The Efficacy and Safety of Acupuncture for Prophylaxis of Menstrually Related Migraine

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Not yet enrolling

Conditions: Menstrually Related Migraine; Electroacupuncture

Treatments: Device: Sham electroacupuncture; Device: electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT07023926

2025-031-KY-01

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

elecrtoacupuncture group (EA group)

Experimental group

Description:

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.

Treatment:

Device: electroacupuncture

Sham elecrtoacupuncture group (sham EA group)

Sham Comparator group

Description:

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.

Treatment:

Device: Sham electroacupuncture