An interventional study of Blood collection arm in Knee Osteoarthritis, sponsored by Ch Mont de Marsan. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-03.
Sponsored by Ch Mont de Marsan · Not applicable, Interventional, and Other
Spa therapy is used in the treatment of various diseases and mainly osteoarthritis. Knee osteoarthritis is a very common rheumatic disease whose prevalence increases with longer life span and is a public health problem.
The Forestier and al. study highlighted the actual benefit and confirmed the improvement of the quality of life and pain of the knee osteoarthritis patients from 6 months of spa treatment.[1] A significant decrease of 30% in the rate of Serum Hyaluronic Acid at 6 months after the end of the spa therapy was also highlighted in the Canteloup et al study.[6] This study aims to measure different osteoarticular biomarkers (hyaluronic acid, coll2-1 and CTX1) before, at the end of the spa therapy and 6 months after the spa therapy and correlate with the clinical evaluation.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 37 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Ch Mont de Marsan is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient with knee osteoarthritis defined according to the recommendations of the American College of Rheumatology (ACR):
Exclusion Criteria:
Blood collection will be performed before the spa therapy (Day 0), at the end of the spa therapy (Week 3) and 6 months later (M6).
Biological: Blood collection arm
Blood collection will be performed before the spa therapy (Day 0), at the end of the spa therapy (Week 3) and 6 months later (M6). In this study, blood samples will be collected by a nurse of the service and centralized by the laboratory of Medical Biology of the General hospital of Dax.
Describe the change of serum level of Hyaluronic acid (a marker of synovial inflammation)
Measure of serum level of Hyaluronic acid before the spa therapy (Day 0), at the end of the spa therapy (Week 3) and 6 months later (M6).
Time frame: 6 months (timepoint: at Day 0, Week 3 and month 6)
Marker of cartilage degradation: Coll2-1
Measure of biological marker of cartilage degradation (Coll2-1) before the spa therapy (Day 0), at the end of the spa therapy (Week 3) and 6 months later (M6).
Time frame: 6 months (timepoint: at Day 0, Week 3 and month 6)
Marker of bone resorption: CTX1
Measure of biological marker of bone resorption (CTX1) before the spa therapy (Day 0), at the end of the spa therapy (Week 3) and 6 months later (M6).
Time frame: 6 months (timepoint: at Day 0, Week 3 and month 6)
Index of symptomatic severity of knee osteoarthritis or WOMAC
Patients will have been asked to answer symptom questionnaire (WOMAC) before the spa therapy (Day 0), at the end of the spa therapy (Week 3) and 6 months later (M6). It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items) and Physical Function (17 items). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.
Time frame: 6 months (timepoint: at Day 0, Week 3 and month 6)
Pain evaluation Visual Analogue Scale
Patients will have been asked to answer pain questionnaire (EVA) before the spa therapy (Day 0), at the end of the spa therapy (Week 3) and 6 months later (M6). The EVA is in the form of a 10 cm plastic strip graduated in mm. On the face presented to the patient, there is a cursor which he mobilizes along a straight line, one end of which corresponds to "No pain", and the other to "Maximum pain imaginable". The patient must, along this line, position the cursor at the place that best locates his pain. On the other side, there are millimeter graduations seen only by the caregiver. The position of the cursor mobilized by the patient makes it possible to read the intensity of the pain, which is measured in mm.
Time frame: 6 months (timepoint: at Day 0, Week 3 and month 6)
SF 36 Quality of Life Questionnaire
Patients will have been asked to answer and quality of life questionnaire (SF-36) before the spa therapy (Day 0), at the end of the spa therapy (Week 3) and 6 months later (M6). There are 11 questions in SF-36, with 36 items in total. The SF-36 items are divided into 8 different areas: Physical component (4 areas: Physical activity, Limitations due to physical condition, Physical pain, Perceived health) and Mental component (4 areas: Life and relationships with others , Psychic health, Limitations due to mental state, Vitality). It is requested to respond according to the last 4 weeks. The rating system recommended for the SF-36 is a weighted Likert system for each item. The items in the subscales are totaled in order to obtain a summary score for each subscale or dimension. Each of the 8 summary scores is linearly transformed on a scale of 0 (negative for health) to 100 (favorable for health) to obtain a score for each subscale.
Time frame: 6 months (timepoint: at Day 0, Week 3 and month 6)
Global clinical evaluation with kne flexion and joint swelling
A global clinical evaluation done with evaluation of different exams: Knee flexion (in degrees), joint swelling (measuring the perimeter of the joint (in cm)) before the spa therapy (Day 0), at the end of the spa therapy (Week 3) and 6 months later (M6).
Time frame: 6 months (timepoint: at Day 0, Week 3 and month 6)
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Ch Mont de Marsan