Rotator cuff and subacromial pathology.

    PubMed

    Yablon, Corrie M; Jacobson, Jon A

    2015-07-01

    Both MRI and ultrasound (US) demonstrate equivalent accuracy in the evaluation of the rotator cuff. Both modalities have their advantages, disadvantages, and pitfalls. Radiography is an important complementary modality in that it can demonstrate occult sources of shoulder pain. MRI is recommended for the evaluation of shoulder pain in patients < 40 years of age because labral pathology is frequently identified. However, in patients > 40 years, US should be the first-line modality because the incidence of rotator cuff pathology increases with age. US is useful to guide procedures such as subacromial injection and calcific tendinosis lavage. Radiologists should be knowledgeable of both MRI and US of the shoulder to tailor these examinations to the specific needs of their patients. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  1. Ultrasound determination of rotator cuff tear repairability

    PubMed Central

    Tse, Andrew K; Lam, Patrick H; Walton, Judie R; Hackett, Lisa

    2015-01-01

    Background Rotator cuff repair aims to reattach the torn tendon to the greater tuberosity footprint with suture anchors. The present study aimed to assess the diagnostic accuracy of ultrasound in predicting rotator cuff tear repairability and to assess which sonographic and pre-operative features are strongest in predicting repairability. Methods The study was a retrospective analysis of measurements made prospectively in a cohort of 373 patients who had ultrasounds of their shoulder and underwent rotator cuff repair. Measurements of rotator cuff tear size and muscle atrophy were made pre-operatively by ultrasound to enable prediction of rotator cuff repairability. Tears were classified following ultrasound as repairable or irreparable, and were correlated with intra-operative repairability. Results Ultrasound assessment of rotator cuff tear repairability has a sensitivity of 86% (p < 0.0001) and a specificity of 67% (p < 0.0001). The strongest predictors of rotator cuff repairability were tear size (p < 0.001) and age (p = 0.004). Sonographic assessments of tear size ≥4 cm2 or anteroposterior tear length ≥25 mm indicated an irreparable rotator cuff tear. Conclusions Ultrasound assessment is accurate in predicting rotator cuff tear repairability. Tear size or anteroposterior tear length and age were the best predictors of repairability. PMID:27582996

  2. Clinical Assessment of Physical Examination Maneuvers for Rotator Cuff Lesions.

    PubMed

    Somerville, Lyndsay E; Willits, Kevin; Johnson, Andrew M; Litchfield, Robert; LeBel, Marie-Eve; Moro, Jaydeep; Bryant, Dianne

    2014-08-01

    Shoulder pain and disability pose a diagnostic challenge for clinicians owing to the numerous causes that exist. Unfortunately, the evidence in support of most clinical tests is weak or absent. To determine the diagnostic validity of physical examination maneuvers for rotator cuff lesions. Cohort study (diagnosis); Level of evidence, 1. Consecutive shoulder patients recruited for this study were referred to 2 tertiary orthopaedic clinics. A surgeon took a thorough history and indicated his or her certainty about each possible diagnosis. A clinician performed the physical examination for diagnoses where uncertainty remained. Arthroscopy was considered the reference standard for patients who underwent surgery, and MRI with arthrogram was considered the reference for patients who did not. The sensitivity, specificity, and likelihood ratios were calculated to investigate whether combinations of the top tests provided stronger predictions of the presence or absence of disease. There were 139 participants. None of the tests were highly sensitive for diagnosing rotator cuff tears or tendinosis. Tests for subscapularis tears were all highly specific. No optimal combination of tests improved the ability to correctly diagnose rotator cuff tears. Closer analysis revealed the internal rotation and lateral rotation lag sign did not improve the ability to diagnose subscapularis or supraspinatus tears, respectively, although the lateral rotation lag sign demonstrated a discriminatory ability for tear size. No test in isolation is sufficient to diagnose a patient with rotator cuff damage. A combination of tests improves the ability to diagnose damage to the rotator cuff. It is recommended that the internal rotation and lateral rotation lag signs be removed from the gamut of physical examination tests for supraspinatus and subscapularis tears. © 2014 The Author(s).

  3. Imaging of the Rotator Cuff With Optical Coherence Tomography.

    PubMed

    Hartshorn, Timothy; Ren, Jian; Vangsness, C Thomas

    2015-09-01

    This study evaluated the utility of optical coherence tomography (OCT) in imaging porcine and human rotator cuff (RTC) tissue, analyzed its effectiveness in identifying clinical pathology, and correlated these findings with histologic examination. Twelve human cadaveric and 6 porcine shoulders were evaluated. Six-millimeter-wide bone sections were harvested from the proximal humerus of each specimen, with each containing the entire enthesis of the respective RTC tendon, as well as 2 cm of tendon medial to the enthesis. Only the supraspinatus tendon was evaluated in the human specimens, whereas the enthesis of multiple RTC tendons were evaluated in the porcine model. All specimens were imaged using OCT and correlated with histologic evaluation. Optical coherence tomography evaluation of macroscopically healthy tissue consistently showed an easily identifiable banding pattern (birefringence) in contrast to a disorganized, homogeneous appearance in grossly diseased tissue. Optical coherence tomography was more effective for qualitative evaluation of RTC tissue, identification of bursal-sided RTC tears, and localization of calcific deposits, whereas intrasubstance tendon delaminations and partial articular-sided tendon avulsion lesions were relatively more difficult to identify. Optical coherence tomography correlated well with histologic evaluation in all specimens. Optical coherence tomography provides high-resolution, subsurface imaging of rotator cuff tissue in real-time to a depth of up to 4 mm with excellent correlation to histology in a cadaveric model. Optical coherence tomography could be an effective adjunctive tool for the identification and localization of rotator cuff pathology. The use of OCT in arthroscopic shoulder surgery potentially provides a minimally invasive modality for qualitative assessment of rotator cuff pathology. This may allow for a decrease in soft tissue dissection, improved qualitative assessment of cuff tissue, and improved patient

  4. Collaborative care for comorbid depression and coronary heart disease: a systematic review and meta-analysis of randomised controlled trials

    PubMed Central

    Tully, Phillip J; Baumeister, Harald

    2015-01-01

    Objectives To systematically review the efficacy of collaborative care (CC) for depression in adults with coronary heart disease (CHD) and depression. Design Systematic review and meta-analysis. Data sources Electronic databases (Cochrane Central Register of Controlled Trials MEDLINE, EMBASE, PsycINFO and CINAHL) were searched until April 2014. Inclusion criteria Population, depression comorbid with CHD; intervention, randomised controlled trial (RCT) of CC; comparison, either usual care, wait-list control group or no further treatment; and outcome, (primary) major adverse cardiac events (MACE), (secondary) standardised measure of depression, anxiety, quality of life (QOL) and cost-effectiveness. Data extraction and analysis RevMan V.5.3 was used to synthesise the data as risk ratios (RRs), ORs and standardised mean differences (SMD) with 95% CIs in random effect models. Results Six RCTs met the inclusion criteria and comprised 655 participants randomised to CC and 629 participants randomised to the control group (total 1284). Collaborative depression care led to a significant reduction in MACE in the short term (three trials, RR 0.54; 95% CI 0.31 to 0.95, p=0.03) that was not sustained in the longer term. Small reductions in depressive symptoms were evident in the short term (6 trials, pooled SMD −0.31; 95% CI −0.43 to −0.19, p<0.00001) and depression remission was more likely to be achieved with CC (5 trials, OR 1.77; 95% CI 1.28 to 2.44, p=0.0005). Likewise, a significant effect was observed for anxiety symptoms (SMD −0.36) and mental QOL (SMD 0.24). The timing of the intervention was a source of between-group heterogeneity for depression symptoms (between groups p=0.04, I2=76.5%). Conclusions Collaborative depression care did not lead to a sustained reduction in the primary MACE end point. Small effects were observed for depression, depression remission, anxiety and mental QOL. Trials registration number PROSPERO CRD42014013653. PMID:26692557

  5. Association between C reactive protein and coronary heart disease: mendelian randomisation analysis based on individual participant data.

    PubMed

    Wensley, Frances; Gao, Pei; Burgess, Stephen; Kaptoge, Stephen; Di Angelantonio, Emanuele; Shah, Tina; Engert, James C; Clarke, Robert; Davey-Smith, George; Nordestgaard, Børge G; Saleheen, Danish; Samani, Nilesh J; Sandhu, Manjinder; Anand, Sonia; Pepys, Mark B; Smeeth, Liam; Whittaker, John; Casas, Juan Pablo; Thompson, Simon G; Hingorani, Aroon D; Danesh, John

    2011-02-15

    To use genetic variants as unconfounded proxies of C reactive protein concentration to study its causal role in coronary heart disease. Mendelian randomisation meta-analysis of individual participant data from 47 epidemiological studies in 15 countries. 194 418 participants, including 46 557 patients with prevalent or incident coronary heart disease. Information was available on four CRP gene tagging single nucleotide polymorphisms (rs3093077, rs1205, rs1130864, rs1800947), concentration of C reactive protein, and levels of other risk factors. Risk ratios for coronary heart disease associated with genetically raised C reactive protein versus risk ratios with equivalent differences in C reactive protein concentration itself, adjusted for conventional risk factors and variability in risk factor levels within individuals. CRP variants were each associated with up to 30% per allele difference in concentration of C reactive protein (P<10(-34)) and were unrelated to other risk factors. Risk ratios for coronary heart disease per additional copy of an allele associated with raised C reactive protein were 0.93 (95% confidence interval 0.87 to 1.00) for rs3093077; 1.00 (0.98 to 1.02) for rs1205; 0.98 (0.96 to 1.00) for rs1130864; and 0.99 (0.94 to 1.03) for rs1800947. In a combined analysis, the risk ratio for coronary heart disease was 1.00 (0.90 to 1.13) per 1 SD higher genetically raised natural log (ln) concentration of C reactive protein. The genetic findings were discordant with the risk ratio observed for coronary heart disease of 1.33 (1.23 to 1.43) per 1 SD higher circulating ln concentration of C reactive protein in prospective studies (P=0.001 for difference). Human genetic data indicate that C reactive protein concentration itself is unlikely to be even a modest causal factor in coronary heart disease.

  6. Randomised controlled trial of screening for Chlamydia trachomatis to prevent pelvic inflammatory disease: the POPI (prevention of pelvic infection) trial.

    PubMed

    Oakeshott, Pippa; Kerry, Sally; Aghaizu, Adamma; Atherton, Helen; Hay, Sima; Taylor-Robinson, David; Simms, Ian; Hay, Phillip

    2010-04-08

    To determine whether screening and treating women for chlamydial infection reduces the incidence of pelvic inflammatory disease over the subsequent 12 months. Randomised controlled trial. Common rooms, lecture theatres, and student bars at universities and further education colleges in London. 2529 sexually active female students, mean age 21 years (range 16-27). Participants completed a questionnaire and provided self taken vaginal swabs, with follow-up after one year. Samples were randomly allocated to immediate testing and treatment for chlamydial infection, or storage and analysis after a year (deferred screening controls). Incidence of clinical pelvic inflammatory disease over 12 months. Baseline prevalence of chlamydia was 5.4% (68/1254) in screened women and 5.9% (75/1265) in controls. 94% (2377/2529) of women were followed up after 12 months. The incidence of pelvic inflammatory disease was 1.3% (15/1191) in screened women compared with 1.9% (23/1186) in controls (relative risk 0.65, 95% confidence interval 0.34 to 1.22). Seven of 74 control women (9.5%, 95% confidence interval 4.7% to 18.3%) who tested positive for chlamydial infection at baseline developed pelvic inflammatory disease over 12 months compared with one of 63 (1.6%) screened women (relative risk 0.17, 0.03 to 1.01). However, most episodes of pelvic inflammatory disease occurred in women who tested negative for chlamydia at baseline (79%, 30/38). 22% (527/2377) of women reported being tested independently for chlamydia during the trial. Although some evidence suggests that screening for chlamydia reduces rates of pelvic inflammatory disease, especially in women with chlamydial infection at baseline, the effectiveness of a single chlamydia test in preventing pelvic inflammatory disease over 12 months may have been overestimated. Trial registration ClinicalTrials.gov NCT00115388.

  7. Infliximab for intensification of primary therapy for Kawasaki disease: a phase 3 randomised, double-blind, placebo-controlled trial.

    PubMed

    Tremoulet, Adriana H; Jain, Sonia; Jaggi, Preeti; Jimenez-Fernandez, Susan; Pancheri, Joan M; Sun, Xiaoying; Kanegaye, John T; Kovalchin, John P; Printz, Beth F; Ramilo, Octavio; Burns, Jane C

    2014-05-17

    Kawasaki disease, the most common cause of acquired heart disease in developed countries, is a self-limited vasculitis that is treated with high doses of intravenous immunoglobulin. Resistance to intravenous immunoglobulin in Kawasaki disease increases the risk of coronary artery aneurysms. We assessed whether the addition of infliximab to standard therapy (intravenous immunoglobulin and aspirin) in acute Kawasaki disease reduces the rate of treatment resistance. We undertook a phase 3, randomised, double-blind, placebo-controlled trial in two children's hospitals in the USA to assess the addition of infliximab (5 mg per kg) to standard therapy. Eligible participants were children aged 4 weeks-17 years who had a fever (temperature ≥38·0°C) for 3-10 days and met American Heart Association criteria for Kawasaki disease. Participants were randomly allocated in 1:1 ratio to two treatment groups: infliximab 5 mg/kg at 1 mg/mL intravenously over 2 h or placebo (normal saline 5 mL/kg, administered intravenously). Randomisation was based on a randomly permuted block design (block sizes 2 and 4), stratified by age, sex, and centre. Patients, treating physicians and staff, study team members, and echocardiographers were all masked to treament assignment. The primary outcome was the difference between the groups in treatment resistance defined as a temperature of 38·0°C or higher at 36 h to 7 days after completion of the infusion of intravenous immunoglobulin. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, NCT00760435. 196 patients were enrolled and randomised: 98 to the infliximab group and 98 to placebo. One patient in the placebo group was withdrawn from the study because of hypotension before receiving treatment. Treatment resistance rate did not differ significantly (11 [11·2%] for infliximab and 11 [11·3%] for placebo; p=0·81). Compared with the placebo group, participants given infliximab had fewer days of fever (median 1

  8. How reliable are randomised controlled trials for studying the relationship between diet and disease? A narrative review.

    PubMed

    Temple, Norman J

    2016-08-01

    Large numbers of randomised controlled trials (RCT) have been carried out in order to investigate diet-disease relationships. This article examines eight sets of studies and compares the findings with those from epidemiological studies (cohort studies in seven of the cases). The studies cover the role of dietary factors in blood pressure, body weight, cancer and heart disease. In some cases, the findings from the two types of study are consistent, whereas in other cases the findings appear to be in conflict. A critical evaluation of this evidence suggests factors that may account for conflicting findings. Very often RCT recruit subjects with a history of the disease under study (or at high risk of it) and have a follow-up of only a few weeks or months. Cohort studies, in contrast, typically recruit healthy subjects and have a follow-up of 5-15 years. Owing to these differences, findings from RCT are not necessarily more reliable than those from well-designed prospective cohort studies. We cannot assume that the results of RCT can be freely applied beyond the specific features of the studies.

  9. An early rehabilitation intervention to enhance recovery during hospital admission for an exacerbation of chronic respiratory disease: randomised controlled trial

    PubMed Central

    Williams, Johanna E A; Hussain, Syed F; Harvey-Dunstan, Theresa C; Bankart, M John; Chaplin, Emma J; Vincent, Emma E; Chimera, Rudo; Morgan, Mike D; Singh, Sally J; Steiner, Michael C

    2014-01-01

    Objective To investigate whether an early rehabilitation intervention initiated during acute admission for exacerbations of chronic respiratory disease reduces the risk of readmission over 12 months and ameliorates the negative effects of the episode on physical performance and health status. Design Prospective, randomised controlled trial. Setting An acute cardiorespiratory unit in a teaching hospital and an acute medical unit in an affiliated teaching district general hospital, United Kingdom. Participants 389 patients aged between 45 and 93 who within 48 hours of admission to hospital with an exacerbation of chronic respiratory disease were randomised to an early rehabilitation intervention (n=196) or to usual care (n=193). Main outcome measures The primary outcome was readmission rate at 12 months. Secondary outcomes included number of hospital days, mortality, physical performance, and health status. The primary analysis was by intention to treat, with prespecified per protocol analysis as a secondary outcome. Interventions Participants in the early rehabilitation group received a six week intervention, started within 48 hours of admission. The intervention comprised prescribed, progressive aerobic, resistance, and neuromuscular electrical stimulation training. Patients also received a self management and education package. Results Of the 389 participants, 320 (82%) had a primary diagnosis of chronic obstructive pulmonary disease. 233 (60%) were readmitted at least once in the following year (62% in the intervention group and 58% in the control group). No significant difference between groups was found (hazard ratio 1.1, 95% confidence interval 0.86 to 1.43, P=0.4). An increase in mortality was seen in the intervention group at one year (odds ratio 1.74, 95% confidence interval 1.05 to 2.88, P=0.03). Significant recovery in physical performance and health status was seen after discharge in both groups, with no significant difference between groups at one year

  10. An early rehabilitation intervention to enhance recovery during hospital admission for an exacerbation of chronic respiratory disease: randomised controlled trial.

    PubMed

    Greening, Neil J; Williams, Johanna E A; Hussain, Syed F; Harvey-Dunstan, Theresa C; Bankart, M John; Chaplin, Emma J; Vincent, Emma E; Chimera, Rudo; Morgan, Mike D; Singh, Sally J; Steiner, Michael C

    2014-07-08

    To investigate whether an early rehabilitation intervention initiated during acute admission for exacerbations of chronic respiratory disease reduces the risk of readmission over 12 months and ameliorates the negative effects of the episode on physical performance and health status. Prospective, randomised controlled trial. An acute cardiorespiratory unit in a teaching hospital and an acute medical unit in an affiliated teaching district general hospital, United Kingdom. 389 patients aged between 45 and 93 who within 48 hours of admission to hospital with an exacerbation of chronic respiratory disease were randomised to an early rehabilitation intervention (n=196) or to usual care (n=193). The primary outcome was readmission rate at 12 months. Secondary outcomes included number of hospital days, mortality, physical performance, and health status. The primary analysis was by intention to treat, with prespecified per protocol analysis as a secondary outcome. Participants in the early rehabilitation group received a six week intervention, started within 48 hours of admission. The intervention comprised prescribed, progressive aerobic, resistance, and neuromuscular electrical stimulation training. Patients also received a self management and education package. Of the 389 participants, 320 (82%) had a primary diagnosis of chronic obstructive pulmonary disease. 233 (60%) were readmitted at least once in the following year (62% in the intervention group and 58% in the control group). No significant difference between groups was found (hazard ratio 1.1, 95% confidence interval 0.86 to 1.43, P=0.4). An increase in mortality was seen in the intervention group at one year (odds ratio 1.74, 95% confidence interval 1.05 to 2.88, P=0.03). Significant recovery in physical performance and health status was seen after discharge in both groups, with no significant difference between groups at one year. Early rehabilitation during hospital admission for chronic respiratory disease

  11. The development of confocal arthroscopy as optical histology for rotator cuff tendinopathy.

    PubMed

    Wu, J-P; Walton, M; Wang, A; Anderson, P; Wang, T; Kirk, T B; Zheng, M H

    2015-09-01

    MRI, ultrasound and video arthroscopy are traditional imaging technologies for noninvasive or minimal invasive assessment of the rotator cuff tendon pathology. However, these imaging modalities do not have sufficient resolution to demonstrate the pathology of rotator cuff tendons at a microstructural level. Therefore, they are insensitive to low-level tendon diseases. Although traditional histology can be used to analyze the physiology of rotator cuff tendons, it requires biopsy that traumatizes the rotator cuff, thus, potentially comprising the mechanical properties of tendons. Besides, it cannot offer real-time histological information. Confocal endoscopy offers a way to assess the microstructural disorder in tissues without biopsy. However, the application of this useful technique for detecting low-level tendon diseases has been restricted by using clinical grade fluorescent contrast agent to acquire high-resolution microstructural images of tendons. In this study, using a clinical grade sodium fluorescein contrast agent, we have reported the development of confocal arthroscopy for optical histological assessment without biopsy. The confocal arthroscopic technique was able to demonstrate rotator cuff tendinopathy in human cadavers, which appeared macroscopically normal under video arthroscopic examinations. The tendinopathy status of the rotator cuff tendons was confirmed by corresponding traditional histology. The development of confocal arthroscopy may provide a minimally invasive imaging technique for real-time histology of rotator cuff without the need for tissue biopsy. This technique has the potential for surgeons to gain in real time the histological information of rotator cuff tendons, which may assist planning repair strategies and potentially improve intervention outcomes. © 2015 The Authors Journal of Microscopy © 2015 Royal Microscopical Society.

  12. Home-based step training using videogame technology in people with Parkinson's disease: a single-blinded randomised controlled trial.

    PubMed

    Song, Jooeun; Paul, Serene S; Caetano, Maria Joana D; Smith, Stuart; Dibble, Leland E; Love, Rachelle; Schoene, Daniel; Menant, Jasmine C; Sherrington, Cathie; Lord, Stephen R; Canning, Colleen G; Allen, Natalie E

    2017-07-01

    To determine whether 12-week home-based exergame step training can improve stepping performance, gait and complementary physical and neuropsychological measures associated with falls in Parkinson's disease. A single-blinded randomised controlled trial. Community (experimental intervention), university laboratory (outcome measures). Sixty community-dwelling people with Parkinson's disease. Home-based step training using videogame technology. The primary outcomes were the choice stepping reaction time test and Functional Gait Assessment. Secondary outcomes included physical and neuropsychological measures associated with falls in Parkinson's disease, number of falls over six months and self-reported mobility and balance. Post intervention, there were no differences between the intervention ( n = 28) and control ( n = 25) groups in the primary or secondary outcomes except for the Timed Up and Go test, where there was a significant difference in favour of the control group ( P = 0.02). Intervention participants reported mobility improvement, whereas control participants reported mobility deterioration-between-group difference on an 11-point scale = 0.9 (95% confidence interval: -1.8 to -0.1, P = 0.03). Interaction effects between intervention and disease severity on physical function measures were observed ( P = 0.01 to P = 0.08) with seemingly positive effects for the low-severity group and potentially negative effects for the high-severity group. Overall, home-based exergame step training was not effective in improving the outcomes assessed. However, the improved physical function in the lower disease severity intervention participants as well as the self-reported improved mobility in the intervention group suggest home-based exergame step training may have benefits for some people with Parkinson's disease.

  13. Screening for hypercholesterolaemia in primary care: randomised controlled trial of postal questionnaire appraising risk of coronary heart disease

    PubMed Central

    Hutchison, Brian; Birch, Stephen; Evans, C Edward; Goldsmith, Laurie J; Markham, Barbara A; Frank, John; Paterson, Michael

    1998-01-01

    Objectives: To validate a self administered postal questionnaire appraising risk of coronary heart disease. To determine whether use of this questionnaire increased the percentage of people at high risk of coronary heart disease and decreased the percentage of people at low risk who had their cholesterol concentration measured. Design: Validation was by review of medical records and clinical assessment. The questionnaire appraising risk of coronary heart disease encouraged those meeting criteria for cholesterol measurement to have a cholesterol test and was tested in a randomised controlled trial. The intervention group was sent the risk appraisal questionnaire with a health questionnaire that determined risk of coronary heart disease without identifying the risk factors as related to coronary heart disease; the control group was sent the health questionnaire alone. Setting: One capitation funded primary care practice in Canada with an enrolled patient population of about 12 000. Subjects: Random sample of 100 participants in the intervention and control groups were included in the validation exercise. 5686 contactable patients aged 20 to 69 years who on the basis of practice records had not had a cholesterol test performed during the preceding 5 years were included in the randomised controlled trial. 2837 were in the intervention group and 2849 were in the control group. Main outcome measures: Sensitivity and specificity of assessment of risk of coronary heart disease with risk appraisal questionnaire. Rate of cholesterol testing during three months of follow up. Results: Sensitivity of questionnaire appraising coronary risk was 87.5% (95% confidence interval 73.2% to 95.8%) and specificity 91.7% (81.6% to 97.2%). Of the patients without pre-existing coronary heart disease who met predefined screening criteria based on risk, 45 out of 421 in the intervention group (10.7%) and 9 out of 504 in the control group (1.8%) had a cholesterol test performed during follow

  14. Patient self-assessed shoulder comfort and function and active motion are not closely related to surgically documented rotator cuff tear integrity.

    PubMed

    Hsu, Jason E; Tang, Anna; Matsen, Frederick A

    2017-07-06

    The rationale for rotator cuff repair surgery is that better integrity of the cuff should be associated with better comfort and function. However, in patients with cuff disease, there is not good evidence that the degree of rotator cuff integrity is closely associated with the shoulder's comfort, function, or active motion. The goal of this study was to explore these relationships in shoulders with surgically documented cuff disease. In 55 shoulders having surgery for cuff-related symptoms, we correlated the preoperative Simple Shoulder Test score with the objectively measured preoperative active shoulder motion and with the integrity of the cuff observed at surgery. The 16 shoulders with tendinosis or partial-thickness tears had an average Simple Shoulder Test score of 3.7 ± 3.3, active abduction of 111° ± 38°, and active flexion of 115° ± 36°. The corresponding values were 3.6 ± 2.8, 94° ± 47°, and 94° ± 52° for the 22 full-thickness supraspinatus tears and 3.9 ± 2.7, 89° ± 39°, and 100° ± 39° for the 17 supraspinatus and infraspinatus tears. In this study, surgically observed cuff integrity was not strongly associated with the shoulder's comfort or function. Whereas surgeons often seek to improve the integrity of the rotator cuff, the management of patients with rotator cuff disorders needs to be informed by a better understanding of the factors other than cuff integrity that influence the comfort and functioning of shoulders with cuff disease. Copyright © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

  15. Comprehensive care programme for patients with chronic obstructive pulmonary disease: a randomised controlled trial.

    PubMed

    Ko, Fanny W S; Cheung, N K; Rainer, Timothy H; Lum, Christopher; Wong, Ivor; Hui, David S C

    2017-02-01

    There have been no randomised controlled trials that specifically evaluate the effect of a comprehensive programme with multidisciplinary input on patients who have just been discharged from hospital after treatment of acute exacerbation of COPD (AECOPD). The aim of this study was to assess whether a comprehensive care programme would decrease hospital readmissions and length of hospital stay (LOS) for patients with COPD. Patients discharged from hospital after an episode of AECOPD were randomised to an intervention group (IG) or usual care group (UG). The IG received a comprehensive, individualised care plan which included education from a respiratory nurse, physiotherapist support for pulmonary rehabilitation, 3-monthly telephone calls by a respiratory nurse over 1 year, and follow-up at a respiratory clinic with a respiratory specialist once every 3 months for 1 year. The UG were managed according to standard practice. The primary outcome was hospital readmission rate at 12 months. 180 patients were recruited (IG, N=90; UG, N=90; mean±SD age 74.7±8.2 years, 172 (95.6%) men; mean±SD FEV1 45.4±16.6% predicted). At 12 months, the adjusted relative risk of readmission was 0.668 (95% CI 0.449 to 0.995, p=0.047) for the IG compared with the UG. At 12 months, the IG had a shorter LOS (4.59±7.16 vs 8.86±10.24 days, p≤0.001), greater improvement in mean Modified Medical Research Council Dyspnoea Scale (-0.1±0.6 vs 0.2±0.6, p=0.003) and St George's Respiratory Questionnaire score (-6.9±15.3 vs -0.1±13.8, p=0.003) compared with the UG. A comprehensive COPD programme can reduce hospital readmissions for COPD and LOS, in addition to improving symptoms and quality of life of the patients. NCT 01108835, Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  16. Implementing guidelines to routinely prevent chronic vascular disease in primary care: the Preventive Evidence into Practice cluster randomised controlled trial

    PubMed Central

    Parker, Sharon M; Litt, John; van Driel, Mieke; Russell, Grant; Mazza, Danielle; Jayasinghe, Upali W; Del Mar, Chris; Lloyd, Jane; Smith, Jane; Zwar, Nicholas; Taylor, Richard; Powell Davies, Gawaine

    2015-01-01

    Objective To evaluate an intervention to improve implementation of guidelines for the prevention of chronic vascular disease. Setting 32 urban general practices in 4 Australian states. Randomisation Stratified randomisation of practices. Participants 122 general practitioners (GPs) and practice nurses (PNs) were recruited at baseline and 97 continued to 12 months. 21 848 patient records were audited for those aged 40–69 years who attended the practice in the previous 12 months without heart disease, stroke, diabetes, chronic renal disease, cognitive impairment or severe mental illness. Intervention The practice level intervention over 6 months included small group training of practice staff, feedback on audited performance, practice facilitation visits and provision of patient education and referral information. Outcome measures Primary: 1. Change in proportion of patients aged 40–69 years with smoking status, alcohol intake, body mass index (BMI), waist circumference (WC), blood pressure (BP) recorded and for those aged 45–69 years with lipids, fasting blood glucose and cardiovascular risk in the medical record. 2. Change in the level of risk for each factor. Secondary change in self-reported frequency and confidence of GPs and PNs in assessment. Results Risk recording improved in the intervention but not the control group for WC (OR 2.52 (95% CI 1.30 to 4.91)), alcohol consumption (OR 2.19 (CI 1.04 to 4.64)), smoking status (OR 2.24 (1.17 to 4.29)) and cardiovascular risk (OR 1.50 (1.04 to 2.18)). There was no change in recording of BP, lipids, glucose or BMI and no significant change in the level of risk factors based on audit data. The confidence but not reported practices of GPs and PNs in the intervention group improved in the assessment of some risk factors. Conclusions This intervention was associated with improved recording of some risk factors but no change in the level of risk at the follow-up audit. Trial registration number

  17. Multifactorial intervention to prevent cardiovascular disease in patients with early rheumatoid arthritis: protocol for a multicentre randomised controlled trial

    PubMed Central

    Svensson, Annemarie Lyng; Løgstrup, Brian Bridal; Giraldi, Annamaria; Graugaard, Christian; Blegvad, Jesper; Thygesen, Tina; Sheetal, Ekta; Svendsen, Lone; Emmertsen, Henrik

    2016-01-01

    Introduction Cardiovascular morbidity is a major burden in patients with rheumatoid arthritis (RA). In this study, we compare the effect of a targeted, intensified, multifactorial intervention with that of conventional treatment of modifiable risk factors for cardiovascular disease (CVD) in patients with early RA fulfilling the 2010 American College of Rheumatology European League Against Rheumatism (ACR/EULAR) criteria. Methods and analysis The study is a prospective, randomised, open label trial with blinded end point assessment and balanced randomisation (1:1) conducted in 10 outpatient clinics in Denmark. The primary end point after 5 years of follow-up is a composite of death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke and cardiac revascularisation. Secondary outcomes are: the proportion of patients achieving low-density lipoprotein cholesterol <2.5 mmol/L, glycated haemoglobin <48 mmol/mol, blood pressure <140/90 mm  Hg for patients without diabetes and <130/80 mm Hg for patients with diabetes and normoalbuminuria (urinary albumin creatinine ratio <30 mg/g) after 1 year of follow-up and the proportion of patients in each treatment group achieving low RA disease activity after 1 year, defined as a disease activity score C-reactive protein (DAS28-CRP) <3.2 and a DAS28-CRP score <2.6 after 12, 24 and 60 months. Furthermore, all hospitalisations for acute and elective reasons will be adjudicated by the event committee after 12, 24 and 60 months. Three hundred treatment-naive patients with early RA will be randomly assigned (1:1) to receive either conventional treatment administered and monitored by their general practitioner according to national guidelines (control group) or a stepwise implementation administered and monitored in a quarterly rheumatological nurse-administered set-up of behaviour modification and pharmacological therapy targeting (1) hyperlipidaemia, (2) hypertension, (3) hyperglycaemia

  18. Plasma levels of the anti-coagulation protein C and the risk of ischaemic heart disease. A Mendelian randomisation study.

    PubMed

    Schooling, C Mary; Zhong, Yi

    2017-01-26

    Protein C is an environmentally modifiable anticoagulant, which protects against venous thrombosis, whether it also protects against ischaemic heart disease is unclear, based on observational studies and relatively small genetic studies. It was our study aim to clarify the role of protein C in ischaemic heart disease. The risk of coronary artery disease/myocardial infarction (CAD/MI) was assessed according to genetically predicted protein C in very large studies. Associations with lipids and diabetes were similarly assessed to rule out effects via traditional cardiovascular disease risk factors. Separate sample instrumental variable analysis with genetic instruments (Mendelian randomisation) was used to obtain an unconfounded estimate of the association of protein C (based on (rs867186 (PROCR), rs3746429 (EDEM2), rs7580658 (inter/PROC)) with CAD/MI in an extensively genotyped case (n=64374)-control (n=130681) study, CARDIoGRAMplusC4D. Associations with lipids and diabetes were similarly assessed using the Global Lipids Genetics Consortium Results (n=196,475) and the DIAbetes Genetics Replication And Meta-analysis case (n=34,380)-control (n=114,981) study. Genetically predicted protein C was negatively associated with CAD/MI, odds ratio (OR) 0.85 µg/ml, 95 % confidence interval 0.80 to 0.90, but had no such negative association with lipids or diabetes. Results were similar for the SNP rs867186 functionally relevant to protein C, and including additional potentially pleiotropic SNPs (rs1260326 (GCKR), rs17145713 (BAZ1B) and rs4321325 (CYP27C1)). In conclusion, protein C may protect against CAD/MI. Whether environmental or dietary items that raise protein C protect against ischaemic cardiovascular disease by that mechanism should be investigated.

  19. Heel raises versus prefabricated orthoses in the treatment of posterior heel pain associated with calcaneal apophysitis (Sever's Disease): study protocol for a randomised controlled trial

    PubMed Central

    2010-01-01

    Background Posterior Heel pain can present in children of 8 to 14 years, associated with or clinically diagnosed as Sever's disease, or calcaneal apophysitis. Presently, there are no comparative randomised studies evaluating treatment options for posterior heel pain in children with the clinical diagnosis of calcaneal apophysitis or Sever's disease. This study seeks to compare the clinical efficacy of some currently employed treatment options for the relief of disability and pain associated with posterior heel pain in children. Method Design: Factorial 2 × 2 randomised controlled trial with monthly follow-up for 3 months. Participants: Children with clinically diagnosed posterior heel pain possibly associated with calcaneal apophysitis/Sever's disease (n = 124). Interventions: Treatment factor 1 will be two types of shoe orthoses: a heel raise or prefabricated orthoses. Both of these interventions are widely available, mutually exclusive treatment approaches that are relatively low in cost. Treatment factor 2 will be a footwear prescription/replacement intervention involving a shoe with a firm heel counter, dual density EVA midsole and rear foot control. The alternate condition in this factor is no footwear prescription/replacement, with the participant wearing their current footwear. Outcomes: Oxford Foot and Ankle Questionnaire and the Faces pain scale. Discussion This will be a randomised trial to compare the efficacy of various treatment options for posterior heel pain in children that may be associated with calcaneal apophysitis also known as Sever's disease. Trial Registration Trial Number: ACTRN12609000696291 Ethics Approval Southern Health: HREC Ref: 09271B PMID:20196866

  20. A randomised comparison of deferasirox versus deferoxamine for the treatment of transfusional iron overload in sickle cell disease.

    PubMed

    Vichinsky, Elliott; Onyekwere, Onyinye; Porter, John; Swerdlow, Paul; Eckman, James; Lane, Peter; Files, Beatrice; Hassell, Kathryn; Kelly, Patrick; Wilson, Felicia; Bernaudin, Françoise; Forni, Gian Luca; Okpala, Iheanyi; Ressayre-Djaffer, Catherine; Alberti, Daniele; Holland, Jaymes; Marks, Peter; Fung, Ellen; Fischer, Roland; Mueller, Brigitta U; Coates, Thomas

    2007-02-01

    Deferasirox is a once-daily, oral iron chelator developed for treating transfusional iron overload. Preclinical studies indicated that the kidney was a potential target organ of toxicity. As patients with sickle cell disease often have abnormal baseline renal function, the primary objective of this randomised, open-label, phase II trial was to evaluate the safety and tolerability of deferasirox in comparison with deferoxamine in this population. Assessment of efficacy, as measured by change in liver iron concentration (LIC) using biosusceptometry, was a secondary objective. A total of 195 adult and paediatric patients received deferasirox (n = 132) or deferoxamine (n = 63). Adverse events most commonly associated with deferasirox were mild, including transient nausea, vomiting, diarrhoea, abdominal pain and skin rash. Abnormal laboratory studies with deferasirox were occasionally associated with mild non-progressive increases in serum creatinine and reversible elevations in liver function tests. Discontinuation rates from deferasirox (11.4%) and deferoxamine (11.1%) were similar. Over 1 year, similar dose-dependent LIC reductions were observed with deferasirox and deferoxamine. Once-daily oral deferasirox has acceptable tolerability and appears to have similar efficacy to deferoxamine in reducing iron burden in transfused patients with sickle cell disease.

  1. Logic-controlled occlusive cuff system

    NASA Technical Reports Server (NTRS)

    Baker, J. T.; Hoffler, G. W. (Inventor); Hursta, W. N.

    1981-01-01

    An occlusive cuff system comprises a pressure cuff and a source of regulated compressed gas feeding the cuff through an electrically operated fill valve. An electrically operated vent valve vents the cuff to the ambient pressure. The fill valve is normally closed and the vent valve is normally open. In response to an external start signal, a logic network opens the fill valve and closes the vent valve, thereby starting the pressurization cycle and a timer. A pressure transducer continuously monitors the pressure in the cuff. When the transducer's output equals a selected reference voltage, a comparator causes the logic network to close the fill valve. The timer, after a selected time delay, opens the vent valve to the ambient pressure, thereby ending the pressurization cycle.

  2. The Effect of Vertical Versus Horizontal Vaginal Cuff Closure on Vaginal Length After Laparoscopic Hysterectomy.

    PubMed

    Hill, Amanda Marie; Davis, K Meryl; Clark-Donat, Lindsay; Hammons, Lee Marvin; Azodi, Masoud; Silasi, Dan-Arin

    2017-01-01

    STUDY OBJECTIVE: To determine whether vertical versus horizontal closure of the vaginal cuff during laparoscopic hysterectomy has an effect on postoperative vaginal length and pelvic organ prolapse. A prospective randomized controlled trial. Subjects were randomly assigned to vertical or horizontal vaginal cuff closure at the time of total laparoscopic hysterectomy. Pelvic organ prolapse quantization (POP-Q) tests were performed before surgery, 2 to 4 weeks after surgery, and 3 to 4 months after surgery (Canadian Task Force classification I). An academic university-affiliated community hospital. Patients undergoing laparoscopic or robotic-assisted laparoscopic total hysterectomy for benign or malignant disease, excluding those undergoing radical hysterectomy or concomitant pelvic floor procedure. Subjects were randomized into the vertical or horizontal vaginal cuff closure group. Total hysterectomy was completed with traditional laparoscopic techniques or with robotic assistance. A colpotomy ring was used in each subject. Vaginal cuff closure was performed with barbed suture in a running fashion according to the group assignment. A total of 43 subjects were enrolled and randomized. One patient was excluded because the vaginal cuff was closed vaginally, 1 cancelled surgery, and 1 was completed without a uterine manipulator. The mean change in vaginal length was -0.89 cm (standard deviation [SD] = 1.03) in the horizontal group and -0.86 cm (SD = 1.19) in the vertical group (p = .57). POP-Q evaluation revealed no differences between groups and an overall trend toward improved POP-Q measurements. The average duration of vaginal cuff closure did not differ (p = .45), and there were no intraoperative complications related to vaginal cuff closure. Horizontal and vertical laparoscopic closure of the vaginal cuff after laparoscopic hysterectomy results in similar changes in vaginal length and other POP-Q scores. Copyright © 2016 AAGL. Published by Elsevier Inc

  3. The impact of faulty posture on rotator cuff tears with and without symptoms.

    PubMed

    Yamamoto, Atsushi; Takagishi, Kenji; Kobayashi, Tsutomu; Shitara, Hitoshi; Ichinose, Tsuyoshi; Takasawa, Eiji; Shimoyama, Daisuke; Osawa, Toshihisa

    2015-03-01

    We hypothesized that the prevalence of rotator cuff tears would be higher among individuals with poor posture, regardless of the presence of symptoms. The study initially comprised 525 residents of a mountain village who participated in an annual health check. Participants completed a background questionnaire, and physical examinations were performed to evaluate shoulder function. Ultrasonographic examinations were also performed to identify rotator cuff tears, and participants were grouped according to the presence or absence of tears. Posture was classified by 2 observers into 4 types according to the classification of Kendall, as follows: ideal alignment, kyphotic-lordotic posture, flat-back posture, and sway-back posture. Univariate analyses were performed to compare differences in background characteristics between groups, then multivariate analysis was performed to identify those factors associated with rotator cuff tears. Final analysis was performed for 379 participants (135 men, 244 women; mean age, 62.0 years; range, 31-94 years) showing the same posture classification from both observers. Of these, 93 (24.5%) showed rotator cuff tear in one shoulder and 45 (11.9%) showed tears in both. Prevalence of rotator cuff tears was 2.9% with ideal alignment, 65.8% with kyphotic-lordotic posture, 54.3% with flat-back posture, and 48.9% with sway-back posture. Logistic regression analysis identified increased age, abnormal posture, and past pain as factors associated with rotator cuff tears. Postural abnormality represented an independent predictor of both symptomatic and asymptomatic rotator cuff tears. These results may help define preventive measures for rotator cuff tears and in design ing rehabilitation therapies for shoulder disease. Copyright © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

  4. Thickness of the Rotator Cuff Tendons at the Articular Margin: An Anatomic Cadaveric Study.

    PubMed

    Sessions, William C; Lawrence, Rebekah L; Steubs, J Tyler; Ludewig, Paula M; Braman, Jonathan P

    2017-01-01

    With a substantial portion of the population experiencing rotator cuff pathology, the importance of understanding mechanisms of rotator cuff disease remains critical. Current research aimed at understanding relationships between shoulder movement and cuff injuries has been hindered by our limited knowledge of the thickness of soft tissue structures within the shoulder. Therefore, the purpose of this study is to measure the thicknesses of all four rotator cuff tendons at the articular margin. An anatomic study of 21 cadaveric shoulders was conducted. The thicknesses of the four rotator cuff tendon insertions were measured by caliper at the articular margin. The mean thickness of the supraspinatus at the articular margin was 4.9 mm ± 2.1 (median: 4.2 mm, range: 2.9-12.7 mm). The mean thickness of the infraspinatus tendon was 4.9 mm ± 1.3 (median: 4.8 mm, range: 3.0-7.2 mm). The mean thickness of the teres minor tendon was 3.20 mm ± 1.14 (median: 2.9 mm, range: 1.7-5.7 mm). Finally, the mean thickness of the subscapularis tendon at the articular margin was 5.5 mm ± 1.3 (median: 5.5 mm, range: 3.5-9.3 mm). This current study provides needed objective data about the thickness of the rotator cuff tendons at the articular margin. Data regarding the infraspinatus, teres minor and teres major, which have been largely understudied, are particularly important. In addition, the current study demonstrates that rotator cuff thicknesses can vary substantially between individuals. There are likely natural age related changes as well as changes from etiologies that are not yet elucidated. Clinical Relevance: Data from this study will allow for improved modelling accuracy of soft tissue structures specific to the shoulder. Eventually knowledge gained through study of shoulder mechanics can be used to pursue prevention of rotator cuff tears and improve targeted treatment planning.

