Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy
Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy Eligible For Reverse Shoulder Arthroplasty: the ReAct Multicenter, Randomized Controlled Trial
University of Aarhus
102 participants
May 28, 2021
INTERVENTIONAL
Conditions
Summary
Reverse shoulder arthroplasty (RSA) is a well-established treatment for rotator cuff arthropathy. However, the effectiveness of RSA has not been compared to non-surgical treatment in a randomised controlled trial. Shoulder exercises may be an effective treatment for reducing pain and improving function in glenohumeral osteoarthritis. The primary aim of this trial is to examine if RSA followed by standard postsurgical rehabilitation is superior to a 12-week exercise programme in patients with rotator cuff arthropathy eligible for unilateral RSA. The investigators hypothesise that surgical intervention followed by standard rehabilitation, results in clinically relevant (14-point, on a scale from 0-100) improvement compared to the exercise intervention.
Eligibility
Inclusion Criteria3
- Patients 60-85 years
- Eligible for RSA
- Rotator cuff arthropathy according to Hamada grade 3, 4 and 5 (33)
Exclusion Criteria7
- Previous shoulder fracture (fracture of the proximal humerus or glenoid fracture)
- Planned other upper extremity surgery within six months
- Rheumatoid arthritis or other types of arthritis not diagnosed as primary glenohumeral OA
- Cancer diagnosis and receiving chemo-, immuno- or radiotherapy
- Neurological diseases affecting shoulder mobility (e.g. disability after previous stroke, multiple sclerosis, Parkinson's, Alzheimer's disease)
- Other reasons for exclusion (i.e. mentally unable to participate) or planned absence for more than 14 days in the first 3 months after baseline test.
- Unable to communicate in the participating countries respective languages
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Interventions
Reverse total shoulder arthroplasty followed by standard rehabilitation.
The exercise-group will attend a 12-week exercise program with one weekly physiotherapist-supervised session supplemented with two weekly sessions of home-based exercises. Utilisation of a predefined training protocol describing procedures and content of each session secure uniformity and standardisation of the intervention. The exercise program consists of two warm-up exercises and five exercises that target shoulder range of motion and muscle strength. Furthermore, a link to a video, informing about glenohumeral osteoarthritis, the role of exercise and exercise related pain, will be sent to all patients in the exercise-group. The physiotherapists delivering the exercise intervention are not otherwise related to the trial.
Locations(8)
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NCT04864158