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临床试验/NCT00904527
NCT00904527已完成不适用

Interest of Relaxation From Patients With Pain Due to Migraine

Centre Hospitalier Universitaire de Saint Etienne18 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2006年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
18
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

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (18)

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