Huazhong University of Science and Technology
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Proportion of people with complete remission of migraine
研究概览
简要总结
Background: Migraine is common but poorly managed with drugs. Acupuncture, a non-pharmacological approach, has shown promise, yet its mechanisms remain unclear. This study aims to assess the efficacy and specificity of acupuncture for acute paroxysmal migraine without aura.
Methods: A randomized, single-blind, sham-controlled trial will recruit 60 patients from Tongji Hospital, China. Patients will receive 20 sessions of Deqi or sham acupuncture over 4 weeks and be followed for 8 weeks. Treatments will occur twice within 4 hours of headache onset. Primary outcome is complete headache remission within 120 minutes after two treatments without analgesics. Secondary outcomes include headache intensity reduction, remission rates, and adverse events. Blind assessment will be conducted after at least one session. Data will be analyzed using full and per-protocol sets.
Ethics: Approved by the Clinical Trial Ethics Committee (approval no: TJ-IRB20220573). Written consent will be obtained. Results will be published in a peer-reviewed journal.
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
- Single (Participant)
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
- •1\They met the diagnostic criteria of migraine without aura and had a history ofmore than 1 year; 2\Age 18-65 years old;
- •18.5kg/m2 ≤ BMI ≤ 30.0kg / m2,right-handed; ④ The average frequency of migraine attacks in recent 6 months was ≥ 2-8 times per month; The average number of migraine attacks per month in recent 6 months was less than 15 days; The neurological examination was negative, and the CT or MRI of the head was normal; There was no experience of acupuncture or migraine prevention and treatment in recent 3 months; Able to complete the baseline migraine diary; Agree to sign the informed consent form.
排除标准
- •Other types of primary headache or secondary headache; It is complicated with serious primary diseases such as cardiovascular,cerebrovascular, liver, kidney, gastrointestinal, blood, nervous system, etc; Complicated with severe mental illness; In the past 12 weeks, migraine drugs were taken orally or headache treatment methods such as acupuncture and physiotherapy were received; Lactation, pregnant women and planned pregnant women; Participate in another clinical trial at the same time; Illiterate, unable to read comprehension scale; Poor compliance.
结局指标
主要结局
Proportion of people with complete remission of migraine
时间窗: 2 hours
次要结局
未报告次要终点
研究者
Bo Huang
Teaching secretary
Huazhong University of Science and Technology