- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06997562
- Original Trial
Greater Occipital Nerve Blockade and Sphenopalatine Ganglion Blockade in Patients With Episodic Migraine
May 21, 2025 updated by: Ahmed Omar Twaisy, New Valley University
Comparative Efficacy of Greater Occipital Nerve Blockade and Sphenopalatine Ganglion Blockade in Patients With Episodic Migraine
This study compares the effectiveness of greater occipital nerve blockade and sphenopalatine ganglion blockade in reducing headache intensity, duration, frequency, and disability in patients with episodic migraine.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Migraine is a chronic neurological disorder characterized by recurrent headaches, affecting millions globally.
Peripheral nerve blocks such as Greater Occipital Nerve (GON) and Sphenopalatine Ganglion (SPG) blockade have emerged as promising non-pharmacologic treatments.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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New Valley, Egypt, 72511
- New Valley University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adults aged 18-65 years.
- Both sexes.
- Diagnosed with episodic migraine per the International Classification of Headache Disorders, 3rd edition (ICHD-3).
- Failure to achieve adequate relief with at least one prophylactic migraine treatment.
Exclusion Criteria:
- Chronic migraine (≥15 headache days per month).
- History of nerve blocks within the last 6 months.
- Known allergy to anesthetic agents.
- Pregnancy or lactation.
- Active psychiatric conditions affecting compliance.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Greater occipital nerve blockade group
Patients will receive greater occipital nerve blockade using 2 mL of 2% lidocaine at the medial one-third of the line between the occipital protuberance and mastoid process.
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Patients will receive greater occipital nerve blockade using 2 mL of 2% lidocaine at the medial one-third of the line between the occipital protuberance and mastoid process.
|
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Experimental: Sphenopalatine ganglion blockade group
Patients will receive greater sphenopalatine ganglion blockade using 2 mL of 2% lidocaine using a transnasal approach with a cotton swab inserted along the superior middle turbinate to the posterior nasopharyngeal wall.
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Patients will receive greater sphenopalatine ganglion blockade using 2 mL of 2% lidocaine using a transnasal approach with a cotton swab inserted along the superior middle turbinate to the posterior nasopharyngeal wall.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Degree of headache intensity
Time Frame: 3 months post-procedure
|
Reduction in headache intensity will be recorded using numeric rating scale (NRS).
Each patient will be instructed about pain assessment with NRS score.
NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").
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3 months post-procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Migraine disability assessment score
Time Frame: 3 months post-procedure
|
The migraine disability assessment scores are as follows: little or no disability, 5 to 10; moderate disability, 1 to 20; and severe disability, more than 20.
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3 months post-procedure
|
|
Headache duration
Time Frame: 3 months post-procedure
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Headache duration will be recorded.
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3 months post-procedure
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Headache frequency
Time Frame: 3 months post-procedure
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Headache frequency will be recorded.
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3 months post-procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2024
Primary Completion (Actual)
May 3, 2025
Study Completion (Actual)
May 3, 2025
Study Registration Dates
First Submitted
May 21, 2025
First Submitted That Met QC Criteria
May 21, 2025
First Posted (Actual)
May 30, 2025
Study Record Updates
Last Update Posted (Actual)
May 30, 2025
Last Update Submitted That Met QC Criteria
May 21, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms
- Connective Tissue Diseases
- Headache Disorders, Primary
- Headache Disorders
- Cysts
- Mucinoses
- Migraine Disorders
- Ganglion Cysts
- Synovial Cyst
- Anti-Infective Agents
- Physiological Effects of Drugs
- Trace Elements
- Micronutrients
- Anti-Infective Agents, Local
- Iodine
Other Study ID Numbers
- 20250430007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD Sharing Time Frame
After the end of study for one year.
IPD Sharing Access Criteria
The data will be available upon a reasonable request from the corresponding author.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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