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Acute Rehabilitation following traumatic anterior shoulder dISlocAtioN (ARTISAN) : protocol for a multicentre randomised controlled trial
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Kearney, Rebecca S., Dhanjal, Gurmit, Parsons, Nicholas R., Ellard, David R., Parsons, Helen, Haque, Aminul, Karasouli, Eleni, Mason, James, Nwankwo, Henry, Brown, Jaclyn, Liew, ZiHeng, Drew, Stephen, Modi, Chetan S., Bush, Howard, Torgerson, David and Underwood, Martin (2020) Acute Rehabilitation following traumatic anterior shoulder dISlocAtioN (ARTISAN) : protocol for a multicentre randomised controlled trial. BMJ Open, 10 (11). e040623. doi:10.1136/bmjopen-2020-040623 ISSN 2044-6055.
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WRAP-Acute-rehabilitation-traumatic-anterior-shoulder-dISlocAtioN-2020.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons Attribution 4.0. Download (299Kb) | Preview |
Official URL: https://doi.org/10.1136/bmjopen-2020-040623
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)
Item Type: | Journal Article | |||||||||
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Subjects: | R Medicine > RM Therapeutics. Pharmacology | |||||||||
Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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SWORD Depositor: | Library Publications Router | |||||||||
Library of Congress Subject Headings (LCSH): | Medical rehabilitation , Shoulder joint -- Dislocation , Shoulder joint -- Dislocation -- Patients -- Rehabilitation, Shoulder joint -- Surgery | |||||||||
Journal or Publication Title: | BMJ Open | |||||||||
Publisher: | BMJ Publishing Group | |||||||||
ISSN: | 2044-6055 | |||||||||
Official Date: | 19 November 2020 | |||||||||
Dates: |
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Volume: | 10 | |||||||||
Number: | 11 | |||||||||
Article Number: | e040623 | |||||||||
DOI: | 10.1136/bmjopen-2020-040623 | |||||||||
Status: | Peer Reviewed | |||||||||
Publication Status: | Published | |||||||||
Re-use Statement: | ** Embargo end date: 19-11-2020 ** From BMJ via Jisc Publications Router ** History: received 18-05-2020; rev-recd 22-09-2020; accepted 13-10-2020; ppub 11-2020; epub 19-11-2020. ** Licence for this article starting on 19-11-2020: https://creativecommons.org/licenses/by/4.0/ | |||||||||
Access rights to Published version: | Open Access (Creative Commons) | |||||||||
Date of first compliant deposit: | 8 February 2021 | |||||||||
Date of first compliant Open Access: | 9 February 2021 | |||||||||
RIOXX Funder/Project Grant: |
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