NCT01628822已完成3 期
Pilot Study, Prospective, Single Center,Randomized, Single Blind, Evaluating the Efficacy of Relaxation to 12 Weeks Against Placebo, in the Overall Care Chronic Pain in Patients With Fibromyalgia
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- scores on Fibromyalgia Impact Questionnaire (FIQ)
研究概览
简要总结
The main objective of this protocol is to measure the improvement of the overall situation of patients with diffuse chronic pain or fibromyalgia to 12 weeks by non-drug treatment relaxation.
Secondarily,is to evaluate the evolution of physical variables, psychological and social improvement of the quality of life. To evaluate the evolution of drug consumption
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Men or women over 18 years
- •established diagnosis of fibromyalgia as defined by the American College of Rheumatology: widespread pain and eleven tender points at 18 sites listed (ACR, 1990)
- •EVA ≥ 4 (on a scale of 10 cm)
- •no change in treatment for 15 days, except for treatment "on demand" or "rescue"
- •patient has given its written consent
- •patient wishing to benefit from relaxation sessions
- •people who can meet the self-assessment and hetero-assessment
- •people with a social security number
排除标准
- •any painful situation that cannot be distinguished from fibromyalgia pain by the patient
- •patients untreated or treated for less than a month
- •patient with psychosis or severe depression or severe anxiety or impulsivity characterized, at the discretion of the clinician.
- •patients receiving benzodiazepines at the request
- •patient with deafness
- •patient after a body treatment using a relaxation method, relaxation therapy or hypnosis
结局指标
主要结局
scores on Fibromyalgia Impact Questionnaire (FIQ)
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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