  5. Lessons we can learn from gene expression patterns in rotator cuff tears and tendinopathies.

    PubMed

    Chaudhury, Salma; Carr, Andrew J

    2012-02-01

    Persistently high failure rates that are reported after rotator cuff repairs have encouraged greater understanding of the pathophysiology that underlies rotator cuff tears. Biologic changes that contribute to the pathogenesis of rotator cuff tears and tendinopathies, as well as adaptation after these changes, have been well described. A subset of patients with a genetic predisposition to early onset of rotator cuff tears and earlier symptom and disease progression have been identified. Many biologic changes occurring at the gene level have been identified. Pathways that are believed to contribute to rotator cuff tendinopathies include extracellular matrix remodeling, angiogenesis, changes in metabolism, apoptosis, and stress-related genes. Metaplasia of rotator cuff cells is contributed to by changes in gene expression. Modification of these gene changes may be possible through mechanical loading, drugs, or cellular manipulation. Gene changes may offer greater insight into why certain tears fail to heal and help to identify therapeutic targets. Copyright © 2012 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

  6. Effect of high flow oxygen on mortality in chronic obstructive pulmonary disease patients in prehospital setting: randomised controlled trial

    PubMed Central

    Wills, Karen E; Blizzard, Leigh; Walters, Eugene H; Wood-Baker, Richard

    2010-01-01

    Objectives To compare standard high flow oxygen treatment with titrated oxygen treatment for patients with an acute exacerbation of chronic obstructive pulmonary disease in the prehospital setting. Design Cluster randomised controlled parallel group trial. Setting Ambulance service in Hobart, Tasmania, Australia. Participants 405 patients with a presumed acute exacerbation of chronic obstructive pulmonary disease who were treated by paramedics, transported, and admitted to the Royal Hobart Hospital during the trial period; 214 had a diagnosis of chronic obstructive pulmonary disease confirmed by lung function tests in the previous five years. Interventions High flow oxygen treatment compared with titrated oxygen treatment in the prehospital (ambulance/paramedic) setting. Main outcome measure Prehospital or in-hospital mortality. Results In an intention to treat analysis, the risk of death was significantly lower in the titrated oxygen arm compared with the high flow oxygen arm for all patients (high flow oxygen n=226; titrated oxygen n=179) and for the subgroup of patients with confirmed chronic obstructive pulmonary disease (high flow n=117; titrated n=97). Overall mortality was 9% (21 deaths) in the high flow oxygen arm compared with 4% (7 deaths) in the titrated oxygen arm; mortality in the subgroup with confirmed chronic obstructive pulmonary disease was 9% (11 deaths) in the high flow arm compared with 2% (2 deaths) in the titrated oxygen arm. Titrated oxygen treatment reduced mortality compared with high flow oxygen by 58% for all patients (relative risk 0.42, 95% confidence interval 0.20 to 0.89; P=0.02) and by 78% for the patients with confirmed chronic obstructive pulmonary disease (0.22, 0.05 to 0.91; P=0.04). Patients with chronic obstructive pulmonary disease who received titrated oxygen according to the protocol were significantly less likely to have respiratory acidosis (mean difference in pH 0.12 (SE 0.05); P=0.01; n=28) or hypercapnia (mean

  7. Respiratory muscle training on pulmonary and swallowing function in patients with Huntington's disease: a pilot randomised controlled trial.

    PubMed

    Reyes, Alvaro; Cruickshank, Travis; Nosaka, Kazunori; Ziman, Mel

    2015-10-01

    To examine the effects of 4-month of respiratory muscle training on pulmonary and swallowing function, exercise capacity and dyspnoea in manifest patients with Huntington's disease. A pilot randomised controlled trial. Home based training program. Eighteen manifest Huntington's disease patients with a positive genetic test and clinically verified disease expression, were randomly assigned to control group (n=9) and training group (n=9). Both groups received home-based inspiratory (5 sets of 5 repetitions) and expiratory (5 sets of 5 repetitions) muscle training 6 times a week for 4 months. The control group used a fixed resistance of 9 centimeters of water, and the training group used a progressively increased resistance from 30% to 75% of each patient's maximum respiratory pressure. Spirometric indices, maximum inspiratory pressure, maximum expiratory pressure, six minutes walk test, dyspnoea, water-swallowing test and swallow quality of life questionnaire were assessed before, at 2 and 4 months after training. The magnitude of increases in maximum inspiratory (d=2.9) and expiratory pressures (d=1.5), forced vital capacity (d=0.8), forced expiratory volume in 1 second (d=0.9) and peak expiratory flow (d=0.8) was substantially greater for the training group in comparison to the control group. Changes in swallowing function, dyspnoea and exercise capacity were small (d ≤ 0.5) for both groups without substantial differences between groups. A home-based respiratory muscle training program appeared to be beneficial to improve pulmonary function in manifest Huntington's disease patients but provided small effects on swallowing function, dyspnoea and exercise capacity. © The Author(s) 2015.

  8. Biceps tendinitis in chronic rotator cuff tears: a histologic perspective.

    PubMed

    Singaraju, Vamsi M; Kang, Richard W; Yanke, Adam B; McNickle, Allison G; Lewis, Paul B; Wang, Vincent M; Williams, James M; Chubinskaya, Susan; Romeo, Anthony A; Cole, Brian J

    2008-01-01

    Patients with chronic rotator cuff tears frequently have anterior shoulder pain attributed to the long head of the biceps brachii (LHBB) tendon. In this study, tenodesis or tenotomy samples and cadaveric controls were assessed by use of immunohistochemical and histologic methods to quantify inflammation, vascularity, and neuronal plasticity. Patients had moderate pain and positive results on at least 1 clinical test of shoulder function. The number of axons in the distal LHBB was significantly less in patients with biceps tendinitis. Calcitonin gene-related peptide and substance P immunostaining was predominantly within nerve roots and blood vessels. A moderate correlation (R = 0.5) was identified between LHBB vascularity and pain scores. On the basis of these results, we conclude that, in the context of rotator cuff disease, the etiology of anterior shoulder pain with macroscopic changes in the biceps tendon is related to the complex interaction of the tendon and surrounding soft tissues, rather than a single entity.

  9. The effect of an active implementation of a disease management programme for chronic obstructive pulmonary disease on healthcare utilization--a cluster-randomised controlled trial.

    PubMed

    Smidth, Margrethe; Christensen, Morten Bondo; Fenger-Grøn, Morten; Olesen, Frede; Vedsted, Peter

    2013-10-03

    The growing population living with chronic conditions calls for efficient healthcare-planning and effective care. Implementing disease-management-programmes is one option for responding to this demand. Knowledge is scarce about the effect of implementation processes and their effect on patients; only few studies have reported the effectiveness of disease-management-programmes targeting patients with chronic obstructive pulmonary disease (COPD). The objective of this paper was to determine the effect on healthcare-utilization of an active implementation model for a disease-management-programme for patients with one of the major multimorbidity diseases, COPD. The standard implementation of a new disease-management-programme for COPD was ongoing during the study-period from November 2008 to November 2010 in the Central Denmark Region. We wanted to test a strategy using Breakthrough Series, academic detailing and lists of patients with COPD. It targeted GPs and three hospitals serving approx. 60,000 inhabitants aged 35 or older and included interventions directed at professionals, organisations and patients. The study was a non-blinded block- and cluster-randomised controlled trial with GP-practices as the unit of randomisation. In Ringkoebing-Skjern Municipality, Denmark, 16 GP-practices involving 38 GPs were randomised to either the intervention-group or the control-group. A comparable neighbouring municipality acted as an external-control-group which included nine GP-practices with 25 GPs. An algorithm based on health-registry-data on lung-related contacts to the healthcare-system identified 2,736 patients who were alive at the end of the study-period. The population included in this study counted 1,372 (69.2%) patients who responded to the baseline questionnaire and confirmed their COPD diagnosis; 458 (33.4%) patients were from the intervention-group, 376 (27.4%) from the control-group and 538(39.2%) from the external-control-group. The primary outcome was

  10. The effect of an active implementation of a disease management programme for chronic obstructive pulmonary disease on healthcare utilization - a cluster-randomised controlled trial

    PubMed Central

    2013-01-01

    Background The growing population living with chronic conditions calls for efficient healthcare-planning and effective care. Implementing disease-management-programmes is one option for responding to this demand. Knowledge is scarce about the effect of implementation processes and their effect on patients; only few studies have reported the effectiveness of disease-management-programmes targeting patients with chronic obstructive pulmonary disease (COPD). The objective of this paper was to determine the effect on healthcare-utilization of an active implementation model for a disease-management-programme for patients with one of the major multimorbidity diseases, COPD. Methods The standard implementation of a new disease-management-programme for COPD was ongoing during the study-period from November 2008 to November 2010 in the Central Denmark Region. We wanted to test a strategy using Breakthrough Series, academic detailing and lists of patients with COPD. It targeted GPs and three hospitals serving approx. 60,000 inhabitants aged 35 or older and included interventions directed at professionals, organisations and patients. The study was a non-blinded block- and cluster-randomised controlled trial with GP-practices as the unit of randomisation. In Ringkoebing-Skjern Municipality, Denmark, 16 GP-practices involving 38 GPs were randomised to either the intervention-group or the control-group. A comparable neighbouring municipality acted as an external-control-group which included nine GP-practices with 25 GPs. An algorithm based on health-registry-data on lung-related contacts to the healthcare-system identified 2,736 patients who were alive at the end of the study-period. The population included in this study counted 1,372 (69.2%) patients who responded to the baseline questionnaire and confirmed their COPD diagnosis; 458 (33.4%) patients were from the intervention-group, 376 (27.4%) from the control-group and 538(39.2%) from the external-control-group. The primary

  11. Rolling-cuff flexible bellows

    DOEpatents

    Lambert, D.R.

    1982-09-27

    A flexible connector apparatus used to join two stiff non-deformable members, such as piping, is described. The apparatus is provided with one or more flexible sections or assemblies each utilizing a bellows of a rolling cuff type connected between two ridge members, with the bellows being supported by a back-up ring, such that only the curved end sections of the bellows are unsupported. Thus, the bellows can be considered as being of a tube-shaped configuration and thus have high pressure resistance. The components of the flexible apparatus are sealed or welded one to another such that it is fluid tight.

  12. Patient-experienced effect of an active implementation of a disease management programme for COPD - a randomised trial.

    PubMed

    Smidth, Margrethe; Olesen, Frede; Fenger-Grøn, Morten; Vedsted, Peter

    2013-10-03

    People living with chronic disease currently account for the majority of the total healthcare costs. The Central Denmark Region implemented a disease management programme (DMP) for chronic obstructive pulmonary disease (COPD) in 2008. This presented an opportunity to examine the effect of an evidence-based, planned and proactive implementation of a DMP compared to the usual implementation strategy. We performed a block- and cluster-randomised controlled trial with two groups and an extra external control group. The primary outcome was patients' assessment of their care after using an active implementation model for a DMP for COPD measured with the Patient-Assessment-of-Chronic-Illness-Care (PACIC) instrument. At baseline, questionnaires were sent to 2,895 patients identified by an algorithm based on health registry data on lung-related contacts to the healthcare system. Patients were asked to confirm or refute their diagnosis of COPD. Of those who responded, 1,445 (72.8%) confirmed their diagnosis. PACIC data were collected at baseline and at a 12-month follow-up for 744 (51.1%) patients. Comparing the three groups after the implementation of the DMP, we found a statistically significantly higher change in the PACIC score in the intervention group than in the control groups. No statistically significant differences were found between the control and the external control groups in any of the dimensions. Reinforcing the role of general practice as coordinator for care-and self-management-support with an active implementation of a DMP for COPD made patients score higher on the PACIC instrument, which indicates a better experience of the received healthcare. NCT01228708.

  13. Collaborative pooled analysis of data on C-reactive protein gene variants and coronary disease: judging causality by Mendelian randomisation.

    PubMed

    2008-01-01

    Many prospective studies have reported associations between circulating C-reactive protein (CRP) levels and risk of coronary heart disease (CHD), but causality remains uncertain. Studies of CHD are being conducted that involve measurement of common polymorphisms of the CRP gene known to be associated with circulating concentrations, thereby utilising these variants as proxies for circulating CRP levels. By analysing data from several studies examining the association between relevant CRP polymorphisms and CHD risk, the present collaboration will undertake a Mendelian randomisation analysis to help assess the likelihood of any causal relevance of CRP levels to CHD risk. A central database is being established containing individual data on CRP polymorphisms, circulating CRP levels, and major coronary outcomes as well as age, sex and other relevant characteristics. Associations between CRP polymorphisms or haplotypes and CHD will be evaluated under different circumstances. This collaboration comprises, at present, about 37,000 CHD outcomes and about 120,000 controls, which should yield suitably precise findings to help judge causality. This work should advance understanding of the relevance of low-grade inflammation to CHD and indicate whether or not CRP itself is involved in long-term pathogenesis.

  14. The effect of gym training on multiple outcomes in Parkinson's disease: a pilot randomised waiting-list controlled trial.

    PubMed

    Poliakoff, Ellen; Galpin, Adam J; McDonald, Kathryn; Kellett, Mark; Dick, Jeremy P R; Hayes, Sue; Wearden, Alison J

    2013-01-01

    There is accumulating evidence for the benefits of exercise in Parkinson's disease (PD), but less is known about group exercise interventions. We evaluated the effect of gym-training programme on people with PD. Thirty-two adults with mild to moderate PD, not currently exercising formally, were randomised to an immediate 20-week biweekly gym training programme at a local leisure complex, or a 10-week programme starting 10 weeks later. Assessments at baseline (T1), 10 weeks (T2) and 20 weeks (T3) included reaction time, motor performance (UPDRS), quality of life and illness perceptions. Experiences of the programme were assessed via questionnaire and a focus group. Overall UPDRS motor function score did not change over time. However, gym training was associated with significant improvements in reaction times and some timed tests in the immediate training group (T1-T2). The delayed group showed similar improvements following gym training (T2-T3). Participants reported enjoyment, obtaining social benefits, and increased confidence. However, the questionnaire measures did not show improvements in subjective health ratings or illness perceptions. Although benefits were not apparent in the questionnaire measures or overall UPDRS scores, our findings suggest that a 10-week gym training programme in a community setting can provide some benefits for people with PD.

  15. Online versus face-to-face pulmonary rehabilitation for patients with chronic obstructive pulmonary disease: randomised controlled trial

    PubMed Central

    Bourne, Simon; DeVos, Ruth; North, Malcolm; Chauhan, Anoop; Green, Ben; Brown, Thomas; Cornelius, Victoria; Wilkinson, Tom

    2017-01-01

    Objective To obtain evidence whether the online pulmonary rehabilitation(PR) programme ‘my-PR’ is non-inferior to a conventional face-to-face PR in improving physical performance and symptom scores in patients with COPD. Design A two-arm parallel single-blind, randomised controlled trial. Setting The online arm carried out pulmonary rehabilitation in their own homes and the face to face arm in a local rehabilitation facility. Participants 90 patients with a diagnosis of chronic obstructive pulmonary disease (COPD), modified Medical Research Council score of 2 or greater referred for pulmonary rehabilitation (PR), randomised in a 2:1 ratio to online (n=64) or face-to-face PR (n=26). Participants unable to use an internet-enabled device at home were excluded. Main outcome measures Coprimary outcomes were 6 min walk distance test and the COPD assessment test (CAT) score at completion of the programme. Interventions A 6-week PR programme organised either as group sessions in a local rehabilitation facility, or online PR via log in and access to 'myPR’. Results The adjusted mean difference for the 6 min walk test (6MWT) between groups for the intention-to-treat (ITT) population was 23.8 m with the lower 95% CI well above the non-inferiority threshold of −40.5 m at −4.5 m with an upper 95% CI of +52.2 m. This result was consistent in the per-protocol (PP) population with a mean adjusted difference of 15 m (−13.7 to 43.8). The CAT score difference in the ITT was −1.0 in favour of the online intervention with the upper 95% CI well below the non-inferiority threshold of 1.8 at 0.86 and the lower 95% CI of −2.9. The PP analysis was consistent with the ITT. Conclusion PR is an evidenced-based and guideline-mandated intervention for patients with COPD with functional limitation. A 6-week programme of online-supported PR was non-inferior to a conventional model delivered in face-to-face sessions in terms of effects on 6MWT distance, and symptom scores

  16. Current Biomechanical Concepts for Rotator Cuff Repair

    PubMed Central

    2013-01-01

    For the past few decades, the repair of rotator cuff tears has evolved significantly with advances in arthroscopy techniques, suture anchors and instrumentation. From the biomechanical perspective, the focus in arthroscopic repair has been on increasing fixation strength and restoration of the footprint contact characteristics to provide early rehabilitation and improve healing. To accomplish these objectives, various repair strategies and construct configurations have been developed for rotator cuff repair with the understanding that many factors contribute to the structural integrity of the repaired construct. These include repaired rotator cuff tendon-footprint motion, increased tendon-footprint contact area and pressure, and tissue quality of tendon and bone. In addition, the healing response may be compromised by intrinsic factors such as decreased vascularity, hypoxia, and fibrocartilaginous changes or aforementioned extrinsic compression factors. Furthermore, it is well documented that torn rotator cuff muscles have a tendency to atrophy and become subject to fatty infiltration which may affect the longevity of the repair. Despite all the aforementioned factors, initial fixation strength is an essential consideration in optimizing rotator cuff repair. Therefore, numerous biomechanical studies have focused on elucidating the strongest devices, knots, and repair configurations to improve contact characteristics for rotator cuff repair. In this review, the biomechanical concepts behind current rotator cuff repair techniques will be reviewed and discussed. PMID:23730471

  17. Masitinib as an adjunct therapy for mild-to-moderate Alzheimer's disease: a randomised, placebo-controlled phase 2 trial

    PubMed Central

    2011-01-01

    Introduction Neuroinflammation is thought to be important in Alzheimer's disease pathogenesis. Mast cells are a key component of the inflammatory network and participate in the regulation of the blood-brain barrier's permeability. Masitinib, a selective oral tyrosine kinase inhibitor, effectively inhibits the survival, migration and activity of mast cells. As the brain is rich in mast cells, the therapeutic potential of masitinib as an adjunct therapy to standard care was investigated. Methods A randomised, placebo-controlled, phase 2 study was performed in patients with mild-to-moderate Alzheimer's disease, receiving masitinib as an adjunct to cholinesterase inhibitor and/or memantine. Patients were randomly assigned to receive masitinib (n = 26) (starting dose of 3 or 6 mg/kg/day) or placebo (n = 8), administered twice daily for 24 weeks. The primary endpoint was change from baseline in the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-Cog) to assess cognitive function and the related patient response rate. Results The rate of clinically relevant cognitive decline according to the ADAS-Cog response (increase >4 points) after 12 and 24 weeks was significantly lower with masitinib adjunctive treatment compared with placebo (6% vs. 50% for both time points; P = 0.040 and P = 0.046, respectively). Moreover, whilst the placebo treatment arm showed worsening mean ADAS-Cog, Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory, and Mini-Mental State Examination scores, the masitinib treatment arm reported improvements, with statistical significance between treatment arms at week 12 and/or week 24 (respectively, P = 0.016 and 0.030; P = 0.035 and 0.128; and P = 0.047 and 0.031). The mean treatment effect according to change in ADAS-Cog score relative to baseline at weeks 12 and 24 was 6.8 and 7.6, respectively. Adverse events occurred more frequently with masitinib treatment (65% vs. 38% of patients); however, the majority of events

  18. Efficacy of transcutaneous electrical nerve stimulation for rotator cuff tendinopathy: a systematic review.

    PubMed

    Desmeules, F; Boudreault, J; Roy, J S; Dionne, C E; Frémont, P; MacDermid, J C

    2016-03-01

    To perform a systematic review on the efficacy of transcutaneous electrical nerve stimulation (TENS) for the treatment of rotator cuff tendinopathy in adults. A literature search was conducted in four databases (CINAHL, Embase, PubMed and PeDRO) for randomised controlled trials published from date of inception until April 2015, comparing the efficacy of TENS for the treatment of rotator cuff tendinopathy with placebo or any other intervention. Risk of bias was evaluated using the Cochrane risk of bias tool. Results were summarised qualitatively. Six studies were included in this review. The mean methodological score was 49% (standard deviation 16%), indicating an overall high risk of bias. One placebo-controlled trial reported that a single TENS session provided immediate pain reduction for patients with rotator cuff tendinopathy, but did not follow the participants in the short, medium or long term. Two trials that compared ultrasound therapy with TENS reported discrepancy and contradictory results in terms of pain reduction and shoulder range of motion. Corticosteroid injections were found to be superior to TENS for pain reduction in the short term, but the differences were not clinically important. Other studies included in this review concluded that TENS was not superior to heat or pulsed radiofrequency. Due to the limited number of studies and the overall high risk of bias of the studies included in this review, no conclusions can be drawn on the efficacy of TENS for the treatment of rotator cuff tendinopathy. More methodologically sound studies are needed to document the efficacy of TENS. Until then, clinicians should prefer other evidence-based rehabilitation interventions proven to be efficacious to treat patients with rotator cuff tendinopathy. Copyright © 2015 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  19. Correlation Between Endotracheal Tube Cuff Pressure and Tracheal Wall Pressure Using Air and Saline Filled Cuffs

    DTIC Science & Technology

    2017-01-31

    AFRL-SA-WP-SR-2017-0004 Correlation Between Endotracheal Tube Cuff Pressure and Tracheal Wall Pressure Using Air - and Saline-Filled... Air Force Research Laboratory 711th Human Performance Wing U.S. Air Force School of Aerospace Medicine Aeromedical Research Department 2510 Fifth...Correlation Between Endotracheal Tube Cuff Pressure and Tracheal Wall Pressure Using Air - and Saline-Filled Cuffs 5a. CONTRACT NUMBER FA8650-14

  20. A double blind randomised placebo controlled trial of hexopal in primary Raynaud's disease.

    PubMed

    Sunderland, G T; Belch, J J; Sturrock, R D; Forbes, C D; McKay, A J

    1988-03-01

    The peripheral vasospastic symptoms associated with Raynaud's disease continue to be an unsolved clinical problem. Hexopal (Hexanicotinate inositol) has shown promise in uncontrolled studies and its use in patients with Raynaud's disease may reduce such vasospasm. This study examines the effects of 4 g/day of Hexopal or placebo, during cold weather, in 23 patients with primary Raynaud's disease. The Hexopal group felt subjectively better and had demonstrably shorter and fewer attacks of vasospasm during the trial period. Serum biochemistry and rheology was not significantly different between the two groups. Although the mechanism of action remains unclear Hexopal is safe and is effective in reducing the vasospasm of primary Raynaud's disease during the winter months.

  1. The effect of age on rat rotator cuff muscle architecture.

    PubMed

    Swan, Malcolm A; Sato, Eugene; Galatz, Leesa M; Thomopoulos, Stavros; Ward, Samuel R

    2014-12-01

    Understanding rotator cuff muscle function during disease development and after repair is necessary for preventing degeneration and improving postsurgical outcomes, respectively. The rat is a commonly used rotator cuff animal model; however, unlike humans, rats continue to grow throughout their lifespan, so age-related changes in muscle structure may complicate an understanding of muscle adaptations to injury. Infraspinatus and supraspinatus muscle mass, fiber length, pennation angle, sarcomere length, and physiological cross-sectional area (PCSA) were measured in Sprague-Dawley rats (n = 30) with a body mass ranging from 51 to 814 g (approximately 3 weeks to approximately 18 months). Both the supraspinatus and infraspinatus showed a striking conservation of sarcomere length throughout growth. There was linear growth in muscle mass and PCSA, nonlinear growth in muscle length and fiber bundle length, and a linear relationship between humeral head diameter and fiber bundle length, suggesting that muscle fiber length (serial sarcomere number) adjusted according to skeletal dimensions. These muscle growth trajectories allowed sarcomere length to remain nearly constant. During the typical rat rotator cuff experimental period (animal mass, 400-600 g), muscle mass will increase by 30%, fiber length will increase by 7%, and PCSA will increase by 27%, but sarcomere lengths are nearly constant. Therefore, these normal growth-induced changes in architecture must be considered when muscle atrophy or fiber shortening is measured after rotator cuff tears in this model. Copyright © 2014 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

  2. Behavioural intervention to increase physical activity among patients with coronary heart disease: protocol for a randomised controlled trial.

    PubMed

    Alsaleh, Eman; Blake, Holly; Windle, Richard

    2012-12-01

    Although physical activity has significant health benefits in the treatment of patients with coronary heart disease, patients often do not follow prescribed physical activity recommendations. Behavioural strategies have been shown to be efficacious in increasing physical activity among those patients with coronary heart disease who are attending structured cardiac rehabilitation programmes. Research has also shown that tailoring consultation according to patients' needs and sending motivational reminders are successful ways of motivating patients to be physically active. However, there is a lack of evidence for the efficacy of behavioural interventions based on individualised consultation in promoting physical activity among those patients with coronary heart disease who are not attending structured physical activity programmes. This paper outlines the study protocol for a trial which is currently underway, to examine the effect of a behavioural change intervention delivered through individualised consultation calls and motivational reminder text messages on the level of physical activity among patients with coronary heart disease. Two large hospitals in Jordan. Eligible patients aged between 18 and 70 years, who are clinically stable, are able to perform physical activity and who have access to a mobile telephone have been randomly allocated to control or intervention group. Two-group randomised controlled trial. Behavioural intervention will be compared with usual care in increasing physical activity levels among patients with coronary heart disease. The control group (n=85) will receive advice from their doctors about physical activity as they would in usual practice. The intervention group (n=71) will receive the same advice, but will also receive behavioural change intervention (goal-setting, feed-back, self-monitoring) that will be delivered over a period of six months. Intervention will be delivered through individually tailored face-to-face and telephone

  3. Randomised β-carotene supplementation and incidence of cancer and cardiovascular disease in women: is the association modified by baseline plasma level?

    PubMed Central

    Lee, I-M; Cook, N R; Manson, J E; Buring, J E

    2002-01-01

    In a nested case-control study of 513 women with cancer; 130 with cardiovascular disease and equal numbers of controls, we found no effect of randomised beta-carotene on risk of cancer or cardiovascular disease within any quartile of baseline plasma beta-carotene, nor was there a trend across quartiles (P for trend 0.15 and 0.62, respectively). British Journal of Cancer (2002) 86, 698–701. DOI: 10.1038/sj/bjc/6600147 www.bjcancer.com © 2002 Cancer Research UK PMID:11875728

  4. Empowering employees with chronic diseases; development of an intervention aimed at job retention and design of a randomised controlled trial.

    PubMed

    Varekamp, Inge; de Vries, Gabe; Heutink, Annelies; van Dijk, Frank J H

    2008-11-04

    Persons with a chronic disease are less often employed than healthy persons. If employed, many of them experience problems at work. Therefore, we developed a training programme aimed at job retention. The objective of this paper is to describe this intervention and to present the design of a study to evaluate its effectiveness. DEVELOPMENT AND DESCRIPTION OF INTERVENTION: A systematic review, a needs assessment and discussions with Dutch experts led to a pilot group training, tested in a pilot study. The evaluation resulted in the development of a seven-session group training combined with three individual counselling sessions. The training is based on an empowerment perspective that aims to help individuals enhance knowledge, skills and self-awareness. These advances are deemed necessary for problem solving in three stages: exploration and clarification of work related problems, communication at the workplace, and development and implementation of solutions. Seven themes are discussed and practised in the group sessions: 1) Consequences of a chronic disease in the workplace, 2) Insight into feelings and thoughts about having a chronic disease, 3) Communication in daily work situations, 4) Facilities for disabled employees and work disability legislation, 5) How to stand up for oneself, 6) A plan to solve problems, 7) Follow-up. Participants are recruited via occupational health services, patient organisations, employers, and a yearly national conference on chronic diseases. They are eligible when they have a chronic physical medical condition, have a paid job, and experience problems at work. Workers on long-term, 100% sick leave that is expected to continue during the training are excluded. After filling in the baseline questionnaire, the participants are randomised to either the control or the intervention group. The control group will receive no care or care as usual. Post-test mail questionnaires will be sent after 4, 8, 12 and 24 months. Primary outcome

  5. Empowering employees with chronic diseases; development of an intervention aimed at job retention and design of a randomised controlled trial

    PubMed Central

    Varekamp, Inge; de Vries, Gabe; Heutink, Annelies; van Dijk, Frank JH

    2008-01-01

    Background Persons with a chronic disease are less often employed than healthy persons. If employed, many of them experience problems at work. Therefore, we developed a training programme aimed at job retention. The objective of this paper is to describe this intervention and to present the design of a study to evaluate its effectiveness. Development and description of intervention A systematic review, a needs assessment and discussions with Dutch experts led to a pilot group training, tested in a pilot study. The evaluation resulted in the development of a seven-session group training combined with three individual counselling sessions. The training is based on an empowerment perspective that aims to help individuals enhance knowledge, skills and self-awareness. These advances are deemed necessary for problem solving in three stages: exploration and clarification of work related problems, communication at the workplace, and development and implementation of solutions. Seven themes are discussed and practised in the group sessions: 1) Consequences of a chronic disease in the workplace, 2) Insight into feelings and thoughts about having a chronic disease, 3) Communication in daily work situations, 4) Facilities for disabled employees and work disability legislation, 5) How to stand up for oneself, 6) A plan to solve problems, 7) Follow-up. Methods Participants are recruited via occupational health services, patient organisations, employers, and a yearly national conference on chronic diseases. They are eligible when they have a chronic physical medical condition, have a paid job, and experience problems at work. Workers on long-term, 100% sick leave that is expected to continue during the training are excluded. After filling in the baseline questionnaire, the participants are randomised to either the control or the intervention group. The control group will receive no care or care as usual. Post-test mail questionnaires will be sent after 4, 8, 12 and 24 months

  6. Optimizing the management of rotator cuff problems.

    PubMed

    Pedowitz, Robert A; Yamaguchi, Ken; Ahmad, Christopher S; Burks, Robert T; Flatow, Evan L; Green, Andrew; Iannotti, Joseph P; Miller, Bruce S; Tashjian, Robert Z; Watters, William C; Weber, Kristy; Turkelson, Charles M; Wies, Janet L; Anderson, Sara; St Andre, Justin; Boyer, Kevin; Raymond, Laura; Sluka, Patrick; McGowan, Richard

    2011-06-01

    Of the 31 recommendations made by the work group, 19 were determined to be inconclusive because of the absence of definitive evidence. Of the remaining recommendations, four were classified as moderate grade, six as weak, and two as consensus statements of expert opinion. The four moderate-grade recommendations include suggestions that exercise and nonsteroidal anti-inflammatory drugs be used to manage rotator cuff symptoms in the absence of a full-thickness tear, that routine acromioplasty is not required at the time of rotator cuff repair, that non-cross-linked, porcine small intestine submucosal xenograft patches not be used to manage rotator cuff tears, and that surgeons can advise patients that workers' compensation status correlates with less favorable outcomes after rotator cuff surgery.

  7. Patient-centered disease management (PCDM) for heart failure: study protocol for a randomised controlled trial.

    PubMed

    Bekelman, David B; Plomondon, Mary E; Sullivan, Mark D; Nelson, Karin; Hattler, Brack; McBryde, Connor; Lehmann, Kenneth G; Potfay, Jonathan; Heidenreich, Paul; Rumsfeld, John S

    2013-07-09

    Chronic heart failure (HF) disease management programs have reported inconsistent results and have not included comorbid depression management or specifically focused on improving patient-reported outcomes. The Patient Centered Disease Management (PCDM) trial was designed to test the effectiveness of collaborative care disease management in improving health status (symptoms, functioning, and quality of life) in patients with HF who reported poor HF-specific health status. Patients with a HF diagnosis at four VA Medical Centers were identified through population-based sampling. Patients with a Kansas City Cardiomyopathy Questionnaire (KCCQ, a measure of HF-specific health status) score of < 60 (heavy symptom burden and impaired quality of life) were invited to enroll in the PCDM trial. Enrolled patients were randomized to receive usual care or the PCDM intervention, which included: (1) collaborative care management by VA clinicians including a nurse, cardiologist, internist, and psychiatrist, who worked with patients and their primary care providers to provide guideline-concordant care management, (2) home telemonitoring and guided patient self-management support, and (3) screening and treatment for comorbid depression. The primary study outcome is change in overall KCCQ score. Secondary outcomes include depression, medication adherence, guideline-based care, hospitalizations, and mortality. The PCDM trial builds on previous studies of HF disease management by prioritizing patient health status, implementing a collaborative care model of health care delivery, and addressing depression, a key barrier to optimal disease management. The study has been designed as an 'effectiveness trial' to support broader implementation in the healthcare system if it is successful. Unique identifier: NCT00461513.

  8. Neoinnervation in rotator cuff tendinopathy.

    PubMed

    Xu, Yinghua; Bonar, Fiona; Murrell, George A C

    2011-12-01

    The aim of this study was to determine whether there are more nerves in tendinopathic human tendon, and if so, where are they located. Tendon biopsies were collected from normal, tendinopathic, and torn human rotator cuff tendons and then analyzed using immunohistochemistry and antibodies against a general nerve marker (protein gene product 9.5, PGP9.5), a nerve regeneration marker (growth-associated protein 43, GAP43), and an endothelial cell marker (CD34). Nerve fibers exhibiting PGP9.5 or GAP43 immunoreactivity were often observed intimately in association with tiny blood vessels in the endotendineum of tendinopathic tendons. The expression of PGP9.5 and GAP43 were significantly higher in tendinopathic tendon compared with control tendon and torn tendon. These data support the hypothesis that early tendinopathy is associated with increases of newly grown nerve fibers and blood vessels inside and around tendinopathic tendon, and these may be the source of pain in tendinopathy.

  9. Use of a monoclonal antibody to sucrase-isomaltase for evaluation of the columnar cuff after stapled restorative proctocolectomy.

    PubMed

    Thompson-Fawcett, Mark W; McC Mortensen, Neil J; Jewel, Derek P; Warren, Bryan F

    2007-09-01

    Restorative proctocolectomy with a double-stapled pouch-anal anastomosis retains a cuff of diseased columnar mucosa (columnar cuff) in the upper anal canal that may require biopsy. Biopsying this can be difficult and colonic phenotypic change in the pouch can lead to errors interpreting the histology. This study was designed to investigate the use of a monoclonal antibody to sucrase-isomaltase for differentiating ileal pouch from columnar cuff mucosa. Then, by using this antibody, the ability to accurately take and report biopsies from the anal canal was examined. The technique of staining for sucrase-isomaltase was developed. From 113 patients who had a double-stapled pouch-anal anastomosis, 467 formalin-fixed biopsies and 177 fresh-frozen biopsies were taken from the ileal pouch, columnar cuff, or anal transitional zone. Biopsies were stained with a monoclonal antibody to sucrase-isomaltase, and fixed biopsies were routinely reported after staining with hematoxylin and eosin. A monoclonal antibody to sucrase-isomaltase reliably discriminated between ileal from rectal mucosa. A biopsy of columnar cuff mucosa as reported by routine histology was obtained during 72 percent of attempted outpatient examinations. Sucrase-isomaltase staining of reported columnar cuff biopsies showed that biopsies were of pouch rather than columnar cuff in 4.4 percent (95 percent confidence interval, 2-8) of outpatient examinations. The monoclonal antibody to sucrase-isomaltase used in this study may have a clinical role when interpreting columnar cuff biopsies from patients being investigated for pouch dysfunction, or in patients having surveillance biopsies to exclude neoplasia in the columnar cuff.

  10. Automatic control of tracheal tube cuff pressure in ventilated patients in semirecumbent position: a randomized trial.

    PubMed

    Valencia, Mauricio; Ferrer, Miquel; Farre, Ramon; Navajas, Daniel; Badia, Joan Ramon; Nicolas, Josep Maria; Torres, Antoni

    2007-06-01

    The aspiration of subglottic secretions colonized by bacteria pooled around the tracheal tube cuff due to inadvertent deflation (<20 cm H2O) of the cuff plays a relevant role in the pathogenesis of ventilator-associated pneumonia. We assessed the efficacy of an automatic, validated device for the continuous regulation of tracheal tube cuff pressure in preventing ventilator-associated pneumonia. Prospective randomized controlled trial. Respiratory intensive care unit and general medical intensive care unit. One hundred and forty-two mechanically ventilated patients (age, 64 +/- 17 yrs; Acute Physiology and Chronic Health Evaluation II score, 18 +/- 6) without pneumonia or aspiration at admission. Within 24 hrs of intubation, patients were randomly allocated to undergo continuous regulation of the cuff pressure with the automatic device (n = 73) or routine care of the cuff pressure (control group, n = 69). Patients remained in a semirecumbent position in bed. The primary end point variable was the incidence of ventilator-associated pneumonia. Main causes for intubation were decreased consciousness (43, 30%) and exacerbation of chronic respiratory diseases (38, 27%). Cuff pressure <20 cm H2O was more frequently observed in the control than the automatic group (45.3 vs. 0.7% determinations, p < .001). However, the rate of ventilator-associated pneumonia with clinical criteria (16, 22% vs. 20, 29%) and microbiological confirmation (11, 15% vs. 10, 15%), the distribution of early and late onset, the causative microorganisms, and intensive care unit (20, 27% vs. 16, 23%) and hospital mortality (30, 41% vs. 23, 33%) were similar for the automatic and control groups, respectively. Cuff pressure is better controlled with the automatic device. However, it did not result in additional benefits to the semirecumbent position in preventing ventilator-associated pneumonia.

  11. The effect of a rotator cuff tear and its size on three-dimensional shoulder motion.

    PubMed

    Kolk, Arjen; Henseler, Jan Ferdinand; de Witte, Pieter Bas; van Zwet, Erik W; van der Zwaal, Peer; Visser, Cornelis P J; Nagels, Jochem; Nelissen, Rob G H H; de Groot, Jurriaan H

    2017-06-01

    Rotator cuff-disease is associated with changes in kinematics, but the effect of a rotator cuff-tear and its size on shoulder kinematics is still unknown in-vivo. In this cross-sectional study, glenohumeral and scapulothoracic kinematics of the affected shoulder were evaluated using electromagnetic motion analysis in 109 patients with 1) subacromial pain syndrome (n=34), 2) an isolated supraspinatus tear (n=21), and 3) a massive rotator cuff tear involving the supraspinatus and infraspinatus (n=54). Mixed models were applied for the comparisons of shoulder kinematics between the three groups during abduction and forward flexion. In the massive rotator cuff-tear group, we found reduced glenohumeral elevation compared to the subacromial pain syndrome (16°, 95% CI [10.5, 21.2], p<0.001) and the isolated supraspinatus tear group (10°, 95% CI [4.0, 16.7], p=0.002) at 110° abduction. Reduced glenohumeral elevation in massive rotator cuff tears coincides with an increase in scapulothoracic lateral rotation compared to subacromial pain syndrome (11°, 95% CI [6.5, 15.2], p<0.001) and supraspinatus tears (7°, 95% CI [1.8, 12.1], p=0.012). Comparable differences were observed for forward flexion. No differences in glenohumeral elevation were found between the subacromial pain syndrome and isolated supraspinatus tear group during arm elevation. The massive posterosuperior rotator cuff-tear group had substantially less glenohumeral elevation and more scapulothoracic lateral rotation compared to the other groups. These observations suggest that the infraspinatus is essential to preserve glenohumeral elevation in the presence of a supraspinatus tear. Shoulder kinematics are associated with rotator cuff-tear size and may have diagnostic potential. Copyright © 2017 Elsevier Ltd. All rights reserved.

  12. Use of cuff tear arthroplasty head prosthesis for rotator cuff arthropathy treatment in elderly patients with comorbidities.

    PubMed

    Carvalho, Cassiano Diniz; Andreoli, Carlos Vicente; Pochini, Alberto de Castro; Ejnisman, Benno

    2016-01-01

    To evaluate the clinical and functional behavior of patients undergoing cuff tear arthroplasty at different stages of the disease. Cuff tear arthroplasty hemiarthroplasties were performed in 34 patients with rotator cuff arthropathy and associated comorbidities, classified according to Seebauer. The mean age was 76.3 years, and the sample comprised 23 females (67.6%) and 11 males (32.4%). The mean follow-up period was 21.7 months, and evaluations were performed using the Visual Analog Scale for pain and the Constant scale. There were no statistically significant differences in the mean reduction in the Visual Analog Scale or in the Constant scale increase between the female and male groups. The variation between the pre- and postoperative Visual Analog Scale and Constant scale evaluations was significant. There was also no statistically significant difference between the Seebauer classification groups regarding the mean Visual Analog Scale reduction, or the mean Constant scale increase. Cuff tear arthroplasty shoulder hemiarthroplasty is a good option for rotator cuff arthropathy in patients with comorbidities. Avaliar o comportamento clínico e funcional dos pacientes submetidos à artroplastia do tipo cuff tear arthroplasty para o tratamento da artropatia do manguito rotador em diferentes estágios da afecção. Foram realizadas 34 hemiartroplastias do tipo cuff tear arthroplasty em 34 pacientes com artropatia do manguito rotador e comorbidades associadas, classificadas de acordo com Seebauer. A média de idade foi de 76,3 anos, sendo 23 pacientes do sexo feminino (67,6%) e 11 do sexo masculino (32,4%). O seguimento médio foi de 21,7 meses e a avaliação foi realizada por meio da Escala Visual Analógica da dor e pela escala de Constant. Não houve diferença estatisticamente significante entre os grupos feminino e masculino, tanto nas médias de redução na Escala Visual Analógica quanto nas de aumento na escala de Constant. A variação entre as avalia

  13. Fusion versus Bryan Cervical Disc in two-level cervical disc disease: a prospective, randomised study

    PubMed Central

    Nie, Lin; Zhang, Li; Hou, Yong

    2008-01-01

    In this prospective study, our aim was to compare the functional results and radiographic outcomes of fusion and Bryan Cervical Disc replacement in the treatment of two-level cervical disc disease. A total of 65 patients with two-level cervical disc disease were randomly assigned to two groups, those operated on with Bryan Cervical Disc replacement (31) and those operated on with anterior cervical fusion with an iliac crest autograft and plate (34). Clinical evaluation was carried out using the visual analogue scale (VAS), the Short Form 36 (SF-36) and the neck disability index (NDI) during a two year follow-up. Radiological evaluation sought evidence of range of motion, stability and subsidence of the prosthesis. Substantial reduction in NDI scores occurred in both groups, with greater percent improvement in the Bryan group (P = 0.023). The arm pain VAS score improvement was substantial in both groups. Bryan artificial cervical disc replacement seems reliable and safe in the treatment of patients with two-level cervical disc disease. PMID:18956190

  14. Effects of anabolic steroids on chronic obstructive pulmonary disease: a meta-analysis of randomised controlled trials.

    PubMed

    Pan, Lei; Wang, Manyuan; Xie, Xiaomei; Du, Changjun; Guo, Yongzhong

    2014-01-01

    Anabolic steroids are known to improve body composition and muscle strength in healthy people. However, whether anabolic steroids improve the physical condition and function in patients with chronic obstructive pulmonary disease (COPD) remains undetermined. A meta-analysis was conducted to review the current evidence regarding the effects of anabolic steroids on COPD patients. A comprehensive literature search of PubMed and EMBASE was performed to identify randomised controlled trials that examine the effects of anabolic steroids on COPD patients. Weighted mean differences (WMDs) with 95% confidence intervals were calculated to determine differences between anabolic steroid administration and control conditions. Eight eligible studies involving 273 COPD patients were identified in this meta-analysis. Significant improvements were found in body weight (0.956 kg), fat-free mass (1.606 kg), St. George's Respiratory Questionnaire total score (-6.336) and symptom score (-12.148). The apparent improvements in maximal inspiratory pressure (2.740 cmH2O) and maximal expiratory pressure (12.679 cmH2O) were not significant. The effects on handgrip strength, forced expiratory volume in one second (FEV1), predicted FEV1 percent, PaO2, PaCO2 and six-min walk distance were negative, with WMDs of -0.245 kg, -0.096 L/sec, -1.996% of predicted, -1.648 cmHg, -0.039 cmHg and -16.102 meters, respectively. Limited evidence available from the published literature suggests that the benefit of anabolic steroids on COPD patients cannot be denied. However, further studies are needed to identify the specific benefits and adverse effects of anabolic steroids on COPD patients and to determine the optimal populations and regimes of anabolic steroids in COPD patients.

  15. Effects of Anabolic Steroids on Chronic Obstructive Pulmonary Disease: A Meta-Analysis of Randomised Controlled Trials

    PubMed Central

    Guo, Yongzhong

    2014-01-01

    Background Anabolic steroids are known to improve body composition and muscle strength in healthy people. However, whether anabolic steroids improve the physical condition and function in patients with chronic obstructive pulmonary disease (COPD) remains undetermined. A meta-analysis was conducted to review the current evidence regarding the effects of anabolic steroids on COPD patients. Methods A comprehensive literature search of PubMed and EMBASE was performed to identify randomised controlled trials that examine the effects of anabolic steroids on COPD patients. Weighted mean differences (WMDs) with 95% confidence intervals were calculated to determine differences between anabolic steroid administration and control conditions. Results Eight eligible studies involving 273 COPD patients were identified in this meta-analysis. Significant improvements were found in body weight (0.956 kg), fat-free mass (1.606 kg), St. George's Respiratory Questionnaire total score (−6.336) and symptom score (−12.148). The apparent improvements in maximal inspiratory pressure (2.740 cmH2O) and maximal expiratory pressure (12.679 cmH2O) were not significant. The effects on handgrip strength, forced expiratory volume in one second (FEV1), predicted FEV1 percent, PaO2, PaCO2 and six-min walk distance were negative, with WMDs of −0.245 kg, −0.096 L/sec, −1.996% of predicted, −1.648 cmHg, −0.039 cmHg and −16.102 meters, respectively. Conclusions Limited evidence available from the published literature suggests that the benefit of anabolic steroids on COPD patients cannot be denied. However, further studies are needed to identify the specific benefits and adverse effects of anabolic steroids on COPD patients and to determine the optimal populations and regimes of anabolic steroids in COPD patients. PMID:24427297

  16. Singing teaching as a therapy for chronic respiratory disease--a randomised controlled trial and qualitative evaluation.

