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Rotator cuff-related shoulder pain: does the type of exercise influence the outcomes? Protocol of a randomised controlled trial.

ABSTRACT: INTRODUCTION:Lifetime prevalence of shoulder pain is 70%, and approximately 50% of people with shoulder pain will experience pain for more than a year. Rotator cuff-related shoulder pain (RCRSP) is the most common shoulder condition and the main non-surgical intervention is exercise therapy. For approximately 30% of people with RCRSP, this approach does not lead to a significant reduction in symptoms. This may be due to an inappropriate dosage or choice of exercises. The aim of this investigation is to compare the short, mid and long-term effects, in terms of symptoms, functional limitations, kinesiophobia and pain catastrophising, of three different shoulder rehabilitation approaches (education, strengthening, motor control) in adults with RCRSP. METHODS AND ANALYSIS:In this single-blind (assessor), parallel-group, randomised clinical trial, 123 adults presenting with RCRSP will take part in a 12-week rehabilitation programme. They will be randomly assigned to one of three groups (education only, strengthening approach or motor control-focused approach). Abbreviated version of the Disabilities of the Arm, Shoulder and Hand Questionnaire, the primary outcome, Western Ontario Rotator Cuff Index and Brief Pain Inventory will evaluate symptoms and functional limitations, while Tampa Scale of Kinesiophobia and Pain Catastrophizing Scale will evaluate pain-related fear and catastrophising at baseline and at 3, 6, 12 and 24 weeks. Ultrasonographic acromiohumeral distances and tendon thickness will be assessed at baseline and 12 weeks. Intervention groups will be compared on outcomes with intention-to-treat analyses using two-way repeated measures analysis of variance if the data are normally distributed or non-parametric analysis of longitudinal data if they are not. ETHICS AND DISSEMINATION:Ethics approval was obtained from the Sectorial Rehabilitation and Social Integration Research Ethics Committee of the Centre Intégré Universitaire de Santé et de Services Sociaux de la Capitale Nationale (CIUSSS-CN). Results will be disseminated through international publications in peer-reviewed journals, in addition to international conference presentations. TRIAL REGISTRATION NUMBER:NCT03892603; pre-results.

SUBMITTER: Dube MO

PROVIDER: S-EPMC7646354 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Rotator cuff-related shoulder pain: does the type of exercise influence the outcomes? Protocol of a randomised controlled trial.

Dubé Marc-Olivier MO Desmeules François F Lewis Jeremy J Roy Jean-Sébastien JS

BMJ open 20201105 11

<h4>Introduction</h4>Lifetime prevalence of shoulder pain is 70%, and approximately 50% of people with shoulder pain will experience pain for more than a year. Rotator cuff-related shoulder pain (RCRSP) is the most common shoulder condition and the main non-surgical intervention is exercise therapy. For approximately 30% of people with RCRSP, this approach does not lead to a significant reduction in symptoms. This may be due to an inappropriate dosage or choice of exercises. The aim of this inve ...[more]

PMID: 33154058

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Project description:BackgroundRotator cuff related pain (RCRP) is one of the most common sources of musculoskeletal shoulder pain affecting the general population. Conservative treatment, in the form of exercise, is considered the first line approach, nonetheless, improvements seem to be modest. One therapeutic modality that might be an adjunct to the treatment of this condition is mobilisation with movement (MWM). MWM is a pain-free manual procedure that targets restricted and painful movements, commonly seen in patients with RCRP. The purpose of clinical trial is to determine whether MWM with exercise has benefits over sham MWM with exercise in RCRP.MethodsA randomised, sham-controlled trial of 70 adults complaining of RCRP will compare the effects of MWM combined with exercise over sham MWM with exercise. Participants will be allocated to one of two groups: exercise and MWM (EG) or exercise and sham MWM (CG). Two weekly individual treatment sessions will be conducted over five weeks. All assessments will be performed by a blinded assessor. Primary outcome measures will be the shoulder pain and disability index (SPADI) and the numeric pain rating scale (NPRS), assessed at baseline, discharge and one-month follow-up. Secondary outcome measures will be active range of motion, self-efficacy and the global rating of change scale. The analyses will be conducted considering a statistically significant p-value ≤0.05. Normality will be assessed with the Kolmogorov-Smirnov test and homogeneity with the Levene's test. For the primary outcome measures (SPADI and NPRS) and self-efficacy, a 2 × 3 ANOVA with treatment group (EG versus CG) and time (baseline, end of the treatment and follow-up) factors will be performed. Separate 2 × 2 ANOVA will be used for range of motion (baseline and end of the treatment). Global rating scale of change analysis will be conducted using descriptive statistics. Intention-to-treat analysis will be adopted.DiscussionAs there is a paucity of longitudinal studies investigating the use of MWM in patients with RCRP, this study will help to better understand its role together with a structured exercise programme.Trial registrationClinical Trials Registry number NCT04175184 . November, 2019.

