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Knee Osteoarthritis and Thermal Spa Treatment

Study acronym: ENERGIE
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Enrollment closed, study ongoing Show 4 more changesShow less
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 22 of 23 entries
    • Site details revised at 2 of 2 sites
    • Publications: details revised at 1 of 1 entry
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    • Start date changed from estimate of Feb 9, 2026 to Jan 27, 2026
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07370480
Lead Sponsor CEN Biotech
Collaborators: Town Hall of Enghien-les-Bains
Conditions
(from sponsor)
Knee Osteoarthritis
Related terms Osteoarthritis, Knee
Enrollment 76 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov