<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/NCT03301766</url>
  </required_header>
  <id_info>
    <org_study_id>17-510</org_study_id>
    <nct_id>NCT03301766</nct_id>
  </id_info>
  <brief_title>Adjunctive 5% Lidocaine Patches for Acute Non-radicular Low Back Pain in Emergency Department Patients</brief_title>
  <official_title>Adjunctive 5% Lidocaine Patches in the Treatment of Acute Non-radicular Low Back Pain in Patients Discharged From the Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cook County Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cook County Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the addition of lidocaine % transdermal patches to standard therapy&#xD;
      in the treatment of acute non-radicular low back pain in patients discharged from the&#xD;
      Emergency Department. In addition to standard therapy, half of the participants will receive&#xD;
      medicated patches while the other half will receive non-medicated patches.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Low back pain is a common emergency department (ED) chief complaint. Multiple therapies have&#xD;
      been evaluated in the treatment of ED patients with low back pain including acetaminophen,&#xD;
      NSAIDS, opioids, steroids, and muscle relaxants.&#xD;
&#xD;
      Lidocaine is a local anesthetic that can be administered by various routes. It is used in a&#xD;
      transdermal patch for the treatment of pain. It is commonly used for focal causes of pain,&#xD;
      including low back pain. The addition of lidocaine 5% patches to standard low back pain&#xD;
      therapy has not been rigorously evaluated, although it is frequently used.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Delay for subject recruitment and then not feasible with COVID&gt;&#xD;
  </why_stopped>
  <start_date type="Actual">March 10, 2017</start_date>
  <completion_date type="Actual">May 22, 2023</completion_date>
  <primary_completion_date type="Actual">May 22, 2023</primary_completion_date>
  <phase>Phase 4</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Numerical Pain Rating Scale (NRS)</measure>
    <time_frame>1 week</time_frame>
    <description>Patient description of pain on a scale of 0-10</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Roland-Morris-24 back pain disability scale</measure>
    <time_frame>1 week and 1 month</time_frame>
    <description>24 point back pain disability scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numerical Pain Rating Scale (NRS)</measure>
    <time_frame>1 month</time_frame>
    <description>Patient description of pain on a scale of 0-10</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Repeat visits</measure>
    <time_frame>1 week and 1 month</time_frame>
    <description>Repeat visits to an emergency department</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Lidocaine 5% patch</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive a 7 day supply (21 patches) of lidocaine 5% patches upon discharge from the emergency department in addition to &quot;standard therapy&quot; at the discretion of the treating emergency department physician.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-medicated patch</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive a 7 day supply (21 patches) of non-medicated patches upon discharge from the emergency department in addition to &quot;standard therapy&quot; at the discretion of the treating emergency department physician.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>lidocaine 5% patch</intervention_name>
    <description>transdermal patch</description>
    <arm_group_label>Lidocaine 5% patch</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>standard therapy</intervention_name>
    <description>Drugs prescribed at the discretion of the treating physician (acetaminophen, NSAIDs, muscle relaxants, etc)</description>
    <arm_group_label>Lidocaine 5% patch</arm_group_label>
    <arm_group_label>Non-medicated patch</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Non-medicated patch</intervention_name>
    <description>non-medicated patch</description>
    <arm_group_label>Non-medicated patch</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pain originating between the lower border of the scapulae and the upper gluteal folds&#xD;
&#xD;
          -  treating ED physician plan for discharge of the patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  radicular pain defined as pain radiating below the gluteal folds&#xD;
&#xD;
          -  direct trauma to the back within previous month&#xD;
&#xD;
          -  pain of greater than 2 weeks duration or greater than 1 LBP episode per month in the&#xD;
             past 3 months&#xD;
&#xD;
          -  patient being pregnant or lactating; no access to phone or ability to participate in&#xD;
             follow-up phone calls&#xD;
&#xD;
          -  known allergy to lidocaine or skin breakdown over site of pain&#xD;
&#xD;
          -  treating physician plan for opioid prescription (tramadol, codeine, hydrocodone)&#xD;
&#xD;
          -  personal history of malignancy, fever (temperature greater than 37.9ºC), or previous&#xD;
             spinal surgery&#xD;
&#xD;
          -  patients who are detainees&#xD;
&#xD;
          -  previous enrollment in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>John H Stroger Jr Hospital of Cook County</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>June 27, 2023</last_update_submitted>
  <last_update_submitted_qc>June 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cook County Health</investigator_affiliation>
    <investigator_full_name>Neeraj Chhabra</investigator_full_name>
    <investigator_title>Attending Physician, Department of Emergency Medicine, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>lidocaine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Emergencies</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>Lidocaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03301766
org study id: 17-510
nct id: NCT03301766
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This study will evaluate the addition of lidocaine % transdermal patches to standard therapy
      in the treatment of acute non-radicular low back pain in patients discharged from the
      Emergency Department. In addition to standard therapy, half of the participants will receive
      medicated patches while the other half will receive non-medicated patches.
Low back pain is a common emergency department (ED) chief complaint. Multiple therapies have
      been evaluated in the treatment of ED patients with low back pain including acetaminophen,
      NSAIDS, opioids, steroids, and muscle relaxants.

      Lidocaine is a local anesthetic that can be administered by various routes. It is used in a
      transdermal patch for the treatment of pain. It is commonly used for focal causes of pain,
      including low back pain. The addition of lidocaine 5% patches to standard low back pain
      therapy has not been rigorously evaluated, although it is frequently used.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Numerical Pain Rating Scale (NRS)
time frame: 1 week
description: Patient description of pain on a scale of 0-10
measure: Roland-Morris-24 back pain disability scale
time frame: 1 week and 1 month
description: 24 point back pain disability scale
measure: Numerical Pain Rating Scale (NRS)
time frame: 1 month
description: Patient description of pain on a scale of 0-10
measure: Repeat visits
time frame: 1 week and 1 month
description: Repeat visits to an emergency department
arm group label: Lidocaine 5% patch
arm group type: Experimental
description: Patients will receive a 7 day supply (21 patches) of lidocaine 5% patches upon discharge from the emergency department in addition to "standard therapy" at the discretion of the treating emergency department physician.
arm group label: Non-medicated patch
arm group type: Active Comparator
description: Patients will receive a 7 day supply (21 patches) of non-medicated patches upon discharge from the emergency department in addition to "standard therapy" at the discretion of the treating emergency department physician.
intervention type: Drug
intervention name: lidocaine 5% patch
description: transdermal patch
arm group label: Lidocaine 5% patch
intervention type: Drug
intervention name: standard therapy
description: Drugs prescribed at the discretion of the treating physician (acetaminophen, NSAIDs, muscle relaxants, etc)
arm group label: Lidocaine 5% patch
arm group label: Non-medicated patch
intervention type: Drug
intervention name: Non-medicated patch
description: non-medicated patch
arm group label: Non-medicated patch
criteria: 
gender: All
minimum age: 24 Years
maximum age: 64 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Cook County Health
investigator full name: Neeraj Chhabra
investigator title: Attending Physician, Department of Emergency Medicine, Principal Investigator
mesh term: Back Pain
mesh term: Emergencies
mesh term: Low Back Pain
mesh term: Lidocaine
sharing ipd: No