Abstract
INTRODUCTION: Chronic migraine (CM) is a prevalent neurovascular disorder that significantly affects quality of life. Research has shown promising results for the efficacy of acupuncture in the treatment of chronic migraine. This study aims to evaluate the efficacy of acupuncture as a prophylactic treatment for chronic migraine through a multicenter randomized controlled trial. MATERIALS AND METHODS: This investigation constitutes a prospective, two-arm, multicenter randomized controlled trial involving a total of 180 patients diagnosed with chronic migraine (CM). Participants will be allocated in a 2:1 ratio to either the treatment group, receiving acupuncture, or the control group, receiving sham acupuncture. The intervention will be administered three times per week over a 6-week treatment period, followed by an 8-week follow-up phase. The primary outcome measure is the change from baseline in the average number of monthly headache days during weeks 3-6 of the treatment period. Secondary outcomes include changes in monthly headache days during follow-up, acute medication use days (AMDs), Migraine-Specific Quality of Life (MSQ), headache symptom scores, and pain severity as assessed using the visual analog scale (VAS). ETHICS AND DISSEMINATION: The study was approved by the Ethics Committee of Shandong University of Traditional Chinese Medicine (approval number: 2024-014-01-KY) and is registered with the Chinese Clinical Trial Registry (registration number: ChiCTR2400084720). Written informed consent was obtained from all participants. The results will be disseminated through peer-reviewed publications and conference presentations. CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn/showproj.html?proj=226947, identifier ChiCTR2400084720.