Health TrialsbyHealthPanel

Knee Osteoarthritis and Thermal Spa Treatment

ConditionKnee Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorCEN Biotech

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 greater than or equal to 30.

Signed inform consent.

With health insurance affiliation.

Disqualifiers

Presented with balneotherapy contraindication or to certain adjuvant treatment techniques (balneation, hydrotherapy jets, massage): chronic infectious pathology, active cancer, decompensated cardiac, hepatic or renal insufficiency, "open" leg ulcer, immune deficiency, phlebitis, erysipelas or history of erysipelas, active thrombosis, behavioral disorders, etc.

Presented with chronic pain for reasons other than osteoarthritis: chronic inflammatory rheumatism (rheumatoid arthritis, ankylosing spondylitis, lupus, psoriatic arthritis) or fibromyalgia.

Patient scheduled for knee osteoarthrosis-related surgery within the next 7 months.

Having had spa treatment in the past 6 months whatever the indication or intra-articular corticosteroid injection within the previous 90 days or hyaluronic acid infiltration or other viscosupplementation or platelet-rich plasma (PRP) injection within the previous 6 months.

Trial design

Design model

Single group

Treatments tested in this trial

  • Thermal spa sessions

    Other intervention

    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.

  • Thermal water

    Other intervention

    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).

  • Standard of Care for Knee Osteoarthritis

    Other intervention

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

Treatment groups

76 Participants
are divided into 1 treatment group
Group A: Thermal spa treatmentExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Minimal Clinically Important Improvement (MCII) at 6 months

MCII is defined as a pain reduction of 19.9 mm or more on a 0-100 visual analogic scale (VAS), where 0 means no pain and 100 worse pain. The percentage of patients achieving MCII is calculated and compared with that of the control group in the reference RCT (external comparison).

Time frame
6 months
2

Minimal Clinically Important Improvement (MCII) at 6 months

MCII is defined as a reduction of 9.1 points or more in the function subscale of the Physical function subscale of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) in absence of knee surgery. 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). The percentage of patients achieving MCII is calculated and compared with that of the control group in the reference RCT (external comparison).

Time frame
6 months

Secondary outcomes

1

Change from baseline of pain-related knee osteoarthritis at 20 days

Pain intensity is measured using a 0 (no pain)-100 (Worse pain) Visual Analogic Scale (VAS). Mean variation is compared with that of the control group in the reference RCT (external comparison).

Time frame
Day 1 and 20 days
2

Change from baseline of pain-related knee osteoarthritis at 3 months

Pain intensity is measured using a 0 (no pain)-100 (Worse pain) Visual Analogic Scale (VAS). Mean variation is compared with that of the control group in the reference RCT (external comparison).

Time frame
Day 1 and 3 months
3

Change from baseline of pain-related knee osteoarthritis at 6 months

Pain intensity is measured using a 0 (no pain)-100 (Worse pain) Visual Analogic Scale (VAS). Mean variation is compared with that of the control group in the reference RCT (external comparison).

Time frame
Day 1 and 6 months
4

Change from baseline of the pain subscale of the WOMAC at 20 days

Pain subscale of the WOMAC is a self-administered questionnaire that consists in 5 items: during walking, using stairs, in bed, sitting or lying, and standing upright. The 100-normalized subscale score ranges from 0 (none) to 100 (worse pain limitations). Mean variation is compared with that of the control group in the reference RCT (external comparison).

Time frame
Day 1 and 20 days

Other outcomes

1

Qualitative assessment of participant experience and engagement with the thermal spa treatment

Semi-structured individual interviews are conducted with a subset of participants to explore their level of engagement, lived experience, and perceived benefits of the thermal spa treatment. The interviews also assess facilitators and barriers encountered during participation, as well as any adaptations made by participants, from their own perspective. Interview data are analyzed using qualitative thematic analysis.

Time frame
Day 20

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CEN Biotech

Lead sponsor

Town Hall of Enghien-les-Bains

Collaborator

Source ClinicalTrials.gov
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