Clinical trial NCT05819437: Knee Osteoarthritis and Balneotherapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Balneotherapy, Osteoarthritis
Lead sponsor: CEN Biotech
Sponsor class: INDUSTRY
Collaborators: name: COMPAGNIE EUROPEENNE DES BAINS
First posted: 2023-04-19
Enrollment: 173
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled Trial, monocentric
Primary purpose: SUPPORTIVE_CARE

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.


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).

Primary outcomes:
measure: Variation from baseline in physical function subscale of the WOMAC at 6 months
timeFrame: Baseline (D1) and final (6 months)
Secondary outcomes:
measure: Variation from baseline in physical function subscale of the WOMAC at 3 months
timeFrame: Baseline (D1) and final (3 months)
measure: Variation from baseline in pain subscale of the WOMAC at 3 months
timeFrame: Baseline (D1) and final (3 months)
measure: Variation from baseline in pain subscale of the WOMAC at 6 months
timeFrame: Baseline (D1) and final (6 months)
measure: Variation from baseline in stiffness subscale of the WOMAC at 3 months
timeFrame: Baseline (D1) and final (3 months)
measure: Variation from baseline in stiffness subscale of the WOMAC at 6 months
timeFrame: Baseline (D1) and final (6 months)
measure: Variation from baseline in WOMAC total score at 3 months
timeFrame: Baseline (D1) and final (3 months)
measure: Variation from baseline in WOMAC total score at 6 months
timeFrame: Baseline (D1) and final (6 months)
measure: Variation from baseline in pain-induced knee osteoarthritis intensity at 3 months
timeFrame: Baseline (D1) and final (3 months)
measure: Variation from baseline in pain-induced knee osteoarthritis intensity at 6 months
timeFrame: Baseline (D1) and final (6 months)
measure: Number of participants achieving minimal clinically important improvement (MCII) at 3 months
timeFrame: 3 months
measure: Number of participants achieving minimal clinically important improvement (MCII) at 6 months
timeFrame: 6 months
measure: Number of participants presented with acceptable symptom state (ASS) at 3 months
timeFrame: 3 months
measure: Number of participants presented with acceptable symptom state (ASS) at 6 months
timeFrame: 6 months
measure: Changes in participants quality of life at 3 months
timeFrame: 3 months
measure: Changes in participants quality of life at 6 months
timeFrame: 6 months
measure: Frequency of adverse events throughout the study
timeFrame: From inclusion to the final visit at 6 months
measure: Participants' opinion with their symptoms related to knee osteoarthritis at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Dijon
country: France
facility: CEN
Study officials:
affiliation: CEN
name: Arnaud TERRILLON-SEYTRE
role: STUDY_DIRECTOR
References: