跳至主要内容
临床试验/NCT01670214
NCT01670214已完成不适用

A Randomized, Placebo-control of Pulsed Electromagnetic Field Therapy as Preventive Treatment of Refractory Migraine

Niyayesh Clinic1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
headache intensity

研究概览

简要总结

Pulsed electromagnetic field (PEMF) as prophylactic treatment may prevent the attacks of migraine or decrease them even in the patients with refractory migraine.

详细描述

Migraine is most common among patients who seek medical care for headache. The prevalence of migraine is around 10 % in Iran. The many studies of migraine pathophysiology imply that the brain of migraine patient is impaired in term of cerebral circulation and baseline activity of brain stem, monoaminergic system and cortex. Then headache is only a sign of the changes that occur in the brain to rid hazardous conditions. Based on this theory many electrophysiological and imaging abnormalities that were appeared in the brain before the aura or the headache were diminished in the early phases of the attack. It means the changes concurrent with headache are associated with a quasi normalization of cortical information processing. The different pharmacological and non-pharmacological treatments have proposed for migraine management. But some patients do not satisfactorily respond to or cannot tolerate current evidence-based treatments. This group of patients is often said to have refractory migraine (RM). Thus according to the enigmatic pathophysiology of migraine, a comprehensive treatment that affected all contributing factors in the migraine with minimal side effects is not provided yet.

Extremely low frequency magnetic fields (ELF MFs) as non-pharmacological treatment of migraine had good effect with weak evidence in the control of migraine. Recently based on extensive studies in the bioeffects of the low frequency electromagnetic field we can hope that this method can respond to many human disorders is unsolvable. The purpose of this study is to apply the best effective treatment protocol of ELF-MF on brain and circulatory system is extracted by using the latest findings of studies of low-frequency electromagnetic fields as intervention and apply it for refractory migraine patients in the form of a randomized one-blind placebo- controlled trial study. The evaluation of interventions is done subjectively (migraine dairy and MIDAS). Also we consider follow up period to confirm results.

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)

入排标准

年龄范围
17 Years 至 55 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Primary Diagnosis A. ICHD-II migraine or chronic migraine Refractory B. Headaches cause significant interference with function or quality of life despite modification of triggers, lifestyle factors, and adequate trials of acute and preventive medicines with established efficacy.
  • Failed adequate trails of preventive medicines, alone or in combination from at least 2 of 4 drug classes:
  • Beta-blockers
  • Anticonvulsants
  • Tricyclics
  • Calcium channel blockers
  • Failed adequate trials of abortive medicines from the following classes, unless contraindicated:
  • Both a triptan and DHE intranasal or injectable formulation
  • Either nonsteroidal anti-inflammatory drugs or combination analgesics
  • Adequate trial Period of time during which an appropriate dose of medicine is administered, typically at least 2 months at optimal or maximum-tolerated doses, unless terminated early due to adverse effects
  • Modifiers With or without medication overuse, as defined by ICHD-2
  • With significant disability, as defined by MIDAS > 11
  • [DHE = dihydroergotamine; ICHD = International Classification of Headache Disorders;MIDAS = Migraine Disability Assessment]
  • The prophylactic medications have been discontinued at least one month prior to enrollment

排除标准

  • pregnancy
  • malignancy

结局指标

主要结局

headache intensity

时间窗: 4 months

headache frequency

时间窗: 4 months

headache duration

时间窗: 4 months

MIDAS

时间窗: 6 months

migraine disability score

次要结局

  • medications(4 months)
  • missed work(4 months)

研究者

发起方
Niyayesh Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Boshra Hatef

Phd student of physiotherapy

Tarbiat Modarres University

研究点 (1)

Loading locations...

相似试验