<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/NCT02196883</url>
  </required_header>
  <id_info>
    <org_study_id>593154-1</org_study_id>
    <nct_id>NCT02196883</nct_id>
  </id_info>
  <brief_title>Steroid Injections Given at the &quot;Level of MRI Pathology&quot; Versus at the &quot;Level of Clinical Symptoms&quot; to See if One is More Effective Than the Other.</brief_title>
  <official_title>A Prospective, Randomized, Single Blind Study Comparing Transforaminal Epidural Steroid Injections at the Level of MRI Pathology vs Clinical Symptoms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>State University of New York - Upstate Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>State University of New York - Upstate Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients are being asked to participate in a research study because the patients are being&#xD;
      treated for low back pain and the patients have decided to have an epidural steroid&#xD;
      injection.&#xD;
&#xD;
      Low back pain has a tremendous impact on the individual and society. It not only affects the&#xD;
      individuals quality of life, it also contributes to lost productivity and increased health&#xD;
      care costs.&#xD;
&#xD;
      Epidural steroid injections (ESIs) are a common treatment option for many forms of low back&#xD;
      pain. They have been used for low back problems since 1952 and are still being used as a&#xD;
      non-surgical form of treatment for low back pain. The goal of the injections is reduction of&#xD;
      pain, increased quality of life and improved function.&#xD;
&#xD;
      This study is being conducted to determine the outcomes of injections given at the &quot;level of&#xD;
      MRI Pathology&quot; versus at the &quot;level of clinical symptoms&quot; to see if one is more effective&#xD;
      than the other and to learn more about the characteristics of the two different injections.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    PI no longer part of practice&#xD;
  </why_stopped>
  <start_date>May 2014</start_date>
  <primary_completion_date type="Anticipated">May 2015</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>Single</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale</measure>
    <time_frame>2 weeks to 6months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Short Form 36 Health Survey</measure>
    <time_frame>2 weeks to 6months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oswestry Disability Index</measure>
    <time_frame>2 weeks to 6months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Radiculopathy</condition>
  <condition>Spinal Stenosis</condition>
  <condition>Intervertebral Disc Displacement</condition>
  <arm_group>
    <arm_group_label>MRI Pathology</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Physical Exam Pathology</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transforaminal Epidural Steroid Injection</intervention_name>
    <arm_group_label>MRI Pathology</arm_group_label>
    <arm_group_label>Physical Exam Pathology</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Single level spinal stenosis.&#xD;
&#xD;
          -  Single level radiculopathy with MRI findings at a different level than clinical&#xD;
             pattern.&#xD;
&#xD;
          -  Chronic low back pain with radicular symptoms of &gt; 4 weeks, but &lt; 6 months.&#xD;
&#xD;
          -  Failure of conservative therapy to include physical and pharmacotherapy.&#xD;
&#xD;
          -  Patient is at least 21 years of age.&#xD;
&#xD;
          -  Patient is willing to be blinded to treatment until after the 3-month follow up visit.&#xD;
&#xD;
          -  Patient is willing and able to review and sign the study's informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has a mental or physical condition that would invalidate evaluation results.&#xD;
&#xD;
          -  Patient has had prior lumbar surgery at any level.&#xD;
&#xD;
          -  Patient is pregnant.&#xD;
&#xD;
          -  Patient has systemic infection or infection at the proposed injection site.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>SUNY Upstate Medical Center</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>June 10, 2016</last_update_submitted>
  <last_update_submitted_qc>June 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 14, 2016</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>Spinal Stenosis</mesh_term>
    <mesh_term>Intervertebral Disc Displacement</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/NCT02196883
org study id: 593154-1
nct id: NCT02196883
lead sponsor: 
has dmc: Yes
Patients are being asked to participate in a research study because the patients are being
      treated for low back pain and the patients have decided to have an epidural steroid
      injection.

      Low back pain has a tremendous impact on the individual and society. It not only affects the
      individuals quality of life, it also contributes to lost productivity and increased health
      care costs.

      Epidural steroid injections (ESIs) are a common treatment option for many forms of low back
      pain. They have been used for low back problems since 1952 and are still being used as a
      non-surgical form of treatment for low back pain. The goal of the injections is reduction of
      pain, increased quality of life and improved function.

      This study is being conducted to determine the outcomes of injections given at the "level of
      MRI Pathology" versus at the "level of clinical symptoms" to see if one is more effective
      than the other and to learn more about the characteristics of the two different injections.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: Single
measure: Visual Analog Scale
time frame: 2 weeks to 6months
measure: Short Form 36 Health Survey
time frame: 2 weeks to 6months
measure: Oswestry Disability Index
time frame: 2 weeks to 6months
arm group label: MRI Pathology
arm group type: Active Comparator
arm group label: Physical Exam Pathology
arm group type: Active Comparator
intervention type: Procedure
intervention name: Transforaminal Epidural Steroid Injection
arm group label: MRI Pathology
arm group label: Physical Exam Pathology
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
facility: 
country: United States
responsible party type: Sponsor
mesh term: Spinal Stenosis
mesh term: Intervertebral Disc Displacement
mesh term: Radiculopathy