    PubMed

    Lord, Victoria M; Cave, Phoene; Hume, Victoria J; Flude, Elizabeth J; Evans, Amanda; Kelly, Julia L; Polkey, Michael I; Hopkinson, Nicholas S

    2010-08-03

    Despite optimal pharmacological therapy and pulmonary rehabilitation, patients with COPD continue to be breathless. There is a need to develop additional strategies to alleviate symptoms. Learning to sing requires control of breathing and posture and might have benefits that translate into daily life. To test this hypothesis we performed a randomised controlled trial, comparing a six week course of twice weekly singing classes to usual care, in 28 COPD patients. The experience of singing was assessed in a qualitative fashion, through interviews with a psychologist. In addition, we surveyed patients with chronic respiratory conditions who participated in a series of open singing workshops. In the RCT, the physical component score of the SF36 improved in the singers (n = 15) compared to the controls (n = 13); +7.5(14.6) vs. -3.8(8.4) p = 0.02. Singers also had a significant fall in HAD anxiety score; -1.1(2.7) vs. +0.8(1.7) p = 0.03. Singing did not improve single breath counting, breath hold time or shuttle walk distance. In the qualitative element, 8 patients from the singing group were interviewed. Positive effects on physical sensation, general well-being, community/social support and achievement/efficacy emerged as common themes. 150 participants in open workshops completed a questionnaire. 96% rated the workshops as "very enjoyable" and 98% thought the workshop had taught them something about breathing in a different way. 81% of attendees felt a "marked physical difference" after the workshop. Singing classes can improve quality of life measures and anxiety and are viewed as a very positive experience by patients with respiratory disease; no adverse consequences of participation were observed. Current Controlled Trials--ISRCTN17544114.

  17. A meta-analysis of randomised placebo-controlled treatment trials for depression and anxiety in Parkinson's disease.

    PubMed

    Troeung, Lakkhina; Egan, Sarah J; Gasson, Natalie

    2013-01-01

    Psychopharmacotherapy currently constitutes the first-line treatment for depression and anxiety in Parkinson's disease (PD) however the efficacy of antidepressant treatments in PD is unclear. Several alternative treatments have been suggested as potentially more viable alternatives including dopamine agonists, repetitive transcranial magnetic stimulation, and cognitive behavioural therapy (CBT). A meta-analysis of randomised placebo-controlled trials for depression and/or anxiety in PD was conducted to systematically examine the efficacy of current treatments for depression and anxiety in PD. Nine trials were included. There was only sufficient data to calculate a pooled effect for antidepressant therapies. The pooled effect of antidepressants for depression in PD was moderate but non-significant (d = .71, 95% CI = -1.33 to 3.08). The secondary effect of antidepressants on anxiety in PD was large but also non-significant (d = 1.13, 95% CI = -.67 to 2.94). Two single-trials of non-pharmacological treatments for depression in PD resulted in significant large effects; Omega-3 supplementation (d = .92, 95% CI = .15 to 1.69) and CBT (d = 1.57, 95% CI = 1.06 to 2.07), and warrant further exploration. There remains a lack of controlled trials for both pharmacological and non-pharmacological treatments for depression and anxiety in PD which limits the conclusions which can be drawn. While the pooled effects of antidepressant therapies in PD were non-significant, the moderate to large magnitude of each pooled effect is promising. Non-pharmacological approaches show potential for depression in PD however more research is required.

  18. Effect of carbocisteine on acute exacerbation of chronic obstructive pulmonary disease (PEACE Study): a randomised placebo-controlled study.

    PubMed

    Zheng, Jin-Ping; Kang, Jian; Huang, Shao-Guang; Chen, Ping; Yao, Wan-Zen; Yang, Lan; Bai, Chun-Xue; Wang, Chang-Zheng; Wang, Chen; Chen, Bao-Yuan; Shi, Yi; Liu, Chun-Tao; Chen, Ping; Li, Qiang; Wang, Zhen-Shan; Huang, Yi-Jiang; Luo, Zhi-Yang; Chen, Fei-Peng; Yuan, Jian-Zhang; Yuan, Ben-Tong; Qian, Hui-Ping; Zhi, Rong-Chang; Zhong, Nan-Shan

    2008-06-14

    Chronic obstructive pulmonary disease (COPD) is characterised by airflow limitation, and has many components including mucus hypersecretion, oxidative stress, and airway inflammation. We aimed to assess whether carbocisteine, a mucolytic agent with anti-inflammatory and antioxidation activities, could reduce the yearly exacerbation rate in patients with COPD. We did a randomised, double-blind, placebo-controlled study of 709 patients from 22 centres in China. Participants were eligible if they were diagnosed as having COPD with a postbronchodilator forced expiratory volume in 1 s (FEV(1)) to forced vital capacity (FVC) ratio (FEV(1)/FVC) of less than 0.7 and an FEV(1) between 25% and 79% of the predicted value, were aged between 40 and 80 years, had a history of at least two COPD exacerbations within the previous 2 years, and had remained clinically stable for over 4 weeks before the study. Patients were randomly assigned to receive 1500 mg carbocisteine or placebo per day for a year. The primary endpoint was exacerbation rate over 1 year, and analysis was by intention to treat. This trial is registered with the Japan Clinical Trials Registry (http://umin.ac.jp/ctr/index/htm) number UMIN-CRT C000000233. 354 patients were assigned to the carbocisteine group and 355 to the placebo group. Numbers of exacerbations per patient per year declined significantly in the carbocisteine group compared with the placebo group (1.01 [SE 0.06] vs 1.35 [SE 0.06]), risk ratio 0.75 (95% CI 0.62-0.92, p=0.004). Non-significant interactions were found between the preventive effects and COPD severity, smoking, as well as concomitant use of inhaled corticosteroids. Carbocisteine was well tolerated. Mucolytics, such as carbocisteine, should be recognised as a worthwhile treatment for prevention of exacerbations in Chinese patients with COPD.

  19. Electrosurgical Settings and Vaginal Cuff Complications

    PubMed Central

    Lawlor, Megan L.; Rao, Rama; Manahan, Kelly J.

    2015-01-01

    Background and Objectives: After being encouraged to change the technique for opening the vaginal cuff during robotic surgery, this study was performed to determine the correlation between vaginal cuff complications and electrosurgical techniques. Methods: The study group consisted of patients who had their vaginal cuffs opened with a cutting current compared to the group of patients having their vaginal cuff opened with a coagulation current. Data were collected on 150 women who underwent robotic surgery for endometrial cancer. All patients received preoperative antibiotics. Data, including operative time, type of electrosurgery used, estimated blood loss, transfusion rate, and complications, were collected from the patients' records. Results: Surgeries in 150 women and the associated complications were studied. The mean age of the patients was not significantly different between the groups (P = .63). The mean body mass index was 38 kg/m2 in the coagulation arm and 36 kg/m2 in the cutting arm (P = .03). Transfusion was not required. Estimated blood loss and operative time were not significantly different in the coagulation versus the cutting arms (P = .29 and .5; respectively). No patients in the cutting arm and 4 patients (with 5 complications) in the coagulation arm had cuff complications (P = .02). Conclusions: Complications involving the vaginal cuff appear to occur more frequently when the vagina is entered by using electrosurgery with coagulation versus cutting in this cohort of patients undergoing robot-assisted surgery for endometrial cancer.. PMID:26681912

  20. Clinical Examination of the Rotator Cuff

    PubMed Central

    Jain, Nitin B.; Wilcox, Reginald; Katz, Jeffrey N.; Higgins, Laurence D.

    2013-01-01

    Rotator cuff tears are the leading cause of shoulder pain and shoulder-related disability accounting for 4.5 million physician visits in the United States annually. A careful history and structured physical examination are often sufficient for diagnosing rotator cuff disorders. We are not aware of a clinical review article that presents a structured physical examination protocol of the rotator cuff for the interested clinician. To fill this void, we present a physical examination protocol developed on the basis of review of prior literature and our clinical experience from dedicated shoulder practices. Our protocol includes range of motion testing using a goniometer, strength testing using a dynamometer, and select special tests. Among the many tests for rotator cuff disorders that have been described, we chose ones that have been more thoroughly assessed for sensitivity and specificity. This protocol can be used to isolate the specific rotator cuff tendon involved. The protocol can be typically completed in 15 minutes. We also discuss the clinical implications and limitations of the physical examination maneuvers described in our protocol. This protocol is thorough yet time-efficient for a busy clinical practice. It is useful in diagnosis of rotator cuff tears, impingement syndrome, and biceps pathology. PMID:23332909

  1. Implementing guidelines to routinely prevent chronic vascular disease in primary care: the Preventive Evidence into Practice cluster randomised controlled trial.

    PubMed

    Harris, Mark Fort; Parker, Sharon M; Litt, John; van Driel, Mieke; Russell, Grant; Mazza, Danielle; Jayasinghe, Upali W; Del Mar, Chris; Lloyd, Jane; Smith, Jane; Zwar, Nicholas; Taylor, Richard; Powell Davies, Gawaine

    2015-12-11

    To evaluate an intervention to improve implementation of guidelines for the prevention of chronic vascular disease. 32 urban general practices in 4 Australian states. Stratified randomisation of practices. 122 general practitioners (GPs) and practice nurses (PNs) were recruited at baseline and 97 continued to 12 months. 21,848 patient records were audited for those aged 40-69 years who attended the practice in the previous 12 months without heart disease, stroke, diabetes, chronic renal disease, cognitive impairment or severe mental illness. The practice level intervention over 6 months included small group training of practice staff, feedback on audited performance, practice facilitation visits and provision of patient education and referral information. Primary: 1. Change in proportion of patients aged 40-69 years with smoking status, alcohol intake, body mass index (BMI), waist circumference (WC), blood pressure (BP) recorded and for those aged 45-69 years with lipids, fasting blood glucose and cardiovascular risk in the medical record. 2. Change in the level of risk for each factor. change in self-reported frequency and confidence of GPs and PNs in assessment. Risk recording improved in the intervention but not the control group for WC (OR 2.52 (95% CI 1.30 to 4.91)), alcohol consumption (OR 2.19 (CI 1.04 to 4.64)), smoking status (OR 2.24 (1.17 to 4.29)) and cardiovascular risk (OR 1.50 (1.04 to 2.18)). There was no change in recording of BP, lipids, glucose or BMI and no significant change in the level of risk factors based on audit data. The confidence but not reported practices of GPs and PNs in the intervention group improved in the assessment of some risk factors. This intervention was associated with improved recording of some risk factors but no change in the level of risk at the follow-up audit. Australian and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000578808, results. Published by the BMJ Publishing Group Limited. For permission to

  2. Mitigating Diseases Transmitted by Aedes Mosquitoes: A Cluster-Randomised Trial of Permethrin-Impregnated School Uniforms

    PubMed Central

    Kittayapong, Pattamaporn; Olanratmanee, Phanthip; Maskhao, Pongsri; Byass, Peter; Logan, James; Tozan, Yesim; Louis, Valérie; Gubler, Duane J.; Wilder-Smith, Annelies

    2017-01-01

    Background Viral diseases transmitted via Aedes mosquitoes are on the rise, such as Zika, dengue, and chikungunya. Novel tools to mitigate Aedes mosquitoes-transmitted diseases are urgently needed. We tested whether commercially insecticide-impregnated school uniforms can reduce dengue incidence in school children. Methods We designed a cluster-randomised controlled trial in Thailand. The primary endpoint was laboratory-confirmed dengue infections. Secondary endpoints were school absenteeism; and impregnated uniforms’ 1-hour knock-down and 24 hour mosquito mortality as measured by standardised WHOPES bioassay cone tests at baseline and after repeated washing. Furthermore, entomological assessments inside classrooms and in outside areas of schools were conducted. Results We enrolled 1,811 pupils aged 6–17 from 5 intervention and 5 control schools. Paired serum samples were obtained from 1,655 pupils. In the control schools, 24/641 (3.7%) and in the intervention schools 33/1,014 (3.3%) students had evidence of new dengue infections during one school term (5 months). There was no significant difference in proportions of students having incident dengue infections between the intervention and control schools, with adjustment for clustering by school. WHOPES cone tests showed a 100% knock down and mortality of Aedes aegypti mosquitoes exposed to impregnated clothing at baseline and up to 4 washes, but this efficacy rapidly declined to below 20% after 20 washes, corresponding to a weekly reduction in knock-down and mosquito mortality by 4.7% and 4.4% respectively. Results of the entomological assessments showed that the mean number of Aedes aegypti mosquitoes caught inside the classrooms of the intervention schools was significantly reduced in the month following the introduction of the impregnated uniforms, compared to those collected in classrooms of the control schools (p = 0.04) Conclusions Entomological assessments showed that the intervention had some impact on

  3. Mitigating Diseases Transmitted by Aedes Mosquitoes: A Cluster-Randomised Trial of Permethrin-Impregnated School Uniforms.

    PubMed

    Kittayapong, Pattamaporn; Olanratmanee, Phanthip; Maskhao, Pongsri; Byass, Peter; Logan, James; Tozan, Yesim; Louis, Valérie; Gubler, Duane J; Wilder-Smith, Annelies

    2017-01-01

    Viral diseases transmitted via Aedes mosquitoes are on the rise, such as Zika, dengue, and chikungunya. Novel tools to mitigate Aedes mosquitoes-transmitted diseases are urgently needed. We tested whether commercially insecticide-impregnated school uniforms can reduce dengue incidence in school children. We designed a cluster-randomised controlled trial in Thailand. The primary endpoint was laboratory-confirmed dengue infections. Secondary endpoints were school absenteeism; and impregnated uniforms' 1-hour knock-down and 24 hour mosquito mortality as measured by standardised WHOPES bioassay cone tests at baseline and after repeated washing. Furthermore, entomological assessments inside classrooms and in outside areas of schools were conducted. We enrolled 1,811 pupils aged 6-17 from 5 intervention and 5 control schools. Paired serum samples were obtained from 1,655 pupils. In the control schools, 24/641 (3.7%) and in the intervention schools 33/1,014 (3.3%) students had evidence of new dengue infections during one school term (5 months). There was no significant difference in proportions of students having incident dengue infections between the intervention and control schools, with adjustment for clustering by school. WHOPES cone tests showed a 100% knock down and mortality of Aedes aegypti mosquitoes exposed to impregnated clothing at baseline and up to 4 washes, but this efficacy rapidly declined to below 20% after 20 washes, corresponding to a weekly reduction in knock-down and mosquito mortality by 4.7% and 4.4% respectively. Results of the entomological assessments showed that the mean number of Aedes aegypti mosquitoes caught inside the classrooms of the intervention schools was significantly reduced in the month following the introduction of the impregnated uniforms, compared to those collected in classrooms of the control schools (p = 0.04). Entomological assessments showed that the intervention had some impact on the number of Aedes mosquitoes inside

  4. Complete revascularisation in ST-elevation myocardial infarction and multivessel disease: meta-analysis of randomised controlled trials.

    PubMed

    Kowalewski, Mariusz; Schulze, Volker; Berti, Sergio; Waksman, Ron; Kubica, Jacek; Kołodziejczak, Michalina; Buffon, Antonino; Suryapranata, Harry; Gurbel, Paul Alfred; Kelm, Malte; Pawliszak, Wojciech; Anisimowicz, Lech; Navarese, Eliano Pio

    2015-08-01

    Current guidelines recommend culprit-only revascularisation (COR) in haemodynamically stable patients with ST-segment elevation myocardial infarction (STEMI) and multivessel (MV) disease. Contrarily, growing body of evidence available from recent randomised controlled trials (RCTs) demonstrates improved outcomes with complete MV-percutaneous coronary intervention (PCI). We performed a meta-analysis of RCTs comparing complete MV-PCI with non-complete MV-PCI in STEMI and MV disease. Complete MV-PCI was defined as revascularisation to non-infarct-related artery lesions during index procedure, non-complete MV-PCI-encompassed COR and staged approaches. Multiple databases and congress proceedings from major cardiovascular societies' meetings were screened for relevant studies. Primary endpoint was the composite of major adverse cardiac events (MACE) typically defined as death, recurrent myocardial infarction (MI) and repeat revascularisation. Secondary endpoints were cardiovascular mortality, recurrent MI and repeat revascularisation. Outcomes were analysed at longest available follow-up with differences accounted for with adjusted models by person-years. Seven RCTs (N=1303) were included. The median follow-up was 12 months. Complete MV-PCI reduced the odds of MACE compared with non-complete MV-PCI (OR (95% CIs) 0.59 (0.36 to 0.97), p=0.04) driven by reduction in recurrent MI (0.48 (0.27 to 0.85), p=0.01) and repeat revascularisation (0.51 (0.31 to 0.84), p=0.008). Complete MV-PCI was associated with a non-significant trend towards reduced cardiovascular mortality (0.54 (0.26 to 1.10), p=0.09) as well. In a sensitivity analysis, none of the baseline clinical variables significantly influenced overall estimates. In STEMI and MV disease, complete MV-PCI as compared with non-complete strategy reduces MACE by 41%, driven by a 52% reduction in recurrent MI and 49% reduction in repeat revascularisation. Published by the BMJ Publishing Group Limited. For permission to use

  5. Biceps sheath fluid on shoulder ultrasound as a predictor of rotator cuff tear: analysis of a consecutive cohort.

    PubMed

    Hanusch, Birgit C; Makaram, Navnit; Utrillas-Compaired, Alfonso; Lawson-Smith, Matthew J; Rangan, Amar

    2016-10-01

    Ultrasound provides evaluation of rotator cuff disease with accuracy comparable to that of magnetic resonance imaging. Fluid in the sheath of the long head of the biceps tendon (LHB), identified on ultrasound scan, has been associated with disease of the rotator cuff, LHB, and glenohumeral joint. Prior literature has compared ultrasound findings only with arthrography, and results have been conflicting. Arthroscopy remains the reference standard in assessing accuracy of imaging modalities. We present the first study investigating the significance of fluid in the LHB on ultrasound in predicting subsequent rotator cuff disease identified on arthroscopy. Records were reviewed of 175 patients undergoing ultrasound and subsequent arthroscopy under 1 shoulder surgeon. Experienced musculoskeletal radiologists and sonographers performed ultrasound. Ultrasound examination and operating records were collected and analyzed. Data were analyzed using descriptive statistics, correlation, and logistic regression modeling. Highly significant correlation (P < .001; ρ = 0.354) was found between fluid in the LHB sheath and rotator cuff tears on arthroscopy. Statistically significant but weak correlation (P < .05; rho = 0.187) was found between fluid in the LHB sheath and both biceps tendon disease and glenohumeral joint disease. Fluid around the LHB was shown to increase the likelihood of having rotator cuff tear (odds ratio, 2.641; 95% confidence interval, 1.229-5.674) and biceps tendon disease (odds ratio, 2.698; 95% confidence interval, 1.216-5.987). This is the first report identifying significant correlation between fluid in the LHB sheath identified on ultrasound and subsequent rotator cuff disease identified at arthroscopy. We recommend routine reporting of fluid in the LHB sheath as it is likely to improve the accuracy of detecting rotator cuff and biceps tendon diseases. Copyright © 2016 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by

  6. Repair of rotator cuff injuries using different composites.

    PubMed

    Lopiz, Y; Arvinius, C; García-Fernández, C; Rodriguez-Bobada, M C; González-López, P; Civantos, A; Marco, F

    Rotator cuff repairs have shown a high level of re-ruptures. It is hypothesised that the use of rhBMP-2 in a carrier could improve the biomechanical and histological properties of the repair. Controlled experimental study conducted on 40 rats with section and repair of the supraspinatus tendon and randomisation to one of five groups: Group 1 (control) only suture; Group 2 (double control), suture and alginate-chitin carrier; Group 3 (alginate-control), the rhBMP-2 was added to the alginate; Group 4 (chitin-control) application of the rhBMP-2 to the chitin, and Group 5 (double sample): The two components of the carrier (alginate and chitin) have rhBMP-2. A biomechanical and histological analysis was performed at 4 weeks. A gap was observed in all cases 4 weeks after supraspinatus detachment. The re-rupture rate was 7.5%, with 20% of them in the control-alginate Group. Histologically the best results were obtained in the double sample group: 4.5 (3.3-5.0). Double sample were also able to support higher loads to failure: 62.9N (59.8 to 69.4) with lower rigidity 12.7 (9.7 to 15.9). The use of alginate-chitin carrier with rhBMP-2 improves the biomechanical and histological properties of the repair site in a chronic rotator cuff tear. Copyright © 2016 SECOT. Publicado por Elsevier España, S.L.U. All rights reserved.

  7. Efficacy of vitamin and antioxidant supplements in prevention of cardiovascular disease: systematic review and meta-analysis of randomised controlled trials

    PubMed Central

    Ju, Woong; Oh, Seung-Won; Park, Sang Min; Koo, Bon-Kwon; Park, Byung-Joo

    2013-01-01

    Objective To assess the efficacy of vitamin and antioxidant supplements in the prevention of cardiovascular diseases. Design Meta-analysis of randomised controlled trials. Data sources and study selection PubMed, EMBASE, the Cochrane Library, Scopus, CINAHL, and ClinicalTrials.gov searched in June and November 2012. Two authors independently reviewed and selected eligible randomised controlled trials, based on predetermined selection criteria. Results Out of 2240 articles retrieved from databases and relevant bibliographies, 50 randomised controlled trials with 294 478 participants (156 663 in intervention groups and 137 815 in control groups) were included in the final analyses. In a fixed effect meta-analysis of the 50 trials, supplementation with vitamins and antioxidants was not associated with reductions in the risk of major cardiovascular events (relative risk 1.00, 95% confidence interval 0.98 to 1.02; I2=42%). Overall, there was no beneficial effect of these supplements in the subgroup meta-analyses by type of prevention, type of vitamins and antioxidants, type of cardiovascular outcomes, study design, methodological quality, duration of treatment, funding source, provider of supplements, type of control, number of participants in each trial, and supplements given singly or in combination with other supplements. Among the subgroup meta-analyses by type of cardiovascular outcomes, vitamin and antioxidant supplementation was associated with a marginally increased risk of angina pectoris, while low dose vitamin B6 supplementation was associated with a slightly decreased risk of major cardiovascular events. Those beneficial or harmful effects disappeared in subgroup meta-analysis of high quality randomised controlled trials within each category. Also, even though supplementation with vitamin B6 was associated with a decreased risk of cardiovascular death in high quality trials, and vitamin E supplementation with a decreased risk of myocardial infarction

  8. Monetary costs of Alzheimer's disease in China: protocol for a cluster-randomised observational study.

    PubMed

    Li, Fangyu; Chen, Shuoqi; Wei, Cuibai; Jia, Jianping

    2017-01-25

    Alzheimer's disease (AD) is the most common type of dementia. International multilateral cost-of-illness (COI) studies have revealed that the cost of treating this disease is huge, which places a significant burden on patients' families and their healthcare systems. However, no such studies have been conducted in China. This study estimates the monetary costs of patients with AD in mainland China. This study planned to start in October 2015 and to finish in March 2016. It covered 30 provincial, municipal, and autonomous regions in mainland China. The sites and research centres in each region were selected randomly. The participating sites include Tier 3 hospitals, psychiatric hospitals, geriatric hospitals, nursing homes, and residences. More than 2500 patients with AD and their caregivers from all of the 81 research centres will be enrolled to fulfil the calculated sample size. The monetary costs of AD, which include direct medical costs, direct non-medical costs, and indirect costs, are being collected using the electronic medical record system and residence health system at each site; face-to-face interviews are being performed when necessary. Descriptive statistics will be used to summarise the patient characteristics and generalised linear models will be developed to calculate the costs. The main findings will include national and per patient annual monetary costs of AD in China. To the best of our knowledge, this is the first large-scale cluster-randomized observational study to estimate the economic burden of AD in Chinese patients. The methodology used was based on China's current healthcare system and is suitable for the purpose of the study. Because the burden of AD on patients, families, healthcare providers, and society is substantial and increasing, it is important and necessary to understand the economic burden caused by this disease. Our trial was retrospectively registered on ClinicalTrials.gov, NCT02694445 , registered on 02/26/2016.

  9. The effectiveness of the Austrian disease management programme for type 2 diabetes: a cluster-randomised controlled trial.

    PubMed

    Sönnichsen, Andreas C; Winkler, Henrike; Flamm, Maria; Panisch, Sigrid; Kowatsch, Peter; Klima, Gert; Fürthauer, Bernhard; Weitgasser, Raimund

    2010-11-05

    Disease management programmes (DMPs) are costly and impose additional work load on general practitioners (GPs). Data on their effectiveness are inconclusive. We therefore conducted a cluster-randomised controlled trial to evaluate the effectiveness of the Austrian DMP for diabetes mellitus type 2 on HbA1c and quality of care for adult patients in primary care. All GPs of Salzburg-province were invited to participate. After cluster-randomisation by district, all patients with diabetes type 2 were recruited consecutively from 7-11/2007. The DMP, consisting mainly of physician and patient education, standardised documentation and agreement on therapeutic goals, was implemented in the intervention group while the control group received usual care. We aimed to show superiority of the intervention regarding metabolic control and process quality. The primary outcome measure was a change in HbA1c after one year. Secondary outcomes were days in the hospital, blood pressure, lipids, body mass index (BMI), enrolment in patient education and regular guideline-adherent examination. Blinding was not possible. 92 physicians recruited 1489 patients (649 intervention, 840 control). After 401 ± 47 days, 590 intervention-patients and 754 controls had complete data. In the intention to treat analysis (ITT) of all 1489 patients, HbA1c decreased 0.41% in the intervention group and 0.28% in controls. The difference of -0.13% (95% CI -0.24; -0.02) was significant at p = 0.026. Significance was lost in mixed models adjusted for baseline value and cluster-effects (adjusted mean difference -0.03 (95% CI -0.15; 0.09, p = 0.607). Of the secondary outcome measures, BMI and cholesterol were significantly reduced in the intervention group compared to controls in ITT after adjustments (-0.53 kg/m²; 95% CI -1.03;-0.02; p = 0.014 and -0.10 mmol/l; 95% CI -0.21; -0.003; p = 0.043). Additionally, more patients received patient education (49.5% vs. 20.1%, p < 0.0001), eye- (71.0% vs. 51.2%, p < 0

  10. The effectiveness of the Austrian disease management programme for type 2 diabetes: a cluster-randomised controlled trial

    PubMed Central

    2010-01-01

    Background Disease management programmes (DMPs) are costly and impose additional work load on general practitioners (GPs). Data on their effectiveness are inconclusive. We therefore conducted a cluster-randomised controlled trial to evaluate the effectiveness of the Austrian DMP for diabetes mellitus type 2 on HbA1c and quality of care for adult patients in primary care. Methods All GPs of Salzburg-province were invited to participate. After cluster-randomisation by district, all patients with diabetes type 2 were recruited consecutively from 7-11/2007. The DMP, consisting mainly of physician and patient education, standardised documentation and agreement on therapeutic goals, was implemented in the intervention group while the control group received usual care. We aimed to show superiority of the intervention regarding metabolic control and process quality. The primary outcome measure was a change in HbA1c after one year. Secondary outcomes were days in the hospital, blood pressure, lipids, body mass index (BMI), enrolment in patient education and regular guideline-adherent examination. Blinding was not possible. Results 92 physicians recruited 1489 patients (649 intervention, 840 control). After 401 ± 47 days, 590 intervention-patients and 754 controls had complete data. In the intention to treat analysis (ITT) of all 1489 patients, HbA1c decreased 0.41% in the intervention group and 0.28% in controls. The difference of -0.13% (95% CI -0.24; -0.02) was significant at p = 0.026. Significance was lost in mixed models adjusted for baseline value and cluster-effects (adjusted mean difference -0.03 (95% CI -0.15; 0.09, p = 0.607). Of the secondary outcome measures, BMI and cholesterol were significantly reduced in the intervention group compared to controls in ITT after adjustments (-0.53 kg/m²; 95% CI -1.03;-0.02; p = 0.014 and -0.10 mmol/l; 95% CI -0.21; -0.003; p = 0.043). Additionally, more patients received patient education (49.5% vs. 20.1%, p < 0.0001), eye

  11. Disease management programme for secondary prevention of coronary heart disease and heart failure in primary care: a cluster randomised controlled trial.

    PubMed

    Khunti, Kamlesh; Stone, Margaret; Paul, Sanjoy; Baines, Jan; Gisborne, Louise; Farooqi, Azhar; Luan, Xiujie; Squire, Iain

    2007-11-01

    To evaluate the effect of a disease management programme for patients with coronary heart disease (CHD) and chronic heart failure (CHF) in primary care. A cluster randomised controlled trial of 1316 patients with CHD and CHF from 20 primary care practices in the UK was carried out. Care in the intervention practices was delivered by specialist nurses trained in the management of patients with CHD and CHF. Usual care was delivered by the primary healthcare team in the control practices. At follow up, significantly more patients with a history of myocardial infarction in the intervention group were prescribed a beta-blocker compared to the control group (adjusted OR 1.43, 95% CI 1.19 to 1.99). Significantly more patients with CHD in the intervention group had adequate management of their blood pressure (<140/85 mm Hg) (OR 1.61, 95% CI 1.22 to 2.13) and their cholesterol (<5 mmol/l) (OR 1.58, 95% CI 1.05 to 2.37) compared to those in the control group. Significantly more patients with an unconfirmed diagnosis of CHF had a diagnosis of left ventricular systolic dysfunction confirmed (OR 4.69, 95% CI 1.88 to 11.66) or excluded (OR 3.80, 95% CI 1.50 to 9.64) in the intervention group compared to the control group. There were significant improvements in some quality-of-life measures in patients with CHD in the intervention group. Disease management programmes can lead to improvements in the care of patients with CHD and presumed CHF in primary care.

  12. Animal models for rotator cuff repair.

    PubMed

    Lebaschi, Amir; Deng, Xiang-Hua; Zong, Jianchun; Cong, Guang-Ting; Carballo, Camila B; Album, Zoe M; Camp, Christopher; Rodeo, Scott A

    2016-11-01

    Rotator cuff (RC) injuries represent a significant source of pain, functional impairment, and morbidity. The large disease burden of RC pathologies necessitates rapid development of research methodologies to treat these conditions. Given their ability to model anatomic, biomechanical, cellular, and molecular aspects of the human RC, animal models have played an indispensable role in reducing injury burden and advancing this field of research for many years. The development of animal models in the musculoskeletal (MSK) research arena is uniquely different from that in other fields in that the similarity of macrostructures and functions is as critical to replicate as cellular and molecular functions. Traditionally, larger animals have been used because of their anatomic similarity to humans and the ease of carrying out realistic surgical procedures. However, refinement of current molecular methods, introduction of novel research tools, and advancements in microsurgical techniques have increased the applicability of small animal models in MSK research. In this paper, we review RC animal models and emphasize a murine model that may serve as a valuable instrument for future RC tendon repair investigations. © 2016 New York Academy of Sciences.

  13. Effects of Electrosurgery and Vaginal Closure Technique on Postoperative Vaginal Cuff Dehiscence

    PubMed Central

    Kesterson, Joshua; Davies, Matthew; Green, Janis; Penezic, Lindsey; Vargas, Roberto; Harkins, Gerald

    2013-01-01

    Background and Objectives: The aim of our study is to evaluate the role of electrosurgery and vaginal closure technique in the development of postoperative vaginal cuff dehiscence. Methods: From prospective surgical databases, we identified 463 patients who underwent total laparoscopic hysterectomy (TLH) for benign disease and 147 patients who underwent laparoscopic-assisted vaginal hysterectomy (LAVH) for cancer. All TLHs and LAVHs were performed entirely by use of electrosurgery, including colpotomy. Colpotomy in the TLH group was performed with Harmonic Ace Curved Shears (Ethicon Endo-Surgery, Cincinnati, OH, USA), and in the LAVH group, it was performed with a monopolar electrosurgical pencil. The main surgical difference was vaginal cuff closure—laparoscopically in the TLH group and vaginally in the LAVH group. Results: Although patients in the LAVH group were at increased risk for poor healing (significantly older, higher body mass index, more medical comorbidities, higher blood loss, and longer operative time), there were no vaginal cuff dehiscences in the LAVH group compared with 17 vaginal cuff dehiscences (4%) in the TLH group (P = .02). Conclusion: It does not appear that the increased vaginal cuff dehiscence rate associated with TLH is due to electrosurgery; rather, it is due to the vaginal closure technique. PMID:24018078

  14. Exacerbations in patients with chronic obstructive pulmonary disease receiving physical therapy: a cohort-nested randomised controlled trial

    PubMed Central

    2014-01-01

    Background Physical exercise training aims at reducing disease-specific impairments and improving quality of life in patients with chronic obstructive pulmonary disease (COPD). COPD exacerbations in particular negatively impact COPD progression. Physical therapy intervention seems indicated to influence exacerbations and their consequences. However, information on the effect of physical therapy on exacerbation occurrence is scarce. This study aims to investigate the potential of a protocol-directed physical therapy programme as a means to prevent or postpone exacerbations, to shorten the duration or to decrease the severity of exacerbations in patients with COPD who have recently experienced an exacerbation. Besides, this study focuses on the effect of protocol-directed physical therapy on health status and quality of life and on cost-effectiveness and cost-utility in patients with COPD who have recently experienced an exacerbation. Methods/Design A prospective cohort of 300 COPD patients in all GOLD stages will be constructed. Patients will receive usual multidisciplinary COPD care including guideline-directed physical therapy. Patients in this cohort who have GOLD stage 2 to 4 (post-bronchodilator FEV1/FVC < 0.7 and FEV1 < 80% of predicted), who receive reimbursement by health insurance companies for physical therapy (post-bronchodilator Tiffeneau-index < 0.6) and who experience a COPD exacerbation will be asked within 56 days to participate in a cohort-nested prospective randomised controlled trial (RCT). In this RCT, the intervention group will receive a strict physical therapy programme for patients with COPD. This protocol-directed physical therapy (pdPT) will be compared to a control group that will receive sham-treatment, meaning no or very low-intensity exercise training (ST). An economic evaluation will be embedded in the RCT. Anthropometric measurements, comorbidities, smoking, functional exercise capacity, peripheral muscle strength

  15. Comprehensive self management and routine monitoring in chronic obstructive pulmonary disease patients in general practice: randomised controlled trial

    PubMed Central

    Akkermans, Reinier; Bourbeau, Jean; van Weel, Chris; Vercoulen, Jan H; Schermer, Tjard R J

    2012-01-01

    Objective To assess the long term effects of two different modes of disease management (comprehensive self management and routine monitoring) on quality of life (primary objective), frequency and patients’ management of exacerbations, and self efficacy (secondary objectives) in patients with chronic obstructive pulmonary disease (COPD) in general practice. Design 24 month, multicentre, investigator blinded, three arm, pragmatic, randomised controlled trial. Setting 15 general practices in the eastern part of the Netherlands. Participants Patients with COPD confirmed by spirometry and treated in general practice. Patients with very severe COPD or treated by a respiratory physician were excluded. Interventions A comprehensive self management programme as an adjunct to usual care, consisting of four tailored sessions with ongoing telephone support by a practice nurse; routine monitoring as an adjunct to usual care, consisting of 2-4 structured consultations a year with a practice nurse; or usual care alone (contacts with the general practitioner at the patients’ own initiative). Outcome measures The primary outcome was the change in COPD specific quality of life at 24 months as measured with the chronic respiratory questionnaire total score. Secondary outcomes were chronic respiratory questionnaire domain scores, frequency and patients’ management of exacerbations measured with the Nijmegen telephonic exacerbation assessment system, and self efficacy measured with the COPD self-efficacy scale. Results 165 patients were allocated to self management (n=55), routine monitoring (n=55), or usual care alone (n=55). At 24 months, adjusted treatment differences between the three groups in mean chronic respiratory questionnaire total score were not significant. Secondary outcomes did not differ, except for exacerbation management. Compared with usual care, more exacerbations in the self management group were managed with bronchodilators (odds ratio 2.81, 95% confidence

  16. Comprehensive self management and routine monitoring in chronic obstructive pulmonary disease patients in general practice: randomised controlled trial.

    PubMed

    Bischoff, Erik W M A; Akkermans, Reinier; Bourbeau, Jean; van Weel, Chris; Vercoulen, Jan H; Schermer, Tjard R J

    2012-11-28

    To assess the long term effects of two different modes of disease management (comprehensive self management and routine monitoring) on quality of life (primary objective), frequency and patients' management of exacerbations, and self efficacy (secondary objectives) in patients with chronic obstructive pulmonary disease (COPD) in general practice. 24 month, multicentre, investigator blinded, three arm, pragmatic, randomised controlled trial. 15 general practices in the eastern part of the Netherlands. Patients with COPD confirmed by spirometry and treated in general practice. Patients with very severe COPD or treated by a respiratory physician were excluded. A comprehensive self management programme as an adjunct to usual care, consisting of four tailored sessions with ongoing telephone support by a practice nurse; routine monitoring as an adjunct to usual care, consisting of 2-4 structured consultations a year with a practice nurse; or usual care alone (contacts with the general practitioner at the patients' own initiative). The primary outcome was the change in COPD specific quality of life at 24 months as measured with the chronic respiratory questionnaire total score. Secondary outcomes were chronic respiratory questionnaire domain scores, frequency and patients' management of exacerbations measured with the Nijmegen telephonic exacerbation assessment system, and self efficacy measured with the COPD self-efficacy scale. 165 patients were allocated to self management (n=55), routine monitoring (n=55), or usual care alone (n=55). At 24 months, adjusted treatment differences between the three groups in mean chronic respiratory questionnaire total score were not significant. Secondary outcomes did not differ, except for exacerbation management. Compared with usual care, more exacerbations in the self management group were managed with bronchodilators (odds ratio 2.81, 95% confidence interval 1.16 to 6.82) and with prednisolone, antibiotics, or both (3.98, 1.10 to 15

  17. Interrupting gel layer between Double cuffs prevents fluid leakage past tracheal tube cuffs.

    PubMed

    Hwang, J Y; Han, S H; Park, S H; Park, S J; Park, S; Oh, S H; Kim, J H

    2013-09-01

    Current tracheal tubes (TTs) cannot guarantee a perfect seal against pulmonary aspiration of upper airway secretions. The purpose of this study was to investigate whether a gel layer between the tracheal tube with double cuffs (Double cuffs) prevents fluid leakage past TT cuffs. In vitro fluid leakage tests were performed using the Double cuff with or without a gel layer between the two cuffs and four commercially available TTs (Euromedical Standard TT, Mallinckrodt Hi-Lo™, Microcuff, and Mallinckrodt TaperGuard™) when placed in artificial tracheas with three-different internal diameters (ID; 16, 20, and 22 mm). Blue-dyed water (5 ml) was placed above the cuff, and the extent of fluid leakage was observed for 48 h. Each test was repeated five times with new tubes at six different intracuff pressures (15, 20, 25, 30, 40, and 50 cm H2O). In all of the conventional TTs and the Double cuff without a gel layer, fluid leakage was observed even at clinically acceptable intracuff pressures (25-30 cm H2O). However, in the Double cuff with a gel layer, no fluid leakage was observed for 48 h at all intracuff pressures in three-different sized artificial tracheas. At an intracuff pressure of 20 cm H2O in a 20 mm ID trachea, the average volume of injected gel was 2.0 ml. After removal of the TT, the mean volume of the remaining gel in the trachea was 0.10 ml. A prototype TT with gel-layered Double cuffs completely blocked fluid leakage past the cuffs for 48 h in a bench-top model. Clinical studies are required to determine whether this TT reduces the risk of ventilator-associated pneumonia.

  18. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials.

    PubMed

    Calverley, Peter M A; Rabe, Klaus F; Goehring, Udo-Michael; Kristiansen, Søren; Fabbri, Leonardo M; Martinez, Fernando J

    2009-08-29

    The phosphodiesterase-4 inhibitor roflumilast can improve lung function and prevent exacerbations in certain patients with chronic obstructive pulmonary disease (COPD). We therefore investigated whether roflumilast would reduce the frequency of exacerbations requiring corticosteroids in patients with COPD. In two placebo-controlled, double-blind, multicentre trials (M2-124 and M2-125) with identical design that were done in two different populations in an outpatient setting, patients with COPD older than 40 years, with severe airflow limitation, bronchitic symptoms, and a history of exacerbations were randomly assigned to oral roflumilast (500 microg once per day) or placebo for 52 weeks. Primary endpoints were change in prebronchodilator forced expiratory volume in 1 s (FEV(1)) and the rate of exacerbations that were moderate (glucocorticosteroid-treated) or severe. Analysis was by intention to treat. The trials are registered with ClinicalTrials.gov, number NCT00297102 for M2-124, and NCT00297115 for M2-125. Patients were assigned to treatment, stratified according to smoking status and treatment with longacting beta(2) agonists, and given roflumilast (n=1537) or placebo (n=1554). In both studies, the prespecified primary endpoints were achieved and were similar in magnitude. In a pooled analysis, prebronchodilator FEV(1) increased by 48 mL with roflumilast compared with placebo (p<0.0001). The rate of exacerbations that were moderate or severe per patient per year was 1.14 with roflumilast and 1.37 with placebo (reduction 17% [95% CI 8-25], p<0.0003). Adverse events were more common with roflumilast (1040 [67%]) than with placebo (963 [62%]); 219 (14%) patients in the roflumilast group and 177 (12%) in the placebo group discontinued because of adverse events. In the pooled analysis, the difference in weight change during the study between the roflumilast and placebo groups was -2.17 kg. Since different subsets of patients exist within the broad spectrum of COPD

  19. Randomised controlled trial of low dose fentanyl infusion in preterm infants with hyaline membrane disease

    PubMed Central

    Lago, P; Benini, F; Agosto, C; Zacchello, F

    1998-01-01

    Aim—To evaluate the effects of low dose fentanyl infusion analgesia on behavioural and neuroendocrine stress response and short term outcome in premature infants ventilated for hyaline membrane disease.
METHODS—Twenty seven ventilated preterm infants were randomly assigned to receive a mean fentanyl infusion of 1.1 (0.08 SE) µg/kg/h for 75 (5) hours, and 28 untreated infants were considered a control group. A behavioural sedation score was used to assess the infants' behaviour. Urinary metanephrine and the normetanephrine:creatinine molar ratio were determined at 0, 24, 48 and 72 hours. Outcome data and ventilatory indexes were recorded for each infant.
RESULTS—The fentanyl group showed significantly lower behavioural stress scores and O2 desaturations than controls and lower urinary concentrations of metanephrine and normetanephrine at 24, 48,72 hours. The two groups showed no significant difference in ventilatory variables or short term outcome.
CONCLUSIONS—A short course of low dose fentanyl infusion reduces behavioural sedation scores, O2 desaturations and neuroendocrine stress response in preterm ventilated infants.

