The Efficacy and Safety of Acupuncture for Prophylaxis of Menstrually Related Migraine: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in standardized monthly headache days (SMHD) compared with baseline.
研究概览
简要总结
Acupuncture is commonly used for the prevention of migraine and tension-type headaches, and has been found to be effective in reducing both the frequency and severity of these conditions. However, studies on acupuncture for menstrually related migraine (MRM) are limited, and current research has not been able to determine whether its efficacy is due to the actual therapeutic effects of acupuncture or psychological benefits. To address this issue, the investigators have designed a clinical trial to evaluate the efficacy of acupuncture for MRM.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •meet the diagnostic criteria for MRM according to the ICHD-3, with a documented history of MRM for at least 12 months;
- •have a confirmed diagnosis of migraine by a neurologist;
- •aged 18-45 years;
- •have regular menstrual cycles (28 ± 7 days) with menstruation lasting 3-7 days;
- •have experienced ≥3 headache days during each menstrual cycle (days -2 to +3) and ≥5 total headache days per cycle over the past 3 months and baseline period; migraine attacks must last 4-72 hours without acute medication, or at least 2 hours when treated;
- •have completed a headache diary during the screening period (covering at least one full menstrual cycle), demonstrating good compliance;
- •headache diary data during screening period must meet the ICHD-3 criteria for MRM and fulfill criteria (4) and (5);
- •voluntarily sign the informed consent.
排除标准
- •irregular menstrual cycles, defined as cycle length outside the range of 28±7 days or menstruation duration <3 days or >7 days;
- •presence of secondary headache disorders, facial neuralgia, or cranial neuralgia;
- •combined with serious primary diseases such as cardiovascular, hepatic, renal, gastrointestinal, or hematological disorders that may interfere with the treatment protocol, or comorbid neurological conditions such as epilepsy, parkinson's disease, or other central nervous system disorders;
- •headache symptoms caused by other conditions, such as moderate to severe head or neck trauma, perimenstrual infections, intracranial tumors, intracranial infections, endocrine or metabolic disorders;
- •receipt of preventive treatment for headache within 1 month prior to the screening visit;
- •afraid of needles or received acupuncture treatment within 3 months;
- •unwillingness to undergo the study intervention or failure to sign the informed consent.
研究组 & 干预措施
elecrtoacupuncture group (EA group)
Participants will be treated by electroacupuncture. During the first week (from day -3 to +4 of menstruation), they will receive 1-2 sessions, followed by 2-3 sessions per week for the next three weeks. This treatment schedule will be repeated for three consecutive menstrual cycles, totaling a 12-week treatment period and 30 sessions. All treatment sessions will be monitored and recorded using a treatment diary.
干预措施: electroacupuncture (Device)
Sham elecrtoacupuncture group (sham EA group)
Participants will be treated by sham electroacupuncture. The treatment frequency and sessions will be the same as in EA group, and the treatment diary will also be used in SEA group.
干预措施: Sham electroacupuncture (Device)
结局指标
主要结局
Change in standardized monthly headache days (SMHD) compared with baseline.
时间窗: At Week 12 post-treatment
The primary outcome is the change in standardized monthly headache days (SMHD). SMHD are calculated by adjusting the actual number of headache days to a standard 28-day menstrual cycle using the following formula: SMHD = (actual headache days × 28) ÷ individual menstrual cycle length
次要结局
- Patient's Global Impression of Change (PGIC)(At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up)
- change in standardized monthly headache days (SMHD) compared with baseline(At Weeks 4 and 8 post-treatment, and at Weeks 16, 20, and 24 during follow-up)
- The proportion of patients with cured MRM(At Week 12 post-treatment, and at weeks 16, 20, and 24 during follow-up)
- The responder rate(At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up)
- Change in standardized monthly headache severity score from baseline(At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up)
- Change in standardized monthly use of rescue medication from baseline(At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up)
- Headache diary completion rate(At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up)
- Overall recruitment rate at End of recruitment phase(At end of the recruitment phase)
- Overall retention rate(At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up)
- Change in Hospital Anxiety and Depression Scale (HADS) score from baseline(At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up)
- Change in Headache Impact Test-6 (HIT-6) score from baseline(At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up)
- Change in Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) score from baseline(At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up)
- Participants' expectation for acupuncture(At baseline)
研究者
weiming wang
Principal Investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences