Effect of structured rehabilitation versus non-structured rehabilitation following non-surgical management of displaced proximal humerus fractures: a protocol for a randomised clinical trial

Behnam Liaghat, Stig Brorson, Behnam Liaghat, Stig Brorson

Abstract

Introduction: An increasing number of patients with displaced proximal humerus fractures (PHF) are being offered non-surgical treatment, including short immobilisation and structured rehabilitation. There are no randomised controlled trials (RCTs) comparing structured rehabilitation with non-structured rehabilitation to investigate the benefits of structured rehabilitation.

Methods and analysis: In this RCT, patients with a displaced PHF will be assessed for eligibility at a Danish university outpatient clinic. Patients with competing injuries or patients offered surgery will be excluded, and randomisation will be 1:1. All patients will receive standard orthopaedic follow-up, including 14-day postinjury immobilisation, and advice about returning to activities of daily living before being allocated to structured rehabilitation in the municipalities or non-structured rehabilitation. The primary outcome is the between-group difference in the Oxford Shoulder Score (0-48 points, 48=best, minimal clinically important difference=10) at 6 months. A sample size of 60 patients will allow us to show a 10-point difference with 80% power.

Ethics and dissemination: Funded by Department of Orthopaedics, Zealand University Hospital (grant number N/A) and Region Zealand Health Science Research Foundation (R32-A1108-B14), 14 January 2022; The Ethics committee in Region Zealand approved (EMN-2022-02449), 8 April 2022. The site opened on 5 May 2022, and the final results will be updated on trial registries, submitted to a peer-reviewed journal, and inform rehabilitation strategies after displaced PHFs. Protocol version 1, 21 April 2022.

Trial registration number: NCT05302089.

Keywords: clinical trials; rehabilitation medicine; shoulder.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

References

    1. Iglesias-Rodríguez S, Domínguez-Prado DM, García-Reza A, et al. . Epidemiology of proximal humerus fractures. J Orthop Surg Res 2021;16:402. 10.1186/s13018-021-02551-x
    1. Court-Brown CM, Garg A, McQueen MM. The epidemiology of proximal humeral fractures. Acta Orthop Scand 2001;72:365–71. 10.1080/000164701753542023
    1. Handoll HH, Elliott J, Thillemann TM, et al. . Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev 2022;6:CD000434. 10.1002/14651858.CD000434.pub5
    1. Brorson S, Palm H. Proximal Humeral Fractures: The Choice of Treatment. In: Falaschi P, Marsh D, eds. Orthogeriatrics: the management of older patients with fragility fractures. Cham, CH: Springer, 2021: 143–53.
    1. Bruder AM, Shields N, Dodd KJ, et al. . Prescribed exercise programs may not be effective in reducing impairments and improving activity during upper limb fracture rehabilitation: a systematic review. J Physiother 2017;63:205–20. 10.1016/j.jphys.2017.08.009
    1. Østergaard HK, Mechlenburg I, Launonen AP, et al. . The benefits and harms of early mobilization and supervised exercise therapy after Non-surgically treated proximal humerus or distal radius fracture: a systematic review and meta-analysis. Curr Rev Musculoskelet Med 2021;14:107–29. 10.1007/s12178-021-09697-5
    1. Bandholm T, Christensen R, Thorborg K, et al. . Preparing for what the reporting checklists will not tell you: the prepare trial guide for planning clinical research to avoid research waste. Br J Sports Med 2017;51:1494–501. 10.1136/bjsports-2017-097527
    1. Chan A-W, Tetzlaff JM, Altman DG, et al. . Spirit 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200–7. 10.7326/0003-4819-158-3-201302050-00583
    1. Neer CS. Displaced proximal humeral fractures. The Journal of Bone & Joint Surgery 1970;52:1077–89. 10.2106/00004623-197052060-00001
    1. Frich LH, Noergaard PM, Brorson S. Validation of the Danish version of Oxford shoulder score. Dan Med Bull 2011;58:A4335.
    1. Brorson S, Alispahic N, Bahrs C, et al. . Complications after non-surgical management of proximal humeral fractures: a systematic review of terms and definitions. BMC Musculoskelet Disord 2019;20:91. 10.1186/s12891-019-2459-6
    1. Handoll H, Brealey S, Rangan A, et al. . Protocol for the ProFHER (proximal fracture of the humerus: evaluation by randomisation) trial: a pragmatic multi-centre randomised controlled trial of surgical versus non-surgical treatment for proximal fracture of the humerus in adults. BMC Musculoskelet Disord 2009;10:140. 10.1186/1471-2474-10-140
    1. Jones IA, Togashi R, Heckmann N, et al. . Minimal clinically important difference (MCID) for patient-reported shoulder outcomes. J Shoulder Elbow Surg 2020;29:1484–92. 10.1016/j.jse.2019.12.033
    1. Harris PA, Taylor R, Thielke R, et al. . Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42:377–81. 10.1016/j.jbi.2008.08.010

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