Greater Occipital and Supraorbital Nerve Blockade in Migraine Patients

March 21, 2022 updated by: Cem Bölük, Dr. Lutfi Kirdar Kartal Training and Research Hospital

Greater Occipital and Supraorbital Nerve Blockade For The Preventive Treatment of Migraine

The investigators aimed to evaluate the efficacy of greater occipital nerve and supraorbital nerve blockade with local anesthetics for the preventive treatment of migraine without aura.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A mixture of 1 ml 2% lidocaine and 0.9% 1 ml saline was injected bilaterally to GON and SON in the blockade patients. Placebo patients received 2 ml 0.9% saline in the same way. Patients were blinded to kind of injection.

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Not Applicable

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Lack of benefits 1 year from preventive treatment or intolerance to their treatments.
  • 18 ≥ years old
  • Migraine without aura for more than 1 year, minimum of two or more migraine attacks per month.

Exclusion Criteria:

  • Patients with any chronic illness, medication overuse headache, a history of cranial and cervical surgery
  • Allergies to local anesthetics
  • Hemorrhagic diathesis
  • Alcohol or drug abuse

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Blockade Group
Lidocaine injections. Procedure. Grater occipital nerve and supraorbital nerve were blocked with %2 lidocaine. These injections were repeated weekly for three weeks. After treatment was completed, patients were followed up for 2 months at the polyclinic to assess the clinical response.
Procedure: Lidocaine injections
Lidocaine injections. A mixture of 1 ml 2% lidocaine and 0.9% 1 ml saline was injected bilaterally to greater occipital nerve and supraorbital nerve in the blockade patients.
PLACEBO_COMPARATOR: Placebo Group
Saline injections. Procedure. Grater occipital nerve and supraorbital nerve were injected with saline.These injections were repeated weekly for three weeks. After treatment was completed, patients were followed up for 2 months at the polyclinic to assess the clinical response.
Procedure: Saline injections
Saline injections. Patients received 2 ml 0.9% saline in bilaterally to greater occipital nerve and supraorbital nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Frequency of Headache
Time Frame: Patients were followed up from baseline to 2 months after first injection.
Number of headache days in a month. Scores from both months were averaged. Minimum=0 Maximum=30. Lower scores mean a better outcome.
Patients were followed up from baseline to 2 months after first injection.
Change of Severity of Headache
Time Frame: Patients were followed up for 2 months from baseline after first injection.
Mean visual analog scale (VAS) scores. Scores from both months were avareged. Minimum=0 Maximum=10. Lower scores mean a better outcome
Patients were followed up for 2 months from baseline after first injection.

Collaborators and Investigators

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

Sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

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, 2014

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

February 8, 2018

First Submitted That Met QC Criteria

February 14, 2018

First Posted (ACTUAL)

February 15, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 23, 2022

Last Update Submitted That Met QC Criteria

March 21, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/514/85/5

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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