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Recruiting Phase 3 NCT06376981

NCT06376981 Hyaluronic Acid in Shoulder Tendinopathy

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Clinical Trial Summary
NCT ID NCT06376981
Status Recruiting
Phase Phase 3
Sponsor Centre Hospitalier Departemental Vendee
Condition Shoulder Tendinitis
Study Type INTERVENTIONAL
Enrollment 132 participants
Start Date 2024-09-19
Primary Completion 2026-12-19

Trial Parameters

Condition Shoulder Tendinitis
Sponsor Centre Hospitalier Departemental Vendee
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 132
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2024-09-19
Completion 2026-12-19
Interventions
Hyaluronic acid injectionCorticosteroid injectionPlacebo injection

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Brief Summary

Multicentric, randomised study to compare the effectiveness on activity pain at 3 months of corticosteroid injection associated with hyaluronic acid with corticosteroids injection alone in patients with tendinopathy of the supraspinatus with clinical reevaluation at one, three and six months.

Eligibility Criteria

Inclusion Criteria: * Active patient aged between 18 and 65; * Patient suffering from pain compatible with supraspinatus tendinopathy for at least 2 months; * Patient with simple tendinopathy or partial tendon rupture; * Patient with tendinopathy confirmed by ultrasound or MRI; * Patient with an active pain visual analog scale ≥ 4 for more than 6 weeks; * Patient with an active pain visual analog scale ≥ 4 on the day of inclusion; * Patient failing medical treatment (rest, analgesics, NSAIDs, physiotherapy); * Patient able to follow the protocol and having given oral informed consent to take part in the research; * Patient affiliated to the social security system or entitled person; Exclusion Criteria: * Patient suffering from a transfixing tendon rupture; * Patients suffering from post-traumatic tendon rupture; * Patients suffering from calcific tendinopathy (calcification \> 5 mm); * Patients with associated glenohumeral osteoarthritis; * Patients with associated symptomatic acromioc

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