TY - JOUR

T1 - Study protocol: Prosthesis versus Active (ProAct) exercise program in patients with glenohumeral osteoarthritis — a multicenter, randomized controlled trial

AU - Larsen, Josefine Beck

AU - Thillemann, Theis Muncholm

AU - Launonen, Antti

AU - Østergaard, Helle Kvistgaard

AU - Falstie-Jensen, Thomas

AU - Reito, Aleksi

AU - Jensen, Steen Lund

AU - Mechlenburg, Inger

PY - 2022

Y1 - 2022

N2 - 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.

AB - 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.

KW - COMPLICATIONS

KW - REVISION

KW - SHOULDER ARTHROPLASTY REGISTRY

KW - Multicenter Studies as Topic

KW - Humans

KW - Quality of Life

KW - Osteoarthritis/surgery

KW - Treatment Outcome

KW - Artificial Limbs

KW - Arthroplasty, Replacement, Shoulder/adverse effects

KW - Exercise Therapy

KW - Randomized Controlled Trials as Topic

U2 - 10.2340/17453674.2022.2043

DO - 10.2340/17453674.2022.2043

M3 - Journal article

C2 - 35138410

VL - 93

SP - 303

EP - 316

JO - Acta Orthopaedica

JF - Acta Orthopaedica

SN - 1745-3674

ER -