Clinical trial NCT07023926: The Efficacy and Safety of Acupuncture for Prophylaxis of Menstrually Related Migraine
Official title: The Efficacy and Safety of Acupuncture for Prophylaxis of Menstrually Related Migraine: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Menstrually Related Migraine
Electroacupuncture
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. meet the diagnostic criteria for MRM according to the ICHD-3, with a documented history of MRM for at least 12 months;
2. have a confirmed diagnosis of migraine by a neurologist;
3. aged 18-45 years;
4. have regular menstrual cycles (28 ± 7 days) with menstruation lasting 3-7 days;
5. 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;
6. have completed a headache diary during the screening period (covering at least one full menstrual cycle), demonstrating good compliance;
7. headache diary data during screening period must meet the ICHD-3 criteria for MRM and fulfill criteria (4) and (5);
8. voluntarily sign the informed consent.

Exclusion Criteria:

1. irregular menstrual cycles, defined as cycle length outside the range of 28±7 days or menstruation duration \<3 days or \>7 days;
2. presence of secondary headache disorders, facial neuralgia, or cranial neuralgia;
3. 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;
4. 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;
5. receipt of preventive treatment for headache within 1 month prior to the screening visit;
6. afraid of needles or received acupuncture treatment within 3 months;
7. unwillingness to undergo the study intervention or failure to sign the informed consent.

Primary outcomes:
measure: Change in standardized monthly headache days (SMHD) compared with baseline.
timeFrame: At Week 12 post-treatment
Secondary outcomes:
measure: change in standardized monthly headache days (SMHD) compared with baseline
timeFrame: At Weeks 4 and 8 post-treatment, and at Weeks 16, 20, and 24 during follow-up
measure: The proportion of patients with cured MRM
timeFrame: At Week 12 post-treatment, and at weeks 16, 20, and 24 during follow-up
measure: The responder rate
timeFrame: At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up
measure: Change in standardized monthly headache severity score from baseline
timeFrame: At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up
measure: Change in standardized monthly use of rescue medication from baseline
timeFrame: At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up
measure: Headache diary completion rate
timeFrame: At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up
measure: Overall recruitment rate at End of recruitment phase
timeFrame: At end of the recruitment phase
measure: Overall retention rate
timeFrame: At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up
measure: Change in Hospital Anxiety and Depression Scale (HADS) score from baseline
timeFrame: At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up
measure: Change in Headache Impact Test-6 (HIT-6) score from baseline
timeFrame: At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up
measure: Change in Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) score from baseline
timeFrame: At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up
measure: Patient's Global Impression of Change (PGIC)
timeFrame: At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up
measure: Participants' expectation for acupuncture
timeFrame: At baseline
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Acupuncture, China Academy of Chinese Medical Sciences Guang'anmen Hospital
state: Beijing
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Weiming Wang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: