<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/NCT03245294</url>
  </required_header>
  <id_info>
    <org_study_id>2017-05-039</org_study_id>
    <nct_id>NCT03245294</nct_id>
  </id_info>
  <brief_title>Factors Contributing to the Pressure Wave Form Changes</brief_title>
  <official_title>Analysis of Factors Contributing to the Pressure Wave Form Changes During Lumbar Epidural Injections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Keimyung University Dongsan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Keimyung University Dongsan Medical Center</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 purpose of this study is to evaluate the decrease pattern of lumbar epidural pressure&#xD;
      from ligamentum flavum to epidural space and analyzing factors contributing this pressure&#xD;
      change pattern.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Loss of resistance (LOR) is the most commonly used method to confirm the epidural space. The&#xD;
      advantage of LOR is its simplicity; only saline or air filled syringe is required. LOR is&#xD;
      felt through the sudden decrease of pressure and this pressure gradient is generated when the&#xD;
      needle is within the passage of interspinous ligament, ligamentum flavum and epidural space.&#xD;
      The presence of ligamentum flavum is crucial for the identification of epidural space by LOR.&#xD;
      However, gaps in ligamentum flavum, paravertebral muscle and cyst in interspinous ligament&#xD;
      can modify this passage and a false LOR is generated consequentially. The false positive rate&#xD;
      of the lumbar and cervical area was reported to be 8.3~17% and 30~68%, respectively. If the&#xD;
      false positive rate is high, repeated attempts of epidural steroid injection (ESI) are&#xD;
      required, with additional discomfort or pain to the patient.&#xD;
&#xD;
      The high rate of false LOR has prompted the design of adjunctive modalities. Among these,&#xD;
      epidural pressure waveform analysis (EPWA) using pressure transducer has been reported. If&#xD;
      the epidural needle or catheter is positioned accurately in the epidural space, a pulsatile&#xD;
      wave coinciding with arterial pulsations can be seen through the monitor.&#xD;
&#xD;
      Recent study suggested that significant abrupt pressure decrease occurs when cervical&#xD;
      epidural injection was done via paramedian approach rather than midline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">April 11, 2018</completion_date>
  <primary_completion_date type="Actual">April 11, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pattern of epidural pressure decrease</measure>
    <time_frame>1 second after the completion of entry from ligamentum flavum to epidural space</time_frame>
    <description>abrupt or gradual decrease of epidural pressure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>factors contributing the epidural pressure pattern</measure>
    <time_frame>60 minutes after the completion of entry from ligamentum flavum to epidural space</time_frame>
    <description>factors contributing the epidural pressure decrease(abrupt vs. gradual) pattern</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Analysis, Event History</condition>
  <arm_group>
    <arm_group_label>Lumbar ESI with paramedian approach</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lumbar ESI with paramedian approach</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lumbar ESI with midline approach</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lumbar ESI with midline approach</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>lumbar epidural injection</intervention_name>
    <description>the pattern of pressure decrease from ligamentum flavum to epidural space</description>
    <arm_group_label>Lumbar ESI with midline approach</arm_group_label>
    <arm_group_label>Lumbar ESI with paramedian approach</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  lumbar herniated nucleus&#xD;
&#xD;
          -  lumbar spinal stenosis&#xD;
&#xD;
          -  internal disc disruption&#xD;
&#xD;
          -  NRS &gt; 5&#xD;
&#xD;
          -  ODI &gt; 20&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  coagulopathy&#xD;
&#xD;
          -  allergy to contrast media&#xD;
&#xD;
          -  infection at needle insertion site&#xD;
&#xD;
          -  absence of lumbar MRI&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  previous lumbar spine surgery&#xD;
&#xD;
          -  neurological symptoms requiring prompt reevalution&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ji Hee Hong, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Keimyung University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ji Hee Hong</name>
      <address>
        <city>Daegu</city>
        <zip>700712</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>April 13, 2018</last_update_submitted>
  <last_update_submitted_qc>April 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Keimyung University Dongsan Medical Center</investigator_affiliation>
    <investigator_full_name>Ji Hee Hong</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>cervical epidural space</keyword>
  <keyword>abrupt pressure decrease</keyword>
  <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/NCT03245294
org study id: 2017-05-039
nct id: NCT03245294
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the decrease pattern of lumbar epidural pressure
      from ligamentum flavum to epidural space and analyzing factors contributing this pressure
      change pattern.
Loss of resistance (LOR) is the most commonly used method to confirm the epidural space. The
      advantage of LOR is its simplicity; only saline or air filled syringe is required. LOR is
      felt through the sudden decrease of pressure and this pressure gradient is generated when the
      needle is within the passage of interspinous ligament, ligamentum flavum and epidural space.
      The presence of ligamentum flavum is crucial for the identification of epidural space by LOR.
      However, gaps in ligamentum flavum, paravertebral muscle and cyst in interspinous ligament
      can modify this passage and a false LOR is generated consequentially. The false positive rate
      of the lumbar and cervical area was reported to be 8.3~17% and 30~68%, respectively. If the
      false positive rate is high, repeated attempts of epidural steroid injection (ESI) are
      required, with additional discomfort or pain to the patient.

      The high rate of false LOR has prompted the design of adjunctive modalities. Among these,
      epidural pressure waveform analysis (EPWA) using pressure transducer has been reported. If
      the epidural needle or catheter is positioned accurately in the epidural space, a pulsatile
      wave coinciding with arterial pulsations can be seen through the monitor.

      Recent study suggested that significant abrupt pressure decrease occurs when cervical
      epidural injection was done via paramedian approach rather than midline.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: pattern of epidural pressure decrease
time frame: 1 second after the completion of entry from ligamentum flavum to epidural space
description: abrupt or gradual decrease of epidural pressure
measure: factors contributing the epidural pressure pattern
time frame: 60 minutes after the completion of entry from ligamentum flavum to epidural space
description: factors contributing the epidural pressure decrease(abrupt vs. gradual) pattern
arm group label: Lumbar ESI with paramedian approach
arm group type: Active Comparator
description: Lumbar ESI with paramedian approach
arm group label: Lumbar ESI with midline approach
arm group type: Active Comparator
description: Lumbar ESI with midline approach
intervention type: Procedure
intervention name: lumbar epidural injection
description: the pattern of pressure decrease from ligamentum flavum to epidural space
arm group label: Lumbar ESI with midline approach
arm group label: Lumbar ESI with paramedian approach
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ji Hee Hong, PhD
role: Principal Investigator
affiliation: Keimyung University
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Keimyung University Dongsan Medical Center
investigator full name: Ji Hee Hong
investigator title: Professor
sharing ipd: No