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Efficacy of acupuncture for chronic migraine: a protocol for a multicenter randomized controlled trial.

Frontiers in neurologyยทDecember 2025ยทQianxiu Chen, Zhe Wang, Yu Tang et al.
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Key Finding

This is a protocol for a multicenter randomized controlled trial that will evaluate whether acupuncture reduces monthly headache days in chronic migraine patients compared to sham acupuncture over a 6-week treatment period with 8-week follow-up.

What This Means For You

Chronic migraine affects millions of people worldwide, causing frequent headaches that significantly impact daily life and overall wellbeing. This upcoming study from Shandong University of Traditional Chinese Medicine will investigate whether acupuncture can help prevent chronic migraines and reduce their frequency. The research team plans to enroll 180 patients with chronic migraine across multiple medical centers in China. Participants will be randomly assigned to receive either real acupuncture or sham acupuncture (a placebo treatment that mimics acupuncture but doesn't use actual needle insertion at therapeutic points). The treatment protocol involves three acupuncture sessions per week for six weeks, followed by an eight-week observation period to track lasting effects. Researchers will measure several important outcomes, including how many headache days patients experience each month, how often they need to take pain medications, their quality of life, and their pain severity levels. The primary goal is to determine whether acupuncture reduces the average number of monthly headache days during the treatment period. This study is significant because chronic migraine is notoriously difficult to manage, and many patients experience unwanted side effects from conventional medications or find them ineffective. Previous research has suggested acupuncture may be helpful for migraine prevention, but more rigorous studies are needed to confirm these findings. If this trial demonstrates that acupuncture effectively reduces migraine frequency and severity, it could offer patients a valuable non-pharmaceutical option for managing this debilitating condition. The results will be published in medical journals and presented at conferences once the study is complete. Patients interested in acupuncture for migraine should consult a licensed, board-certified acupuncturist with experience treating headache disorders.

Clinical Notes for Practitioners

This prospective multicenter randomized controlled trial will evaluate acupuncture efficacy for chronic migraine prophylaxis. The study will enroll 180 CM patients randomized 2:1 to acupuncture versus sham acupuncture intervention. Treatment protocol consists of three sessions weekly over six weeks, with an eight-week follow-up phase. The primary endpoint is change from baseline in mean monthly headache days during weeks 3-6 of treatment. Secondary outcomes include monthly headache days during follow-up, acute medication use days, Migraine-Specific Quality of Life scores, headache symptom scores, and VAS pain severity ratings. The trial received ethics approval from Shandong University of Traditional Chinese Medicine (2024-014-01-KY) and is registered with ChiCTR (ChiCTR2400084720). This protocol represents a methodologically rigorous approach to evaluating acupuncture for CM, utilizing appropriate sham controls and clinically relevant outcome measures. Results may provide high-quality evidence regarding acupuncture's role in chronic migraine prophylaxis, addressing the need for non-pharmaceutical therapeutic options in this challenging patient population.

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