Sphenopalatine Block Versus BOTOX in Management of Chronic Migraine

Cairo University (CU)

Status: Enrolling

Conditions: BOTOX; Sphenopalatine Block; Chronic Migraine

Treatments: Drug: Botulinum Toxin Type A; Drug: Sphenopalatine block

Study type: Interventional

Funder types: Other

Identifiers

NCT06974617

AP2411-501-101-193

Details and patient eligibility

About

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

Full 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

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

64 participants in 2 patient groups

Sphenopalatine block group

Experimental group

Description:

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

Treatment:

Drug: Sphenopalatine block

BOTOX group

Experimental group

Description:

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

Treatment:

Drug: Botulinum Toxin Type A