1. Acute Rehabilitation following Traumatic anterior shoulder dISlocAtioN (ARTISAN): protocol for a multicentre randomised controlled trial.
- Author
-
Kearney RS, Dhanjal G, Parsons N, Ellard D, Parsons H, Haque A, Karasouli E, Mason J, Nwankwo H, Brown J, Liew Z, Drew S, Modi C, Bush H, Torgerson D, and Underwood M
- Subjects
- Activities of Daily Living, Adult, Aged, Humans, Ireland, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Surveys and Questionnaires, Joint Instability, Shoulder Dislocation
- 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)., Competing Interests: Competing interests: RSK is a member of the UK NIHR HTA CET board, NIHR ICA Doctoral panel and previous member of the NIHR RfPB board. RSK, NP, DRE, HP, JM, MU, SD, CM and DT have all been awarded current and previous NIHR research grants. JB, GD, ZHL, AH, HN, EK and HB have none to declare. MU has received travel expenses for speaking at conferences from the professional organisations hosting the conferences. He is a director and shareholder of Clinvivo Ltd that provides electronic data collection for health services research. He is part of an academic partnership with Serco. He was an editor of the NIHR journal series for which he received a fee., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)
- Published
- 2020
- Full Text
- View/download PDF