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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A01474-45 | Other Identifier | IDRCB |
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| Name | Class |
|---|---|
| Centre thermal de Balaruc les Bains | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yves-Marie PERS, MD | Contact | 04 67 33 80 74 | 33 | ym-pers@chu-montpellier.fr |
| Hugues DESFOUR, MD | Contact | 0467485063 | 33 | Hugues.DESFOUR@thermesbalaruc.com |
| Name | Affiliation | Role |
|---|---|---|
| Yves-Marie PERS, MD | University Hospital, Montpellier | Study Director |
| Hugues DESFOUR, MD | University Hospital, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre thermal de Balaruc les Bains | Balaruc-les-Bains | France |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| 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 |
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| 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). |
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| Baseline to post-spa (Day 21) |
| 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. | Baseline to 3 months post-spa |
| 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. | Baseline to 12 months post-spa |
| 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. | Baseline to post-spa (Day 21) |
| 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. | Baseline to 3 months post-spa |
| 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. | Baseline to 12 months post-spa |
| 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. | Baseline to post-spa (Day 21) |
| 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. | Baseline to 3 months post-spa |
| 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. | Baseline to 12 months post-spa |
| 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. | Baseline to post-spa (Day 21) |
| 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. | Baseline to 3 months post-spa |
| 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. | Baseline to 12 months post-spa |
| 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. | Baseline to post-spa (Day 21) |
| 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. | Baseline to 3 months post-spa |
| 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. | Baseline to 12 months post-spa |
| 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. | Baseline to post-spa (Day 21) |
| D012216 |
| Rheumatic Diseases |