Actively Recruiting
Sphenopalatine Block Versus BOTOX in Management of Chronic Migraine: A Randomized Clinical Trial
Led by Cairo University · Updated on 2025-05-16
64
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of sphenopalatine ganglion block (SPGB) compared to intramuscular Botulinum Toxin Type A (BOTOX) injections in people with chronic migraine. Migraines are classified as primary headaches and involve complex nerve interactions. The study aims to compare these two treatments to better understand their effects on migraine pain. Participants are randomly assigned to one of two groups: one receiving 2 ml of 2% lidocaine administered via a nasal applicator in each nostril as the sphenopalatine block, and the other receiving 100 units of Botulinum Toxin Type A injected at fixed sites. Both treatments are given once, and the study does not use masking or blinding. During the 12 weeks after treatment, participants will have their pain levels assessed to measure treatment impact. Researchers will also track the percentage of patients free from headache and the rate of headache relief. The study involves regular monitoring of symptoms and treatment effects over this period to evaluate and compare both interventions.
CONDITIONS
Brief Title
Sphenopalatine Block Versus BOTOX in Management of Chronic Migraine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 and 65 years.
- Both sexes.
- Chronic migraine with headaches on 15 or more days per month for at least 3 months, including at least 8 days meeting migraine criteria or responding to migraine-specific treatment.
You will not qualify if you...
- Patients with medication overuse headache.
- Bleeding disorders.
- Abnormal neurological examination.
- History of allergy to local anesthetics or BOTOX.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment with 12 weeks of observation
Participants receive either a sphenopalatine block with lidocaine or Botulinum Toxin Type A injections to manage chronic migraine.
1 treatment visit and periodic follow-up visits up to 12 weeks
Trial Site Locations
Total: 1 location
1
Cairo University
Cairo, Egypt, 12613
Actively Recruiting
Research Team
M
Mohamed E Abdel Fattah, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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