A Randomized, Placebo-control of Pulsed Electromagnetic Field Therapy as Preventive Treatment of Refractory Migraine
pulsed electromagnetic field
+ pulsed electromagnetic field
Brain Diseases+3
+ Central Nervous System Diseases
+ Nervous System Diseases
Treatment Study
Summary
Study start date: January 1, 2012
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 17 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 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 Exclusion Criteria: pregnancy epilepsy malignancy
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location