Study protocol: Prosthesis versus Active (ProAct) exercise program in patients with glenohumeral osteoarthritis - a multicenter, randomized controlled trial.

Autor: Beck Larsen J; Department of Orthopaedic Surgery, Aarhus University Hospital, Aarhus N, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus N, Denmark . josefinebl@clin.au.dk., Thillemann TM; Department of Orthopaedic Surgery, Aarhus University Hospital, Aarhus N, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus N, Denmark. theithil@rm.dk., Launonen AP; Department of Orthopaedic Surgery, Tampere University Hospital, Tampere, Finland. antti@loosi.ee., Østergaard HK; Department of Clinical Medicine, Aarhus University, Aarhus N, Denmark; Department of Orthopaedic Surgery, Viborg Regional Hospital, Viborg, Denmark. helle.oestergaard@viborg.rm.dk., Falstie-Jensen T; Department of Orthopaedic Surgery, Aarhus University Hospital, Aarhus N, Denmark. thomfals@rm.dk., Reito A; Department of Orthopaedic Surgery, Tampere University Hospital, Tampere, Finland; Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland. aleksi@reito.fi., Lund Jensen S; Department of Orthopaedics, Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. steen.lund.jensen@rn.dk., Mechlenburg I; Department of Orthopaedic Surgery, Aarhus University Hospital, Aarhus N, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus N, Denmark. inger.mechlenburg@clin.au.dk.
Jazyk: angličtina
Zdroj: Acta orthopaedica [Acta Orthop] 2022 Feb 08; Vol. 93, pp. 303-316. Date of Electronic Publication: 2022 Feb 08.
DOI: 10.2340/17453674.2022.2043
Abstrakt: Background and Purpose: Total shoulder arthroplasty (TSA) and shoulder exercises are both effective treatments for reducing pain and improving function in glenohumeral osteoarthritis. However, the effectiveness of TSA has not been compared with non-surgical treatment in a randomized controlled trial. We will examine whether TSA followed bystandard postsurgical rehabilitation is superior to a 12-week exercise program in patients with primary glenohumeral OA who are eligible for unilateral TSA.
Patients and Methods: In this Nordic multicenter randomized controlled clinical trial, patients with glenohumeral osteoarthritis eligible for TSA will be allocated to either TSA followed by usual care or exercise only. The exercise intervention comprises 12 weeks of exercise with one weekly physiotherapist-supervised session. Based on the sample size calculation, the trial needs to include 102 patients. Duration and outcome:  Recruitment was initiated in April 2021 and is expected to be completed by the end of March 2024. Primary outcome is patient-reported quality of life, measured as total WOOS score 12 months after initiation of treatment. The key secondary outcomes include patient-reported pain intensity at rest and during activity; Disabilities of the Arm, Shoulder, and Hand score (DASH); the use of analgesics during the previous week; and adverse events.
Trial Registration: The trial is approved by the Central Denmark Region Committee on Biomedical Research Ethics (Journal No 1-10-72-29-21) and by the Danish Data Protection Agency (Journal No 1-16-02-199-21). ClinicalTrials.gov Identifier: NCT04845074.
Databáze: MEDLINE
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