PhysiOtherapist-led Exercise Versus Waiting-list Control for patiEnts Awaiting Rotator Cuff Repair Surgery: a Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Rate of recruitment.
研究概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients on the elective orthopaedic waiting list for surgical repair of the rotator cuff.
排除标准
- •Unable to provide informed consent.
结局指标
主要结局
Rate of recruitment.
时间窗: 6 months
Numbers of patients approached and then randomised as a proportion of the number of eligible patients will be reported descriptively.
Treatment fidelity (number of appointments attended) relating to the programme of physiotherapist-led exercise.
时间窗: 6 months
The number of appointments attended will be reported descriptively.
Numbers of eligible patients.
时间窗: 6 months
Numbers of patients screened and then deemed eligible will be reported descriptively.
Treatment fidelity (numbers of participants who receive physiotherapy) relating to the programme of physiotherapist-led exercise.
时间窗: 6 months
Numbers of participants who receive physiotherapy will be reported descriptively.
Treatment fidelity (self-report exercise adherence) relating to the programme of physiotherapist-led exercise.
时间窗: 6 months
Self-report exercise adherence (intervention group only) will be reported descriptively.
Reasons for patients not wanting to participate.
时间窗: 6 months
Reasons for patients not wanting to participate will be reported descriptively.
Proportion of participants who report an intention to proceed to surgery or who have received surgery.
时间窗: 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.
Completion rate of clinical outcome measures.
时间窗: 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.
时间窗: 6 months
The number and nature of adverse events which occur will be reported descriptively overall and by study arm.
次要结局
- Health related quality of life assessed using the EQ-5D-5L(6 weeks, 3 and 6 months post-randomisation)
- Pain and disability assessed using the Shoulder Pain & Disability Index (SPADI)(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)