Electroacupuncture for Menstrual-Related Migraine: Protocol for a Multicenter Single-Blinded Randomized Controlled Trial.

IMPORTANCE

Menstrual-related migraine (MRM) is a prevalent neurological condition affecting females, with prolonged duration, severe symptoms, and poor drug response, significantly impairing their quality of life. Electroacupuncture shows promise as a nonpharmacological intervention for migraine. However, there is a deficiency in high-quality evidence-based research assessing its efficacy in MRM. To address this gap, we present a detailed protocol to evaluate electroacupuncture's therapeutic effects in MRM.

METHODS AND ANALYSIS: A total of 120 participants with MRM will be randomly divided into two groups (1:1): the electroacupuncture group and the sham electroacupuncture group. Participants will receive 30-min treatments (electroacupuncture or sham) for 6 sessions every 4 weeks (18 sessions over 12 consecutive weeks). The primary outcome will be migraine days and attacks during Weeks 9-12 vs. baseline. Secondary outcomes (all vs. baseline unless specified) include the following: (1) frequency-related: migraine days/attacks per 4 weeks (Weeks 1-24, excluding Weeks 9-12; and during menstrual/nonmenstrual periods). (2) Symptom characteristics: days/attacks with migraine-associated symptoms and attack duration per 4 weeks. (3) Patient-reported: visual analog scale (VAS), Migraine Disability Assessment (MIDAS) questionnaire, Insomnia Severity Index (ISI), Generalized Anxiety Disorder-7 (GAD-7), and Patient Health Questionnaire-9 (PHQ-9). (4) Others: treatment response rate, average dosage, and frequency of emergency drugs. All adverse events during the research will be documented. SAS 9.4 statistical software will be used for analyses.

TRIAL AND DISSEMINATION: Ethical approval was obtained from the Medical Ethics Committee of LongHua Hospital Shanghai University of Traditional Chinese Medicine (No. 2024LCSY150), Shanghai Gongli Hospital of Pudong New Area (GLYY1s2024-085), and Shanghai Municipal Hospital of Traditional Chinese Medicine (2025SHL-KY-60-01), and the study was registered with the International Traditional Medicine Clinical Trials Registry. All participants who fulfill the inclusion criteria and consent to join the study will sign a written informed consent form before randomization.

TRIAL REGISTRATION: International Traditional Medicine Clinical Trials Registry: ITMCTR2024000795.