<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/NCT03308149</url>
  </required_header>
  <id_info>
    <org_study_id>503/2016BO2</org_study_id>
    <nct_id>NCT03308149</nct_id>
  </id_info>
  <brief_title>Predictability of the Effects of Facet Joint Infiltration in the Degenerate Lumbar Spine When Assessing MRI Scans</brief_title>
  <official_title>Predictability of the Effects of Facet Joint Infiltration in the Degenerate Lumbar Spine When Assessing MRI Scans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Tuebingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Tuebingen</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>
      Fifty MRI scans of patients with chronic lumbar back pain were graded radiologically using a&#xD;
      wide range of classification and measurement systems. The reported effect of facet joint&#xD;
      injections at the site was recorded and a comparative analysis performed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2016</start_date>
  <completion_date type="Actual">January 10, 2017</completion_date>
  <primary_completion_date type="Actual">January 10, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation of radiologic findings and reported pain relief</measure>
    <time_frame>Improvement in pain level within 24 hours</time_frame>
    <description>Pain relief is assessed as an improvement in % on the NRS. Radiologic findings consist of numerous classification systems and measurement techniques to evaluate and classify spinals and neural foramen stenosis, like for example as suggested by Schizas, or the sagittal diameter of the spinal canal</description>
  </primary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Infiltration Facet Joint</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>infiltration with triamcinolone and bupivacaine</intervention_name>
    <description>facet joint infiltration</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients who had received inpatient gradual diagnostics in our department&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who had received inpatient gradual diagnostics for chronic lumbar back pain&#xD;
&#xD;
          -  monosegmental facet joint infiltration on the first day of inpatient gradual&#xD;
             diagnostics&#xD;
&#xD;
          -  clearly stated pain relief in percentage (%) for that specific infiltration in the&#xD;
             medical documentation&#xD;
&#xD;
          -  pain level prior to infiltration needed to be clearly documented&#xD;
&#xD;
          -  a high-quality MRI available before infiltration.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ositive history of lumbar surgery or the presence of artificial implants in the area&#xD;
             of interest&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ulf Hofmann, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Orthpaedic Surgery, University Hospital of Tuebingen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Tuebingen, Department of Orthopaedics</name>
      <address>
        <city>Tuebingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>October 6, 2017</last_update_submitted>
  <last_update_submitted_qc>October 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Tuebingen</investigator_affiliation>
    <investigator_full_name>Dr. Ulf Krister Hofmann</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triamcinolone</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>General data file from which statistical analyses were performed may be requested from the authors after publication</ipd_description>
  </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/NCT03308149
org study id: 503/2016BO2
nct id: NCT03308149
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Fifty MRI scans of patients with chronic lumbar back pain were graded radiologically using a
      wide range of classification and measurement systems. The reported effect of facet joint
      injections at the site was recorded and a comparative analysis performed.
observational model: Cohort
time perspective: Retrospective
measure: Correlation of radiologic findings and reported pain relief
time frame: Improvement in pain level within 24 hours
description: Pain relief is assessed as an improvement in % on the NRS. Radiologic findings consist of numerous classification systems and measurement techniques to evaluate and classify spinals and neural foramen stenosis, like for example as suggested by Schizas, or the sagittal diameter of the spinal canal
intervention type: Drug
intervention name: infiltration with triamcinolone and bupivacaine
description: facet joint infiltration
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ulf Hofmann, M.D.
role: Principal Investigator
affiliation: Department of Orthpaedic Surgery, University Hospital of Tuebingen
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital Tuebingen
investigator full name: Dr. Ulf Krister Hofmann
investigator title: Principal Investigator
mesh term: Triamcinolone
mesh term: Bupivacaine
sharing ipd: Undecided
ipd description: General data file from which statistical analyses were performed may be requested from the authors after publication