 PMID:10194990

  20. Probiotics and the Microbiome in Celiac Disease: A Randomised Controlled Trial

    PubMed Central

    Myers, Stephen P.; Rolfe, Margaret

    2016-01-01

    Background. There is limited research investigating the composition of the gastrointestinal microbiota in individuals with celiac disease (CoeD) reporting only partial symptom improvement despite adherence to a strict gluten-free diet (GFD). The aim of this research was to determine if the gastrointestinal microbiota could be altered by probiotic bacteria and provide a potential new therapy for this subgroup. Methods. A multicentre RCT was conducted between January and August 2011 in Australia. Participants included 45 people with CoeD reporting only partial symptom improvement despite adherence to a strict GFD for a minimum of 12 months. Participants took 5 g of VSL#™ probiotic formulation (n = 23) or 5 g placebo (n = 22) orally twice daily for 12 weeks. The main outcome measured was the efficacy of the probiotic formula in altering faecal microbiota counts between baseline and week 12. Safety was determined by safety blood and monitoring adverse events. Results. SPSS™ multivariate repeated measures analysis (95th confidence level) revealed no statistically significant changes between the groups in the faecal microbiota counts or blood safety measures over the course of the study. Conclusion. The probiotic formula when taken orally over the 12-week period did not significantly alter the microbiota measured in this population. The trial was registered with Australian and New Zealand Clinical Trials Register ACTRN12610000630011. PMID:27525027

  1. Calcific tendinitis of the rotator cuff: state of the art in diagnosis and treatment.

    PubMed

    Merolla, Giovanni; Singh, Sanjay; Paladini, Paolo; Porcellini, Giuseppe

    2016-03-01

    Calcific tendinitis is a painful shoulder disorder characterised by either single or multiple deposits in the rotator cuff tendon. Although the disease subsides spontaneously in most cases, a subpopulation of patients continue to complain of pain and shoulder dysfunction and the deposits do not show any signs of resolution. Although several treatment options have been proposed, clinical results are controversial and often the indication for a given therapy remains a matter of clinician choice. Herein, we report on the current state of the art in the pathogenesis, diagnosis and treatment of calcific tendinitis of the rotator cuff.

  2. Management of irreparable rotator cuff tears and glenohumeral arthritis.

    PubMed

    Laudicina, Laurence; D'Ambrosia, Robert

    2005-04-01

    Glenohumeral arthritis with irreparable rotator cuff tears remain a difficult entity to treat. Varied causes include rotator cuff tear arthropathy, osteoarthritis, or rheumatoid arthritis with irreparable cuff tear. Common symptoms are progressive pain and dysfunction. Physical examination may reveal pain, crepitance, rotator cuff weakness, and loss of motion and function. Radiographs may reveal varying degrees of osteophyte formation, sclerotic bone, superior humeral head migration, and bony erosion. Additional imaging modalities may reveal cuff tear size, retraction, atrophy, and fatty infiltration. Failure of nonoperative management may lead to operative intervention. Rotator cuff repair or reconstruction may help prevent progression of tears and future arthritic changes. In patients with moderate to severe glenohumeral arthritis and irreparable rotator cuff tears, hemiarthroplasty is currently the procedure of choice. For patients with severe cuff dysfunction or loss of coracoacromial arch, or for patients who require revision, the reverse shoulder prosthesis may offer a treatment option. Future management continues to be defined with additional study.

  3. Results and lessons from the Spironolactone To Prevent Cardiovascular Events in Early Stage Chronic Kidney Disease (STOP-CKD) randomised controlled trial

    PubMed Central

    Ng, Khai P; Jain, Poorva; Gill, Paramjit S; Heer, Gurdip; Townend, Jonathan N; Freemantle, Nick; Greenfield, Sheila; Ferro, Charles J

    2016-01-01

    Objectives To determine whether low-dose spironolactone can safely lower arterial stiffness in patients with chronic kidney disease stage 3 in the primary care setting. Design A multicentre, prospective, randomised, placebo-controlled, double-blinded study. Setting 11 primary care centres in South Birmingham, England. Participants Adult patients with stage 3 chronic kidney disease. Main exclusion criteria were diagnosis of diabetes mellitus, chronic heart failure, atrial fibrillation, severe hypertension, systolic blood pressure <120 mm Hg or baseline serum potassium ≥5 mmol/L. Intervention Eligible participants were randomised to receive either spironolactone 25 mg once daily, or matching placebo for an intended period of 40 weeks. Outcome measures The primary end point was the change in arterial stiffness as measured by pulse wave velocity. Secondary outcome measures included the rate of hyperkalaemia, deterioration of renal function, barriers to participation and expected recruitment rates to a potential future hard end point study. Results From the 11 practices serving a population of 112 462, there were 1598 (1.4%) patients identified as being eligible and were invited to participate. Of these, 134 (8.4%) attended the screening visit of which only 16 (1.0%) were eligible for randomisation. The main reasons for exclusion were low systolic blood pressure (<120 mm Hg: 40 patients) and high estimated glomerular filtration rate (≥60 mL/min/1.73 m2: 38 patients). The trial was considered unfeasible and was terminated early. Conclusions We highlight some of the challenges in undertaking research in primary care including patient participation in trials. This study not only challenged our preconceptions, but also provided important learning for future research in this large and important group of patients. Trial registration number ISRCTN80658312. PMID:26916697

  4. Single and dual task gait training in people with Parkinson's Disease: A protocol for a randomised controlled trial

    PubMed Central

    2011-01-01

    Background Difficulty performing more than one task at a time (dual tasking) is a common and disabling problem experienced by people with Parkinson disease (PD). If asked to perform another task when walking, people with PD often take shorter steps or walk more slowly. Currently there is uncertainty about whether clinicians should teach people with PD to avoid dual tasking or whether they should encourage them to practice dual tasking with the hope that practice will lead to enhanced performance. This study will address this issue by comparing single to dual task gait training. Methods and design A prospective randomised clinical trial is being conducted. Sixty participants with idiopathic PD will be recruited, provided they score I-IV on the modified Hoehn and Yahr (1967) scale, and fulfil other inclusion criteria. Participants will be randomly allocated to either a single or dual task gait training group. Both groups will receive 12 hours of walking training over 4 weeks. The single task group will undertake gait training with cueing strategies to increase step length. The dual task group will train to improve step length when walking and performing a variety of added tasks. Both groups will receive a tailored home program for 6 months. Blinded assessors will conduct four assessments: two baseline assessments, one post intervention and one at 6 months follow-up. The primary outcome measure will be step length when dual tasking over 8 m. Secondary outcome measures include: spatiotemporal gait parameters when walking under single and dual task conditions, measures of executive function, the timed up and go test, measures of community mobility, and quality of life. All analyses will be based on intention to treat principle. Discussion This trial will examine the immediate and longer term effect of dual task walking training as compared to single task training in people with idiopathic PD, at the impairment, activity, and participation levels. It has the potential to

  5. Estimating the causal influence of body mass index on risk of Parkinson disease: A Mendelian randomisation study

    PubMed Central

    Price, T. Ryan; De Pablo-Fernandez, Eduardo; Haycock, Philip C.; Schrag, Anette; Lees, Andrew J.; Hardy, John; Singleton, Andrew; Nalls, Mike A.; Pearce, Neil; Wood, Nicholas W.

    2017-01-01

    Background Both positive and negative associations between higher body mass index (BMI) and Parkinson disease (PD) have been reported in observational studies, but it has been difficult to establish causality because of the possibility of residual confounding or reverse causation. To our knowledge, Mendelian randomisation (MR)—the use of genetic instrumental variables (IVs) to explore causal effects—has not previously been used to test the effect of BMI on PD. Methods and findings Two-sample MR was undertaken using genome-wide association (GWA) study data. The associations between the genetic instruments and BMI were obtained from the GIANT consortium and consisted of the per-allele difference in mean BMI for 77 independent variants that reached genome-wide significance. The per-allele difference in log-odds of PD for each of these variants was estimated from a recent meta-analysis, which included 13,708 cases of PD and 95,282 controls. The inverse-variance weighted method was used to estimate a pooled odds ratio (OR) for the effect of a 5-kg/m2 higher BMI on PD. Evidence of directional pleiotropy averaged across all variants was sought using MR–Egger regression. Frailty simulations were used to assess whether causal associations were affected by mortality selection. A combined genetic IV expected to confer a lifetime exposure of 5-kg/m2 higher BMI was associated with a lower risk of PD (OR 0.82, 95% CI 0.69–0.98). MR–Egger regression gave similar results, suggesting that directional pleiotropy was unlikely to be biasing the result (intercept 0.002; p = 0.654). However, the apparent protective influence of higher BMI could be at least partially induced by survival bias in the PD GWA study, as demonstrated by frailty simulations. Other important limitations of this application of MR include the inability to analyse non-linear associations, to undertake subgroup analyses, and to gain mechanistic insights. Conclusions In this large study using two-sample MR

  6. Estimating the causal influence of body mass index on risk of Parkinson disease: A Mendelian randomisation study.

    PubMed

    Noyce, Alastair J; Kia, Demis A; Hemani, Gibran; Nicolas, Aude; Price, T Ryan; De Pablo-Fernandez, Eduardo; Haycock, Philip C; Lewis, Patrick A; Foltynie, Thomas; Davey Smith, George; Schrag, Anette; Lees, Andrew J; Hardy, John; Singleton, Andrew; Nalls, Mike A; Pearce, Neil; Lawlor, Debbie A; Wood, Nicholas W

    2017-06-01

    Both positive and negative associations between higher body mass index (BMI) and Parkinson disease (PD) have been reported in observational studies, but it has been difficult to establish causality because of the possibility of residual confounding or reverse causation. To our knowledge, Mendelian randomisation (MR)-the use of genetic instrumental variables (IVs) to explore causal effects-has not previously been used to test the effect of BMI on PD. Two-sample MR was undertaken using genome-wide association (GWA) study data. The associations between the genetic instruments and BMI were obtained from the GIANT consortium and consisted of the per-allele difference in mean BMI for 77 independent variants that reached genome-wide significance. The per-allele difference in log-odds of PD for each of these variants was estimated from a recent meta-analysis, which included 13,708 cases of PD and 95,282 controls. The inverse-variance weighted method was used to estimate a pooled odds ratio (OR) for the effect of a 5-kg/m2 higher BMI on PD. Evidence of directional pleiotropy averaged across all variants was sought using MR-Egger regression. Frailty simulations were used to assess whether causal associations were affected by mortality selection. A combined genetic IV expected to confer a lifetime exposure of 5-kg/m2 higher BMI was associated with a lower risk of PD (OR 0.82, 95% CI 0.69-0.98). MR-Egger regression gave similar results, suggesting that directional pleiotropy was unlikely to be biasing the result (intercept 0.002; p = 0.654). However, the apparent protective influence of higher BMI could be at least partially induced by survival bias in the PD GWA study, as demonstrated by frailty simulations. Other important limitations of this application of MR include the inability to analyse non-linear associations, to undertake subgroup analyses, and to gain mechanistic insights. In this large study using two-sample MR, we found that variants known to influence BMI had

  7. Secondary prevention clinics for coronary heart disease: four year follow up of a randomised controlled trial in primary care.

    PubMed

    Murchie, Peter; Campbell, Neil C; Ritchie, Lewis D; Simpson, Julie A; Thain, Joan

    2003-01-11

    To evaluate the effects of nurse led clinics in primary care on secondary prevention, total mortality, and coronary event rates after four years. Follow up of a randomised controlled trial by postal questionnaires and review of case notes and national datasets. Stratified, random sample of 19 general practices in north east Scotland. 1343 patients (673 intervention and 670 control) under 80 years with a working diagnosis of coronary heart disease but without terminal illness or dementia and not housebound. Nurse led secondary prevention clinics promoted medical and lifestyle components of secondary prevention and offered regular follow up for one year. Components of secondary prevention (aspirin, blood pressure management, lipid management, healthy diet, exercise, non-smoking), total mortality, and coronary events (non-fatal myocardial infarctions and coronary deaths). Mean follow up was at 4.7 years. Significant improvements were shown in the intervention group in all components of secondary prevention except smoking at one year, and these were sustained after four years except for exercise. The control group, most of whom attended clinics after the initial year, caught up before final follow up, and differences between groups were no longer significant. At 4.7 years, 100 patients in the intervention group and 128 in the control group had died: cumulative death rates were 14.5% and 18.9%, respectively (P=0.038). 100 coronary events occurred in the intervention group and 125 in the control group: cumulative event rates were 14.2% and 18.2%, respectively (P=0.052). Adjusting for age, sex, general practice, and baseline secondary prevention, proportional hazard ratios were 0.75 for all deaths (95% confidence intervals 0.58 to 0.98; P=0.036) and 0.76 for coronary events (0.58 to 1.00; P=0.049) CONCLUSIONS: Nurse led secondary prevention improved medical and lifestyle components of secondary prevention and this seemed to lead to significantly fewer total deaths and

  8. Augmentation techniques for rotator cuff repair.

    PubMed

    Papalia, Rocco; Franceschi, Francesco; Zampogna, Biagio; D'Adamio, Stefano; Maffulli, Nicola; Denaro, Vincenzo

    2013-01-01

    There is a high rate of recurrence of tear and failed healing after rotator cuff repair. Several strategies have proposed to augment rotator cuff repairs to improve postoperative outcome and shoulder performance. We systematically review the literature on clinical outcome following rotator cuff augmentation. We performed a comprehensive search of Medline, CINAHL, Embase and the Cochrane Central Registry of Controlled Trials, from inception of the database to 20 June 2012, using various combinations of keywords. The reference lists of the previously selected articles were then examined by hand. Only studies focusing on clinical outcomes of human patients who had undergone augmented rotator cuff repair were selected. We then evaluated the methodological quality of each article using the Coleman methodology score (CMS), a 10 criteria scoring list assessing the methodological quality of the selected studies (CMS). Thirty-two articles were included in the present review. Two were retrospective studies, and 30 were prospective. Biologic, synthetic and cellular devices were used in 24, 7 and 1 studies, respectively. The mean modified Coleman methodology score was 64.0. Heterogeneity of the clinical outcome scores makes it difficult to compare different studies. None of the augmentation devices available is without problems, and each one presents intrinsic weaknesses. There is no dramatic increase in clinical and functional assessment after augmented procedures, especially if compared with control groups. More and better scientific evidence is necessary to use augmentation of rotator cuff repairs in routine clinical practice.

  9. 21 CFR 870.1120 - Blood pressure cuff.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Blood pressure cuff. 870.1120 Section 870.1120...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1120 Blood pressure cuff. (a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an...

  10. 21 CFR 868.5750 - Inflatable tracheal tube cuff.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Inflatable tracheal tube cuff. 868.5750 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5750 Inflatable tracheal tube cuff. (a) Identification. An inflatable tracheal tube cuff is a device used to provide an airtight...

  11. 21 CFR 868.5800 - Tracheostomy tube and tube cuff.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Tracheostomy tube and tube cuff. 868.5800 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5800 Tracheostomy tube and tube cuff. (a) Identification. A tracheostomy tube and tube cuff is a device intended to be placed into...

  12. 21 CFR 868.5750 - Inflatable tracheal tube cuff.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Inflatable tracheal tube cuff. 868.5750 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5750 Inflatable tracheal tube cuff. (a) Identification. An inflatable tracheal tube cuff is a device used to provide an airtight...

  13. 21 CFR 868.5800 - Tracheostomy tube and tube cuff.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Tracheostomy tube and tube cuff. 868.5800 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5800 Tracheostomy tube and tube cuff. (a) Identification. A tracheostomy tube and tube cuff is a device intended to be placed into...

  14. 21 CFR 868.5800 - Tracheostomy tube and tube cuff.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Tracheostomy tube and tube cuff. 868.5800 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5800 Tracheostomy tube and tube cuff. (a) Identification. A tracheostomy tube and tube cuff is a device intended to be placed into...

  15. 21 CFR 868.5750 - Inflatable tracheal tube cuff.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Inflatable tracheal tube cuff. 868.5750 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5750 Inflatable tracheal tube cuff. (a) Identification. An inflatable tracheal tube cuff is a device used to provide an airtight...

  16. 21 CFR 868.5750 - Inflatable tracheal tube cuff.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Inflatable tracheal tube cuff. 868.5750 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5750 Inflatable tracheal tube cuff. (a) Identification. An inflatable tracheal tube cuff is a device used to provide an airtight...

  17. 21 CFR 868.5750 - Inflatable tracheal tube cuff.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Inflatable tracheal tube cuff. 868.5750 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5750 Inflatable tracheal tube cuff. (a) Identification. An inflatable tracheal tube cuff is a device used to provide an airtight...

  18. 21 CFR 870.1120 - Blood pressure cuff.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood pressure cuff. 870.1120 Section 870.1120...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1120 Blood pressure cuff. (a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an...

  19. 21 CFR 870.1120 - Blood pressure cuff.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Blood pressure cuff. 870.1120 Section 870.1120...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1120 Blood pressure cuff. (a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an...

  20. 21 CFR 870.1120 - Blood pressure cuff.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Blood pressure cuff. 870.1120 Section 870.1120...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1120 Blood pressure cuff. (a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an...

  1. 21 CFR 870.1120 - Blood pressure cuff.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Blood pressure cuff. 870.1120 Section 870.1120...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1120 Blood pressure cuff. (a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an...

  2. No Effect of Omega-3 Fatty Acid Supplementation on Cognition and Mood in Individuals with Cognitive Impairment and Probable Alzheimer’s Disease: A Randomised Controlled Trial

    PubMed Central

    Phillips, Michelle A.; Childs, Caroline E.; Calder, Philip C.; Rogers, Peter J.

    2015-01-01

    Findings from epidemiological and observational studies have indicated that diets high in omega-3 polyunsaturated fatty acids (PUFAs) such as docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) may reduce the risk of cognitive decline and Alzheimer’s disease (AD). To determine if increasing intake of DHA and EPA through supplementation is beneficial to cognition and mood in individuals with cognitive impairment no dementia (CIND) or Alzheimer’s disease (AD) a four month, randomised, double-blind, placebo controlled study was conducted. Fifty-seven participants with CIND and nineteen with AD were randomised to receive either omega-3 PUFAs (600 mg EPA and 625 mg DHA per day) or placebo (olive oil) over a four month period. Elevating depleted levels of EPA and DHA through supplementation in individuals with CIND or AD was found to have negligible beneficial effect on their cognition or mood. These findings confirm an overall negligible benefit of omega-3 PUFA supplementation for those with cognitive impairment and dementia. More intervention studies need to be undertaken with longer study durations and larger sample sizes. It may prove fruitful to examine effects of different doses as well as effects in other dementia subtypes. PMID:26501267

  3. Role of metalloproteinases in rotator cuff tear.

    PubMed

    Garofalo, Raffaele; Cesari, Eugenio; Vinci, Enzo; Castagna, Alessandro

    2011-09-01

    The role of matrix metalloproteinases (MMPs) and their inhibitors (TIMPS) in the pathophysiology of rotator cuff tears has not been established yet. Recent advances empathize about the role of MMPs and TIMPS in extracellular matrix (ECM) remodeling and degradation in rotator cuff tears pathogenesis and healing after surgical repair. An increase in MMPs synthesis and the resulting MMPs mediated alterations in the ECM of tendons have been implicated in the etiopathogenesis of tendinopathy, and there is an increase in the expression of MMPs and a decrease in TIMP messenger ribonucleic acid expression in tenocytes from degenerative or ruptured tendons. Importantly, MMPs are amenable to inhibition by cheap, safe, and widely available drugs such as the tetracycline antibiotics and bisphosphonates. A better understanding of relationship and activity of these molecules could provide better strategies to optimize outcomes of rotator cuff therapy.

  4. The Effect of Souvenaid on Functional Brain Network Organisation in Patients with Mild Alzheimer’s Disease: A Randomised Controlled Study

    PubMed Central

    de Waal, Hanneke; Stam, Cornelis J.; Lansbergen, Marieke M.; Wieggers, Rico L.; Kamphuis, Patrick J. G. H.; Scheltens, Philip; Maestú, Fernando; van Straaten, Elisabeth C. W.

    2014-01-01

    Background Synaptic loss is a major hallmark of Alzheimer’s disease (AD). Disturbed organisation of large-scale functional brain networks in AD might reflect synaptic loss and disrupted neuronal communication. The medical food Souvenaid, containing the specific nutrient combination Fortasyn Connect, is designed to enhance synapse formation and function and has been shown to improve memory performance in patients with mild AD in two randomised controlled trials. Objective To explore the effect of Souvenaid compared to control product on brain activity-based networks, as a derivative of underlying synaptic function, in patients with mild AD. Design A 24-week randomised, controlled, double-blind, parallel-group, multi-country study. Participants 179 drug-naïve mild AD patients who participated in the Souvenir II study. Intervention Patients were randomised 1∶1 to receive Souvenaid or an iso-caloric control product once daily for 24 weeks. Outcome In a secondary analysis of the Souvenir II study, electroencephalography (EEG) brain networks were constructed and graph theory was used to quantify complex brain structure. Local brain network connectivity (normalised clustering coefficient gamma) and global network integration (normalised characteristic path length lambda) were compared between study groups, and related to memory performance. Results The network measures in the beta band were significantly different between groups: they decreased in the control group, but remained relatively unchanged in the active group. No consistent relationship was found between these network measures and memory performance. Conclusions The current results suggest that Souvenaid preserves the organisation of brain networks in patients with mild AD within 24 weeks, hypothetically counteracting the progressive network disruption over time in AD. The results strengthen the hypothesis that Souvenaid affects synaptic integrity and function. Secondly, we conclude that advanced EEG

  5. Is Risk of Artificial Urethral Sphincter Cuff Erosion Higher in Patients with Penile Prosthesis?

    PubMed

    Sundaram, Varun; Cordon, Billy H; Hofer, Matthias D; Morey, Allen F

    2016-09-01

    Frequently encountered morbidities after prostatectomy include stress urinary incontinence and erectile dysfunction. Patients with severe disease may undergo placement of both a penile prosthesis (PP) and an artificial urethral sphincter (AUS). We hypothesized that concomitant PP may promote AUS cuff erosion by impaired corporal blood flow and/or direct pressure on the cuff. The aim of this study was to compare the rate of AUS cuff erosion in patients with and without a PP. We reviewed 366 AUS operations at our tertiary center between 2007 and 2015 with a mean follow-up of 41 months (range 6-104). Included in the analysis were first-time AUS cuff erosions. Patients with recurrent erosions, AUS revisions, and iatrogenic erosions were excluded. In a separate analysis, we analyzed AUS explantations for all causes. Cohorts were compared by demographic information, preoperative characteristics, and rates of erosion and explantation. Erosion confirmed by cystourethroscopy and explantation of the AUS for all causes. Among 366 AUS surgeries at a mean follow-up of 41 months, there were 248 (67.8%) AUS alone cases compared to 118 (32.2%) AUS and PP cases (AUS/PP). Sixty-two patients met exclusion criteria for first-time cuff erosion. Among 304 evaluable AUS patients, we found a significantly higher rate of erosion in the AUS/PP group (11/95, 11.6%) compared to the AUS alone group (9/209, 4.3%, P = .037). When examining explantations for all causes in the entire cohort (n = 366), we observed a significantly higher rate of device removal, (20/118, 17%) in the AUS/PP group compared to the AUS group (23/248, 9.2%, P = .044). AUS/PP patients appear to have a higher risk of AUS cuff erosion and explantation compared to men with AUS alone. Copyright © 2016 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

  6. Symptomatic rotator cuff tears show higher radioisotope uptake on bone scintigraphy compared with asymptomatic tears.

    PubMed

    Koike, Yoichi; Sano, Hirotaka; Kita, Atushi; Itoi, Eiji

    2013-09-01

    Some patients with rotator cuff tears complain of pain, whereas others are asymptomatic. Previous studies have pointed out the presence of active bone metabolism in the painful shoulder, identified with increased radioisotope uptake during bone scintigraphy. Shoulders with symptomatic rotator cuff tears will demonstrate higher radioisotope uptake than shoulders with asymptomatic tears with bone scintigraphy, reflecting active bone metabolism in symptomatic tears. Cross-sectional study; Level of evidence, 3. The study consisted of 3 groups: patients with symptomatic tears (symptomatic group), patients with asymptomatic tears (asymptomatic group), and controls (no tear group). The symptomatic group consisted of 28 shoulders from 28 patients with symptomatic rotator cuff tears (pain score ≤4 on the University of California, Los Angeles [UCLA] shoulder evaluation form) who underwent bone scintigraphy followed by rotator cuff repair. Of 70 volunteers who had previously undergone bone scintigraphy for diseases unrelated to their shoulder, 34 were selected for the asymptomatic group (pain score ≥8 on the UCLA shoulder form), and 32 were selected for the no tear group. The mean radioisotope uptake in the symptomatic group was significantly higher than that in the asymptomatic group (P = .02) and the no tear group (P = .02). Ten of 28 shoulders (36%) in the symptomatic group showed increased radioisotope uptake exceeding 2 standard deviations from the mean of the no tear group. This percentage was significantly higher when compared with the asymptomatic group (0%) (P < .01). Shoulders with a symptomatic rotator cuff tear showed higher radioisotope uptake on bone scintigraphy than those with an asymptomatic tear. The radioisotope uptake in shoulders with an asymptomatic tear was comparable with that in shoulders without a tear. Positive radioisotope uptake may be associated with pain in a subgroup of patients with rotator cuff tears.

  7. The use of carer assisted adherence therapy for people with Parkinson's disease and their carers (CAAT-PARK): study protocol for a randomised controlled trial

    PubMed Central

    2011-01-01

    Background Pharmacological intervention is essential for managing the symptoms of Parkinson's disease. Adherence to medication regimens however is a major problem. Poor adherence leads to significant motor deterioration and inadequate symptom control. This results in poor quality of life. Whilst interventions to improve medication adherence have shown considerable benefit in other chronic conditions, the efficacy of such treatments in Parkinson's disease is less well researched. Many people with Parkinson's disease require substantial support from spouse/caregivers. This often extends to medication taking. Consequently, spouse/caregiver's support for timely medication management is paramount. We aim to investigate the benefit of a novel intervention, Carer Assisted Adherence Therapy, for improving medication adherence and quality of life in people with Parkinson's disease. Adherence therapy may help to optimise the efficacy of anti-parkinsonian agents, subsequently improving clinical outcomes. Methods/Design A parallel, randomised controlled trial will be conducted to investigate whether carer assisted adherence therapy is effective for improving medication adherence and quality of life. We aim to recruit 40 patient/carer pairs into each group. Participants will be randomly assigned by the Clinical Research Trials Unit at the University of East Anglia. Adherence therapy is a brief cognitive-behavioural approach aimed at facilitating a process of shared decision making. The central theory is that when patients make shared choices with a professional they are more likely to continue with those choices because they are personally owned and meaningful. Outcomes will be rates of adherence and quality of life, determined by the Morisky Medication Adherence Scale-4 and the Parkinson's disease Questionnaire-39 respectively. Assessments will take place post randomisation, immediately post intervention and 12-weeks post randomisation. Primary outcomes are adherence and

  8. Full thickness tears: retaining the cuff.

    PubMed

    Osti, Leonardo; Rizzello, Giacomo; Panascì, Manlio; Denaro, Vincenzo; Maffulli, Nicola

    2011-12-01

    Repair of rotator cuff tears is technically challenging. Full thickness rotator cuff tears have no potential for spontaneous healing, no reliable tendons substitutes are available, and their management is only partially understood. Many factors seem to contribute to the final outcome, and considerable variations in the decision-making process exist. For these reasons, decisions are often taken on the basis of surgeon's clinical experience. Accurate and prompt diagnosis is fundamental to guide correct management, and the tear pattern should be carefully evaluated to planning the most appropriate repair.

  9. Challenges and Controversies in Treating Massive Rotator Cuff Tears.

    PubMed

    Burkhart, Stephen S; Ricchetti, Eric T; Levine, William N; Galatz, Leesa M

    2016-01-01

    Massive rotator cuff tears present several challenges for orthopaedic surgeons. Many rotator cuff tears can be repaired; however, some chronic rotator cuff tears require advanced reconstructive techniques. Repair, if possible, is the optimal treatment for rotator cuff tears. In general, muscle transfers are an option for patients younger than 60 years who do not have pseudoparalysis. Arthroplasty is an option for older patients who have concomitant arthritis and for patients who have pseudoparalysis. Biologic augmentation in the setting of rotator cuff tears continues to evolve, and the application of biologic products should be guided by sound evidence and cost-benefit considerations.

  10. Clinical and biological aspects of rotator cuff tears

    PubMed Central

    Giai Via, Alessio; De Cupis, Mauro; Spoliti, Marco; Oliva, Francesco

    2013-01-01

    Summary Rotator cuff tears are common and are a frequent source of shoulder pain and disability. A wide variation in the prevalence of rotator cuff tears has been reported. The etiology of rotator cuff tear remains multifactorial and attempts to unify intrinsic and extrinsic theories tried to explain the etiopathogenesis of rotator cuff tears. Knowledge of the etiopathogenesis of rotator cuff tears is important to improve our therapies, surgical techniques and promote tendon repair. Several strategies have been proposed to enhance tendon healing and recently research has focused on regenerative therapies, such as Growth Factors (GFs) and Plasma Rich Platelet (PRP), with high expectations of success. PMID:23888289

  11. Shear Wave Ultrasound Elastographic Evaluation of the Rotator Cuff Tendon.

    PubMed

    Hou, Stephanie W; Merkle, Alexander N; Babb, James S; McCabe, Robert; Gyftopoulos, Soterios; Adler, Ronald S

    2017-01-01

    (1) Assess the association between the B-mode morphologic appearance and elasticity in the rotator cuff tendon using shear wave elastography (SWE). (2) Assess the association between SWE and symptoms. Institutional Review Board approval and informed consent were obtained. A retrospective review identified 21 studies in 19 eligible patients for whom SWE was performed during routine sonographic evaluations for shoulder pain. Evaluations were compared with 55 studies from 16 asymptomatic volunteers and 6 patients with asymptomatic contralateral shoulders. Repeated studies were accounted for by resampling. Proximal and distal tendon morphologic characteristics were graded from 1 to 4 (normal to full-thickness tear), and average shear wave velocity (SWV) measurements were obtained at both locations. In 68 examinations, deltoid muscle SWV measurements were available for post hoc analysis. The morphologic grade and SWV showed weak-to-moderate negative correlations in the proximal (P < .001) and distal (P = .002) rotator cuff tendon. A weakly significant SWV decrease was found in the proximal tendon in symptomatic patients (P = .049); no significant difference was seen in the distal tendon. The deltoid muscle SWV showed weak-to-moderate negative correlations with the morphologic grade in the proximal (P = .004) and distal (P = .007) tendon; the deltoid SWV was also significantly lower in symptomatic shoulders (P = .001). Shear wave elastography shows tendon softening in rotator cuff disease. It captures information not obtained by a morphologic evaluation alone; however, a poor correlation with symptoms suggests that SWE will be less useful in workups for shoulder pain than for preoperative assessments of tendon quality. Deltoid muscle softening seen in morphologically abnormal and symptomatic patients requires further exploration. © 2016 by the American Institute of Ultrasound in Medicine.

  12. Impact of cuff positioning on blood pressure measurement accuracy: may a specially designed cuff make a difference?

    PubMed Central

    Bilo, Grzegorz; Sala, Oscar; Perego, Carlotta; Faini, Andrea; Gao, Lan; Głuszewska, Anna; Ochoa, Juan Eugenio; Pellegrini, Dario; Lonati, Laura Maria; Parati, Gianfranco

    2017-01-01

    During blood pressure (BP) measurement, the recommended positioning of the cuff bladder center is directly above the brachial artery. We investigated the relevance of incorrect cuff positioning during (1) auscultatory measurement with an appropriate or improperly small cuff and (2) oscillometric measurement with a wide-range cuff designed to guarantee accurate measurements regardless of position. In subjects with wide BP and arm circumference ranges, (1) auscultatory BP was repeatedly measured with a properly positioned cuff (reference) and, simultaneously, with an identical cuff placed on the other arm in either a correct or an incorrect position (test). The measurements were performed with a properly sized (N=57) or an improperly small cuff (N=33). (2) Auscultatory measurements obtained with a properly positioned and sized cuff were compared with oscillometric measurements obtained with a specially designed wide-range cuff (Omron IntelliWrap) placed on the contralateral arm either in a correct or an incorrect position. Auscultatory BP measures were unaffected by incorrect positioning of a properly sized cuff, whereas with undercuffing, BP was overestimated with the cuff displaced by 90° laterally (systolic/diastolic BP differences: 4.9±4.6/4.0±4.6 mm Hg, P<0.01) or by 180° (3.9±5.4/4.2±5.1 mm Hg, P<0.01) in relation to the correct position. Incorrect placement of the oscillometric cuff had no significant effect on the accuracy of the measurements (difference with correct position <1.5 mm Hg). Incorrect cuff positioning introduces a systematic overestimation of auscultatory BP when the cuff is too small in relation to arm circumference but not when it is correctly sized. No systematic error was observed with oscillometric measurements obtained with a specially designed wide-range cuff. PMID:28077860

  13. Effect of Nintendo Wii™-based motor and cognitive training on activities of daily living in patients with Parkinson's disease: a randomised clinical trial.

    PubMed

    Pompeu, José Eduardo; Mendes, Felipe Augusto Dos Santos; Silva, Keyte Guedes da; Lobo, Alexandra Modenesi; Oliveira, Tatiana de Paula; Zomignani, Andrea Peterson; Piemonte, Maria Elisa Pimentel

    2012-09-01

    To investigate the effect of Nintendo Wii™-based motor cognitive training versus balance exercise therapy on activities of daily living in patients with Parkinson's disease. Parallel, prospective, single-blind, randomised clinical trial. Brazilian Parkinson Association. Thirty-two patients with Parkinson's disease (Hoehn and Yahr stages 1 and 2). Fourteen training sessions consisting of 30 minutes of stretching, strengthening and axial mobility exercises, plus 30 minutes of balance training. The control group performed balance exercises without feedback or cognitive stimulation, and the experimental group performed 10 Wii Fit™ games. Section II of the Unified Parkinson's Disease Rating Scale (UPDRS-II). Participants were randomised into a control group (n=16) and an experimental group (n=16) through blinded drawing of names. Repeated-measures analysis of variance (RM-ANOVA). Both groups showed improvement in the UPDRS-II with assessment effect (RM-ANOVA P<0.001, observed power=0.999). There was no difference between the control group and the experimental group before training {8.9 [standard deviation (SD) 2.9] vs 10.1 (SD 3.8)}, after training [7.6 (SD 2.9) vs 8.1 (SD 3.5)] or 60 days after training [8.1 (SD 3.2) vs 8.3 (SD 3.6)]. The mean difference of the whole group between before training and after training was -0.9 (SD 2.3, 95% confidence interval -1.7 to -0.6). Patients with Parkinson's disease showed improved performance in activities of daily living after 14 sessions of balance training, with no additional advantages associated with the Wii-based motor and cognitive training. Registered on http://www.clinicaltrials.gov (identifier: NCT01580787). Copyright © 2012 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  14. The ReSPonD trial--rivastigmine to stabilise gait in Parkinson's disease a phase II, randomised, double blind, placebo controlled trial to evaluate the effect of rivastigmine on gait in patients with Parkinson's disease who have fallen.

    PubMed

    Henderson, Emily J; Lord, Stephen R; Close, Jacqueline C T; Lawrence, Andrew D; Whone, Alan; Ben-Shlomo, Yoav

    2013-12-03

    Gait impairment is common in people with Parkinson's disease. There is a lack of effective interventions to target this debilitating complication and therefore a need to identify new therapeutic options. An underlying cholinergic deficit contributes to both the gait and cognitive dysfunction seen in Parkinson's disease. The combined impact of both impairments can be assessed in gait tasks performed with concomitant cognitive tasks. The aim of this trial is to evaluate the impact of a cholinesterase inhibitor on cognitive function and gait performance in people with established Parkinson's disease. This is a single centre, double-blind, randomised placebo-controlled trial in 130 people with Hoehn and Yahr stage 2-3 idiopathic Parkinson's disease who have fallen in the past year. Participants will be randomised to two groups, receiving either rivastigmine capsules or identical placebo capsules for 8 months. Assessment will be undertaken at baseline and at the end of medication prescription (i.e. 8 months) with participants remaining enrolled in the trial for a further 4 months to monitor for falls and adverse events. The primary outcome is step time variability, assessed with and without the addition of concurrent cognitive tasks. Secondary outcomes will include other gait parameters, sensorimotor and balance performances, cognitive indices, falls and fall related injury, fear of falling, Parkinson's symptoms and data pertaining to possible harms. This randomised controlled trial will examine the effect of cholinesterase inhibitor therapy on gait, balance and falls in Parkinson's disease. If effective, it would offer a new therapeutic option to ameliorating gait and cognitive deficits in a population at high risk of falls. ISRCTN19880883, UTN U1111-1124-0244.

  15. HealthMap: a cluster randomised trial of interactive health plans and self-management support to prevent coronary heart disease in people with HIV.

    PubMed

    Dodson, Sarity; Klassen, Karen M; McDonald, Karalyn; Millard, Tanya; Osborne, Richard H; Battersby, Malcolm W; Fairley, Christopher K; Simpson, Julie A; Lorgelly, Paula; Tonkin, Andrew; Roney, Janine; Slavin, Sean; Sterjovski, Jasminka; Brereton, Margot; Lewin, Sharon R; Crooks, Levinia; Watson, Jo; Kidd, Michael R; Williams, Irith; Elliott, Julian H

    2016-03-05

    The leading causes of morbidity and mortality for people in high-income countries living with HIV are now non-AIDS malignancies, cardiovascular disease and other non-communicable diseases associated with ageing. This protocol describes the trial of HealthMap, a model of care for people with HIV (PWHIV) that includes use of an interactive shared health record and self-management support. The aims of the HealthMap trial are to evaluate engagement of PWHIV and healthcare providers with the model, and its effectiveness for reducing coronary heart disease risk, enhancing self-management, and improving mental health and quality of life of PWHIV. The study is a two-arm cluster randomised trial involving HIV clinical sites in several states in Australia. Doctors will be randomised to the HealthMap model (immediate arm) or to proceed with usual care (deferred arm). People with HIV whose doctors are randomised to the immediate arm receive 1) new opportunities to discuss their health status and goals with their HIV doctor using a HealthMap shared health record; 2) access to their own health record from home; 3) access to health coaching delivered by telephone and online; and 4) access to a peer moderated online group chat programme. Data will be collected from participating PWHIV (n = 710) at baseline, 6 months, and 12 months and from participating doctors (n = 60) at baseline and 12 months. The control arm will be offered the HealthMap intervention at the end of the trial. The primary study outcomes, measured at 12 months, are 1) 10-year risk of non-fatal acute myocardial infarction or coronary heart disease death as estimated by a Framingham Heart Study risk equation; and 2) Positive and Active Engagement in Life Scale from the Health Education Impact Questionnaire (heiQ). The study will determine the viability and utility of a novel technology-supported model of care for maintaining the health and wellbeing of people with HIV. If shown to be effective, the HealthMap model

  16. Effect of increased water intake on plasma copeptin in patients with chronic kidney disease: results from a pilot randomised controlled trial

    PubMed Central

    Sontrop, Jessica M; Huang, Shi-Han; Garg, Amit X; Moist, Louise; House, Andrew A; Gallo, Kerri; Clark, William F

    2015-01-01

    Objectives Increased water intake may have a beneficial effect on the kidney through suppression of plasma vasopressin. We examined the effect of increased water intake on plasma copeptin (a marker of vasopressin) over 6 weeks in patients with chronic kidney disease. Design Secondary analysis of a randomised controlled parallel-group pilot trial. Setting Canada, 2012–2013. Participants 28 patients with stage 3 chronic kidney disease randomised (2:1) to a hydration (n=17) or control group (n=11). Intervention The hydration group was coached to increase water intake by up to 1.5 L/day for 6 weeks. The control group was asked to maintain regular water intake. Measures and outcomes Participants provided blood and 24 h urine samples at baseline and 6 weeks. Change in plasma copeptin was compared within and between study groups. Results Participants were 64% male with a mean age of 62 years and an estimated glomerular filtration rate of 40 mL/min/1.73 m2. Between baseline and 6 weeks, 24 h urine volume increased by 0.7 L/day in the hydration group, rising from 2.3 to 3.0 L/day (p=0.01), while decreasing by 0.3 L/day among controls, from 2.0 to 1.7 L/day (p=0.07); between-group difference: 0.9 L/day (95% CI 0.37 to 1.46; p=0.002). In the hydration group, median copeptin decreased by 3.6 pmol/L, from 15.0 to 10.8 pmol/L (p=0.005), while remaining stable among controls at 19 pmol/L (p=0.76; p=0.19 for the between-group difference in median change); the between-group difference in mean change was 5.4 pmol/L (95% CI −1.2 to 12.0; p=0.11). Conclusions Adults with stage 3 chronic kidney disease can be successfully randomised to drink approximately 1 L more per day than controls. This increased water intake caused a significant decrease in plasma copeptin concentration. Our larger 12-month trial will examine whether increased water intake can slow renal decline in patients with chronic kidney disease. Trial registration number NCT

  17. Effect of increased water intake on plasma copeptin in patients with chronic kidney disease: results from a pilot randomised controlled trial.

    PubMed

    Sontrop, Jessica M; Huang, Shi-Han; Garg, Amit X; Moist, Louise; House, Andrew A; Gallo, Kerri; Clark, William F

    2015-11-24

    Increased water intake may have a beneficial effect on the kidney through suppression of plasma vasopressin. We examined the effect of increased water intake on plasma copeptin (a marker of vasopressin) over 6 weeks in patients with chronic kidney disease. Secondary analysis of a randomised controlled parallel-group pilot trial. Canada, 2012-2013. 28 patients with stage 3 chronic kidney disease randomised (2:1) to a hydration (n=17) or control group (n=11). The hydration group was coached to increase water intake by up to 1.5 L/day for 6 weeks. The control group was asked to maintain regular water intake. Participants provided blood and 24 h urine samples at baseline and 6 weeks. Change in plasma copeptin was compared within and between study groups. Participants were 64% male with a mean age of 62 years and an estimated glomerular filtration rate of 40 mL/min/1.73 m(2). Between baseline and 6 weeks, 24 h urine volume increased by 0.7 L/day in the hydration group, rising from 2.3 to 3.0 L/day (p=0.01), while decreasing by 0.3 L/day among controls, from 2.0 to 1.7 L/day (p=0.07); between-group difference: 0.9 L/day (95% CI 0.37 to 1.46; p=0.002). In the hydration group, median copeptin decreased by 3.6 pmol/L, from 15.0 to 10.8 pmol/L (p=0.005), while remaining stable among controls at 19 pmol/L (p=0.76; p=0.19 for the between-group difference in median change); the between-group difference in mean change was 5.4 pmol/L (95% CI -1.2 to 12.0; p=0.11). Adults with stage 3 chronic kidney disease can be successfully randomised to drink approximately 1 L more per day than controls. This increased water intake caused a significant decrease in plasma copeptin concentration. Our larger 12-month trial will examine whether increased water intake can slow renal decline in patients with chronic kidney disease. NCT01753466. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence

  18. Effect of Vitamin K on Vascular Health and Physical Function in Older People with Vascular Disease--A Randomised Controlled Trial.

    PubMed

    Fulton, R L; McMurdo, M E T; Hill, A; Abboud, R J; Arnold, G P; Struthers, A D; Khan, F; Vermeer, C; Knapen, M H J; Drummen, N E A; Witham, M D

    2016-03-01

    Vitamin K insufficiency is common and linked to an increased risk of cardiovascular disease and osteoporotic fractures. The aim of this study was to examine whether daily supplementation with oral vitamin K could improve vascular health and physical function in older people with established vascular disease. A double blind, randomised, placebo-controlled trial. Participants aged ≤ 70 years with a history of vascular disease were randomised to receive 6 months of daily oral 100mcg vitamin K2 (MK7 subtype) or matching placebo with outcomes measured at 0, 3 and 6 months. The primary outcome was between-group difference in endothelial function assessed using flow-mediated dilatation of the brachial artery at 6 months. Secondary outcomes included carotid-radial pulse wave velocity, augmentation index, blood pressure, carotid intima-media thickness, C-reactive protein, B-type natriuretic peptide, cholesterol and desphospho-uncarboxylated matrix Gla protein levels. Handgrip strength and the Short Physical Performance Battery assessed physical function, while postural sway was measured using a 3-dimensional force platform. 80 participants were randomised, mean age 77 (SD 5) years; 44/80 were male. Vitamin K levels rose in the intervention arm compared to placebo (+48 pg/ml vs -6 pg/ml, p=0.03) at 6 months. Desphospho-uncarboxylated Matrix Gla protein levels fell in the intervention group compared to placebo at 6 months (-130 [SD 117] pmol/L vs +13 [SD 180] pmol/L, p<0.001). No change was seen in endothelial function (between group difference -0.3% [95%CI -1.3 to 0.8], p=0.62). A modest, non-significant improvement in pulse wave velocity was seen in the vitamin K group (-0.8m/s [95%CI -1.8 to 0.3], p=0.15) while all other vascular and physical function outcomes unchanged. Six months of vitamin K2 supplementation did not improve markers of vascular health or physical function in older patients with vascular disease.

