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IRCT20210212050334N3 IRCT 2022-05-30 Rasht University of Medical Sciences Evaluation of the effect of RIPC (remote ischemic preconditioning) on Migraine headache Evaluation of the effect of RIPC (remote ischemic preconditioning) on Migraine headache in patients with migraine : a pilot study 2022-06-22 anticipated 30 Complete https://irct.ir/trial/63227 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, restricted randomization method in the form of block randomization will be used to allocate patients into intervention and control groups. For this purpose, four blocks with a ratio of 1: 1 will be considered. Sequences are marked in sealed envelopes with the letters A (intervention group) and B (control group). We will consider the size of the blocks randomly with a size of 4 or 6 to prevent the latest allocation from being detected. In the randomization process, random allocation sequences are identified by a statistician, and two student collaborators in the project will register participants and allocate them to interventions, Blinding description: Factors that cause errors in clinical trial studies are: patient awareness, researcher and researcher evaluation of the type of treatment prescribed. In the present study, according to the type of intervention approach used, patients, nurses and physicians will be aware of the new treatment process and there is no way to not inform them. However, analysts and the assignment of ten samples to groups will be blind. Therefore, the present study is designed for double blinds. N/A Migraine. Intervention 1: Intervention group: The patient undergoes RIPC protocol 6 days/ week. sphygmomanometer will be fastened to the patient's arm and will be remained under the pressure of 200 mmHg for 5 minutes (ischemic phase) , followed by 5 minutes of rest (reperfusion phase). This cycle will be performed 3 times. Intervention 2: Control group: In the control group, RIPC operation is performed as a sham or pseudo-ischemia, and no pressure is applied on arm. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is -It will be determined later.
public Amaneh Mohammadi Roushandeh
Anatomical Sciences department, Medicine faculty, Guilan University of Medical Sciences, rasht, Guilan
Rasht Iran (Islamic Republic of) 4144666949 +98 13 3333 5820 mohammadi_roushandeh@gums.ac.ir Rasht University of Medical Sciences scientific Amaneh Mohammadi Roushandeh
Anatomical Sciences department, Medicine faculty, Guilan University of Medical Sciences, rasht, Guilan
Rasht Iran (Islamic Republic of) 4144666949 +98 13 3333 5820 mohammadi_roushandeh@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) Patient have at least 5 headache attacks lasting 4–72 hours (without treatment or unsuccessful treatment) Age range 18 to 50 years Both male and female Gender The onset of migraines before menopause Ability of Patient to distinguish migraine headaches from other conditions Ability to fill out questionnaire Signed informed consent 18 years 50 years Both Presence of underlying diseases, history of chronic diseases or kidney, liver, cardiovascular, renal, pulmonary diseases, any malignancy, autoimmunity diseases, diabetes mellitus Convulsions Menopause Head and neck trauma Existence of asthenic damage Mental disorders and major depression according to DSM4 Botox injection in the last 6 months Pregnancy and lactation Severe hypertension greater than 160/90 mm / hg Non-migraine headaches such as tension headaches that occur more than 12 times a month and cervicogenic Drug and alcohol dependency during one year prior to the study Rheumatism Migraine with aura History of off - pump surgery G43.711 Chronic migraine without aura, Intractable, With status migraineurs Treatment - Other Treatment - Other Intervention group: The patient undergoes RIPC protocol 6 days/ week. sphygmomanometer will be fastened to the patient's arm and will be remained under the pressure of 200 mmHg for 5 minutes (ischemic phase) , followed by 5 minutes of rest (reperfusion phase). This cycle will be performed 3 times. Control group: In the control group, RIPC operation is performed as a sham or pseudo-ischemia, and no pressure is applied on arm. Headache intensity. Timepoint: Each time after the migraine attack (day 0 -60). Method of measurement: According to the VAS index. Migraine-induced disability. Timepoint: Days 0 and 90. Method of measurement: According to the MIDAS index. Time of migraine start. Timepoint: At the admission. Method of measurement: Asking from patients. Blood CGRP level. Timepoint: Days 0and 60. Method of measurement: ELISA kit. Blood lactate level. Timepoint: ِDays 0 and 60. Method of measurement: Blood test. Migraine-induced disability. Timepoint: Days 0 and 90. Method of measurement: According to the MIDAS index. Rasht University of Medical Sciences Approved 2022-03-09 Research Ethic Committees of Guilan University of Medical science Vice Chancellor of Research and Technology of Guilan University of Medical Sciences,Shahid Siadati St., Namjoo St. rasht Guilan Iran (Islamic Republic of)