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Tight Control for Rotator Cuff Tendinopathy

RecruitingNAAges 18 Years - 65 YearsAllNantes University Hospital
NCT06517680 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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
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What it tests

  • tight control management
  • standard follow-up
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Where

8 sites
CHU Angers
Angers, France
CHU de Brest
Brest, France
CHRU de Tours
Chambray-lès-Tours, France
CH Cholet
Cholet, France
CH Vendée
La Roche-sur-Yon, France
CH du Mans
Le Mans, France
CHU de Nantes
Nantes, France
Chotard Emilie
Rennes, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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