Efficacy of Nerve Block Versus Botox in Chronic Migraine Management

NCT ID: NCT06684249

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-10
• Study Completion Date: 2025-07-10

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.

Detailed Description

This randomized controlled trial aims to assess the comparative efficacy of supratrochlear and greater occipital nerve block injections versus Botulinum toxin A (Botox) injections in the management of chronic migraine. Chronic migraine, characterized by headaches on fifteen or more days per month, significantly impacts quality of life and productivity. Effective management strategies are crucial for improving patient outcomes.

Study Design: Participants will be randomly assigned to one of two treatment arms:

• Nerve block injections group, receiving supratrochlear and greater occipital nerve injections with a combination of local anesthetics and corticosteroids.
• Botox injections group, receiving the standard Botox treatment protocol recommended for chronic migraine.

Each participant will receive their assigned treatment once every 12 weeks for a total of 6 months.

The primary endpoint will be the reduction in the number of migraine days per month from baseline to the end of the treatment period. Secondary endpoints will include changes in migraine severity, frequency of acute medication use, patient-reported outcomes on pain and migraine-related disability, and treatment safety and tolerability.

Procedures:

• Baseline evaluation will include medical history, migraine frequency and severity assessment, and previous treatment history.
• Follow-up visits will occur monthly, with additional evaluations at the end of the treatment period.
• Participants will be asked to maintain a headache diary throughout the study period to record migraine occurrence, characteristics, and any acute medication use.

Significance: This study will provide valuable data on the efficacy of nerve block injections compared to Botox, potentially offering an alternative treatment for patients who do not respond well to Botox injections. Additionally, findings may influence clinical practice guidelines and patient management strategies for chronic migraine.

Relevance: Given the burden of chronic migraine and the variable patient response to existing therapies, exploring alternative treatments is crucial. This study addresses this need by comparing two distinct therapeutic approaches, thus contributing to personalized migraine management.

Conditions

Chronic Migraine; Chronic Migraine, Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Nerve Block Therapy

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.

Group Type: EXPERIMENTAL

Nerve Block Injections

Intervention Type: 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.

Botulinum Toxin A (Botox) Therapy

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.

Group Type: ACTIVE_COMPARATOR

Botulinum Toxin A

Intervention Type: 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.

Interventions

Nerve Block Injections

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.

Intervention Type: PROCEDURE

Botulinum Toxin A

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.

Intervention Type: DRUG

Other Intervention Names

Supratrochlear and Greater Occipital Nerve Block; Botox

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

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

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ahmed Awad Bessar

Assistant Professor of Diagnostic and Interventional Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Bessar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.

Locations

Zagazig University, Faculty of Medicine

Zagazig, Sharqia Province, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed A Bessar, MD, PhD

Role: CONTACT

Ahmedawadbessar@gmail.com

+201000089595

Facility Contacts

Ahmed A Bessar, MD, PhD

Role: primary

ahmedawadbessar@gmail.com

+201000089595

Other Identifiers

MigraineNBvsBotox

Identifier Type: -

Identifier Source: org_study_id