NCT06684249

Efficacy of Nerve Block Versus Botox in Chronic Migraine Management

A Randomized Controlled Trial Comparing the Efficacy of Supratrochlear and Greater Occipital Nerve Blocks to Botulinum Toxin A in the Management of Chronic Migraine

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Zagazig University · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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.
DRUG	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.

Timeline

• Start date: 2024-11-10
• Primary completion: 2025-05-10
• Completion: 2025-07-10
• First posted: 2024-11-12
• Last updated: 2024-11-12

Locations

1 site across 1 country: Egypt