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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Valvital - Thermes de Santenay
RECRUITING
Santenay
Contact Information
Primary
Christine JUHEL, Ph.D
christine.juhel@groupecen.com
+33380680511
Backup
Amandine FRY
amandine.fry@groupecen.com
+33380680513
Time Frame
Start Date: 2024-10-14
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 80
Treatments
Experimental: Balneotherapy
18-day balneotherapy program with Mineral Water of Santenay in addition to standard of care for knee osteoarthritis
Related Therapeutic Areas
Sponsors
Collaborators: COMPAGNIE EUROPEENNE DES BAINS, VALVITAL Santenay
Leads: CEN Biotech

This content was sourced from clinicaltrials.gov