<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/NCT02185508</url>
  </required_header>
  <id_info>
    <org_study_id>ABC-14-06</org_study_id>
    <nct_id>NCT02185508</nct_id>
  </id_info>
  <brief_title>Intra-operatory Neurophysiological Monitoring Changes as a Predictive Clinical Outcome Measure in Lumbar Radiculopathy.</brief_title>
  <official_title>Intra-operatory Neurophysiological Monitoring Changes as a Predictive Clinical Outcome Measure in Radiculopathy Associated to Lumbar Disk Disease. Two Years Follow-up</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>American British Cowdray Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>American British Cowdray Medical Center</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the relation among: (1) changes in voltage and&#xD;
      amplitude of trans-operatory records obtained through the use of Intra-operative&#xD;
      Neurophysiological Monitoring (IONM), and (2) clinical outcomes; of patients who underwent 1&#xD;
      or 2 levels surgical decompression at lumbar spine.&#xD;
&#xD;
      IONM is the use of real time neurophysiological techniques during spinal surgeries. The&#xD;
      modalities included in this study are:&#xD;
&#xD;
        -  Somatosensory evoked potentials (SSEPs).&#xD;
&#xD;
        -  Trans-cranial electric motor evoked potentials (tceMEPs).&#xD;
&#xD;
        -  Spontaneous electromyography (EMG).&#xD;
&#xD;
      Clinical outcome of the patients will be assessed through a careful evaluation of clinical&#xD;
      data, as well as the application of three outcome scales:&#xD;
&#xD;
        -  Oswestry Disability Index 2.1a&#xD;
&#xD;
        -  Visual Analogue Scale for Pain&#xD;
&#xD;
        -  Patient's Overall Impression of Change&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Radiculopathy associated to lumbar disk disease is one of the most common reasons for a spine&#xD;
      surgeon to be consulted. The pathophysiology of degenerative spine disease is acknowledged as&#xD;
      complex, involving a wide array of risk factors ranging from genetic polymorphisms, to&#xD;
      behavioural characteristics. While conflicting opinions exist with regard the direction of&#xD;
      treatment for lumbar disk disease, de-compressive surgery is currently the gold standard for&#xD;
      patients in which protocols of physiotherapy and analgesics have failed to comply.&#xD;
&#xD;
      Intraoperative neurophysiological monitoring (IONM) is widely used in the practice of spine&#xD;
      surgery as a mean of preventing and reducing severe complications inherent to surgical&#xD;
      techniques like paraparesis, paraplegia and quadriplegia. Indeed, a great deal of funding and&#xD;
      work have been devoted to research projects seeking to determine the impact of IONM in&#xD;
      reducing these risks. The results of such projects have been notoriously interesting, and&#xD;
      frequently opposing to each other. This has lead to an open debate on weather the use of IONM&#xD;
      may or not be justified by better outcomes in patients who undergo such procedure. To our&#xD;
      knowledge there is no study in the literature that has addressed the potential role of the&#xD;
      IOM to predict the long-term outcome of the patient in therms of radicular symptoms&#xD;
      improvement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2011</start_date>
  <completion_date type="Anticipated">August 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Electrophysiological changes measured through intraoperative neurophysiological monitoring.</measure>
    <time_frame>Trans-operative</time_frame>
    <description>Standard register electrodes where placed from L1 to L5 myotomes and dermatomes. Through trans-operative real time modalities (trans-cranial electric motor evoked potentials, somatosensory evoked potentials, and spontaneous electromyography) measurements on amplitude and voltage were recorded at the beginning and at the end of the spinal decompression. This change will be studied to determine its predictive power in the clinical long-term outcome of the patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual analogue scale for pain</measure>
    <time_frame>In the pre-operatory consult with the surgeon, and in the follow-up visits up to two years after the completion of the neurological surgery; the patient will be asked to complete the Visual Analogue Scale for Pain</time_frame>
    <description>The visual analogue scale is a written survey used to assess the pain a person endures. The patient will select a number from one to ten to express the relative amount of pain she is suffering. Data collected throughout the study will be used as a clinical follow-up measure to be compared with that obtained through intraoperative neurophysiological monitoring. Approximate time of completion is &lt;5 minutes; and no physical examination, nor additional pain may be experienced by completing such survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oswestry Disability Index 2.1a</measure>
    <time_frame>In the pre-operatory consult with the surgeon, and in the follow-up visits up to two years after the completion of the neurological surgery; the patient will be asked to complete the Oswestry Disability Index 2.1a</time_frame>
    <description>The Oswestry Disability Index 2.1a is a written survey used to quantify the amount of disability a person endures due to low-back pain. The patient will answer a series of 10 questions enquiring about experiences of her life, and how the pain she suffers affects the quality of these experiences. Data collected throughout the study will be used as a clinical follow-up measure to be compared with that obtained through intraoperative neurophysiological monitoring. Approximate time of completion is &lt;5 minutes; and no physical examination, nor additional pain may be experienced by completing such survey.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's Global Impression of Change Survey</measure>
    <time_frame>In the follow-up visits up to two years after the completion of the neurological surgery, the patient will be asked to complete the Patient's Global Impression of Change Survey</time_frame>
