Interest of Relaxation From Patients With Pain Due to Migraine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 9
- 主要终点
- Comparison of reduction of migraine frequency between the 2 groups (with or without relaxation)
研究概览
简要总结
The purpose of this study is to determine whether relaxation (autogenic training of Schultz) is effective in treatment for migraine.
详细描述
This randomized, multicenter study compares 2 parallel groups of patients with migraine :
- I: patients are treated with relaxation + medical treatment (beta-bloquant or Oxetorone)+ patients' education
- II: patients are treated only with medical treatment + patients' education.
Visit 1 : 1 month before randomization for patient's selection and baseline data
Visit 2 (J0): inclusion (randomization) During the first 2 months patients from group I benefit from relaxation consultations.
Visit 3 (2 months after randomization)and visit 4 (4 months after randomization) : evaluation of the efficacy of the two treatment strategies.
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
- 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
- •age > 18 years
- •5 to 14 days of migraines per month
排除标准
- •Headache by medication abuse
- •Patients who already know relaxation technics
- •Depression
- •Contra indication of using beta-bloquant or Oxetorone
研究组 & 干预措施
Relaxation
Relaxation (Schultz)+ medical treatment (beta-bloquant or Oxetorone)+ patient's education
干预措施: relaxation (Schultz) (Behavioral)
without relaxation
Patients have no relaxation (only medical treatment+ education)
结局指标
主要结局
Comparison of reduction of migraine frequency between the 2 groups (with or without relaxation)
时间窗: 4 months
次要结局
- Comparison between the 2 groups of intensity of migraine, medication use and quality of life(4 months)