Chronic Migraine Prophylaxis: Ultrasound-Guided Greater Occipital Nerve Block Versus Medical Treatment

NCT06122545 | Unknown

• 1 other identifier: 35459/4/22
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this work is to assess the efficacy of ultrasound guided greater occipital nerve block either by local anesthetic or by botulinum toxin in comparison to medical treatment in prevention of chronic migraine.

Conditions

Greater Occipital Nerve Block; Medical Treatment; Chronic Migraine

Outcome Measures

Primary Outcomes (1)

• severity of headache

  severity of headache will be assessed by the total Migraine Disability Assessment (MIDAS) score used to define four grades of migraine-related disability with grade I for "little or no disability" (0-5); grade II for "mild disability" (6-10); grade III for "moderate disability" (11-20); and grade IV for "severe disability" (≥ 21).

  Follow up after 3 months

Secondary Outcomes (2)

• Reduction in headache days per month

  Follow up after 3 months

• Migraine specific quality of life

  Follow up after 3 months

Study Arms (2)

Greater Occipital Nerve Block

EXPERIMENTAL

Patients will receive greater occipital nerve block (GONB) either with local anesthetic (bupivacaine 0.5% 1.5 mL) or with onabotulinum toxin A injection. Ultrasound-guided Greater Occipital Nerve Block (GONB) will be performed to more accurately locate the nerve through searching for the occipital artery in the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process and injection will be done medial to the artery

Procedure: Greater Occipital Nerve Block; Drug: bupivacaine or onabotulinum toxin A injection.

Medical Treatment

EXPERIMENTAL

Patients who will receive medical treatment

Other: Medical Treatment

Interventions

Greater Occipital Nerve Block PROCEDURE

Patients will receive Greater Occipital Nerve Block (GONB) either with local anesthetic (bupivacaine 0.5% 1.5 mL) or with onabotulinum toxin A injection. Ultrasound-guided GONB will be performed to more accurately locate the nerve through searching for the occipital artery in the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process and injection will be done medial to the artery

Greater Occipital Nerve Block

Medical Treatment OTHER

Patients who will receive medical treatment

Medical Treatment

bupivacaine or onabotulinum toxin A injection. DRUG

bupivacaine 0.5% 1.5 mL) or with onabotulinum toxin A injection.

Greater Occipital Nerve Block

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years old.
• Both sexes.
• Patients with chronic migraine.

You may not qualify if:

• Age less than 18 years.
• Patients with medication overuse headache.
• Patients who had used acute pain medications within 24 hours prior to the study visit.
• History of injury to the area of the GON.
• Any prior adverse reactions to local anesthetics.
• Patients with impaired sensation in the occipital area.
• Any neurological or dermatological disease that may have affected skin sensation, bleeding tendency, any skull defect.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

MeSH Terms

Interventions

Bupivacaine; onabotulinum toxin A

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Sarah Z Elramady, Master

CONTACT

00201122848960; sara.zakria@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Neurology

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 8, 2023
• Study Start: May 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: November 8, 2023

Record last verified: 2023-11

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)