    <description>The Patient's Global Impression of Change Survey is a written survey used to quantify the amount of improvement a person perceives for herself after receiving a certain treatment. The patient will select from a list of previously defined statements, the one that best describes her impression of change after the surgery, and will select a number ranging from one to ten representing her perception of improvement. Data collected throughout the study will be used as a clinical follow-up measure to be compared with that obtained through intraoperative neurophysiological monitoring. Approximate time of completion is &lt;5 minutes; and no physical examination, nor additional pain may be experienced by completing such survey.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>General demographic, personal and biometrical data</measure>
    <time_frame>In the pre-operatory consult with the surgeon, the patient will be asked to complete a survey enquiring about general demographic, personal and biometrical data</time_frame>
    <description>The survey used to capture general demographic, personal and biometrical data is designed according to the stipulations of the Official Mexican Norm for the Clinical Record (NOM-004-SSA3-2012). The data obtained through such survey will help the surgeon in assessing the case of the patient. Some or all of this data may be used for analysis in this study, to be compared with the rest of the outcome measures. A privacy policy statement may be provided to the patient according to the Federal Law for the Protection of Personal Data in Possession of Particulars (Ley Federal de Protección de Datos Personales en Posesión de los Particulares). Regardless of such formality, the privacy of the patient will be assured throughout the study.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Lumbar Disc Disease</condition>
  <arm_group>
    <arm_group_label>Lumbar spine surgery with IONM</arm_group_label>
    <description>Patients diagnosed with 1 or 2 level lumbar disk disease and radicular symptoms who underwent decompressive surgery, and for whom IONM records exist.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with lumbar disk disease with radiculopathy, undergoing neurological&#xD;
        surgery of the spine at the ABC Neurological Center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Lumbar Disk Disease&#xD;
&#xD;
          -  Clinical Signs of Radiculopathy&#xD;
&#xD;
          -  Undergoing neurological surgery of the spine&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous neurological surgery of the lumbar spine&#xD;
&#xD;
          -  More than 2 levels intervened at the surgery&#xD;
&#xD;
          -  Serious post-operatory complications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roberto De Leo Vargas, MD</last_name>
    <role>Study Director</role>
    <affiliation>American British Cowdray Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maximino Tellez, MD</last_name>
    <role>Study Chair</role>
    <affiliation>American British Cowdray Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ildefonso Muñoz Romero, MD</last_name>
    <role>Study Chair</role>
    <affiliation>American British Cowdray Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Miguel Angel Collado Corona, MD</last_name>
    <role>Study Chair</role>
    <affiliation>American British Cowdray Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Leopoldo Torres Vyera, MD</last_name>
    <role>Study Chair</role>
    <affiliation>American British Cowdray Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christian Cerecedo, MD</last_name>
    <role>Study Chair</role>
    <affiliation>American British Cowdray Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eduardo Galvan Hernandez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>American British Cowdray Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>American British Cowdray Medical Center</name>
      <address>
        <city>Mexico City</city>
        <state>Distrito Federal</state>
        <zip>05300</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <link>
    <url>http://www.nlm.nih.gov/medlineplus/spanish/ency/article/000442.htm</url>
    <description>Para mas informacion sobre hernias de disco, porfavor visite la siguiente pagina de internet:</description>
  </link>
  <link>
    <url>http://www.nlm.nih.gov/medlineplus/ency/article/000442.htm</url>
    <description>For more information on disk hernias, please visit the following web page:</description>
  </link>
  <reference>
    <citation>Koerner JD, Glaser J, Radcliff K. Which Variables Are Associated With Patient-reported Outcomes After Discectomy? Review of SPORT Disc Herniation Studies. Clin Orthop Relat Res. 2015 Jun;473(6):2000-6. doi: 10.1007/s11999-014-3671-1.</citation>
    <PMID>24818737</PMID>
  </reference>
  <reference>
    <citation>Sabnis AB, Diwan AD. The timing of surgery in lumbar disc prolapse: A systematic review. Indian J Orthop. 2014 Mar;48(2):127-35. doi: 10.4103/0019-5413.128740.</citation>
    <PMID>24741132</PMID>
  </reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>July 4, 2014</last_update_submitted>
  <last_update_submitted_qc>July 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>American British Cowdray Medical Center</investigator_affiliation>
    <investigator_full_name>Galvan Ernesto Eduardo</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>IONM</keyword>
  <keyword>Lumbar Disk Disease</keyword>
  <keyword>Degenerative Spine Disease</keyword>
  <keyword>Radiculopathy</keyword>
  <keyword>Intraoperative Neurophysiological Monitoring</keyword>
  <keyword>Somatosensory Evoked Potentials</keyword>
  <keyword>Electromyography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intervertebral Disc Displacement</mesh_term>
    <mesh_term>Intervertebral Disc Degeneration</mesh_term>
    <mesh_term>Radiculopathy</mesh_term>
  </condition_browse>
  <!-- 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/NCT02185508
org study id: ABC-14-06
nct id: NCT02185508
lead sponsor: 
The purpose of this study is to determine the relation among: (1) changes in voltage and
      amplitude of trans-operatory records obtained through the use of Intra-operative
      Neurophysiological Monitoring (IONM), and (2) clinical outcomes; of patients who underwent 1
      or 2 levels surgical decompression at lumbar spine.

