NCT04974242

Physiotherapy for Patients Awaiting Rotator Cuff Repair

PhysiOtherapist-led Exercise Versus Waiting-list Control for patiEnts Awaiting Rotator Cuff Repair Surgery: a Pilot Randomised Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

POWER is a pragmatic multi-centre, external pilot randomised controlled trial with feasibility objectives using a parallel group design with 1:1 allocation ratio and integrated qualitative study. The study aims to answer the question: In adult patients diagnosed with tears of the rotator cuff and awaiting elective surgical repair, is it feasible to conduct a future, fully powered, multi-site RCT to test the hypothesis that physiotherapist-led exercise is superior to waiting-list control in terms of clinical and cost-effectiveness?

Detailed description

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. In this pilot study, the investigators will 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. Working with 4 NHS hospitals, the investigators 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 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. the investigators will monitor patients through the study by asking participants to complete one questionnaire at the start and then three more electronic questionnaires after 6 weeks, 3 months and 6 months. The investigators will invite approximately 25 patients to take part in an interview to discuss experience of the treatments and the study. The study is being funded by the UK National Institute for Health Research.

Conditions

• Rotator Cuff Tears

Interventions

Type	Name	Description
OTHER	Physiotherapist-led exercise	A programme of physiotherapist-led exercise over approximately 12 weeks.

Timeline

• Start date: 2021-09-29
• Primary completion: 2022-08-01
• Completion: 2022-10-01
• First posted: 2021-07-23
• Last updated: 2021-10-11

Locations

1 site across 1 country: United Kingdom