Pulsed Electromagnetic Field Therapy in the Refractory Migraine

A Randomized, Placebo-control of Pulsed Electromagnetic Field Therapy as Preventive Treatment of Refractory Migraine

Sponsors

Lead Sponsor: Niyayesh Clinic

Collaborator: Tehran University of Medical Sciences

Source Niyayesh Clinic
Brief Summary

Pulsed electromagnetic field (PEMF) as prophylactic treatment may prevent the attacks of migraine or decrease them even in the patients with refractory migraine.

Detailed Description

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.

Overall Status Completed
Start Date January 2012
Completion Date October 2013
Primary Completion Date August 2013
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
MIDAS 6 months
headache frequency 4 months
headache duration 4 months
headache intensity 4 months
Secondary Outcome
Measure Time Frame
medications 4 months
missed work 4 months
Enrollment 30
Condition
Intervention

Intervention Type: Procedure

Intervention Name: pulsed electromagnetic field

Description: parameters of the pulsed electromagnetic field are frequency:10 Hz, intensity 4-5 mT, 6 sessions( 2 week) for placebo and phase 1 treatment ( 3 sessions in week) and added 6 sessions for phase 2 treatment. the solenoid diameter of instrument is 70 cm is placed around the head.

Eligibility

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. 1. 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 2. 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

Gender: All

Minimum Age: 17 Years

Maximum Age: 55 Years

Healthy Volunteers: No

Overall Official
Location
Facility: Niyayesh clinic
Location Countries

Iran, Islamic Republic of

Verification Date

August 2012

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Tarbiat Modarres University

Investigator Full Name: Boshra Hatef

Investigator Title: Phd student of physiotherapy

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Pulsed electromagnetic field

Type: Active Comparator

Description: parameters of the pulsed electromagnetic field are frequency:10 Hz, intensity 4-5 mT, 6 sessions phase 1 treatment and added 6 sessions for phase 2 treatment (3 sessions per week)

Label: pulsed electromagnetic field

Type: Placebo Comparator

Description: patients are placed under off instrument while who is kept blind to know it for 6 sessions (3 sessions per week).

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Participant)

Source: ClinicalTrials.gov