Evaluation of Spa Therapy in the Treatment of Fibromyalgia : a Randomized, Controlled, Open Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 10
- 主要终点
- Handicap in everyday life
研究概览
简要总结
Fibromyalgia is a common health problem that causes widespread pain and tenderness (sensitive to touch). The pain and tenderness tend to come and go, and move about the body. There is no cure for fibromyalgia. Complementary and alternative therapy such as acupuncture, chiropractic and massage therapy, can be useful to manage fibromyalgia symptoms. Many of these treatments have not been well tested in patients with fibromyalgia. Fibromyalgia affect 3 to 4% of the general population and 14 % of patients with rheumatologic disease. Fibromyalgia is most common in women 90 % in many studies. It most often starts in middle adulthood. A chronic evolution occured for Fibromyalgic patients with a major alteration of quality of life.
Thermalgi is a randomized, multicentre, open label trial wich aims to evaluate the effects of spa therapy in rheumatologia on evolution of disability in daily life of patients with fibromyalgia.
详细描述
THERMALGI is a controlled, randomized, multicentre, open label trial wich aims to evaluate the effects of spa therapy in rheumatologia on evolution of disability in daily life of patients with fibromyalgia.
Patients with fibromyalgia (American College of Rheumatology Criteria) and a FIQ score (Fibromyalgia Impact Questionnaire) > 39 will be randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •both sexes, more than 18 years old patients
- •available for a spa treatment in rheumatology during 18 days (immediate or late spa) and a follow-up period of 12 months
- •with fibromyalgia ( ACR criteria 2010) for at least 1 year and with a stable treatment for at least 3 months
- •with a FIQ score > or = 39 (fibromyalgia moderate to severe)
- •voluntary to participate to the study, informed consent form signed after appropriate information
- •affiliation to the social security system or equivalent
排除标准
- •contra-indication of spa treatment (cancer in progress, psychiatrics disorders, immunodeficiency)
- •no previous spa treatment in rheumatology within 1 year prior to inclusion
- •substantial variation of the therapeutic coverage in the previous 3 months the inclusion (change of medicinal class, starting up of a réentrainement in the effort or a cognitivio-behavioral technique)
- •subject with an other chronic severe disease (severe asthma, severe cardiac insuffisiancy, respiratory, renal or liver failures, evolutive rheumatic disease, inflammatory colitis...)
- •subject participating to an other clinical study inerventionnal
- •pregnancy, parturient or breast feeding
- •no psychiatric illness or social situation that would preclude study compliance
结局指标
主要结局
Handicap in everyday life
时间窗: 6 months
Decrease of 14% (success rate) of FIQ questionnaire at 6 months compare to baseline
次要结局
- Fatigue(at baseline, 3, 6, 9 and 12 months)
- Depression(at baseline, 3, 6, 9 and 12 months)
- Ability to cope(at baseline, 6 and 12 months)
- Physical activity(at baseline, 3, 6, 9 and 12 months)
- Pain evolution(at baseline, 3, 6, 9 and 12 months)
- Quality of life(at baseline, 3, 6, 9 and 12 months)
- Sleep quality(at baseline, 3, 6, 9 and 12 months)
- Objective sleep quality(at baseline, 3, and 6 months)
- Medico economic impact(at baseline, 3, 6, 9 and 12 months)
- Objective physical activity(at baseline, 3, and 6 months)