Actively Recruiting
Hyaluronic Acid in Shoulder Tendinopathy
Led by Centre Hospitalier Departemental Vendee · Updated on 2024-10-03
132
Participants Needed
2
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- Active pain with visual analog scale of 4 or higher for more than 6 weeks
- Active pain with visual analog scale of 4 or higher on the day of inclusion
- Failure of medical treatment including rest, analgesics, NSAIDs, and physiotherapy
- Ability to follow study protocol and provide oral informed consent
- Affiliated with social security or entitled to it
You will not qualify if you...
- Transfixing tendon rupture
- Post-traumatic tendon rupture
- Calcific tendinopathy with calcification greater than 5 mm
- Associated glenohumeral osteoarthritis
- Symptomatic acromioclavicular osteoarthritis
- Shoulder pain caused by conditions other than tendinopathy such as capsulitis, chronic inflammatory rheumatism, fibromyalgia, or amyloidosis
- Subacromial infiltration within the previous 6 months
- Known allergy to study products or their excipients including methyl parahydroxybenzoate, propyl parahydroxybenzoate, benzyl alcohol
- Known allergy to lidocaine
- Local or generalized infection or suspected infection
- Severe coagulation disorders or use of anticoagulants
- Severe or uncontrolled hypertension above 160/100 mmHg
- Uncontrolled diabetes with last HbA1c above 8.5%
- History of addiction to psychoactive substances
- Participation in another clinical research protocol impacting study objectives
- Prior randomization in this study
- Pregnancy, parturition, breastfeeding, or ability to procreate without effective contraception
- Under guardianship, curatorship, deprived of liberty, or court protection
AI-Screening
AI-Powered Screening
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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
CONTACT
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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