Sphenopalatine Block Versus BOTOX in Management of Chronic Migraine

Not Applicable

Recruiting

• Conditions: Sphenopalatine Block; Chronic Migraine; BOTOX
• Interventions: Drug: Sphenopalatine block; Drug: Botulinum Toxin Type A

• Registration Number: NCT06974617
• Lead Sponsor: Cairo University

Brief 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

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-08
• Study Start: 2025-05-15
• Study First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-15
• Study First Posted: 2025-05-16
• Last Update Posted: 2025-05-16
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Degree of pain	12 weeks post-procedure	The patients will be shown how to use the Visual Analogue Scale (VAS); 0-10 point where 0 = no pain and 10 = worst imaginable pain. VAS will be noted as well as after procedure, four-week, and 12-weeks period.

Secondary Outcome Measures

Name	Time	Method
Headache relief rate	12 weeks post-procedure	Headache relief rate (percentage of patients with 50% or more reduction in headache intensity at four-week and 12-weeks period).
Percentage of patients free of headache	12 weeks post-procedure	The percentage of patients free of headache at baseline (just before the procedure), after procedure, four-week, and 12-weeks period.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt