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临床试验/NCT00901862
NCT00901862已完成1 期

Magnetic Therapy in Migraine Prophylaxis; Placebo-Controlled, Double-Blind, Crossed Study

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2007年3月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
19
试验地点
2
主要终点
The primary outcome measure was change from baseline in the number and peak severity of migraine attacks during each double-blind phase

研究概览

简要总结

Background: The therapy with pulsed electromagnetic fields (PEFs) has been used as a therapeutic modality for at least 40 years. However, their effect in the migraine prophylaxis is unclear.

Objectives: Evaluate the prophylactic effectiveness of the therapy with PEFs in the handling of migraines.

Methodology: Placebo-controlled, randomized, double-blind, crossed clinical study.

详细描述

Migraine is a disease which considerably affects the individual, the family and society.[1-3] In spite of the recent advances in the symptomatic and preventive treatment of migraine, the relative effectiveness of many commonly used prophylactic medicines is not well established. Most of these drugs have indirect effects that force their suspension or their restriction of prescription to patients with certain pathologies. This fact reduces their clinic effectiveness. [4]

The therapy with pulsed electromagnetic fields (PEF's) has been used as a therapeutic modality for at least 40 years. One of its well acknowledged uses is the healing of non-union fractures, [5] although there are other medical conditions that have also been susceptible to be treated with this type of therapies, like migraine [6], Parkinson disease, [7] and epilepsia, [8] among others. Nevertheless, only a few published studies demonstrate the effectiveness of the PEF's in the handling of migraine. These studies have been carried out in a small number of patients, without control groups6 or for very short periods of time [6, 9] as to demonstrate a suitable prophylactic effect. Therefore, this placebo-controlled, double-blind, crossed clinical study was carried out in order to evaluate the prophylactic effectiveness of the therapy with PEF's in the handling of migraine.

METHODOLOGY

Patients:

The subjects were selected from the Clinic of Headache of our hospital from 2006 to 2007. All the patients included in the study aged between 18-55yrs and fulfilled the diagnose criteria of migraine with and without aura in agreement to the International Headache Classification, 2004. The study was conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki (1996). The protocol and statement of informed consent were approved by the Institutional Review Board. All the patients accepted to participate voluntarily and signed an informed consent. Patients with cluster, medicines overuse, post-traumatic headache, sinusitis or other headache types, women who were pregnant, became pregnant during the study or were lactating, patients who were under other prophylactic treatments of migraine or did not signed the informed consent were excluded from this study. Patients were allowed to continue with the medication for the acute attacks of migraine; which consisted of administering 30 mg of sublingual ketorolac every eight hours, in case of migraine. The investigator was supplied with a sealed code for each individual patient that would be opened in case of an emergency that required knowledge of the treatment being taken.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • Patients aged between 18-55 years
  • Fulfilled the diagnose criteria of migraine with and without aura in agreement to the International Headache Classification, 2004

排除标准

  • Patients with cluster, medicines overuse, post-traumatic headache, sinusitis or other headache types
  • Women who were pregnant, became pregnant during the study or were lactating
  • Patients who were under other prophylactic treatments of migraine or did not signed the informed consent were excluded from this study

结局指标

主要结局

The primary outcome measure was change from baseline in the number and peak severity of migraine attacks during each double-blind phase

时间窗: 3 months

次要结局

  • The secondary outcome was the proportion of patients who responded to each treatment with at least a 50% reduction in migraine attacks relative to baseline(6 months)

研究者

发起方
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
申办方类型
Other

研究点 (2)

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