Evaluation of the Efficacy of the Osteo-Fluidic-sensitive (OFS) Versus Placebo Method in the Management of Frequent Episodic Tension-type Headache. Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- numbers of days with headaches
研究概览
简要总结
The hypothesis of the study is the Osteo-fluidic-Senstive is effective for lowering headache pains (Reduction of the number of days of headaches per month) for patients having frequent episodic tension-type headache. The OFS method will improve quality of life and will reduce the consumption of crisis treatments.
Compare the efficacy of the Osteo-Fluidic-Sensitive method versus a placebo method on patients with tension type headache for the reduction of the number of days of headaches per month after 3 months of treatment at Centre Hospitalier Universitaire de Poitiers.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 and 75 years' old
- •Person having highly frequent episodic tension type headache (between 2 and 14 days of headaches per month) associated or not to headache with characteristic of a migraine per International Classification of Headache Disorders 3rd edition criteria
- •Person who completed his headache agenda the month before the study.
- •Patient who understands and accepts the effects of the study
- •Signed consent
- •Person with health insurance coverage
排除标准
- •Person having secondary or primary headaches (chronic tension type headache, migraines only, Cluster headaches, Neuralgias ...)
- •Person on treatment of venlafaxine, gabapentine, duloxetine, clomipramine et toxine botulique.
- •Concomitant participation to another clinical research
- •Pregnant or lactating women, women of child-bearing age who do not have effective contraception.
- •People with reinforced protection (juvenile), people deprived of liberty per justice or administrative decision, people living in a sanitary and social establishment, adults under legal protection and people in critical medical conditions
研究组 & 干预措施
Osteo-Fluidic-Sensitive method
干预措施: Osteo fluidic Sensitive méthod (Other)
Placebo method
干预措施: Placebo method (Other)
结局指标
主要结局
numbers of days with headaches
时间窗: one month
The main criteria for the study will be the difference of the number of days with headaches evaluated based on a calendar of headaches between the month prior to the beginning of the treatment and the month following the last session (1st month).
次要结局
未报告次要终点