Clinical trial NCT06684249: Efficacy of Nerve Block Versus Botox in Chronic Migraine Management
Official title: A Randomized Controlled Trial Comparing the Efficacy of Supratrochlear and Greater Occipital Nerve Blocks to Botulinum Toxin A in the Management of Chronic Migraine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Migraine
Chronic Migraine, Headache
Keywords: Migraine
Chronic Migraine
Nerve Block
Botulinum Toxin
Botox
Headache
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-11-12
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-group parallel design comparing nerve block injections with Botox injections in chronic migraine management.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Reduction in Monthly Migraine Days
timeFrame: Baseline, 3 months, 6 months post-procedure
Secondary outcomes:
measure: Change in Migraine Severity
timeFrame: Baseline, 3 months, 6 months post-procedure
measure: Frequency of Acute Medication Use
timeFrame: Baseline, 3 months, 6 months post-procedure
measure: Patient Satisfaction and Quality of Life
timeFrame: Baseline, 3 months, 6 months post-procedure
measure: Adverse Events
timeFrame: Throughout the study period (6 months)
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University, Faculty of Medicine
state: El-Sharkia
Study officials:
affiliation: Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.
name: Ahmed Bessar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: