NCT06617975

Knee Osteoarthritis and Spa Therapy

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: CEN Biotech · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

For study purposes, two medical visits with the investigator are organized: the first in the 28 days preceding the 18-day balneotherapy program, or at the latest on the first day of the program, before the first care, and the second 6 months after the start of the program. A remote visit at 3 months is also organized. The data required for study evaluations are collected by the investigator or self-evaluated by patients during the visits. Patients of the study receive the same exercise recommendations than the patients of the Control group of the reference study, and their body weight as well as physical ability are monitored.

Conditions

• Knee Osteoarthritis
• Knee Osteoarthritis (OA)

Interventions

Type	Name	Description
OTHER	Balneotherapy program in rheumatology indication	At least 4 balneotherapy sessions per day, 6 days a week during 3 consecutive weeks that may include: 1 whirlpool bath per day, 1 poultice application per day, 1 bath with immersion showers in a pool per day, a local jet shower every other day, a penetrating shower every other day. Alternative treatments may replace penetrating shower or local jet shower, or other care, e.g., collective jet shower or steam bath. 10-minute air diffusion baths are taken in individual tubs at 37°C. Mud is applied 10 minutes as a poultice to both knees (minimum 2 per knee, 52°C), if necessary, to other painful osteoarthritis areas. 10-minute collective pool bathing takes place in a thermal pool equipped with jet stations immersed in water at 32°C. 3-minute local jet shower is applied to the predefined area using thermal water at 37°C. 10-minute penetrating showers are delivered by an affusion ramp on the patient lying down and directed on the area defined, using thermal water at 37°C.

Timeline

• Start date: 2024-10-14
• Primary completion: 2026-12-15
• Completion: 2026-12-31
• First posted: 2024-10-01
• Last updated: 2025-08-07

Locations

1 site across 1 country: France