Hyaluronic Acid in Shoulder Tendinopathy (ACCTE)

Centre Hospitalier Departemental Vendee

Status and phase: Enrolling; Phase 3

Conditions: Shoulder Tendinitis

Treatments: Drug: Corticosteroid injection; Drug: Placebo injection; Drug: Hyaluronic acid injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06376981

CHD23_0025

Details and patient eligibility

About

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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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;
• 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 ;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 2 patient groups, including a placebo group

Combination of corticosteroid and hyaluronic acid injection

Experimental group

Description:

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

Treatment:

Drug: Hyaluronic acid injection

Drug: Corticosteroid injection

Corticosteroid injection alone

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo injection

Drug: Corticosteroid injection