Physiotherapy for patients awaiting rotator cuff repair_v0.1
Research type
Research Study
Full title
PhysiOtherapist-led exercise versus Waiting-list control for patiEnts awaiting Rotator cuff repair surgery: a pilot randomised controlled trial with nested qualitative study
IRAS ID
295809
Contact name
Chris Littlewood
Contact email
Sponsor organisation
University Hospitals of Derby & Burton
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Research Summary
WHY IS THIS STUDY IMPORTANT?
Tears of the shoulder rotator cuff tendons are a common cause of shoulder pain, disability, and absence from work.Once a decision to undergo rotator cuff repair surgery has been made, patients are placed on a waiting list, and it can take weeks or months to receive the surgery. While waiting for surgery, many patients continue to experience significant pain and disability, and some will be unable to work.
If treatment could be delivered to patients while on the waiting list with potential to reduce pain and disability, and also potentially reduce the need for surgery, there would be clear and significant patient benefit and also benefit to the NHS.
WHAT IS THE AIM OF THIS STUDY?
In this pilot study, we aim to find if it is possible to carry out a larger study to determine if a programme of physiotherapist-led exercise for patients awaiting surgery to repair torn shoulder rotator cuff tendons is clinically and cost-effective.
HOW WILL THE STUDY BE DESIGNED?
Working with 4 NHS hospitals, we will recruit 76 patients waiting for rotator cuff repair surgery. One group of patients will receive a programme of specific exercise, supported by a physiotherapist. The second group will just continue waiting for their surgery without additional treatment, which is current standard care.The programme of specific exercise can be supported over the telephone, via secure video platform, or face-to-face. We will monitor patients through the study by asking them to complete one questionnaire at the start and then three more electronic questionnaires after 6 weeks, 3 months and 6 months.
We will invite approximately 25 patients to take part in an interview to discuss their experience of the treatments and the study.
The study is being funded by the National Institute for Health Research.
Summary of Results
Background: Once a decision to undergo surgery to repair the rotator cuff of the shoulder, 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 is the best treatment option for them.
Objective: To evaluate the feasibility, as measured by recruitment rates, whether the treatment was delivered as intended, 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.REC name
West of Scotland REC 1
REC reference
21/WS/0067
Date of REC Opinion
7 Jun 2021
REC opinion
Favourable Opinion