Physiotherapist-led exercise versus usual care (waiting-list) control for patients awaiting rotator cuff repair surgery: A pilot randomised controlled trial (POWER).

BACKGROUND: Once a decision to undergo rotator cuff repair surgery is made, patients are placed on the waiting list. It can take weeks or months to receive surgery. There has been a call to move from waiting lists to 'preparation' lists to better prepare patients for surgery and to ensure it remains an appropriate treatment option for them. OBJECTIVE: To evaluate the feasibility, as measured by recruitment rates, treatment fidelity and follow-up rates, of a future multi-centre randomised controlled trial to compare the clinical and cost-effectiveness of undertaking a physiotherapist-led exercise programme while waiting for surgery versus usual care (waiting-list control). DESIGN: Two-arm, multi-centre pilot randomised controlled trial with feasibility objectives in six NHS hospitals in England. METHOD: Adults (n = 76) awaiting rotator cuff repair surgery were recruited and randomly allocated to a programme of physiotherapist-led exercise (n = 38) or usual care control (n = 38). RESULTS: Of 302 eligible patients, 76 (25%) were randomised. Of 38 participants randomised to physiotherapist-led exercise, 28 (74%) received the exercise programme as intended. 51/76 (67%) Shoulder Pain and Disability Index questionnaires were returned at 6-months. Of 76 participants, 32 had not received surgery after 6-months (42%). Of those 32, 20 were allocated to physiotherapist-led exercise; 12 to usual care control. CONCLUSIONS: A future multi-centre randomised controlled trial is feasible but would require planning for variable recruitment rates between sites, measures to improve treatment fidelity and opportunity for surgical exit, and optimisation of follow-up. A fully powered, randomised controlled trial is now needed to robustly inform clinical decision-making.

Development of a physiotherapist-led exercise programme for traumatic tears of the rotator cuff for the SPeEDy study.

OBJECTIVES: The SPeEDy study (Surgery vs. physiotherapist-led exercise for traumatic tears of the rotator cuff) is a two-arm, parallel group, pilot and feasibility randomised controlled trial aiming to evaluate the feasibility of a future main trial. In this paper, the development process and the resultant physiotherapist-led exercise programme used in the SPeEDy study is described. METHODS: Thirteen physiotherapists and three patients met to discuss and develop the key principles that should underpin the exercise programme. RESULTS: Taking in to account the current research evidence and incorporating expert clinical and patient opinion, the group developed an individualised, structured and progressive physiotherapist-led exercise programme based on the principle of self dosing. Exercise prescription within the programme is based on establishing the current functional capacity of the patient in relation to the most challenging shoulder movements and is supported over approximately six contact sessions across a 12-week period. CONCLUSION: The SPeEDy study aims to recruit 76 participants across eight hospitals and will provide high quality evidence about the feasibility of a future main randomised controlled trial in a clinical area where there is a lack of evidence from randomised controlled trials to support clinical decision-making. ClinicalTrials.gov (NCT04027205) - Registered on 19 July 2019. Available via https://clinicaltrials.gov/ct2/show/NCT04027205.