Physiotherapy for Patients Awaiting Rotator Cuff Repair

NCT ID: NCT04974242

Last Updated: 2021-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-29

Study Completion Date

2022-10-31

Brief Summary

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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

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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

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Rotator Cuff Tears

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Physiotherapist-led exercise

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.

Group Type EXPERIMENTAL

Physiotherapist-led exercise

Intervention Type OTHER

A programme of physiotherapist-led exercise over approximately 12 weeks.

Waiting-list control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Physiotherapist-led exercise

A programme of physiotherapist-led exercise over approximately 12 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Unable to provide informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospitals of Derby and Burton NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chris Littlewood

Role: STUDY_CHAIR

Manchester Met University

Locations

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University Hospitals Derby and Burton NHS Foundation Trust

Derby, Derbyshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Chris Littlewood

Role: CONTACT

0161 247 5235

Facility Contacts

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Lisa Pitt

Role: primary

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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UHDB/2021/016

Identifier Type: -

Identifier Source: org_study_id

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