Physiotherapy for Patients Awaiting Rotator Cuff Repair
POWER
PhysiOtherapist-led Exercise Versus Waiting-list Control for patiEnts Awaiting Rotator Cuff Repair Surgery: a Pilot Randomised Controlled Trial
1 other identifier
interventional
76
1 country
1
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2021
CompletedFirst Posted
Study publicly available on registry
July 23, 2021
CompletedStudy Start
First participant enrolled
September 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedOctober 11, 2021
October 1, 2021
10 months
June 9, 2021
October 7, 2021
Conditions
Outcome Measures
Primary Outcomes (11)
Numbers of eligible patients.
Numbers of patients screened and then deemed eligible will be reported descriptively.
6 months
Rate of recruitment.
Numbers of patients approached and then randomised as a proportion of the number of eligible patients will be reported descriptively.
6 months
Reasons for patients not wanting to participate.
Reasons for patients not wanting to participate will be reported descriptively.
6 months
Treatment fidelity (numbers of participants who receive physiotherapy) relating to the programme of physiotherapist-led exercise.
Numbers of participants who receive physiotherapy will be reported descriptively.
6 months
Treatment fidelity (number of appointments attended) relating to the programme of physiotherapist-led exercise.
The number of appointments attended will be reported descriptively.
6 months
Treatment fidelity (self-report exercise adherence) relating to the programme of physiotherapist-led exercise.
Self-report exercise adherence (intervention group only) will be reported descriptively.
6 months
Completion rate of clinical outcome measures.
The proportion of clinical outcome questionnaires completed at 6-weeks post-randomisation, including via minimal data collection, will be reported descriptively.
6 weeks
Completion rate of clinical outcome measures.
The proportion of clinical outcome questionnaires completed at three months post-randomisation, including via minimal data collection, will be reported descriptively.
3 months
Completion rate of clinical outcome measures.
The proportion of clinical outcome questionnaires completed at six months post-randomisation, including via minimal data collection, will be reported descriptively.
6 months
Number and nature of adverse events.
The number and nature of adverse events which occur will be reported descriptively overall and by study arm.
6 months
Proportion of participants who report an intention to proceed to surgery or who have received surgery.
The proportion of participants who report an intention to proceed to surgery or who have received surgery within six-months post randomisation will be reported descriptively.
6 months
Secondary Outcomes (4)
Pain and disability assessed using the Shoulder Pain & Disability Index (SPADI)
6 weeks, 3 and 6 months post-randomisation
Health related quality of life assessed using the EQ-5D-5L
6 weeks, 3 and 6 months post-randomisation
Days lost from work due to the shoulder problem
6 weeks, 3 and 6 months post-randomisation
Days lost from driving
6 weeks, 3 and 6 months post-randomisation
Study Arms (2)
Physiotherapist-led exercise
EXPERIMENTALStructured 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.
Waiting-list control
NO INTERVENTIONContinue on the waiting list for rotator cuff repair surgery, as per usual care.
Interventions
A programme of physiotherapist-led exercise over approximately 12 weeks.
Eligibility Criteria
You may qualify if:
- Adult patients on the elective orthopaedic waiting list for surgical repair of the rotator cuff.
You may not qualify if:
- Unable to provide informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals Derby and Burton NHS Foundation Trust
Derby, Derbyshire, DE22 3DT, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Chris Littlewood
Manchester Met University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2021
First Posted
July 23, 2021
Study Start
September 29, 2021
Primary Completion
August 1, 2022
Study Completion
October 1, 2022
Last Updated
October 11, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Following publication of the study results and for up to 10 years thereafter.
- Access Criteria
- An email request should be sent to the chief investigator outlining the type of data to be obtained, the reason for obtaining this data (research question / objective), and the timing for when the data is required to be available (start date/end date). The chief investigator will check that the data set requested is appropriately suited to answer the research question/objective and that the request fits with the original ethical approval and participant consent and adheres to funder and legal restrictions.
The anonymised datasets generated during and/or analysed during the current study are/will be available upon request from the chief investigator. Only de-identified data will be available for request in aggregated format or at the level of the individual participant.