Surgery Versus PhysiothErapist-leD Exercise for Traumatic Tears of the Rotator Cuff: a Multi-site Pilot and Feasibility Randomised Controlled Trial (the SPeEDy Study)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Numbers of patients screened, number eligible, number approached, number consenting, number randomised, and number accepting allocation
研究概览
简要总结
The SPeEDy study is a parallel group, pilot and feasibility randomised controlled trial (RCT) with integrated Quintet Recruitment Intervention (QRI) and further qualitative interviews. The study hypothesis is: In adult patients diagnosed with traumatic tears of the rotator cuff, is it feasible to conduct a future, substantive, multi-site RCT to test the hypothesis that physiotherapist-led exercise is not inferior to surgical repair of the rotator cuff in terms of clinical outcomes but is more cost-effective.
详细描述
Tears of the rotator cuff are a significant cause of shoulder pain. Rates of surgical repair have risen approximately 200% over the last 20 years across Europe and the USA. 9 189 repairs were undertaken in 2015/ 2016 in the NHS. The cost of surgery ranges from £2 897 to £5 593 meaning that direct NHS treatment costs alone are £26.6 to £51.4 million annually.
If a patient is suspected of having a traumatic rotator cuff tear, then guidance from the British Elbow and Shoulder Society and British Orthopaedic Association suggests this is a 'red flag' needing urgent surgical opinion. But, this guidance is open to question. Three randomised controlled trials (RCT) (n = 252) have been synthesised in a systematic review which concluded that surgery is not more effective than conservative care for rotator cuff tears. But, of the 252 patients included, only 40 (16%), were diagnosed with traumatic tears. Hence, there is a dearth of randomised evidence to inform decision-making.
Given uncertainty about the comparative effectiveness of surgery and considering the cost, risk, for example infection, there is an urgent need to carry out high-quality research in this area.
Research Question: In patients diagnosed with traumatic tears of the rotator cuff, is it feasible to conduct a future multicentre RCT to test the hypothesis that physiotherapist-led exercise is not inferior to surgical repair in terms of clinical outcomes but is more cost-effective.
Research Design: Two-arm, parallel group, pilot and feasibility RCT with nested Quintet Recruitment Intervention (QRI) and qualitative interviews.
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 (≥18 years)
- •Diagnosed with a symptomatic tear of the rotator cuff following a traumatic incident thought to be of sufficient force to induce a tear.
- •Rotator cuff tear confirmed by diagnostic ultrasound or MRI scan undertaken as part of routine diagnostic work-up
- •Eligible for rotator cuff repair surgery or a programme of physiotherapist-led exercise as determined by the attending clinician (surgeon or physiotherapist, where appropriate)
- •Able to return to the participating NHS hospital or associated orthopaedic and physiotherapy services (where physiotherapists have been trained in trial interventions) for post-operative rehabilitation or the programme of physiotherapist-led exercise.
- •Able to understand English.
排除标准
- •Not eligible for rotator cuff repair surgery or a programme of physiotherapist-led exercise as determined by the attending clinician (surgeon or physiotherapist, where appropriate)
- •Patients who are unable to give full informed consent.
结局指标
主要结局
Numbers of patients screened, number eligible, number approached, number consenting, number randomised, and number accepting allocation
时间窗: Over recruitment period, 15 months
Numbers of patients screened, number eligible, number approached, number consenting, number randomised, and number accepting allocation will be recorded descriptively
Treatment cross-over
时间窗: Six months
Numbers of participants receiving treatment (surgery or PT-led exercise) other than that which was allocated to determine proportion of participants who cross-over will be recorded descriptively
Determination of zone of clinical equipoise
时间窗: Over recruitment period, 15 months
Data from screening logs, including reasons for not approaching potentially eligible patients will be recorded descriptively to inform determination of zone of clinical equipoise
Participant satisfaction with the interventions: five-point ordinal scale
时间窗: Six months
Participant satisfaction with the interventions on a five-point ordinal scale; Very Satisfied/Satisfied/Neutral/Dissatisfied/Very Dissatisfied
Numbers of participants continuing in allocated treatment
时间窗: Six months
Numbers of participants continuing in allocated treatment will be recorded descriptively
Follow-up response rates to questionnaires (including Oxford Shoulder Score and EQ-5D-5L)
时间窗: Six months post-randomisation
Follow-up response rates to questionnaires will be recorded descriptively
次要结局
- Pain and disability assessed using the Oxford Shoulder Score (OSS)(Three and six months post-randomisation)
- Days lost from work due to the shoulder problem(Three and six months post-randomisation)
- Time taken to return to driving(Three and six months post-randomisation)
- Health related quality of life assessed using the EQ-5D-5L(Three and six months post-randomisation)