The Efficacy and Safety of Electroacupuncture for Prophylaxis of Menstrually Related Migraine: Study Protocol for a Pilot Randomized Controlled Trial.

Researchers are studying whether electroacupuncture can help prevent menstrually related migraines (MRM), which are headaches that occur predictably around a woman's menstrual cycle. This pilot study will involve 40 women with MRM who will be randomly assigned to receive either real electroacupuncture or sham (fake) acupuncture. Treatment will be timed to each woman's menstrual cycle, beginning three days before menstruation is expected. Participants will receive 30 acupuncture sessions over 12 weeks, with more frequent treatments during the first week of menstruation (1-2 sessions) and 2-3 sessions weekly for the following three weeks. Neither the participants nor the researchers assessing outcomes will know who receives real versus sham treatment. The main measure of success will be the reduction in the number of headache days per month after 12 weeks of treatment. Researchers will also track headache severity, medication use, quality of life, anxiety and depression levels, and how much the headaches interfere with daily activities. Participants will be monitored for an additional 12 weeks after treatment ends. This is the first sham-controlled study specifically designed for menstrually related migraines, making it an important step in understanding whether electroacupuncture can help women who suffer from these predictable, hormone-related headaches. If you're considering acupuncture for menstrual migraines, seek a licensed acupuncturist with experience in women's health conditions.

This single-center, sham-controlled pilot RCT will evaluate electroacupuncture efficacy for menstrually related migraine prophylaxis in 40 patients randomized 1:1 to active EA or sham EA. The protocol employs a menstrual cycle-tailored approach with treatment initiation at day -3 of each cycle, delivering 1-2 sessions during the perimenstrual week (days -3 to +4) and 2-3 sessions weekly thereafter, totaling 30 sessions over 12 weeks with 12-week follow-up. The primary outcome is change from baseline in standardized monthly headache days at week 12. Secondary outcomes include MRM cure rate, responder rate (≥50% reduction in SMHDs), headache severity, medication use, quality of life (MSQoLv2.1), psychological status (HADS), disability (HIT-6), and PGIC scores. This represents the first sham-controlled trial specifically targeting MRM with cycle-synchronized EA intervention. Results will inform feasibility and effect size estimates for future definitive trials examining non-pharmacological MRM prophylaxis.