Knee Osteoarthritis and Balneotherapy (ANGELLO)

CEN Biotech

Status

Completed

Conditions

Knee Osteoarthritis

Treatments

Other: Balneotherapy program

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT05819437

C1650

Details and patient eligibility

About

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.

Enrollment

173 patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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).