Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT04766762.