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The Efficacy and Safety of Acupuncture for Prophylaxis of Menstrually Related Migraine | Clinical Trials | Clareo Health

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

The Efficacy and Safety of Acupuncture for Prophylaxis of Menstrually Related Migraine: a Pilot Randomized Controlled Trial

NCT07023926•Guang'anmen Hospital of China Academy of Chinese Medical Sciences

View on ClinicalTrials.gov

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

Age

18 - 45 years

Sex

FEMALE

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.

Locations (1)

Department of Acupuncture, China Academy of Chinese Medical Sciences Guang'anmen Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

July 1, 2025

Primary Completion Date

December 31, 2026

Completion Date

January 31, 2027

Last Updated

June 17, 2025

Enrollment

ESTIMATED participants

Conditions

Menstrually Related MigraineElectroacupuncture

Interventions

electroacupuncture

DEVICE

Sham electroacupuncture

DEVICE

Contacts

Weiming Wang, Ph.D

CONTACT

+8613426424993 wangweiming1a1@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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