Knee Osteoarthritis and Balneotherapy

NCT05819437 | Completed DMC

• 1 other identifier: C1650
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 1

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

Keywords

Balneotherapy, Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Variation from baseline in physical function subscale of the WOMAC at 6 months

  Physical function subscale of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a self-administered questionnaire that consists in 17 items: (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties. The 100-normalized subscale score ranges from 0 (none) to 100 (worse functional limitations).

  Baseline (D1) and final (6 months)

Secondary Outcomes (17)

• Variation from baseline in physical function subscale of the WOMAC at 3 months

  Baseline (D1) and final (3 months)

• Variation from baseline in pain subscale of the WOMAC at 3 months

  Baseline (D1) and final (3 months)

• Variation from baseline in pain subscale of the WOMAC at 6 months

  Baseline (D1) and final (6 months)

• Variation from baseline in stiffness subscale of the WOMAC at 3 months

  Baseline (D1) and final (3 months)

• Variation from baseline in stiffness subscale of the WOMAC at 6 months

  Baseline (D1) and final (6 months)

Study Arms (2)

CONTROL

NO INTERVENTION

Standard of care for knee osteoarthritis

BALNEOTHERAPY PROGRAM

EXPERIMENTAL

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

Other: Balneotherapy program

Interventions

Balneotherapy program 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.

BALNEOTHERAPY PROGRAM

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Knee osteoarthritis with Kellgren and Lawrence stage 2 to 4 evidenced by a knee X-ray examination in the past 3 years);
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• CEN Biotech: lead
• COMPAGNIE EUROPEENNE DES BAINS: collaborator

Study Sites (1)

CEN

Dijon, 21000, France

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Arnaud TERRILLON-SEYTRE

  CEN

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized controlled Trial, monocentric

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 19, 2023
• Study Start: August 26, 2020
• Primary Completion: July 3, 2021
• Study Completion: September 20, 2022
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)