Hyaluronic Acid in Shoulder Tendinopathy

Launched by CENTRE HOSPITALIER DEPARTEMENTAL VENDEE · Apr 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of combining hyaluronic acid with corticosteroid injections to treat shoulder tendinitis, specifically in a tendon called the supraspinatus. The goal is to see if this combination helps reduce pain more effectively than using corticosteroids alone over a period of three months. The study is open to adults aged 18 to 65 who have been experiencing shoulder pain for at least two months and have not found relief from other treatments like rest, pain medications, or physical therapy.

If you or someone you know is interested in participating, it's important to note that potential participants must not have certain shoulder conditions, such as severe tendon tears or arthritis. Throughout the study, participants will receive follow-up evaluations at one, three, and six months to monitor their pain levels and overall shoulder function. This trial is currently recruiting participants, and those interested should be prepared to provide informed consent and be committed to following the study's guidelines.

Gender

ALL

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 ;