Physiotherapy for Patients Awaiting Rotator Cuff Repair (POWER)
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| ClinicalTrials.gov Identifier: NCT04974242 |
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Recruitment Status :
Recruiting
First Posted : July 23, 2021
Last Update Posted : October 11, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Rotator Cuff Tears | Other: Physiotherapist-led exercise | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 76 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | PhysiOtherapist-led Exercise Versus Waiting-list Control for patiEnts Awaiting Rotator Cuff Repair Surgery: a Pilot Randomised Controlled Trial |
| Actual Study Start Date : | September 29, 2021 |
| Estimated Primary Completion Date : | August 2022 |
| Estimated Study Completion Date : | October 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Other: Physiotherapist-led exercise
A programme of physiotherapist-led exercise over approximately 12 weeks. |
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No Intervention: Waiting-list control
Continue on the waiting list for rotator cuff repair surgery, as per usual care.
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- 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.
- Pain and disability assessed using the Shoulder Pain & Disability Index (SPADI) [ Time Frame: 6 weeks, 3 and 6 months post-randomisation ]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.
- Health related quality of life assessed using the EQ-5D-5L [ Time Frame: 6 weeks, 3 and 6 months post-randomisation ]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.
- Days lost from work due to the shoulder problem [ Time Frame: 6 weeks, 3 and 6 months post-randomisation ]Days lost from work due to the shoulder problem will be recorded descriptively on a self-report questionnaire
- Days lost from driving [ Time Frame: 6 weeks, 3 and 6 months post-randomisation ]Days lost from driving due to the shoulder problem will be recorded descriptively on a self-report questionnaire
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult patients on the elective orthopaedic waiting list for surgical repair of the rotator cuff.
Exclusion Criteria:
- Unable to provide informed consent.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04974242
| Contact: Chris Littlewood | 0161 247 5235 | c.littlewood@mmu.ac.uk |
| United Kingdom | |
| University Hospitals Derby and Burton NHS Foundation Trust | Recruiting |
| Derby, Derbyshire, United Kingdom, DE22 3DT | |
| Contact: Lisa Pitt | |
| Study Chair: | Chris Littlewood | Manchester Met University |
Documents provided by University Hospitals of Derby and Burton NHS Foundation Trust:
| Responsible Party: | University Hospitals of Derby and Burton NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT04974242 |
| Other Study ID Numbers: |
UHDB/2021/016 |
| First Posted: | July 23, 2021 Key Record Dates |
| Last Update Posted: | October 11, 2021 |
| Last Verified: | October 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Rotator Cuff Injuries Rupture Wounds and Injuries Shoulder Injuries Tendon Injuries |