Actively Recruiting

Phase Not Applicable
Age: 50Years - 80Years
All Genders
ID06617975

Evaluation of the Effectiveness of the Spa Therapy Program for Rheumatology at Santenay in Patients With Knee Osteoarthritis

Led by CEN Biotech · Updated on 2025-08-07

80

Participants Needed

1

Research Sites

2 weeks

Total Duration

On this page

Sponsors

C

CEN Biotech

Lead Sponsor

C

COMPAGNIE EUROPEENNE DES BAINS

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating an 18-day balneotherapy program using Mineral Water of Santenay for patients aged 50 to 80 with knee osteoarthritis. The study aims to assess how this spa therapy affects functional ability, pain, and joint stiffness associated with knee osteoarthritis, and whether it improves patients' quality of life compared to standard care. The study uses an external control group from a previous randomized trial receiving standard pain management and exercise recommendations. Participants receive at least four balneotherapy sessions per day, six days a week for three weeks, which may include whirlpool baths, poultice applications, immersion baths, local jet showers, and penetrating showers using thermal water at specific temperatures. Alternative treatments may be used in some cases. Patients also receive the same exercise advice as the control group. Medical visits are scheduled before starting the program and six months after, with a remote visit at three months. During the study, patients will be monitored for body weight, physical ability, and self-evaluations of pain and function. The main outcome measured is Minimal Clinically Important Improvement at six months. Other assessments include changes in pain, stiffness, physical function, and quality of life at three and six months using the WOMAC scale and Acceptable Symptom State. Safety and overall management of knee osteoarthritis will also be evaluated. Participation lasts at least six months with follow-up visits and evaluations.

CONDITIONS

Brief Title

Knee Osteoarthritis and Spa Therapy

Who Can Participate

Age: 50Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Knee osteoarthritis with Kellgren and Lawrence stage 2 to 4 confirmed by knee X-ray in the past 3 years
  • WOMAC physical function subscale score of 30 or higher
  • Accepting a prescription for the Rheumatology balneotherapy program at Santenay spa
  • Signed informed consent
  • Affiliated with health insurance
Not Eligible

You will not qualify if you...

  • Contraindications to balneotherapy or related treatments (e.g., chronic infections, active cancer, severe heart, liver, or kidney failure, open leg ulcers, immune deficiency, phlebitis, erysipelas, active thrombosis, behavioral disorders)
  • Chronic pain from conditions other than osteoarthritis (e.g., rheumatoid arthritis, lupus, fibromyalgia)
  • Spa treatment in the past 6 months or recent corticosteroid or hyaluronic acid injections
  • Planned spa treatment for other indications during the study
  • Scheduled knee surgery related to osteoarthritis within 7 months
  • Residence more than 30 km from Santenay during spa treatment
  • Women of childbearing potential not using effective contraception or planning to stop within 7 months
  • Unable to comply with protocol or attend visits or unable to read/understand French
  • Legal guardianship or current participation in another clinical trial
  • Already included in or within exclusion period of another clinical trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 18 days

Participants undergo an 18-day balneotherapy program with mineral water at the Santenay spa, including multiple daily sessions of baths, poultices, and showers designed to support knee osteoarthritis care.

1 baseline visit (in-person) before starting the program

Follow-up

Duration - 6 months

Participants are monitored through visits to assess pain, physical function, and quality of life after the balneotherapy program.

1 remote visit at 3 months and 1 in-person visit at 6 months

Trial Site Locations

Total: 1 location

1

Valvital - Thermes de Santenay

Santenay, Burgundy, France, 21590

Actively Recruiting

Loading map...

Research Team

C

Christine JUHEL, Ph.D

A

Amandine FRY

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

Similar Trials

Effect of High-Intensity Pulsed Electromagnetic Field Therap...

Knee Osteoarthritis

Actively Recruiting

1 location

Effectiveness of Mulligan Mobilization Technique and Proprio...

Knee Osteoarthritis

Actively Recruiting

1 location

A Clinical Study to Evaluate the Safety, Tolerability and Ef...

Knee Osteoarthritis

Actively Recruiting

2 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here