Physiotherapy for Patients Awaiting Rotator Cuff Repair (POWER)

University Hospitals of Derby and Burton NHS Foundation Trust

Status: Unknown

Conditions: Rotator Cuff Tears

Treatments: Other: Physiotherapist-led exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04974242

UHDB/2021/016

Details and patient eligibility

About

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?

Full 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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients on the elective orthopaedic waiting list for surgical repair of the rotator cuff.

Exclusion criteria

• Unable to provide informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Physiotherapist-led exercise

Experimental group

Description:

Structured and progressive physiotherapist-led exercise programme. Reflective of current guidance for exercise programmes for people with rotator cuff disorders, an individualised programme developed in relation to the participant's specific goals will be prescribed by the physiotherapist and supported over approximately six contact sessions across a 12-week period.

Treatment:

Other: Physiotherapist-led exercise

Waiting-list control

No Intervention group

Description:

Continue on the waiting list for rotator cuff repair surgery, as per usual care.