Jia Jingnan, Yan Chaoqun, Zheng Xiancheng, Shi Anqi, Li Zhijun, Xu Lufan, Hui Zhiyuan, Chen Yichao, Cao Zimin, Wang Jun
Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, People's Republic of China.
J Pain Res. 2023 Jan 18;16:129-140. doi: 10.2147/JPR.S377289. eCollection 2023.
Acupuncture has been recognized as an effective and safe alternative therapy for migraine, but its central mechanism has not yet been adequately explained. Meanwhile, research into the clinical efficacy and central mechanism of true acupuncture (TA) and sham acupuncture (SA) is lacking. It is necessary to investigate whether TA has better efficacy than SA, and how they achieve different effects. This study aims to evaluate the efficacy of TA and SA, observe the brain response caused by TA and SA, and further investigate the central nervous mechanism of TA and SA treatment for patients with migraine.
This is a randomized controlled neuroimaging trial combining acupuncture treatment with functional magnetic resonance imaging, with patients and outcome assessors blinded. A total of 60 patients with migraine will be randomly allocated to receive 12 sessions of either TA or SA treatments (three sessions per week for 4 weeks), and 30 healthy participants will be recruited as the healthy control (HC) group. Outcome assessment and neuroimaging will be conducted before and after the entire intervention. A headache diary and questionnaires of life quality and psychological properties will be used to evaluate clinical efficacy. Multimodal magnetic resonance imagining data analysis will be used to investigate the central mechanism of TA or SA in treating migraine. Pearson's correlation analysis will be used to reveal the relationship between the brain response and clinical improvements.
The results of this study will reveal the brain response to TA and SA in patients with migraine and contribute to further expanding the knowledge of their central mechanism.
This trial has been approved by the ethics committee of Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine (DZMEC-KY-2020-38) and registered in the Chinese Clinical Trial Registry (registration number ChiCTR2000033995).
针灸已被公认为是一种治疗偏头痛的有效且安全的替代疗法，但其核心机制尚未得到充分解释。同时，对于真穴针刺（TA）和假穴针刺（SA）的临床疗效及核心机制的研究尚显不足。有必要探究TA是否比SA具有更好的疗效，以及它们是如何产生不同效果的。本研究旨在评估TA和SA的疗效，观察TA和SA引起的脑部反应，并进一步探究TA和SA治疗偏头痛患者的中枢神经机制。
这是一项将针刺治疗与功能磁共振成像相结合的随机对照神经影像学试验，患者和结果评估者均处于盲态。总共60例偏头痛患者将被随机分配接受12次TA或SA治疗（每周3次，共4周），并招募30名健康参与者作为健康对照组（HC）。在整个干预前后进行结果评估和神经影像学检查。使用头痛日记以及生活质量和心理状态问卷来评估临床疗效。采用多模态磁共振成像数据分析来探究TA或SA治疗偏头痛的中枢机制。使用Pearson相关分析来揭示脑部反应与临床改善之间的关系。
本研究结果将揭示偏头痛患者对TA和SA的脑部反应，并有助于进一步拓展对其核心机制的认识。
本试验已获得北京中医药大学东直门医院伦理委员会批准（DZMEC-KY-2020-38），并在中国临床试验注册中心注册（注册号ChiCTR2000033995）。
