Actively Recruiting
Knee Osteoarthritis and Spa Therapy
Led by CEN Biotech · Updated on 2025-08-07
80
Participants Needed
1
Research Sites
115 weeks
Total Duration
On this page
Sponsors
C
CEN Biotech
Lead Sponsor
C
COMPAGNIE EUROPEENNE DES BAINS
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aim of this clinical trial is to assess the efficacy of the 18-day balneotherapy program (therapeutic indication: Rheumatology) in terms of functional incapacity and the disorders (pain, joint stiffness) induced by osteoarthritis of the knee, and thus improves patients\' quality of life, in patients presented with knee osteoarthritis. The French National Academy of Medicine encourages the re-use of RCT data when available. In this context, the current study is designed as a single-arm prospective study with external comparison using the propensity score. The Control group consists of the patients which were allocated to the Control group of reference randomized clinical trial (RCT) "ANGELLO Study" (NCT05819437). These patients received standard care for knee osteoarthritis, i.e., pain management and exercise recommendations. All patients enrolled in the current study benefit of 18-day balneotherapy program (therapeutic indication: Rheumatology) with Mineral Water of Santenay (Burgundy, France), and examination with a practitioner at enrollment and 6 months after the beginning of spa treatment.
CONDITIONS
Official Title
Knee Osteoarthritis and Spa Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Knee osteoarthritis with Kellgren and Lawrence stage 2 to 4 confirmed by knee X-ray within the past 3 years
- Physical function score on the WOMAC scale of 30 or higher (normalized to 100)
- Accepts a prescription for the balneotherapy program at Santenay spa for knee osteoarthritis management
- Signed informed consent
- Has health insurance coverage
You will not qualify if you...
- Contraindications to balneotherapy or related treatments such as chronic infections, active cancer, severe heart, liver, or kidney failure, open leg ulcers, immune deficiency, phlebitis, erysipelas or history of it, active thrombosis, or behavioral disorders
- Chronic pain from other causes than osteoarthritis, including inflammatory rheumatisms or fibromyalgia
- Received spa treatment in past 6 months for any reason, intra-articular corticosteroid injection within 90 days, or hyaluronic acid injection within 6 months
- Planned spa treatment for other indications between study inclusion and final visit
- Scheduled knee surgery related to osteoarthritis within 7 months
- Residence more than 30 kilometers from Santenay at time of treatment
- Women of childbearing potential not using effective contraception or planning to stop within 7 months
- Unable to comply with protocol or attend visits, or unable to read or understand French
- Under guardianship or currently enrolled in or recently completed another clinical trial
- Already included in a clinical trial or within exclusion period of one
AI-Screening
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Trial Site Locations
Total: 1 location
1
Valvital - Thermes de Santenay
Santenay, Burgundy, France, 21590
Actively 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
SUPPORTIVE_CARE
Number of Arms
1
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