Knee Osteoarthritis and Thermal Spa Treatment
Recruiting · NCT07370480 · Interventional (participants receive a specific treatment) · Lead sponsor: CEN Biotech
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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.
- 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.
- Patient scheduled for knee osteoarthrosis-related surgery within the next 7 months.
- 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 or other viscosupplementation or platelet-rich plasma (PRP) injection within the previous 6 months.
- Having planned a spa treatment in another indication between inclusion and final visit.
- Residing more than 30 kilometers from Enghien-les-Bains 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 is running
2 locations listed.
- Thermes d'Enghien-les-Bains - Enghien-les-Bains, France
- Thermes d'Enghien-les-Bains - Enghien-les-Bains, Île-de-France Region, France