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NCT Number: NCT07534189

Prospective Cohort Study Evaluating a Thermal Spa Programme in 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.

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Key information

Conditions

Gonarthrosis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

X-sens sensor

Device

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.

Transcriptomic

Other

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-questionnaire

Other

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).

Primary outcomes

  1. Comparison of fluidity of knee joint movement

    Time frame: Baseline to post-spa (Day 21)

    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.

Secondary outcomes

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

    Time frame: Baseline to post-spa (Day 21)

    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.

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

    Time frame: Baseline to 3 months post-spa

    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.

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

    Time frame: Baseline to 12 months post-spa

    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.

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

    Time frame: Baseline to post-spa (Day 21)

    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.

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

    Time frame: Baseline to 3 months post-spa

    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.

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

    Time frame: Baseline to 12 months post-spa

    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.

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

    Time frame: Baseline to post-spa (Day 21)

    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.

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

    Time frame: Baseline to 3 months post-spa

    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.

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

    Time frame: Baseline to 12 months post-spa

    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.

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

    Time frame: Baseline to post-spa (Day 21)

    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.

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

    Time frame: Baseline to 3 months post-spa

    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.

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

    Time frame: Baseline to 12 months post-spa

    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.

  13. Change in gait spatiotemporal and kinematic parameters

    Time frame: Baseline to post-spa (Day 21)

    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.

  14. Change in gait spatiotemporal and kinematic parameters

    Time frame: Baseline to 3 months post-spa

    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.

  15. Change in gait spatiotemporal and kinematic parameters

    Time frame: Baseline to 12 months post-spa

    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.

  16. Differential gene expression in blood transcriptome

    Time frame: Baseline to post-spa (Day 21)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hugues DESFOUR, MD

CONTACT

[email protected]

0467485063 ext. 33

Yves-Marie PERS, MD

CONTACT

[email protected]

04 67 33 80 74 ext. 33

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Centre thermal de Balaruc les Bains

Registry information

Official study title

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

Acronym: THERMOG

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Apr 16, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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