Acute Rehabilitation following Traumatic anterior shoulder dISlocAtioN (ARTISAN): protocol for a multicentre randomised controlled trial. Issue 11 (19th November 2020)

• Record Type: Journal Article
• Authors: Kearney, Rebecca Samantha; Dhanjal, Gurmit; Parsons, Nicholas; Ellard, David; Parsons, Helen; Haque, Aminul; Karasouli, Eleni; Mason, James; Nwankwo, Henry; Brown, Jaclyn; Liew, ZiHeng; Drew, Stephen; Modi, Chetan; Bush, Howard; Torgerson, David; Underwood, Martin
• Is Part Of: BMJ open. Volume 10:Issue 11(2020)
• Publication Date: 2020-11-19
• Subjects: shoulder -- rehabilitation medicine -- clinical trials; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2020-040623
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: First-time traumatic anterior shoulder dislocation (TASD) is predominantly managed non-operatively. People sustaining TASD have ongoing pain, disability and future risk of redislocation. There are no published randomised controlled trials (RCTs) comparing different non-operative rehabilitation strategies to ascertain the optimum clinically effective approach after TASD. Methods and analysis: In this multicentre adaptive RCT, with internal pilot, adults with a radiologically confirmed first time TASD treated non-surgically will be screened at a minimum of 30 sites. People with neurovascular complications, bilateral dislocations or are unable to attend physiotherapy will be excluded. Randomisation will be on a 1:1 treatment allocation, stratified by age, hand dominance and site. Participants will receive a single session of advice; or a single session of advice plus offer of further physiotherapy (maximum 4 months). The primary analysis will be the difference in Oxford Shoulder Instability Score at 6 months. A sample size of a minimum of 478 participants will allow us to show a four point difference with 90% power. An embedded qualitative study will explore the participants' experiences of the trial interventions. Ethics, registration and dissemination: Funded by NIHR HTA (16/167/56), 1 June 2018; National Research Ethic Committee approved (18/WA/0236), 26 July 2018. First site opened 5 November 2018 and final results will be updated on trial registries and submitted to a peer-reviewed journal and will inform rehabilitation strategies after a TASD. Study Within A Trial (SWAT) funded by MRC (MR/R013748/1), 1 May 2019; registered on the MRC-HTMR All-Ireland Hub (reference number SWAT 121). Trial registration number: ISRCTN63184243 . (Trial stage: Pre-results)