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NOT YET RECRUITING
NCT07534189
NA

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

Sponsor: University Hospital, Montpellier

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-07-01

Completion Date

2029-07-01

Last Updated

2026-04-16

Healthy Volunteers

No

Conditions

Interventions

DEVICE

X-sens sensor

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.

OTHER

Transcriptomic

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

OTHER

Self-questionnaire

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).

Locations (1)

Centre thermal de Balaruc les Bains

Balaruc-les-Bains, France