Magnetic Therapy in Migraine Prophylaxis
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|ClinicalTrials.gov Identifier: NCT00901862|
Recruitment Status : Completed
First Posted : May 14, 2009
Last Update Posted : May 14, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Device: Pulsed magnetic fields (Quantum MH-2MR bracelet) Device: Sham pulsed magnetic fields (Quantum MH-2MR bracelet)||Phase 1|
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|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Magnetic Therapy in Migraine Prophylaxis; Placebo-Controlled, Double-Blind, Crossed Study|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||April 2008|
Active Comparator: 1 Active PEFs
The pulsed electromagnetic fields were directed to the wrist. The model used has the form of a bracelet called Quantum MH-2MR which uses, as a source of power, an alkaline battery of 1.5 volts connected to an electronic circuit formed by two hybrid circuits of magnetic oscillation and a control system of all the generating frequency system.
Device: Pulsed magnetic fields (Quantum MH-2MR bracelet)
Pulsed magnetic fields
Sham Comparator: 2 Sham
The sham machines were identical to the machines in actual operation in both phases of the study. The only difference was that the hybrid circuits crucial for the generation of the electromagnetic field had been removed.
Device: Sham pulsed magnetic fields (Quantum MH-2MR bracelet)
Hybrid circuits crucial for the generation of the electromagnetic field had been removed.
- The primary outcome measure was change from baseline in the number and peak severity of migraine attacks during each double-blind phase [ Time Frame: 3 months ]
- 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 [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00901862
|Instituto Nacional de Neurologia y Neurocirugía Manuel Velasco Suarez|
|Mexico City, Mexico, 14269|
|Principal Investigator:||DANIEL SAN JUAN ORTA, MD||Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez|