Knee Osteoarthritis and Spa Therapy

Launched by CEN BIOTECH · Sep 25, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the effects of an 18-day spa therapy program on people with knee osteoarthritis, a condition that causes pain and stiffness in the knee joints. The goal is to see if this treatment can help improve patients' ability to move around and enhance their overall quality of life. Participants will take part in this program at the Santenay spa in France, where they will be treated with mineral water and receive guidance from a healthcare professional.

To be eligible for the trial, participants should have knee osteoarthritis confirmed by an X-ray and meet certain criteria related to their physical function. They must also be willing to follow the treatment plan and have health insurance. It's important to note that some individuals, like those with certain medical conditions or recent treatments, may not qualify. Participants will be monitored at the beginning and again six months after completing the spa treatment to evaluate its effectiveness.

Gender

ALL

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.