<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/NCT04453449</url>
  </required_header>
  <id_info>
    <org_study_id>14010</org_study_id>
    <nct_id>NCT04453449</nct_id>
  </id_info>
  <brief_title>The Effect of Midazolam Sedation on Diagnostic Medial Branch Blocks</brief_title>
  <acronym>MBB</acronym>
  <official_title>A Prospective Study Investigating the Effect of Midazolam Sedation on Diagnostic Lumbar Medial Branch Blocks</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henry Ford Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Henry Ford Health System</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective observational study aims to investigate the effect of midazolam sedation on&#xD;
      the diagnostic validity of diagnostic lumbar medial branch block in patients diagnosed with&#xD;
      lumbar spondylosis without myelopathy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective observational study aims to investigate the effects of midazolam sedation on&#xD;
      the diagnostic validity of lumbar medial branch blocks in patients diagnosed with lumbar&#xD;
      spondylosis without myelopathy. Patients typically receive two subsequent diagnostic blocks&#xD;
      prior RFTC, to ensure that the correct location has been targeted. When patients achieve at&#xD;
      least 80% pain relief after both diagnostic blocks, this is considered a positive result and&#xD;
      they can proceed to receive RFTC. If patients have positive diagnostic blocks but their RFTC&#xD;
      is not successful, this is considered a false positive diagnostic result. This study will&#xD;
      determine 1) if a higher number of sedated patients proceed to radiofrequency&#xD;
      thermocoagulation (RFTC) than non-sedated patients, and 2) if there are a higher number of&#xD;
      false positive results in sedated patients. The hypothesis is that the use of midazolam&#xD;
      sedation will increase the number of patients who perceive to have pain relief from their&#xD;
      diagnostic block results, resulting in more patients proceeding to RFTC, and that there will&#xD;
      be a higher number of false positive results in sedated patients. The primary outcome measure&#xD;
      is the number of sedated versus non-sedated patients that have positive block results. A&#xD;
      positive result will be calculated by having at least one NRS score that is at least 80%&#xD;
      lower than their baseline NRS score in the 8 hours following lumbar MBB. The secondary&#xD;
      outcome will be the number of false positive blocks in sedated versus non-sedated patients.&#xD;
      After patients achieve 80% relief after each of the two diagnostic lumbar medial branch&#xD;
      blocks and proceeds with lumbar RFTC, we will then collect NRS scores 24 hours after both&#xD;
      diagnostic Lumbar MBB, and 4 weeks and at 8 weeks after the lumbar RFTC. If a patient has not&#xD;
      received at least 50% reduction from their baseline NRS score by 8 weeks, this will be&#xD;
      considered a false positive. A 7-point Patient Global Impression of Change (PGIC) score 8&#xD;
      hours after each Lumbar MBB will also be collected, and at 4 weeks and 8 weeks after the&#xD;
      lumbar RFTC, and any adverse effects patients experience. In addition, Oswestry Disability&#xD;
      Index (ODI) will be collected at 4 and 8 weeks after lumbar RFTC. The results of this study&#xD;
      will help guide the use of sedation when performing diagnostic blocks on patients with lumbar&#xD;
      spondylosis, in order to reduce the number of false positive blocks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 25, 2020</start_date>
  <completion_date type="Actual">October 15, 2021</completion_date>
  <primary_completion_date type="Actual">September 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of positive blocks</measure>
    <time_frame>8 hours post diagnostic block</time_frame>
    <description>The number of positive diagnostic lumbar medial branch blocks (defined by at least 80% pain relief) in patients who receive midazolam sedation during their diagnostic blocks will be compared to patients who do not receive sedation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of false positive blocks</measure>
    <time_frame>2.5-3 months</time_frame>
    <description>The number of false positive diagnostic lumbar medial branch blocks (defined by at least 80% pain relief in the two diagnostic blocks, and then less than 80% pain relief following the subsequent radiofrequency thermocoagulation treatment) in patients who receive midazolam sedation during their diagnostic blocks will be compared to patients who do not receive sedation.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient Global Impression of Change-7 (PGIC-7) scores</measure>
    <time_frame>24 hours post diagnostic block; 4 and 8 weeks after radiofrequency thermocoagulation</time_frame>
    <description>The PGIC-7 scores of patients who received sedation will be compared to those who did not receive sedation during their diagnostic lumbar medial branch block.</description>
  </other_outcome>
  <other_outcome>
    <measure>Oswestry Disability Index (ODI) scores</measure>
    <time_frame>4 and 8 weeks after radiofrequency thermocoagulation</time_frame>
    <description>The ODI scores of patients who received sedation will be compared to those who did not receive sedation during their diagnostic lumbar medial branch block.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">95</enrollment>
  <condition>Lumbar Spine Spondylosis</condition>
  <condition>Anxiety Generalized</condition>
  <arm_group>
    <arm_group_label>No sedation</arm_group_label>
    <description>Patients who will undergo the diagnostic lumbar medial branch blocks without sedation (control group).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sedation</arm_group_label>
    <description>Patients who will undergo the diagnostic lumbar medial branch blocks with midazolam sedation (treatment group).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midazolam</intervention_name>
    <description>Midazolam given as a sedative during diagnostic lumbar medial branch block</description>
    <arm_group_label>Sedation</arm_group_label>
    <other_name>sedation</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients diagnosed with Lumbar Spondylosis without Myelopathy at either of five study&#xD;
        locations (HFMC - Ford Rd, HFMC Main, HFMC West Bloomfield, HFMC Pierson, HFMC - Jackson)&#xD;
        from June 1st, 2020 - June 1st, 2021.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients at least 18 years of age&#xD;
&#xD;
          -  History of axial low back pain for at least 3 months&#xD;
&#xD;
          -  Indication for bilateral lumbar medial branch block (L3, L4, L5 medial branch nerves)&#xD;
