Progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of patients with rotator cuff disorders (GRASP): a multicentre, pragmatic, 2 × 2 factorial, randomised controlled trial

Background Corticosteroid injections and physiotherapy exercise programmes are commonly used to treat rotator cuff disorders but the treatments' effectiveness is uncertain. We aimed to compare the clinical effectiveness and cost-effectiveness of a progressive exercise programme with a single session of best practice physiotherapy advice, with or without corticosteroid injection, in adults with a rotator cuff disorder. Methods In this pragmatic, multicentre, superiority, randomised controlled trial (2 × 2 factorial), we recruited patients from 20 UK National Health Service trusts. We included patients aged 18 years or older with a rotator cuff disorder (new episode within the past 6 months). Patients were excluded if they had a history of significant shoulder trauma (eg, dislocation, fracture, or full-thickness tear requiring surgery), neurological disease affecting the shoulder, other shoulder conditions (eg, inflammatory arthritis, frozen shoulder, or glenohumeral joint instability), received corticosteroid injection or physiotherapy for shoulder pain in the past 6 months, or were being considered for surgery. Patients were randomly assigned (centralised computer-generated system, 1:1:1:1) to progressive exercise (≤6 sessions), best practice advice (one session), corticosteroid injection then progressive exercise, or corticosteroid injection then best practice advice. The primary outcome was the Shoulder Pain and Disability Index (SPADI) score over 12 months, analysed on an intention-to-treat basis (statistical significance set at 1%). The trial was registered with the International Standard Randomised Controlled Trial Register, ISRCTN16539266, and EuDRACT, 2016-002991-28. Findings Between March 10, 2017, and May 2, 2019, we screened 2287 patients. 708 patients were randomly assigned to progressive exercise (n=174), best practice advice (n=174), corticosteroid injection then progressive exercise (n=182), or corticosteroid injection then best practice advice (n=178). Over 12 months, SPADI data were available for 166 (95%) patients in the progressive exercise group, 164 (94%) in the best practice advice group, 177 (97%) in the corticosteroid injection then progressive exercise group, and 175 (98%) in the corticosteroid injection then best practice advice group. We found no evidence of a difference in SPADI score between progressive exercise and best practice advice when analysed over 12 months (adjusted mean difference −0·66 [99% CI −4·52 to 3·20]). We also found no evidence of a difference between corticosteroid injection compared with no injection when analysed over 12 months (−1·11 [–4·47 to 2·26]). No serious adverse events were reported. Interpretation Progressive exercise was not superior to a best practice advice session with a physiotherapist in improving shoulder pain and function. Subacromial corticosteroid injection provided no long-term benefit in patients with rotator cuff disorders

57. Development and Validation of a Musculoskeletal Patient Reported Outcome Measure

Background: The UK government has called for clinical services to gather data from patients to evaluate quality of healthcare and monitor progress over time. However, practical, brief clinical tools for this purpose are lacking. We aimed to develop and validate a musculoskeletal patient reported outcome measure (MSK-PROM) suitable for evaluating care and also monitoring patient progress within community musculoskeletal services.Methods: In Phase 1 we developed the MSK-PROM through two consensus workshops (to identify and prioritize the key domains for inclusion in the tool), an online consultation survey with relevant stakeholders, and two face validity workshops to test the readability and comprehension of the draft tool. In Phase 2 we tested the reliability and sensitivity to change of the draft tool with a prospective cohort of adults attending musculoskeletal physiotherapy services in the West Midlands region, and discussed acceptability and feasibility with samples of participating patients and clinicians.Results: Eleven key domains were prioritized for inclusion in the MSK-PROM: independence, physical function, severity of the worst symptom, pain severity, work interference, difficulty with activities and roles, quality of life, understanding how to deal with symptoms, anxiety/depression, and overall impact. For five of the identified health domains (function, anxiety, mood, pain and quality of life) questions from the existing validated and recommended quality of life measure (EQ-5D-5L) were used to avoid duplication in clinical practice. The MSK-PROM therefore includes six new single items in addition to five from the EQ-5D-5L. 425 physiotherapy consulters with musculoskeletal problems completed the MSK-PROM at every treatment visit (88% had a completed MSK-PROM for at least 1 follow-up, and 225 (53%) responded to a three month follow-up questionnaire. Completion rates for the MSK-PROM items were high (>97%) with scores Normally distributed (mean = 28, S.D. = 6.5, 10 of the 11 items are scored giving a scale range 10–50, with the work item excluded as for over a third of patients this item was not applicable). Data from stable patients with unchanged symptoms at visit 2 confirmed the MSK-PROM’s reliability (ICC 0.98 (95% CI 0.96, 0.98) and demonstrated its superior sensitivity to change compared with the EQ-5D-5L weighted score (MSK-PROM: standardized response mean (SRM) = 0.66, AUC 0.81 vs EQ-5D-5L: SRM 0.44, AUC 0.74). The MSK-PROM was found to be acceptable and feasible to use in community physiotherapy services, with minor modifications to improve the wording of the tool.Conclusion: A new patient reported outcome measure (MSK-PROM) has been developed using domains that matter the most to musculoskeletal patients, clinicians and service managers, and has been shown to be feasible, valid and reliable for use in clinical practice. The tool will be made freely available for clinical use