      IONM is the use of real time neurophysiological techniques during spinal surgeries. The
      modalities included in this study are:

        -  Somatosensory evoked potentials (SSEPs).

        -  Trans-cranial electric motor evoked potentials (tceMEPs).

        -  Spontaneous electromyography (EMG).

      Clinical outcome of the patients will be assessed through a careful evaluation of clinical
      data, as well as the application of three outcome scales:

        -  Oswestry Disability Index 2.1a

        -  Visual Analogue Scale for Pain

        -  Patient's Overall Impression of Change
Radiculopathy associated to lumbar disk disease is one of the most common reasons for a spine
      surgeon to be consulted. The pathophysiology of degenerative spine disease is acknowledged as
      complex, involving a wide array of risk factors ranging from genetic polymorphisms, to
      behavioural characteristics. While conflicting opinions exist with regard the direction of
      treatment for lumbar disk disease, de-compressive surgery is currently the gold standard for
      patients in which protocols of physiotherapy and analgesics have failed to comply.

      Intraoperative neurophysiological monitoring (IONM) is widely used in the practice of spine
      surgery as a mean of preventing and reducing severe complications inherent to surgical
      techniques like paraparesis, paraplegia and quadriplegia. Indeed, a great deal of funding and
      work have been devoted to research projects seeking to determine the impact of IONM in
      reducing these risks. The results of such projects have been notoriously interesting, and
      frequently opposing to each other. This has lead to an open debate on weather the use of IONM
      may or not be justified by better outcomes in patients who undergo such procedure. To our
      knowledge there is no study in the literature that has addressed the potential role of the
      IOM to predict the long-term outcome of the patient in therms of radicular symptoms
      improvement.
observational model: Case-Only
time perspective: Retrospective
measure: Electrophysiological changes measured through intraoperative neurophysiological monitoring.
time frame: Trans-operative
description: Standard register electrodes where placed from L1 to L5 myotomes and dermatomes. Through trans-operative real time modalities (trans-cranial electric motor evoked potentials, somatosensory evoked potentials, and spontaneous electromyography) measurements on amplitude and voltage were recorded at the beginning and at the end of the spinal decompression. This change will be studied to determine its predictive power in the clinical long-term outcome of the patients.
measure: Visual analogue scale for pain
time frame: In the pre-operatory consult with the surgeon, and in the follow-up visits up to two years after the completion of the neurological surgery; the patient will be asked to complete the Visual Analogue Scale for Pain
description: The visual analogue scale is a written survey used to assess the pain a person endures. The patient will select a number from one to ten to express the relative amount of pain she is suffering. Data collected throughout the study will be used as a clinical follow-up measure to be compared with that obtained through intraoperative neurophysiological monitoring. Approximate time of completion is <5 minutes; and no physical examination, nor additional pain may be experienced by completing such survey
measure: Oswestry Disability Index 2.1a
time frame: In the pre-operatory consult with the surgeon, and in the follow-up visits up to two years after the completion of the neurological surgery; the patient will be asked to complete the Oswestry Disability Index 2.1a
description: The Oswestry Disability Index 2.1a is a written survey used to quantify the amount of disability a person endures due to low-back pain. The patient will answer a series of 10 questions enquiring about experiences of her life, and how the pain she suffers affects the quality of these experiences. Data collected throughout the study will be used as a clinical follow-up measure to be compared with that obtained through intraoperative neurophysiological monitoring. Approximate time of completion is <5 minutes; and no physical examination, nor additional pain may be experienced by completing such survey.
