Taking peopleNo phase

Spa water treatment program for people with knee osteoarthritis

Tests an 18-day spa bath program for pain and stiffness in knee osteoarthritis.

Key facts

Who runs it: CEN Biotech
Where: France1 site in 1 countryChoose a country to see its sites
Trial code: NCT06617975
Registry title: Knee Osteoarthritis and Spa Therapy
Status: Recruiting
People taking part: 80 people, planned
Started: 14 Oct 2024
Expected to end: 31 Dec 2026
Type of study: Interventional
Treatments tested: Balneotherapy program in rheumatology indication
Record updated: 7 August 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 50 to 80 with knee osteoarthritis. Everyone gets an 18-day spa water treatment program at Santenay, France.

Age: 50 to 80 years
Sex: All sexes
Disease stage: Knee osteoarthritis at Kellgren and Lawrence stage 2 to 4, shown on a knee X-ray in the past 3 years. The WOMAC physical function score (normalized to 100) must be 30 or more.
Earlier treatment: No spa treatment in the past 6 months. No corticosteroid injection into the joint within the previous 90 days. No hyaluronic acid injection within the previous 6 months.

Main reasons for not taking part

Health problems that rule out spa treatment, such as active cancer, chronic infection, severe heart, liver or kidney failure, open leg ulcer, phlebitis or active thrombosis
Chronic pain from other causes, such as rheumatoid arthritis, ankylosing spondylitis, lupus, psoriatic arthritis or fibromyalgia
Knee surgery for osteoarthritis planned within the next 7 months
Living more than 30 kilometers (19 mi) from Santenay during the spa treatment
Women who can become pregnant and do not use effective contraception, or cannot read or understand French

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

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

Who cannot take part

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
Patient scheduled for knee osteoarthrosis-related surgery within the next 7 months
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 planned a spa treatment in another indication between inclusion and final visit
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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 50 and 80 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

BalneotherapyTreatment being tested
18-day balneotherapy program with Mineral Water of Santenay in addition to standard of care for knee osteoarthritis
Treatment: Balneotherapy program in rheumatology indication