<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/NCT02239627</url>
  </required_header>
  <id_info>
    <org_study_id>1407358518</org_study_id>
    <nct_id>NCT02239627</nct_id>
  </id_info>
  <brief_title>Epidural Clonidine Versus Corticosteroid for Low Back Pain</brief_title>
  <official_title>Prospective, Randomized, Double Blinded Comparison of the Analgesic Efficacy of Epidural Clonidine Versus Corticosteroid for Low Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West Virginia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West Virginia University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Low back pain is a common condition, affecting majority of the adults in the United States at&#xD;
      some point in their lives. Fortunately, most resolve, even without treatment. However, some&#xD;
      suffer from continued or recurrent pain.&#xD;
&#xD;
      For those suffering from continued or recurrent low back pain, numerous treatment options&#xD;
      exist. One such option is an epidural injection, particularly when other non-surgical&#xD;
      treatment options have failed. An epidural injection is the placement of a needle into the&#xD;
      space around the spinal cord with the aid of a live X-Ray machine, followed by an injection&#xD;
      of various medications. Typically, the medication that is injected is a steroid, commonly&#xD;
      with the combination of local anesthetic medication. Epidural steroid injections, with or&#xD;
      without local anesthetic is part of the established standard of care in the United States for&#xD;
      those with continued or recurrent low back pain. The steroid is believed to reduce&#xD;
      inflammation and edema of the injured or irritated nerves. However, despite the routine use&#xD;
      of epidural steroids, the steroid itself is not without risks or side effects. Though rare,&#xD;
      the steroids have been associated with complications including osteoporosis, steroid induced&#xD;
      myopathy, cataracts and many others. In order to minimize the side effects associated with&#xD;
      epidural steroids, limiting the dose and frequency have been outlined.&#xD;
&#xD;
      Clonidine is another medication, commonly used in numerous clinical settings. U. S. Food and&#xD;
      Drug Administration approved the medication for epidural use for cancer pain but studies have&#xD;
      shown effectiveness in non-cancer pain was well and is routinely used for various conditions.&#xD;
      There is growing evidence on the use of epidural clonidine for treatment of pain, including&#xD;
      low back pain.&#xD;
&#xD;
      This research will study and compare the effectiveness, if any, of clonidine compared to&#xD;
      steroid in an epidural injection for low back pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    based on interim anaylsis&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Intensity Measured on Visual Analog Scale (VAS)</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Pain Relief</measure>
    <time_frame>Day 0, 3 weeks, 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of Disability (Oswestry Back Scale)</measure>
    <time_frame>3 weeks, 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Day 0, 3 weeks, 3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Back Pain</condition>
  <arm_group>
    <arm_group_label>Steroid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Epidural steroid injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clonidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Epidural clonidine injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Epidural steroid</intervention_name>
    <arm_group_label>Steroid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clonidine</intervention_name>
    <arm_group_label>Clonidine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject has clinical diagnosis of low back due to intervertebral disc disease, spinal&#xD;
             stenosis or herniated disc&#xD;
&#xD;
          2. Subject has average pain score (VAS) at least 5&#xD;
&#xD;
          3. Subject has persistent pain despite conservative care&#xD;
&#xD;
          4. Subjects has experienced pain for at least 1 month&#xD;
&#xD;
          5. 18 years of age or older when written informed consent is obtained&#xD;
&#xD;
          6. Signed Institutional Review Board (IRB) approved informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Allergy to clonidine, dexamethasone, ropivicaine or lidocaine&#xD;
&#xD;
          2. Coagulopathy&#xD;
&#xD;
          3. Active Infection&#xD;
&#xD;
          4. Serious neurologic deficit&#xD;
&#xD;
          5. Subject is pregnant or planning on becoming pregnant during the course of the study&#xD;
&#xD;
          6. Subject is member of a vulnerable population&#xD;
&#xD;
          7. Investigator suspects substance abuse that might confound the study results&#xD;
&#xD;
          8. Subject has unresolved major issues of secondary gain (as determined by the&#xD;
             investigator)&#xD;
&#xD;
          9. Subject exhibits major psychiatric morbidity, untreated or refractory to treatment as&#xD;
             determined by the investigator&#xD;
&#xD;
         10. Currently diagnosed with cognitive impairment, or exhibits any characteristic, that&#xD;
             would limit study candidate's ability to assess pain relief or complete study&#xD;
             assessments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>West Virginia University Hospitals</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <results_first_submitted>December 22, 2020</results_first_submitted>
  <results_first_submitted_qc>December 22, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 20, 2021</results_first_posted>
  <last_update_submitted>December 22, 2020</last_update_submitted>
  <last_update_submitted_qc>December 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2021</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>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clonidine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was terminated and the PI has left the institution. The numbers presented are what was initially entered by the research team. From data available, 16 participants were enrolled on the study; no information about those participants could be located. No other data could be located and it cannot be determined which arm the16 participants were enrolled in or if they completed the study.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Steroid</title>
          <description>Epidural steroid injection&#xD;
Epidural steroid</description>
        </group>
        <group group_id="P2">
          <title>Clonidine</title>
          <description>Epidural clonidine injection&#xD;
Clonidine</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The study was terminated and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.</population>
      <group_list>
        <group group_id="B1">
          <title>Steroid</title>
          <description>Epidural steroid injection&#xD;
Epidural steroid</description>
        </group>
        <group group_id="B2">
          <title>Clonidine</title>
          <description>Epidural clonidine injection&#xD;
Clonidine</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="0"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="0"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                </category>
                <category>
                  <title>Male</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pain Intensity Measured on Visual Analog Scale (VAS)</title>
        <time_frame>3 months</time_frame>
        <population>The study was terminated and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.</population>
        <group_list>
          <group group_id="O1">
            <title>Steroid</title>
            <description>Epidural steroid injection&#xD;
Epidural steroid</description>
          </group>
          <group group_id="O2">
            <title>Clonidine</title>
            <description>Epidural clonidine injection&#xD;
Clonidine</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Intensity Measured on Visual Analog Scale (VAS)</title>
          <population>The study was terminated and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Pain Relief</title>
        <time_frame>Day 0, 3 weeks, 3 months</time_frame>
        <population>The study was terminated and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.</population>
        <group_list>
          <group group_id="O1">
            <title>Steroid</title>
            <description>Epidural steroid injection&#xD;
Epidural steroid</description>
          </group>
          <group group_id="O2">
            <title>Clonidine</title>
            <description>Epidural clonidine injection&#xD;
Clonidine</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Pain Relief</title>
          <population>The study was terminated and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Level of Disability (Oswestry Back Scale)</title>
        <time_frame>3 weeks, 3 months</time_frame>
        <population>The study was terminated and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.</population>
        <group_list>
          <group group_id="O1">
            <title>Steroid</title>
            <description>Epidural steroid injection&#xD;
Epidural steroid</description>
          </group>
          <group group_id="O2">
            <title>Clonidine</title>
            <description>Epidural clonidine injection&#xD;
Clonidine</description>
          </group>
        </group_list>
        <measure>
          <title>Level of Disability (Oswestry Back Scale)</title>
          <population>The study was terminated and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adverse Events</title>
        <time_frame>Day 0, 3 weeks, 3 months</time_frame>
        <population>The study was terminated and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.</population>
        <group_list>
          <group group_id="O1">
            <title>Steroid</title>
            <description>Epidural steroid injection&#xD;
Epidural steroid</description>
          </group>
          <group group_id="O2">
            <title>Clonidine</title>
            <description>Epidural clonidine injection&#xD;
Clonidine</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events</title>
          <population>The study was terminated and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>The study was terminated and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.</desc>
      <group_list>
        <group group_id="E1">
          <title>Steroid</title>
          <description>Epidural steroid injection&#xD;
Epidural steroid</description>
        </group>
        <group group_id="E2">
          <title>Clonidine</title>
          <description>Epidural clonidine injection&#xD;
Clonidine</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trials Compliance Coordinator</name_or_title>
      <organization>West Virginia Universtiy, WVCTSI</organization>
      <phone>304-293-0216</phone>
      <email>ctgovadmin@hsc.wvu.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02239627
org study id: 1407358518
nct id: NCT02239627
lead sponsor: 
has dmc: No
Low back pain is a common condition, affecting majority of the adults in the United States at
      some point in their lives. Fortunately, most resolve, even without treatment. However, some
      suffer from continued or recurrent pain.