  19. Tumour necrosis factor inhibitors versus combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis: TACIT non-inferiority randomised controlled trial.

    PubMed

    Scott, David L; Ibrahim, Fowzia; Farewell, Vern; O'Keeffe, Aidan G; Walker, David; Kelly, Clive; Birrell, Fraser; Chakravarty, Kuntal; Maddison, Peter; Heslin, Margaret; Patel, Anita; Kingsley, Gabrielle H

    2015-03-13

    To determine whether intensive combinations of synthetic disease modifying drugs can achieve similar clinical benefits at lower costs to high cost biologics such as tumour necrosis factor inhibitors in patients with active rheumatoid arthritis resistant to initial methotrexate and other synthetic disease modifying drugs. Open label pragmatic randomised multicentre two arm non-inferiority trial over 12 months. 24 rheumatology clinics in England. Patients with rheumatoid arthritis who were eligible for treatment with tumour necrosis factor inhibitors according to current English guidance were randomised to either the tumour necrosis factor inhibitor strategy or the combined disease modifying drug strategy. Biologic strategy: start tumour necrosis factor inhibitor; second biologic in six month for non-responders. Alternative strategy: start combination of disease modifying drugs; start tumour necrosis factor inhibitors after six months in non-responders. reduction in disability at 12 months measured with patient recorded heath assessment questionnaire (range 0.00-3.00) with a 0.22 non-inferiority margin for combination treatment versus the biologic strategy. quality of life, joint damage, disease activity, adverse events, and costs. Intention to treat analysis used multiple imputation methods for missing data. 432 patients were screened: 107 were randomised to tumour necrosis factor inhibitors and 101 started taking; 107 were randomised to the combined drug strategy and 104 started taking the drugs. Initial assessments were similar; 16 patients were lost to follow-up (seven with the tumour necrosis factor inhibitor strategy, nine with the combined drug strategy); 42 discontinued the intervention but were followed-up (19 and 23, respectively). The primary outcome showed mean falls in scores on the health assessment questionnaire of -0.30 with the tumour necrosis factor inhibitor strategy and -0.45 with the alternative combined drug strategy. The difference between

  20. Tumour necrosis factor inhibitors versus combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis: TACIT non-inferiority randomised controlled trial

    PubMed Central

    Ibrahim, Fowzia; Farewell, Vern; O’Keeffe, Aidan G; Walker, David; Kelly, Clive; Birrell, Fraser; Chakravarty, Kuntal; Maddison, Peter; Heslin, Margaret; Patel, Anita; Kingsley, Gabrielle H

    2015-01-01

    Objective To determine whether intensive combinations of synthetic disease modifying drugs can achieve similar clinical benefits at lower costs to high cost biologics such as tumour necrosis factor inhibitors in patients with active rheumatoid arthritis resistant to initial methotrexate and other synthetic disease modifying drugs. Design Open label pragmatic randomised multicentre two arm non-inferiority trial over 12 months. Setting 24 rheumatology clinics in England. Participants Patients with rheumatoid arthritis who were eligible for treatment with tumour necrosis factor inhibitors according to current English guidance were randomised to either the tumour necrosis factor inhibitor strategy or the combined disease modifying drug strategy. Interventions Biologic strategy: start tumour necrosis factor inhibitor; second biologic in six month for non-responders. Alternative strategy: start combination of disease modifying drugs; start tumour necrosis factor inhibitors after six months in non-responders. Main outcome measure Primary outcome: reduction in disability at 12 months measured with patient recorded heath assessment questionnaire (range 0.00-3.00) with a 0.22 non-inferiority margin for combination treatment versus the biologic strategy. Secondary outcomes: quality of life, joint damage, disease activity, adverse events, and costs. Intention to treat analysis used multiple imputation methods for missing data. Results 432 patients were screened: 107 were randomised to tumour necrosis factor inhibitors and 101 started taking; 107 were randomised to the combined drug strategy and 104 started taking the drugs. Initial assessments were similar; 16 patients were lost to follow-up (seven with the tumour necrosis factor inhibitor strategy, nine with the combined drug strategy); 42 discontinued the intervention but were followed-up (19 and 23, respectively). The primary outcome showed mean falls in scores on the health assessment questionnaire of −0.30 with the

  1. Progression of Fatty Muscle Degeneration in Atraumatic Rotator Cuff Tears.

    PubMed

    Hebert-Davies, Jonah; Teefey, Sharlene A; Steger-May, Karen; Chamberlain, Aaron M; Middleton, William; Robinson, Kathryn; Yamaguchi, Ken; Keener, Jay D

    2017-05-17

    The purpose of this prospective study was to examine the progression of fatty muscle degeneration over time in asymptomatic shoulders with degenerative rotator cuff tears. Subjects with an asymptomatic rotator cuff tear in 1 shoulder and pain due to rotator cuff disease in the contralateral shoulder were enrolled in a prospective cohort. Subjects were followed annually with shoulder ultrasonography, which evaluated tear size, location, and fatty muscle degeneration. Tears that were either full-thickness at enrollment or progressed to a full-thickness defect during follow-up were examined. A minimum follow-up of 2 years was necessary for eligibility. One hundred and fifty-six shoulders with full-thickness rotator cuff tears were potentially eligible. Seventy shoulders had measurable fatty muscle degeneration of at least 1 rotator cuff muscle at some time point. Patients with fatty muscle degeneration in the shoulder were older than those without degeneration (mean, 65.8 years [95% confidence interval (CI), 64.0 to 67.6 years] compared with 61.0 years [95% CI, 59.1 to 62.9 years]; p < 0.05), and the median size of the tears at baseline was larger in shoulders with degeneration than in shoulders that did not develop degeneration (13 and 10 mm wide, respectively, and 13 and 10 mm long; p < 0.05). Tears with fatty muscle degeneration were more likely to have enlarged during follow-up than were tears that never developed muscle degeneration (79% compared with 58%; odds ratio, 2.64 [95% CI, 1.29 to 5.39]; p < 0.05). Progression of fatty muscle degeneration occurred more frequently in shoulders with tears that had enlarged (43%; 45 of 105) than in shoulders with tears that had not enlarged (20%; 10 of 51; p < 0.05). Additionally, tears with enlargement and progression of muscle degeneration were more likely to extend into the anterior supraspinatus than were those without progression (53% and 17%, respectively; p < 0.05); however, this relationship was lost when

  2. Thickness of the Rotator Cuff Tendons at the Articular Margin: An Anatomic Cadaveric Study

    PubMed Central

    Sessions, William C.; Lawrence, Rebekah L.; Steubs, J. Tyler; Braman, Jonathan P.

    2017-01-01

    Abstract Background With a substantial portion of the population experiencing rotator cuff pathology, the importance of understanding mechanisms of rotator cuff disease remains critical. Current research aimed at understanding relationships between shoulder movement and cuff injuries has been hindered by our limited knowledge of the thickness of soft tissue structures within the shoulder. Therefore, the purpose of this study is to measure the thicknesses of all four rotator cuff tendons at the articular margin. Methods An anatomic study of 21 cadaveric shoulders was conducted. The thicknesses of the four rotator cuff tendon insertions were measured by caliper at the articular margin. Results The mean thickness of the supraspinatus at the articular margin was 4.9 mm ± 2.1 (median: 4.2 mm, range: 2.9-12.7 mm). The mean thickness of the infraspinatus tendon was 4.9 mm ± 1.3 (median: 4.8 mm, range: 3.0-7.2 mm). The mean thickness of the teres minor tendon was 3.20 mm ± 1.14 (median: 2.9 mm, range: 1.7-5.7 mm). Finally, the mean thickness of the subscapularis tendon at the articular margin was 5.5 mm ± 1.3 (median: 5.5 mm, range: 3.5-9.3 mm) Conclusions This current study provides needed objective data about the thickness of the rotator cuff tendons at the articular margin. Data regarding the infraspinatus, teres minor and teres major, which have been largely understudied, are particularly important. In addition, the current study demonstrates that rotator cuff thicknesses can vary substantially between individuals. There are likely natural age related changes as well as changes from etiologies that are not yet elucidated. Clinical Relevance: Data from this study will allow for improved modelling accuracy of soft tissue structures specific to the shoulder. Eventually knowledge gained through study of shoulder mechanics can be used to pursue prevention of rotator cuff tears and improve targeted treatment planning. PMID:28852340

  3. Distribution and expression of type VI collagen and elastic fibers in human rotator cuff tendon tears.

    PubMed

    Thakkar, Dipti; Grant, Tyler M; Hakimi, Osnat; Carr, Andrew J

    2014-01-01

    There is increasing evidence for a progressive extracellular matrix change in rotator cuff disease progression. Directly surrounding the cell is the pericellular matrix, where assembly of matrix aggregates typically occurs making it critical in the response of tendon cells to pathological conditions. Studies in animal models have identified type VI collagen, fibrillin-1 and elastin to be located in the pericellular matrix of tendon and contribute in maintaining the structural and biomechanical integrity of tendon. However, there have been no reports on the localization of these proteins in human tendon biopsies. This study aimed to characterize the distribution of these ECM components in human rotator cuffs and gain greater insight into the relationship of pathology to tear size by analyzing the distribution and expression profiles of these ECM components. Confocal microscopy confirmed the localization of these structural molecules in the pericellular matrix of the human rotator cuff. Tendon degeneration led to an increased visibility of these components with a significant disorganization in the distribution of type VI collagen. At the genetic level, an increase in tear size was linked to an increased transcription of type VI collagen and fibrillin-1 with no significant alteration in the elastin levels. This is the first study to confirm the localization of type VI collagen, elastin and fibrillin-1 in the pericellular region of human supraspinatus tendon and assesses the effect of tendon degeneration on these structures, thus providing a useful insight into the composition of human rotator cuff tears which can be instrumental in predicting disease prognosis.

  4. [Cold or hot sitz baths in the emergency treatment of acute anal pain due to anorectal disease? Results of a randomised clinical trial].

    PubMed

    Maestre, Yolanda; Parés, David; Salvans, Silvia; Ibáñez-Zafón, Inés; Nve, Esther; Pons, Maria-José; Martínez-Casas, Isidro; Pascual, Marta; Pera, Miguel; Grande, Luis

    2010-08-01

    The popular belief advocates the use of sitz (sitting) baths with cold water for the treatment of acute anal pain, but clinical practice guides recommend the use of hot water for its known effect on the at-rest anal pressure. The objective of the study was to examine the analgesic effect on the quality of life, manometer data and clinical progress, of the two temperatures in sitz baths in patients with anal pain. A randomised clinical trial on patients with acute anal pain due to haemorrhoids or anal fissures, divided into Group 1: Sitz baths with water at a temperature of less than 15 degrees C, and Group 2: Baths with a water temperature above 30 degrees C. The analgesia was the same in both groups. An analysis was made of the pain at 7 days (visual analogue scale), quality of life (SF-36), anal at-rest pressure and disease progress. Of the 27 eligible patients, 24 were randomised (Group 1: n=12 y Group 2: n=12). There were no statistical differences in pain, but it remained stable in Group 1, but gradually decreased in the patients of Group 2, the difference being in the pain scores on the first day compared to the seventh in Group 2 (p=0.244). The rest of the variables were similar. There were no statistically significant differences in pain control from day 1 to day 7 in the Group with sitz baths with hot water. (ISRCTN Number: 50105150).

  5. The minimal leak test technique for endotracheal cuff maintenance.

    PubMed

    Harvie, D A; Darvall, J N; Dodd, M; De La Cruz, A; Tacey, M; D'Costa, R L; Ward, D

    2016-09-01

    Endotracheal tube (ETT) cuff pressure management is an essential part of airway management in intubated and mechanically ventilated patients. Both under- and over-inflation of the ETT cuff can lead to patient complications, with an ideal pressure range of 20-30 cmH2O defined. A range of techniques are employed to ensure adequate ETT cuff inflation, with little comparative data. We performed an observational cross-sectional study in a tertiary metropolitan ICU, assessing the relationship between the minimal leak test and cuff manometry. Forty-five mechanically ventilated patients, over a three-month period, had ETT cuff manometry performed at the same time as their routine cuff maintenance (minimal leak test). Bedside nurse measurements were compared with investigator measurements. At the endpoint of cuff inflation, 20 of 45 patients (44%) had cuff pressures between 20 and 30 cmH2O; 11 of 45 patients (24%) had cuff pressures <20 cmH2O; 14 of 45 patients (31%) had cuff pressures ≥30 cmH2O. Univariate analysis demonstrated an association between both patient obesity and female gender requiring less ETT cuff volume (P=0.008 and P <0.001 respectively), though this association was lost on multivariate analysis. No association was demonstrated between any measured variables and cuff pressures. Inter-operator reliability in performing the minimal leak test showed no evidence of bias between nurse and investigators (Pearson coefficient = 0.897). We conclude the minimal leak test for maintenance of ETT cuffs leads to both over- and under-inflation, and alternative techniques, such as cuff manometry, should be employed.

  6. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial.

    PubMed

    Coles, Alasdair J; Twyman, Cary L; Arnold, Douglas L; Cohen, Jeffrey A; Confavreux, Christian; Fox, Edward J; Hartung, Hans-Peter; Havrdova, Eva; Selmaj, Krzysztof W; Weiner, Howard L; Miller, Tamara; Fisher, Elizabeth; Sandbrink, Rupert; Lake, Stephen L; Margolin, David H; Oyuela, Pedro; Panzara, Michael A; Compston, D Alastair S

    2012-11-24

    The anti-CD52 monoclonal antibody alemtuzumab reduces disease activity in previously untreated patients with relapsing-remitting multiple sclerosis. We aimed to assess efficacy and safety of alemtuzumab compared with interferon beta 1a in patients who have relapsed despite first-line treatment. In our 2 year, rater-masked, randomised controlled phase 3 trial, we enrolled adults aged 18-55 years with relapsing-remitting multiple sclerosis and at least one relapse on interferon beta or glatiramer. Eligible participants were randomly allocated in a 1:2:2 ratio by an interactive voice response system, stratified by site, to receive subcutaneous interferon beta 1a 44 μg, intravenous alemtuzumab 12 mg per day, or intravenous alemtuzumab 24 mg per day. Interferon beta 1a was given three-times per week and alemtuzumab was given once per day for 5 days at baseline and for 3 days at 12 months. The 24 mg per day group was discontinued to aid recruitment, but data are included for safety assessments. Coprimary endpoints were relapse rate and time to 6 month sustained accumulation of disability, comparing alemtuzumab 12 mg and interferon beta 1a in all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, number NCT00548405. 202 (87%) of 231 patients randomly allocated interferon beta 1a and 426 (98%) of 436 patients randomly allocated alemtuzumab 12 mg were included in the primary analyses. 104 (51%) patients in the interferon beta 1a group relapsed (201 events) compared with 147 (35%) patients in the alemtuzumab group (236 events; rate ratio 0·51 [95% CI 0·39-0·65]; p<0·0001), corresponding to a 49·4% improvement with alemtuzumab. 94 (47%) patients in the interferon beta 1a group were relapse-free at 2 years compared with 278 (65%) patients in the alemtuzumab group (p<0·0001). 40 (20%) patients in the interferon beta 1a group had sustained accumulation of disability compared with 54 (13%) in the alemtuzumab group

  7. Rotator cuff strength balance in glovebox workers

    DOE PAGES

    Lawton, Cindy M.; Weaver, Amelia M.; Chan, Martha Kwan Yi; ...

    2016-11-23

    Gloveboxes are essential to the pharmaceutical, semi-conductor, nuclear, and biochemical industries. While gloveboxes serve as effective containment systems, they are often difficult to work in and present a number of ergonomic hazards. One such hazard is injury to the rotator cuff, a group of tendons and muscles in the shoulder, connecting the upper arm to the shoulder blade. Rotator cuff integrity is critical to shoulder health. This study compared the rotator cuff muscle strength ratios of glovebox workers to the healthy norm. Descriptive statistics were collected using a short questionnaire. Handheld dynamometry was used to quantify the ratio of forcesmore » produced for shoulder internal and external rotation. Results showed this population to have shoulder strength ratios significantly different from the healthy norm. Strength ratios were found to be a sound predictor of symptom incidence. The deviation from the normal ratio demonstrates the need for solutions designed to reduce the workload on the rotator cuff musculature in order to improve health and safety. Assessment of strength ratios can be used to screen for risk of symptom development. As a result, this increases technical knowledge and augments operational safety.« less

  8. Rotator cuff strength balance in glovebox workers

    SciTech Connect

    Lawton, Cindy M.; Weaver, Amelia M.; Chan, Martha Kwan Yi; Cournoyer, Michael Edward

    2016-11-23

    Gloveboxes are essential to the pharmaceutical, semi-conductor, nuclear, and biochemical industries. While gloveboxes serve as effective containment systems, they are often difficult to work in and present a number of ergonomic hazards. One such hazard is injury to the rotator cuff, a group of tendons and muscles in the shoulder, connecting the upper arm to the shoulder blade. Rotator cuff integrity is critical to shoulder health. This study compared the rotator cuff muscle strength ratios of glovebox workers to the healthy norm. Descriptive statistics were collected using a short questionnaire. Handheld dynamometry was used to quantify the ratio of forces produced for shoulder internal and external rotation. Results showed this population to have shoulder strength ratios significantly different from the healthy norm. Strength ratios were found to be a sound predictor of symptom incidence. The deviation from the normal ratio demonstrates the need for solutions designed to reduce the workload on the rotator cuff musculature in order to improve health and safety. Assessment of strength ratios can be used to screen for risk of symptom development. As a result, this increases technical knowledge and augments operational safety.

  9. Control device for prosthetic urinary sphincter cuff

    NASA Technical Reports Server (NTRS)

    Reinicke, Robert H. (Inventor)

    1983-01-01

    A device for controlling flow of fluid to and from a resilient inflatable cuff implanted about the urethra to control flow of urine therethrough. The device comprises a flexible bulb reservoir and a control unit that includes a manually operated valve that opens automatically when the bulb is squeezed to force fluid into the cuff for closing the urethra. The control unit also includes a movable valve seat member having a relatively large area exposed to pressure of fluid in a chamber that is connected to the cuff and which moves to a position in which the valve member is unseated by an abutment when fluid pressure in the chamber exceeds a predetermined value to thereby relieve excess fluid pressure in the cuff. The arrangement is such that the valve element is held closed against the seat member by the full differential in fluid pressures acting on both sides of the valve element until the seat member is moved away from the valve element to thus insure positive closing of the valve element until the seat member is moved out of engagement with the valve element by excess pressure differential.

  10. Cytokines in rotator cuff degeneration and repair.

    PubMed

    Bedi, Asheesh; Maak, Travis; Walsh, Christopher; Rodeo, Scott A; Grande, Dan; Dines, David M; Dines, Joshua S

    2012-02-01

    The pathogenesis of rotator cuff degeneration remains poorly defined, and the incidence of degenerative tears is increasing in the aging population. Rates of recurrent tear and incomplete tendon-to-bone healing after repair remain significant for large and massive tears. Previous studies have documented a disorganized, fibrous junction at the tendon-to-bone interface after rotator cuff healing that does not recapitulate the organization of the native enthesis. Many biologic factors have been implicated in coordinating tendon-to-bone healing and maintenance of the enthesis after rotator cuff repair, including the expression and activation of transforming growth factor-β, basic fibroblast growth factor, platelet-derived growth factor-β, matrix metalloproteinases, and tissue inhibitors of metalloproteinases. Future techniques to treat tendinopathy and enhance tendon-to-bone healing will be driven by our understanding of the biology of this healing process after rotator cuff repair surgery. The use of cytokines to provide important signals for tissue formation and differentiation, the use of gene therapy techniques to provide sustained cytokine delivery, the use of stem cells, and the use of transcription factors to modulate endogenous gene expression represent some of these possibilities. Copyright © 2012 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

  11. Randomised controlled trial of non-invasive ventilation (NIV) for nocturnal hypoventilation in neuromuscular and chest wall disease patients with daytime normocapnia

    PubMed Central

    Ward, S; Chatwin, M; Heather, S; Simonds, A

    2005-01-01

    Background: Long term non-invasive ventilation (NIV) reduces morbidity and mortality in patients with neuromuscular and chest wall disease with hypercapnic ventilatory failure, but preventive use has not produced benefit in normocapnic patients with Duchenne muscular dystrophy. Individuals with nocturnal hypercapnia but daytime normocapnia were randomised to a control group or nocturnal NIV to examine whether nocturnal hypoventilation is a valid indication for NIV. Methods: Forty eight patients with congenital neuromuscular or chest wall disease aged 7–51 years and vital capacity <50% predicted underwent overnight respiratory monitoring. Twenty six with daytime normocapnia and nocturnal hypercapnia were randomised to either nocturnal NIV or to a control group without ventilatory support. NIV was started in the control group if patients fulfilled preset safety criteria. Results: Peak nocturnal transcutaneous carbon dioxide tension (TcCO2) did not differ between the groups, but the mean (SD) percentage of the night during which TcCO2 was >6.5 kPa decreased in the NIV group (–57.7 (26.1)%) but not in controls (–11.75 (46.1)%; p = 0.049, 95% CI –91.5 to –0.35). Mean (SD) arterial oxygen saturation increased in the NIV group (+2.97 (2.57)%) but not in controls (–1.12 (2.02)%; p = 0.024, 95% CI 0.69 to 7.5). Nine of the 10 controls failed non-intervention by fulfilling criteria to initiate NIV after a mean (SD) of 8.3 (7.3) months. Conclusion: Patients with neuromuscular disease with nocturnal hypoventilation are likely to deteriorate with the development of daytime hypercapnia and/or progressive symptoms within 2 years and may benefit from the introduction of nocturnal NIV before daytime hypercapnia ensues. PMID:16299118

  12. Effectiveness of telemonitoring integrated into existing clinical services on hospital admission for exacerbation of chronic obstructive pulmonary disease: researcher blind, multicentre, randomised controlled trial

    PubMed Central

    Hanley, Janet; McCloughan, Lucy; Todd, Allison; Krishan, Ashma; Lewis, Stephanie; Stoddart, Andrew; van der Pol, Marjon; MacNee, William; Sheikh, Aziz; Pagliari, Claudia; McKinstry, Brian

    2013-01-01

    Objective To test the effectiveness of telemonitoring integrated into existing clinical services such that intervention and control groups have access to the same clinical care. Design Researcher blind, multicentre, randomised controlled trial. Setting UK primary care (Lothian, Scotland). Participants Adults with at least one admission for chronic obstructive pulmonary disease (COPD) in the year before randomisation. We excluded people who had other significant lung disease, who were unable to provide informed consent or complete the study, or who had other significant social or clinical problems. Interventions Participants were recruited between 21 May 2009 and 28 March 2011, and centrally randomised to receive telemonitoring or conventional self monitoring. Using a touch screen, telemonitoring participants recorded a daily questionnaire about symptoms and treatment use, and monitored oxygen saturation using linked instruments. Algorithms, based on the symptom score, generated alerts if readings were omitted or breached thresholds. Both groups received similar care from existing clinical services. Main outcome measures The primary outcome was time to hospital admission due to COPD exacerbation up to one year after randomisation. Other outcomes included number and duration of admissions, and validated questionnaire assessments of health related quality of life (using St George’s respiratory questionnaire (SGRQ)), anxiety or depression (or both), self efficacy, knowledge, and adherence to treatment. Analysis was intention to treat. Results Of 256 patients completing the study, 128 patients were randomised to telemonitoring and 128 to usual care; baseline characteristics of each group were similar. The number of days to admission did not differ significantly between groups (adjusted hazard ratio 0.98, 95% confidence interval 0.66 to 1.44). Over one year, the mean number of COPD admissions was similar in both groups (telemonitoring 1.2 admissions per person

  13. Symptoms of Pain Do Not Correlate with Rotator Cuff Tear Severity

    PubMed Central

    Dunn, Warren R.; Kuhn, John E.; Sanders, Rosemary; An, Qi; Baumgarten, Keith M.; Bishop, Julie Y.; Brophy, Robert H.; Carey, James L.; Holloway, G. Brian; Jones, Grant L.; Ma, C. Benjamin; Marx, Robert G.; McCarty, Eric C.; Poddar, Sourav K.; Smith, Matthew V.; Spencer, Edwin E.; Vidal, Armando F.; Wolf, Brian R.; Wright, Rick W.

    2014-01-01

    Background: For many orthopaedic disorders, symptoms correlate with disease severity. The objective of this study was to determine if pain level is related to the severity of rotator cuff disorders. Methods: A cohort of 393 subjects with an atraumatic symptomatic full-thickness rotator-cuff tear treated with physical therapy was studied. Baseline pretreatment data were used to examine the relationship between the severity of rotator cuff disease and pain. Disease severity was determined by evaluating tear size, retraction, superior humeral head migration, and rotator cuff muscle atrophy. Pain was measured on the 10-point visual analog scale (VAS) in the patient-reported American Shoulder and Elbow Surgeons (ASES) score. A linear multiple regression model was constructed with use of the continuous VAS score as the dependent variable and measures of rotator cuff tear severity and other nonanatomic patient factors as the independent variables. Forty-eight percent of the patients were female, and the median age was sixty-one years. The dominant shoulder was involved in 69% of the patients. The duration of symptoms was less than one month for 8% of the patients, one to three months for 22%, four to six months for 20%, seven to twelve months for 15%, and more than a year for 36%. The tear involved only the supraspinatus in 72% of the patients; the supraspinatus and infraspinatus, with or without the teres minor, in 21%; and only the subscapularis in 7%. Humeral head migration was noted in 16%. Tendon retraction was minimal in 48%, midhumeral in 34%, glenohumeral in 13%, and to the glenoid in 5%. The median baseline VAS pain score was 4.4. Results: Multivariable modeling, controlling for other baseline factors, identified increased comorbidities (p = 0.002), lower education level (p = 0.004), and race (p = 0.041) as the only significant factors associated with pain on presentation. No measure of rotator cuff tear severity correlated with pain (p > 0.25). Conclusions

  14. Tissue discrimination in magnetic resonance imaging of the rotator cuff

    NASA Astrophysics Data System (ADS)

    Meschino, G. J.; Comas, D. S.; González, M. A.; Capiel, C.; Ballarin, V. L.

    2016-04-01

    Evaluation and diagnosis of diseases of the muscles within the rotator cuff can be done using different modalities, being the Magnetic Resonance the method more widely used. There are criteria to evaluate the degree of fat infiltration and muscle atrophy, but these have low accuracy and show great variability inter and intra observer. In this paper, an analysis of the texture features of the rotator cuff muscles is performed to classify them and other tissues. A general supervised classification approach was used, combining forward-search as feature selection method with kNN as classification rule. Sections of Magnetic Resonance Images of the tissues of interest were selected by specialist doctors and they were considered as Gold Standard. Accuracies obtained were of 93% for T1-weighted images and 92% for T2-weighted images. As an immediate future work, the combination of both sequences of images will be considered, expecting to improve the results, as well as the use of other sequences of Magnetic Resonance Images. This work represents an initial point for the classification and quantification of fat infiltration and muscle atrophy degree. From this initial point, it is expected to make an accurate and objective system which will result in benefits for future research and for patients’ health.

  15. PneuMum: Impact from a randomised controlled trial of maternal 23-valent pneumococcal polysaccharide vaccination on middle ear disease amongst Indigenous infants, Northern Territory, Australia.

    PubMed

    Binks, Michael J; Moberley, Sarah A; Balloch, Anne; Leach, Amanda J; Nelson, Sandra; Hare, Kim M; Wilson, Cate; Morris, Peter S; Nelson, Jane; Chatfield, Mark D; Tang, Mimi L K; Torzillo, Paul; Carapetis, Jonathan R; Mulholland, E Kim; Andrews, Ross M

    2015-11-27

    We assessed maternal 23-valent pneumococcal polysaccharide (23vPPV) vaccine efficacy (VE) against middle ear disease and pneumococcal carriage amongst Australian Indigenous infants. In an open label, allocation concealed, outcome-assessor blinded, community stratified, randomised controlled trial, healthy pregnant Indigenous women aged 17-39 years in the Northern Territory of Australia received the 23vPPV (1:1:1) at: 30-36 weeks gestation, birth, or were unvaccinated (ClinicalTrials.gov NCT00714064). Co-primary outcomes were the point prevalences of infant middle ear disease and 23vPPV-type carriage at age 7 months. The consent rate was 50% (313/632). Among 227 eligible participants randomised, retention rates were 86% (66/77) controls; 89% (67/75) pregnancy vaccinees; 88% (66/75) birth vaccinees. At infant age 7 months, ear disease prevalence was: 71% (47/66) controls, 63% (42/67) pregnancy vaccinees, 76% (50/66) birth vaccinees; and 23vPPV-type carriage was: 26% (17/66) controls, 18% (12/67) pregnancy vaccinees, 18% (12/66) birth vaccinees. For pregnancy vaccinees, VE was 12% (95% CI -12% to 31%) against infant ear disease and 30% (95% CI -34% to 64%) against 23vPPV-type carriage. In a post-hoc analysis, VE against infant ear disease concurrent with carriage of 23vPPV or related types was 51% (95% CI -2% to 76%). There were no serious adverse effects following receipt of the 23vPPV in pregnancy or at birth. In a high risk population, our study was unable to demonstrate efficacy of 23vPPV in pregnancy against the co-primary outcomes of either all-cause infant ear disease or 23vPPV-type nasopharyngeal carriage at age 7 months. Efficacy against ear disease concurrent with carriage of vaccine-related serotypes (a more specific outcome) suggests 23vPPV in pregnancy may complement childhood pneumococcal vaccination programs. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

  16. Comparison of efficacy and safety between benidipine and hydrochlorothiazide in fosinopril-treated hypertensive patients with chronic kidney disease: protocol for a randomised controlled trial

    PubMed Central

    Xue, Cheng; Zhou, Chenchen; Yang, Bo; Lv, Jiayi; Dai, Bing; Yu, Shengqiang; Wang, Yi; Zhao, Guanren; Mei, Changlin

    2017-01-01

    Introduction Co-administration of a diuretic or calcium channel blocker with an ACE inhibitor are both preferred combinations in patients with hypertensive chronic kidney disease (CKD). According to the available evidence, it is still unknown which combination plays a more active role in renal protection. We hypothesised that a combination of fosinopril and benidipine may delay the progression of CKD more effectively than a combination of fosinopril and hydrochlorothiazide (HCTZ). Methods and analysis This study will be a multicentred, prospective, double-blind, randomised parallel controlled trial for hypertensive CKD patients in China. Patients will be randomised to one of two treatment groups: a combination of benidipine 4–8 mg/day and fosinopril 20 mg/day; or a combination of HCTZ 12.5–25 mg/day and fosinopril 20 mg/day. Patients will be followed up for 24 months after a month's fosinopril run-in. There will be dose-titration after 1 and 2 months. The primary endpoint is changes in estimated glomerular filtration rate (eGFR) from baseline to month 24. Secondary endpoints include changes in home blood pressure (BP), ambulatory BP, proteinuria, urinary albumin/creatinine ratio, and composite renal events in 24 months. Inclusion criteria are: age 18–80 years, non-dialysis CKD patients with eGFR >30 mL/min/1.73 m2, home BP >130 mm Hg systolic or BP >80 mm Hg diastolic at the screening and randomisation, and 24 hour proteinuria <3.5 g. Principal exclusions are hypertensive crisis, transplantation, cancer, severe diabetes complications, hyperkalaemia and severe allergy. The required sample size was 511 patients for detecting a difference in the change of eGFR (one sided α=0.025, power 1-β=0.90). Ethics and dissemination BEAHIT (Benidipine and Hydrochlorothiazide in Fosinopril Treated Chronic Kidney Disease Patients with Hypertension) was approved by Changzheng Hospital Ethics Committee (CZ-20160504-16). The outcomes will be

  17. Cost-effectiveness of telehealthcare to patients with chronic obstructive pulmonary disease: results from the Danish ‘TeleCare North’ cluster-randomised trial

    PubMed Central

    Witt Udsen, Flemming; Lilholt, Pernille Heyckendorff; Hejlesen, Ole; Ehlers, Lars

    2017-01-01

    Objectives To investigate the cost-effectiveness of a telehealthcare solution in addition to usual care compared with usual care. Design A 12-month cost-utility analysis conducted alongside a cluster-randomised trial. Setting Community-based setting in the geographical area of North Denmark Region in Denmark. Participants 26 municipality districts define randomisation clusters with 13 districts in each arm. 1225 patients with chronic obstructive pulmonary disease were enrolled, of which 578 patients were randomised to telehealthcare and 647 to usual care. Interventions In addition to usual care, patients in the intervention group received a set of telehealthcare equipment and were monitored by a municipality-based healthcare team. Patients in the control group received usual care. Main outcome measure Incremental costs per quality-adjusted life-years gained from baseline up to 12 months follow-up. Results From a healthcare and social sector perspective, the adjusted mean difference in total costs between telehealthcare and usual care was €728 (95% CI −754 to 2211) and the adjusted mean difference in quality-adjusted life-years gained was 0.0132 (95% CI −0.0083 to 0.0346). The incremental cost-effectiveness ratio was €55 327 per quality-adjusted life-year gained. Decision-makers should be willing to pay more than €55 000 to achieve a probability of cost-effectiveness >50%. This conclusion is robust to changes in the definition of hospital contacts and reduced intervention costs. Only in the most optimistic scenario combining the effects of all sensitivity analyses, does the incremental cost-effectiveness ratio fall below the UK thresholds values (€21 068 per quality-adjusted life-year). Conclusions Telehealthcare is unlikely to be a cost-effective addition to usual care, if it is offered to all patients with chronic obstructive pulmonary disease and if the willingness-to-pay threshold values from the National Institute for Health and Care

  18. Ocular tolerability and efficacy of a cationic emulsion in patients with mild to moderate dry eye disease - a randomised comparative study.

    PubMed

    Amrane, M; Creuzot-Garcher, C; Robert, P-Y; Ismail, D; Garrigue, J-S; Pisella, P-J; Baudouin, C

    2014-10-01

    The purpose of this study was to compare the safety and efficacy of a new cationic emulsion (CE) with a formulation of polyvinyl alcohol and povidone (PVA-P) for the treatment of mild to moderate dry eye disease. This was a multicenter, open-label, comparative study. Patients were randomised to receive CE (Cationorm) or PVA-P (Refresh) (1:1). The following objective criteria were assessed to compare the two eye drops: tear Break-up Time (TBUT), Schirmer's test, lissamine green staining (Van Bijsterveld score), corneal fluorescein staining (Oxford scale) and oculopalpebral examination, on D7 and D28 (end of study). At these visits, ocular symptoms and safety were also assessed. Seventy-nine patients were randomised: CE: 44 patients; PVA-P: 35 patients. At D28, improvement was significantly better for TBUT [CE: 1.7 ± 2.4 s; PVA-P: 0.6 ± 1.8 s; P=0.015] and for the Van Bijsterveld score [CE: -1.4 ± 1.2; PVA-P: -0.9 ± 1.2; P=0.046] in the CE group. The same applied for the palpebral erythema score (P=0.023), overall efficacy assessed by the investigators (P<0.001), and symptoms not related to eye drop instillation (P=0.021). Improvement was observed from D7. No difference was observed between the two treatments with regard to ocular safety. These results suggest that in patients with mild to moderate dry eye, Cationorm, in addition to its moisturizing and lubricating properties, also helps stabilize the tear film due to its oily component. This study demonstrates the benefit of this new pharmaceutical form for the treatment of mild to moderate dry eye disease. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  19. Ineffectiveness of Lactobacillus johnsonii LA1 for prophylaxis of postoperative recurrence in Crohn's disease: a randomised, double blind, placebo controlled GETAID trial

    PubMed Central

    Marteau, P; Lémann, M; Seksik, P; Laharie, D; Colombel, J F; Bouhnik, Y; Cadiot, G; Soulé, J C; Bourreille, A; Metman, E; Lerebours, E; Carbonnel, F; Dupas, J L; Veyrac, M; Coffin, B; Moreau, J; Abitbol, V; Blum‐Sperisen, S; Mary, J Y

    2006-01-01

    Background and aims Early endoscopic recurrence is frequent after intestinal resection for Crohn's disease. Bacteria are involved, and probiotics may modulate immune responses to the intestinal flora. Here we tested the probiotic strain Lactobacillus johnsonii LA1 in this setting. Patients and methods This was a randomised, double blind, placebo controlled study. Patients were eligible if they had undergone surgical resection of <1 m, removing all macroscopic lesions within the past 21 days. Patients were randomised to receive two packets per day of lyophilised LA1 (2×109 cfu) or placebo for six months; no other treatment was allowed. The primary endpoint was endoscopic recurrence at six months, with grade >1 in Rutgeerts' classification or an adapted classification for colonic lesions. Endoscopic score was the maximal grade of ileal and colonic lesions. Analyses were performed primarily on an intent to treat basis. Results Ninety eight patients were enrolled (48 in the LA1 group). At six months, endoscopic recurrence was observed in 30/47 patients (64%) in the placebo group and in 21/43 (49%) in the LA1 group (p = 0.15). Per protocol analysis confirmed this result. Endoscopic score distribution did not differ significantly between the LA1 and placebo groups. There were four clinical recurrences in the LA1 group and three in the placebo group. Conclusion L johnsonii LA1 (4×109 cfu/day) did not have a sufficient effect, if any, to prevent endoscopic recurrence of Crohn's disease. PMID:16377775

  20. HELPing older people with very severe chronic obstructive pulmonary disease (HELP-COPD): mixed-method feasibility pilot randomised controlled trial of a novel intervention

    PubMed Central

    Buckingham, Susan; Kendall, Marilyn; Ferguson, Susie; MacNee, William; Sheikh, Aziz; White, Patrick; Worth, Allison; Boyd, Kirsty; Murray, Scott A; Pinnock, Hilary

    2015-01-01

    Background: Extending palliative care to those with advanced non-malignant disease is advocated, but the implications in specific conditions are poorly understood. AIMs: We piloted a novel nurse-led intervention, HELPing older people with very severe chronic obstructive pulmonary disease (HELP-COPD), undertaken 4 weeks after discharge from hospital, which sought to identify and address the holistic care needs of people with severe COPD. Methods: This 6-month mixed-method feasibility pilot trial randomised (ratio 3:1) patients to HELP-COPD or usual care. We assessed the feasibility of using validated questionnaires as outcome measures and analysed the needs/actions recorded in the HELP-COPD records. Semi-structured interviews with a purposive sample of patients, carers and professionals explored the perceptions of HELP-COPD. Verbatim transcriptions and field notes were analysed using Normalisation Process Theory as a framework. Results: We randomised 32 patients (24 to HELP-COPD); 19 completed the study (death=3, ill-health=4, declined=6). The HELP-COPD record noted a mean of 1.6 actions/assessment, mostly provision of information or self-help actions: only five referrals were made. Most patients were positive about HELP-COPD, discussing their concerns and coping strategies in all domains, but the questionnaires were burdensome for some patients. Adaptation to their slowly progressive disability and a strong preference to rely on family support was reflected in limited acceptance of formal services. Professionals perceived HELP-COPD as addressing an important aspect of care, although timing overlapped with discharge planning. Conclusions: The HELP-COPD intervention was well received by patients and the concept resonated with professionals, although delivery post discharge overlapped with existing services. Integration of brief holistic care assessments in the routine primary care management of COPD may be more appropriate. PMID:26028347

  1. Rotator cuff tendinopathy: is there a role for polyunsaturated Fatty acids and antioxidants?

    PubMed

    Lewis, Jeremy S; Sandford, Fiona M

    2009-01-01

    Despite the lack of robust evidence, there has been a steady increase in the use of dietary supplements, including Omega 3 fatty acids and antioxidants, in the management of musculoskeletal conditions. One reason for this is that unsatisfactory outcomes with conventional treatments have lead sufferers to seek alternative solutions including the use of nutritional supplements. In the United Kingdom alone, the current supplement market is estimated to be over 300 pounds million per annum. One target market for nutritional supplements is tendinopathies including conditions involving the rotator cuff. This condition is debilitating and associated with considerable morbidity. Incidence increases with advancing age. High levels of cytokines, such as the pro-inflammatory interleukin 1 beta and vascular endothelial growth factor, have been reported within the bursa of patients with rotator cuff disease. There is also evidence that high concentrations of free-radical oxidants may also be involved in tendon pathology. Therefore, the possibility exists that dietary supplements may have a beneficial effect on tendon pathology, including that of the rotator cuff. A review was conducted to synthesize the available research literature on the histopathology of rotator cuff disease and the effectiveness of polyunsaturated fatty acids (PUFAs) and antioxidants on tendinopathies. A search was conducted using the MEDLINE, CINAHL, AMED, EMBASE, Cochrane, and PEDro databases using the terms "rotator cuff" and "tear/s" and "subacromial impingement syndrome," "burase," "bursitis," "tendinopathy," "tendinitis," "tendinosis," "polyunsaturated fatty acids," "PUFA," "Omega 3," "histopathology," "etiology," and "antioxidants." English language was an inclusion criterion. There were no randomized clinical trials found relating specifically to the rotator cuff. Only one trial was found that investigated the efficacy of PUFAs and antioxidants on tendinopathies. The findings suggest that some (low

  2. Evaluating the effectiveness of a healthy lifestyle clinician in addressing the chronic disease risk behaviours of community mental health clients: study protocol for a randomised controlled trial.

    PubMed

    Fehily, Caitlin; Bartlem, Kate; Wiggers, John; Wye, Paula; Clancy, Richard; Castle, David; Wutzke, Sonia; Rissel, Chris; Wilson, Andrew; McCombie, Paul; Murphy, Fionna; Bowman, Jenny

    2017-06-15

    People with a mental illness experience a greater morbidity and mortality from chronic diseases relative to the general population. A higher prevalence of modifiable health risk behaviours such as smoking, poor nutrition, physical inactivity and harmful alcohol consumption contribute substantially to this disparity. Despite clinical practice guidelines recommending that mental health services routinely provide care to address these risk behaviours, the provision of such care is consistently reported to be low internationally and in Australia. This protocol describes a randomised controlled trial that aims to assess the effectiveness of allocating a clinician within a community mental health service to the specific role of providing assessment, advice and referral for clients' chronic disease risk behaviours. Approximately 540 clients of one community mental health service will be randomised to receive either usual care for chronic disease risks provided in routine consultations or usual care plus an additional face-to-face consultation and follow-up telephone call with a 'healthy lifestyle clinician'. The clinician will assess clients' chronic disease risk behaviours, provide advice to change behaviours, and refer at-risk clients to free telephone coaching services (New South Wales (NSW) Quitline and NSW Get Healthy Information and Coaching Service) for specialist behaviour change care. The primary outcomes, regarding referral to and client uptake of the telephone services, will be obtained from the respective services. Telephone interviews of clients at baseline and at 1 and 6 months post baseline follow-ups will assess secondary outcomes: receipt of any assessment, advice and referral from the mental health service; satisfaction with the receipt of such care; satisfaction with the receipt of any care provided by the telephone services; interest and confidence in and perceived importance of changing risk behaviours; and risk behaviour status. This study will add

  3. New Surgery May Fix Tough-To-Treat Rotator Cuff Tears

    MedlinePlus

    ... html New Surgery May Fix Tough-to-Treat Rotator Cuff Tears Procedure could offer option for otherwise irreparable ... It was developed by Japanese surgeons to fix rotator cuff injuries once considered irreparable. The rotator cuff is ...

