Rotator Cuff TearsPOWERNCT04974242
Physiotherapy for Patients Awaiting Rotator Cuff Repair
A study testing Physiotherapist-led exercise in people with Rotator Cuff Tears, run by University Hospitals of Derby and Burton NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Physiotherapist-led exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Sep 2021to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients on the elective orthopaedic waiting list for surgical repair of the rotator cuff.
Who cannot join
- Unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals Derby and Burton NHS Foundation Trust
Derby, Derbyshire, DE22 3DT
Lisa Pitt
About this study
Official title: PhysiOtherapist-led Exercise Versus Waiting-list Control for patiEnts Awaiting Rotator Cuff Repair Surgery: a Pilot Randomised Controlled Trial
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?
Read the 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.
- Conditions
- Rotator Cuff Tears
- Being tested
- Physiotherapist-led exercise
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapist-led exerciseOther
A programme of physiotherapist-led exercise over approximately 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapist-led exercise | Experimental | 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. Receives: Other: Physiotherapist-led exercise |
| Waiting-list control | No intervention | Continue on the waiting list for rotator cuff repair surgery, as per usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of eligible patients.
Numbers of patients screened and then deemed eligible will be reported descriptively.
Measured: 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.
Measured: 6 months
Reasons for patients not wanting to participate.
Reasons for patients not wanting to participate will be reported descriptively.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (4)
Pain and disability assessed using the Shoulder Pain & Disability Index (SPADI)
The SPADI is a 13-item shoulder-specific self-report measure of shoulder pain and disability. The SPADI is reliable, valid, responsive and acceptable to patients. Overall score ranges from 0 to 100, with 0 being the best outcome.
Measured: 6 weeks, 3 and 6 months post-randomisation
Health related quality of life assessed using the EQ-5D-5L
The EQ-5D-5L is a generic measure of health related quality of life that can be used for the purpose of clinical and health economic evaluation. The EQ-5D-5L consists of questions relating to five health domains and respondents rate their degree of impairment using five response levels (no problems, slight problems, moderate problems, severe problems and extreme problems). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. A total of 3125 possible health states can be defined in this way which can then be converted in to a single index value between 0 and 1, where a higher score indicates a better health state.
Measured: 6 weeks, 3 and 6 months post-randomisation
Days lost from work due to the shoulder problem
Days lost from work due to the shoulder problem will be recorded descriptively on a self-report questionnaire
Measured: 6 weeks, 3 and 6 months post-randomisation
Days lost from driving
Days lost from driving due to the shoulder problem will be recorded descriptively on a self-report questionnaire
Measured: 6 weeks, 3 and 6 months post-randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start29 Sep 2021
- Primary completionAug 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chris Littlewood, Study chair, Manchester Met University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974242
- Sponsor's protocol ID
- UHDB/2021/016
- Acronym
- POWER
- Status last verified
- Oct 2021
- First submitted
- 9 Jun 2021
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PhysiOtherapist-led Exercise Versus Waiting-list Control for patiEnts Awaiting Rotator Cuff Repair Surgery: a Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04974242
- Acronym / sponsor ID
- POWER / UHDB/2021/016
- Conditions
- Rotator Cuff Tears
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation TrustUniversity, hospital or other
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapist-led exercise | Experimental | Other: Physiotherapist-led exerciseStructured 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 intervention | –Continue on the waiting list for rotator cuff repair surgery, as per usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients on the elective orthopaedic waiting list for surgical repair of the rotator cuff.
Key exclusion criteria (1 listed)
- Unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapist-led exerciseA programme of physiotherapist-led exercise over approximately 12 weeks. | Other | Physiotherapist-led exercise |
Primary outcome
Numbers of eligible patients.
Time frame: 6 months
Numbers of patients screened and then deemed eligible will be reported descriptively.
Rate of recruitment.
Time frame: 6 months
Numbers of patients approached and then randomised as a proportion of the number of eligible patients will be reported descriptively.
Reasons for patients not wanting to participate.
Time frame: 6 months
Reasons for patients not wanting to participate will be reported descriptively.
Treatment fidelity (numbers of participants who receive physiotherapy) relating to the programme of physiotherapist-led exercise.
Time frame: 6 months
Numbers of participants who receive physiotherapy will be reported descriptively.
Treatment fidelity (number of appointments attended) relating to the programme of physiotherapist-led exercise.
Time frame: 6 months
The number of appointments attended will be reported descriptively.
Treatment fidelity (self-report exercise adherence) relating to the programme of physiotherapist-led exercise.
Time frame: 6 months
Self-report exercise adherence (intervention group only) will be reported descriptively.
Completion rate of clinical outcome measures.
Time frame: 6 weeks
The proportion of clinical outcome questionnaires completed at 6-weeks post-randomisation, including via minimal data collection, will be reported descriptively.
Completion rate of clinical outcome measures.
Time frame: 3 months
The proportion of clinical outcome questionnaires completed at three months post-randomisation, including via minimal data collection, will be reported descriptively.
Completion rate of clinical outcome measures.
Time frame: 6 months
The proportion of clinical outcome questionnaires completed at six months post-randomisation, including via minimal data collection, will be reported descriptively.
Number and nature of adverse events.
Time frame: 6 months
The number and nature of adverse events which occur will be reported descriptively overall and by study arm.
Proportion of participants who report an intention to proceed to surgery or who have received surgery.
Time frame: 6 months
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.
4 secondary outcomes
Pain and disability assessed using the Shoulder Pain & Disability Index (SPADI)
Time frame: 6 weeks, 3 and 6 months post-randomisation
Health related quality of life assessed using the EQ-5D-5L
Time frame: 6 weeks, 3 and 6 months post-randomisation
Days lost from work due to the shoulder problem
Time frame: 6 weeks, 3 and 6 months post-randomisation
Days lost from driving
Time frame: 6 weeks, 3 and 6 months post-randomisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Littlewood study chair
Manchester Met University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapist-led exercise in people with Rotator Cuff Tears, run by University Hospitals of Derby and Burton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chris Littlewood (0161 247 5235, c.littlewood@mmu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of eligible patients. (time frame: 6 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.