Actively Recruiting
Benefit of a Subacromial Injection Combining Corticosteroid and Hyaluronic Acid Versus Corticosteroid Alone in Supraspinatus Tendinopathy
Led by Centre Hospitalier Departemental Vendee · Updated on 2024-10-03
132
Participants Needed
2
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing the effects of combining corticosteroid and hyaluronic acid injections versus corticosteroid injections alone for patients with supraspinatus tendinopathy, a condition causing shoulder pain. This randomized, double-blind, phase 3 study aims to evaluate pain during activity at three months to determine if the combination helps more than corticosteroids alone. Participants will receive either an injection of 1 ml corticosteroid plus 2 ml hyaluronic acid or 1 ml corticosteroid plus 2 ml placebo (physiological serum). The study will reassess patients clinically at one, three, and six months to monitor changes in pain and shoulder function. During the study, participants will be assessed using a visual analog scale measuring pain on activity, with the main focus at three months. Researchers will monitor pain levels, safety, and any side effects. The total participation duration includes follow-up visits up to six months, ensuring thorough evaluation of treatment outcomes.
CONDITIONS
Brief Title
Hyaluronic Acid in Shoulder Tendinopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged between 18 and 65 years
- Shoulder pain compatible with supraspinatus tendinopathy lasting at least 2 months
- Simple tendinopathy or partial tendon rupture
- Tendinopathy confirmed by ultrasound or MRI
- Pain level of at least 4 on a visual analog scale for more than 6 weeks and on the day of inclusion
- Failure of medical treatments including rest, analgesics, NSAIDs, and physiotherapy
- Ability to follow the study protocol and provide oral informed consent
- Affiliated to or entitled to the social security system
You will not qualify if you...
- Transfixing or post-traumatic tendon rupture
- Calcific tendinopathy with calcification greater than 5 mm
- Associated glenohumeral or symptomatic acromioclavicular osteoarthritis
- Shoulder pain caused by other conditions such as capsulitis, chronic inflammatory rheumatism, fibromyalgia, or amyloidosis
- Subacromial infiltration in the previous 6 months
- Known allergy to study products or lidocaine
- Local or generalized infection or suspected infection
- Severe coagulation disorders or use of anticoagulants
- Severe or uncontrolled hypertension above 160/100 mmHg
- Unbalanced diabetes with HbA1c above 8.5%
- History of addiction to psychoactive substances
- Participation in another clinical trial impacting this study's objectives
- Previous randomization in this study
- Pregnancy, breastfeeding, or able to procreate without effective contraception during the study period
- Under guardianship, curatorship, deprived of liberty, or under any court protection mandate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment with follow-up until Month 3
Participants receive injections of corticosteroids combined with either hyaluronic acid or placebo to treat shoulder tendinopathy.
1 injection visit and follow-up visits up to Month 3
Trial Site Locations
Total: 2 locations
1
CHD Vendée
La Roche-sur-Yon, France
Actively Recruiting
2
CHU Nantes
Nantes, France
Not Yet Recruiting
Research Team
L
Laura SOULARD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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