NCT07534189

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 aims to evaluate the effects of a 3-week thermal spa treatment on knee joint movement in patients with knee osteoarthritis. Movement analysis will be performed using wearable inertial sensors (Xsens) placed on the lower limbs to quantify kinematic and spatiotemporal gait parameters during standardized functional tasks. The primary outcome will assess changes in knee movement fluidity during walking, quantified using normalized angular jerk in the sagittal plane. Secondary outcomes will include changes in pain intensity, osteoarthritis symptoms, physical activity level, and health-related quality of life assessed using validated questionnaires. In addition, blood samples will be collected before and after the intervention to explore transcriptomic changes associated with the treatment. Assessments will be conducted at baseline, immediately after the spa treatment, and during follow-up visits at 3 and 12 months.

Conditions

• Gonarthrosis

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2026-07-01
• Primary completion: 2028-08-01
• Completion: 2029-07-01
• First posted: 2026-04-16
• Last updated: 2026-04-16

Locations

1 site across 1 country: France