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GonarthrosisTHERMOGNCT07534189

Prospective Cohort Study Evaluating a Thermal Spa Programme in Symptomatic Knee Osteoarthritis

A study testing X-sens sensor, Transcriptomic and Self-questionnaire in people with Gonarthrosis, run by University Hospital, Montpellier at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Knee osteoarthritis is a common cause of pain, functional limitation, and reduced quality of life in older adults. Thermal spa treatment is widely used as a non-pharmacological intervention for the management of osteoarthritis symptoms, but its effects on joint movement and motor control remain insufficiently… Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Gonarthrosis
What is being tested?
X-sens sensor, Transcriptomic and Self-questionnaire
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteFrance
Study dates
1 Jul 2026to 1 Jul 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Average knee pain intensity > 30 mm on a 100-mm Visual Analog Scale (VAS) during the month prior to inclusion
  • Participants scheduled to undergo a 3-week thermal spa treatment at the Balaruc-les-Bains thermal center

Who cannot join

  • Use of systemic or injectable corticosteroids within 1 month prior to inclusion
  • Intra-articular injection of hyaluronic acid or platelet-rich plasma (PRP) within the 3 months prior to inclusion
  • 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
Show all 13Show fewer
  • 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)
  • Participation in another clinical study with an ongoing exclusion period

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site
  • Centre thermal de Balaruc les Bains

    Balaruc-les-Bains

    Hugues DESFOUR, MD, 04 67 33 80 74 ext. 33, Hugues.DESFOUR@thermesbalaruc.com

Other trials in France

About this study

Official title: Prospective Cohort Study Evaluating a Thermal Spa Programme for the Management of Symptomatic Knee Osteoarthritis

Knee osteoarthritis is a common cause of pain, functional limitation, and reduced quality of life in older adults. Thermal spa treatment is widely used as a non-pharmacological intervention for the management of osteoarthritis symptoms, but its effects on joint movement and motor control remain insufficiently characterized using objective biomechanical measures. 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. In addition, blood samples will be collected before and after the intervention to explore transcriptomic changes associated with the treatment.

This project proposes a combination of innovative kinematic and biological biomarkers with the aim of objectively describing the benefits of spa therapy for people with knee osteoarthritis.

Conditions
Gonarthrosis
Being tested
X-sens sensor, Transcriptomic, Self-questionnaire
Keywords
Knee osteoarthritis, Spa Therapy, Gait analysis, Inertial sensors, Kinematics, Mobility, Transcriptomics
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • TranscriptomicOther

    Approximately 8.5 mL of blood will be collected from each participant before and after the thermal spa treatment. 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

  • 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).

Study groups in NCT07534189
Study groupRoleWhat they receive
Evaluation of the benefits of spa treatment for osteoarthritis of the kneesExperimentalAssessment 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)
Receives: Device: X-sens sensor; Other: Transcriptomic; Other: Self-questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to post-spa (Day 21)

Secondary outcomes (16)
  1. Change in pain intensity measured by Visual Analog Scale (VAS)

    Pain intensity over the previous 48 hours measured using a 100-mm Visual Analog Scale (VAS). The VAS is a continuous scale ranging from 0 to 100 mm, where 0 represents no pain and 100 represents the worst imaginable pain.

    Higher scores indicate greater pain severity. The outcome measure corresponds to the change in VAS score from baseline to follow-up assessments.

    Measured: Baseline to post-spa (Day 21)

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

    Pain intensity over the previous 48 hours measured using a 100-mm Visual Analog Scale (VAS). The VAS is a continuous scale ranging from 0 to 100 mm, where 0 represents no pain and 100 represents the worst imaginable pain.

    Higher scores indicate greater pain severity. The outcome measure corresponds to the change in VAS score from baseline to follow-up assessments.

    Measured: Baseline to 3 months post-spa

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

    Pain intensity over the previous 48 hours measured using a 100-mm Visual Analog Scale (VAS). The VAS is a continuous scale ranging from 0 to 100 mm, where 0 represents no pain and 100 represents the worst imaginable pain.

    Higher scores indicate greater pain severity. The outcome measure corresponds to the change in VAS score from baseline to follow-up assessments.

    Measured: Baseline to 12 months post-spa

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

    Osteoarthritis symptoms assessed using the WOMAC questionnaire including the total score and subscales : (pain, stiffness, and physical function). Scores range from 0 to 100, where 0 represents no symptoms and 100 represents maximum pain, stiffness, and functional limitation. Higher scores indicate worse clinical status. The outcome measure corresponds to changes in WOMAC scores from baseline to follow-up assessments.

    Measured: Baseline to post-spa (Day 21)

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

    Osteoarthritis symptoms assessed using the WOMAC questionnaire including the total score and subscales : (pain, stiffness, and physical function). Scores range from 0 to 100, where 0 represents no symptoms and 100 represents maximum pain, stiffness, and functional limitation. Higher scores indicate worse clinical status. The outcome measure corresponds to changes in WOMAC scores from baseline to follow-up assessments.

    Measured: Baseline to 3 months post-spa

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

    Osteoarthritis symptoms assessed using the WOMAC questionnaire including the total score and subscales : (pain, stiffness, and physical function). Scores range from 0 to 100, where 0 represents no symptoms and 100 represents maximum pain, stiffness, and functional limitation. Higher scores indicate worse clinical status. The outcome measure corresponds to changes in WOMAC scores from baseline to follow-up assessments.

