Background:Progressive high-load exercise (PHLE) has led to positive clinical results in patients with patellar and Achilles tendinopathy. However, its effects on rotator cuff tendinopathy still need to be investigated.Purpose:To assess the clinical effects of PHLE versus low-load exercise (LLE) among patients with rotator cuff tendinopathy.Study Design:Randomized controlled trial; Level of evidence, 1.Methods:Patients with rotator cuff tendinopathy were recruited and randomized to 12 weeks of PHLE or LLE, stratified for concomitant administration of corticosteroid injection. The primary outcome measure was change from baseline to 12 weeks in the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, assessed in the intention-to-treat population.Results:A total of 100 patients were randomized to PHLE (n = 49) or LLE (n = 51). Mean changes in the DASH questionnaire were 7.11 points (95% CI, 3.07-11.16) and 8.39 points (95% CI, 4.35-12.44) in the PHLE and LLE groups, respectively; this corresponded to a statistically nonsignificant adjusted mean group difference of −1.37 points (95% CI, −6.72 to 3.99; P = .61). Similar nonsignificant results were seen for pain, range of motion, and strength. However, a significant interaction effect was found between the 2 groups and concomitant corticosteroid use (P = .028), with the largest positive change in DASH in favor of PHLE for the group receiving concomitant corticosteroid.Conclusion:The study results showed no superior benefit from PHLE over traditional LLE among patients with rotator cuff tendinopathy. Further investigation of the possible interaction between exercise type and corticosteroid injection is needed to establish optimal and potentially synergistic combinations of these 2 factors.Registration:NCT01984203 (ClinicalTrials.gov identifier): Rotator Cuff Tendinopathy Exercise Trial (RoCTEx).

BackgroundShoulder 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.Methods/DesignThe 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.DiscussionPrevious 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.Trial registrationThe trial was registered with Clinicaltrials.gov (NCT01984203) on 31 October 2013.

ObjectivesThe reliability of ultrasonic strain elastography (SEL) used to detect abnormalities in the supraspinatus tendon is unclear. Thus, the aim of this study was to investigate the reliability of SEL in the supraspinatus tendon.DesignAn intra-rater and inter-rater reliability study.SettingA single-centre study conducted at the University of Southern Denmark.ParticipantsTwenty participants with shoulder pain and MRI-verified supraspinatus tendinosis and 20 asymptomatic participants (no MRI).Primary and secondary outcome measuresRaw values (RAW) and ratios (deltoid muscle (DELT) and gel pad (GEL) as reference tissues) were calculated and mean values of measurements from three regions of the supraspinatus tendon were reported. Colour scale ratings and number of yellow/red lesions from the three areas were also included.ResultsIntra-rater reliability showed intraclass correlation coefficients (ICCs) for RAW, DELT and GEL: 0.97 (minimal detectable change (MDC): 0.28 (6.36% of the mean)), 0.89 (MDC: 2.91 (20.37%)) and 0.73 (MDC: 1.61 (58.82%)), respectively. The ICCs for inter-rater reliability were 0.89 (MDC: 0.47 (10.53%)), 0.78 (MDC: 3.69 (25.51%)) and 0.70 (MDC: 1.75 (62.63%)), respectively.For colour scale ratings, intra-rater reliability (linear weighted kappa) ranged from 0.76 to 0.79, with the inter-rater reliability from 0.71 to 0.81. For the number of lesions, intra-rater reliability ranged from 0.40 to 0.82 and inter-rater reliability from 0.24 to 0.67.ConclusionsIntra-rater and inter-rater reliability were excellent for raw values and for ratios with deltoid muscle as the reference tissue, and good for ratios with gel pad as the reference tissue. The reliability of colour scale ratings was substantial-to-almost perfect, and for the number of lesions fair-to-almost perfect.Although high reliability was found, validity and responsiveness of these elastographic methods needs further investigation.Ethics approvalThe study protocol was approved by the Ethics Committee for the Region of South Denmark (S-20160115) and reported to the Danish Data Protection Agency (2014-41-3266).

