<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/NCT03247413</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00113297</org_study_id>
    <nct_id>NCT03247413</nct_id>
  </id_info>
  <brief_title>Post-lesion Administration of Dexamethasone to Prevent the Development of Neuritis After Radiofrequency Ablation</brief_title>
  <official_title>Post-lesion Administration of Dexamethasone to Prevent the Development of Neuritis After Radiofrequency Ablation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</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>
      Chronic neck and back pain has become one of the leading causes of disability and loss of&#xD;
      productivity. For many patients with facet or sacroiliac joint mediated pain who have&#xD;
      responded to diagnostic nerve blocks, radiofrequency ablation of the nerves innervating the&#xD;
      joints can provide long term relief. Radiofrequency ablation (RFA) is a relatively safe&#xD;
      procedure with minimal risk of adverse events. However, with any procedure involving damage&#xD;
      to the peripheral nervous system, there is risk of post-procedure neuropathic pain. The&#xD;
      investigators will test the hypothesis that dexamethasone injection delivered at the time of&#xD;
      lesion effectively prevents the development of post-ablation neuritis through a&#xD;
      placebo-controlled, double-blind, randomized trial in patients undergoing cervical, thoracic,&#xD;
      lumbar, and sacroiliac joint radiofrequency denervations&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study has been halted prematurely&#xD;
  </why_stopped>
  <start_date type="Actual">September 1, 2019</start_date>
  <completion_date type="Actual">October 14, 2022</completion_date>
  <primary_completion_date type="Actual">October 14, 2022</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>
    <intervention_model_description>Each patient serves as his or her own control. Investigators are recruiting patients who are undergoing bilateral procedures. Each patient will receive dexamethasone at each lesion site post-ablation on one side, and placebo (saline) on the other.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>The patient, care providers, and principle investigator will be blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of post-ablation neuritis</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">366</enrollment>
  <condition>Neuritis</condition>
  <condition>Radiofrequency Ablation</condition>
  <arm_group>
    <arm_group_label>Dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lesions where dexamethasone 4 milligram is administered post-radiofrequency ablation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Lesions where 1 milliliter of normal saline is administered post-radiofrequency ablation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone 4 mg/ml</intervention_name>
    <description>dexamethasone 4 milligram given post-ablation at each lesion site</description>
    <arm_group_label>Dexamethasone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>Placebo, normal saline administered post-ablation at each lesion site</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with a diagnosis of either cervical, thoracic, or lumbar facet or sacroiliac&#xD;
             joint pain who have responded to medial branch blocks and are already scheduled for&#xD;
             bilateral radiofrequency ablations&#xD;
&#xD;
          -  age greater than 18 years old&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient not previously scheduled for radiofrequency ablation of the cervical,&#xD;
             thoracic, or lumbar facets, or sacroiliac joints&#xD;
&#xD;
          -  on anticoagulation&#xD;
&#xD;
          -  have a pacemaker&#xD;
&#xD;
          -  age less than 18 years old&#xD;
&#xD;
          -  non-English speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Akhil Chhatre, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>October 14, 2022</last_update_submitted>
  <last_update_submitted_qc>October 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2022</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>Neuritis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03247413
org study id: IRB00113297
nct id: NCT03247413
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Chronic neck and back pain has become one of the leading causes of disability and loss of
      productivity. For many patients with facet or sacroiliac joint mediated pain who have
      responded to diagnostic nerve blocks, radiofrequency ablation of the nerves innervating the
      joints can provide long term relief. Radiofrequency ablation (RFA) is a relatively safe
      procedure with minimal risk of adverse events. However, with any procedure involving damage
      to the peripheral nervous system, there is risk of post-procedure neuropathic pain. The
      investigators will test the hypothesis that dexamethasone injection delivered at the time of
      lesion effectively prevents the development of post-ablation neuritis through a
      placebo-controlled, double-blind, randomized trial in patients undergoing cervical, thoracic,
      lumbar, and sacroiliac joint radiofrequency denervations
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Each patient serves as his or her own control. Investigators are recruiting patients who are undergoing bilateral procedures. Each patient will receive dexamethasone at each lesion site post-ablation on one side, and placebo (saline) on the other.
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
masking description: The patient, care providers, and principle investigator will be blinded.
measure: Incidence of post-ablation neuritis
time frame: 4 weeks
arm group label: Dexamethasone
arm group type: Experimental
description: Lesions where dexamethasone 4 milligram is administered post-radiofrequency ablation
arm group label: Placebo
arm group type: Placebo Comparator
description: Lesions where 1 milliliter of normal saline is administered post-radiofrequency ablation
intervention type: Drug
intervention name: Dexamethasone 4 mg/ml
description: dexamethasone 4 milligram given post-ablation at each lesion site
arm group label: Dexamethasone
intervention type: Drug
intervention name: Normal saline
description: Placebo, normal saline administered post-ablation at each lesion site
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Akhil Chhatre, MD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neuritis
mesh term: Dexamethasone
sharing ipd: Undecided