NCT07534189

Brief Summary

This study evaluates the effects of a 3-week thermal spa treatment on knee joint movement in patients with knee osteoarthritis. Knee movement fluidity and gait parameters will be analyzed during standardized tasks using wearable inertial sensors (Xsens). Secondary outcomes include changes in pain, physical function, physical activity, quality of life, and blood transcriptomic profiles. Assessments will be performed at baseline, after treatment, and at 3- and 12-month follow-up visits.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
37mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

April 9, 2026

Last Update Submit

April 9, 2026

Conditions

Gonarthrosis

Keywords

Knee osteoarthritisSpa TherapyGait analysisInertial sensorsKinematicsMobilityTranscriptomics

Outcome Measures

Primary Outcomes (1)

  • Comparison of fluidity of knee joint movement

    Knee joint movement fluidity in the sagittal plane will be quantified using the normalized angular jerk derived from inertial motion capture sensors (Xsens) during walking. Higher normalized angular jerk values indicate reduced movement fluidity. The primary analysis will compare the normalized angular jerk between baseline and post-thermal spa treatment assessments.

    Baseline to post-spa (Day 21)

Secondary Outcomes (16)

  • Change in pain intensity measured by Visual Analog Scale (VAS)

    Baseline to post-spa (Day 21)

  • Change in pain intensity measured by Visual Analog Scale (VAS)

    Baseline to 3 months post-spa

  • Change in pain intensity measured by Visual Analog Scale (VAS)

    Baseline to 12 months post-spa

  • Change in osteoarthritis symptoms measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Baseline to post-spa (Day 21)

  • Change in osteoarthritis symptoms measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Baseline to 3 months post-spa

  • +11 more secondary outcomes

Study Arms (1)

Evaluation of the benefits of spa treatment for osteoarthritis of the knees

EXPERIMENTAL

Assessment of the benefits of spa treatment for osteoarthritis of the knees between the start and end of treatment and in the medium to long term (3 and 12 months after treatment)

Device: X-sens sensorOther: TranscriptomicOther: Self-questionnaire

Interventions

X-sens sensorDEVICE

Participants will be equipped with an Xsens wearable motion capture system consisting of eight inertial sensors placed on the feet, shanks, thighs, pelvis, and trunk. Assessments will be conducted before and after the thermal spa treatment and at follow-up visits at 3 and 12 months. Participants will perform standardized functional tasks including level walking (four 20-m round trips), stair ascent and descent (five 15-cm steps), and a chair sit-to-stand task performed without using the hands. Each task, except walking, will be repeated five times. All measurements will be performed under the supervision of a healthcare professional or an adapted physical activity specialist, and movement data will be recorded continuously.

Evaluation of the benefits of spa treatment for osteoarthritis of the knees
TranscriptomicOTHER

Approximately 5 mL of blood will be collected from each participant before and after the thermal spa treatment using RNA-stabilizing tubes. Samples will be pseudonymized using a coded identifier. Total RNA will be extracted and analyzed using transcriptomic approaches (RNA sequencing) to assess gene expression changes associated with the intervention. Differential gene expression analyses will be performed, and selected results may be validated using RT-qPCR

Evaluation of the benefits of spa treatment for osteoarthritis of the knees
Self-questionnaireOTHER

Self-administered questionnaires will be completed at baseline, after the thermal spa treatment, and at 3- and 12-month follow-up visits. These include: pain intensity measured using a Visual Analog Scale (VAS); osteoarthritis symptoms assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC); physical activity level evaluated with the International Physical Activity Questionnaire - Short Form (IPAQ-SF); and health-related quality of life assessed using the 12-Item Short Form Health Survey (SF-12).

Evaluation of the benefits of spa treatment for osteoarthritis of the knees

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 50 years or older
  • Diagnosis of knee osteoarthritis affecting at least one knee, with radiographic Kellgren-Lawrence grade ≥ 2 confirmed by an X-ray performed within the past 3 years
  • Participants scheduled to undergo a 3-week thermal spa treatment at the Balaruc-les-Bains thermal center

You may not qualify if:

  • Active inflammatory joint disease (e.g., rheumatoid arthritis, spondyloarthritis, or crystal-induced arthropathies)
  • Current major depressive episode or psychotic disorders
  • Thermal spa treatment within the previous 6 months
  • Inability to read or write
  • Inability to complete follow-up for the entire study period (e.g., planned relocation, travel, professional commitments, or residence located more than 100 km from the study site)
  • Lack of informed consent
  • Pregnant or breastfeeding women
  • Individuals under legal protection (guardianship or curatorship)
  • Not affiliated with a national health insurance system
  • Individuals under judicial protection (safeguard of justice)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre thermal de Balaruc les Bains

Balaruc-les-Bains, France

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Yves-Marie PERS, MD

    University Hospital, Montpellier

    STUDY DIRECTOR

  • Hugues DESFOUR, MD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yves-Marie PERS, MD

CONTACT

04 67 33 80 74ym-pers@chu-montpellier.fr

Hugues DESFOUR, MD

CONTACT

0467485063Hugues.DESFOUR@thermesbalaruc.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 16, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

July 1, 2029

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations

FR(1)