<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/NCT03303261</url>
  </required_header>
  <id_info>
    <org_study_id>MODIC 1 PRO</org_study_id>
    <nct_id>NCT03303261</nct_id>
  </id_info>
  <brief_title>Study On Discopathie With Modic 1</brief_title>
  <official_title>Study On Discopathie With Modic 1</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Hôpital Saint-Joseph</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Hôpital Saint-Joseph</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>
      The chronic lumbago can be associated with an active discopathie, objectified on the MRI by&#xD;
      the presence of an inflammatory signal (Modic 1) or greasy (Modic 2) vertebral trays framing&#xD;
      the pathological vertebral disk The treatment recommended by t consists in particular of a&#xD;
      local infiltration of corticoids which the efficiency is variable according to the patients.&#xD;
      The objective of this study is to estimate the efficiency of the local treatment and to&#xD;
      highlight some of the factors associated to the advantage of the infiltration by corticoids.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The principal investigator decided to stop the study.&#xD;
  </why_stopped>
  <start_date type="Actual">April 18, 2016</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">September 25, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>pain VAS ( VISUAL ANALOGIC SCORE)</measure>
    <time_frame>Day 1 - Day 30</time_frame>
  </primary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Lumbar Hernia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patient hospitalized in GHPSJ for infiltration&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient admitted in Rhumatology service for intra-disc infiltration&#xD;
&#xD;
          -  Chronic pain (&gt;3 monts)&#xD;
&#xD;
          -  VAS &gt;3&#xD;
&#xD;
          -  MRI stipulating MODIC 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  radiculalgy&#xD;
&#xD;
          -  radicular VAS&lt; lumbar VAS&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  local infection&#xD;
&#xD;
          -  corticoid allergy&#xD;
&#xD;
          -  previous rachial surgery&#xD;
&#xD;
          -  previous spondylodiscite&#xD;
&#xD;
          -  psychiatric disorder&#xD;
&#xD;
          -  MRI contraindication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>COHEN SOLAL P Julien, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondation Hôpital Saint-Joseph</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Groupe Hospitalier Paris Saint Joseph</name>
      <address>
        <city>Paris</city>
        <state>Ile-de-France</state>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>February 1, 2019</last_update_submitted>
  <last_update_submitted_qc>February 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</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/NCT03303261
org study id: MODIC 1 PRO
nct id: NCT03303261
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The chronic lumbago can be associated with an active discopathie, objectified on the MRI by
      the presence of an inflammatory signal (Modic 1) or greasy (Modic 2) vertebral trays framing
      the pathological vertebral disk The treatment recommended by t consists in particular of a
      local infiltration of corticoids which the efficiency is variable according to the patients.
      The objective of this study is to estimate the efficiency of the local treatment and to
      highlight some of the factors associated to the advantage of the infiltration by corticoids.
observational model: Cohort
time perspective: Prospective
measure: pain VAS ( VISUAL ANALOGIC SCORE)
time frame: Day 1 - Day 30
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: COHEN SOLAL P Julien, MD
role: Principal Investigator
affiliation: Fondation Hôpital Saint-Joseph
facility: 
country: France
responsible party type: Sponsor
mesh term: Hernia