NCT06517680 Tight Control for Rotator Cuff Tendinopathy
| NCT ID | NCT06517680 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nantes University Hospital |
| Condition | Rotator Cuff Tendinopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 156 participants |
| Start Date | 2024-11-25 |
| Primary Completion | 2027-11-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 156 participants in total. It began in 2024-11-25 with a primary completion date of 2027-11-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria : 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 Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06517680 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Rotator Cuff Tendinopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06517680 currently recruiting?
Yes, NCT06517680 is actively recruiting participants. Contact the research team at christelle.darrieutort@chu-nantes.fr for enrollment information.
Where is the NCT06517680 trial being conducted?
This trial is being conducted at Angers, France, Brest, France, Chambray-lès-Tours, France, Cholet, France and 4 additional locations.
Who is sponsoring the NCT06517680 clinical trial?
NCT06517680 is sponsored by Nantes University Hospital. The trial plans to enroll 156 participants.