Abstract
BACKGROUND: Acupuncture, a well-established non-pharmacological intervention, has displayed promise in migraine management, but high-quality evidence for its effectiveness in menstrually related migraine (MRM) prophylaxis remains scarce. This pilot randomized controlled trial will evaluate the feasibility, efficacy, and safety of electroacupuncture (EA) for MRM prevention and provide evidence-based support for future large-scale trials. METHODS/DESIGN: This single-center, participant- and assessor-blinded, sham-controlled pilot trial will assign 40 eligible patients with MRM in a 1:1 ratio to the EA or sham EA (SEA) group via block randomization. Participants will begin treatment on day -3 of each menstrual cycle (estimated according to the previous cycle), receiving 1-2 sessions during the first week (from day -3 to +4 of menstruation) and 2-3 sessions per week for the following 3 weeks. The intervention period will last 12 weeks and total 30 sessions, followed by 12 weeks of follow-up. The primary outcome is the change from baseline in standardized monthly headache days (SMHDs) at week 12. Secondary outcomes include the MRM cure rate, responder rate for MRM (≥50% reduction in SMHDs), changes in headache severity and medication use, quality of life (Migraine-Specific Quality of Life Questionnaire v2.1), psychological status (Hospital Anxiety and Depression Scale), headache-related disability (Headache Impact Test-6), global impression of change (Patient's Global Impression of Change), and feasibility measures. All analyses will follow the intention-to-treat principle with two-sided P < 0.05 considered significant. DISCUSSION: As the first sham-controlled RCT specifically targeting MRM, this study will apply a menstrual cycle-tailored EA protocol and use uniformly assessed SMHDs as the primary outcome to enhance methodological rigor and novelty. The findings are expected to provide preliminary evidence and inform the design of future large-scale trials. TRIAL REGISTRATION: The trial protocol has been registered at ClinicalTrials.gov (NCT07023926).