Title: Surgery versus PhysiothErapist-leD exercise for traumatic tears of the rotator cuff: A multi-centre pilot and feasibility randomised controlled trial (SPeEDy)
Funder: Department of Health and Social Care

Abstract: 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 1) Determine feasibility of recruiting and retaining patients, 2) 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), 3) 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.

Lay abstract: Shoulder pain is common. The muscles and tendons of the shoulder, known as the rotator cuff, are thought to be the most common cause of this pain. These muscles and tendons control the movement of the shoulder and so any injury to them, for example a tear, can result in significant shoulder pain and disability. Tears of the rotator cuff are reasonably common and can occur due to ageing or following injury, for example a fall or a sudden awkward movement of the shoulder.Currently if people develop shoulder pain following injury and there is concern that the rotator cuff is torn, guidance states that they should be fast-tracked for a surgical opinion. Some guidelines, based on expert clinical opinion and limited research evidence, argue that surgery should happen as soon as possible to get the best outcomes. But further research evidence, albeit limited, casts doubt on this certainty with suggestions that surgery need only be undertaken within four months of onset and other studies suggesting that time to surgery is not a critical factor. Also, it is not always clear whether the tear is due to the injury or whether it was there already, as a result of ageing rather than the injury. Furthermore, some research evidence suggests that surgery is no better than conservative care, for example physiotherapist-led exercise, for patients with tears of the rotator cuff. For some clinicians, there is concern that if the rotator cuff tear is not surgically repaired then it will get bigger over time and cause more problems but this belief is not supported by research evidence. Importantly, in around 40% of patients who do have a repair of the torn rotator cuff, the tendon may not heal or may subsequently re-tear, but they still seem to do well despite this.Given the uncertainty about the effectiveness of surgery, the risks associated with surgery, for example infection, and costs (cost of surgery ranges from 2 897 to 5 593 versus 115 to 204 for a course of physiotherapist-led exercise), there is a clear need for high-quality research comparing these two treatment approaches.The plan is to first work out if a large high-quality trial might be feasible by conducting a pilot study, working with eight UK NHS hospitals. People with a tear of the rotator cuff related to injury, for example a fall, for whom an operation is being considered, will be offered the opportunity to take part. Participants will be allocated to receive either surgery or a programme of physiotherapist-led exercise. As well as collecting information about shoulder pain and function, given the current strong clinical beliefs, the SPeEDy pilot and feasibility study also aims to find out whether orthopaedic surgeons, physiotherapists and patients will want to participate in the study and if they do, whether they remain in the study. It will also find out whether those who are allocated to receive a programme of physiotherapist-led exercise still end up having surgery.Patients and clinicians have helped to develop this idea and the plans for the study. In addition, interviews will be conducted with the patients and clinicians involved in the study to understand any barriers to taking part and also whether the treatments were acceptable from the patient perspective.All this information will be used to determine if a future large trial is feasible. The future large trial would determine the most effective treatment for patients with traumatic rotator cuff tears.

Research activity codes: 6.4 SURGERY;6.7 PHYSICAL
Health categories: MUSCULOSKELETAL