Hyaluronic Acid in Shoulder Tendinopathy

Phase 3

Recruiting

• Conditions: Shoulder Tendinitis
• Interventions: Drug: Hyaluronic acid injection; Drug: Corticosteroid injection; Drug: Placebo injection

• Registration Number: NCT06376981
• Lead Sponsor: Centre Hospitalier Departemental Vendee

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-11
• Study First Submitted QC: 2024-04-18
• Study First Posted: 2024-04-22
• Study Start: 2024-09-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-03
• Primary Completion: 2026-12-19
• Study Completion: 2027-03-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 132

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;
• Patients with severe coagulation disorders or taking anticoagulants;
• Patients with severe and/or uncontrolled hypertension > 160/100 mmHg;
• Patients with unbalanced diabetes (last HbA1c > 8.5%);
• Patients with a history of addiction to psychoactive substances;
• Patient participating in another clinical research protocol with an impact on the research objectives;
• Patient already randomised in the study;
• Patient who is pregnant, parturient, breastfeeding or able to procreate without effective contraception* in the month prior to inclusion and up to 15 days after infiltration;
• Patients under guardianship, curators or deprived of liberty;
• Patient under a mandate for future protection activated ;
• Patient under family guardianship ;
• Patient under court protection ;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination of corticosteroid and hyaluronic acid injection	Hyaluronic acid injection	An injection of 1 ml if corticosteroids and an injection of 2 ml of hyaluronic acid
Combination of corticosteroid and hyaluronic acid injection	Corticosteroid injection	An injection of 1 ml if corticosteroids and an injection of 2 ml of hyaluronic acid
Corticosteroid injection alone	Corticosteroid injection	An injection of 1 ml of corticosteroids and an injection of 2 ml of placebo (physiological serum).
Corticosteroid injection alone	Placebo injection	An injection of 1 ml of corticosteroids and an injection of 2 ml of placebo (physiological serum).

Primary Outcome Measures

Name	Time	Method
Visual analog scale pain on activity ranging from 0 to 100 mm at month 3.	Month 3	Visual analog scale pain on activity ranging from 0 to 100 mm at month 3. Pain is defined by the worst pain felt during active examination: anterior elevation, abduction, internal and external rotation, etc.

Trial Locations

Locations (2)

CHD Vendée; 🇫🇷 La Roche-sur-Yon, France

CHU Nantes; 🇫🇷 Nantes, France