measure: Patient's Global Impression of Change Survey
time frame: In the follow-up visits up to two years after the completion of the neurological surgery, the patient will be asked to complete the Patient's Global Impression of Change Survey
description: The Patient's Global Impression of Change Survey is a written survey used to quantify the amount of improvement a person perceives for herself after receiving a certain treatment. The patient will select from a list of previously defined statements, the one that best describes her impression of change after the surgery, and will select a number ranging from one to ten representing her perception of improvement. Data collected throughout the study will be used as a clinical follow-up measure to be compared with that obtained through intraoperative neurophysiological monitoring. Approximate time of completion is <5 minutes; and no physical examination, nor additional pain may be experienced by completing such survey.
measure: General demographic, personal and biometrical data
time frame: In the pre-operatory consult with the surgeon, the patient will be asked to complete a survey enquiring about general demographic, personal and biometrical data
description: The survey used to capture general demographic, personal and biometrical data is designed according to the stipulations of the Official Mexican Norm for the Clinical Record (NOM-004-SSA3-2012). The data obtained through such survey will help the surgeon in assessing the case of the patient. Some or all of this data may be used for analysis in this study, to be compared with the rest of the outcome measures. A privacy policy statement may be provided to the patient according to the Federal Law for the Protection of Personal Data in Possession of Particulars (Ley Federal de Protección de Datos Personales en Posesión de los Particulares). Regardless of such formality, the privacy of the patient will be assured throughout the study.
arm group label: Lumbar spine surgery with IONM
description: Patients diagnosed with 1 or 2 level lumbar disk disease and radicular symptoms who underwent decompressive surgery, and for whom IONM records exist.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Roberto De Leo Vargas, MD
role: Study Director
affiliation: American British Cowdray Medical Center
last name: Maximino Tellez, MD
role: Study Chair
affiliation: American British Cowdray Medical Center
last name: Ildefonso Muñoz Romero, MD
role: Study Chair
affiliation: American British Cowdray Medical Center
last name: Miguel Angel Collado Corona, MD
role: Study Chair
affiliation: American British Cowdray Medical Center
last name: Leopoldo Torres Vyera, MD
role: Study Chair
affiliation: American British Cowdray Medical Center
last name: Christian Cerecedo, MD
role: Study Chair
affiliation: American British Cowdray Medical Center
last name: Eduardo Galvan Hernandez, MD
role: Principal Investigator
affiliation: American British Cowdray Medical Center
facility: 
country: Mexico
url: http://www.nlm.nih.gov/medlineplus/spanish/ency/article/000442.htm
description: Para mas informacion sobre hernias de disco, porfavor visite la siguiente pagina de internet:
url: http://www.nlm.nih.gov/medlineplus/ency/article/000442.htm
description: For more information on disk hernias, please visit the following web page:
citation: Koerner JD, Glaser J, Radcliff K. Which Variables Are Associated With Patient-reported Outcomes After Discectomy? Review of SPORT Disc Herniation Studies. Clin Orthop Relat Res. 2015 Jun;473(6):2000-6. doi: 10.1007/s11999-014-3671-1.
PMID: 24818737
citation: Sabnis AB, Diwan AD. The timing of surgery in lumbar disc prolapse: A systematic review. Indian J Orthop. 2014 Mar;48(2):127-35. doi: 10.4103/0019-5413.128740.
PMID: 24741132
responsible party type: Principal Investigator
investigator affiliation: American British Cowdray Medical Center
investigator full name: Galvan Ernesto Eduardo
investigator title: MD
mesh term: Intervertebral Disc Displacement
mesh term: Intervertebral Disc Degeneration
mesh term: Radiculopathy