<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/NCT03832036</url>
  </required_header>
  <id_info>
    <org_study_id>201170138</org_study_id>
    <nct_id>NCT03832036</nct_id>
  </id_info>
  <brief_title>The Diagnostic and Prognostic Value of Two Quantitative Clinical Tests in Patients With Lumbar Disc Herniation</brief_title>
  <official_title>The Diagnostic and Prognostic Value of Two Quantitative Clinical Tests in Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spine Centre of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Frederiksberg University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Center for Rheumatology and Spine Diseases, Frederiksberg Hospital, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Spine Centre of Southern Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will investigate whether two clinical tests can be used to diagnose and predict&#xD;
      the outcome in patients with lumbar disc herniation undergoing surgery and non-surgery&#xD;
      treatment.&#xD;
&#xD;
      The two quantitative clinical tests include: electromyographic measurements using Paraspinal&#xD;
      Mapping and pain responses using Quantitative Sensory Pain Testing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      150 patients will be included for the prospective cohort study. Patients will be recruited&#xD;
      from the Region of Southern Denmark and Capital Region. Participants will undergo MRI&#xD;
      scanning of the lumbar spine, fillout a questionnaire and undergo assessment with the two&#xD;
      clinical tests. An 8-week follow-up will be made with patients completing a questionnaire.&#xD;
      The two quantitative clinical tests include: electromyographic measurements using Paraspinal&#xD;
      Mapping and pain responses using Quantitative Sensory Pain Testing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Actual">January 1, 2021</completion_date>
  <primary_completion_date type="Actual">January 1, 2021</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The diagnostic value of Paraspinal Mapping and Quantitative Sensory Pain Testing</measure>
    <time_frame>8 week follow-up</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Pain</condition>
  <condition>Lumbar Disc Herniation</condition>
  <condition>Back Pain</condition>
  <condition>Spinal Diseases</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Patients with lumbar disc herniation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Paraspinal Mapping and Quantitative Sensory Pain Test</intervention_name>
    <description>Participants will be tested at baseline.</description>
    <arm_group_label>Patients with lumbar disc herniation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical and radiologically diagnosed lumbar disc herniation.&#xD;
&#xD;
          -  Low back pain with pain below the knee or anterior thigh pain in one or both legs.&#xD;
&#xD;
          -  Dermatomal leg pain.&#xD;
&#xD;
          -  Average pain intensity of 3 or more on a Numerical Rating Scale (0-10 NRS).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of previous lumbar spine surgery.&#xD;
&#xD;
          -  Surgery in general in the past 4 months.&#xD;
&#xD;
          -  Current use of anticoagulants.&#xD;
&#xD;
          -  Diagnoses which could confound with the diagnosis e.g. lumbar spinal stenosis, local&#xD;
             muscle trauma, cancer metastases, fibromyalgia, neuropathy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Johanne B Filtenborg, M.Sc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Spine Centre Southern Denmark</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Berit Schiøttz-Christensen, MD</last_name>
    <role>Study Director</role>
    <affiliation>Spine Centre Southern Denmark</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Søren O'Neill, DC</last_name>
    <role>Study Chair</role>
    <affiliation>Spine Centre Southern Denmark</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kirstine Amris, MD</last_name>
    <role>Study Chair</role>
    <affiliation>The Parker Institute, Frederiksberg Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gilles Fournier, MD, DC</last_name>
    <role>Study Chair</role>
    <affiliation>Center for Rheumatology and Spine Diseases, Frederiksberg Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Andrew J Haig, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Rheumatology and Spine Diseases, Frederiksberg Hospital.</name>
      <address>
        <city>Frederiksberg</city>
        <zip>2000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>October 26, 2018</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>May 4, 2022</last_update_submitted>
  <last_update_submitted_qc>May 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Electromyography</keyword>
  <keyword>Paraspinal Mapping</keyword>
  <keyword>Quantitative clinical tests</keyword>
  <keyword>Conditioned pain modulation</keyword>
  <keyword>Temporal pain summation</keyword>
  <keyword>Pain threshold</keyword>
  <keyword>Pain tolerance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intervertebral Disc Displacement</mesh_term>
    <mesh_term>Spinal Diseases</mesh_term>
    <mesh_term>Hernia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03832036
org study id: 201170138
nct id: NCT03832036
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will investigate whether two clinical tests can be used to diagnose and predict
      the outcome in patients with lumbar disc herniation undergoing surgery and non-surgery
      treatment.

      The two quantitative clinical tests include: electromyographic measurements using Paraspinal
      Mapping and pain responses using Quantitative Sensory Pain Testing.
150 patients will be included for the prospective cohort study. Patients will be recruited
      from the Region of Southern Denmark and Capital Region. Participants will undergo MRI
      scanning of the lumbar spine, fillout a questionnaire and undergo assessment with the two
      clinical tests. An 8-week follow-up will be made with patients completing a questionnaire.
      The two quantitative clinical tests include: electromyographic measurements using Paraspinal
      Mapping and pain responses using Quantitative Sensory Pain Testing.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The diagnostic value of Paraspinal Mapping and Quantitative Sensory Pain Testing
time frame: 8 week follow-up
arm group label: Patients with lumbar disc herniation
arm group type: Experimental
intervention type: Diagnostic Test
intervention name: Paraspinal Mapping and Quantitative Sensory Pain Test
description: Participants will be tested at baseline.
arm group label: Patients with lumbar disc herniation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Johanne B Filtenborg, M.Sc.
role: Principal Investigator
affiliation: Spine Centre Southern Denmark
last name: Berit Schiøttz-Christensen, MD
role: Study Director
affiliation: Spine Centre Southern Denmark
last name: Søren O'Neill, DC
role: Study Chair
affiliation: Spine Centre Southern Denmark
last name: Kirstine Amris, MD
role: Study Chair
affiliation: The Parker Institute, Frederiksberg Hospital
last name: Gilles Fournier, MD, DC
role: Study Chair
affiliation: Center for Rheumatology and Spine Diseases, Frederiksberg Hospital
last name: Andrew J Haig, MD
role: Study Chair
affiliation: University of Michigan
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Intervertebral Disc Displacement
mesh term: Spinal Diseases
mesh term: Hernia
sharing ipd: Undecided