Knee Osteoarthritis and Balneotherapy

NCT ID: NCT05819437

Last Updated: 2023-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 173 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-26
• Study Completion Date: 2022-09-20

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

CONTROL

Standard of care for knee osteoarthritis

Group Type: NO_INTERVENTION

No interventions assigned to this group

BALNEOTHERAPY PROGRAM

3-week balneotherapy program with Mineral Water of Saint Jean d'Angely in addition to standard of care for knee osteoarthritis

Group Type: EXPERIMENTAL

Balneotherapy program

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 of 30 or greater;
• Available for balneotherapy program and the 6-month study follow-up;
• Signed inform consent;
• with health insurance affiliation.

Exclusion Criteria

• Presented with balneotherapy contra-indication;
• Having had spa treatment in the past 6 months or intra-articular corticosteroid injection within the previous 90 days or hyaluronic acid infiltration within the previous 6 months;
• Presented with chronic pain other than osteoarthritis, with scheduled surgery related to knee osteoarthritis;
• regulatory reason (guardianship or already enrolled in a clinical trial).

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

COMPAGNIE EUROPEENNE DES BAINS

UNKNOWN

Sponsor Role: collaborator

CEN Biotech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arnaud TERRILLON-SEYTRE

Role: STUDY_DIRECTOR

CEN

Locations

CEN

Dijon, , France

Countries

France

Other Identifiers

C1650

Identifier Type: -

Identifier Source: org_study_id