Progressive exercise compared with best-practice advice, with or without corticosteroid injection, for rotator cuff disorders: the GRASP factorial RCT

• DOI: 10.3310/hta25480
• Publication Date: 2021-08-12T13:13:33Z
• Authors: Sally Hopewell; David J Keene; Peter Heine; Ioana R Marian; Melina Dritsaki; Lucy Cureton; Susan J Dutton; Helen Dakin; Andrew Carr; Willie Hamilton; Zara Hansen; Anju Jaggi; Chris Littlewood; Karen Barker; Alastair Gray; Sarah E Lamb
• Keywords: Rotator cuff injury

Background Rotator cuff-related shoulder pain is very common, but there uncertainty regarding which modes of exercise delivery are optimal and the long-term benefits corticosteroid injections. Objectives To assess clinical effectiveness cost-effectiveness progressive compared with best-practice physiotherapy advice, or without injection, in adults a rotator cuff disorder. Design This was pragmatic multicentre superiority randomised controlled trial (with 2 × factorial design). Setting Twenty NHS primary care-based musculoskeletal related services. Participants Adults aged ≥ 18 years new episode previous 6 months. Interventions A total 708 participants were (March 2017–May 2019) by centralised computer-generated 1 : allocation ratio to one four interventions: (1) ( n = 174) (six fewer sessions), (2) advice (one session), (3) injection then 182) sessions) (4) 178) session). Main outcome measures The Shoulder Pain Disability Index (SPADI) score over 12 Secondary outcomes included SPADI subdomains, EuroQol 5 Dimensions, five-level version, sleep disturbance, fear avoidance, self-efficacy, return activity, Global Impression Treatment health resource use. Outcomes collected postal questionnaires at 8 weeks within-trial economic evaluation also conducted. analysis intention treat. Results had mean age 55.5 (standard deviation 13.1) 49.3% female. baseline 54.1 18.5). Follow-up rates 91% 87% There an overall improvement from each group time. Over months, no evidence difference scores between intervention function (adjusted groups months –0.66, 99% confidence interval –4.52 3.20). when analysed 8-week 6- 12-month time points. Injection resulted –5.64, –9.93 –1.35), not –1.11, –4.47 2.26), serious adverse events. In base-case analysis, adding gained 0.021 quality-adjusted life-years p 0.184) increased cost £10 per participant 0.747). Progressive alone £52 0.247) more expensive than 0.019 QALYs 0.220). At ceiling £20,000 life-year, plus 54.93% probability being most cost-effective treatment. Limitations physiotherapists blinded allocation. Twelve-month follow-up may be insufficient for identifying all safety concerns. Conclusions superior session physiotherapist. Subacromial improved function, provided only modest short-term benefit. Best-practice combination expected cost-effective, although substantial uncertainty. Future work Longer-term follow-up, including any effects injection. Trial registration Current Controlled Trials ISRCTN16539266 EudraCT 2016-002991-28. Funding project funded National Institute Health Research (NIHR) Technology Assessment programme will published full ; Vol. 25, No. 48. See NIHR Journals Library website further information.