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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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180203038600N1
Enrollment
40
Registered
2019-04-09
Start date
2018-02-08
Completion date
Unknown
Last updated
2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic migraine. Migraine without aura [common migraine]

Interventions

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.

Sponsors

Rafsanjan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Frequency of migraine headache attacks. Timepoint: The days 0, 30, 60, 90, 120 after injection. Method of measurement: Migraine diary chart.

Secondary

MeasureTime frame
Quality of life improvement. Timepoint: Synchronous to first variable outcome evaluation. Method of measurement: Quality of life questionnaire approved by WHO.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Fekri Mohadese

Rafsanjan University of Medical Sciences

fekri.mhds@gmail.com+98 34 3428 0038

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026