Knee Osteoarthritis and Thermal Spa Treatment

Summary

The goal of this interventional study is to evaluate the effectiveness at 6 months of the Enghien-les-Bains thermal spa treatment on functional disability and pain, assessed by the Minimal Clinically Important Improvement (MCII), in patients with knee osteoarthritis.

The study is conducted in patients aged 50 to 80 years with knee osteoarthritis (Kellgren-Lawrence grade 2 to 4) and a baseline functional impairment defined by a normalized WOMAC function score ≥ 30.

The main questions it aims to answer are:

* Does the Enghien-les-Bains thermal spa treatment result in a clinically meaningful improvement in pain and functional disability at 6 months in patients with knee osteoarthritis?
* Is the effectiveness of the Enghien-les-Bains thermal spa treatment superior to standard care, as assessed through an indirect comparison with an external control group from the ANGELLO randomized controlled trial (NCT0581943)? Patients receiving the Enghien-les-Bains thermal spa treatment are compared to the external control group of the ANGELLO randomized controlled trial (Saint-Jean-d'Angély), composed of non-spa-treated patients receiving standard care, to assess differences in pain and functional disability outcomes at 6 months.

Patients of the study:

* Undergo a standardized thermal spa treatment at Enghien-les-Bains.
* Continue usual medical care for knee osteoarthritis.
* Complete questionnaires and clinical assessments at baseline and at 6 months.

Conditions

• Knee Osteoarthritis

Interventions

OTHER

Thermal spa sessions

At least 4 spa sessions per day, 6 days a week during 3 consecutive weeks that may include daily: one whirlpool bath, one poultice application, one overall jet shower and one underwater massage with thermal water. With the exception of the application of mud poultices and whirlpool bath, which cannot be substituted, other treatments may be replaced by: immersion bath with shower, penetrating shower, and local jet shower. 10-minute air diffusion baths are taken in individual tubs at 37°C. Mud is applied for 10 minutes as a poultice to both knees (minimum 2 per knee, 45°C), if necessary, to other painful osteoarthritis areas. A 3-minute overall jet shower is administered by a thermal spa staff member, using thermal water at 37°C. A 10-minute underwater massage is administered by a physiotherapist, under a thermal water spray bar at 37°C.

OTHER

Thermal water

The water has a neutral pH (7), is cold (14 °C), and presents a moderate level of mineralization (571 mg/L) with a balanced ionic profile. It contains calcium (128 mg/L), bicarbonates (440 mg/L), sulfates (93 mg/L), magnesium (27.9 mg/L), and sodium (12.4 mg/L).

OTHER

Standard of Care for Knee Osteoarthritis

Participants continue standard medical care for knee osteoarthritis as prescribed by their primary care physician, including analgesics and physiotherapy, according to routine clinical practice.

Sponsors & Collaborators

• Town Hall of Enghien-les-Bains

  collaborator UNKNOWN

• CEN Biotech

  lead INDUSTRY

Principal Investigators

• Magali Ballard, MD

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

50 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-27

Primary Completion

2027-02-10

Completion

2027-12-31

Countries

• France

Study Locations