Sphenopalatine Block Versus BOTOX in Management of Chronic Migraine

NCT ID: NCT06974617

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-15
• Study Completion Date: 2025-10-01

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

Conditions

Sphenopalatine Block; BOTOX; Chronic Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sphenopalatine block group

Patients will receive 2 ml of 2% lidocaine using a nasal applicator in each nostril.

Group Type: EXPERIMENTAL

Sphenopalatine block

Intervention Type: DRUG

Patients will receive 2 ml of 2% lidocaine using a nasal applicator in each nostril.

BOTOX group

Patients will receive Botulinum Toxin Type A 100 units administered in a fixed dose and site paradigm.

Group Type: EXPERIMENTAL

Botulinum Toxin Type A

Intervention Type: DRUG

Patients will receive Botulinum Toxin Type A 100 units administered in a fixed dose and site paradigm.

Interventions

Sphenopalatine block

Patients will receive 2 ml of 2% lidocaine using a nasal applicator in each nostril.

Intervention Type: DRUG

Botulinum Toxin Type A

Patients will receive Botulinum Toxin Type A 100 units administered in a fixed dose and site paradigm.

Intervention Type: DRUG

Other Intervention Names

Lidocaine

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Elsaid Abdel Fattah

Lecturer of Anesthesia, Surgical ICU and Pain Management, Faculty of Medicine, National Cancer Institute, Cairo University, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohamed E Abdel Fattah, MD

Role: CONTACT

mohamed-elsaid@cu.edu.eg

00201284475792

Facility Contacts

Mohamed E Abdel Fattah, MD

Role: primary

mohamed-elsaid@cu.edu.eg

00201284475792

Other Identifiers

AP2411-501-101-193

Identifier Type: -

Identifier Source: org_study_id