NCT00715195已完成不适用
Evaluation of Improving Quality of Life of Fibromyalgia Patients Treated With a Plurifocal Program : a Controlled Study With 12 Months Monitoring.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Score of the Fibromyalgia Impact Questionnaire, at one month and twelve months after program end
研究概览
简要总结
Comparison of two treatments of fibromyalgia; the QOL score should improve rather and, twelve months after the end of the program, remain higher in "Plurifocal educational group" than in control group
详细描述
Comparing two forms of non-drug treatment of fibromyalgia: "Information" (an information group session on the fibromyalgia management modalities) versus "Plurifocal educational program " (intensive group program of 8 weeks, including, in addition to the briefing, measures and exercises for the implementation of the principles of managing fibromyalgia, and cognitive-behavioral therapy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Fibromyalgia Patients according to the criteria of the American College of Rheumatology defined by:
- •diffuse pain evolving for over three months
- •pain on palpation of at least 11 of the 18 sites listed
- •age between 18 and 65
- •FIQ Score higher than 35/100 at inclusion
- •Ability to respond to questionnaires
- •monitoring possibility for at least a year
- •Affiliation to the French Health System (social security)
排除标准
- •Association with chronic pain from other sources which can interfere with fibromyalgia assessment
- •Inability to follow the full educational program
- •previous participation in an educational program of same nature
- •psychological disorder (personality disorder or behaviour, schizophrenia), preventing participation in the program group
结局指标
主要结局
Score of the Fibromyalgia Impact Questionnaire, at one month and twelve months after program end
时间窗: one month and twelve months after program end
次要结局
- Pain Numeric scale,Number of tender points, Sleep quality numeric scale,Pain Impact Questionnaire ANAES,STAI-Y anxiety questionnaire,Beck Depression Index II,Coping Strategy Questionnaire,Multidimensional self-assessment(SF36, PSOCQ)(one , six and twelve months after program end)
研究者
研究点 (2)
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