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IRCT20180203038600N1 IRCT 2019-04-09 Rafsanjan University of Medical Sciences Comparison of two methods of BOTOX injection (FTP & FSFD) to improve of chronic migrainous headache patients A randomized clinical trial for comparison of two methods of BOTOX injection (FTP & FSFD) to improve headache frequency & quality of life of migrainous headache patients 2018-02-08 anticipated 40 Complete https://irct.ir/trial/29418 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: randomization as simple randomized & individualization with using of locked pockets that data bases is hiding from neurologist who visits & evaluates patients & statistical consultant will analyses data bases, too. 2 chronic migraine. Intervention 1: BOTOX injection for chronic migraine headache patients by FTP method. Intervention 2: Intervention group: BOTOX injection for chronic migraine headache patients by FSFD method. Yes - There is a plan to make this available What will be shared: All documents reveal based on approved international diary migraine chart & life style questionnaire. When: We can publish all result 6 month after data collection & analysis. To whom: All physicians & researchers can use data for research & treatment. Conditions: All physicians & researchers can use data for research & treatment. Where to obtain: they can contact with this E-mail : fekri.mhds@gmail.com. How to obtain: Job & reasons of user Comments:
public Dr.Fekri Mohadese
Ali ebne Abi taleb hospital, Imam Ali Blvd., Ali ebne Abi Taleb square, Rafsanjan Town
Rafsanjan Iran (Islamic Republic of) 7717933777 +98 34 3428 0038 fekri.mhds@gmail.com Rafsanjan University of Medical Sciences scientific Dr.Salehi Hossein
Ali ebne Abitaleb hospital, Imam Ali Blvd., Ali ebne Abitaleb Square, Rafsanjan Town
Rafsanjan Iran (Islamic Republic of) 7717933777 +98 34 3428 0038 dr_hosseinsalehi@yahoo.com Rafsanjan University of Medical Sciences Iran (Islamic Republic of) Patients who have at least 15 days headache that maintain for 4 hour or more Patients who had no improvement in severity & frequency of headaches by using prophylactic drug agents like that Beta blockers, CCB, anti convulsive drugs & anti depressant 18 years 65 years Both Pregnancy History of BOTOX injection or other Botulinum serotypes Neuromuscular junction disease Psychologic disorders that have negative impact on clinical trial Beck severity scale of depression more than 24 Primary or secondary headaches due to another reasons Complicated migraine Drug sensivity Coagulopathy Infection of injection skin site G43.0 Migraine without aura [common migraine] Treatment - Drugs Treatment - Drugs BOTOX injection for chronic migraine headache patients by FTP method Intervention group: BOTOX injection for chronic migraine headache patients by FSFD method Frequency of migraine headache attacks. Timepoint: The days 0, 30, 60, 90, 120 after injection. Method of measurement: Migraine diary chart. Quality of life improvement. Timepoint: Synchronous to first variable outcome evaluation. Method of measurement: Quality of life questionnaire approved by WHO. Rafsanjan University of Medical Sciences Approved 2017-12-26 Ethics committee of Rafsanjan university of medical science Rafsanjan university of medical science, Imam Ali Blvd., Ali ebne Abi taleb square, Rafsanjan Town Rafsanjan Kerman Iran (Islamic Republic of)