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