Evaluation of the Efficiency of a Therapeutic Education Program in Standardized Thermal Cure for Fibromyalgia Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Change in quality of life
研究概览
简要总结
The study evaluates the efficiency, in terms of quality of life improvement, of a patient's therapeutic education program (ETP), based on long term commitment in adapted physical activities carried out during a standardized thermal cure (CTS) for fibromyalgia among patients continuing regular drug treatment or not
详细描述
Fibromyalgia is a poorly known and understood disease. Patients suffer from pain, fatigue, sleep disorders, anxiety, depression, preventing them from moving and going out, resulting in an alteration of social life. Multiple drugs treatment is frequently used but is burdensome and poorly effective. However, thermal cure proved efficacious to improve quality of life during the cure and beyond. This study aims at demonstrating the added value of a patient's therapeutic education program provided during a thermal cure, a moment where patients are available and receptive to guidance.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnostic of fibromyalgia done at least 6 months before thermal cure
- •Diagnostic of fibromyalgia confirmed by FIRST questionnaire (score 5) during the initial thermal checkup
- •Age between 18 and 65 years
- •Access to an Internet connection during remote follow-up
- •Affiliation to a social security system (recipient or assignee)
- •Signed written inform consent form
排除标准
- •Infectious diseases with ongoing treatment (except for winter upper respiratory tract pathologies)
- •Active tumorous pathology
- •Concomitant inflammatory rheumatism
- •Stage III chronic venous insufficiency with history of phlebitis and/or pulmonary embolism
- •Incapacity to receive treatment in hot water ( ≥36°)
- •Total incapacity to practice physical activities of therapeutic education program
- •Ongoing pregnancy
- •Involvement in a structured educational program specific to fibromyalgia during the previous year
- •Incapacity to understand French language making the follow up impossible
结局指标
主要结局
Change in quality of life
时间窗: Month 06 after cure completion
Change from baseline in quality of life assessed through the self-administered Fibromyalgia Impact Questionnaire (FIQ) month 06 after cure completion.
次要结局
- Pain intensity(Week 03, Month 03, Month 06, Month 12)
- Function impairment(Week 03, Month 03, Month 06, Month 12)
- Responder rate(Week 03, Month 03, Month 06, Month 12)
- Somnolence(Week 03, Month 03, Month 06, Month 12)
- Serious adverse reactions (SARs)(Day 00 to Month 12)
- non-drug treatment consumption(Day 00, Week 03, Month 03, Month 06, Month 12)
- Kinesiophobia index(Week 03, Month 03, Month 06, Month 12)
- Anxiety and depression(Week 03, Month 03, Month 06, Month 12)
- drug consumption(Day 00, Week 03, Month 03, Month 06, Month 12)
- Thermal outbreaks(Day 00 to Week 03)
- Change in quality of life(Week 03, Month 03, Month 12)
- Pain relief(Week 03, Month 03, Month 06, Month 12)
- Catastrophizing index(Week 03, Month 03, Month 06, Month 12)
- Fatigue(Week 03, Month 03, Month 06, Month 12)
- Fibromyalgia outbreaks(Week 03 to Month 12)