Refractory Migraine Clinical Trial
Official title:
A Randomized, Placebo-control of Pulsed Electromagnetic Field Therapy as Preventive Treatment of Refractory Migraine
Pulsed electromagnetic field (PEMF) as prophylactic treatment may prevent the attacks of migraine or decrease them even in the patients with refractory migraine.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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