Clinical trial NCT04974242: Physiotherapy for Patients Awaiting Rotator Cuff Repair
Official title: PhysiOtherapist-led Exercise Versus Waiting-list Control for patiEnts Awaiting Rotator Cuff Repair Surgery: a Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rotator Cuff Tears
Lead sponsor: University Hospitals of Derby and Burton NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Unable to provide informed consent.

Primary outcomes:
measure: Numbers of eligible patients.
timeFrame: 6 months
measure: Rate of recruitment.
timeFrame: 6 months
measure: Reasons for patients not wanting to participate.
timeFrame: 6 months
measure: Treatment fidelity (numbers of participants who receive physiotherapy) relating to the programme of physiotherapist-led exercise.
timeFrame: 6 months
measure: Treatment fidelity (number of appointments attended) relating to the programme of physiotherapist-led exercise.
timeFrame: 6 months
measure: Treatment fidelity (self-report exercise adherence) relating to the programme of physiotherapist-led exercise.
timeFrame: 6 months
measure: Completion rate of clinical outcome measures.
timeFrame: 6 weeks
measure: Completion rate of clinical outcome measures.
timeFrame: 3 months
measure: Completion rate of clinical outcome measures.
timeFrame: 6 months
measure: Number and nature of adverse events.
timeFrame: 6 months
measure: Proportion of participants who report an intention to proceed to surgery or who have received surgery.
timeFrame: 6 months
Secondary outcomes:
measure: Pain and disability assessed using the Shoulder Pain & Disability Index (SPADI)
timeFrame: 6 weeks, 3 and 6 months post-randomisation
measure: Health related quality of life assessed using the EQ-5D-5L
timeFrame: 6 weeks, 3 and 6 months post-randomisation
measure: Days lost from work due to the shoulder problem
timeFrame: 6 weeks, 3 and 6 months post-randomisation
measure: Days lost from driving
timeFrame: 6 weeks, 3 and 6 months post-randomisation
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: University Hospitals Derby and Burton NHS Foundation Trust
state: Derbyshire
Study officials:
affiliation: Manchester Met University
name: Chris Littlewood
role: STUDY_CHAIR
References: