<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/NCT03245671</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0615</org_study_id>
    <nct_id>NCT03245671</nct_id>
  </id_info>
  <brief_title>Particulate vs. Nonparticulate Epidural Steroid Injections for Lumbar Foraminal Stenosis</brief_title>
  <official_title>Particulate vs. Nonparticulate Epidural Steroid Injections for the Treatment of Symptomatic Unilateral Lumbar Foraminal Stenosis: a Prospective Double-blinded Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital for Special Surgery, New York</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital for Special Surgery, New York</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic lumbosacral radiculopathy secondary to lumbar spinal stenosis affects a large number&#xD;
      of individuals, and there is a general lack of consensus in the medical community in terms of&#xD;
      effective treatments for this problem. By assessing the relative efficacy of transforaminal&#xD;
      epidural injections of particulate and nonparticulate steroids, this study attempts to&#xD;
      further define the appropriate conservative management of painful unilateral radiculopathies&#xD;
      due to unilateral lumbar foraminal stenosis. Patients will be randomized to receive a&#xD;
      transforaminal epidural injection of either a particulate (Kenalog) or nonparticulate&#xD;
      (Decadron) steroid. Outcomes will be assessed at 2 weeks, 6 weeks, 3 months, and 6 months&#xD;
      following the injection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Unable to address regulatory concerns.&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 2017</start_date>
  <completion_date type="Anticipated">April 2019</completion_date>
  <primary_completion_date type="Anticipated">April 2019</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, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in function (2 weeks post-injection)</measure>
    <time_frame>2 weeks post-injection</time_frame>
    <description>This will be measured using the Oswestry Disability Index (ODI; 0-100 scale). A higher score represents greater disability (greater pain and functional limitations).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improvement in function (6 weeks post-injection)</measure>
    <time_frame>6 weeks post-injection</time_frame>
    <description>This will be measured using the ODI (0-100 scale). A higher score represents greater disability (greater pain and functional limitations).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improvement in function (3 months post-injection)</measure>
    <time_frame>3 months post-injection</time_frame>
    <description>This will be measured using the ODI (0-100 scale). A higher score represents greater disability (greater pain and functional limitations).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improvement in function (6 months post-injection)</measure>
    <time_frame>6 months post-injection</time_frame>
    <description>This will be measured using the ODI (0-100 scale). A higher score represents greater disability (greater pain and functional limitations).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Medication use</measure>
    <time_frame>2 weeks, 6 weeks, 3 months, and 6 months post-injection</time_frame>
    <description>The use of any pain medications (e.g., opioids, anti-inflammatory drugs, neuropathic medications) will be collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction with the procedure</measure>
    <time_frame>2 weeks, 6 weeks, 3 months, and 6 months post-injection</time_frame>
    <description>Satisfaction will be assessed using the North American Spine Society Outcome Questionnaire. Patients will be asked to pick from 4 multiple choice statements regarding their satisfaction with their procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>2 weeks, 6 weeks, 3 months, and 6 months post-injection</time_frame>
    <description>This will be assessed using the Veterans RAND 12-item Health Survey.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects</measure>
    <time_frame>2 weeks, 6 weeks, 3 months, and 6 months post-injection</time_frame>
    <description>Side effects, including bleeding, infection, allergic reaction, dural puncture, nerve damage, and paralysis, will be collected.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Lumbar Spinal Stenosis</condition>
  <arm_group>
    <arm_group_label>Decadron</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the Decadron group will receive epidural injections containing a total of 15 mg Decadron.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kenalog</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the Kenalog group will receive epidural injections containing a total of 80 mg Kenalog.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Kenalog Injectable Product</intervention_name>
    <description>80 mg of Kenalog will be used.</description>
    <arm_group_label>Kenalog</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Decadron Phosphate, Injectable</intervention_name>
    <description>15 mg of Decadron will be used.</description>
    <arm_group_label>Decadron</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Epidural Steroid Injection</intervention_name>
    <description>Patient will receive epidural steroid injections of either Kenalog or Decadron.</description>
    <arm_group_label>Decadron</arm_group_label>
    <arm_group_label>Kenalog</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speaking/reading adults age 18-90 years&#xD;
&#xD;
          -  Patients with complaints of unilateral radicular lower extremity symptoms&#xD;
&#xD;
          -  NRS pain score &gt;= 5&#xD;
&#xD;
          -  Pain symptoms for at least 1 month's duration&#xD;
&#xD;
          -  Patients deemed appropriate for lumbar transforaminal epidural steroid injections by&#xD;
             treating spine specialist&#xD;
&#xD;
          -  Targeted injection level for L4 or L5&#xD;
&#xD;
          -  MRI of lumbosacral spine that demonstrates and confirms single-level neural&#xD;
             compression secondary to unilateral lumbosacral foraminal or subarticular stenosis&#xD;
             consistent with clinical history and findings&#xD;
&#xD;
          -  Lumbar foraminal stenosis severity of grades 1, 2, and 3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with multiple symptomatic levels&#xD;
&#xD;
          -  Patients who are deemed not appropriate to undergo lumbar transforaminal epidural&#xD;
             steroid injections (e.g., allergy to local anesthetics, radiographic dye contrast,&#xD;
             patients with high bleeding tendency, pregnancy)&#xD;
&#xD;
          -  Patients involved with litigation or worker's compensation cases&#xD;
&#xD;
          -  Patients who are unable to answer the questionnaires and perform follow-up visits&#xD;
&#xD;
          -  Patients who have active, concurrent painful diagnoses (e.g., hip osteoarthritis,&#xD;
             greater trochanteric pain syndrome, knee pain, peripheral vascular disease, or&#xD;
             peripheral neuropathy) that may confuse clinical picture and impact patients' rating&#xD;
             and perception of their low back and radicular symptoms&#xD;
&#xD;
          -  Patients with other spinal pathologies confirmed on imaging that may explain patient's&#xD;
             pain&#xD;
&#xD;
          -  Patients who have additional severe foraminal stenosis inferior to the symptomatic&#xD;
             level (e.g., symptomatic L4 foraminal stenosis with severe L5 foraminal stenosis) will&#xD;
             not have those levels injected&#xD;
&#xD;
          -  Non-English speakers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital for Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>December 4, 2017</last_update_submitted>
  <last_update_submitted_qc>December 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2017</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>Constriction, Pathologic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Dexamethasone acetate</mesh_term>
    <mesh_term>Triamcinolone Acetonide</mesh_term>
    <mesh_term>Dexamethasone 21-phosphate</mesh_term>
    <mesh_term>BB 1101</mesh_term>
  </intervention_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/NCT03245671
org study id: 2016-0615
nct id: NCT03245671
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
Chronic lumbosacral radiculopathy secondary to lumbar spinal stenosis affects a large number
      of individuals, and there is a general lack of consensus in the medical community in terms of
      effective treatments for this problem. By assessing the relative efficacy of transforaminal
      epidural injections of particulate and nonparticulate steroids, this study attempts to
      further define the appropriate conservative management of painful unilateral radiculopathies
      due to unilateral lumbar foraminal stenosis. Patients will be randomized to receive a
      transforaminal epidural injection of either a particulate (Kenalog) or nonparticulate
      (Decadron) steroid. Outcomes will be assessed at 2 weeks, 6 weeks, 3 months, and 6 months
      following the injection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Improvement in function (2 weeks post-injection)
time frame: 2 weeks post-injection
description: This will be measured using the Oswestry Disability Index (ODI; 0-100 scale). A higher score represents greater disability (greater pain and functional limitations).
measure: Improvement in function (6 weeks post-injection)
time frame: 6 weeks post-injection
description: This will be measured using the ODI (0-100 scale). A higher score represents greater disability (greater pain and functional limitations).
measure: Improvement in function (3 months post-injection)
time frame: 3 months post-injection
description: This will be measured using the ODI (0-100 scale). A higher score represents greater disability (greater pain and functional limitations).
measure: Improvement in function (6 months post-injection)
time frame: 6 months post-injection
description: This will be measured using the ODI (0-100 scale). A higher score represents greater disability (greater pain and functional limitations).
measure: Medication use
time frame: 2 weeks, 6 weeks, 3 months, and 6 months post-injection
description: The use of any pain medications (e.g., opioids, anti-inflammatory drugs, neuropathic medications) will be collected.
measure: Patient satisfaction with the procedure
time frame: 2 weeks, 6 weeks, 3 months, and 6 months post-injection
description: Satisfaction will be assessed using the North American Spine Society Outcome Questionnaire. Patients will be asked to pick from 4 multiple choice statements regarding their satisfaction with their procedure.
measure: Quality of life
time frame: 2 weeks, 6 weeks, 3 months, and 6 months post-injection
description: This will be assessed using the Veterans RAND 12-item Health Survey.
measure: Side effects
time frame: 2 weeks, 6 weeks, 3 months, and 6 months post-injection
description: Side effects, including bleeding, infection, allergic reaction, dural puncture, nerve damage, and paralysis, will be collected.
arm group label: Decadron
arm group type: Active Comparator
description: Patients in the Decadron group will receive epidural injections containing a total of 15 mg Decadron.
arm group label: Kenalog
arm group type: Active Comparator
description: Patients in the Kenalog group will receive epidural injections containing a total of 80 mg Kenalog.
intervention type: Drug
intervention name: Kenalog Injectable Product
description: 80 mg of Kenalog will be used.
arm group label: Kenalog
intervention type: Drug
intervention name: Decadron Phosphate, Injectable
description: 15 mg of Decadron will be used.
arm group label: Decadron
intervention type: Procedure
intervention name: Epidural Steroid Injection
description: Patient will receive epidural steroid injections of either Kenalog or Decadron.
arm group label: Decadron
arm group label: Kenalog
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Spinal Stenosis
mesh term: Constriction, Pathologic
mesh term: Dexamethasone
mesh term: Dexamethasone acetate
mesh term: Triamcinolone Acetonide
mesh term: Dexamethasone 21-phosphate
mesh term: BB 1101