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Greater Occipital and Supraorbital Nerve Blockade in Migraine Patients

Primary Purpose

Migraine Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lidocaine injections
Saline injections
Sponsored by
Dr. Lutfi Kirdar Kartal Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Disorders focused on measuring Pain, Nerve Blocks, Headache, Local Anaesthetics, Migraine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Blockade Group

    Placebo Group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change of Frequency of Headache
    Number of headache days in a month. Scores from both months were averaged. Minimum=0 Maximum=30. Lower scores mean a better outcome.
    Change of Severity of Headache
    Mean visual analog scale (VAS) scores. Scores from both months were avareged. Minimum=0 Maximum=10. Lower scores mean a better outcome

    Secondary Outcome Measures

    Full Information

    First Posted
    February 8, 2018
    Last Updated
    March 21, 2022
    Sponsor
    Dr. Lutfi Kirdar Kartal Training and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03435185
    Brief Title
    Greater Occipital and Supraorbital Nerve Blockade in Migraine Patients
    Official Title
    Greater Occipital and Supraorbital Nerve Blockade For The Preventive Treatment of Migraine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2014 (Actual)
    Primary Completion Date
    June 1, 2015 (Actual)
    Study Completion Date
    June 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Dr. Lutfi Kirdar Kartal Training and Research Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Migraine Disorders
    Keywords
    Pain, Nerve Blocks, Headache, Local Anaesthetics, Migraine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    103 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Blockade Group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Placebo Group
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Lidocaine injections
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Saline injections
    Intervention Description
    Saline injections. Patients received 2 ml 0.9% saline in bilaterally to greater occipital nerve and supraorbital nerve
    Primary Outcome Measure Information:
    Title
    Change of Frequency of Headache
    Description
    Number of headache days in a month. Scores from both months were averaged. Minimum=0 Maximum=30. Lower scores mean a better outcome.
    Time Frame
    Patients were followed up from baseline to 2 months after first injection.
    Title
    Change of Severity of Headache
    Description
    Mean visual analog scale (VAS) scores. Scores from both months were avareged. Minimum=0 Maximum=10. Lower scores mean a better outcome
    Time Frame
    Patients were followed up for 2 months from baseline after first injection.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28844531
    Citation
    Tang Y, Kang J, Zhang Y, Zhang X. Influence of greater occipital nerve block on pain severity in migraine patients: A systematic review and meta-analysis. Am J Emerg Med. 2017 Nov;35(11):1750-1754. doi: 10.1016/j.ajem.2017.08.027. Epub 2017 Aug 14.
    Results Reference
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    Greater Occipital and Supraorbital Nerve Blockade in Migraine Patients

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