Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Headache Intensity
研究概览
简要总结
This study recruits 30 subjects into three groups, including two experimental groups and one control group. The two experimental groups receive acupuncture treatment for 4 weeks and two times functional magnetic resonance imaging scans as well as clinical symptom assessments. The control group receive one scan without any intervention. The aim of this study is to find the whether the effect of acupuncture treatment have diversity among migraineurs with different disease course.
详细描述
This study recruits 10 patients with long course (> 5 years) without aura migraine, 10 patients with short course (< 5 years) without aura migraine and 10 healthy volunteers who meet the inclusion and exclusion criteria. Among the study, two migraine patient groups receive acupuncture treatment for 4 weeks, the frequency is 30 minutes each time, three times a week. According to the national standard of the people's Republic of China (GB / T 12346-2006) acupoint name and location, the acupuncture treatment includes SJ23 (Si Zhu Kong, unilateral), GB8 (Shuai Gu, unilateral), EX-HN5 (Tai Yang, unilateral), GB20 (Feng Chi, unilateral), LI4 (He Gu, bilateral), GB41 (Zu Lin Qi, bilateral), GB34 (Yang Ling Quan, bilateral) and SJ5 (Wai Guan, bilateral) acupoints. Both migraine patients receive scan in functional magnetic resonance imaging (Siemens 3.0T superconducting magnetic resonance scanner, Germany) and symptom scale assessment before the first acupuncture stimulation and post the last acupuncture stimulation. Healthy volunteers receive only one scanning without intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fitting to the standard of migraine without aura in the international classification of headache disease (ICHD-2) issued by the international headache society in
- •Age from 18 to 55, male or female, with right-handedness.
- •Having no depression or other serious mental illness.
- •Having no psychoactive drugs taken in the past 3 months, or vasoactive drugs in the past 2 weeks.
- •Having no habit of taking analgesics from a long time.
排除标准
- •Having the first headache attack of migraine after 55 years old.
- •Having a history of head injury, cluster headache, or other unclassified headaches.
- •Taking medicine to prevent migraine in recent 4 weeks.
- •Having the serious asymmetry or definite pathological changes in the anatomical structure of the head through the MRI scan.
- •Cannot hold on the times of the MRI scan.
结局指标
主要结局
Headache Intensity
时间窗: Change from Visual Analogue Scale at 1 months.
The headache intensity is measured by the value of Visual Analogue Scale which limits 1 to 10. The higher value of this scale represents the worse headache.
Headache Days
时间窗: Change from the number of day at 1 months.
The days when headache attacked. The increased day represents the worse headache.
Headache Frequency
时间窗: Change from the times of headache attack at 1 months.
The maximum times in one day during the headache attacked. The increased time represents the worse headache.
Dataset of functional magnetic resonance imaging on brain
时间窗: Changes from the dataset of subject's brain area at 1 months.
Dataset of functional magnetic resonance imaging on brain includes functional images, structural images and diffusion tensor images.
次要结局
- Pittsburgh Sleep Quality Index(Change from the value of Pittsburgh Sleep Quality Index at 1 months.)
- Medical Outcomes Study Short-Form 36 questionnaire(Change from the value of Medical Outcomes Study Short-Form 36 questionnaire at 1 months.)
研究者
Yi Ren
Deputy director of Neurology
Beijing University of Chinese Medicine