Efficacy of Nerve Block Versus Botox in Chronic Migraine Management
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorZagazig University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Nerve Block Injections
Procedure/SurgeryThis 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
DrugParticipants 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.
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: Nerve Block TherapyExperimental treatment 1 intervention
Group B: Botulinum Toxin A (Botox) TherapyActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline, 3 months, 6 months post-procedureSecondary outcomes
1
Change in Migraine Severity
Assessment of changes in the severity of migraine episodes using a Visual Analog Scale (VAS), a continuous scale ranging from 0 to 100, where 0 represents "no pain" and 100 represents "worst possible pain". This measure evaluates whether the treatment reduces the pain intensity of migraines.
Time frame
Baseline, 3 months, 6 months post-procedure2
Frequency of Acute Medication Use
Evaluation of the change in the frequency of acute migraine medication use, documenting any reductions as a result of the treatment.
Time frame
Baseline, 3 months, 6 months post-procedure3
Patient Satisfaction and Quality of Life
Measured using the Migraine-Specific Quality of Life Questionnaire (MSQ), this outcome assesses changes in the patient's quality of life and satisfaction with treatment.
Time frame
Baseline, 3 months, 6 months post-procedure4
Adverse Events
Monitoring and recording any adverse events associated with the treatments to evaluate safety profiles of the nerve block and Botox interventions.
Time frame
Throughout the study period (6 months)Sponsors and contacts
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Source ClinicalTrials.gov