      For those suffering from continued or recurrent low back pain, numerous treatment options
      exist. One such option is an epidural injection, particularly when other non-surgical
      treatment options have failed. An epidural injection is the placement of a needle into the
      space around the spinal cord with the aid of a live X-Ray machine, followed by an injection
      of various medications. Typically, the medication that is injected is a steroid, commonly
      with the combination of local anesthetic medication. Epidural steroid injections, with or
      without local anesthetic is part of the established standard of care in the United States for
      those with continued or recurrent low back pain. The steroid is believed to reduce
      inflammation and edema of the injured or irritated nerves. However, despite the routine use
      of epidural steroids, the steroid itself is not without risks or side effects. Though rare,
      the steroids have been associated with complications including osteoporosis, steroid induced
      myopathy, cataracts and many others. In order to minimize the side effects associated with
      epidural steroids, limiting the dose and frequency have been outlined.

      Clonidine is another medication, commonly used in numerous clinical settings. U. S. Food and
      Drug Administration approved the medication for epidural use for cancer pain but studies have
      shown effectiveness in non-cancer pain was well and is routinely used for various conditions.
      There is growing evidence on the use of epidural clonidine for treatment of pain, including
      low back pain.

      This research will study and compare the effectiveness, if any, of clonidine compared to
      steroid in an epidural injection for low back pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Pain Intensity Measured on Visual Analog Scale (VAS)
time frame: 3 months
measure: Percentage of Pain Relief
time frame: Day 0, 3 weeks, 3 months
measure: Level of Disability (Oswestry Back Scale)
time frame: 3 weeks, 3 months
measure: Adverse Events
time frame: Day 0, 3 weeks, 3 months
arm group label: Steroid
arm group type: Active Comparator
description: Epidural steroid injection
arm group label: Clonidine
arm group type: Experimental
description: Epidural clonidine injection
intervention type: Drug
intervention name: Epidural steroid
arm group label: Steroid
intervention type: Drug
intervention name: Clonidine
arm group label: Clonidine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
mesh term: Clonidine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 