Effectiveness of a 3-week Balneotherapy Program With Mineral Water of Saint Jean d'Angely in Knee Osteoarthritis: A Superiority, Randomised, Controlled Study Versus Standard of Care Alone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 173
- 试验地点
- 2
- 主要终点
- Variation from baseline in physical function subscale of the WOMAC at 6 months
研究概览
简要总结
The goal of this clinical trial is to assess the efficacy of a 18-day balneotherapy program in the rheumatology indication in patients presented with knee osteoarthritis. The main questions of the study aims to answer are how balneotherapy improves functional incapacity and the disorders (pain, joint stiffness) induced by osteoarthritis of the knee, and thus improves patients' quality of life.
Participants are randomly assigned in control or treatment (spa) groups. All receive standard of care for knee osteoarthritis throughout the study. Balneotherapy program consists of 18-days of spa treatment with Mineral Water of Saint Jean d'Angely. Functional incapacity, disorders and quality of life induced were measured at baseline and then 6 months later.
Variation from baseline were compared in control and treatment groups to assess the efficacy of the balneotherapy program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Knee osteoarthritis with Kellgren and Lawrence stage 2 to 4 evidenced by a knee X-ray examination in the past 3 years);
- •100-normalized score of the WOMAC physical function subscale of 30 or greater;
- •Available for balneotherapy program and the 6-month study follow-up;
- •Signed inform consent;
- •with health insurance affiliation.
排除标准
- •Presented with balneotherapy contra-indication;
- •Having had spa treatment in the past 6 months or intra-articular corticosteroid injection within the previous 90 days or hyaluronic acid infiltration within the previous 6 months;
- •Presented with chronic pain other than osteoarthritis, with scheduled surgery related to knee osteoarthritis;
- •regulatory reason (guardianship or already enrolled in a clinical trial).
结局指标
主要结局
Variation from baseline in physical function subscale of the WOMAC at 6 months
时间窗: Baseline (D1) and final (6 months)
Physical function subscale of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a self-administered questionnaire that consists in 17 items: (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties. The 100-normalized subscale score ranges from 0 (none) to 100 (worse functional limitations).
次要结局
- Variation from baseline in pain-induced knee osteoarthritis intensity at 6 months(Baseline (D1) and final (6 months))
- Variation from baseline in pain subscale of the WOMAC at 3 months(Baseline (D1) and final (3 months))
- Variation from baseline in pain subscale of the WOMAC at 6 months(Baseline (D1) and final (6 months))
- Variation from baseline in WOMAC total score at 3 months(Baseline (D1) and final (3 months))
- Variation from baseline in pain-induced knee osteoarthritis intensity at 3 months(Baseline (D1) and final (3 months))
- Number of participants achieving minimal clinically important improvement (MCII) at 6 months(6 months)
- Number of participants achieving minimal clinically important improvement (MCII) at 3 months(3 months)
- Variation from baseline in stiffness subscale of the WOMAC at 6 months(Baseline (D1) and final (6 months))
- Number of participants presented with acceptable symptom state (ASS) at 3 months(3 months)
- Changes in participants quality of life at 6 months(6 months)
- Frequency of adverse events throughout the study(From inclusion to the final visit at 6 months)
- Variation from baseline in physical function subscale of the WOMAC at 3 months(Baseline (D1) and final (3 months))
- Variation from baseline in stiffness subscale of the WOMAC at 3 months(Baseline (D1) and final (3 months))
- Variation from baseline in WOMAC total score at 6 months(Baseline (D1) and final (6 months))
- Number of participants presented with acceptable symptom state (ASS) at 6 months(6 months)
- Changes in participants quality of life at 3 months(3 months)
- Participants' opinion with their symptoms related to knee osteoarthritis at 6 months(6 months)