NCT05819437

Knee Osteoarthritis and Balneotherapy

Effectiveness of a 3-week Balneotherapy Program With Mineral Water of Saint Jean d'Angely in Knee Osteoarthritis: A Superiority, Randomised, Controlled Study Versus Standard of Care Alone

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: CEN Biotech · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to assess the efficacy of a 18-day balneotherapy program in the rheumatology indication in patients presented with knee osteoarthritis. The main questions of the study aims to answer are how balneotherapy improves functional incapacity and the disorders (pain, joint stiffness) induced by osteoarthritis of the knee, and thus improves patients' quality of life. Participants are randomly assigned in control or treatment (spa) groups. All receive standard of care for knee osteoarthritis throughout the study. Balneotherapy program consists of 18-days of spa treatment with Mineral Water of Saint Jean d'Angely. Functional incapacity, disorders and quality of life induced were measured at baseline and then 6 months later. Variation from baseline were compared in control and treatment groups to assess the efficacy of the balneotherapy program.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
OTHER	Balneotherapy program	Whirlpool bath, bath with immersion showers, poultice application and underwater massage. The baths were performed in an individual tub in ten-minute sessions. The temperature was set specifically for each patient, on average from 34 to 38°C. These were baths with jets and air diffusion. The mud was applied as a poultice to the 2 knees and if necessary (duration of application: 10 minutes). The massages were carried out by qualified physiotherapists under an affusion ramp of thermal water at 38°C for 10 minutes. The water used is a mixed sulphated Natural Mineral Water, collected by drilling the "capuchins" at a depth of 975 m. The temperature of the water at the outlet of the borehole is 41.8°C and is lowered to 35°C.

Timeline

• Start date: 2020-08-26
• Primary completion: 2021-07-03
• Completion: 2022-09-20
• First posted: 2023-04-19
• Last updated: 2023-04-19

Locations

1 site across 1 country: France