Hyaluronic Acid in Shoulder Tendinopathy

Last updated: October 2, 2024
Sponsor: Centre Hospitalier Departemental Vendee
Overall Status: Active - Recruiting

Phase

3

Condition

Frozen Shoulder (Adhesive Capsulitis)

Tendon Injuries

Sprains

Treatment

Hyaluronic acid injection

Placebo injection

Corticosteroid injection

Clinical Study ID

NCT06376981
CHD23_0025
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 takepart in the research;

  • Patient affiliated to the social security system or entitled person;

Exclusion

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, chronicinflammatory 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 theresearch objectives;

  • Patient already randomised in the study;

  • Patient who is pregnant, parturient, breastfeeding or able to procreate withouteffective contraception* in the month prior to inclusion and up to 15 days afterinfiltration;

  • Patients under guardianship, curators or deprived of liberty;

  • Patient under a mandate for future protection activated ;

  • Patient under family guardianship ;

  • Patient under court protection ;

Study Design

Total Participants: 132
Treatment Group(s): 3
Primary Treatment: Hyaluronic acid injection
Phase: 3
Study Start date:
September 19, 2024
Estimated Completion Date:
March 19, 2027

Connect with a study center

  • CHD Vendée

    La Roche-sur-Yon,
    France

    Active - Recruiting

  • CHU Nantes

    Nantes,
    France

    Site Not Available

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