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

Josefine Beck Larsen; Theis Muncholm Thillemann; Antti P Launonen; Helle Kvistgaard Østergaard; Thomas Falstie-Jensen; Aleksi Reito; Steen Lund Jensen; Inger Mechlenburg

doi:10.2340/17453674.2022.2043

Authors

Josefine Beck Larsen Department of Orthopaedic Surgery, Aarhus University Hospital, Aarhus N, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus N, Denmark https://orcid.org/0000-0001-8290-350X
Theis Muncholm Thillemann Department of Orthopaedic Surgery, Aarhus University Hospital, Aarhus N, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus N, Denmark
Antti P Launonen Department of Orthopaedic Surgery, Tampere University Hospital, Tampere, Finland https://orcid.org/0000-0002-3125-0171
Helle Kvistgaard Østergaard Department of Clinical Medicine, Aarhus University, Aarhus N, Denmark; Department of Orthopaedic Surgery, Viborg Regional Hospital, Viborg, Denmark
Thomas Falstie-Jensen Department of Orthopaedic Surgery, Aarhus University Hospital, Aarhus N, Denmark
Aleksi Reito Department of Orthopaedic Surgery, Tampere University Hospital, Tampere, Finland; Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland https://orcid.org/0000-0002-6903-6461
Steen Lund Jensen Department of Orthopaedics, Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark
Inger Mechlenburg Department of Orthopaedic Surgery, Aarhus University Hospital, Aarhus N, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus N, Denmark https://orcid.org/0000-0001-5432-8691

DOI:

https://doi.org/10.2340/17453674.2022.2043

Keywords:

Anatomical total shoulder arthroplasty, Arthroplasty, Exercise , Glenohumeral osteoarthritis, Shoulder

Abstract

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.