    Measured: Baseline to 12 months post-spa

  7. Change in physical activity level measured by the International Physical Activity Questionnaire - Short Form

    Physical activity level assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF) questionnaire. IPAQ-SF estimate frequency and duration of walking, moderate, and vigorous activities over the past 7 days: the time spent doing physical activities (intense and moderate), the time spent walking and the time spent sitting. Responses were converted into MET-minutes per weekby multiplying the minutes of daily activity by an activity coefficient (3.3 for walking, 4 for intense physical activity and 8 for moderate). Higher scores indicating greater levels of physical activity. Participants were categorized as having low (<600), moderate (≥600), or high (≥3000 MET-min/week) activity levels.

    Measured: Baseline to post-spa (Day 21)

  8. Change in physical activity level measured by the International Physical Activity Questionnaire - Short Form

    Physical activity level assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF) questionnaire. IPAQ-SF estimate frequency and duration of walking, moderate, and vigorous activities over the past 7 days: the time spent doing physical activities (intense and moderate), the time spent walking and the time spent sitting. Responses were converted into MET-minutes per weekby multiplying the minutes of daily activity by an activity coefficient (3.3 for walking, 4 for intense physical activity and 8 for moderate). Higher scores indicating greater levels of physical activity. Participants were categorized as having low (<600), moderate (≥600), or high (≥3000 MET-min/week) activity levels.

    Measured: Baseline to 3 months post-spa

  9. Change in physical activity level measured by the International Physical Activity Questionnaire - Short Form

    Physical activity level assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF) questionnaire. IPAQ-SF estimate frequency and duration of walking, moderate, and vigorous activities over the past 7 days: the time spent doing physical activities (intense and moderate), the time spent walking and the time spent sitting. Responses were converted into MET-minutes per weekby multiplying the minutes of daily activity by an activity coefficient (3.3 for walking, 4 for intense physical activity and 8 for moderate). Higher scores indicating greater levels of physical activity. Participants were categorized as having low (<600), moderate (≥600), or high (≥3000 MET-min/week) activity levels.

    Measured: Baseline to 12 months post-spa

  10. Change in health-related quality of life measured by the 12-Item Short Form Health Survey (SF-12)

    Health-related quality of life assessed using the SF-12 questionnaire. Scores range from 0 to 100, with higher scores indicating better health-related quality of life. The outcome measure corresponds to changes in SF-12 scores from baseline to follow-up assessments.

    Measured: Baseline to post-spa (Day 21)

  11. Change in health-related quality of life measured by the 12-Item Short Form Health Survey (SF-12)

    Health-related quality of life assessed using the SF-12 questionnaire. Scores range from 0 to 100, with higher scores indicating better health-related quality of life. The outcome measure corresponds to changes in SF-12 scores from baseline to follow-up assessments.

    Measured: Baseline to 3 months post-spa

  12. Change in health-related quality of life measured by the 12-Item Short Form Health Survey (SF-12)

    Health-related quality of life assessed using the SF-12 questionnaire. Scores range from 0 to 100, with higher scores indicating better health-related quality of life. The outcome measure corresponds to changes in SF-12 scores from baseline to follow-up assessments.

    Measured: Baseline to 12 months post-spa

  13. Change in gait spatiotemporal and kinematic parameters

    Spatiotemporal and kinematic gait parameters measured using wearable inertial sensors during standardized walking tasks. The outcome measure corresponds to changes in gait parameters between baseline and follow-up assessments.

    Measured: Baseline to post-spa (Day 21)

  14. Change in gait spatiotemporal and kinematic parameters

    Spatiotemporal and kinematic gait parameters measured using wearable inertial sensors during standardized walking tasks. The outcome measure corresponds to changes in gait parameters between baseline and follow-up assessments.

    Measured: Baseline to 3 months post-spa

  15. Change in gait spatiotemporal and kinematic parameters

    Spatiotemporal and kinematic gait parameters measured using wearable inertial sensors during standardized walking tasks. The outcome measure corresponds to changes in gait parameters between baseline and follow-up assessments.

    Measured: Baseline to 12 months post-spa

  16. Differential gene expression in blood transcriptome

    Differential gene expression in blood samples analyzed using transcriptomic approaches to identify genes modulated by the intervention. Gene expression profiles will be compared between baseline and post-treatment assessments.

    Measured: Baseline to post-spa (Day 21)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion1 Aug 2028 (estimated)
  4. Study completion1 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07534189
Sponsor's protocol ID
RECHMPL25_0061
Other IDs
2025-A01474-45
Acronym
THERMOG
Status last verified
Jun 2026
First submitted
9 Apr 2026
Last updated
15 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing X-sens sensor, Transcriptomic and Self-questionnaire in people with Gonarthrosis, run by University Hospital, Montpellier at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yves-Marie PERS, MD (04 67 33 80 74 ext. 33, ym-pers@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of fluidity of knee joint movement (time frame: Baseline to post-spa (Day 21)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026; AzTrials last refreshed its copy on 29 Oct 2026.

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