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Study aim:
Determining the effect of botulinum toxin A in patients with treatment-resistant migraine and tension headaches in individuals aged 20 to 70 years
Design:
Phase 3 clinical trial study without a control group with two parallel groups without blinding on 50 patients divided into two groups of 25 people receiving standard medication
Settings and conduct:
We do the work in the city of Qom. We have two groups of patients for injection. One group of patients with treatment-resistant tension and one group of patients with treatment-resistant migraine. It is done with an insulin syringe and subcutaneously and in the injection areas according to the preempt protocol in migraine patients and dispersion and spasm of painful areas in tension patients.
Participants/Inclusion and exclusion criteria:
Inclusion criteria: All patients aged 20 to 70 years with treatment-resistant migraine and tension headaches
Exclusion criteria: Age less than 20 and more than 70 years old, presence of neuromuscular diseases, and pregnancy
Intervention groups:
We will have two intervention groups: one group of people with treatment-resistant tension headaches and one group of people with treatment-resistant migraine headaches. We will inject each group with the drug and then evaluate them over a period of 3 months
Main outcome variables:
Change in frequency (number of headaches per week) ; severity (via VAS scale) ; headache duration (in hours) ; change in quality of life (with WHO questionnaire)