| NCT ID | NCT06617975 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CEN Biotech |
| Condition | Knee Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-10-14 |
| Primary Completion | 2026-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2024-10-14 with a primary completion date of 2026-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Bruno COLLOMBIER, MD
PRINCIPAL INVESTIGATOR
Frequently Asked Questions
Who can join the NCT06617975 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06617975 currently recruiting?
Yes, NCT06617975 is actively recruiting participants. Contact the research team at christine.juhel@groupecen.com for enrollment information.
Where is the NCT06617975 trial being conducted?
This trial is being conducted at Santenay, France.
Who is sponsoring the NCT06617975 clinical trial?
NCT06617975 is sponsored by CEN Biotech. The principal investigator is Bruno COLLOMBIER, MD. The trial plans to enroll 80 participants.