| Background:Migraine without Aura(MWoA)is a serious neurological disorder with a high incidence worldwide and a significant impact on patient’s quality of life.Currently,the existing migraine treatment options mainly include pharmacological and non-pharmacological approaches.Pharmacological approaches have a low usage rate due to unsatisfactory individual efficacy and side effects.In addition,frequent use of medication can increase the risk of substance abuse and prolong the course of the disease.However,acupuncture,as a preventive non-pharmacological treatment with fewer side effects,is attracting more attention.It has been proved by many clinical studies in improving headache-related symptoms and the quality of life of migraine patients.Among them,"Wang’s eight-acupoint" has been created by Wang Leting-a famous acupuncturist from the Beijing Hospital of Traditional Chinese Medicine,according to long-term clinical practice.This acupoint prescription has achieved a good effect in a clinical trial.However,the mechanism of acupuncture in the treatment of migraines is still unclear,so more relevant studies are needed to provide full support for this acupuncture regimen.On the other hand,in recent years,the development of image analysis technology has provided help for the study of the neural mechanism of acupuncture.As a neurological disease,the abnormal brain structure and function of migraine have been found to be one of the reasons that lead to and aggravate the course of headache.Previous studies have found that migraine patients have varying degrees of change in the white matter connectivity structure and functional network.Acupuncture therapy has also been proven to regulate the abnormal white matter function and structural network in stroke patients.However,there is no research on the regulation of white matter networks in the acupuncture treatment of migraines.Objective:Based on the problems above,the purpose of this study was to evaluate the clinical efficacy of acupuncture therapy on patients with MWoA in terms of pain symptoms,quality of life,and mental state.At the same time,resting-state functional magnetic resonance imaging(fMRI)was used to observe the changes in cerebral white matter network function in M Wo A patients before and after acupuncture treatment based on graph theory,so as to explore the neural mechanism of acupuncture on migraine.Methods:A prospective,randomized,two-arm,parallel study design was used.During the 4-week screening period(baseline:-4 weeks to 0 weeks),patients will be assessed to confirm whether they meet the inclusion criteria.In this study,block randomized grouping was adopted,and qualified patients were divided into two groups in a ratio of 1:1.The treatment group received acupuncture treatment,and the control grorup received non-point superficial skin penetration treatment.The treatment was performed 12 times a week for 4 weeks(treatment period:0 weeks to 4 weeks).One assessment will be conducted after the treatment,and three follow-up assessments were conducted once in one month for a total of 12 weeks(follow-up period:4-16 weeks).The clinical efficacy of acupuncture therapy was analyzed according to the clinical evaluation results before treatment,after treatment,and 3 follow-up visits.The clinical outcome measures included changes in the number of migraine days,headache duration,percentage of acute headache analgesic usage,headache Impact Test score(HIT-6),migraine-specific Quality of Life Questionnaire(MSQ),pain intensity VAS score during the treatment and follow-up periods compared to baseline,and 50%treatment response rate.On the other hand,MRI scans were performed before and after treatment to collect structural and functional image data.The white matter functional network was constructed,and the graph theory analysis was carried out to compare the changes in the white matter functional network before and after treatment.The MRI outcome measures included the area under the curve of clustering coefficient,characteristic path length,small-world topology,global efficiency,local efficiency,and nodal efficiency.Results:In this study,acupuncture treatment significantly reduced the number of migraine days,headache duration,HIT-6,and VAS score and increased the score of MSQ in MWoA patients.It also has long-term effects on preventing migraine attacks and improving patients’ physical function and emotional functions.MRI data analysis showed that two groups of patients included had small-world attributes both before and after the treatments.4-week acupuncture treatment could significantly reduce the Global efficiency and Local efficiency of the global network of the white matter in MWoA patients(P<0.05),while the global network of the patients before and after sham acupuncture treatment had no significant change.There was no significant difference between the two treatment groups in the white matter network before treatment.Compared with sham acupuncture treatment,4-week verum acupuncture treatment could significantly reduce the global efficiency and increase the characteristic path length of white matter functional network in MWoA patients(P<0.05),but the global network index had no significant change before and after treatment in each group.No significant difference was found in nodal efficiency between the two groups after treatment.In the intragroup comparison before and after treatment,the nodal efficiency of the white matter functional network of MWoA patients in the verum acupuncture group showed a rise in the left angular gyrus,the right anterior cingulate gyrus,the left medial prefrontal lobe,and the right cerebellum;the efficiency of the right amygdala was significantly increased in the sham acupuncture group(P<0.05).Conclusion:Acupuncture can effectively improve headache-related symptoms,quality of life,and mental state of MWoA patients,and has a long-term effect.On the other hand,acupuncture may achieve the therapeutic effect by regulating the abnormal function of the network of white matter in MWoA patients,reducing the abnormally elevated local network efficiency,and increasing the efficiency of information transmission in brain regions related to pain and emotional processing. |