Actively Recruiting
Knee Osteoarthritis and Thermal Spa Treatment
Led by CEN Biotech · Updated on 2026-01-30
76
Participants Needed
2
Research Sites
100 weeks
Total Duration
On this page
Sponsors
C
CEN Biotech
Lead Sponsor
T
Town Hall of Enghien-les-Bains
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this interventional study is to evaluate the effectiveness at 6 months of the Enghien-les-Bains thermal spa treatment on functional disability and pain, assessed by the Minimal Clinically Important Improvement (MCII), in patients with knee osteoarthritis. The study is conducted in patients aged 50 to 80 years with knee osteoarthritis (Kellgren-Lawrence grade 2 to 4) and a baseline functional impairment defined by a normalized WOMAC function score ≥ 30. The main questions it aims to answer are: * Does the Enghien-les-Bains thermal spa treatment result in a clinically meaningful improvement in pain and functional disability at 6 months in patients with knee osteoarthritis? * Is the effectiveness of the Enghien-les-Bains thermal spa treatment superior to standard care, as assessed through an indirect comparison with an external control group from the ANGELLO randomized controlled trial (NCT0581943)? Patients receiving the Enghien-les-Bains thermal spa treatment are compared to the external control group of the ANGELLO randomized controlled trial (Saint-Jean-d'Angély), composed of non-spa-treated patients receiving standard care, to assess differences in pain and functional disability outcomes at 6 months. Patients of the study: * Undergo a standardized thermal spa treatment at Enghien-les-Bains. * Continue usual medical care for knee osteoarthritis. * Complete questionnaires and clinical assessments at baseline and at 6 months.
CONDITIONS
Official Title
Knee Osteoarthritis and Thermal Spa Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Knee osteoarthritis with Kellgren and Lawrence stage 2 to 4 shown by a knee X-ray within the past 3 years
- A normalized WOMAC physical function score of 30 or higher
- Signed informed consent
- Affiliation with health insurance
You will not qualify if you...
- Contraindications to balneotherapy or related treatments, including chronic infections, active cancer, severe heart, liver or kidney failure, open leg ulcers, immune deficiency, phlebitis, erysipelas or history of erysipelas, active thrombosis, or behavioral disorders
- Chronic pain due to conditions other than osteoarthritis such as rheumatoid arthritis, ankylosing spondylitis, lupus, psoriatic arthritis, or fibromyalgia
- Scheduled knee surgery related to osteoarthritis within the next 7 months
- Spa treatment in the past 6 months or recent intra-articular corticosteroid, hyaluronic acid, viscosupplementation, or platelet-rich plasma injections within specified time frames
- Planned spa treatment for other reasons between inclusion and final visit
- Living more than 30 kilometers from Enghien-les-Bains at the time of spa treatment
- Women of childbearing potential not using effective contraception or planning to stop contraception within 7 months
- Likely inability to comply with the study protocol or attend visits, or inability to read or understand French
- Under guardianship or already enrolled in another clinical trial or within exclusion period of a clinical trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Thermes d'Enghien-les-Bains
Enghien-les-Bains, France, 95880
Actively Recruiting
2
Thermes d'Enghien-les-Bains
Enghien-les-Bains, Île-de-France Region, France, 95880
Not Yet Recruiting
Research Team
C
Christine Juhel, Ph.D
CONTACT
A
Amandine Fry
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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