AimTo evaluate the inter-rater reliability of measuring structural changes in the tendon of patients, clinically diagnosed with supraspinatus tendinopathy (cases) and healthy participants (controls), on ultrasound (US) images captured by standardised procedures.MethodsA total of 40 participants (24 patients) were included for assessing inter-rater reliability of measurements of fibrillar disruption, neovascularity, as well as the number and total length of calcifications and tendon thickness. Linear weighted κ, intraclass correlation (ICC), SEM, limits of agreement (LOA) and minimal detectable change (MDC) were used to evaluate reliability.Results‘Moderate—almost perfect’ κ was found for grading fibrillar disruption, neovascularity and number of calcifications (k 0.60–0.96). For total length of calcifications and tendon thickness, ICC was ‘excellent’ (0.85–0.90), with SEM(Agreement) ranging from 0.63 to 2.94 mm and MDC(group) ranging from 0.28 to 1.29 mm. In general, SEM, LOA and MDC showed larger variation for calcifications than for tendon thickness.ConclusionsInter-rater reliability was moderate to almost perfect when a standardised procedure was applied for measuring structural changes on captured US images and movie sequences of relevance for patients with supraspinatus tendinopathy. Future studies should test intra-rater and inter-rater reliability of the method in vivo for use in clinical practice, in addition to validation against a gold standard, such as MRI.Trial registration numberNCT01984203; Pre-results.

ObjectiveFirst, to investigate the intertester reliability of clinical shoulder instability and laxity tests, and second, to describe the mutual dependency of each test evaluated by each tester for identifying self-reported shoulder instability and laxity.MethodsA standardised protocol for conducting reliability studies was used to test the intertester reliability of the six clinical shoulder instability and laxity tests: apprehension, relocation, surprise, load-and-shift, sulcus sign and Gagey. Cohen’s kappa (κ) with 95% CIs besides prevalence-adjusted and bias-adjusted kappa (PABAK), accounting for insufficient prevalence and bias, were computed to establish the intertester reliability and mutual dependency.ResultsForty individuals (13 with self-reported shoulder instability and laxity-related shoulder problems and 27 normal shoulder individuals) aged 18–60 were included. Fair (relocation), moderate (load-and-shift, sulcus sign) and substantial (apprehension, surprise, Gagey) intertester reliability were observed across tests (κ 0.39–0.73; 95% CI 0.00 to 1.00). PABAK improved reliability across tests, resulting in substantial to almost perfect intertester reliability for the apprehension, surprise, load-and-shift and Gagey tests (κ 0.65–0.90). Mutual dependencies between each test and self-reported shoulder problem showed apprehension, relocation and surprise to be the most often used tests to characterise self-reported shoulder instability and laxity conditions.ConclusionsFour tests (apprehension, surprise, load-and-shift and Gagey) out of six were considered intertester reliable for clinical use, while relocation and sulcus sign tests need further standardisation before acceptable evidence. Furthermore, the validity of the tests for shoulder instability and laxity needs to be studied.

IntroductionHip osteoarthritis (OA) is the leading cause for total hip arthroplasty (THA). Although, being considered as the surgery of the century up to 23% of the patients report long-term pain, and deficits in physical function and muscle strength may persist after THA. Progressive resistance training (PRT) appears to improve multiple outcomes moderately in patients with hip OA. Current treatment selection is based on low-level evidence as no randomised controlled trials have compared THA to non-surgical treatment. The primary aim of this trial is to investigate whether THA followed by standard care is superior to 12 weeks of supervised PRT followed by 12 weeks of optional unsupervised PRT for improving hip pain and function in patients with severe hip OA.Methods and analysisThis is a protocol for a multicentre, parallel-group, assessor-blinded, randomised controlled superiority trial conducted at four hospitals across three healthcare regions in Denmark. 120 patients aged ≥50 years with clinical and radiographic hip OA found eligible for THA by an orthopaedic surgeon will be randomised to THA followed by standard care, or 12 weeks of PRT (allocation 1:1). The primary outcome will be change in patient-reported hip pain and function, measured using the Oxford Hip Score, from baseline to 6 months after initiating the treatment. Key secondary outcomes will be change in the Hip disability and Osteoarthritis Outcome Score subscales, University of California Los Angeles Activity Score, 40 m fast-paced walk test, 30 s chair stand test and occurrence of serious adverse events. Patients declining participation in the trial will be invited into a prospective observational cohort study.Ethics and disseminationThe trial has been approved by The Regional Committees on Health Research Ethics for Southern Denmark (Project-ID: S-20180158). All results will be presented in peer-reviewed scientific journals and international conferences.Trial registration numberClinicalTrials.gov (NCT04070027).

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