Actively Recruiting
Evaluation of the Effectiveness of the Spa Therapy Program for Rheumatology at Santenay in Patients With Knee Osteoarthritis
Led by CEN Biotech · Updated on 2025-08-07
80
Participants Needed
1
Research Sites
2 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
Researchers are evaluating an 18-day balneotherapy program using Mineral Water of Santenay for patients aged 50 to 80 with knee osteoarthritis. The study aims to assess how this spa therapy affects functional ability, pain, and joint stiffness associated with knee osteoarthritis, and whether it improves patients' quality of life compared to standard care. The study uses an external control group from a previous randomized trial receiving standard pain management and exercise recommendations. Participants receive at least four balneotherapy sessions per day, six days a week for three weeks, which may include whirlpool baths, poultice applications, immersion baths, local jet showers, and penetrating showers using thermal water at specific temperatures. Alternative treatments may be used in some cases. Patients also receive the same exercise advice as the control group. Medical visits are scheduled before starting the program and six months after, with a remote visit at three months. During the study, patients will be monitored for body weight, physical ability, and self-evaluations of pain and function. The main outcome measured is Minimal Clinically Important Improvement at six months. Other assessments include changes in pain, stiffness, physical function, and quality of life at three and six months using the WOMAC scale and Acceptable Symptom State. Safety and overall management of knee osteoarthritis will also be evaluated. Participation lasts at least six months with follow-up visits and evaluations.
CONDITIONS
Brief 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 in the past 3 years
- WOMAC physical function subscale score of 30 or higher
- Accepting a prescription for the Rheumatology balneotherapy program at Santenay spa
- Signed informed consent
- Affiliated with health insurance
You will not qualify if you...
- Contraindications to balneotherapy or related treatments (e.g., chronic infections, active cancer, severe heart, liver, or kidney failure, open leg ulcers, immune deficiency, phlebitis, erysipelas, active thrombosis, behavioral disorders)
- Chronic pain from conditions other than osteoarthritis (e.g., rheumatoid arthritis, lupus, fibromyalgia)
- Spa treatment in the past 6 months or recent corticosteroid or hyaluronic acid injections
- Planned spa treatment for other indications during the study
- Scheduled knee surgery related to osteoarthritis within 7 months
- Residence more than 30 km from Santenay during spa 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/understand French
- Legal guardianship or current participation in another clinical trial
- Already included in or within exclusion period of another clinical trial
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 18 days
Participants undergo an 18-day balneotherapy program with mineral water at the Santenay spa, including multiple daily sessions of baths, poultices, and showers designed to support knee osteoarthritis care.
1 baseline visit (in-person) before starting the program
Duration - 6 months
Participants are monitored through visits to assess pain, physical function, and quality of life after the balneotherapy program.
1 remote visit at 3 months and 1 in-person visit at 6 months
Trial Site Locations
Total: 1 location
1
Valvital - Thermes de Santenay
Santenay, Burgundy, France, 21590
Actively Recruiting
Research Team
C
Christine JUHEL, Ph.D
A
Amandine FRY
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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