<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04505280</url>
  </required_header>
  <id_info>
    <org_study_id>2011-KAEK-2</org_study_id>
    <nct_id>NCT04505280</nct_id>
  </id_info>
  <brief_title>Greater Occipital Nerve and Cervical Region Injection in Patients With Trigeminal Neuralgia</brief_title>
  <official_title>Greater Occipital Nerve and Cervical Region Injection in Patients With Trigeminal Neuralgia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Lutfi Kirdar Kartal Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dr. Lutfi Kirdar Kartal Training and Research Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate the efficacy of greater occipital nerve block and&#xD;
      cervical injections with lidocaine&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After being informed about the study and potantiel risks, all patients giving informed&#xD;
      consent will undergo randomization in 1:1 ratio to 1% lidocaine or 0.9% saline groups&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">December 30, 2022</completion_date>
  <primary_completion_date type="Actual">October 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy on pain severity</measure>
    <time_frame>3 months</time_frame>
    <description>Efficacy on pain scores. Visual Analogue Scale (VAS). VAS is a ten-point scale where zero refers to no pain and ten refers to maximal pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy on pain frequency</measure>
    <time_frame>3 months</time_frame>
    <description>Pain frequency per day</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Trigeminal Neuralgia</condition>
  <arm_group>
    <arm_group_label>Active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>%1 lidocaine injections to greater occipital nerve and cervical region once a week for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine 1% Injectable Solution</intervention_name>
    <description>Greater occipital nerve and cervical region injections once a week for 4 weeks</description>
    <arm_group_label>Active</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Classical Trigeminal Neuralgia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Secondary Trigeminal Neuralgia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Afyonkarahisar University of Health Sciences</name>
      <address>
        <city>Afyonkarahisar</city>
        <state>Kartal/Soğanlık</state>
        <zip>03217</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>February 18, 2023</last_update_submitted>
  <last_update_submitted_qc>February 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dr. Lutfi Kirdar Kartal Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Cem Bölük</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Trigeminal Neuralgia</keyword>
  <keyword>Greater Occipital Nerve Block</keyword>
  <keyword>Lidocaine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trigeminal Neuralgia</mesh_term>
    <mesh_term>Neuralgia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04505280
org study id: 2011-KAEK-2
nct id: NCT04505280
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate the efficacy of greater occipital nerve block and
      cervical injections with lidocaine
After being informed about the study and potantiel risks, all patients giving informed
      consent will undergo randomization in 1:1 ratio to 1% lidocaine or 0.9% saline groups
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Efficacy on pain severity
time frame: 3 months
description: Efficacy on pain scores. Visual Analogue Scale (VAS). VAS is a ten-point scale where zero refers to no pain and ten refers to maximal pain
measure: Efficacy on pain frequency
time frame: 3 months
description: Pain frequency per day
arm group label: Active
arm group type: Experimental
description: %1 lidocaine injections to greater occipital nerve and cervical region once a week for 4 weeks
intervention type: Drug
intervention name: Lidocaine 1% Injectable Solution
description: Greater occipital nerve and cervical region injections once a week for 4 weeks
arm group label: Active
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Dr. Lutfi Kirdar Kartal Training and Research Hospital
investigator full name: Cem Bölük
investigator title: Principal Investigator
mesh term: Trigeminal Neuralgia
mesh term: Neuralgia
mesh term: Lidocaine
sharing ipd: No