Hyaluronic Acid in Shoulder Tendinopathy

NCT ID: NCT06376981

Last Updated: 2024-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-19
• Study Completion Date: 2027-03-19

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.

Conditions

Shoulder Tendinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Combination of corticosteroid and hyaluronic acid injection

An injection of 1 ml if corticosteroids and an injection of 2 ml of hyaluronic acid

Group Type: EXPERIMENTAL

Hyaluronic acid injection

Intervention Type: DRUG

An injection of 2 ml of Acid hyaluronic

Corticosteroid injection

Intervention Type: DRUG

An injection of 1 ml of corticosteroids

Corticosteroid injection alone

An injection of 1 ml of corticosteroids and an injection of 2 ml of placebo (physiological serum).

Group Type: PLACEBO_COMPARATOR

Corticosteroid injection

Intervention Type: DRUG

An injection of 1 ml of corticosteroids

Placebo injection

Intervention Type: DRUG

An injection of 2 ml of placebo (physiological serum)

Interventions

Hyaluronic acid injection

An injection of 2 ml of Acid hyaluronic

Intervention Type: DRUG

Corticosteroid injection

An injection of 1 ml of corticosteroids

Intervention Type: DRUG

Placebo injection

An injection of 2 ml of placebo (physiological serum)

Intervention Type: DRUG

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 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 ;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Departemental Vendee

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Céline COZIC, Dr

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Départemental Vendée

Locations

CHD Vendée

La Roche-sur-Yon, , France

Site Status: RECRUITING

CHU Nantes

Nantes, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Laura SOULARD

Role: CONTACT

laura.soulard@ght85.fr

0251080582 ext. +33

Facility Contacts

Céline COZIC, Dr

Role: primary

Christelle DARRIEUTORT-LAFFITE, Dr

Role: primary

Other Identifiers

CHD23_0025

Identifier Type: -

Identifier Source: org_study_id