Sphenopalatine Block Versus BOTOX in Management of Chronic Migraine

NCT06974617 | Recruiting

• 1 other identifier: AP2411-501-101-193
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sphenopalatine Block; BOTOX; Chronic Migraine

Outcome Measures

Primary Outcomes (1)

• Degree of pain

  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.

  12 weeks post-procedure

Secondary Outcomes (2)

• Percentage of patients free of headache

  12 weeks post-procedure

• Headache relief rate

  12 weeks post-procedure

Study Arms (2)

Sphenopalatine block group

EXPERIMENTAL

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

Drug: Sphenopalatine block

BOTOX group

EXPERIMENTAL

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

Drug: Botulinum Toxin Type A

Interventions

Sphenopalatine block DRUG

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

Also known as: Lidocaine

Sphenopalatine block group

Botulinum Toxin Type A DRUG

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

BOTOX group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

RECRUITING

MeSH Terms

Interventions

Sphenopalatine Ganglion Block; Lidocaine; Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Autonomic Nerve Block; Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Central Study Contacts

Mohamed E Abdel Fattah, MD

CONTACT

00201284475792; mohamed-elsaid@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Surgical ICU and Pain Management, Faculty of Medicine, National Cancer Institute, Cairo University, Egypt.

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 16, 2025
• Study Start: May 15, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)