Project description:Purpose To compare patient-reported and surgical outcome measures in patients with and without secondary shoulder stiffness (SSS) undergoing rotator cuff repair (RCR). Methods Patients undergoing rotator cuff repair from 2014 to 2020 with complete patient-reported outcome measures (PROMs) by the short-form 12 survey (SF-12) were retrospectively reviewed to identify if operative intervention for SSS was performed alongside the RCR. Those patients with operative intervention for SSS were propensity matched to a group without prior intervention for stiffness by age, sex, laterality, body mass index, diabetes mellitus status, and the presence of a thyroid disorder. The groups were compared by rotator cuff tear (RCT) size, surgical outcomes, further surgical intervention, rotator cuff retear rate, postoperative range of motion (ROM), and SF-12 results at 1 year after surgery. Delta values were calculated for component scores of the SF-12 and ROM values by subtracting the preoperative result from the postoperative result. Results A total of 89 patients with SSS were compared to 156 patients in the control group at final analysis. The patients in the SSS group experienced a significant improvement in the delta mental health component score (MCS-12) of the SF-12 survey that was not seen in the control group (P = .005 to P = .539). Both groups experienced significant improvement by the delta physical health component score (PCS-12) of the SF-12 survey (SSS: 7.68; P < .001; control: 6.95; P < .001). The SSS group also experienced greater improvement of their forward flexion (25.8° vs 12.9°; P = .005) and external rotation (7.13° vs 1.65°; P = .031) ROM than the control group. Conclusions Operative intervention of SSS at the time of RCR has equivalent postoperative SF-12 survey outcome scores when compared to patients undergoing RCR without preoperative stiffness despite those patients having lower preoperative scores. Level of Evidence Level III retrospective comparative study.

Project description:BackgroundRotator cuff-related shoulder pain (RCRSP) is a common and disabling musculoskeletal condition. Internet-based and telerehabilitation delivery of recommended care may improve access to care and improve adherence and outcomes.ObjectiveThe primary aim of this pilot randomized controlled trial was to assess the feasibility of a 12-week internet-delivered intervention for RCRSP comparing advice only, recommended care, and recommended care with group-based telerehabilitation.MethodsReporting was in accordance with the Consolidated Standards of Reporting Trials (CONSORT) checklist for pilot and feasibility trials. People with a primary complaint of RCRSP for 3 months or longer were identified via a paid Facebook strategy. Screening involved an online questionnaire followed by a 20-minute telehealth assessment. Participants were randomly allocated (via a Zelen design) to receive (1) advice only, (2) recommended care (internet-delivered evidence-based exercise and education), or (3) recommended care and telerehabilitation (including a weekly group teleconference session). Progression criteria for a full-scale trial included (1) recruitment of 20% or greater of eligible participants, (2) acceptable adherence (two or more of the three prescribed weekly sessions) among 70% or greater of participants, (3) 80% or greater retention of participants, (4) absence of intervention-related serious adverse events, and (5) 80% or greater response rates to questionnaires. Secondary clinical and patient knowledge outcomes were collected (via email or text) at baseline, six weeks, and 12 weeks (for clinical and patient knowledge), and within-group change was reported descriptively.ResultsWe enrolled 36 of 38 (95%) eligible participants and all participants were recruited within a 3-week period. Of the 36 participants, 12 participants were allocated to each of the three trial arms. The mean age of participants was between 51 and 56 years, and 83% (10/12) to 92% (11/12) were female. Retention at the 12-week endpoint was 94% (34/36) and response to email questionnaires at other time points was 83% or greater. We found acceptable adherence (defined as greater than 70% of participants performing exercise 2 or 3 times/week) in the recommended care group with telerehabilitation but not in the recommended care group without telerehabilitation. There was a total of 24 adverse events over 108 person-months of observation. All adverse events were mild or moderate (mainly muscle and shoulder symptoms), with the exception of one instance of elective surgery (unrelated to the person's shoulder condition).ConclusionsOur prespecified success criteria were met or exceeded, but there was a gender imbalance toward women. It is feasible to progress to a fully powered trial, but strategies to address the gender imbalance need to be implemented.Trial registrationAustralian New Zealand Clinical Trials Registry (ACTRN12620000248965); https://tinyurl.com/yy6eztf5.

Dataset Information

Rotator cuff-related shoulder pain: does the type of exercise influence the outcomes? Protocol of a randomised controlled trial.

Publications

Rotator cuff-related shoulder pain: does the type of exercise influence the outcomes? Protocol of a randomised controlled trial.

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