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Pulsed Electromagnetic Field Therapy in the Refractory Migraine

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ClinicalTrials.gov Identifier: NCT01670214
Recruitment Status : Completed
First Posted : August 22, 2012
Last Update Posted : February 17, 2016
Sponsor:
Collaborator:
Tehran University of Medical Sciences
Information provided by (Responsible Party):
Boshra Hatef, Tarbiat Modarres University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Refractory Migraine Procedure: pulsed electromagnetic field Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-control of Pulsed Electromagnetic Field Therapy as Preventive Treatment of Refractory Migraine
Study Start Date : January 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Pulsed electromagnetic field
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)
 Procedure: pulsed electromagnetic field
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.
Placebo Comparator: pulsed electromagnetic field
patients are placed under off instrument while who is kept blind to know it for 6 sessions (3 sessions per week).
 Procedure: pulsed electromagnetic field
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.


Outcome Measures
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Primary Outcome Measures :
  1. MIDAS [ Time Frame: 6 months ]
    migraine disability score

  2. headache frequency [ Time Frame: 4 months ]
  3. headache duration [ Time Frame: 4 months ]
  4. headache intensity [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. medications [ Time Frame: 4 months ]
  2. missed work [ Time Frame: 4 months ]

Eligibility Criteria
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Ages Eligible for Study:   17 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01670214


Locations
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Iran, Islamic Republic of
Niyayesh clinic
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Niyayesh Clinic
Tehran University of Medical Sciences
Investigators
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Principal Investigator: Boshra Hatef, Phd student PT,TMU Niyayesh Clinic
Study Director: mansoore toghae, prof. neurology,TUMS sina hospital of Medical Science University of Tehran
More Information
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Additional Information:

Publications of Results:
Boshra Hatef, Fahime Hashemirad, Gholam Hossein Meftahi, Leila Simorgh, Soodeh Razeghi Jahromi, Forough Rahimi, Mansoureh ToghaThe efficiency of pulsed electromagnetic field in refractory migraine headaches: a randomized, single-blinded, placebo-controlled, parallel group. international journal of clinical trial 3(1): 24-31, 2016

Other Publications:
B Hatef, B Majdoleslam, M Toghae, F Hashemirad. The Prophylactic Treatment of PEMF in the Refractory Migraine Headache, Double-Blind, Parallel Placebo-Controlled Study. CEPHALALGIA 33(s8): 98-99, 2013

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Responsible Party: Boshra Hatef, Phd student of physiotherapy, Tarbiat Modarres University
ClinicalTrials.gov Identifier: NCT01670214    
Other Study ID Numbers: NIYAYESH CLINIC 1
First Posted: August 22, 2012    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: August 2012
Keywords provided by Boshra Hatef, Tarbiat Modarres University:
RM
R-CM
based on ICHD-2 criteria
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases