Follow-up of Osteo-articular Biomarkers After Spa Therapy at Dax in a Population With Knee Osteoarthritis and Their Correlation With the Clinical Evolution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Describe the change of serum level of Hyaluronic acid (a marker of synovial inflammation)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient with knee osteoarthritis defined according to the recommendations of the American College of Rheumatology (ACR):
- •painful articulation and at least one of the following three criteria: age > 50 years and/or articular crepitation and/or morning stiffness less than 30min
- •and radiographic sign of gonarthrosis with osteophyte (on X-rays of less than 3 years).
- •Patient can come to the final visit at 6 months and living within a perimeter of 30km around Dax.
- •Patient affiliated to a social security scheme.
排除标准
- •Osteoarthritis limited to patellofemoral joint.
- •A previous spa therapy of less than 6 months.
- •Spa therapies with double indication rheumatology and phlebology.
- •Patient with osteoporosis.
- •A known hepatocellular failure or known acute or end-stage renal failure.
- •Severe depressive syndrome, psychotic syndrome, immune deficiency, cardiopathy, evolutive neoplasia or infection.
- •Infiltration and/or viscosupplementation < 6 months.
- •Change in anti-osteoarthritis treatment of less than 3 months.
- •Patient under tutorship or curatorship.
结局指标
主要结局
Describe the change of serum level of Hyaluronic acid (a marker of synovial inflammation)
时间窗: 6 months (timepoint: at Day 0, Week 3 and month 6)
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).
次要结局
- Index of symptomatic severity of knee osteoarthritis or WOMAC(6 months (timepoint: at Day 0, Week 3 and month 6))
- Marker of cartilage degradation: Coll2-1(6 months (timepoint: at Day 0, Week 3 and month 6))
- Marker of bone resorption: CTX1(6 months (timepoint: at Day 0, Week 3 and month 6))
- Pain evaluation Visual Analogue Scale(6 months (timepoint: at Day 0, Week 3 and month 6))
- SF 36 Quality of Life Questionnaire(6 months (timepoint: at Day 0, Week 3 and month 6))
- Global clinical evaluation with kne flexion and joint swelling(6 months (timepoint: at Day 0, Week 3 and month 6))