S. Hopewell1, D. Keene1, P. Heine1, L. Cureton1, I. Marian1, M. Dritsaki1, S. Dutton1, A. Carr1, W. Hamilton2, Z. Hansen1, A. Jaggi3, C. Littlewood4, K. Barker1,5, S. Lamb2
1University of Oxford, Oxford, United Kingdom, 2University of Exeter, Exeter, United Kingdom, 3Royal National Orthopaedic Hospital NHS Trust, London, United Kingdom, 4Manchester Metropolitan University, Manchester, United Kingdom, 5Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom
Background: Rotator cuff disorders are very common but there is uncertainty about which modes of exercise delivery are optimal, and around long-term benefits of corticosteroid injections.
Purpose: The aim of the GRASP trial was to assess the clinical and cost-effectiveness of progressive exercise versus best practice advice, with or without corticosteroid injection, in adults with a rotator cuff disorder.
Methods: 708 participants aged ≥18 years with a new episode of rotator-cuff related shoulder pain within the last 6 months from 20 UK National Health Service centres were randomised (March 2017 to May 2019) by a centralised computer-generated 1:1:1:1 allocation ratio to one of four interventions: progressive exercise (n=174) (≤6 physiotherapy sessions); best practice advice (n=174) (one physiotherapy session); corticosteroid injection then progressive exercise (n=182) (≤6 sessions) or corticosteroid injection then best practice advice (n=178) (one session). The primary outcome was the mean difference in the Shoulder Pain and Disability Index (SPADI; scale 0-100, higher scores worse) over 12 months. Outcomes were collected by postal questionnaires at 8 weeks, 6 and 12 months. The primary analysis was intention to treat. Trial registration: ISRCTN16539266.
Results: Participants were mean age 55.5 years, 49% female, mean baseline SAPDI 54.1 (SD 18.4). Baseline characteristics were balanced across groups. Follow up rates were 90% at 8 weeks, and 87% at 6 and 12 months. Adherence to prescribed interventions in line with the trial protocol was good. Participants randomised to progressive exercise attended a median of 4 sessions (IQR 3-5). There were no serious adverse events or evidence of an interaction effect.
There was an overall improvement in the SPADI score from baseline in each group over time. There was no difference between progressive exercise and best practice advice in shoulder pain and function over 12 months (adjusted mean SPADI difference between groups -0.66; 99%CI -4.52 to 3.20), or at the 8 week, 6 and 12 month timepoints.
Corticosteroid injection resulted in improvement in shoulder pain and function at 8 weeks compared to no injection (adjusted mean SPADI difference between groups -5.64; 99%CI -9.93 to -1.35), but there was no difference between injection and no injection over 12 months (adjusted MD -1.11; 99%CI -4.47 to 2.26), or at the 6 and 12 month timepoints.
There was an overall improvement in the SPADI score from baseline in each group over time. There was no difference between progressive exercise and best practice advice in shoulder pain and function over 12 months (adjusted mean SPADI difference between groups -0.66; 99%CI -4.52 to 3.20), or at the 8 week, 6 and 12 month timepoints.
Corticosteroid injection resulted in improvement in shoulder pain and function at 8 weeks compared to no injection (adjusted mean SPADI difference between groups -5.64; 99%CI -9.93 to -1.35), but there was no difference between injection and no injection over 12 months (adjusted MD -1.11; 99%CI -4.47 to 2.26), or at the 6 and 12 month timepoints.
Conclusion(s): Improvement in shoulder pain and function from corticosteroid injection was small in the short term (8 weeks) and there was no benefit over 12 months compared to no injection. There was no additional benefit of progressive exercise (≤6 physiotherapy sessions) when compared to a high quality best practice advice session with a physiotherapist. We are planning extended follow-up to assess the longer term effects of corticosteroid injections.
Implications: We are preparing training materials to support implementation of the GRASP best practice advice intervention.
Funding, acknowledgements: This research was funded by the National Institute of Health Research Health Technology Assessment Programme (15/26/06).
Keywords: Shoulder, Corticosteroid injection, Exercise
Topic: Musculoskeletal: upper limb
Did this work require ethics approval? Yes
Institution: National Research Ethics Service
Committee: South Central - Berkshire B Research Ethics Committee
Ethics number: 16/SC/0508
All authors, affiliations and abstracts have been published as submitted.