  4. Melissa officinalis extract in the treatment of patients with mild to moderate Alzheimer's disease: a double blind, randomised, placebo controlled trial

    PubMed Central

    Akhondzadeh, S; Noroozian, M; Mohammadi, M; Ohadinia, S; Jamshidi, A; Khani, M

    2003-01-01

    Objective: To assess the efficacy and safety of Melissa officinalis extract using a fixed dose (60 drops/day) in patients with mild to moderate Alzheimer's disease. Design: A four month, parallel group, placebo controlled trial undertaken in three centres in Tehran, Iran. Methods: Patients with mild to moderate Alzheimer's disease aged between 65 and 80 years (n = 42; 18 women, 24 men) with a score of ≥ 12 on the cognitive subscale of Alzheimer's disease assessment scale (ADAS-cog) and ≤ 2 on the clinical dementia rating (CDR) were randomised to placebo or fixed dose of Melissa officinalis extract. The main efficacy measures were the change in the ADAS-cog and CDR-SB scores compared with baseline. Side effects were systematically recorded. Results: At four months, Melissa officinalis extract produced a significantly better outcome on cognitive function than placebo (ADAS-cog: df = 1, F = 6.93, p = 0.01; CDR: df = 1, F = 16.87, p < 0.0001). There were no significant differences in the two groups in terms of observed side effects except agitation, which was more common in the placebo group (p = 0.03). Conclusions: Melissa officinalis extract is of value in the management of mild to moderate Alzheimer's disease and has a positive effect on agitation in such patients. PMID:12810768

  5. Treatment of lesions of the rotator cuff.

    PubMed

    Saggini, R; Cavezza, T; Di Pancrazio, L; Pisciella, V; Saladino, G; Zuccaro, M C; Bellomo, R G

    2010-01-01

    The impingement syndrome and tendinopathy of the rotator cuff are the most common causes (complaints) of pain and disability of the shoulder. The aim of this study is to evaluate the efficacy of a specific rehabilitative protocol, integrated with the administration of a nutritional supplement, in the conservative rehabilitative treatment, as well as in post-surgery, of patients with lesions of the rotator cuff. Two groups with syndrome of the rotator cuff were formed to follow different therapeutic courses, in relation to the choice of each subject to undergo the conservative treatment (Arm A) or the surgical one (Arm B). In Arm A the study included the association of therapy with ESWT (shock waves) with the proprioceptive Multi Joint System, for rehabilitating joint movement and muscle strength of the shoulder, and a specific nutritional supplement to reduce the pain and conserve the cartilage tissue. Between February 2009 and June 2009, we enrolled 30 subjects (randomized into three homogenous groups A1, A2, A3), average age 45±10 years, with rotator cuff syndrome with calcification of the shoulder, diagnosed through clinical examination and investigative instruments (X-ray, echography or NMR). In Arm B, from September 2009 to January 2010, we enrolled 50 patients (randomized into two groups, B1 and B2), 24 male (average age 58.4: min 28 and max 78) and 26 females (average age 59.5: min 30 and max 80), who had undergone rotator cuff operations and acromionplasty for non-massive lesions without important gleno-humeral instability, with either open or arthroscopic procedures. The analysis of the results of Arm A highlights that in terms of reducing pain the main benefits were found in Group A1 where the supplement was given. From the analysis of the data of Arm B, in both groups an improvement of the first 4 items evaluated was evident. In Group B1, 84 percent of the patients declared to be satisfied and improved and 16 percent were dissatisfied; in Group B2

  6. Significant association of full-thickness rotator cuff tears and estrogen-related receptor-β (ESRRB).

    PubMed

    Teerlink, Craig C; Cannon-Albright, Lisa A; Tashjian, Robert Z

    2015-02-01

    The precise etiology of rotator cuff disease is unknown, but prior evidence suggests a role for genetic factors. Variants of estrogen-related receptor-β (ESRRB) have been previously associated with rotator cuff disease. The purpose of the present study was to confirm the association between multiple candidate genes, including ESRRB, and rotator cuff disease in an independent set of patients with rotator cuff tear. The Illumina 5M (Illumina Inc, San Diego, CA, USA) single nucleotide polymorphism (SNP) platform was used to genotype 175 patients with rotator cuff tear. Genotypes were used to select a set of 2595 genetically matched Caucasian controls available from the Illumina iControls database. Tests of association were performed with Genome-wide Efficient Mixed Model Association (GEMMA) software at 69 SNPs that fell within 20 kb of 6 candidate genes (DEFB1, DENND2C, ESRRB, FGF3, FGF10, and FGFR1). Tests of association revealed 1 significantly associated SNP occurring in ESRRB (rs17583842; P = 4.4E-4). Another SNP within ESRRB (rs7157192) had a nominal P value of 7.8E-3. FastPHASE software estimated 2 frequent haplotypes among 54 individuals who carried both risk alleles at these 2 SNPs. The first haplotype had a frequency of 13.9% (n = 15) in risk-allele carriers and only 2.2% in controls (odds ratio, 6.9; 95% confidence interval, 3.9-2.2). The second haplotype had a frequency of 12.9% in risk-allele carriers and only 2.7% in controls (odds ratio, 5.3; 95% confidence interval, 3.0-9.5). The significant association and the presence of high-risk haplotypes identified in the ESRRB gene confirm the association of variants in ESRRB and rotator cuff disease. Copyright © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. All rights reserved.

  7. Effects of telephone health mentoring in community-recruited chronic obstructive pulmonary disease on self-management capacity, quality of life and psychological morbidity: a randomised controlled trial

    PubMed Central

    Walters, Julia; Cameron-Tucker, Helen; Wills, Karen; Schüz, Natalie; Scott, Jenn; Robinson, Andrew; Nelson, Mark; Turner, Paul; Wood-Baker, Richard; Walters, E Haydn

    2013-01-01

    Objectives To assess benefits of telephone-delivered health mentoring in community-based chronic obstructive pulmonary disease (COPD). Design Cluster randomised controlled trial. Setting Tasmanian general practices: capital city (11), large rural (3), medium rural (1) and small rural (16). Participants Patients were invited (1207) from general practitioner (GP) databases with COPD diagnosis and/or tiotropium prescription, response rate 49% (586), refused (176) and excluded (criteria: smoking history or previous study, 68). Spirometry testing (342) confirmed moderate or severe COPD in 182 (53%) patients. Randomisation By random numbers code, block stratified on location, allocation by sequentially numbered, opaque and sealed envelopes. Intervention Health mentor (HM) group received regular calls to manage illness issues and health behaviours from trained community health nurses using negotiated goal setting: problem solving, decision-making and action planning. Control: usual care (UC) group received GP care plus non-interventional brief phone calls. Outcomes Measured at 0, 6 and 12 months, the Short Form 36 (SF-36) and St George’s Respiratory Questionnaire (SGRQ, primary); Partners In Health (PIH) Scale for self-management capacity, Hospital Anxiety and Depression Scale (HADS), Center for Epidemiologic Studies-Depression (CES-D) questionnaire, Post-Traumatic Stress Disorder Checklist, Satisfaction with life and hospital admissions (secondary). Results 182 participants with COPD (age 68±8 years, 62% moderate COPD and 53% men) were randomised (HM=90 and UC=92). Mixed model regression analysis accounting for clustering, adjusting for age, gender, smoking status and airflow limitation assessed efficacy (regression coefficient, β, reported per 6-month visit). There was no difference in quality of life between groups, but self-management capacity increased in the HM group (PIH overall 0.15, 95% CI 0.03 to 0.29; knowledge domain 0.25, 95% CI 0.00 to 0

  8. 'Decision support system (DSS) for prevention of cardiovascular disease (CVD) among hypertensive (HTN) patients in Andhra Pradesh, India'--a cluster randomised community intervention trial.

    PubMed

    Anchala, Raghupathy; Pant, Hira; Prabhakaran, Dorairaj; Franco, Oscar H

    2012-05-31

    Very few studies having decision support systems as an intervention report on patient outcomes for cardiovascular disease in the Western world. The potential role of decision support system for the management of blood pressure among Indian hypertensives remains unclear. We propose a cluster randomised trial that aims to test the effectiveness and cost effectiveness of DSS among Indian hypertensive patients. The trial design is a cluster randomised community intervention trial, in which the participants would be adult male and female hypertensive patients, in the age group of 35 to 64 years, reporting to the Primary Health Care centres of Mahabubnagar district, Andhra Pradesh, India. The objective of the study is to test the effectiveness and compare the cost effectiveness and cost utility among hypertensive subjects randomized to receive either decision support system or a chart based algorithmic support system in urban and rural areas of a district in the state of Andhra Pradesh, India (baseline versus 12 months follow up). The primary outcome would be a comparison of the systolic blood pressure at 0 and 12 months among hypertensive patients randomized to receive the decision support system or the chart based algorithmic support system. Computer generated randomisation and an investigator and analyser blinded method would be followed. 1600 participants; 800 to each arm; each arm having eight clusters of hundred participants each have been recruited between 01 August 2011 - 01 March 2012. A twelve month follow up will be completed by March 2013 and results are expected by April 2013. This cluster randomized community intervention trial on DSS will enable policy makers to find out the effectiveness, cost effectiveness and cost utility of decision support system for management of blood pressure among hypertensive patients in India. Most of the previous studies on decision support system have focused on physician performance, adherence and on preventive care reminders

  9. Single inhaler extrafine triple therapy versus long-acting muscarinic antagonist therapy for chronic obstructive pulmonary disease (TRINITY): a double-blind, parallel group, randomised controlled trial.

    PubMed

    Vestbo, Jørgen; Papi, Alberto; Corradi, Massimo; Blazhko, Viktor; Montagna, Isabella; Francisco, Catherine; Cohuet, Géraldine; Vezzoli, Stefano; Scuri, Mario; Singh, Dave

    2017-05-13

    Limited data are available for the efficacy of triple therapy with two long-acting bronchodilators and an inhaled corticosteroid in chronic obstructive pulmonary disease (COPD). We compared treatment with extrafine beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide (BDP/FF/GB; fixed triple) with tiotropium, and BDP/FF plus tiotropium (open triple). For this double-blind, parallel-group, randomised, controlled trial, eligible patients had COPD, post-bronchodilator forced expiratory volume in 1 s (FEV1) of less than 50%, at least one moderate-to-severe COPD exacerbation in the previous 12 months, and a COPD Assessment Test total score of at least 10. After a 2-week run-in period receiving one inhalation per day via single-dose dry-powder inhaler of open-label 18 μg tiotropium, patients were randomised (2:2:1) using a interactive response technology system to 52 weeks treatment with tiotropium, fixed triple, or open triple. Randomisation was stratified by country and severity of airflow limitation. The primary endpoint was moderate-to-severe COPD exacerbation rate. The key secondary endpoint was change from baseline in pre-dose FEV1 at week 52. The trial is registered with ClinicalTrials.gov, number NCT01911364. Between Jan 21, 2014, and March 18, 2016, 2691 patients received fixed triple (n=1078), tiotropium (n=1075), or open triple (n=538). Moderate-to-severe exacerbation rates were 0·46 (95% CI 0·41-0·51) for fixed triple, 0·57 (0·52-0·63) for tiotropium, and 0·45 (0·39-0·52) for open triple; fixed triple was superior to tiotropium (rate ratio 0·80 [95% CI 0·69-0·92]; p=0·0025). For week 52 pre-dose FEV1, fixed triple was superior to tiotropium (mean difference 0·061 L [0·037 to 0·086]; p<0·0001) and non-inferior to open triple (-0·003L [-0·033 to 0·027]; p=0·85). Adverse events were reported by 594 (55%) patients with fixed triple, 622 (58%) with tiotropium, and 309 (58%) with open triple. In our TRINITY study

  10. Chronic Degeneration Leads to Poor Healing of Repaired Massive Rotator Cuff Tears in Rats

    PubMed Central

    Killian, Megan L.; Cavinatto, Leonardo M.; Ward, Samuel R.; Havlioglu, Necat; Thomopoulos, Stavros; Galatz, Leesa M.

    2016-01-01

    Background Chronic rotator cuff tears present a clinical challenge, often with poor outcomes after surgical repair. Degenerative changes to the muscle, tendon, and bone are thought to hinder healing after surgical repair; additionally, the ability to overcome degenerative changes after surgical repair remains unclear. Purpose/Hypothesis The purpose of this study was to evaluate healing outcomes of muscle, tendon, and bone after tendon repair in a model of chronic rotator cuff disease and to compare these outcomes to those of acute rotator cuff injuries and repair. The hypothesis was that degenerative rotator cuff changes associated with chronic multitendon tears and muscle unloading would lead to poor structural and mechanical outcomes after repair compared with acute injuries and repair. Study Design Controlled laboratory study. Methods Chronic rotator cuff injuries, induced via detachment of the supraspinatus (SS) and infraspinatus (IS) tendons and injection of botulinum toxin A into the SS and IS muscle bellies, were created in the shoulders of rats. After 8 weeks of injury, tendons were surgically reattached to the humeral head, and an acute, dual-tendon injury and repair was performed on the contralateral side. After 8 weeks of healing, muscles were examined histologically, and tendon-to-bone samples were examined microscopically, histologically, and biomechanically and via micro–computed tomography. Results All repairs were intact at the time of dissection, with no evidence of gapping or ruptures. Tendon-to-bone healing after repair in our chronic injury model led to reduced bone quality and morphological disorganization at the repair site compared with acute injuries and repair. SS and IS muscles were atrophic at 8 weeks after repair of chronic injuries, indicating incomplete recovery after repair, whereas SS and IS muscles exhibited less atrophy and degeneration in the acute injury group at 8 weeks after repair. After chronic injuries and repair, humeral

  11. Chronic Degeneration Leads to Poor Healing of Repaired Massive Rotator Cuff Tears in Rats.

    PubMed

    Killian, Megan L; Cavinatto, Leonardo M; Ward, Samuel R; Havlioglu, Necat; Thomopoulos, Stavros; Galatz, Leesa M

    2015-10-01

    Chronic rotator cuff tears present a clinical challenge, often with poor outcomes after surgical repair. Degenerative changes to the muscle, tendon, and bone are thought to hinder healing after surgical repair; additionally, the ability to overcome degenerative changes after surgical repair remains unclear. The purpose of this study was to evaluate healing outcomes of muscle, tendon, and bone after tendon repair in a model of chronic rotator cuff disease and to compare these outcomes to those of acute rotator cuff injuries and repair. The hypothesis was that degenerative rotator cuff changes associated with chronic multitendon tears and muscle unloading would lead to poor structural and mechanical outcomes after repair compared with acute injuries and repair. Controlled laboratory study. Chronic rotator cuff injuries, induced via detachment of the supraspinatus (SS) and infraspinatus (IS) tendons and injection of botulinum toxin A into the SS and IS muscle bellies, were created in the shoulders of rats. After 8 weeks of injury, tendons were surgically reattached to the humeral head, and an acute, dual-tendon injury and repair was performed on the contralateral side. After 8 weeks of healing, muscles were examined histologically, and tendon-to-bone samples were examined microscopically, histologically, and biomechanically and via micro-computed tomography. All repairs were intact at the time of dissection, with no evidence of gapping or ruptures. Tendon-to-bone healing after repair in our chronic injury model led to reduced bone quality and morphological disorganization at the repair site compared with acute injuries and repair. SS and IS muscles were atrophic at 8 weeks after repair of chronic injuries, indicating incomplete recovery after repair, whereas SS and IS muscles exhibited less atrophy and degeneration in the acute injury group at 8 weeks after repair. After chronic injuries and repair, humeral heads had decreased total mineral density and an altered

  12. Assessment and treatment strategies for rotator cuff tears

    PubMed Central

    Al-Hakim, Wisam; Noorani, Ali

    2014-01-01

    Tears of the rotator cuff are common and becoming an increasingly frequent problem. There is a vast amount of literature on the merits and limitations of the various methods of clinical and radiological assessment of rotator cuff tears. This is also the case with regard to treatment strategies. Certain popular beliefs and principles practiced widely and the basis upon which they are derived may be prone to inaccuracy. We provide an overview of the historical management of rotator cuff tears, as well as an explanation for how and why rotator cuff tears should be managed, and propose a structured methodology for their assessment and treatment. PMID:27582960

  13. Management of massive and irreparable rotator cuff tears.

    PubMed

    Neri, Brian R; Chan, Keith W; Kwon, Young W

    2009-01-01

    Massive rotator cuff tears pose a distinct clinical challenge for the orthopaedist. In this review, we will discuss the classification, diagnosis, and evaluation of massive rotator cuff tears before discussing various treatment options for this problem. Nonoperative treatment has had inconsistent results and proven unsuccessful for chronic symptoms while operative treatment including debridement and partial and complete repairs have had varying degrees of success. For rotator cuff tears that are deemed irreparable, treatment options are limited. The use of tendon transfers in younger patients to reconstruct rotator cuff function and restore shoulder kinematics can be useful in salvaging this difficult problem.

  14. Effectiveness of disease-specific cognitive–behavioural therapy on depression, anxiety, quality of life and the clinical course of disease in adolescents with inflammatory bowel disease: study protocol of a multicentre randomised controlled trial (HAPPY-IBD)

    PubMed Central

    van den Brink, Gertrude; Stapersma, Luuk; El Marroun, Hanan; Henrichs, Jens; Szigethy, Eva M; Utens, Elisabeth MWJ; Escher, Johanna C

    2016-01-01

    Introduction Adolescents with inflammatory bowel disease (IBD) show a higher prevalence of depression and anxiety, compared to youth with other chronic diseases. The inflammation-depression hypothesis might explain this association, and implies that treating depression can decrease intestinal inflammation and improve disease course. The present multicentre randomised controlled trial aims to test the effectiveness of an IBD-specific cognitive–behavioural therapy (CBT) protocol in reducing symptoms of subclinical depression and anxiety, while improving quality of life and disease course in adolescents with IBD. Methods and analysis Adolescents with IBD (10–20 years) from 7 hospitals undergo screening (online questionnaires) for symptoms of depression and anxiety. Those with elevated scores of depression (Child Depression Inventory (CDI) ≥13 or Beck Depression Inventory (BDI) II ≥14) and/or anxiety (Screen for Child Anxiety Related Disorders: boys ≥26, girls ≥30) receive a psychiatric interview. Patients meeting criteria for depressive/anxiety disorders are referred for psychotherapy outside the trial. Patients with elevated (subclinical) symptoms are randomly assigned to medical care-as-usual (CAU; n=50) or CAU plus IBD-specific CBT (n=50). Main outcomes: (1) reduction in depressive and/or anxiety symptoms after 3 months and (2) sustained remission for 12 months. Secondary outcomes: quality of life, psychosocial functioning, treatment adherence. In addition, we will assess inflammatory cytokines in peripheral blood mononuclear cells and whole blood RNA expression profiles. For analysis, multilevel linear models and generalised estimating equations will be used. Ethics and dissemination The Medical Ethics Committee of the Erasmus MC approved this study. If we prove that this CBT improves emotional well-being as well as disease course, implementation is recommended. Trial registration number NCT02265588. PMID:26966551

  15. Effectiveness of disease-specific cognitive-behavioural therapy on depression, anxiety, quality of life and the clinical course of disease in adolescents with inflammatory bowel disease: study protocol of a multicentre randomised controlled trial (HAPPY-IBD).

    PubMed

    van den Brink, Gertrude; Stapersma, Luuk; El Marroun, Hanan; Henrichs, Jens; Szigethy, Eva M; Utens, Elisabeth Mwj; Escher, Johanna C

    2016-01-01

    Adolescents with inflammatory bowel disease (IBD) show a higher prevalence of depression and anxiety, compared to youth with other chronic diseases. The inflammation-depression hypothesis might explain this association, and implies that treating depression can decrease intestinal inflammation and improve disease course. The present multicentre randomised controlled trial aims to test the effectiveness of an IBD-specific cognitive-behavioural therapy (CBT) protocol in reducing symptoms of subclinical depression and anxiety, while improving quality of life and disease course in adolescents with IBD. Adolescents with IBD (10-20 years) from 7 hospitals undergo screening (online questionnaires) for symptoms of depression and anxiety. Those with elevated scores of depression (Child Depression Inventory (CDI) ≥13 or Beck Depression Inventory (BDI) II ≥14) and/or anxiety (Screen for Child Anxiety Related Disorders: boys ≥26, girls ≥30) receive a psychiatric interview. Patients meeting criteria for depressive/anxiety disorders are referred for psychotherapy outside the trial. Patients with elevated (subclinical) symptoms are randomly assigned to medical care-as-usual (CAU; n=50) or CAU plus IBD-specific CBT (n=50). (1) reduction in depressive and/or anxiety symptoms after 3 months and (2) sustained remission for 12 months. quality of life, psychosocial functioning, treatment adherence. In addition, we will assess inflammatory cytokines in peripheral blood mononuclear cells and whole blood RNA expression profiles. For analysis, multilevel linear models and generalised estimating equations will be used. The Medical Ethics Committee of the Erasmus MC approved this study. If we prove that this CBT improves emotional well-being as well as disease course, implementation is recommended. NCT02265588.

  16. Randomised controlled crossover trial of the effect on PtCO2 of oxygen-driven versus air-driven nebulisers in severe chronic obstructive pulmonary disease.

    PubMed

    Edwards, Llifon; Perrin, Kyle; Williams, Mathew; Weatherall, Mark; Beasley, Richard

    2012-11-01

    The comparative safety of oxygen versus air-driven nebulised bronchodilators in patients with acute exacerbations of chronic obstructive pulmonary disease (COPD) is uncertain. A randomised controlled trial was performed to assess the effect on the arterial partial pressure of carbon dioxide of nebulised bronchodilator driven with oxygen versus air in stable severe COPD. In an open label randomised study, 18 subjects with stable severe COPD attended on 2 days to receive nebulised bronchodilator therapy driven by air or oxygen. Subjects received 5 mg salbutamol and 0.5 mg ipratropium bromide by nebulisation over 15 min, then, after 5 min, 5 mg salbutamol nebulised over 15 min, followed by 15 min of observation. Transcutaneous carbon dioxide tension (PtCO(2)) and oxygen saturations were recorded at 5 min intervals during the study. The primary outcome was the PtCO(2) after the completion of the second bronchodilator treatment. PtCO(2) was higher with nebulised bronchodilator therapy delivered by oxygen, but decreased back to the level associated with air nebulisation 15 min after completion of the second nebulised dose. One subject experienced an increase in PtCO(2) of 11 mm Hg after the first bronchodilator nebulisation driven by oxygen. The mean PtCO(2) difference between the oxygen and air groups after the second nebulisation was 3.1 mm Hg (95% CI 1.6 to 4.5, p<0.001). Nebulisers driven with oxygen result in significantly higher levels of PtCO(2) than those driven with air in patients with severe COPD. The study was registered on the Australian New Zealand Clinical Trials Registry (ACTRN12610000080022).

  17. 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

  18. Rivastigmine in apathetic but dementia and depression-free patients with Parkinson's disease: a double-blind, placebo-controlled, randomised clinical trial.

    PubMed

    Devos, David; Moreau, Caroline; Maltête, David; Lefaucheur, Romain; Kreisler, Alexandre; Eusebio, Alexandre; Defer, Gilles; Ouk, Thavarak; Azulay, Jean-Philippe; Krystkowiak, Pierre; Witjas, Tatiana; Delliaux, Marie; Destée, Alain; Duhamel, Alain; Bordet, Régis; Defebvre, Luc; Dujardin, Kathy

    2014-06-01

    Even with optimal dopaminergic treatments, many patients with Parkinson's disease (PD) are frequently incapacitated by apathy prior to the development of dementia. We sought to establish whether rivastigmine's ability to inhibit acetyl- and butyrylcholinesterases could relieve the symptoms of apathy in dementia-free, non-depressed patients with advanced PD. We performed a multicentre, parallel, double-blind, placebo-controlled, randomised clinical trial (Protocol ID: 2008-002578-36; clinicaltrials.gov reference: NCT00767091) in patients with PD with moderate to severe apathy (despite optimised dopaminergic treatment) and without dementia. Patients from five French university hospitals were randomly assigned 1:1 to rivastigmine (transdermal patch of 9.5 mg/day) or placebo for 6 months. The primary efficacy criterion was the change over time in the Lille Apathy Rating Scale (LARS) score. 101 consecutive patients were screened, 31 were eligible and 16 and 14 participants were randomised into the rivastigmine and placebo groups, respectively. Compared with placebo, rivastigmine improved the LARS score (from -11.5 (-15/-7) at baseline to -20 (-25/-12) after treatment; F(1, 25)=5.2; p=0.031; adjusted size effect: -0.9). Rivastigmine also improved the caregiver burden and instrumental activities of daily living but failed to improve quality of life. No severe adverse events occurred in the rivastigmine group. Rivastigmine may represent a new therapeutic option for moderate to severe apathy in advanced PD patients with optimised dopaminergic treatment and without depression dementia. These findings require confirmation in a larger clinical trial. Our results also confirmed that the presence of apathy can herald a pre-dementia state in PD. Clinicaltrials.gov reference: NCT00767091.

  19. Cerebrovascular effects of the thigh cuff maneuver

    PubMed Central

    Saeed, N. P.; Robinson, T. G.

    2015-01-01

    Arterial hypotension can be induced by sudden release of inflated thigh cuffs (THC), but its effects on the cerebral circulation have not been fully described. In nine healthy subjects [aged 59 (9) yr], bilateral cerebral blood flow velocity (CBFV) was recorded in the middle cerebral artery (MCA), noninvasive arterial blood pressure (BP) in the finger, and end-tidal CO2 (ETCO2) with nasal capnography. Three THC maneuvers were performed in each subject with cuff inflation 20 mmHg above systolic BP for 3 min before release. Beat-to-beat values were extracted for mean CBFV, BP, ETCO2, critical closing pressure (CrCP), resistance-area product (RAP), and heart rate (HR). Time-varying estimates of the autoregulation index [ARI(t)] were also obtained using an autoregressive-moving average model. Coherent averages synchronized by the instant of cuff release showed significant drops in mean BP, CBFV, and RAP with rapid return of CBFV to baseline. HR, ETCO2, and ARI(t) were transiently increased, but CrCP remained relatively constant. Mean values of ARI(t) for the 30 s following cuff release were not significantly different from the classical ARI [right MCA 5.9 (1.1) vs. 5.1 (1.6); left MCA 5.5 (1.4) vs. 4.9 (1.7)]. HR was strongly correlated with the ARI(t) peak after THC release (in 17/22 and 21/24 recordings), and ETCO2 was correlated with the subsequent drop in ARI(t) (19/22 and 20/24 recordings). These results suggest a complex cerebral autoregulatory response to the THC maneuver, dominated by myogenic mechanisms and influenced by concurrent changes in ETCO2 and possible involvement of the autonomic nervous system and baroreflex. PMID:25659488

  20. Disease management for co-morbid depression and anxiety in diabetes mellitus: design of a randomised controlled trial in primary care

    PubMed Central

    2011-01-01

    Background Depression and anxiety are common co-morbid health problems in patients with type 2 diabetes. Both depression and anxiety are associated with poor glycaemic control and increased risk of poor vascular outcomes and higher mortality rates. Results of previous studies have shown that in clinical practice, treatment of depression and anxiety is far from optimal as these symptoms are frequently overlooked and undertreated. Methods/Design This randomised controlled trial will examine the effectiveness of a disease management programme treating symptoms of depression and anxiety in primary care patients with Type 2 diabetes. Patients will be randomized on patient level in 1:1 ratio. Random block sizes of 2 and 4 are used. The disease management programme consists of screening, stepped treatment and monitoring of symptoms (n = 80). This will be compared to care as usual (n = 80). Discussion The disease management model for co-morbid depression and anxiety in primary care patients with diabetes is expected to result in reduced symptoms of depression and anxiety, improved quality of life, reduced diabetes specific distress and improved glyceamic control, compared to care as usual. Trial Registration Dutch Trial Register NTR2626 PMID:22171804

  1. Disease management for co-morbid depression and anxiety in diabetes mellitus: design of a randomised controlled trial in primary care.

    PubMed

    Stoop, Corinne H; Spek, Viola R M; Pop, Victor J M; Pouwer, François

    2011-12-15

    Depression and anxiety are common co-morbid health problems in patients with type 2 diabetes. Both depression and anxiety are associated with poor glycaemic control and increased risk of poor vascular outcomes and higher mortality rates. Results of previous studies have shown that in clinical practice, treatment of depression and anxiety is far from optimal as these symptoms are frequently overlooked and undertreated. This randomised controlled trial will examine the effectiveness of a disease management programme treating symptoms of depression and anxiety in primary care patients with Type 2 diabetes. Patients will be randomized on patient level in 1:1 ratio. Random block sizes of 2 and 4 are used. The disease management programme consists of screening, stepped treatment and monitoring of symptoms (n = 80). This will be compared to care as usual (n = 80). The disease management model for co-morbid depression and anxiety in primary care patients with diabetes is expected to result in reduced symptoms of depression and anxiety, improved quality of life, reduced diabetes specific distress and improved glyceamic control, compared to care as usual. Dutch Trial Register NTR2626.

  2. Glenohumeral interposition of rotator cuff stumps: a rare complication of traumatic rotator cuff tear.

    PubMed

    Agnollitto, Paulo Moraes; Chu, Marcio Wen King; Lorenzato, Mario Muller; Zatiti, Salomão Chade Assan; Nogueira-Barbosa, Marcello Henrique

    2016-01-01

    The present report describes a case where typical findings of traumatic glenohumeral interposition of rotator cuff stumps were surgically confirmed. This condition is a rare complication of shoulder trauma. Generally, it occurs in high-energy trauma, frequently in association with glenohumeral joint dislocation. Radiography demonstrated increased joint space, internal rotation of the humerus and coracoid process fracture. In addition to the mentioned findings, magnetic resonance imaging showed massive rotator cuff tear with interposition of the supraspinatus, infraspinatus and subscapularis stumps within the glenohumeral joint. Surgical treatment was performed confirming the injury and the rotator cuff stumps interposition. It is important that radiologists and orthopedic surgeons become familiar with this entity which, because of its rarity, might be neglected in cases of shoulder trauma.

  3. Glenohumeral interposition of rotator cuff stumps: a rare complication of traumatic rotator cuff tear*

    PubMed Central

    Agnollitto, Paulo Moraes; Chu, Marcio Wen King; Lorenzato, Mario Muller; Zatiti, Salomão Chade Assan; Nogueira-Barbosa, Marcello Henrique

    2016-01-01

    The present report describes a case where typical findings of traumatic glenohumeral interposition of rotator cuff stumps were surgically confirmed. This condition is a rare complication of shoulder trauma. Generally, it occurs in high-energy trauma, frequently in association with glenohumeral joint dislocation. Radiography demonstrated increased joint space, internal rotation of the humerus and coracoid process fracture. In addition to the mentioned findings, magnetic resonance imaging showed massive rotator cuff tear with interposition of the supraspinatus, infraspinatus and subscapularis stumps within the glenohumeral joint. Surgical treatment was performed confirming the injury and the rotator cuff stumps interposition. It is important that radiologists and orthopedic surgeons become familiar with this entity which, because of its rarity, might be neglected in cases of shoulder trauma. PMID:26929462

  4. Expanded allogeneic adipose-derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn's disease: a phase 3 randomised, double-blind controlled trial.

    PubMed

    Panés, Julián; García-Olmo, Damián; Van Assche, Gert; Colombel, Jean Frederic; Reinisch, Walter; Baumgart, Daniel C; Dignass, Axel; Nachury, Maria; Ferrante, Marc; Kazemi-Shirazi, Lili; Grimaud, Jean C; de la Portilla, Fernando; Goldin, Eran; Richard, Marie Paule; Leselbaum, Anne; Danese, Silvio

    2016-09-24

    Complex perianal fistulas in Crohn's disease are challenging to treat. Allogeneic, expanded, adipose-derived stem cells (Cx601) are a promising new therapeutic approach. We aimed to assess the safety and efficacy of Cx601 for treatment-refractory complex perianal fistulas in patients with Crohn's disease. We did this randomised, double-blind, parallel-group, placebo-controlled study at 49 hospitals in seven European countries and Israel from July 6, 2012, to July 27, 2015. Adult patients (≥18 years) with Crohn's disease and treatment-refractory, draining complex perianal fistulas were randomly assigned (1:1) using a pre-established randomisation list to a single intralesional injection of 120 million Cx601 cells or 24 mL saline solution (placebo), with stratification according to concomitant baseline treatment. Treatment was administered by an unmasked surgeon, with a masked gastroenterologist and radiologist assessing the therapeutic effect. The primary endpoint was combined remission at week 24 (ie, clinical assessment of closure of all treated external openings that were draining at baseline, and absence of collections >2 cm of the treated perianal fistulas confirmed by masked central MRI). Efficacy was assessed in the intention-to-treat (ITT) and modified ITT populations; safety was assessed in the safety population. This study is registered with ClinicalTrials.gov, number NCT01541579. 212 patients were randomly assigned: 107 to Cx601 and 105 to placebo. A significantly greater proportion of patients treated with Cx601 versus placebo achieved combined remission in the ITT (53 of 107 [50%] vs 36 of 105 [34%]; difference 15·2%, 97·5% CI 0·2-30·3; p=0·024) and modified ITT populations (53 of 103 [51%] vs 36 of 101 [36%]; 15·8%, 0·5-31·2; p=0·021). 18 (17%) of 103 patients in the Cx601 group versus 30 (29%) of 103 in the placebo group experienced treatment-related adverse events, the most common of which were anal abscess (six in the Cx601 group vs nine

  5. The Lake Victoria Island Intervention Study on Worms and Allergy-related diseases (LaVIISWA): study protocol for a randomised controlled trial.

    PubMed

    Nampijja, Margaret; Webb, Emily L; Kaweesa, James; Kizindo, Robert; Namutebi, Milly; Nakazibwe, Esther; Oduru, Gloria; Kabuubi, Prossy; Kabagenyi, Joyce; Kizito, Dennison; Muhangi, Lawrence; Akello, Mirriam; Verweij, Jaco J; Nerima, Barbara; Tukahebwa, Edridah; Elliott, Alison M

    2015-04-23

    The Hygiene Hypothesis proposes that infection exposure protects against inflammatory conditions. Helminths possess allergen-like molecules and may specifically modulate allergy-related immunological pathways to inhibit responses which protect against them. Mass drug administration is recommended for helminth-endemic communities to control helminth-induced pathology, but may also result in increased rates of inflammation-mediated diseases in resource-poor settings. Immunological studies integrated with implementation of helminth control measures may elucidate how helminth elimination contributes to ongoing epidemics of inflammatory diseases. We present the design of the Lake Victoria Island Intervention Study on Worms and Allergy-related diseases (LaVIISWA), a cluster-randomised trial evaluating the risks and benefits of intensive versus standard anthelminthic treatment for allergy-related diseases and other health outcomes. The setting is comprised of island fishing communities in Mukono district, Uganda. Twenty-six communities have been randomised in a 1:1 ratio to receive standard or intensive anthelminthic intervention for a three-year period. Baseline characteristics were collected immediately prior to intervention rollout, commenced in February 2013. Primary outcomes are reported wheeze in the past 12 months and atopy (skin prick test response and allergen-specific immunoglobulin (asIg) E concentration). Secondary outcomes are visible flexural dermatitis, helminth infections, haemoglobin, growth parameters, hepatosplenomegaly, and responses to vaccine antigens. The trial provides a platform for in-depth analysis of clinical and immunological consequences of the contrasting interventions. The baseline survey has been completed successfully in a challenging environment. Baseline characteristics were balanced between trial arms. Prevalence of Schistosoma mansoni, hookworm, Strongyloides stercoralis and Trichuris trichiura was 52%, 23%, 13%, and 12%, respectively

  6. The INSPIRED study: a randomised controlled trial of the Whole Person Model of disease self-management for people with type 2 diabetes.

    PubMed

    Clarke, David M; Baird, Donita E; Perera, Dinali N; Hagger, Virginia L; Teede, Helena J

    2014-02-08

    The prevalence of type 2 diabetes has increased dramatically in the last decade, and is continuing to rise. It is a chronic condition, often related to obesity, diet and sedentary lifestyles, and can lead to significant health complications, disability and early death. Diabetes is commonly associated with depression, which can impact significantly on a person's ability to manage their illness and, consequently, on disease outcomes. Disease self-management is fundamental in diabetes and requires support from multiple health professionals and the active participation of the person, including in maintaining a healthy lifestyle. The Whole Person Model was developed in order to integrate emotional and behavioural aspects into a self-management program for people with type 2 diabetes. Here we describe a study designed to test the efficacy of the Whole Person Model of disease self-management in type 2 diabetes. In a parallel-group randomised trial, 180 people with type 2 diabetes of between 2-10 years duration will be recruited via invitation through the Australian National Diabetes Services Scheme. Participants will undergo baseline assessment, followed by randomisation to either intervention or control condition. Control participants will receive fact sheets containing key information about diabetes self-management. The intervention group will receive the INSPIRED (Individual Support & Resources for Diabetes) Manual and be assigned a Health Coach. The INSPIRED Manual consists of six modules that provide key information about diabetes and disease management using the Whole Person Model. Engagement is facilitated by interactive tasks and contact with a Health Coach over seven weeks--an introductory face-to-face session, and six subsequent contacts by phone following each module. Follow-up assessments occur at 13 weeks (post-intervention) and 26 weeks. Primary outcomes include blood glucose management (HbA1c), weight and mood. Secondary outcomes include level of exercise

  7. [Arthroscopic treatment of rotator cuff calcifying tendinitis].

    PubMed

    Ozkoç, Gürkan; Akpinar, Sercan; Hersekli, Murat Ali; Ozalay, Metin; Tandoğan, Reha N

    2002-01-01

    We evaluated the effectiveness of arthroscopic treatment in patients with rotator cuff calcifying tendinitis unresponsive to conservative treatment. Arthroscopic treatment was performed in 10 patients (6 females, 4 males; mean age 46 years; range 34 to 53 years) in whom pain and functional disability persisted for more than a year despite conservative therapy for rotator cuff calcifying tendinitis. Arthroscopic bursectomy was also carried out. One patient underwent repair for rotator cuff tear. The patients were evaluated before and after surgery with the use of Constant scores and direct radiographs. The mean follow-up period was 12 months (range 6 to 19 months). The mean Constant scores were 66 (range 45 to 70) and 93 (range 89 to 96) before surgery and on final examinations, respectively. Postoperative radiographs demonstrated incomplete removal of calcifications in four patients; however, complaints of pain disappeared in these patients and radiologic controls showed that residual deposits underwent spontaneous resorption. Arthroscopic removal of calcium deposits together with bursectomy seems to be effective and reliable in patients with chronic calcifying tendinitis unresponsive to conservative treatment.

  8. Biological Augmentation of Rotator Cuff Tendon Repair

    PubMed Central

    Kovacevic, David

    2008-01-01

    A histologically normal insertion site does not regenerate following rotator cuff tendon-to-bone repair, which is likely due to abnormal or insufficient gene expression and/or cell differentiation at the repair site. Techniques to manipulate the biologic events following tendon repair may improve healing. We used a sheep infraspinatus repair model to evaluate the effect of osteoinductive growth factors and BMP-12 on tendon-to-bone healing. Magnetic resonance imaging and histology showed increased formation of new bone and fibrocartilage at the healing tendon attachment site in the treated animals, and biomechanical testing showed improved load-to-failure. Other techniques with potential to augment repair site biology include use of platelets isolated from autologous blood to deliver growth factors to a tendon repair site. Modalities that improve local vascularity, such as pulsed ultrasound, have the potential to augment rotator cuff healing. Important information about the biology of tendon healing can also be gained from studies of substances that inhibit healing, such as nicotine and antiinflammatory medications. Future approaches may include the use of stem cells and transcription factors to induce formation of the native tendon-bone insertion site after rotator cuff repair surgery. PMID:18264850

  9. Design and rationale of the tobacco, exercise and diet messages (TEXT ME) trial of a text message-based intervention for ongoing prevention of cardiovascular disease in people with coronary disease: a randomised controlled trial protocol

    PubMed Central

    Chow, C K; Thiagalingam, A; Jan, S; Whittaker, R; Hackett, M; Graves, N; Mooney, J; Hillis, G S

    2012-01-01

    Background Although supporting lifestyle change is an effective way of preventing further events in people with cardiovascular disease, providing access to such interventions is a major challenge. This study aims to investigate whether simple reminders about behaviour change sent via mobile phone text message decrease cardiovascular risk. Methods and analysis Randomised controlled trial with 6 months of follow-up to evaluate the feasibility, acceptability and effect on cardiovascular risk of repeated lifestyle reminders sent via mobile phone text messages compared to usual care. A total of 720 patients with coronary artery disease will be randomised to either standard care or the TEXT ME intervention. The intervention group will receive multiple weekly text messages that provide information, motivation, support to quit smoking (if relevant) and recommendations for healthy diets and exercise. The primary end point is a change in plasma low-density lipoprotein cholesterol at 6 months. Secondary end points include a change in systolic blood pressure, smoking status, quality of life, medication adherence, waist circumference, physical activity levels, nutritional status and mood at 6 months. Process outcomes related to acceptability and feasibility of TEXT ME will also be collected. Ethics and dissemination Primary ethics approval was received from Western Sydney Local Health Network Human Research Ethics Committee—Westmead. Results will be disseminated via the usual scientific forums including peer-reviewed publications and presentations at international conferences. Clinical trials registration number ACTRN12611000161921. PMID:22267690

  10. Current concepts: rotator cuff pathology in athletes--a source of pain or adaptive pathology?

    PubMed

    Kuhn, John E

    2013-01-01

    Magnetic resonance imaging (MRI) findings are common in patients and athletes with shoulder pain. Historically these anatomic derangements have been thought to be the source of the patient's symptoms, and approaches have been focused on restoring the anatomy. This manuscript will address three objectives: (1) suggest that the approach to rotator cuff disease should be based on the patient's history and physical examination, and not necessarily on the anatomic disorders apparent on imaging; (2) review the data that supports the contention that rotator cuff disease is not the source of pain in the symptomatic shoulder, and (3) describe the concept of adaptive pathology. The findings on the MRI in the thrower's painful shoulder may be adaptive, and these alterations may be required to allow performance at high levels in sport.

  11. Retraction pattern of delaminated rotator cuff tears: dual-layer rotator cuff repair.

    PubMed

    Cha, Sang-Won; Lee, Choon-Key; Sugaya, Hiroyuki; Kim, Taegyun; Lee, Su-Chan

    2016-07-06

    There has been no report to date regarding retraction patterns of delaminated rotator cuff tears. The purpose of this study was to evaluate the incidence and tearing patterns of delamination and repair integrity after the dual-layer repair of delaminated cuff tears. A consecutive series of 64 patients with posterosuperior rotator cuff tears underwent arthroscopic rotator cuff repair from August 2011 to September 2012. Among the patients, 53 who received either dual-layer double-row (DLDR) repair or dual-layer suture bridge (DLSB) repair and 11 who received a single-layer repair were evaluated. The mean follow-up period after surgery was 26.5 months. The retraction direction of the deep and superficial layers was analyzed, and the integrity of the repaired constructs was determined in 37 patients through magnetic resonance imaging at a mean of 12.1 months after surgery. The incidence of delamination was 82.8 %. Posteromedial retraction of the deep and superficial layers was observed in 98.1 and 88.5 % of cases, respectively. The Constant score and UCLA score increased preoperatively to postoperatively, showing no significant differences between the dual-layer repair group and single-layer repair group. Retear was found in two (7.6 %) patients in the dual-layer repair group and three (27.2 %) patients in the single-layer repair group (p = 0.016). Differential rotator cuff repair strategies are needed to address rotator cuff tears, since recent studies have changed our concept of rotator cuff tears. We have focused on three areas: incidence, retraction patterns, and clinical outcomes. The incidence of delamination was extremely high. Both the superficial layer and deep layer were mainly retracted posteromedially. The retraction of the deep layer and superficial layer may be affected by the infraspinatus. Dual-layer rotator cuff repair based on the retraction pattern of delamination is recommended for improvement of repair integrity and of clinical outcomes.

  12. Symptomatic Progression of Asymptomatic Rotator Cuff Tears

    PubMed Central

    Mall, Nathan A.; Kim, H. Mike; Keener, Jay D.; Steger-May, Karen; Teefey, Sharlene A.; Middleton, William D.; Stobbs, Georgia; Yamaguchi, Ken

    2010-01-01

    Background: The purposes of this study were to identify changes in tear dimensions, shoulder function, and glenohumeral kinematics when an asymptomatic rotator cuff tear becomes painful and to identify characteristics of individuals who develop pain compared with those who remain asymptomatic. Methods: A cohort of 195 subjects with an asymptomatic rotator cuff tear was prospectively monitored for pain development and examined annually for changes in various parameters such as tear size, fatty degeneration of the rotator cuff muscle, glenohumeral kinematics, and shoulder function. Forty-four subjects were found to have developed new pain, and the parameters before and after pain development were compared. The forty-four subjects were then compared with a group of fifty-five subjects who remained asymptomatic over a two-year period. Results: With pain development, the size of a full-thickness rotator cuff tear increased significantly, with 18% of the full-thickness tears showing an increase of >5 mm, and 40% of the partial-thickness tears had progressed to a full-thickness tear. In comparison with the assessments made before the onset of pain, the American Shoulder and Elbow Surgeons scores for shoulder function were significantly decreased and all measures of shoulder range of motion were decreased except for external rotation at 90° of abduction. There was an increase in compensatory scapulothoracic motion in relation to the glenohumeral motion during early shoulder abduction with pain development. No significant changes were found in external rotation strength or muscular fatty degeneration. Compared with the subjects who remained asymptomatic, the subjects who developed pain were found to have significantly larger tears at the time of initial enrollment. Conclusions: Pain development in shoulders with an asymptomatic rotator cuff tear is associated with an increase in tear size. Larger tears are more likely to develop pain in the short term than are smaller

  13. Outer diameter and shape of paediatric tracheal tube cuffs at higher inflation pressures.

    PubMed

    Bernet, V; Dullenkopf, A; Maino, P; Weiss, M

    2005-11-01

    Cuffed tracheal tubes are becoming increasingly popular in paediatric anaesthesia and intensive care medicine. To avoid cuff related complications and airway morbidity, a thorough understanding of cuff volume/pressure behaviour and management is required. In this study, the outer cuff diameter and form stability of the cuff at high cuff pressure were assessed in a series of different paediatric cuffed tracheal tubes with internal diameter of between 3.0 and 5.0 mm. The main findings were that small amounts of inflated air led to a rapid increase in cuff pressure and volume and that the outer cuff diameters increased to 2-2.5 times the age-corresponding internal tracheal diameter following inadvertent syringe inflation. Careful cuff inflation under cuff pressure monitoring and/or automatic cuff pressure release is recommended in paediatric tracheal tube cuffs to prevent airway damage caused by manual inflation, pilot balloon compression and nitrous oxide diffusion.

