Spa therapy program for knee osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.