About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
X-sens sensor
DeviceParticipants 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 interventionApproximately 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 interventionSelf-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).
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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University Hospital, Montpellier
Lead sponsor
Centre thermal de Balaruc les Bains
Collaborator
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