Spa therapy program for knee osteoarthritis
Evaluation of the Effectiveness of the Spa Therapy Program for Rheumatology at Santenay in Patients With Knee Osteoarthritis
This program tests whether an 18-day balneotherapy (spa) treatment helps people with knee osteoarthritis reduce pain, stiffness, and improve physical function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | CEN Biotech Industry-sponsored |
| Locations | 1 site (Santenay, Burgundy) |
| Trial ID | NCT06617975 on ClinicalTrials.gov |
What this trial studies
This is a single-arm prospective study where all participants receive an 18-day balneotherapy program using the mineral waters of Santenay, with outcomes compared to an external control group from a prior randomized trial using propensity-score methods. Participants have a baseline visit within 28 days before the program (or on day 1), a remote visit at 3 months, and an in-person visit at 6 months to collect patient-reported outcomes and clinical data. Key measures include WOMAC physical function and symptoms (pain, stiffness) plus monitoring of body weight and physical ability, with patients given standardized exercise recommendations similar to the external control. The control group received standard care (pain management and exercise advice), allowing estimation of the spa program's additional effect on function and quality of life.
Who should consider this trial
Good fit: Ideal candidates are people with radiographic knee osteoarthritis (Kellgren–Lawrence stage 2–4), a WOMAC physical function score normalized to 100 of at least 30, who can attend the 18-day program at Santenay and have a prescription and health insurance.
Not a fit: Patients with contraindications to balneotherapy, other causes of chronic pain (for example inflammatory arthritis), or severe comorbidities that limit participation are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could reduce knee pain and stiffness and improve physical function and quality of life for people with knee osteoarthritis.
How similar studies have performed: Previous randomized trials and meta-analyses of balneotherapy for osteoarthritis have shown short-term improvements in pain and function, but long-term benefits are less certain.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Knee osteoarthritis with Kellgren and Lawrence stage 2 to 4 evidenced by a knee X-ray examination in the past 3 years. * 100-normalized score of the WOMAC physical function subscale greater than or equal to 30. * Accepting a prescription for a balneotherapy program in the Rheumatology at Santenay spa as part of the management of their knee osteoarthritis issued by the investigator. * Signed inform consent. * With health insurance affiliation. Exclusion Criteria: * Presented with balneotherapy contraindication or to certain adjuvant treatment techniques (balneation, hydrotherapy jets, massage): chronic infectious pathology, active cancer, decompensated cardiac, hepatic or renal insufficiency, "open" leg ulcer, immune deficiency, phlebitis, erysipelas or history of erysipelas, active thrombosis, behavioral disorders, etc. * Presented with chronic pain for reasons other than osteoarthritis: chronic inflammatory rheumatism (rheumatoid arthritis, ankylosing spondylitis, lupus, psoriatic arthritis) or fibromyalgia. * Having had spa treatment in the past 6 months whatever the indication or intra-articular corticosteroid injection within the previous 90 days or hyaluronic acid infiltration within the previous 6 months. * Having planned a spa treatment in another indication between inclusion and final visit. * Patient scheduled for knee osteoarthrosis-related surgery within the next 7 months. * Residing more than 30 kilometers from Santenay at the time of spa treatment. Women of childbearing potential who are not using effective contraception (estrogen/progestin or progestin-only oral, vaginal, transdermal, injectable or subcutaneous) or who plan to discontinue contraception within the next 7 months. * Likely to be unable to comply with protocol or to attend visits, particularly in view of the duration of the research, or unable to read or understand French. * Regulatory reason (guardianship or already enrolled in a clinical trial). * Already included in a clinical trial or in the exclusion period of a clinical trial.
Where this trial is running
Santenay, Burgundy
- Valvital - Thermes de Santenay — Santenay, Burgundy, France (Recruiting)
Study contacts
- Principal investigator: Bruno COLLOMBIER, MD
- Study coordinator: Christine JUHEL, Ph.D
- Email: christine.juhel@groupecen.com
- Phone: +33380680511
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.