Hyaluronic Acid in Shoulder Tendinopathy (NCT06376981) | Clinical Trial Compass
RecruitingPhase 3
Hyaluronic Acid in Shoulder Tendinopathy
France132 participantsStarted 2024-09-19
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Visual analog scale pain on activity ranging from 0 to 100 mm at month 3.