Tight Control for Rotator Cuff Tendinopathy
Recruiting now · Not applicable
Conditions studied: Rotator Cuff Tendinopathy
In brief
The main objective of the study is to determine whether tight management of patients in early rotator cuff tendinopathy would lead to better clinical improvement than standard management. In a randomized study, we propose to compare two types of management, with a tight control group having one consultation per month for the first 3 months, in order to readapt or intensify management, whereas the control group will only be seen at 3 months after inclusion. We hypothesize that this close follow-up will lead to more rapid clinical improvement and reduce the transition to chronicity and the associated costs (inclusion of a medico-economic analysis taking into account, in particular, healthcare consumption and time off work).
Key facts
- Study ID
- NCT06517680
- Run by
- Nantes University Hospital
- People needed
- 156
- Starts
- 2024-11-25
- Expected to finish
- 2027-11-25
- Last updated by the study team
- 2026-01-15
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient with new-onset shoulder pain related to rotator cuff tendinopathy
- Age between 18 and 65
- Shoulder pain on activity for less than 6 months with VAS≥4/10 and/or OSS≥20
- Pain compatible with rotator cuff tendinopathy according to the rotator cuff tendinopathy according to the BESS (British Elbow and Shoulder Society) guidelines
You may not qualify if…
- Contraindication to steroid injections
- Shoulder pain related to trauma (dislocation, fracture) or acute tendon rupture requiring short-term surgery
- Steroid injection already performed on the shoulder studied for the current episode
- Neurological pathology affecting the shoulder
- Other shoulder disorders (inflammatory arthritis, frozen shoulder, glenohumeral joint instability, pain associated with acromioclavicular arthropathy)
- Tendon calcification > 0.5 cm.
- Previous shoulder surgery
- Full-thickness tear of one tendon
- Pregnant women
Where it is running
- CHU Angers — Angers, France (enrolling)
- CHU de Brest — Brest, France (enrolling)
- CHRU de Tours — Chambray-lès-Tours, France (enrolling)
- CH Cholet — Cholet, France (enrolling)
- CH Vendée — La Roche-sur-Yon, France (enrolling)
- CH du Mans — Le Mans, France (enrolling)
- CHU de Nantes — Nantes, France (enrolling)
- Chotard Emilie — Rennes, France (enrolling)
Full record on ClinicalTrials.gov
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