Hyaluronic Acid in Shoulder Tendinopathy

Benefit of a Subacromial Injection Combining Corticosteroid and Hyaluronic Acid Versus Corticosteroid Alone in Supraspinatus Tendinopathy

NCT06376981•Centre Hospitalier Departemental Vendee

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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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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 acromioclavicular osteoarthritis;
•Patients with shoulder pain for reasons other than tendinopathy (capsulitis, chronic inflammatory rheumatism, fibromyalgia, amyloidosis);
•Patients who have had a subacromial infiltration in the previous 6 months;
•Patients with a known allergy to one of the products including their excipients (methyl parahydroxybenzoate, propyl parahydroxybenzoate, benzyl alcohol);
•Patients with a known allergy to lidocaine;
•Patients with a local or generalised infection, or suspected infection;
+11 more criteria

Locations (2)

CHD Vendée

La Roche-sur-Yon, France

CHU Nantes

Nantes, France

Key Dates

Start Date

September 19, 2024

Primary Completion Date

December 19, 2026

Completion Date

March 19, 2027

Last Updated

October 3, 2024

Enrollment

132

ESTIMATED participants

Conditions

Shoulder Tendinitis

Interventions

Hyaluronic acid injection

DRUG

Corticosteroid injection

DRUG

Placebo injection

DRUG

Contacts

Laura SOULARD

CONTACT

0251080582 laura.soulard@ght85.fr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 3, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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