Comparison of two methods of BOTOX injection (FTP & FSFD) to improve of chronic migrainous headache patients
Phase 2
- Conditions
- chronic migraine.Migraine without aura [common migraine]
- Registration Number
- IRCT20180203038600N1
- Lead Sponsor
- Rafsanjan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
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
Exclusion Criteria
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of migraine headache attacks. Timepoint: The days 0, 30, 60, 90, 120 after injection. Method of measurement: Migraine diary chart.
- Secondary Outcome Measures
Name Time Method Quality of life improvement. Timepoint: Synchronous to first variable outcome evaluation. Method of measurement: Quality of life questionnaire approved by WHO.