Efficacy of Nerve Block Versus Botox in Chronic Migraine Management

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.
• Препарат 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.

Первичные конечные точки

• Reduction in Monthly Migraine Days [Срок оценки: Baseline, 3 months, 6 months post-procedure]

Вторичные конечные точки (4)

• Change in Migraine Severity [Срок оценки: Baseline, 3 months, 6 months post-procedure]
• Frequency of Acute Medication Use [Срок оценки: Baseline, 3 months, 6 months post-procedure]
• Patient Satisfaction and Quality of Life [Срок оценки: Baseline, 3 months, 6 months post-procedure]
• Adverse Events [Срок оценки: Throughout the study period (6 months)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Zagazig University, Faculty of Medicine — Zagazig

Идентификаторы

NCT: NCT06684249 · MigraineNBvsBotox

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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