Prospective Cohort Study Evaluating a Thermal Spa Programme for the Management of Symptomatic Knee Osteoarthritis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Comparison of fluidity of knee joint movement
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Evaluation of the benefits of spa treatment for osteoarthritis of the knees
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)
Intervention: Self-questionnaire (Other)
Evaluation of the benefits of spa treatment for osteoarthritis of the knees
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)
Intervention: X-sens sensor (Device)
Evaluation of the benefits of spa treatment for osteoarthritis of the knees
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)
Intervention: Transcriptomic (Other)
Outcomes
Primary Outcomes
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
- Change in pain intensity measured by Visual Analog Scale (VAS)(Baseline to post-spa (Day 21))
- Change in pain intensity measured by Visual Analog Scale (VAS)(Baseline to 3 months post-spa)
- Change in pain intensity measured by Visual Analog Scale (VAS)(Baseline to 12 months post-spa)
- Change in osteoarthritis symptoms measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Baseline to post-spa (Day 21))
- Change in osteoarthritis symptoms measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Baseline to 3 months post-spa)
- Change in osteoarthritis symptoms measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Baseline to 12 months post-spa)
- Change in physical activity level measured by the International Physical Activity Questionnaire - Short Form (IPAQ-SF)(Baseline to post-spa (Day 21))
- Change in physical activity level measured by the International Physical Activity Questionnaire - Short Form (IPAQ-SF)(Baseline to 3 months post-spa)
- Change in physical activity level measured by the International Physical Activity Questionnaire - Short Form (IPAQ-SF)(Baseline to 12 months post-spa)
- Change in health-related quality of life measured by the 12-Item Short Form Health Survey (SF-12)(Baseline to post-spa (Day 21))
- Change in health-related quality of life measured by the 12-Item Short Form Health Survey (SF-12)(Baseline to 3 months post-spa)
- Change in health-related quality of life measured by the 12-Item Short Form Health Survey (SF-12)(Baseline to 12 months post-spa)
- Change in gait spatiotemporal and kinematic parameters(Baseline to post-spa (Day 21))
- Change in gait spatiotemporal and kinematic parameters(Baseline to 3 months post-spa)
- Change in gait spatiotemporal and kinematic parameters(Baseline to 12 months post-spa)
- Differential gene expression in blood transcriptome(Baseline to post-spa (Day 21))