Zhou Chuanlong, Bao Jie, Hu Hantong, Ye Siting, Shao Xiaomei, Liang Yi, Fang Jianqiao
Department of Acupuncture, the Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, People's Republic of China.
School of Basic Medical Sciences, Zhejiang Chinese Medical University, Hangzhou, People's Republic of China.
J Pain Res. 2022 Aug 4;15:2211-2221. doi: 10.2147/JPR.S372311. eCollection 2022.
Migraine without aura (MWoA) is a nervous system disease, which is closely related to autonomic nerves dysfunction. As a popular non-pharmacological alternative treatment for preventing migraine, it remains unclear whether the acupuncture can prevent MWoA. Thus, this trial aims to evaluate the preventive effect and safety of the acupuncture method of stimulating acupoints that regulate autonomic nerves in MWoA patients.
This is a single-center, prospective, double-dummy, randomized controlled clinical trial. A total of ninety-six patients with MWoA are randomly allocated to acupuncture combined with the placebo group and sham acupuncture combined with the medication group in a 1:1 ratio. All subjects will receive intervention for 8 weeks and follow-up assessments three times (one month, three months, and six months in follow-up visiting). The frequency of acupuncture in both groups is three times a week for eight weeks. The primary outcome will be evaluated using a visual analog scale (VAS) and the number of migraine attacks per four weeks. The secondary outcome measures will include the migraine-specific quality of life (MSQOL) scale and headache needs assessment survey (HANA) questionnaire scale.
The acupoint selection of this clinical trial is based on the combination of traditional Chinese medicine theory with modern medicine, thereby evaluating the efficacy and safety of the acupuncture method of stimulating acupoints that regulate autonomic nerves in the prevention of MWoA. The results may provide evidence of the beneficial effects of acupuncture on the prevention of MWoA by regulating autonomic nerves dysfunction.
ClinicalTrials.gov NCT04766762.
无先兆偏头痛（MWoA）是一种神经系统疾病，与自主神经功能障碍密切相关。作为一种流行的预防偏头痛的非药物替代疗法，针刺是否能预防无先兆偏头痛仍不清楚。因此，本试验旨在评估针刺调节自主神经穴位的方法对无先兆偏头痛患者的预防效果和安全性。
这是一项单中心、前瞻性、双盲、随机对照临床试验。总共96例无先兆偏头痛患者按1:1的比例随机分配到针刺联合安慰剂组和假针刺联合药物组。所有受试者将接受8周的干预，并进行三次随访评估（随访1个月、3个月和6个月）。两组针刺频率均为每周3次，共8周。主要结局将采用视觉模拟量表（VAS）和每四周偏头痛发作次数进行评估。次要结局指标将包括偏头痛特异性生活质量（MSQOL）量表和头痛需求评估调查问卷（HANA）量表。
本临床试验的穴位选择基于中医理论与现代医学的结合，从而评估针刺调节自主神经穴位的方法在预防无先兆偏头痛中的疗效和安全性。结果可能为针刺通过调节自主神经功能障碍预防无先兆偏头痛的有益作用提供证据。
ClinicalTrials.gov NCT04766762。
