Title: Clinical and cost effectiveness of progressive exercise compared to best practice advice, with or without corticosteroid injection, for the treatment of rotator cuff disorders: a 2x2 factorial randomised controlled trial (The GRASP trial)
Funder: Department of Health and Social Care

Abstract: Design: 2x2 factorial randomised controlled trial. Setting: Primary care based musculoskeletal Integrated Clinical Assessment and Treatment (ICAT) services. Inclusion criteria: 1) Men and women aged 18 years and over; 2) new episode of shoulder pain attributable to a rotator cuff disorder (tendonitis, impingement syndrome, tendinopathy, tears) as per British Elbow and Shoulder Society (BESS) guidelines (6); 3) not currently receiving physiotherapy; 4) not being considered for surgery. Exclusion criteria: 1) Neurological disease affecting the shoulder; 2) other shoulder disorders e.g., frozen shoulder, instability, red flags consistent with BESS guidelines; 3) received injection or physiotherapy for shoulder pain within 6 months; 4) contra-indications to corticosteroid injection. Health technologies being assessed: Participants randomised to 1 of 4 treatment groups: 1) progressive exercise (up to 6 sessions); 2) best practice advice (1 session); 3) progressive exercise and corticosteroid injection; or 4) best practice advice and corticosteroid injection. Measurement of cost and outcomes: Primary: Shoulder Pain and Disability Index (SPADI) score (1) at 12 months. Secondary: health-related quality of life (EQ-5D-5L), patient experience score, return to activity, fatigue, serious adverse events, health resource use, out-of-pocket expenses, work absence. We will conduct a parallel within-trial economic evaluation, from the NHS and personal social services perspective, using NICE recommended standards for economic evaluation. We will estimate QALYs gained over a 1 year period, and collect resource use from participants and HES records. We will undertake an incremental cost-effectiveness analysis. Sample size: 704 participants are required to show a clinically important difference (SPADI SMD=0.33) at the 1% 2-sided significance level with 90% power for the comparisons exercise vs. advice and injection vs. no injection at 12 months, assuming no interaction; with allowance for 20% dropout rate and small therapist effect. Fidelity, process evaluation: We will collect data on therapist fidelity to the intervention protocol, compliance of patients to treatment sessions and key treatment actions. Analysis: Will be conducted as intention to treat and CONSORT standards. We will use longitudinal models to assess effect with appropriate baseline covariate adjustment. Difference between current and planned pathways: The interventions tested are part of the current patient pathway in primary care. We want to assess which of these routine interventions, or combination of interventions, are most clinically and cost effective for the NHS. Project timetables and recruitment rate: Study duration is 44 months; 0-4 months: regulatory approvals and site set up; 5-28 months: recruitment; 17-40 months: follow up; 41-44 months: analysis and reporting. For a sample size of 704, we plan to recruit 30 participants per month over 24 months, giving 4-5 participants per month from 8 sites. Expertise in team: Our team has substantial experience conducting trials in primary care, including experts in physiotherapy, injections, psychology, clinical trials, IMP trials, statistics and health economics. We are strongly committed to working with patient and user groups to refine and deliver research.

Lay abstract: Shoulder pain is very common. Pain is caused by problems with the joints and muscles in the shoulder, called the rotator cuff. This is the most common type of shoulder pain, accounting for 70% of all new cases. The rotator cuff can be damaged through irritation and inflammation, trapping of the tendons and/or muscle tears. The main symptoms are pain and painful movement of the shoulder. It can substantially affect a person’s ability to work, to sleep soundly and perform daily tasks. Common treatments include advice, rest, painkillers, anti-inflammatories, physiotherapy and steroid injections. Although used quite often, the effectiveness of physiotherapy is unclear. There is uncertainty about which techniques are most effective, how they should be delivered and whether an injection, in addition to exercise, may be of more benefit. The aim of our study is to test whether a progressive exercise programme supervised over a 16 week period compared with a single best practice advice session with a physiotherapist can improve outcomes for people with a rotator cuff problem. We will also test whether the addition of an injection of a corticosteroid into the shoulder joint helps to relieve pain, so enable comfortable exercise and improve function. To answer this question, we are recruiting men and women with a new episode of shoulder pain due to a rotator cuff problem and not currently receiving physiotherapy or being considered for surgery. We will recruit 704 people referred by their GP to 1 of 8 centres in the UK. People who consent will be randomised to 1 of 4 treatment groups: 1) progressive exercise (up to 6 sessions); 2) best practice advice (1 session); 3) progressive exercise and shoulder corticosteroid injection; or 4) best practice advice and shoulder corticosteroid injection. The exercise programme will include techniques to help people stick to the exercises given, as there is strong evidence that how a person thinks affects their compliance. We will ask people about their level of shoulder pain and ability to perform basic daily tasks over a one year period. We want to assess which of these routine interventions, or combination of interventions, are most clinically and cost effective for patients and the NHS. We have chosen to test exercise because it shows the greatest promise of all physiotherapy techniques; it is practical and relatively simple to deliver and has the strongest scientific basis. We will compare with best practice advice because several of our previous trials, in other areas, show that a typical course of NHS physiotherapy is no more effective than a single well-structured advice session that tackles people’s anxieties about moving, reassures them and examines the shoulder to exclude serious underlying problems. Providing a single session is far more cost effective for the NHS. Injections will be given by physiotherapists, reflecting increasingly common practice across the NHS. The views of patients with rotator cuff disorders have been central to the development of our study. We have built on existing networks for patient involvement such as the Oxford Nuffield Orthopaedic Centre user groups for upper limb and physiotherapy, input obtained from the James Lind initiative (which brings together patients, carers and clinicians to address treatment uncertainties) for common shoulder problems, which members of our team are involved in, and through a formal Patient and Public Involvement development meeting.

Research activity codes: 6.7 PHYSICAL
Health categories: MUSCULOSKELETAL