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.~Setting: Eight NHS hospitals.~Objectives:~Determine feasibility of recruiting and retaining patients,~Identify barriers and facilitators to recruitment and retention, including patient and clinician equipoise and proportion and reasons for treatment cross-over (reflective of known challenges in surgical RCTs),~Estimate the number of potential and willing sites for the future main trial.~Participants: Adults with traumatic tears of the rotator cuff, eligible for surgery.~Intervention/ control: Participants will be allocated on a 1:1 ratio, stratified by tear size to: 1) Structured and progressive physiotherapist-led exercise; 2) Surgical repair and usual post-operative rehabilitation.~Key feasibility outcomes: 1) Numbers of patients screened, eligible, approached, consenting, randomised, and accepting allocation; 2) Rate of retention and follow-up; 3) Feasibility of recruiting participating sites; 4) Participant satisfaction.~Key clinical outcomes: 1) Shoulder pain and function (Oxford Shoulder Score): Quality of life (EQ-5D-5L) at baseline, three, and six months.~Health economic outcomes: Health care resource use and days lost from work over six-months.~Sample size: 76 participants.~Analysis: Analysis will focus on process outcomes (recruitment, retention, and treatment cross-over). Means and confidence intervals of clinical outcomes will be calculated only to inform the sample size calculation for the future main trial.~The QRI will use targeted methods including interviews with clinicians and patients, audio-recording of recruitment appointments and document review to understand and then develop an action plan to optimise recruitment and informed consent. Semi-structured qualitative interviews will explore treatment acceptability and the data will be analysed thematically.
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.