Physiotherapy for Patients Awaiting Rotator Cuff Repair
NCT ID: NCT04974242
Last Updated: 2021-10-11
Study Results
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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UNKNOWN
NA
76 participants
INTERVENTIONAL
2021-09-29
2022-10-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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.
Physiotherapist-led exercise
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.
No interventions assigned to this group
Interventions
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Physiotherapist-led exercise
A programme of physiotherapist-led exercise over approximately 12 weeks.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University Hospitals of Derby and Burton NHS Foundation Trust
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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Lisa Pitt
Role: primary
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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UHDB/2021/016
Identifier Type: -
Identifier Source: org_study_id
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