&#xD;
          -  Diagnosis of Lumbar Spondylosis without Myelopathy &gt;4/10 pain on a 0-10 numerical&#xD;
             rating scale (NRS)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Low back pain with radiculopathy symptoms (this is a diagnosis of sciatica and&#xD;
             treatment is not with lumbar medial branch block)&#xD;
&#xD;
          -  Uncontrolled major depression or other mental health issues causing instability&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  &lt;18 years old&#xD;
&#xD;
          -  History of adverse reaction to either midazolam, lidocaine, or bupivacaine&#xD;
&#xD;
          -  Focal neurological deficits, cognitive impairments, or memory issues&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Hearing impaired that are unable to understand verbal instructions&#xD;
&#xD;
          -  Active Infection&#xD;
&#xD;
          -  On Anticoagulation or Antiplatelet Therapy&#xD;
&#xD;
          -  History of Clotting Disorder&#xD;
&#xD;
          -  Previous Lumbar Medial Branch Block and/or Lumbar Radiofrequency Ablation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>March 3, 2022</last_update_submitted>
  <last_update_submitted_qc>March 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Henry Ford Health System</investigator_affiliation>
    <investigator_full_name>Katherine Nowak</investigator_full_name>
    <investigator_title>Research Manager</investigator_title>
  </responsible_party>
  <keyword>midazolam</keyword>
  <keyword>sedation</keyword>
  <keyword>diagnostic lumbar medial branch block</keyword>
  <keyword>radiofrequency thermocoagulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Midazolam</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/NCT04453449
org study id: 14010
nct id: NCT04453449
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This prospective observational study aims to investigate the effect of midazolam sedation on
      the diagnostic validity of diagnostic lumbar medial branch block in patients diagnosed with
      lumbar spondylosis without myelopathy.
This prospective observational study aims to investigate the effects of midazolam sedation on
      the diagnostic validity of lumbar medial branch blocks in patients diagnosed with lumbar
      spondylosis without myelopathy. Patients typically receive two subsequent diagnostic blocks
      prior RFTC, to ensure that the correct location has been targeted. When patients achieve at
      least 80% pain relief after both diagnostic blocks, this is considered a positive result and
      they can proceed to receive RFTC. If patients have positive diagnostic blocks but their RFTC
      is not successful, this is considered a false positive diagnostic result. This study will
      determine 1) if a higher number of sedated patients proceed to radiofrequency
      thermocoagulation (RFTC) than non-sedated patients, and 2) if there are a higher number of
      false positive results in sedated patients. The hypothesis is that the use of midazolam
      sedation will increase the number of patients who perceive to have pain relief from their
      diagnostic block results, resulting in more patients proceeding to RFTC, and that there will
      be a higher number of false positive results in sedated patients. The primary outcome measure
      is the number of sedated versus non-sedated patients that have positive block results. A
      positive result will be calculated by having at least one NRS score that is at least 80%
      lower than their baseline NRS score in the 8 hours following lumbar MBB. The secondary
      outcome will be the number of false positive blocks in sedated versus non-sedated patients.
      After patients achieve 80% relief after each of the two diagnostic lumbar medial branch
      blocks and proceeds with lumbar RFTC, we will then collect NRS scores 24 hours after both
      diagnostic Lumbar MBB, and 4 weeks and at 8 weeks after the lumbar RFTC. If a patient has not
      received at least 50% reduction from their baseline NRS score by 8 weeks, this will be
      considered a false positive. A 7-point Patient Global Impression of Change (PGIC) score 8
      hours after each Lumbar MBB will also be collected, and at 4 weeks and 8 weeks after the
      lumbar RFTC, and any adverse effects patients experience. In addition, Oswestry Disability
      Index (ODI) will be collected at 4 and 8 weeks after lumbar RFTC. The results of this study
      will help guide the use of sedation when performing diagnostic blocks on patients with lumbar
      spondylosis, in order to reduce the number of false positive blocks.
observational model: Case-Control
time perspective: Prospective
measure: Number of positive blocks
time frame: 8 hours post diagnostic block
description: The number of positive diagnostic lumbar medial branch blocks (defined by at least 80% pain relief) in patients who receive midazolam sedation during their diagnostic blocks will be compared to patients who do not receive sedation.
measure: Number of false positive blocks
time frame: 2.5-3 months
description: The number of false positive diagnostic lumbar medial branch blocks (defined by at least 80% pain relief in the two diagnostic blocks, and then less than 80% pain relief following the subsequent radiofrequency thermocoagulation treatment) in patients who receive midazolam sedation during their diagnostic blocks will be compared to patients who do not receive sedation.
measure: Patient Global Impression of Change-7 (PGIC-7) scores
time frame: 24 hours post diagnostic block; 4 and 8 weeks after radiofrequency thermocoagulation
description: The PGIC-7 scores of patients who received sedation will be compared to those who did not receive sedation during their diagnostic lumbar medial branch block.
measure: Oswestry Disability Index (ODI) scores
time frame: 4 and 8 weeks after radiofrequency thermocoagulation
description: The ODI scores of patients who received sedation will be compared to those who did not receive sedation during their diagnostic lumbar medial branch block.
arm group label: No sedation
description: Patients who will undergo the diagnostic lumbar medial branch blocks without sedation (control group).
arm group label: Sedation
description: Patients who will undergo the diagnostic lumbar medial branch blocks with midazolam sedation (treatment group).
intervention type: Drug
intervention name: Midazolam
description: Midazolam given as a sedative during diagnostic lumbar medial branch block
arm group label: Sedation
other name: sedation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Henry Ford Health System
investigator full name: Katherine Nowak
investigator title: Research Manager
mesh term: Spondylosis
mesh term: Midazolam