RESUMEN
BACKGROUND: Little is known about the feasibility of progressive shoulder exercises (PSE) for patients with glenohumeral osteoarthritis (OA) or rotator cuff tear arthropathy (CTA). The aim of this study was to investigate whether 12 weeks of PSE is feasible in patients with glenohumeral OA or CTA eligible for shoulder arthroplasty. Moreover, to report changes in shoulder function and range of motion (ROM) following the exercise program. METHODS: Twenty patients were included. Eighteen patients (11 women, 15 with OA), mean age 70 years (range 57-80), performed 12 weeks of PSE with one weekly physiotherapist-supervised and two weekly home-based sessions. Feasibility was measured by dropout rate, adverse events, pain, and adherence to PSE. At baseline and end of intervention, patients completed the Western Ontario Osteoarthritis of the Shoulder (WOOS) score and Disabilities of the Arm, Shoulder and Hand (DASH). Data to assess feasibility were analyzed using descriptive statistics. RESULTS: Two patients dropped out and no adverse events were observed. Sixteen of the eighteen patients (89%) had a high adherence (≥ 70%) to the physiotherapist-supervised sessions. Acceptable pain levels were reported; in 76% of all exercise sessions with no numeric rating scale (NRS) score over five for any exercise. WOOS improved with a mean of 23 points (95% CI 13;33), and DASH improved with a mean of 13 points (95% CI 6;19). CONCLUSION: Adherence to PSE was high and dropout rates were low. PSE is feasible, safe and may relieve shoulder pain, improve function and ROM in patients with glenohumeral OA or CTA. The patient-experienced gains after PSE seem clinically relevant and should be compared to arthroplasty surgery in a RCT setting. TRIAL REGISTRATION: According to Danish law, this study did not need an approval by the Central Denmark Region Committee on Health Research Ethics. Approval from The Danish Data Protection Agency (journal number 1-16-02-15-20) was obtained.
RESUMEN
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.
