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Recruiting NCT06376981

Hyaluronic Acid in Shoulder Tendinopathy

Phase III Interventional Shoulder Tendinitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hyaluronic acid injection, Corticosteroid injection, Placebo injection.
Who it may be relevant to
Registry conditions: Shoulder Tendinitis. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Hyaluronic acid injection
    An injection of 2 ml of Acid hyaluronic
  • Drug Corticosteroid injection
    An injection of 1 ml of corticosteroids
  • Drug Placebo injection
    An injection of 2 ml of placebo (physiological serum)

Primary outcome measures

  • Visual analog scale pain on activity ranging from 0 to 100 mm at month 3. [Time frame: Month 3]

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 ;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

France · 2 centers
  • CHD Vendée — La Roche-sur-Yon
  • CHU Nantes — Nantes

Identifiers

NCT: NCT06376981 · CHD23_0025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