Comparing hyaluronic acid and corticosteroid injections for shoulder tendinitis

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

This study is testing whether adding hyaluronic acid injections to corticosteroid injections can help people with shoulder tendinitis feel less pain compared to just using corticosteroids alone.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Centre Hospitalier Departemental Vendee (Academic / other)
• Locations: 2 sites (La Roche-sur-Yon and 1 other locations)
• Trial ID: NCT06376981 on ClinicalTrials.gov

What this trial studies

This multicentric, randomized study aims to evaluate the effectiveness of combining hyaluronic acid injections with corticosteroid injections compared to corticosteroid injections alone in patients suffering from supraspinatus tendinopathy. Participants will be assessed for pain relief at three months, with clinical evaluations conducted at one, three, and six months post-treatment. The study targets individuals who have experienced pain for at least two months and have not responded to standard medical treatments. The goal is to determine if the addition of hyaluronic acid can enhance pain management outcomes.

Who should consider this trial

Good fit: Ideal candidates are active individuals aged 18 to 65 with supraspinatus tendinopathy and significant pain who have not benefited from previous treatments.

Not a fit: Patients with severe tendon injuries, such as complete ruptures or calcific tendinopathy, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide improved pain relief and functional outcomes for patients with shoulder tendinitis.

How similar studies have performed: Previous studies have shown promising results with hyaluronic acid in similar conditions, suggesting potential for success in this approach.

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 ;

Where this trial is running

La Roche-sur-Yon and 1 other locations

• CHD Vendée — La Roche-sur-Yon, France (Recruiting)
• CHU Nantes — Nantes, France (Not_yet_recruiting)

Study contacts

• Principal investigator: Céline COZIC, Dr — Centre Hospitalier Départemental Vendée
• Study coordinator: Laura SOULARD

Conditions Shoulder Tendinitis; Shoulder tendinitis; Hyaluronic acid; Corticosteroid injection