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

Xinkun Liu,1,* Ruimin Jiao,2,* Yaqing Zheng,1,* Yan Liu,3 Guangxian Yu,1 Jiaxiang Shi,1 Wei Wang,1 Weiming Wang1 1Department of Acupuncture and Moxibustion, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, People’s Republic of China; 2Department of Traditional Chinese Medicine, Beijing Friendship Hospital, Capital Medical University, Beijing, 100050, People’s Republic of China; 3Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, People’s Republic of China*These authors contributed equally to this workCorrespondence: Weiming Wang, Department of Acupuncture and Moxibustion, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, No. 5 Beixiange St., Xicheng District, Beijing, People’s Republic of China, Email [email protected]: 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