Efficacy of Nerve Block Versus Botox in Chronic Migraine Management

NCT06684249 | Recruiting

• 1 other identifier: MigraineNBvsBotox
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine whether nerve block injections (specifically, supratrochlear and greater occipital nerve injections) are as effective as Botulinum toxin A (Botox) injections in treating chronic migraine in adults. The main questions it aims to answer are:

• Do nerve block injections reduce the number of monthly migraine days compared to baseline?
• Are there any differences in the frequency of migraine-related symptoms between the nerve block and Botox treatment groups?
• Which treatment leads to higher patient satisfaction and improved quality of life? Participants in this study will:
• Receive either nerve block injections or Botox injections every 12 weeks.
• Visit the clinic once every month for follow-ups and assessments.
• Maintain a headache diary to record the frequency and severity of their migraines and any adverse effects experienced.
• Researchers will compare the outcomes of the two groups to determine if one treatment is superior in terms of efficacy and patient satisfaction.

Conditions

Chronic Migraine; Chronic Migraine, Headache

Keywords

Migraine; Chronic Migraine; Nerve Block; Botulinum Toxin; Botox; Headache

Outcome Measures

Primary Outcomes (1)

• Reduction in Monthly Migraine Days

  The primary outcome is the reduction in the number of migraine days per month. This measure assesses the effectiveness of nerve block injections versus Botox injections in decreasing the frequency of migraine days from baseline to the end of the treatment period.

  Baseline, 3 months, 6 months post-procedure

Secondary Outcomes (4)

• Change in Migraine Severity

  Baseline, 3 months, 6 months post-procedure

• Frequency of Acute Medication Use

  Baseline, 3 months, 6 months post-procedure

• Patient Satisfaction and Quality of Life

  Baseline, 3 months, 6 months post-procedure

• Adverse Events

  Throughout the study period (6 months)

Study Arms (2)

Nerve Block Therapy

EXPERIMENTAL

Participants in this group will receive supratrochlear and greater occipital nerve injections consisting of a combination of local anesthetics and corticosteroids. Injections will be administered once every 12 weeks for a total of 6 months.

Procedure: Nerve Block Injections

Botulinum Toxin A (Botox) Therapy

ACTIVE COMPARATOR

Participants in this group will receive Botulinum toxin A (Botox) injections according to the standard PREEMPT injection protocol for chronic migraine. Injections will be administered once every 12 weeks for a total of 6 months.

Drug: Botulinum Toxin A

Interventions

Nerve Block Injections PROCEDURE

This intervention involves the administration of supratrochlear and greater occipital nerve block injections. The injections consist of a mixture of local anesthetics and corticosteroids, designed to reduce the frequency and severity of migraine episodes. The procedure will be repeated every 12 weeks for a total duration of 6 months to assess the long-term efficacy and safety in managing chronic migraine.

Also known as: Supratrochlear and Greater Occipital Nerve Block

Nerve Block Therapy

Botulinum Toxin A DRUG

Participants in this arm will receive Botulinum toxin A injections as per the PREEMPT protocol tailored for chronic migraine treatment. The treatment involves multiple injections around the head and neck regions, administered every 12 weeks over a 6-month period. This standard approach aims to reduce migraine frequency through neuromodulation of pain pathways.

Also known as: Botox

Botulinum Toxin A (Botox) Therapy

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 to 65 years.
• Diagnosis of chronic migraine, defined as having headaches on 15 or more days per month for more than three months, with at least 8 of those days meeting criteria for migraine.
• Ability to provide informed consent and comply with study requirements.
• No changes in prophylactic migraine medications in the last 3 months.

You may not qualify if:

• History of allergy or hypersensitivity to local anesthetics or Botulinum toxin.
• Previous nerve block or Botox treatment within the last 6 months.
• Significant comorbid psychiatric or neurological disorders that could interfere with study participation or evaluation.
• Pregnancy or breastfeeding.
• Contraindications to either treatment as per product labels.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University, Faculty of Medicine

Zagazig, Sharqia Province, 44519, Egypt

RECRUITING

MeSH Terms

Conditions

Headache; Migraine Disorders

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ahmed Bessar, MD, PhD

  Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed A Bessar, MD, PhD

CONTACT

+201000089595; Ahmedawadbessar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors will be blinded to treatment allocation to ensure unbiased evaluation of efficacy and safety outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Diagnostic and Interventional Radiology

Model Details: Two-group parallel design comparing nerve block injections with Botox injections in chronic migraine management.

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: November 12, 2024
• Study Start: November 10, 2024
• Primary Completion: May 10, 2025
• Study Completion: July 10, 2025
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)