NCT04429048 | COMPLETED | Migraine; Status

Detailed Description:

Introduction: Migraine is one of the most complex, prevalent, debilitating neurologic disorder and the prevalence higher in female group. In general, there are many kinds of therapy for migraine nowadays including of acute abortion oral drugs such as triptan, ergotamine, non-steroid anti-inflammatory drugs, acetaminophen and preventive agents such as calcium channel blocker (Flunarizine), anti-epileptic drugs (valproic acid, Topiramate, Pregabalin), beta adrenergic-blocker (Propranolol), Selective Serotonin Reuptake Inhibitors(SSRI), anti-emetic agents (Prochlorperazine) and other injection therapy such as Onabotulinum Toxin A or CGRP (Calcitonin gene-related peptide) antagonist etc. The CGRP plays an important role of trigemino-vascular responses in migraine. The serum CGRP levels elevated while migraine attack and chronic migraine, therefore, CGRP is a potential biomarker. In recent studies, higher plasma CGRP level during interictal phase of migraine or chronic migraine is indicated the better response for Onabotulinum Toxin A and reduced plasma CGRP level can relieve the discomfort of migraine. Neurokinin A (NKA) levels of venous blood are significantly higher in responders than these nonresponse before the rizatriptan treatment, whereas reduced the levels of both CGRP and NKA one hours after the treatment . The headache is associated with nausea in about 80% of episodes, vomiting in about 30% in patients with migraine. PC6 is belong to pericardium meridian locates the anterior aspect of forearm between the tendons of the palmaris longus and the flexor carpi radialis, 2 cun proximal to the wrist transverse stripes just on the median nerve . The antiemetic is lower for preventing postoperative nausea and vomiting in the combination PC6 acupoint stimulation than these patients with antiemetic only. Acupuncture at the PC6 is an effective alternative treatment to conventional pharmacological treatment and resulted in almost immediate cessation of intraoperative nausea and vomiting. Therefore, acupressure at PC6 is an effective and safety method for nausea and vomiting. In addition, stimulation at PC6 can activate hypothalamic orexin neurons, and that release orexins to induce analgesia. Taken together, PC6 stimulation can produce effect of both analgesia and antiemetic effects. The present study suppose stimulation at PC6 is beneficial for the treatment of migraine. Therefore, the investigators designed a single-blinded, randomized, controlled trial to evaluate the effect of acupressure at PC6 on headache in patients with migraine. Method and study design: (A) Participants The patients with migraine were enrolled from the outdoor patients (OPD) of neurological department, Yunlin branch of National Taiwan University hospital. The basic laboratory data including peripheral blood cells, Na/K/Ca/Mg, alanine aminotransferase (ALT), creatinine, iron/total iron-binding capacity (TIBC)/ferritin to exclude extremely abnormal metabolic disturbance or liver/renal functional impairment which may cause secondary headache; and the awake electroencephalography (EEG) and brain image including computer tomography (C-T) or magnetic resonance image (MRI) also were done to rule out any intracranial structure lesion prior to the trial. The migraine was diagnosed according to clinical manifestation and criteria from beta version of the third edition of the International Classification of Headache Disorders (ICHD-3). In addition, non-steroid anti-inflammatory drugs (NSAIDs) are used as episodic way while migraine attack and Propranolol (Inderal R) is used as preventive way no matter when migraine attack. In addition, the participants needed to finish the Migraine Disability Assessment (MIDAS) questionnaire evaluation of 6 weeks. (B) Study design: Single-blinded, randomized, controlled clinical trial. (C) Assessment time: before PC6 acupressure (V1), two weeks after acupressure (V2), four weeks after acupressure (V3) and six weeks after acupressure (D) Statistical analysis : Categorical data will be displayed in numbers and percentages, whereas continuous variables will be given as means ± standard deviations or median (Q1, Q3). Differences in categorical variables will be tested using the chi-square test or Fisher exact test and differences in continuous variables will be tested using the two sample independent t test or Mann-Whitney test between groups. The generalized estimating equations (GEE) will be used to compare the change of primary outcomes over time (the four time points (V1-V4)) between two groups. A p value of less than 0.05 will be considered statistically significant. All statistical analyses will be performed using SPSS Statistics 24or R version 3.4.4 . Outcome : The study of the present study predicts that PC6 acupressure may reduce severity of headaches, the frequency of headache attacks and duration of headache, and also reduce the dose of NSAID. In addition, the PC6 acupressure also may reduce levels of serum CGRP and NKA, and also may improve the quality of life.