Prof Chris Littlewood C.D.Littlewood@salford.ac.uk
Professor
Prof Chris Littlewood C.D.Littlewood@salford.ac.uk
Professor
Maria Moffatt
Jacqueline Beckhelling
Daniel Davis
Adrian Burden
Lisa Pitt
Stacey Lalande
Catrin Maddocks
Gareth Stephens
Helen Tunnicliffe
Jessica Pawson
James Lloyd
Andrea Manca
Julia Wade
Nadine E. Foster
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.
Journal Article Type | Article |
---|---|
Acceptance Date | Oct 19, 2023 |
Online Publication Date | Oct 30, 2023 |
Publication Date | Nov 3, 2023 |
Deposit Date | Nov 15, 2024 |
Publicly Available Date | Nov 15, 2024 |
Journal | Musculoskeletal Science and Practice |
Print ISSN | 2468-7812 |
Publisher | Elsevier |
Peer Reviewed | Peer Reviewed |
Volume | 68 |
Article Number | 102874 |
DOI | https://doi.org/10.1016/j.msksp.2023.102874 |
Keywords | Randomised controlled trial, Rehabilitation, Rotator cuff, Rotator Cuff/surgery, Pilot Projects, Multicenter Studies as Topic, Humans, England, Adult, Waiting Lists, Physical Therapists |
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