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Sphenopalatine Block Versus BOTOX in Management of Chronic Migraine

Sphenopalatine Block Versus BOTOX in Management of Chronic Migraine

Recruiting
18-65 years
All
Phase N/A

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Overview

This trial compares the efficacy and safety of sphenopalatine ganglion block (SPGB) and intramuscular BOTOX injection in chronic migraine.

Description

The International Headache Society's Headache Classification Committee recognizes three broad categories of headaches: primary headaches, secondary headaches, and a third catchall category called "painful cranial neuropathies, other facial pain, and other headaches." Migraines fall into the primary headache category.

Sphenopalatine ganglion (SPG), or the pterygopalatine ganglion (PPG), is a large extracranial parasympathetic ganglion with multiple neural connections, including autonomic and motor.

The botulinum toxin (BOTOX®), which can exert a paralytic effect by binding to presynaptic cholinergic nerve terminals at the neuromuscular junction, is produced by the Gram-positive, rod-shaped, spore-forming, anaerobic bacterium Clostridium botulinum. It internalizes and inhibits the exocytosis of the neurotransmitter acetylcholine by decreasing the frequency of acetylcholine release

Eligibility

Inclusion Criteria:

  • Age 18 and 65 years.
  • Both sexes.
  • Chronic migraine. Chronic migraine, defined as headaches on ≥15 days per month for ≥3 months, of which ≥8 days meet criteria for migraine without aura or respond to migraine-specific treatment according to International Classification of Headache Disorders-3 Beta.

Exclusion Criteria:

  • Patients with medication over use headache.
  • Bleeding disorders.
  • Abnormal neurological examination.
  • History of allergy to local anesthetics or BOTOX.

Study details
    Sphenopalatine Block
    BOTOX
    Chronic Migraine

NCT06974617

Cairo University

21 October 2025

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