{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T12:55:21Z","timestamp":1792500921650,"version":"4.5.0"},"update-to":[{"DOI":"10.3310\/hta25480","type":"corrigendum","label":"Corrigendum","source":"publisher","updated":{"date-parts":[[2022,8,23]],"date-time":"2022-08-23T00:00:00Z","timestamp":1661212800000}}],"reference-count":136,"publisher":"National Institute for Health and Care Research","issue":"48","license":[{"start":{"date-parts":[[2021,8,1]],"date-time":"2021-08-01T00:00:00Z","timestamp":1627776000000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/www.nationalarchives.gov.uk\/doc\/non-commercial-government-licence\/non-commercial-government-licence.htm"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["15\/26\/06"],"award-info":[{"award-number":["15\/26\/06"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journalslibrary.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"\n Background<\/jats:title>\n Rotator cuff-related shoulder pain is very common, but there is uncertainty regarding which modes of exercise delivery are optimal and the long-term benefits of corticosteroid injections.<\/jats:p>\n <\/jats:sec>\n \n Objectives<\/jats:title>\n To assess the clinical effectiveness and cost-effectiveness of progressive exercise compared with best-practice physiotherapy advice, with or without corticosteroid injection, in adults with a rotator cuff disorder.<\/jats:p>\n <\/jats:sec>\n \n Design<\/jats:title>\n This was a pragmatic multicentre superiority randomised controlled trial (with a 2\u2009\u00d7\u20092 factorial design).<\/jats:p>\n <\/jats:sec>\n \n Setting<\/jats:title>\n Twenty NHS primary care-based musculoskeletal and related physiotherapy services.<\/jats:p>\n <\/jats:sec>\n \n Participants<\/jats:title>\n Adults aged \u2265\u200918 years with a new episode of rotator cuff-related shoulder pain in the previous 6 months.<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n \n A total of 708 participants were randomised (March 2017\u2013May 2019) by a centralised computer-generated 1\u2009:\u20091\u2009:\u20091\u2009:\u20091 allocation ratio to one of four interventions: (1) progressive exercise (\n n<\/jats:italic>\n \u2009=\u2009174) (six or fewer physiotherapy sessions), (2) best-practice advice (\n n<\/jats:italic>\n \u2009=\u2009174) (one physiotherapy session), (3) corticosteroid injection then progressive exercise (\n n<\/jats:italic>\n \u2009=\u2009182) (six or fewer physiotherapy sessions) or (4) corticosteroid injection then best-practice advice (\n n<\/jats:italic>\n \u2009=\u2009178) (one physiotherapy session).\n <\/jats:p>\n <\/jats:sec>\n \n Main outcome measures<\/jats:title>\n The primary outcome was Shoulder Pain and Disability Index (SPADI) score over 12 months. Secondary outcomes included SPADI subdomains, the EuroQol 5 Dimensions, five-level version, sleep disturbance, fear avoidance, pain self-efficacy, return to activity, Global Impression of Treatment and health resource use. Outcomes were collected by postal questionnaires at 8 weeks and at 6 and 12 months. A within-trial economic evaluation was also conducted. The primary analysis was intention to treat.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Participants had a mean age of 55.5 (standard deviation 13.1) years and 49.3% were female. The mean baseline SPADI score was 54.1 (standard deviation 18.5). Follow-up rates were 91% at 8 weeks and 87% at 6 and 12 months. There was an overall improvement in SPADI score from baseline in each group over time. Over 12 months, there was no evidence of a difference in the SPADI scores between the progressive exercise intervention and the best-practice advice intervention in shoulder pain and function (adjusted mean difference between groups over 12 months \u20130.66, 99% confidence interval \u20134.52 to 3.20). There was also no difference in SPADI scores between the progressive exercise intervention and best-practice advice intervention when analysed at the 8-week and 6- and 12-month time points. Injection resulted in improvement in shoulder pain and function at 8 weeks compared with no injection (adjusted mean difference \u20135.64, 99% confidence interval \u20139.93 to \u20131.35), but not when analysed over 12 months (adjusted mean difference \u20131.11, 99% confidence interval \u20134.47 to 2.26), or at 6 and 12 months. There were no serious adverse events. In the base-case analysis, adding injection to best-practice advice gained 0.021 quality-adjusted life-years (\n p<\/jats:italic>\n \u2009=\u20090.184) and increased the cost by \u00a310 per participant (\n p<\/jats:italic>\n \u2009=\u20090.747). Progressive exercise alone was \u00a352 (\n p<\/jats:italic>\n \u2009=\u20090.247) more expensive per participant than best-practice advice, and gained 0.019 QALYs (\n p<\/jats:italic>\n \u2009=\u20090.220). At a ceiling ratio of \u00a320,000 per quality-adjusted life-year, injection plus best-practice advice had a 54.93% probability of being the most cost-effective treatment.\n <\/jats:p>\n <\/jats:sec>\n \n Limitations<\/jats:title>\n Participants and physiotherapists were not blinded to group allocation. Twelve-month follow-up may be insufficient for identifying all safety concerns.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n Progressive exercise was not superior to a best-practice advice session with a physiotherapist. Subacromial corticosteroid injection improved shoulder pain and function, but provided only modest short-term benefit. Best-practice advice in combination with corticosteroid injection was expected to be most cost-effective, although there was substantial uncertainty.<\/jats:p>\n <\/jats:sec>\n \n Future work<\/jats:title>\n Longer-term follow-up, including any serious adverse effects of corticosteroid injection.<\/jats:p>\n <\/jats:sec>\n \n Trial registration<\/jats:title>\n Current Controlled Trials ISRCTN16539266 and EudraCT 2016-002991-28.<\/jats:p>\n <\/jats:sec>\n \n Funding<\/jats:title>\n \n This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in\n Health Technology Assessment<\/jats:italic>\n ; Vol. 25, No. 48. See the NIHR Journals Library website for further project information.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.3310\/hta25480","type":"journal-article","created":{"date-parts":[[2021,8,12]],"date-time":"2021-08-12T09:13:33Z","timestamp":1628759613000},"page":"1-158","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":31,"title":["Progressive exercise compared with best-practice advice, with or without corticosteroid injection, for rotator cuff disorders: the GRASP factorial RCT"],"prefix":"10.3310","volume":"25","clinical-trial-number":[{"clinical-trial-number":"isrctn16539266","registry":"10.18810\/isrctn","type":"results"},{"clinical-trial-number":"2016-002991-28","registry":"10.18810\/euctr","type":"results"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6881-6984","authenticated-orcid":true,"given":"Sally","family":"Hopewell","sequence":"first","affiliation":[{"name":"Oxford Clinical Trials Research Unit, Nuffield 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