Progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of patients with rotator cuff disorders (GRASP): a multicentre, pragmatic, 2 × 2 factorial, randomised controlled trial
Progressive exercise was not superior to a best practice advice session with a physiotherapist in improving shoulder pain and function. Subacromial corticosteroid injection provided no long-term benefit in patients with rotator cuff disorders.
Background: Corticosteroid injections and physiotherapy exercise programmes are commonly used to treat rotator cuff disorders but the treatments’ effectiveness is uncertain. We aimed to compare the clinical effectiveness and cost-effectiveness of a progressive exercise programme with a single session of best practice physiotherapy advice, with or without corticosteroid injection, in adults with a rotator cuff disorder.
In this pragmatic, multicentre, superiority, randomised controlled trial (2 × 2 factorial), we recruited patients from 20 UK National Health Service trusts. We included patients aged 18 years or older with a rotator cuff disorder (new episode within the past 6 months). Patients were excluded if they had a history of significant shoulder trauma (eg, dislocation, fracture, or full-thickness tear requiring surgery), neurological disease affecting the shoulder, other shoulder conditions (eg, inflammatory arthritis, frozen shoulder, or glenohumeral joint instability), received corticosteroid injection or physiotherapy for shoulder pain in the past 6 months, or were being considered for surgery. Patients were randomly assigned (centralised computer-generated system, 1:1:1:1) to progressive exercise (≤6 sessions), best practice advice (one session), corticosteroid injection then progressive exercise, or corticosteroid injection then best practice advice. The primary outcome was the Shoulder Pain and Disability Index (SPADI) score over 12 months, analysed on an intention-to-treat basis (statistical significance set at 1%). The trial was registered with the International Standard Randomised Controlled Trial Register, ISRCTN16539266, and EuDRACT, 2016-002991-28.
Between March 10, 2017, and May 2, 2019, we screened 2287 patients. 708 patients were randomly assigned to progressive exercise (n=174), best practice advice (n=174), corticosteroid injection then progressive exercise (n=182), or corticosteroid injection then best practice advice (n=178). Over 12 months, SPADI data were available for 166 (95%) patients in the progressive exercise group, 164 (94%) in the best practice advice group, 177 (97%) in the corticosteroid injection then progressive exercise group, and 175 (98%) in the corticosteroid injection then best practice advice group. We found no evidence of a difference in SPADI score between progressive exercise and best practice advice when analysed over 12 months (adjusted mean difference -0·66 [99% CI -4·52 to 3·20]). We also found no evidence of a difference between corticosteroid injection compared with no injection when analysed over 12 months (-1·11 [-4·47 to 2·26]). No serious adverse events were reported.
Funding: UK National Institute for Health Research Technology Assessment Programme.
Plain Language Summary
The rotator cuff is a group of muscles and tendons that stabilise the shoulder and allow it to move. Problems with the rotator cuff are very common. Symptoms include pain, which can affect a person’s ability to work, sleep well or perform daily tasks. It is not known which treatments work best for shoulder pain, how exactly they should be delivered and whether or not people do better if they are given a steroid injection.
The GRASP (Getting it Right: Addressing Shoulder Pain) trial tested whether or not people with a rotator cuff disorder would do better after a progressive exercise programme (supervised by a physiotherapist over six appointments spread out over 16 weeks) compared with a one-off best-practice advice session with a physiotherapist. The trial also tested whether or not giving a corticosteroid injection in the shoulder before starting either regime would help people recover more. We assessed the cost of delivering these treatments to the NHS. We recruited 708 people from 20 NHS-based musculoskeletal centres in the UK. People were allocated to one of four treatment groups at random: (1) progressive exercise (six or fewer physiotherapy sessions), (2) best-practice advice (one physiotherapy session), (3) corticosteroid injection then progressive exercise (six or fewer physiotherapy sessions) or (4) corticosteroid injection then best-practice advice (one physiotherapy session). Trial participants were asked to complete a questionnaire that asked about their level of shoulder pain and their ability to perform basic daily tasks before treatment, and then again at 8 weeks and at 6 and 12 months. Participants’ shoulder pain and function improved over time in each of the four treatment groups. The GRASP trial showed that there was no difference between the best-practice advice session with a physiotherapist and the more comprehensive exercise programme. Corticosteroid injection improved people’s shoulder pain and function, but only by a small amount and in the short term. No serious side effects were observed during the 12-month follow-up period. Best-practice advice in combination with corticosteroid injection is likely to be most cost-effective to the NHS.