Effect of Acupressure at PC6 on Headache in Patients With Migraine: Single-blinded, Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Headache severity
研究概览
简要总结
Background :
Migraine is one of the most complex, prevalent, debilitating neurologic disorder in the world. In clinical experience, there are limitation over western medicine for migraine, especially some extra adverse effects. In traditional Chinese medicine(TCM), there are some reviews and clinical practice point out acupressure at PC6 could relieve nausea/ vomiting and pain while migraine. Recent researches also mention Calcitonin gene-related peptide (CGRP) and Neurokinin A (NKA) in some degree correlated with the mechanism of migraine.
Objective:
CGRP and NKA play vital roles of migraine. In comparison with oral medication only and PC6 acupressure via oral medication, if there were better effect for migraine control. In addition, investigators evaluate the plasma CGRP and NKA level before and after study to figure out if any positive value and any correlation with acupressure.
Method:
By single-blinded, randomized, controlled clinical trial, total of 56 patients with migraine were divided equally into acupressure group (modern routing standard therapy plus PC6 acupressure) and control group (modern routing standard therapy). Before intervention, the participants needed to finish the Migraine Disability Assessment (MIDAS) questionnaire evaluation. After 6 weeks, investigators will evaluate the severity, frequencies of headaches and pain-killer consumption as primary outcome. In addition, investigators will investigate if there were change of serum CGRP/NKA level after 6 weeks and the score changes of MOS 36-Item Short-Form Health Survey as secondary outcome.
Expected results:
The investigators predict that PC6 acupressure may not only reduce severity, frequencies and duration of headaches but also reduce the dose of NSAIDs. In addition, the PC6 acupressure also may reduce levels of serum CGRP and NKA, and improve the quality of life meanwhile.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
single blind
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Headache severity
时间窗: After 6 weeks, evaluate the headache severity (VAS score) if any decreased
Severity by visual analog scale (0\~10), if VAS score decreased 2 points which means better results
dosage of pain killers
时间窗: evaluation total amount of pain-killer consumption after 6 weeks
how many dosage of pain kill taken (if pain killer taken less than 20 pills which means effective therapy)
Headache frequency
时间窗: evaluate total headache episodes after 6 weeks
how many times headache occurred (if attack \< 8 times which means effective)
Headache duration
时间窗: After 6 weeks , evaluate how many episodes of lesser duration(<4hours) of the two groups
duration (if attack less than 4hours which means better response)
次要结局
- Neurokinin A (NKA) level(1st time: 1 day of sign informed consent ; 2nd time: through study completion, an average of 6 weeks)
- the score of 36-Item Short Form Health Survey (SF-36)(through study completion, an average of 6 weeks)
- Calcitonin gene-related peptide (CGRP) level(1st time: 1 day of sign informed consent ; 2nd time: through study completion, an average of 6 weeks)