Randomized feasibility study of an autologous protein solution versus corticosteroids injection for treating subacromial pain in the primary care setting – the SPiRIT trial

Author:

Woods Alex1ORCID,Howard Anthony2ORCID,Peckham Nicholas3,Rombach Ines3,Saleh Asma3,Achten Juul4ORCID,Appelbe Duncan3ORCID,Thamattore Praveen5,Gwilym Stephen E.1ORCID

Affiliation:

1. Oxford University Hospitals NHS Foundation Trust, Oxford, UK

2. Leeds Teaching Hospitals NHS Trust, Leeds, UK

3. Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK

4. Oxford Trauma and Emergency Care, Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences, University of Oxford, Oxford, UK

5. Healthshare Ltd, London, UK

Abstract

AimsThe primary aim of this study was to assess the feasibility of recruiting and retaining patients to a patient-blinded randomized controlled trial comparing corticosteroid injection (CSI) to autologous protein solution (APS) injection for the treatment of subacromial shoulder pain in a community care setting. The study focused on recruitment rates and retention of participants throughout, and collected data on the interventions’ safety and efficacy.MethodsParticipants were recruited from two community musculoskeletal treatment centres in the UK. Patients were eligible if aged 18 years or older, and had a clinical diagnosis of subacromial impingement syndrome which the treating clinician thought was suitable for treatment with a subacromial injection. Consenting patients were randomly allocated 1:1 to a patient-blinded subacromial injection of CSI (standard care) or APS. The primary outcome measures of this study relate to rates of recruitment, retention, and compliance with intervention and follow-up to determine feasibility. Secondary outcome measures relate to the safety and efficacy of the interventions.ResultsA total of 53 patients were deemed eligible, and 50 patients (94%) recruited between April 2022 and October 2022. Overall, 49 patients (98%) complied with treatment. Outcome data were collected in 100% of participants at three months and 94% at six months. There were no significant adverse events. Both groups demonstrated improvement in patient-reported outcome measures over the six-month period.ConclusionOur study shows that it is feasible to recruit to a patient-blinded randomized controlled trial comparing APS and CSI for subacromial pain in terms of clinical outcomes and health-resource use in the UK. Safety and efficacy data are presented.Cite this article: Bone Jt Open 2024;5(7):534–542.

Publisher

British Editorial Society of Bone & Joint Surgery

Reference30 articles.

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3. Association of occupational physical demands and psychosocial working environment with disabling shoulder pain;Pope;Ann Rheum Dis,2001

4. Mechanical and psychosocial factors predict new onset shoulder pain: a prospective cohort study of newly employed workers;Harkness;Occup Environ Med,2003

5. Occupational risk factors for shoulder pain: a systematic review;van der Windt;Occup Environ Med,2000

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