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
Zagazig University
64 participants
Nov 10, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria5
- 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.
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Interventions
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.
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.
Locations(1)
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NCT06684249