NCT06974617

Sphenopalatine Block Versus BOTOX in Management of Chronic Migraine

Sphenopalatine Block Versus BOTOX in Management of Chronic Migraine: A Randomized Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Sphenopalatine Block
• BOTOX
• Chronic Migraine

Interventions

Type	Name	Description
DRUG	Sphenopalatine block	Patients will receive 2 ml of 2% lidocaine using a nasal applicator in each nostril.
DRUG	Botulinum Toxin Type A	Patients will receive Botulinum Toxin Type A 100 units administered in a fixed dose and site paradigm.

Timeline

• Start date: 2025-05-15
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2025-05-16
• Last updated: 2025-05-16

Locations

1 site across 1 country: Egypt