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IRCT20200825048515N37 IRCT 2021-08-14 Esfahan University of Medical Sciences The effect of two methods of transcutaneous supraorbital nerve stimulation and transcutaneous infraorbital nerve stimulation in improving clinical symptoms in patients with migraine A comparative study of the effect of two methods of transcutaneous supraorbital nerve stimulation and transcutaneous infraorbital nerve stimulation in improving clinical symptoms and preventing a new attack in patients with migraine 2021-08-22 anticipated 81 Complete https://irct.ir/trial/57906 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 81 eligible patients will be randomly selected. Then random numbers are created by computer software "Random Allocation". We randomly divide these numbers into three parts. Each number is written on paper and placed in an envelope. Then each patient is asked to choose an envelope from among the envelopes. According to the selected envelope, the patient will be assigned to one of the three groups, Blinding description: Due to the difference in the area under nerve stimulation, the intervener is aware of the type of intervention. However, the patient and the person recording the patient's clinical information and the statistical analyst will not be aware of the type of intervention. N/A Migraine. Intervention 1: Intervention group: Intervention group 1: For patients, TENS therapy is performed through the electrode pads for the TENS device in the bilateral supraorbital area (intensity: 10 mA, which of course can be reduced depending on individual tolerance - frequency 100 for 30 minutes) for six sessions per week for 4 weeks. Intervention 2: Intervention group 2: For patients, TENS therapy is performed through the electrode pads for the TENS device in the bilateral infraorbital area (intensity: 10 mA, which of course can be reduced depending on individual tolerance - frequency 100 for 30 minutes) for six sessions per week for four weeks. Intervention 3: Control group: Sham-TENS electrodes are installed in the supraorbital area that does not conduct current. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Saeid Khosrawi
Department of Physical Medicine and Rehabilitation, Al-Zahra Hospital, Sofeh Blvd.
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 khosrawi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Saeid Khosrawi
Department of Physical Medicine and Rehabilitation, Al-Zahra Hospital, Sofeh Blvd.
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 khosrawi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age category above 18 and under 65 years Patients with migraine 18 years 65 years Both Use of migraine prevention in the last two weeks Use of migraine prevention methods such as nerve block, Botox injection, etc. in the previous year Headache due to overdose medication Having severe psychiatric illnesses or physical disorders Having other types of headaches (such as tension and clustering) Pregnancy and lactation Opioid use Failure to complete treatment sessions G43.909 Migraine, unspecified, not intractable, without status migrainosus Treatment - Other Treatment - Other N/A Intervention group: Intervention group 1: For patients, TENS therapy is performed through the electrode pads for the TENS device in the bilateral supraorbital area (intensity: 10 mA, which of course can be reduced depending on individual tolerance - frequency 100 for 30 minutes) for six sessions per week for 4 weeks Intervention group 2: For patients, TENS therapy is performed through the electrode pads for the TENS device in the bilateral infraorbital area (intensity: 10 mA, which of course can be reduced depending on individual tolerance - frequency 100 for 30 minutes) for six sessions per week for four weeks Control group: Sham-TENS electrodes are installed in the supraorbital area that does not conduct current. Migraine severity. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Questionnare of Headache Impact Test 6 score (HIT-6). Disability score in a person's life. Timepoint: Before the intervention, 1 and 3 months after the intervention. Method of measurement: Migrain disability assessment test (MIDAS). Pain. Timepoint: Before the intervention, 1 and 3 months after the intervention. Method of measurement: Visual Analog Scale (VAS). Isfahan University of Medical Sciences Approved 2021-02-07 Ethics committee of Isfahan University of Medical Sciences Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)