  14. A home program of strength training, movement strategy training and education did not prevent falls in people with Parkinson's disease: a randomised trial.

    PubMed

    Morris, Meg E; Taylor, Nicholas F; Watts, Jennifer J; Evans, Andrew; Horne, Malcolm; Kempster, Peter; Danoudis, Mary; McGinley, Jennifer; Martin, Clarissa; Menz, Hylton B

    2017-04-01

    For people with idiopathic Parkinson's disease, does a 6-week, comprehensive, home exercise program reduce falls and disability and improve health-related quality of life? Is the program cost-effective? Randomised, controlled trial with concealed allocation and assessor blinding. One hundred and thirty-three community-dwelling adults with Parkinson's disease. The experimental group completed a 6-week home program comprising progressive resistance strength training, movement strategy training and falls education. The control group completed 6 weeks of non-specific life skills training. Participants in both groups received weekly therapist-guided sessions for 6 consecutive weeks and a weekly self-directed home program. The primary outcome was the rate of falls, documented for the 12-month period immediately after therapy. Secondary outcomes were disability and health-related quality of life, assessed before and after intervention and at a 12-month follow-up. A total of 2255 falls were reported by the 12-month follow-up. The proportion of fallers in the experimental and control groups was 61 and 72%, respectively, which was not statistically significantly different (RR=0.85, 95% CI 0.66 to 1.09). There was no significant between-group difference in the rate of falls (incidence rate ratio=1.58, 95% CI 0.73 to 3.43). A survival analysis of participant time to first fall did not show a significant between-group difference (log-rank test χ(2)=0.79, p=0.37). No significant between-group differences occurred for mobility, disability or quality of life. The mean cost of delivering the experimental intervention was AUD1596. A home program of strength and movement strategy training and falls education does not prevent falls when applied at the dose used in this study. Arguably, the dosage of therapy was insufficient. Future trials need to explore further therapy content, repetitions and duration, in order to optimise outcomes and cost-effectiveness. [Morris ME, Taylor NF

  15. The effects of a mindfulness-based lifestyle programme for adults with Parkinson's disease: protocol for a mixed methods, randomised two-group control study.

    PubMed

    Advocat, Jenny; Russell, Grant; Enticott, Joanne; Hassed, Craig; Hester, Jennifer; Vandenberg, Brooke

    2013-10-10

    Parkinson's disease (PD) is the second most common neurodegenerative disorder in developed countries. There is an increasing interest in the use of mindfulness-related interventions in the management of patients with a chronic disease. In addition, interventions that promote personal control, stress-management and other lifestyle factors, such as diet and exercise, assist in reducing disability and improving quality of life in people with chronic illnesses. There has been little research in this area for people with PD. A prospective mixed-method randomised clinical trial involving community living adults with PD aged <76 years and with moderate disease severity (Hoehn and Yahr stage 2) PD. Participants will be randomised into the ESSENCE 6-week programme or a matched wait list control group. ESSENCE is a multifaceted, healthy lifestyle and mindfulness programme designed to improve quality of life. We aim to determine whether participation in a mindfulness and lifestyle programme could improve PD-related function and explore self-management related experiences and changing attitudes towards self-management. The outcome measures will include 5 self-administered questionnaires: PD function and well-being questionnaire (PDQ39), Health Behaviours, Mental health, Multidimensional locus of control, and Freiburg mindfulness inventory. An embedded qualitative protocol will include in-depth interviews with 12 participants before and after participation in the 6-week programme and a researcher will observe the programme and take notes. Repeated measures of Analysis of Variance (ANOVA) will examine the outcome measures for any significant effects from the group allocation, age, sex, adherence score and attendance. Qualitative data will be analysed thematically. We will outline the benefits of, and barriers to, the uptake of the intervention. This protocol has received ethics approval from the Monash University Human Research Ethics Committee project number CF11

  16. Measurement of endotracheal tube cuff pressure: Instrumental versus conventional method

    PubMed Central

    Khan, Mueen Ullah; Khokar, Rashid; Qureshi, Sadia; Al Zahrani, Tariq; Aqil, Mansoor; Shiraz, Motasim

    2016-01-01

    Objective: To evaluate the conventional practice of endotracheal tube (ETT) cuff inflation and pressure measurement as compared to the instrumental method. Study Design: Prospective observational study. Place and Duration of Study: Department of Anaesthesia, King Saud University Hospital, Riyadh, Saudi Arabia (June 2014–July 2014). Methods: A total of 100 adult patients were observed according to the syringe size used Group-1 (10 ml) and Group-2 (20 ml) for ETT cuff inflation in general anesthesia. Patients with anticipated difficult intubation, risk for aspiration, known anatomical laryngotracheal abnormalities, and emergency cases were excluded. Trachea was intubated with size 8 or 8.5 mm and 7.0 or 7.5 mm ETT in male and female patients respectively. The ETT cuff was inflated with air by one of the anesthesia technician. Cuff pressures were measured using aneroid manometer. ETT cuff pressure of 20–30 cm of water was considered as standard. Results: In 69% of the patients, the cuff pressure measurements were above the standard. Age (P = 0.806), weight (P = 0.527), height (P = 0.850), and gender (P = 1.00) were comparable in both groups. The mean cuff pressure in Group-1 and Group-2 was 32.52 ± 6.39 and 38.90 ± 6.60 cm of water (P = 0.001). The cuff inflation with 20 ml syringe resulted in higher cuff pressure as compared to 10cc syringe 37.73 ± 4.23 versus 40.74 ± 5.01 (86% vs. 52%, P = 0.013). Conclusion: The conventional method for ETT cuff inflation and pressure measuring is unreliable. As a routine instrumental cuff pressure, monitoring is suggested. PMID:27833487

  17. CDP571, a humanised monoclonal antibody to tumour necrosis factor alpha, for moderate to severe Crohn's disease: a randomised, double blind, placebo controlled trial.

    PubMed

    Sandborn, W J; Feagan, B G; Radford-Smith, G; Kovacs, A; Enns, R; Innes, A; Patel, J

    2004-10-01

    Targeting tumour necrosis factor alpha (TNF-alpha) has demonstrated efficacy in Crohn's disease. To evaluate CDP571, a humanised antibody to TNF-alpha, for treating active Crohn's disease. A total of 396 patients with moderate to severe Crohn's disease. In a 28 week, randomised, double blind, placebo controlled trial, patients received intravenous CDP571 (10 mg/kg) or placebo every eight weeks to week 24. The primary outcome measure was clinical response (a decrease in the Crohn's disease activity index (CDAI) to > or =100 points or remission (CDAI score < or =150 points)) at week 28. A secondary outcome measure was clinical response (using the same definition) at week 2. Clinical response occurred at week 28 in 80/263 (30.4%) CDP571 patients and 31/132 (23.5%) placebo patients (p = 0.102). Clinical response at week 2 occurred in 90/263 (34.2%) CDP571 patients and 28/132 (21.2%) placebo patients (p = 0.011). Post hoc exploratory subgroup analysis of 159 patients with baseline C reactive protein (CRP) > or =10 mg/l demonstrated significant differences between CDP571 and placebo in clinical response rates at weeks 2 (CDP571, 50/101 (49.5%); placebo, 9/58 (15.5%); p<0.001) and 28 (CDP571, 29/101 (28.7%); placebo, 7/58 (12.1%); p = 0.018). Adverse events occurred at similar frequencies in both treatment groups. CDP571 is modestly effective for short but not long term treatment of unselected patients with moderate to severe Crohn's disease. The clinical relevance of this short term effect is unclear. Post hoc analysis suggests both short and long term efficacy of CDP571 in patients with elevated baseline CRP (> or =10 mg/l). CDP571 is well tolerated.

  18. Adalimumab combined with ciprofloxacin is superior to adalimumab monotherapy in perianal fistula closure in Crohn's disease: a randomised, double-blind, placebo controlled trial (ADAFI).

    PubMed

    Dewint, Pieter; Hansen, Bettina E; Verhey, Elke; Oldenburg, Bas; Hommes, Daniel W; Pierik, Marieke; Ponsioen, Cyriel I J; van Dullemen, Hendrik M; Russel, Maurice; van Bodegraven, Ad A; van der Woude, C Janneke

    2014-02-01

    To assess whether a combination of adalimumab and ciprofloxacin is superior to adalimumab alone in the treatment of perianal fistulising Crohn's disease (CD). Randomised, double-blind, placebo controlled trial in eight Dutch hospitals. In total, 76 CD patients with active perianal fistulising disease were enrolled. After adalimumab induction therapy (160/80 mg week 0, 2), patients received 40 mg every other week together with ciprofloxacin 500 mg or placebo twice daily for 12 weeks. After 12 weeks, adalimumab was continued. Follow-up was 24 weeks. Primary endpoint (clinical response) was defined as 50% reduction of fistulas from baseline to week 12. Secondary endpoints included remission (closure of all fistulas), Perianal Crohn's Disease Activity Index, Crohn's Disease Activity Index (CDAI) and Inflammatory Bowel Disease Questionnaire (IBDQ). Clinical response was observed in 71% of patients treated with adalimumab plus ciprofloxacin and in 47% treated with adalimumab plus placebo (p=0.047). Likewise, remission rate at week 12 was significantly higher (p=0.009) in the combination group (65%) compared with adalimumab plus placebo (33%). Combination treatment was associated with a higher mean CDAI change and mean IBDQ change at week 12 (p=0.005 and p=0.009, respectively). At week 24, no difference in clinical response between the two treatment groups was observed (p=0.22). No difference in safety issues was observed. Combination therapy of adalimumab and ciprofloxacin is more effective than adalimumab monotherapy to achieve fistula closure in CD. However, after discontinuation of antibiotic therapy, the beneficial effect of initial coadministration is not maintained. ClinicalTrials.gov Identifier: NCT00736983.

  19. Comparison of three types of exercise in the treatment of rotator cuff tendinopathy/shoulder impingement syndrome: A randomized controlled trial.

    PubMed

    Heron, Stuart R; Woby, Steve R; Thompson, Dave P

    2017-06-01

    To assess the efficacy of three different exercise programmes in treating rotator cuff tendinopathy/shoulder impingement syndrome. Parallel group randomised clinical trial. Two out-patient NHS physiotherapy departments in Manchester, United Kingdom. 120 patients with shoulder pain of at least three months duration. Pain was reproduced on stressing the rotator cuff and participants had full passive range of movement at the shoulder. Three dynamic rotator cuff loading programmes; open chain resisted band exercises (OC) closed chain exercises (CC) and minimally loaded range of movement exercises (ROM). Change in Shoulder Pain and Disability Index (SPADI) score and the proportion of patients making a Minimally Clinically Important Change (MCIC) in symptoms 6 weeks after commencing treatment. All three programmes resulted in significant decreases in SPADI score, however there were no significant differences between the groups. Participants making a MCIC in symptoms were similar across all groups, however more participants deteriorated in the ROM group. Dropout rate was higher in the CC group, but when only patients completing treatment were considered more patients in the CC group made a meaningful reduction in pain and disability. Open chain, closed chain and range of movement exercises all seem to be effective in bringing about short term changes in pain and disability in patients with rotator cuff tendinopathy. ISRCTN76701121. Crown Copyright © 2016. Published by Elsevier Ltd. All rights reserved.

  20. Meta-analysis of randomised controlled trials in patients with primary IgA nephropathy (Berger's disease).

    PubMed

    Schena, F P; Montenegro, M; Scivittaro, V

    1990-01-01

    An overview of the papers published in the last 10 years was performed to evaluate whether treatment with currently available drugs was beneficial in patients with primary IgA nephropathy (IgAN). Eight selected papers involving 196 IgAN patients with moderate or heavy proteinuria, associated in some cases with the nephrotic syndrome, were analysed. The criteria for inclusion were strict, because meta-analysis requires randomised controlled trials with full descriptions. Furthermore, papers were selected in which treatment was performed on IgAN patients with proteinuria, since prognosis is poor in the presence of this sign. The results of statistical analysis show that IgAN patients with heavy proteinuria, whether or not associated with the nephrotic syndrome, benefit from the administration of corticosteroids and/or cytotoxic drugs, as 66.7% of patients had complete or partial remission both in controlled trials and in retrospective studies; renal function also improved in treated patients. In contrast, no beneficial effect was observed in IgAN patients with moderate proteinuria. These results suggest that it is advisable to administer corticosteroids and/or cytotoxic drugs to IgAN patients with heavy proteinuria, irrespective of the association of this condition with the nephrotic syndrome in individual patients.

  1. Study protocol: Randomised controlled trial to evaluate the impact of an educational programme on Alzheimer’s disease patients’ quality of life

    PubMed Central

    2014-01-01

    Introduction Therapeutic education is expanding in the management of Alzheimer’s disease (AD) patients. Several studies have revealed a positive impact of therapeutic educational programmes on the caregiver’s burden and/or quality of life. However, to date, no study has evaluated its impact on the quality of life of the AD patient. Methods The THERAD study (THerapeutic Education in Alzheimer’s Disease) is a 12-month randomised controlled trial that started in January 2013. This paper describes the study protocol. THERAD plans to enroll 170 dyads (AD patient and caregiver) on the basis of the following criteria: patient at a mild to moderately severe stage of AD, living at home, receiving support from a family caregiver. The main outcome is the patient’s quality of life assessed by the Logsdon QoL-AD scale at 2 months, reported by the caregiver. The study is being led by geriatricians trained in therapeutic education at Toulouse University Hospital in France. To date, 107 caregiver/patient dyads have been recruited. Conclusion This is the first trial designed to assess the specific impact of a therapeutic educational programme on the AD patient’s quality of life. The final results will be available in 2015. Trial registration [ClinicalTrials.gov: NCT01796314] Registered 19 February 2013 PMID:25478028

  2. Cost-effectiveness of functional cardiac testing in the diagnosis and management of coronary artery disease: a randomised controlled trial. The CECaT trial.

    PubMed

    Sharples, L; Hughes, V; Crean, A; Dyer, M; Buxton, M; Goldsmith, K; Stone, D

    2007-12-01

    To assess the acceptability and feasibility of functional tests as a gateway to angiography for management of coronary artery disease (CAD), the ability of diagnostic strategies to identify patients who should undergo revascularisation, patient outcomes in each diagnostic strategy, and the most cost-effective diagnostic strategy for patients with suspected or known CAD. A rapid systematic review of economic evaluations of alternative diagnostic strategies for CAD was carried out. A pragmatic and generalisable randomised controlled trial was undertaken to assess the use of the functional cardiac tests: angiography (controls); single photon emission computed tomography (SPECT); magnetic resonance imaging (MRI); stress echocardiography. The setting was Papworth Hospital NHS Foundation Trust, a tertiary cardiothoracic referral centre. Patients with suspected or known CAD and an exercise test result that required non-urgent angiography. Patients were randomised to one of the four initial diagnostic tests. Eighteen months post-randomisation: exercise time (modified Bruce protocol); cost-effectiveness compared with angiography (diagnosis, treatment and follow-up costs). The aim was to demonstrate equivalence in exercise time between those randomised to functional tests and those randomised to angiography [defined as the confidence interval (CI) for mean difference from angiography within 1 minute]. The 898 patients were randomised to angiography (n = 222), SPECT (n = 224), MRI (n = 226) or stress echo (n = 226). Initial diagnostic tests were completed successfully with unequivocal results for 98% of angiography, 94% of SPECT (p = 0.05), 78% of MRI (p < 0.001) and 90% of stress echocardiography patients (p < 0.001). Some 22% of SPECT patients, 20% of MRI patients and 25% of stress echo patients were not subsequently referred for an angiogram. Positive functional tests were confirmed by positive angiography in 83% of SPECT patients, 89% of MRI patients and 84% of stress

  3. The Effect of Endotracheal Inflation Technique on Endotracheal Cuff Pressure

    DTIC Science & Technology

    1999-10-01

    estimation of cuff pressure, with no effect of provider experience on accuracy (Fernandez, Blanch, Mancebo, Bonsoms, & Artigas , 1990). With the minimal...London: Oxford University Press. Fernandez, R., Blanch, L., Mancebo, J., Bonsoms, N., Artigas , A. (1990). Endotracheal tube cuff pressure assessment

  4. Rotator Cuff Damage: Reexamining the Causes and Treatments.

    ERIC Educational Resources Information Center

    Nash, Heyward L.

    1988-01-01

    Sports medicine specialists are beginning to reexamine the causes and treatments of rotator cuff problems, questioning the role of primary impingement in a deficient or torn cuff and trying new surgical procedures as alternatives to the traditional open acromioplasty. (Author/CB)

  5. Rotator Cuff Damage: Reexamining the Causes and Treatments.

    ERIC Educational Resources Information Center

    Nash, Heyward L.

    1988-01-01

    Sports medicine specialists are beginning to reexamine the causes and treatments of rotator cuff problems, questioning the role of primary impingement in a deficient or torn cuff and trying new surgical procedures as alternatives to the traditional open acromioplasty. (Author/CB)

  6. Internet-based treatment for older adults with depression and co-morbid cardiovascular disease: protocol for a randomised, double-blind, placebo controlled trial.

    PubMed

    Cockayne, Nicole L; Glozier, Nick; Naismith, Sharon L; Christensen, Helen; Neal, Bruce; Hickie, Ian B

    2011-01-14

    Depression, cardiovascular disease (CVD) risk factors and cognitive impairment are important causes of disability and poor health outcomes. In combination they lead to an even worse prognosis. Internet or web-based interventions have been shown to deliver efficacious psychological intervention programs for depression on a large scale, yet no published studies have evaluated their impact among patients with co-existing physical conditions. The aims of this randomised controlled trial are to determine the effects of an evidence-based internet intervention program for depression on depressive mood symptoms, cognitive function and treatment adherence in patients at risk of CVD. This study is an internet-based, double-blind, parallel group randomised controlled trial. The trial will compare the effectiveness of online cognitive behavioural therapy with an online attention control placebo. The trial will consist of a 12-week intervention phase with a 40-week follow-up. It will be conducted in urban and rural New South Wales, Australia and will recruit a community-based sample of adults aged 45 to 75 years. Recruitment, intervention, cognitive testing and follow-up data collection will all be internet-based and automated. The primary outcome is a change in severity of depressive symptoms from baseline to three-months. Secondary outcomes are changes in cognitive function and adherence to treatment for CVD from baseline to three, six and 12-months. Prior studies of depression amongst patients with CVD have targeted those with previous vascular events and major depression. The potential for intervening earlier in these disease states appears to have significant potential and has yet to be tested. Scalable psychological programs using web-based interventions could deliver care to large numbers in a cost effective way if efficacy were proved. This study will determine the effects of a web-based intervention on depressive symptoms and adherence to treatment among patients at

  7. Effects of cardiac telerehabilitation in patients with coronary artery disease using a personalised patient-centred web application: protocol for the SmartCare-CAD randomised controlled trial.

    PubMed

    Brouwers, Rutger W M; Kraal, Jos J; Traa, Simone C J; Spee, Ruud F; Oostveen, Laurence M L C; Kemps, Hareld M C

    2017-01-31

    Cardiac rehabilitation has beneficial effects on morbidity and mortality in patients with coronary artery disease, but is vastly underutilised and short-term improvements are often not sustained. Telerehabilitation has the potential to overcome these barriers, but its superiority has not been convincingly demonstrated yet. This may be due to insufficient focus on behavioural change and development of patients' self-management skills. Moreover, potentially beneficial communication methods, such as internet and video consultation, are rarely used. We hypothesise that, when compared to centre-based cardiac rehabilitation, cardiac telerehabilitation using evidence-based behavioural change strategies, modern communication methods and on-demand coaching will result in improved self-management skills and sustainable behavioural change, which translates to higher physical activity levels in a cost-effective way. This randomised controlled trial compares cardiac telerehabilitation with centre-based cardiac rehabilitation in patients with coronary artery disease. We randomise 300 patients entering cardiac rehabilitation to centre-based cardiac rehabilitation (control group) or cardiac telerehabilitation (intervention group). The core component of the intervention is a patient-centred web application, which enables patients to adjust rehabilitation goals, inspect training and physical activity data, share data with other caregivers and to use video consultation. After six supervised training sessions, the intervention group continues exercise training at home, wearing an accelerometer and heart rate monitor. In addition, physical activity levels are assessed by the accelerometer for four days per week. Patients upload training and physical activity data weekly and receive feedback through video consultation once a week. After completion of the rehabilitation programme, on-demand coaching is performed when training adherence or physical activity levels decline with 50% or more

  8. Advance care planning uptake among patients with severe lung disease: a randomised patient preference trial of a nurse-led, facilitated advance care planning intervention

    PubMed Central

    Sinclair, Craig; Auret, Kirsten Anne; Evans, Sharon Frances; Williamson, Fiona; Dormer, Siobhan; Greeve, Kim; Koay, Audrey; Price, Dot; Brims, Fraser

    2017-01-01

    Objective Advance care planning (ACP) clarifies goals for future care if a patient becomes unable to communicate their own preferences. However, ACP uptake is low, with discussions often occurring late. This study assessed whether a systematic nurse-led ACP intervention increases ACP in patients with advanced respiratory disease. Design A multicentre open-label randomised controlled trial with preference arm. Setting Metropolitan teaching hospital and a rural healthcare network. Participants 149 participants with respiratory malignancy, chronic obstructive pulmonary disease or interstitial lung disease. Intervention Nurse facilitators offered facilitated ACP discussions, prompted further discussions with doctors and loved ones, and assisted participants to appoint a substitute medical decision-maker (SDM) and complete an advance directive (AD). Outcome measures The primary measure was formal (AD or SDM) or informal (discussion with doctor) ACP uptake assessed by self-report (6 months) and medical notes audit. Secondary measures were the factors predicting baseline readiness to undertake ACP, and factors predicting postintervention ACP uptake in the intervention arm. Results At 6 months, formal ACP uptake was significantly higher (p<0.001) in the intervention arm (54/106, 51%), compared with usual care (6/43, 14%). ACP discussions with doctors were also significantly higher (p<0.005) in the intervention arm (76/106, 72%) compared with usual care (20/43, 47%). Those with a strong preference for the intervention were more likely to complete formal ACP documents than those randomly allocated. Increased symptom burden and preference for the intervention predicted later ACP uptake. Social support was positively associated with ACP discussion with loved ones, but negatively associated with discussion with doctors. Conclusions Nurse-led facilitated ACP is acceptable to patients with advanced respiratory disease and effective in increasing ACP discussions and completion

  9. The Manual Diaphragm Release Technique improves diaphragmatic mobility, inspiratory capacity and exercise capacity in people with chronic obstructive pulmonary disease: a randomised trial.

    PubMed

    Rocha, Taciano; Souza, Helga; Brandão, Daniela Cunha; Rattes, Catarina; Ribeiro, Luana; Campos, Shirley Lima; Aliverti, Andrea; de Andrade, Armèle Dornelas

    2015-10-01

    In people with chronic obstructive pulmonary disease, does the Manual Diaphragm Release Technique improve diaphragmatic mobility after a single treatment, or cumulatively? Does the technique also improve exercise capacity, maximal respiratory pressures, and kinematics of the chest wall and abdomen? Randomised, controlled trial with concealed allocation, intention-to-treat analysis, and blinding of participants and assessors. Twenty adults aged over 60 years with clinically stable chronic obstructive pulmonary disease. The experimental group received six treatments with the Manual Diaphragm Release Technique on non-consecutive days within a 2-week period. The control group received sham treatments following the same regimen. The primary outcome was diaphragmatic mobility, which was analysed using ultrasonography. The secondary outcomes were: the 6-minute walk test; maximal respiratory pressures; and abdominal and chest wall kinematics measured by optoelectronic plethysmography. Outcomes were measured before and after the first and sixth treatments. The Manual Diaphragm Release Technique significantly improved diaphragmatic mobility over the course of treatments, with a between-group difference in cumulative improvement of 18mm (95% CI 8 to 28). The technique also significantly improved the 6-minute walk distance over the treatment course, with a between-group difference in improvement of 22 m (95% CI 11 to 32). Maximal expiratory pressure and sniff nasal inspiratory pressure both showed significant acute benefits from the technique during the first and sixth treatments, but no cumulative benefit. Inspiratory capacity estimated by optoelectronic plethysmography showed significant cumulative benefit of 330ml (95% CI 100 to 560). The effects on other outcomes were non-significant or small. The Manual Diaphragm Release Technique improves diaphragmatic mobility, exercise capacity and inspiratory capacity in people with chronic obstructive pulmonary disease. This

  10. Electronic messaging support service programs improve adherence to lipid-lowering therapy among outpatients with coronary artery disease: an exploratory randomised control study.

    PubMed

    Fang, Ronghua; Li, Xia

    2016-03-01

    To compare drug adherence to lipid-lowering therapy among outpatients with coronary artery disease who received information via short message service, via short message service and Micro Letter, or via phone only. Messaging applications and short message service are commonly used internationally. However, little is known about how coronary artery disease outpatients in China may benefit from receiving health education through these technologies. Random sampling method. Data were collected from March-December 2013. Subjects from Chengdu City, China, were randomised to three groups: short message service, short message service + Micro Letter, and phone (control). Appointment reminders and health information were delivered to patients in accordance with designations. After six months, adherence to statin prescriptions was compared among the groups by using the Morisky Medication Adherence Scale. Logistic regression analysis was applied to determine those independent variables that were related to adherence. The short message service and short message service + Micro Letter groups had better cumulative adherence (lower Morisky Medication Adherence Scale scores) after six months than phone group, and the short message service + Micro Letter group had better cumulative adherence (lower Morisky Medication Adherence Scale scores) than the short message service group. Female sex, older age and marriage show positive associations with adherence. Short message service and messaging applications, such as Micro Letter, are effective means of providing discharged patients with reminders and coronary artery disease-related health information. Implementation of a short message service + Micro Letter program can improve outpatient adherence to medication. This research offers useful information to help medical staff design effective interventions to improve medication compliance among coronary artery disease patients. © 2015 John Wiley & Sons Ltd.

  11. Randomised clinical trial: sodium alginate oral suspension is non-inferior to omeprazole in the treatment of patients with non-erosive gastroesophageal disease.

    PubMed

    Chiu, C-T; Hsu, C-M; Wang, C-C; Chang, J-J; Sung, C-M; Lin, C-J; Chen, L-W; Su, M-Y; Chen, T-H

    2013-11-01

    The burden of gastroesophageal reflux disease (GERD) is increasing in the Asia area and the majority of GERD patients have non-erosive reflux disease (NERD). To evaluate the efficacy and safety of sodium alginate suspension compared to omeprazole in adult subjects with NERD. In this 4-week, double-blind, parallel study, 195 NERD subjects were randomised to one of two treatment groups: sodium alginate suspension 20 mL three times a day and omeprazole 20 mg once daily. The primary efficacy endpoint was the percentage of patients achieving adequate heartburn or regurgitation relief at day 28 assessed by patient diary. The secondary efficacy endpoints included percentage of patients achieving adequate heartburn or regurgitation relief, change from baseline of the Reflux Disease Questionnaire total score at day 14 and 28 from baseline, and patients' overall satisfaction. In this study, 183 subjects were included in the intent-to-treat population, and 172 subjects were included in the per-protocol population. Non-inferiority of sodium alginate to omeprazole was demonstrated in the intent-to-treat population [difference, 2.7% (53.3% vs. 50.5%, P = 0.175), 95% lower confidence interval -11.9%, above the preset margin of -19%]. All of the secondary efficacy endpoints were comparable between two groups. The incidence of adverse event was relatively low and there was no difference between the two groups (5.4% vs. 5.5% for sodium alginate vs. omeprazole). No severe adverse event was noted in this study. The study showed that sodium alginate was as effective as omeprazole for symptomatic relief in patients with non-erosive reflux disease (Clinicaltrials.gov NCT01338077). © 2013 John Wiley & Sons Ltd.

  12. Consistent Prebiotic Effect on Gut Microbiota With Altered FODMAP Intake in Patients with Crohn's Disease: A Randomised, Controlled Cross-Over Trial of Well-Defined Diets

    PubMed Central

    Halmos, Emma P; Christophersen, Claus T; Bird, Anthony R; Shepherd, Susan J; Muir, Jane G; Gibson, Peter R

    2016-01-01

    Objectives: Altering FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) intake has substantial effects on gut microbiota. This study aimed to investigate effects of altering FODMAP intake on markers of colonic health in patients with Crohn's disease. Methods: After evaluation of their habitual diet, 9 patients with clinically quiescent Crohn's disease were randomised to 21 days of provided low or typical (“Australian”) FODMAP diets with ≥21-day washout in between. Five-day fecal samples were collected at the end of each diet and analyzed for calprotectin, pH, short-chain fatty acids (SCFA) and bacterial abundance. Gastrointestinal symptoms were recorded daily. Results: Eight participants collected feces and were adherent to the diets. FODMAP intake differed across the three dietary periods with lowdisease, altering dietary FODMAP intake is associated with marked changes in fecal microbiota, most consistent with a prebiotic effect of increasing FODMAPs as shown in an irritable bowel/healthy cohort. This strategy might be favorable for gut health in Crohn's disease, but at the cost of inducing symptoms. PMID:27077959

  13. Low-glycaemic index diet to improve glycaemic control and cardiovascular disease in type 2 diabetes: design and methods for a randomised, controlled, clinical trial

    PubMed Central

    Chiavaroli, Laura; Mirrahimi, Arash; Ireland, Christopher; Mitchell, Sandra; Sahye-Pudaruth, Sandhya; Coveney, Judy; Olowoyeye, Omodele; Maraj, Tishan; Patel, Darshna; de Souza, Russell J; Augustin, Livia S A; Bashyam, Balachandran; Blanco Mejia, Sonia; Nishi, Stephanie K; Leiter, Lawrence A; Josse, Robert G; McKeown-Eyssen, Gail; Moody, Alan R; Berger, Alan R; Kendall, Cyril W C; Sievenpiper, John L; Jenkins, David J A

    2016-01-01

    Introduction Type 2 diabetes (T2DM) produces macrovascular and microvascular damage, significantly increasing the risk of cardiovascular disease (CVD), renal failure and blindness. As rates of T2DM rise, the need for effective dietary and other lifestyle changes to improve diabetes management become more urgent. Low-glycaemic index (GI) diets may improve glycaemic control in diabetes in the short term; however, there is a lack of evidence on the long-term adherence to low-GI diets, as well as on the association with surrogate markers of CVD beyond traditional risk factors. Recently, advances have been made in measures of subclinical arterial disease through the use of MRI, which, along with standard measures from carotid ultrasound (CUS) scanning, have been associated with CVD events. We therefore designed a randomised, controlled, clinical trial to assess whether low-GI dietary advice can significantly improve surrogate markers of CVD and long-term glycaemic control in T2DM. Methods and analysis 169 otherwise healthy individuals with T2DM were recruited to receive intensive counselling on a low-GI or high-cereal fibre diet for 3 years. To assess macrovascular disease, MRI and CUS are used, and to assess microvascular disease, retinal photography and 24-hour urinary collections are taken at baseline and years 1 and 3. Risk factors for CVD are assessed every 3 months. Ethics and dissemination The study protocol and consent form have been approved by the research ethics board of St. Michael's Hospital. If the study shows a benefit, these data will support the use of low-GI and/or high-fibre foods in the management of T2DM and its complications. Trial Registration number NCT01063374; Pre-results. PMID:27388364

  14. US of the shoulder: rotator cuff and non-rotator cuff disorders.

    PubMed

    Papatheodorou, Athanasios; Ellinas, Panagiotis; Takis, Fotios; Tsanis, Antonios; Maris, Ioannis; Batakis, Nikolaos

    2006-01-01

    Ultrasonography (US) has been shown to be an effective imaging modality in the evaluation of both rotator cuff and non-rotator cuff disorders, usually serving in a complementary role to magnetic resonance imaging of the shoulder. US technique for shoulder examination depends on patient positioning, scanning protocol for every tendon and anatomic part, and dynamic imaging. The primary US signs for rotator cuff supraspinatus tendon tears are tendon nonvisualization for complete tears, focal tendon defect for full-thickness tears, a hypoechoic defect of the articular side of the tendon for an articular-side partial-thickness tear, and flattening of the bursal surface of the tendon for a bursal-side partial-thickness tear. Secondary US signs such as cortical irregularity of the greater tuberosity and joint and subacromial-subdeltoid bursal fluid are helpful when correlated with the primary signs. Tendon degeneration, tendinosis, and intrasubstance tear are demonstrated as internal heterogeneity. Long-head biceps tendon abnormalities include instability, acute or chronic tear, and tendinosis. The acromioclavicular joint is assessed for dislocation, fluid collection, cysts, and bone erosions. Other non-rotator cuff disorders include synovial disorders such as adhesive capsulitis and synovial osteochondromatosis; degenerative disorders such as osteoarthritis, amyloid arthropathy, hemarthrosis, and chondrocalcinosis; infectious disorders such as septic arthritis and bursitis; and space-occupying lesions.

  15. Status of the contralateral rotator cuff in patients undergoing rotator cuff repair.

    PubMed

    Ro, Kyung-Han; Park, Jong-Hoon; Lee, Soon-Hyuck; Song, Dong-Ik; Jeong, Ha-Joon; Jeong, Woong-Kyo

    2015-05-01

    Although the prevalence of rotator cuff tear (RCT) in the general population has been analyzed, little information is available on the status of the opposite-side rotator cuff in patients who have undergone arthroscopic rotator cuff repair. To identify the characteristics of the contralateral shoulder and to identify factors associated with RCT of the contralateral shoulder in patients who underwent surgery for symptomatic RCT. The hypothesis was that the prevalence of RCT in the contralateral shoulder would be higher in patients with increasingly larger cuff tears requiring surgical intervention. Case series; Level of evidence, 4. The study cohort consisted of 140 patients with RCT who underwent arthroscopic rotator cuff repair. Opposite-shoulder rotator cuff tendons of all patients were evaluated by ultrasonography. Demographic information and factors related to contralateral RCT were investigated, and risk factors associated with contralateral RCT were assessed. Of the 140 patients who underwent arthroscopic rotator cuff repair, 54 (38.6%) had an RCT of the contralateral shoulder. Of 51 patients with partial-thickness and small-sized full-thickness tears of the operated shoulder, 35 (68.6%) had no tears; 14 (27.5%) had partial-thickness tears; and 2 (3.9%) had small-sized full-thickness tears of the contralateral shoulder. Of 75 patients with medium-sized full-thickness tears, 43 (57.3%) had no tears; 12 (16%) had partial-thickness tears; and 20 (26.7%) had full-thickness tears of the contralateral shoulder. Of 14 patients with large to massive full-thickness tears, 8 (57.1%) had no tears; 1 (7.1%) had a partial-thickness tear; and 5 (35.7%) had full-thickness tears of the contralateral shoulder. The prevalence of RCT of the contralateral shoulder differed significantly among groups classified by tear size (P=.007). The mean American Shoulder and Elbow Surgeons score was significantly lower in the RCT than in the nontear group (55.8±16.9 vs 61.6±13.3; P=.03

  16. Biological factors in the pathogenesis of rotator cuff tears.

    PubMed

    Maffulli, Nicola; Longo, Umile Giuseppe; Berton, Alessandra; Loppini, Mattia; Denaro, Vincenzo

    2011-09-01

    Rotator cuff tears are common, and lead to shoulder pain and functional impairment. Despite their frequency and related disability, etiology and pathogenesis are still debated. Multiple factors contribute to tears of the rotator cuff. Extrinsic factors are anatomic variables, such as acromial morphologic characteristics, os acromiale, and acromial spurs that compress the rotator cuff by bony impingement or direct pressure from the surrounding soft tissue. Intrinsic factors arise from the tendon itself, because of tensile overload, aging, microvascular supply, traumatisms, or degeneration. Little information is available from a cellular and molecular point of view. We reviewed the biological factors involved in the pathogenesis of rotator cuff tears. Understanding the mechanism of rotator cuff pathology would facilitate the rationale for therapeutic interventions, by guiding the design, selection, and implementation of treatment strategies such as biologic modulation and preventive measures.

  17. High-resolution MR imaging of the normal rotator cuff.

    PubMed

    Middleton, W D; Kneeland, J B; Carrera, G F; Cates, J D; Kellman, G M; Campagna, N G; Jesmanowicz, A; Froncisz, W; Hyde, J S

    1987-03-01

    The shoulders of six normal volunteers were imaged with high-resolution MR in the axial, sagittal, and coronal planes. An angled pair of counter-rotating current loop-gap resonators designed specifically for the shoulder was used as a local coil. All images were compared with corresponding cryomicrotome sections from cadaver shoulders. The rotator cuff was analyzed in detail. It appeared as a complex, heterogeneous band to tissue superficial to the humeral head. The areas of low signal intensity corresponded to the central tendons of the four rotator cuff muscles. These tendons could be distinguished from each other as well as from the intervening components of the cuff, which have a moderate intensity. We concluded that MR is capable of imaging the normal rotator cuff and of separating the various components. This may allow for improved precision in the diagnosis of rotator cuff disorders.

  18. Safety, tolerability, and efficacy of PBT2 in Huntington's disease: a phase 2, randomised, double-blind, placebo-controlled trial.

    PubMed

    2015-01-01

    PBT2 is a metal protein-attenuating compound that might reduce metal-induced aggregation of mutant huntingtin and has prolonged survival in a mouse model of Huntington's disease. We aimed to assess the safety, tolerability, and efficacy of PBT2 in patients with Huntington's disease. In this 26-week, randomised, double-blind, placebo-controlled trial, adults (≥25 years old) with early-stage to mid-stage Huntington's disease were randomly assigned (1:1:1) by a centralised interactive response system to once daily PBT2 250 mg, PBT2 100 mg, or placebo. Randomisation was stratified by site with a block size of three. Participants, carers, the steering committee, site investigators, study staff, and the study sponsor were masked to treatment assignment. Primary endpoints were safety and tolerability. The safety population consisted of all participants who were randomly assigned and had at least one dose of study drug. The principal secondary endpoint was cognition, measured by the change from baseline to week 26 in the main composite Z score of five cognitive tests (Category Fluency Test, Trail Making Test Part B, Map Search, Symbol Digit Modalities Test, and Stroop Word Reading Test) and scores on eight individual cognitive tests (the five aforementioned plus the Trail Making Test Part A, Montreal Cognitive Assessment, and the Speeded Tapping Test). The intention-to-treat population comprised participants who were randomly assigned and had at least one efficacy assessment after administration of study drug. This trial is registered with ClinicalTrials.gov, NCT01590888. Between April 18, 2012, and Dec 14, 2012, 109 participants were randomly assigned to PBT2 250 mg (n=36), PBT2 100 mg (n=38), or placebo (n=35) at 19 research centres in Australia and the USA. 32 (89%) individuals on PBT2 250 mg, 38 (100%) on PBT2 100 mg, and 34 (97%) on placebo completed the study. Six serious adverse events (acute coronary syndrome, major depression, pneumonia, suicide attempt, viral

  19. Pramipexole for the treatment of depressive symptoms in patients with Parkinson's disease: a randomised, double-blind, placebo-controlled trial.

    PubMed

    Barone, Paolo; Poewe, Werner; Albrecht, Stefan; Debieuvre, Catherine; Massey, Dan; Rascol, Olivier; Tolosa, Eduardo; Weintraub, Daniel

    2010-06-01

    Depression is common in patients with Parkinson's disease, but evidence on the efficacy of antidepressants in this population is lacking. Because depression in patients with Parkinson's disease might be related to dopaminergic dysfunction, we aimed to assess the efficacy of the dopamine agonist pramipexole for treatment of depressive symptoms in patients with Parkinson's disease. We did a 12-week randomised, double-blind, placebo-controlled (1:1 ratio) trial of pramipexole (0.125-1.0 mg three times per day) compared with placebo in patients with mild-to-moderate Parkinson's disease. Patients from 76 centres in 12 European countries and South Africa were included if they were on stable antiparkinsonian therapy without motor fluctuations and had depressive symptoms (15-item geriatric depression scale score > or =5 and unified Parkinson's disease rating scale [UPDRS] part 1 depression item score > or =2). Patients were randomly assigned by centre in blocks of four by use of a randomisation number generating system. Clinical monitors, the principal investigator, and patients were masked to treatment allocation. The primary endpoint was change in Beck depression inventory (BDI) score and all treated patients who had at least one post-baseline efficacy assessment were included in the primary analysis. We also did a pre-specified path analysis with regression models to assess the relation between BDI and UPDRS part 3 (motor score) changes. This trial is registered with ClinicalTrials.gov, number NCT00297778, and EudraCT, number 2005-003788-22. Between March, 2006, and February, 2008, we enrolled 323 patients. Of 296 patients randomly assigned to pramipexole or placebo, 287 were included in the primary analysis: 139 in the pramipexole group and 148 in the placebo group. BDI scores decreased by an adjusted mean 5.9 (SE 0.5) points in the pramipexole group and 4.0 (0.5) points in the placebo group (difference 1.9, 95% CI 0.5-3.4; p=0.01, ANCOVA). The UPDRS motor score

  20. Ascorbic acid in Charcot–Marie–Tooth disease type 1A (CMT-TRIAAL and CMT-TRAUK): a double-blind randomised trial

    PubMed Central

    Pareyson, Davide; Reilly, Mary M; Schenone, Angelo; Fabrizi, Gian Maria; Cavallaro, Tiziana; Santoro, Lucio; Vita, Giuseppe; Quattrone, Aldo; Padua, Luca; Gemignani, Franco; Visioli, Francesco; Laurà, Matilde; Radice, Davide; Calabrese, Daniela; Hughes, Richard AC; Solari, Alessandra

    2011-01-01

    Summary Background Ascorbic acid reduced the severity of neuropathy in transgenic mice overexpressing peripheral myelin protein 22 (PMP22), a model of Charcot–Marie–Tooth disease type 1A (CMT1A) associated with the PMP22 duplication. However, in three 1-year trials, ascorbic acid had no benefit in human beings. We did a multicentre 2-year trial to test the efficacy and tolerability of ascorbic acid in patients with CMT1A. Methods Adult patients (aged 18–70 years) with symptomatic CMT1A were enrolled from nine centres in Italy and the UK, and were randomly assigned (1:1 ratio) to receive 1·5 g/day oral ascorbic acid or matching placebo for 24 months. The randomisation sequence was computer generated by block randomisation, stratified by centre and disease severity, and patients were allocated to treatment by telephone. The primary outcome was change in the CMT neuropathy score (CMTNS) at 24 months. Secondary outcomes were timed 10 m walk test, nine-hole peg test, overall neuropathy limitations scale, distal maximal voluntary isometric contraction, visual analogue scales for pain and fatigue, 36-item short-form questionnaire, and electrophysiological measurements. Patients, treating physicians, and physicians assessing outcome measures were masked to treatment allocation. Analysis of the primary outcome was done on all randomised patients who received at least one dose of study drug. This study is registered, numbers ISRCTN61074476 (CMT-TRAUK) and EudraCT 2006-000032-27 (CMT-TRIAAL). Findings We enrolled and randomly assigned 277 patients, of whom six (four assigned to receive ascorbic acid) withdrew consent before receiving treatment; 138 receiving ascorbic acid and 133 receiving placebo were eligible for analysis. Treatment was well tolerated: 241 of 271 patients (89% in each group) completed the study; 20 patients (nine receiving ascorbic acid) dropped out because of adverse events. Mean CMTNS at baseline with missing data imputed was 14·7 (SD 4·8) in the

  1. Ascorbic acid in Charcot-Marie-Tooth disease type 1A (CMT-TRIAAL and CMT-TRAUK): a double-blind randomised trial.

    PubMed

    Pareyson, Davide; Reilly, Mary M; Schenone, Angelo; Fabrizi, Gian Maria; Cavallaro, Tiziana; Santoro, Lucio; Vita, Giuseppe; Quattrone, Aldo; Padua, Luca; Gemignani, Franco; Visioli, Francesco; Laurà, Matilde; Radice, Davide; Calabrese, Daniela; Hughes, Richard A C; Solari, Alessandra

    2011-04-01

    Ascorbic acid reduced the severity of neuropathy in transgenic mice overexpressing peripheral myelin protein 22 (PMP22), a model of Charcot-Marie-Tooth disease type 1A (CMT1A) associated with the PMP22 duplication. However, in three 1-year trials, ascorbic acid had no benefit in human beings. We did a multicentre 2-year trial to test the efficacy and tolerability of ascorbic acid in patients with CMT1A. Adult patients (aged 18-70 years) with symptomatic CMT1A were enrolled from nine centres in Italy and the UK, and were randomly assigned (1:1 ratio) to receive 1·5 g/day oral ascorbic acid or matching placebo for 24 months. The randomisation sequence was computer generated by block randomisation, stratified by centre and disease severity, and patients were allocated to treatment by telephone. The primary outcome was change in the CMT neuropathy score (CMTNS) at 24 months. Secondary outcomes were timed 10 m walk test, nine-hole peg test, overall neuropathy limitations scale, distal maximal voluntary isometric contraction, visual analogue scales for pain and fatigue, 36-item short-form questionnaire, and electrophysiological measurements. Patients, treating physicians, and physicians assessing outcome measures were masked to treatment allocation. Analysis of the primary outcome was done on all randomised patients who received at least one dose of study drug. This study is registered, numbers ISRCTN61074476 (CMT-TRAUK) and EudraCT 2006-000032-27 (CMT-TRIAAL). We enrolled and randomly assigned 277 patients, of whom six (four assigned to receive ascorbic acid) withdrew consent before receiving treatment; 138 receiving ascorbic acid and 133 receiving placebo were eligible for analysis. Treatment was well tolerated: 241 of 271 patients (89% in each group) completed the study; 20 patients (nine receiving ascorbic acid) dropped out because of adverse events. Mean CMTNS at baseline with missing data imputed was 14·7 (SD 4·8) in the ascorbic acid group and 13·9 (4·2) in

  2. Rotator cuff repair using cell sheets derived from human rotator cuff in a rat model.

    PubMed

    Harada, Yoshifumi; Mifune, Yutaka; Inui, Atsuyuki; Sakata, Ryosuke; Muto, Tomoyuki; Takase, Fumiaki; Ueda, Yasuhiro; Kataoka, Takeshi; Kokubu, Takeshi; Kuroda, Ryosuke; Kurosaka, Masahiro

    2017-02-01

    To achieve biological regeneration of tendon-bone junctions, cell sheets of human rotator-cuff derived cells were used in a rat rotator cuff injury model. Human rotator-cuff derived cells were isolated, and cell sheets were made using temperature-responsive culture plates. Infraspinatus tendons in immunodeficient rats were resected bilaterally at the enthesis. In right shoulders, infraspinatus tendons were repaired by the transosseous method and covered with the cell sheet (sheet group), whereas the left infraspinatus tendons were repaired in the same way without the cell sheet (control group). Histological examinations (safranin-O and fast green staining, isolectin B4, type II collagen, and human-specific CD31) and mRNA expression (vascular endothelial growth factor; VEGF, type II collagen; Col2, and tenomodulin; TeM) were analyzed 4 weeks after surgery. Biomechanical tests were performed at 8 weeks. In the sheet group, proteoglycan at the enthesis with more type II collagen and isolectin B4 positive cells were seen compared with in the control group. Human specific CD31-positive cells were detected only in the sheet group. VEGF and Col2 gene expressions were higher and TeM gene expression was lower in the sheet group than in the control group. In mechanical testing, the sheet group showed a significantly higher ultimate failure load than the control group at 8 weeks. Our results indicated that the rotator-cuff derived cell sheet could promote cartilage regeneration and angiogenesis at the enthesis, with superior mechanical strength compared with the control. Treatment for rotator cuff injury using cell sheets could be a promising strategy for enthesis of tendon tissue engineering. © 2016 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 35:289-296, 2017. © 2016 Orthopaedic Research Society. Published by Wiley Periodicals, Inc.

  3. The Rotator Cuff Organ: Integrating Developmental Biology, Tissue Engineering, and Surgical Considerations to Treat Chronic Massive Rotator Cuff Tears.

    PubMed

    Rothrauff, Benjamin B; Pauyo, Thierry; Debski, Richard E; Rodosky, Mark W; Tuan, Rocky S; Musahl, Volker

    2017-08-01

    The torn rotator cuff remains a persistent orthopedic challenge, with poor outcomes disproportionately associated with chronic, massive tears. Degenerative changes in the tissues that comprise the rotator cuff organ, including muscle, tendon, and bone, contribute to the poor healing capacity of chronic tears, resulting in poor function and an increased risk for repair failure. Tissue engineering strategies to augment rotator cuff repair have been developed in an effort to improve rotator cuff healing and have focused on three principal aims: (1) immediate mechanical augmentation of the surgical repair, (2) restoration of muscle quality and contractility, and (3) regeneration of native enthesis structure. Work in these areas will be reviewed in sequence, highlighting the relevant pathophysiology, developmental biology, and biomechanics, which must be considered when designing therapeutic applications. While the independent use of these strategies has shown promise, synergistic benefits may emerge from their combined application given the interdependence of the tissues that constitute the rotator cuff organ. Furthermore, controlled mobilization of augmented rotator cuff repairs during postoperative rehabilitation may provide mechanotransductive cues capable of guiding tissue regeneration and restoration of rotator cuff function. Present challenges and future possibilities will be identified, which if realized, may provide solutions to the vexing condition of chronic massive rotator cuff tears.

  4. Deep brain stimulation plus best medical therapy versus best medical therapy alone for advanced Parkinson's disease (PD SURG trial): a randomised, open-label trial

    PubMed Central

    Williams, Adrian; Gill, Steven; Varma, Thelekat; Jenkinson, Crispin; Quinn, Niall; Mitchell, Rosalind; Scott, Richard; Ives, Natalie; Rick, Caroline; Daniels, Jane; Patel, Smitaa; Wheatley, Keith

    2010-01-01

    Summary Background Surgical intervention for advanced Parkinson's disease is an option if medical therapy fails to control symptoms adequately. We aimed to assess whether surgery and best medical therapy improved self-reported quality of life more than best medical therapy alone in patients with advanced Parkinson's disease. Methods The PD SURG trial is an ongoing randomised, open-label trial. At 13 neurosurgical centres in the UK, between November, 2000, and December, 2006, patients with Parkinson's disease that was not adequately controlled by medical therapy were randomly assigned by use of a computerised minimisation procedure to immediate surgery (lesioning or deep brain stimulation at the discretion of the local clinician) and best medical therapy or to best medical therapy alone. Patients were analysed in the treatment group to which they were randomised, irrespective of whether they received their allocated treatment. The primary endpoint was patient self-reported quality of life on the 39-item Parkinson's disease questionnaire (PDQ-39). Changes between baseline and 1 year were compared by use of t tests. This trial is registered with Current Controlled Trials, number ISRCTN34111222. Findings 366 patients were randomly assigned to receive immediate surgery and best medical therapy (183) or best medical therapy alone (183). All patients who had surgery had deep brain stimulation. At 1 year, the mean improvement in PDQ-39 summary index score compared with baseline was 5·0 points in the surgery group and 0·3 points in the medical therapy group (difference −4·7, 95% CI −7·6 to −1·8; p=0·001); the difference in mean change in PDQ-39 score in the mobility domain between the surgery group and the best medical therapy group was −8·9 (95% CI −13·8 to −4·0; p=0·0004), in the activities of daily living domain was −12·4 (−17·3 to −7·5; p<0·0001), and in the bodily discomfort domain was −7·5 (−12·6 to −2·4; p=0·004). Differences

  5. Medialized repair for retracted rotator cuff tears.

    PubMed

    Kim, Young-Kyu; Jung, Kyu-Hak; Won, Jun-Sung; Cho, Seung-Hyun

    2017-08-01

    The purpose of this study was to evaluate the functional outcomes of medialized rotator cuff repair and the continuity of repaired tendon in chronic retracted rotator cuff tears. Thirty-five consecutive patients were selected from 153 cases that underwent arthroscopic rotator cuff repair for more than medium-sized posterosuperior rotator cuff tears between July 2009 and July 2012 performed with the medialized repair. All cases were available for at least 2 years of postoperative follow-up. The visual analog scale of pain, muscle strength, Constant score, American Shoulder and Elbow Surgeons (ASES) score, and University of California-Los Angeles score were evaluated. At the final follow-up, all clinical outcomes were significantly improved. The visual analog scale score for pain improved from 6 ± 1 preoperatively to 2 ± 1 postoperatively. The range of motion increased from preoperatively to postoperatively: active forward elevation, from 134° ± 49° to 150° ± 16°; active external rotation at the side, from 47° ± 15° to 55° ± 10°; and active internal rotation, from L3 to L1. The shoulder score also improved: Constant score, from 53.5 ± 16.7 to 79 ± 10; American Shoulder and Elbow Surgeons score, from 51 ± 15 to 82 ± 8; and University of California-Los Angeles score, from 14 ± 4 to 28 ± 4. The retear cases at the final follow-up were 6 (17%). Medialized repair may be useful in cases in which anatomic bone-to-tendon repair would be difficult because of the excessive tension of the repaired tendon and a torn tendon that does not reach the anatomic insertion. Copyright © 2016 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

  6. Endotracheal Tube Cuff Management at Altitude

    DTIC Science & Technology

    2014-02-05

    Thomas C. Blakeman, RRT2; Dario Rodriquez Jr., RRT1; Capt Heather Ortiz, RN , FNP-C3; Maj John Eggert, RN1 1U.S. Air Force School of Aerospace...Middle East and is credited with improvements in outcomes (Ingalls N, Zonies D, Bailey JA, et al. A decade of care in the air: review of the first 10... quality , and postsleep performance. Aviat Space Environ Med 2009; 80(8):691-7. 7. Ruth MJ. Pressure changes in tracheal tube cuffs at altitude

  7. Calcific tendinopathy of the rotator cuff tendons.

    PubMed

    Oliva, Francesco; Via, Alessio Giai; Maffulli, Nicola

    2011-09-01

    Calcific tendinopathy (CT) of the tendons of the rotator cuff is common in white populations, with a reported prevalence varying from 2.7% to 22%, mostly affecting women between 30 and 50 years. Although CT shows a strong tendency toward self-healing by spontaneous resorption of the deposits, it does not always follow this typical pattern. The etiopathogenesis of CT is still unknown. Many pathogenetic theories have been proposed, and clinical associations between CT and diabetes and thyroid disorders have been reported. The choice of therapeutic approach should depend on the evolution of the condition.

  8. Rotator Cuff Tear Consequent to Glenohumeral Dislocation.

    PubMed

    Gilotra, Mohit N; Christian, Matthew W; Lovering, Richard M

    2016-08-01

    The patient was a 21-year-old collegiate running back who was tackled during a football game and sustained a posterior glenohumeral dislocation. He was referred to an orthopaedist and presented 3 weeks after the injury, and, following examination, further imaging was ordered by the orthopaedist due to rotator cuff weakness. Magnetic resonance imaging showed a complete tear of the supraspinatus and infraspinatus, as well as a posterior Bankart lesion, a subscapularis tear, and a dislocation of the biceps long head tendon into the reverse Hill-Sachs lesion. J Orthop Sports Phys Ther 2016;46(8):708. doi:10.2519/jospt.2016.0413.

  9. Internet-delivered cognitive behavioural therapy for adults with mild to moderate depression and high cardiovascular disease risks: a randomised attention-controlled trial.

    PubMed

    Glozier, Nicholas; Christensen, Helen; Naismith, Sharon; Cockayne, Nicole; Donkin, Liesje; Neal, Bruce; Mackinnon, Andrew; Hickie, Ian

    2013-01-01

    Mild to moderate depression is common in those with cardiovascular disease and undertreated. We aimed to evaluate the effectiveness of internet-delivered Cognitive Behaviour Therapy (iCBT) on depressive symptom severity and adherence to medical advice and lifestyle interventions in adults with mild to moderate depression and high cardiovascular disease (CVD) risks. Randomised double-blind, 12 week attention-controlled trial comparing an iCBT programme (E-couch) with an internet-delivered attention control health information package (HealthWatch, n = 282). The primary outcome was depression symptom level on the nine-item Patient Health Questionnaire (PHQ-9) (trial registration: ACTRN12610000085077). 487/562 (88%) participants completed the endpoint assessment. 383/562 (70%) were currently treated for cardiovascular disease and 314/562 (56%) had at least one other comorbid condition. In ITT analysis of 562 participants iCBT produced a greater decline in the mean PHQ-9 score compared to the attention control of 1.06 (95% CI: 0.23-1.89) points, with differences between the two arms increasing over the intervention period (time by treatment effect interaction p = .012). There were also larger improvements in adherence (2.16 points; 95% CI: 0.33-3.99), reductions in anxiety (0.96 points; 95% CI: 0.19-1.73), and a greater proportion engaging in beneficial physical activity (Odds Ratio 1.91, 95%CI: 1.01-3.61) in the iCBT participants but no effect upon disability, or walking time/day. There were no withdrawals due to study related adverse events. In people with mild to moderate depression and high levels of CVD risk factors, a freely accessible iCBT programme (http://www.ecouch.anu.edu.au) produced a small, but robust, improvement in depressive symptoms, adherence and some health behaviours. Australian and New Zealand Clinical Trials Registry ACTRN12610000085077.

  10. Perinatal probiotic supplementation in the prevention of allergy related disease: 6 year follow up of a randomised controlled trial.

    PubMed

    Simpson, Melanie Rae; Dotterud, Christian Kvikne; Storrø, Ola; Johnsen, Roar; Øien, Torbjørn

    2015-08-01

    Perinatal probiotics supplementation has been shown to be effective in the primary prevention of atopic dermatitis (AD) in early childhood, although the long term effects of probiotics on AD and other allergic diseases is less certain. We have previously reported a significant reduction in the cumulative incidence of AD at 2 years after maternal probiotic supplementation. In this study we present the effects of perinatal probiotics given to women from a general population on allergy related diseases in their offspring at 6 years. Four hundred and fifteen pregnant women were randomised to receive probiotic or placebo milk in a double-blinded trial from 36 week gestation until 3 months postpartum. Probiotic milk contained Lactobacillus rhamnosos GG, L. acidophilus La-5 and Bifidobacterium animalis subsp. lactis Bb-12. At 6 years, children were re-assessed for AD, atopic sensitisation, asthma and allergic rhinoconjunctivitis (ARC). At 6 years, 81 and 82 children were assessed for AD in the probiotic and placebo groups, respectively. In a multiple imputation analysis, there was as trend towards a lower cumulative incidence of AD in the probiotic group compared to the placebo group (OR 0.64, 95 % CI 0.39-1.07, p = 0.086; NNT = 10). This finding was statistically significantly in the complete case analysis (OR 0.48, 95 % CI 0.25-0.92, p = 0.027, NNT = 6). The prevalence of asthma and atopic sensitisation, and the cumulative incidence of ARC were not significantly affected by the probiotic regime at 6 years of age. Maternal probiotic ingestion alone may be sufficient for long term reduction in the cumulative incidence of AD, but not other allergy related diseases. ClinicalTrials.gov identifier: NCT00159523.

  11. Efficacy, safety, and tolerance of the non-ergoline dopamine agonist pramipexole in the treatment of advanced Parkinson's disease: a double blind, placebo controlled, randomised, multicentre study

    PubMed Central

    Pinter, M; Pogarell, O; Oertel, W

    1999-01-01

    OBJECTIVES—Pramipexole, a non-ergot dopamine D2/D3 receptor agonist, was investigated as an add on drug in advanced parkinsonian patients with motor fluctuations to assess efficacy, safety, and tolerance.
METHODS—Seventy eight patients of either sex with advanced Parkinson's disease and treatment complications such as motor fluctuations were enrolled into a double blind, placebo controlled, randomised, multicentre study (phase II) and assigned to add on treatment with pramipexole (n=34) versus placebo (n=44) to a previously stabilised antiparkinsonian medication (7 week dose titration interval, 4 week maintenance period). The primary end point of efficacy was the change from baseline in the total score of the unified Parkinson's disease rating scale (UPDRS) in the on "period" (2 hours after intake of study medication). Safety and tolerability were assessed on the basis of adverse events, vital signs, laboratory measurements, and ECG recordings.
RESULTS—There was a significant improvement of the pramipexole group in UPDRS total scores, subscores part II, III (activities of daily living and motor examination), and IV (complications of therapy). Mean UPDRS total score decreased by 37.3% under pramipexole compared with 12.2% under placebo (p<0.001). Patients under pramipexole reported an overall reduction in "off" periods of 12%—resulting in 1.7 more hours "on" time a day—compared with an increase in "off" periods of 2% under placebo. There were no unexpected safety results. The adverse event profile disclosed a high tolerability. The most important adverse events under pramipexole were fatigue, dyskinesia, and vivid dreams.
CONCLUSION—Pramipexole administration is an efficacious and well tolerated add on therapy in patients with advanced Parkinson's disease with an improvement in activities of daily living, motor function, and treatment associated complications.

 PMID:10201413

  12. Framing of research question using the PICOT format in randomised controlled trials of venous ulcer disease: a protocol for a systematic survey of the literature

    PubMed Central

    Abbade, Luciana P F; Wang, Mei; Sriganesh, Kamath; Mbuagbaw, Lawrence; Thabane, Lehana

    2016-01-01

    Introduction Although venous ulcers have a great social and economic impact, there is a lack of evidence from randomised controlled trials (RCTs) to support appropriate management for this disease. Framing the research question using the Population; Intervention; Comparator; Outcome; Time frame (PICOT) format in RCTs can improve the quality of the research design. Objectives To evaluate how the PICOT format is used to frame a research question in reports of RCTs of venous ulcer disease and to determine the factors associated with better adherence to the PICOT format in framing the research question. Methods and analyses We will conduct a systematic survey of RCTs on venous ulcers published in the National Institute of Health, PubMed database between January 2009 and May 2016. We will include all RCTs addressing therapeutic intervention for venous ulcer disease involving human subjects, and published in the English language. The selection process will be carried out in duplicate by two independent investigators. First, titles and abstracts will be screened, then full-text articles. We will examine whether the five elements of the PICOT format are used in formulating the research question and give a score between 0 and 5. The primary outcome will be the proportion of studies that have adequately reported all five PICOT elements. Dissemination This will be the first survey to assess how the PICOT format is used to frame research questions on the management of venous ulcers in reports of RCTs. On completion, this review will be submitted to a peer-reviewed biomedical journal for publication and the findings will also be presented at scientific conferences. PMID:27836875

  13. Effect of a hospital outreach intervention programme on decreasing hospitalisations and medical costs in patients with chronic obstructive pulmonary disease in China: protocol of a randomised controlled trial

    PubMed Central

    Yan, Jin; Wang, Lianhong; Liu, Chun; Yuan, Hong; Wang, Xiaowan; Yu, Baorong; Luo, Qian

    2016-01-01

    Introduction Patients with chronic obstructive pulmonary disease (COPD) often have multiple hospitalisations because of exacerbation. Evidence shows disease management programmes are one of the most cost-effective measures to prevent re-hospitalisation for COPD exacerbation, but lack implementation and economic appraisal in China. The aims of the proposed study are to determine whether a hospital outreach invention programme for disease management can decrease hospitalisations and medical costs in patients with COPD in China. Economic appraisal of the programme will also be carried out. Methods and analysis A randomised single-blinded controlled trial will be conducted. 220 COPD patients with exacerbations will be recruited from the Third Xiangya Hospital, Central South University, China. After hospital discharge they will be randomly allocated into an intervention or a control group. Participants in the intervention group will attend a 3-month hospital-based pulmonary rehabilitation intervention and then receive a home-based programme. Both groups will receive identical usual discharge care before discharge from hospital. The primary outcomes will include rate of hospitalisation and medical cost, while secondary outcomes will include mortality, self-efficacy, self-management, health status, quality of life, exercise tolerance and pulmonary function, which will be evaluated at baseline and at 3, 12 and 24 months after the intervention. Cost-effectiveness analysis will be employed for economic appraisal. Ethics and dissemination The study has been approved by the institutional review board (IRB) of the Third Xiangya Hospital, Central South University (IRB2014-S159). Findings will be shared widely through conference presentations and peer-reviewed publications. Furthermore, the results of the programme will be submitted to health authorities and policy reform will be recommended. Trial registration number Chi CTR-TRC-14005108; Pre-results. PMID:27311900

  14. The effects of resveratrol supplementation on cardiovascular risk factors in patients with non-alcoholic fatty liver disease: a randomised, double-blind, placebo-controlled study.

    PubMed

    Faghihzadeh, Forouzan; Adibi, Payman; Hekmatdoost, Azita

    2015-09-14

    Non-alcoholic fatty liver disease (NAFLD) is usually associated with insulin resistance, central obesity, reduced glucose tolerance, type 2 diabetes mellitus and hypertriacylglycerolaemia. The beneficial effects of resveratrol on metabolic disorders have been shown previously. The aim of this study was to evaluate the effects of resveratrol supplementation on cardiovascular risk factors in patients with NAFLD. In this randomised double-blinded placebo-controlled clinical trial, fifty NAFLD patients were supplemented with either a 500-mg resveratrol capsule or a placebo capsule for 12 weeks. Both groups were advised to follow an energy-balanced diet and physical activity recommendations. resveratrol supplementation reduced alanine aminotransferase (ALT) and hepatic steatosis significantly more than placebo (P0·05). There were no significant changes in blood pressure, insulin resistance markers and TAG in either group (P>0·05). Our data have shown that 12-week supplementation of 500 mg resveratrol does not have any beneficial effect on anthropometric measurements, insulin resistance markers, lipid profile and blood pressure; however, it reduced ALT and hepatic steatosis in patients with NAFLD.

  15. Community-deliverable exercise and anxiety in adults with arthritis and other rheumatic diseases: a protocol for a systematic review and meta-analysis of randomised controlled trials

    PubMed Central

    Kelley, George A; Kelley, Kristi S; Callahan, Leigh F

    2017-01-01

    Introduction While anxiety is a major public health problem in adults with arthritis and other rheumatic diseases (AORD), the effects of exercise on anxiety in adults are not well established despite numerous studies on this topic. The purpose of this study is to conduct a systematic review with an aggregate data meta-analysis to determine the effects of community-deliverable exercise interventions (aerobic, strength training or both) on anxiety in adults with AORD. Methods and analysis Randomised controlled exercise intervention trials ≥4 weeks and published in any language up to 31 December 2016 will be included. Studies will be retrieved by searching 8 electronic databases, cross-referencing and expert review. Dual selection and abstraction of data will occur. The primary outcome will be changes in anxiety. Risk of bias will be assessed using the Cochrane risk of bias assessment instrument while confidence in the cumulative evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) instrument. Standardised effect sizes for anxiety will be calculated from each study and then pooled using the inverse variance heterogeneity (IVhet) model. Meta-regression based on the IVhet model will be used to examine the relationship between changes in anxiety and selected covariates. Dissemination The results of this study will be presented at a professional conference and published in a peer-reviewed journal. Trial registration number CRD42016048728. PMID:28264834

  16. Identifiable risk factors for thirty-day complications following arthroscopic rotator cuff repair.

    PubMed

    Heyer, Jessica H; Kuang, Xiangyu; Amdur, Richard L; Pandarinath, Rajeev

    2017-10-11

    Shoulder arthroscopy has increased in frequency over the past decade, with rotator cuff repair comprising the majority of cases performed. Prior studies have detailed risk factors for 30-day complications and readmission rates after arthroscopic shoulder surgery using the National Surgical Quality Improvement Program (NSQIP) database, but no study has specifically looked at arthroscopic rotator cuff repair. The purpose of the study is to evaluate the risk factors for 30-day complications following arthroscopic rotator cuff repair using the NSQIP database. The NSQIP database was queried for all patients undergoing arthroscopic rotator cuff repair from 2006-2015. Demographics and thirty-day outcomes for these patients were analyzed using univariate analyses and multivariate regression analysis to determine the risk factors for complications. 21,143 patients underwent arthroscopic rotator cuff repair, with 147 patients (0.70%) having a complication within 30-days. Univariate analysis found age >65 (p = 0.0028), male gender (p = 0.0053), elevated BMI (p = 0.0054), ASA class >2 (p < 0.0001), history of chronic obstructive pulmonary disease (p < 0.0001), hypertension (p < 0.0002), dyspnea (p < 0.0001), steroid use (p = 0.0350), and operative time >90 min (p = 0.0316) to be associated with increased risk of complications. Multivariate analysis found female sex to be protective or complication (OR 0.56, p = 0.0017), while American Society of Anesthesiology (ASA) class >2 (OR 1.51, p = 0.0335) and history of COPD (OR 2.41, p = 0.0030) and dyspnea (OR 1.89, p = 0.0359) to be risk factors for complication. The most common complication is venothromboembolic events, accounting for 36.7% of all complications. Male sex, ASA class > 2, and history of COPD and dyspnea were independent risk factors for thirty-day complications following arthroscopic rotator cuff repair. IV.

  17. Double-needle ultrasound-guided percutaneous treatment of rotator cuff calcific tendinitis: tips & tricks.

    PubMed

    Sconfienza, Luca Maria; Viganò, Sara; Martini, Chiara; Aliprandi, Alberto; Randelli, Pietro; Serafini, Giovanni; Sardanelli, Francesco

    2013-01-01

    Rotator cuff calcific tendinitis is a very common disease and may result in a very painful shoulder. Aetiology of this disease is still poorly understood. When symptoms are mild, this disease may be treated conservatively. Several treatment options have been proposed. Among them, ultrasound-guided procedures have been recently described. All procedures use one or two needles to inject a fluid, to dissolve calcium and to aspirate it. In the present article, we review some tips and tricks that may be useful to improve performance of an ultrasound-guided double-needle procedure.

  18. Short- and long-term effects of tactile massage on salivary cortisol concentrations in Parkinson’s disease: a randomised controlled pilot study

    PubMed Central

    2013-01-01

    Background Parkinson’s disease (PD) is a chronic neurodegenerative disorder with limited knowledge about the normal function and effects of non-pharmacological therapies on the hypothalamic-pituitary-adrenal (HPA) axis. The aim of the study was to analyse the basal diurnal and total secretion of salivary cortisol in short- and long-term aspects of tactile massage (TM). Methods Design: Prospective, Controlled and Randomised Multicentre Trial. Setting and interventions: Forty-five women and men, aged 50–79 years, were recruited. Twenty-nine of them were blindly randomised to tactile massage (TM) and 16 of them to the control group, rest to music (RTM). Ten interventions were given during 8 weeks followed by a 26 weeks of follow up. Salivary cortisol was collected at 8 am, 1 pm, 8 pm, and 8 am the next day, on five occasions. With the first and eighth interventions, it was collected immediately before and after intervention. Main outcome measures: The primary aim was to assess and compare cortisol concentrations before and immediately after intervention and also during the follow-up period. The secondary aim was to assess the impact of age, gender, body mass index (BMI), duration and severity of PD, effects of interventional time-point of the day, and levodopa doses on cortisol concentration. Results The median cortisol concentrations for all participants were 16.0, 5.8, 2.8, and 14.0 nmol/L at baseline, later reproduced four times without significant differences. Cortisol concentrations decreased significantly after TM intervention but no change in diurnal salivary cortisol pattern was found. The findings of reduced salivary cortisol concentrations immediately after the interventions are in agreement with previous studies. However, there was no significant difference between the TM and control groups. There were no significant correlations between cortisol concentrations and age, gender, BMI, time-point for intervention, time interval between anti

  19. Short- and long-term effects of tactile massage on salivary cortisol concentrations in Parkinson's disease: a randomised controlled pilot study.

    PubMed

    Törnhage, Carl-Johan; Skogar, Örjan; Borg, Astrid; Larsson, Birgitta; Robertsson, Laila; Andersson, Lena; Andersson, Lena; Backström, Paulina; Fall, Per-Arne; Hallgren, Gunnar; Bringer, Birgitta; Carlsson, Miriam; Lennartsson, Ulla Birgitta; Sandbjörk, Håkan; Lökk, Johan

    2013-12-13

    Parkinson's disease (PD) is a chronic neurodegenerative disorder with limited knowledge about the normal function and effects of non-pharmacological therapies on the hypothalamic-pituitary-adrenal (HPA) axis. The aim of the study was to analyse the basal diurnal and total secretion of salivary cortisol in short- and long-term aspects of tactile massage (TM). Prospective, Controlled and Randomised Multicentre Trial. Forty-five women and men, aged 50-79 years, were recruited. Twenty-nine of them were blindly randomised to tactile massage (TM) and 16 of them to the control group, rest to music (RTM). Ten interventions were given during 8 weeks followed by a 26 weeks of follow up. Salivary cortisol was collected at 8 am, 1 pm, 8 pm, and 8 am the next day, on five occasions. With the first and eighth interventions, it was collected immediately before and after intervention. The primary aim was to assess and compare cortisol concentrations before and immediately after intervention and also during the follow-up period. The secondary aim was to assess the impact of age, gender, body mass index (BMI), duration and severity of PD, effects of interventional time-point of the day, and levodopa doses on cortisol concentration. The median cortisol concentrations for all participants were 16.0, 5.8, 2.8, and 14.0 nmol/L at baseline, later reproduced four times without significant differences. Cortisol concentrations decreased significantly after TM intervention but no change in diurnal salivary cortisol pattern was found. The findings of reduced salivary cortisol concentrations immediately after the interventions are in agreement with previous studies. However, there was no significant difference between the TM and control groups. There were no significant correlations between cortisol concentrations and age, gender, BMI, time-point for intervention, time interval between anti-parkinson pharmacy intake and sampling, levodopa doses, duration, or severity of PD. Diurnal salivary

  20. The effect of a comprehensive lifestyle intervention on cardiovascular risk factors in pharmacologically treated patients with stable cardiovascular disease compared to usual care: a randomised controlled trial.

    PubMed

    Ijzelenberg, Wilhelmina; Hellemans, Irene M; van Tulder, Maurits W; Heymans, Martijn W; Rauwerda, Jan A; van Rossum, Albert C; Seidell, Jaap C

    2012-09-10

    The additional benefit of lifestyle interventions in patients receiving cardioprotective drug treatment to improve cardiovascular risk profile is not fully established.The objective was to evaluate the effectiveness of a target-driven multidisciplinary structured lifestyle intervention programme of 6 months duration aimed at maximum reduction of cardiovascular risk factors in patients with cardiovascular disease (CVD) compared with usual care. A single centre, two arm, parallel group randomised controlled trial was performed. Patients with stable established CVD and at least one lifestyle-related risk factor were recruited from the vascular and cardiology outpatient departments of the university hospital. Blocked randomisation was used to allocate patients to the intervention (n = 71) or control group (n = 75) using an on-site computer system combined with allocations in computer-generated tables of random numbers kept in a locked computer file. The intervention group received the comprehensive lifestyle intervention offered in a specialised outpatient clinic in addition to usual care. The control group continued to receive usual care. Outcome measures were the lifestyle-related cardiovascular risk factors: smoking, physical activity, physical fitness, diet, blood pressure, plasma total/HDL/LDL cholesterol concentrations, BMI, waist circumference, and changes in medication. The intervention led to increased physical activity/fitness levels and an improved cardiovascular risk factor profile (reduced BMI and waist circumference). In this setting, cardiovascular risk management for blood pressure and lipid levels by prophylactic treatment for CVD in usual care was already close to optimal as reflected in baseline levels. There was no significant improvement in any other risk factor. Even in CVD patients receiving good clinical care and using cardioprotective drug treatment, a comprehensive lifestyle intervention had a beneficial effect on some cardiovascular

  1. Use of low-dose oral theophylline as an adjunct to inhaled corticosteroids in preventing exacerbations of chronic obstructive pulmonary disease: study protocol for a randomised controlled trial.

    PubMed

    Devereux, Graham; Cotton, Seonaidh; Barnes, Peter; Briggs, Andrew; Burns, Graham; Chaudhuri, Rekha; Chrystyn, Henry; Davies, Lisa; De Soyza, Anthony; Fielding, Shona; Gompertz, Simon; Haughney, John; Lee, Amanda J; McCormack, Kirsty; McPherson, Gladys; Morice, Alyn; Norrie, John; Sullivan, Anita; Wilson, Andrew; Price, David

    2015-06-10

    Chronic obstructive pulmonary disease (COPD) is associated with high morbidity, mortality, and health-care costs. An incomplete response to the anti-inflammatory effects of inhaled corticosteroids is present in COPD. Preclinical work indicates that 'low dose' theophylline improves steroid responsiveness. The Theophylline With Inhaled Corticosteroids (TWICS) trial investigates whether the addition of 'low dose' theophylline to inhaled corticosteroids has clinical and cost-effective benefits in COPD. TWICS is a randomised double-blind placebo-controlled trial conducted in primary and secondary care sites in the UK. The inclusion criteria are the following: an established predominant respiratory diagnosis of COPD (post-bronchodilator forced expiratory volume in first second/forced vital capacity [FEV1/FVC] of less than 0.7), age of at least 40 years, smoking history of at least 10 pack-years, current inhaled corticosteroid use, and history of at least two exacerbations requiring treatment with antibiotics or oral corticosteroids in the previous year. A computerised randomisation system will stratify 1424 participants by region and recruitment setting (primary and secondary) and then randomly assign with equal probability to intervention or control arms. Participants will receive either 'low dose' theophylline (Uniphyllin MR 200 mg tablets) or placebo for 52 weeks. Dosing is based on pharmacokinetic modelling to achieve a steady-state serum theophylline of 1-5 mg/l. A dose of theophylline MR 200 mg once daily (or placebo once daily) will be taken by participants who do not smoke or participants who smoke but have an ideal body weight (IBW) of not more than 60 kg. A dose of theophylline MR 200 mg twice daily (or placebo twice daily) will be taken by participants who smoke and have an IBW of more than 60 kg. Participants will be reviewed at recruitment and after 6 and 12 months. The primary outcome is the total number of participant-reported COPD exacerbations requiring

  2. The effect of a comprehensive lifestyle intervention on cardiovascular risk factors in pharmacologically treated patients with stable cardiovascular disease compared to usual care: a randomised controlled trial

    PubMed Central

    2012-01-01

    Background The additional benefit of lifestyle interventions in patients receiving cardioprotective drug treatment to improve cardiovascular risk profile is not fully established. The objective was to evaluate the effectiveness of a target-driven multidisciplinary structured lifestyle intervention programme of 6 months duration aimed at maximum reduction of cardiovascular risk factors in patients with cardiovascular disease (CVD) compared with usual care. Methods A single centre, two arm, parallel group randomised controlled trial was performed. Patients with stable established CVD and at least one lifestyle-related risk factor were recruited from the vascular and cardiology outpatient departments of the university hospital. Blocked randomisation was used to allocate patients to the intervention (n = 71) or control group (n = 75) using an on-site computer system combined with allocations in computer-generated tables of random numbers kept in a locked computer file. The intervention group received the comprehensive lifestyle intervention offered in a specialised outpatient clinic in addition to usual care. The control group continued to receive usual care. Outcome measures were the lifestyle-related cardiovascular risk factors: smoking, physical activity, physical fitness, diet, blood pressure, plasma total/HDL/LDL cholesterol concentrations, BMI, waist circumference, and changes in medication. Results The intervention led to increased physical activity/fitness levels and an improved cardiovascular risk factor profile (reduced BMI and waist circumference). In this setting, cardiovascular risk management for blood pressure and lipid levels by prophylactic treatment for CVD in usual care was already close to optimal as reflected in baseline levels. There was no significant improvement in any other risk factor. Conclusions Even in CVD patients receiving good clinical care and using cardioprotective drug treatment, a comprehensive lifestyle intervention had a

  3. Interdisciplinary model of care (RADICALS) for early detection and management of chronic obstructive pulmonary disease (COPD) in Australian primary care: study protocol for a cluster randomised controlled trial.

    PubMed

    Liang, Jenifer; Abramson, Michael J; Zwar, Nicholas; Russell, Grant; Holland, Anne E; Bonevski, Billie; Mahal, Ajay; Hecke, Benjamin van; Phillips, Kirsten; Eustace, Paula; Paul, Eldho; Petrie, Kate; Wilson, Sally; George, Johnson

    2017-09-18

    Up to half of all smokers develop clinically significant chronic obstructive pulmonary disease (COPD). Gaps exist in the implementation and uptake of evidence-based guidelines for managing COPD in primary care. We describe the methodology of a cluster randomised controlled trial (cRCT) evaluating the efficacy and cost-effectiveness of an interdisciplinary model of care aimed at reducing the burden of smoking and COPD in Australian primary care settings. A cRCT is being undertaken to evaluate an interdisciplinary model of care (RADICALS - Review of Airway Dysfunction and Interdisciplinary Community-based care of Adult Long-term Smokers). General practice clinics across Melbourne, Australia, are identified and randomised to the intervention group (RADICALS) or usual care. Patients who are current or ex-smokers, of at least 10 pack years, including those with an existing diagnosis of COPD, are being recruited to identify 280 participants with a spirometry-confirmed diagnosis of COPD. Handheld lung function devices are being used to facilitate case-finding. RADICALS includes individualised smoking cessation support, home-based pulmonary rehabilitation and home medicines review. Patients at control group sites receive usual care and Quitline referral, as appropriate. Follow-ups occur at 6 and 12 months from baseline to assess changes in quality of life, abstinence rates, health resource utilisation, symptom severity and lung function. The primary outcome is change in St George's Respiratory Questionnaire score of patients with COPD at 6 months from baseline. This project has been approved by the Monash University Human Research Ethics Committee and La Trobe University Human Ethics Committee (CF14/1018 - 2014000433). Results of the study will be disseminated in peer-reviewed journals and research conferences. If the intervention is successful, the RADICALS programme could potentially be integrated into general practices across Australia and sustained over time. ACTRN

  4. Effects of telephone health mentoring in community-recruited chronic obstructive pulmonary disease on self-management capacity, quality of life and psychological morbidity: a randomised controlled trial.

    PubMed

    Walters, Julia; Cameron-Tucker, Helen; Wills, Karen; Schüz, Natalie; Scott, Jenn; Robinson, Andrew; Nelson, Mark; Turner, Paul; Wood-Baker, Richard; Walters, E Haydn

    2013-09-06

    To assess benefits of telephone-delivered health mentoring in community-based chronic obstructive pulmonary disease (COPD). Cluster randomised controlled trial. Tasmanian general practices: capital city (11), large rural (3), medium rural (1) and small rural (16). Patients were invited (1207) from general practitioner (GP) databases with COPD diagnosis and/or tiotropium prescription, response rate 49% (586), refused (176) and excluded (criteria: smoking history or previous study, 68). Spirometry testing (342) confirmed moderate or severe COPD in 182 (53%) patients. By random numbers code, block stratified on location, allocation by sequentially numbered, opaque and sealed envelopes. Health mentor (HM) group received regular calls to manage illness issues and health behaviours from trained community health nurses using negotiated goal setting: problem solving, decision-making and action planning. usual care (UC) group received GP care plus non-interventional brief phone calls. Measured at 0, 6 and 12 months, the Short Form 36 (SF-36) and St George's Respiratory Questionnaire (SGRQ, primary); Partners In Health (PIH) Scale for self-management capacity, Hospital Anxiety and Depression Scale (HADS), Center for Epidemiologic Studies-Depression (CES-D) questionnaire, Post-Traumatic Stress Disorder Checklist, Satisfaction with life and hospital admissions (secondary). 182 participants with COPD (age 68±8 years, 62% moderate COPD and 53% men) were randomised (HM=90 and UC=92). Mixed model regression analysis accounting for clustering, adjusting for age, gender, smoking status and airflow limitation assessed efficacy (regression coefficient, β, reported per 6-month visit). There was no difference in quality of life between groups, but self-management capacity increased in the HM group (PIH overall 0.15, 95% CI 0.03 to 0.29; knowledge domain 0.25, 95% CI 0.00 to 0.50). Anxiety decreased in both groups (HADS A 0.35; 95% CI -0.65 to -0.04) and coping capacity improved

  5. General practitioner use of a C-reactive protein point-of-care test to help target antibiotic prescribing in patients with acute exacerbations of chronic obstructive pulmonary disease (the PACE study): study protocol for a randomised controlled trial.

    PubMed

    Bates, Janine; Francis, Nick A; White, Patrick; Gillespie, David; Thomas-Jones, Emma; Breen, Rachel; Kirby, Nigel; Hood, Kerry; Gal, Micaela; Phillips, Rhiannon; Naik, Gurudutt; Cals, Jochen; Llor, Carl; Melbye, Hasse; Wootton, Mandy; Riga, Evgenia; Cochrane, Ann; Howe, Robin; Fitzsimmons, Deborah; Sewell, Bernadette; Alam, Mohammed Fasihul; Butler, Christopher C

    2017-09-29

    Most patients presenting with acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in primary care are prescribed an antibiotic, which may not always be appropriate and may cause harm. C-reactive protein (CRP) is an acute-phase biomarker that can be rapidly measured at the point of care and may predict benefit from antibiotic treatment in AECOPD. It is not clear whether the addition of a CRP point-of-care test (POCT) to clinical assessment leads to a reduction in antibiotic consumption without having a negative impact on COPD health status. This is a multicentre, individually randomised controlled trial (RCT) aiming to include 650 participants with a diagnosis of AECOPD in primary care. Participants will be randomised to be managed according to usual care (control) or with the addition of a CRP POCT to guide antibiotic prescribing. Antibiotic consumption for AECOPD within 4 weeks post randomisation and COPD health status (total score) measured by the Clinical COPD Questionnaire (CCQ) at 2 weeks post randomisation will be co-primary outcomes. Primary analysis (by intention-to-treat) will determine differences in antibiotic consumption for superiority and COPD health status for non-inferiority. Secondary outcomes include: COPD health status, CCQ domain scores, use of other COPD treatments (weeks 1, 2 and 4), EQ-5D utility scores (weeks 1, 2 and 4 and month 6), disease-specific, health-related quality of life (HRQoL) at 6 months, all-cause antibiotic consumption (antibiotic use for any condition) during first 4 weeks post randomisation, total antibiotic consumption (number of days during first 4 weeks of antibiotic consumed for AECOPD/any reason), antibiotic prescribing at the index consultation and during following 4 weeks, adverse effects over the first 4 weeks, incidence of pneumonia (weeks 4 and 6 months), health care resource use and cost comparison over the 6 months following randomisation. Prevalence and resistance profiles of bacteria will be

  6. The biology of rotator cuff healing.

    PubMed

    Zumstein, M-A; Lädermann, A; Raniga, S; Schär, M-O

    2017-02-01

    Despite advances in surgical reconstruction of chronic rotator cuff (RC) tears leading to improved clinical outcomes, failure rates of 13-94% have been reported. Reasons for this rather high failure rate include compromised healing at the bone-tendon interface, as well as the musculo-tendinous changes that occur after RC tears, namely retraction and muscle atrophy, as well as fatty infiltration. Significant research efforts have focused on gaining a better understanding of these pathological changes in order to design effective therapeutic solutions. Biological augmentation, including the application of different growth factors, platelet concentrates, cells, scaffolds and various drugs, or a combination of the above have been studied. It is important to note that instead of a physiological enthesis, an abundance of scar tissue is formed. Even though cytokines have demonstrated the potential to improve rotator cuff healing in animal models, there is little information about the correct concentration and timing of the more than 1500 cytokines that interact during the healing process. There is only minimal evidence that platelet concentrates may lead to improvement in radiographic, but not clinical outcome. Using stem cells to biologically augment the reconstruction of the tears might have a great potential since these cells can differentiate into various cell types that are integral for healing. However, further studies are necessary to understand how to enhance the potential of these stem cells in a safe and efficient way. This article intends to give an overview of the biological augmentation options found in the literature.