Electroacupuncture for Menstrual-Related Migraine: Protocol for a Multicenter Single-Blinded Randomized Controlled Trial
Abstract
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,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 120 participants or records.
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