Comparison of Occipital Nerve and Sphenopalatine Ganglion Blockade

February 5, 2024 updated by: Hanzade Aybuke Unal, Ankara University

Comparison of Greater Occipital Nerve Blockade and Sphenopalatine Ganglion Blockade in Patients With Episodic Migraine

Migraine is a chronic disorder that causes disability. Episodic migraine can be managed by prophylactic medical treatment or interventional pain procedures. Interventional methods used in migraine treatment are greater occipital nerve blockade, lesser occipital nerve blockade, supraorbital nerve blockade, infraorbital nerve blockade, sphenopalatine ganglion blockade, botulinum toxin injection and various radiofrequency applications. The effectiveness of greater occipital nerve blockade and transnasal sphenopalatine ganglion blockade in the treatment of migraine has been proven in various studies.We aimed to evaluate the effects of repetitive greater occipital nerve blockade and transnasal sphenopalatine ganglion blockade in patients with episodic migraine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Migraine is a common primary headache and causes a significant personal, social and financial burden. Migraine is characterized by a semi-headache lasting 4-72 hours, accompanied by nausea/vomiting and photophobia/phonophobia. Migraine can be episodic or chronic. Non-steroidal anti-inflammatory drugs, triptan and ergotamine derivatives can be used in the treatment of acute migraine attacks. Beta-blockers, calcium channel blockers, antiepileptic drugs and antidepressant drugs are among the prophylactic medical treatments. When medical treatment cannot provide adequate pain palliation, in case of side effects or when the patient does not prefer medical treatment, interventional methods come to the fore. Interventional methods that applied in migraine treatment are greater occipital nerve blockade, lesser occipital nerve blockade, supraorbital nerve blockade, infraorbital nerve blockade, sphenopalatine ganglion blockade, botulinum toxin injection and various radiofrequency applications. The effectiveness of greater occipital nerve blockade and transnasal sphenopalatine ganglion blockade in the treatment of migraine has been proven in various studies.

It is stated that sphenopalatine ganglion blockade reduces the number of headache days and is effective in the treatment of acute migraine attacks. Although there are studies on the effectiveness of greater occipital nerve blockade and transnasal sphenopalatine ganglion blockade in migraine treatment, there are no studies comparing their superiority over each other. This study aims to evaluate the effects of repetitive greater occipital nerve blockade and transnasal sphenopalatine ganglion blockade on headache severity, number of days with headache, headache duration, functionality and medication use in patients with episodic migraine, and to compare whether they are superior to each other.

In this single center randomised study participants' episodic migraine will be diagnosed according to the International Classification of Headache Disorders 3rd version (ICHD-3) criteria. Demographic information of the patients, including age, gender, comorbidities, educational status, marital status and migraine duration, will be recorded. Pain intensity of patients will be evaluated using the Numeric Rating Scala (NRS 11) scale, and functionality will be evaluated using MIDAS. Before the procedure, the number of headache days in a 1-month period, headache severity, duration, amount of medication use (non-steroidal anti-inflammatory analgesic, triptan) and MIDAS score will be recorded. Participants will be randomized into 2 groups. When 21 participants are randomized in each group, participant 26 will be excluded from the list because it is in both groups. Group 1 greater occipital nerve block; It will be applied for participants 37, 27, 35, 13, 36, 18, 34, 33, 6, 12, 3, 25, 19, 1, 14, 9, 21, 38, 10, 2. Group 2 sphenopalatine block; It will be applied to patients 22, 1, 24, 11, 35, 33, 17, 14, 8, 31, 39, 5, 2, 28, 41, 36, 15, 7, 34, 27. Greater occipital nerve block will be applied to participant number 26 by repeating the procedure order since the number of participants in each group is equally divided.

Participants will receive greater occipital nerve blockade and transnasal sphenopalatine ganglion blockade once a week for the first month and then once a week for a further 1 month. At the 1st month, 2nd month and 3rd month follow-up visits of the participants, the number of headache days, average pain intensity and pain duration, MIDAS scores and the amount of medication used (non-steroidal anti-inflammatory analgesic, triptan) will be recorded with pain diaries. Participants' pain diaries, MIDAS scores and the amount of medication they use will be recorded. Additionally, possible complications in patients will also be recorded.

Study Type

Interventional

Enrollment (Actual)

40

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

  • Turkey
      • Ankara, Turkey, 06230
        • Ankara University

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:

  • Patients aged 18-65
  • Diagnosing migraine according to the International Classification of Headache Disorders 3rd version (ICHD-3) criteria
  • Patients diagnosed with episodic migraine
  • Failure to provide pain palliation with at least 1 prophylactic medication

Exclusion Criteria:

  • Presence of psychiatric disease that is unstable/not controlled by medical treatment
  • Pregnant patients
  • Those with bleeding diathesis
  • Patients who are allergic to local anesthetics given during the procedure
  • Patients with open skull defects who have undergone craniotomy
  • Patients with previous nasal/sinus surgery
  • Patients with medication overuse headaches
  • Presence of causes such as hypertension, vasculitis, malignancy, etc. that may cause headaches
  • Patients who have received interventional headache treatment in the last 6 months

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: greater occipital nerve block

Following intravenous access and monitoring, participants are placed in the prone position. The medial 1/3 of the line between the protuberance occipital externa and the mastoid process is palpated. The intervention area is cleaned with antiseptic solution. Then, 2 cc of 2% lidocaine is injected into the palpated area after confirming that it is not in the vascular area by negative aspiration. Participants are observed for 30 minutes for possible complications.

The participant will receive a block once a week for the first month and then once a month for the next 2 months.
Procedure: greater occipital nerve block
greater occipital nerve block
Other: transnasal sphenopalatine ganglion block

Following intravenous access and monitoring, patients are placed in the supine position. A cotton swab impregnated with 2 cc of 2% lidocaine is advanced from the nostril along the upper edge of the middle turbinate until it reaches the posterior wall of the nasopharynx. The stick impregnated with local anesthetic is kept in the target area for 20 minutes. Participants are observed for 30 minutes for possible complications.

The participant will receive a block once a week for the first month and then once a month for the next 2 months.
Procedure: transnasal sphenopalatine ganglion block
transnasal sphenopalatine ganglion block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Rating Scale
Time Frame: Post treatment 3 months
Range pain severity 0-10, 0: No pain, 10: Worst Pain
Post treatment 3 months
Migraine attack duration
Time Frame: Post treatment 3 months
mean migraine attack duration (hours) that patients suffer in a month.
Post treatment 3 months
Number of migraine days
Time Frame: Post treatment 3 months
Number of migraine days that patients suffer in a month.
Post treatment 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Migraine Disability Assessment (MIDAS) questionnaire
Time Frame: Post treatment 3 months
Four point likert for every question. Scores ranging from 0 to 5, little or no disability; Scores ranging from 6 to 10 indicate mild disability; Scores ranging from 11 to 20 indicate moderate disability; 21 or over, severe disability.
Post treatment 3 months
medication use
Time Frame: Post treatment 3 months
use of medication (non-steroidal anti-inflammatory analgesic, triptan) recorded during 3 months
Post treatment 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Investigators

  • Principal Investigator: Hanzade A Unal, MD, Ankara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 1, 2023

Primary Completion (Actual)

November 1, 2023

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

February 5, 2024

First Posted (Estimated)

February 6, 2024

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/381

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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