A Continuous Study on Abiding Effect of Acupuncture for Migraine Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 249
- 试验地点
- 1
- 主要终点
- frequency of migraine attacks
研究概览
简要总结
Hypothesis: Acupuncture obtains an abiding effect on migraine prophylaxis Design: A open-label randomized controlled trial. 249 participants will be included. Three arms: acupuncture in acupoint-meridian， non-acupoint-meridian group, and waiting list.
详细描述
Aim: to attest the abiding efficacy and safety of acupuncture for migraine prophylaxis Design: A open-label randomized controlled trial will be performed in Chengdu, Hunan and Chongqing province. Two hundred and forty-three participants will be randomly assign to acupoint-meridian group, non-acupoint-meridian group, and wait-and-see group. Each participants will receive 20 sessions of acupuncture in 4 weeks, with a duration of 30 minutes in a session. After all the treatments was accomplished, there will be 5 times follow-ups in the impending every 4 weeks. The primary outcome is frequency of migraine attacks 16 weeks after inclusion. Secondary outcomes include frequency of migraine attacks at the 4th and 24th week, headache severity, MSQ(Migraine Specific Quality of Life Questionnaire MSQ Version2.1), etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Age of a subject is between 18 and 65 years old(initially occured beneath the age of 50), male or female;
- •in accordance with diagnosis of migraine without aura in International Classification of Headache Disorders, ICHD-2, by IHS;
- •2 to 8 times attack per month in recent 3 months, with each period beyond 15 days;
- •with migraine history for over 1 year;
- •be able and willing to finish the headache diary in baseline ;
- •informed consent form must be signed by patient or lineal relative;
排除标准
- •Patients who are unconscious, psychotic.
- •Patients with aggravating tumor and other serious consumptive disease, and who are subject to infection and bleeding.
- •With serious primary illness or disease of cardiovascular, liver, renal, gastrointestinal, hematological systems and so on.
- •Pregnant women or women in lactation.
结局指标
主要结局
frequency of migraine attacks
时间窗: 16th week after inclusion
to assess the frequency of migraine attacks at the 16th week after inclusion
次要结局
- headache severity(0 day, 4th, 8th, 12th, 16th, 20th, 24th week after inclusion)
- frequency of migraine attacks(4th and 24th week after inclusion)
研究者
Li ying
Chengdu University of Traditional Chinese Medicine
Chengdu University of Traditional Chinese Medicine