<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/NCT03273036</url>
  </required_header>
  <id_info>
    <org_study_id>ID 03-54-23</org_study_id>
    <nct_id>NCT03273036</nct_id>
  </id_info>
  <brief_title>Perioperative Outcome of Corticosteroids in Transforaminal Endoscopic Lumbar Discectomy</brief_title>
  <official_title>Comparison of Perioperative Outcome Between Corticosteroids and Placebo in Transforaminal Endoscopic Lumbar Discectomy. A Single-center Randomized Placebo-controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ramathibodi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ramathibodi Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</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>
      The endoscopic discectomy has rapidly developed and increased need by patients. This&#xD;
      procedure is widely performed by interventional pain physicians as well as by spine surgeons&#xD;
      because it requires no general anesthesia or admission to a hospital. Many studies were&#xD;
      reported that corticosteroid injection can inhibit persistent postoperative pain in lumbar&#xD;
      discectomy. However, data of perioperative epidural steroids after an endoscopic discectomy&#xD;
      is lacking.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To examine whether corticosteroid administered epidural space in patients undergoing&#xD;
      endoscopic lumbar discectomy reduces postoperative morphine consumption, back and leg pain&#xD;
      relief, improves functional disability comparing to placebo&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2014</start_date>
  <completion_date type="Actual">May 1, 2015</completion_date>
  <primary_completion_date type="Actual">May 1, 2015</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-operative morphine consumption</measure>
    <time_frame>Post operative 24 hour of morphine consumption in mg</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual analog score (back and leg) 0-10</measure>
    <time_frame>1 day, 2, 6 ,12, 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oswestry disability index (ODI</measure>
    <time_frame>2, 6 ,12, 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MacNab scores</measure>
    <time_frame>2, 6 ,12, 24 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Lumbar Disc Herniation</condition>
  <arm_group>
    <arm_group_label>epidural steroid injection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>40 mg triamcinolone acetate 1 cc</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo injection</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>no injection agent</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>40 mg Triamcinolone acetate 1 cc</intervention_name>
    <description>40 mg Triamcinolone acetate 1 cc</description>
    <arm_group_label>epidural steroid injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>no injected agent</description>
    <arm_group_label>placebo injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Lumbar disc herniation patient age 20-45 year-old who have symptom duration was at&#xD;
             least 6 weeks and conservative treatment failed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refuse to participate and inform consent, Previous spinal surgery, History of allergic&#xD;
             to steroid&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 1, 2017</last_update_submitted>
  <last_update_submitted_qc>September 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ramathibodi Hospital</investigator_affiliation>
    <investigator_full_name>Jatupon Kongtharvonskul</investigator_full_name>
    <investigator_title>principle investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intervertebral Disc Displacement</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triamcinolone</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/NCT03273036
org study id: ID 03-54-23
nct id: NCT03273036
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The endoscopic discectomy has rapidly developed and increased need by patients. This
      procedure is widely performed by interventional pain physicians as well as by spine surgeons
      because it requires no general anesthesia or admission to a hospital. Many studies were
      reported that corticosteroid injection can inhibit persistent postoperative pain in lumbar
      discectomy. However, data of perioperative epidural steroids after an endoscopic discectomy
      is lacking.
To examine whether corticosteroid administered epidural space in patients undergoing
      endoscopic lumbar discectomy reduces postoperative morphine consumption, back and leg pain
      relief, improves functional disability comparing to placebo
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Post-operative morphine consumption
time frame: Post operative 24 hour of morphine consumption in mg
measure: Visual analog score (back and leg) 0-10
time frame: 1 day, 2, 6 ,12, 24 weeks
measure: Oswestry disability index (ODI
time frame: 2, 6 ,12, 24 weeks
measure: MacNab scores
time frame: 2, 6 ,12, 24 weeks
arm group label: epidural steroid injection
arm group type: Active Comparator
description: 40 mg triamcinolone acetate 1 cc
arm group label: placebo injection
arm group type: Placebo Comparator
description: no injection agent
intervention type: Drug
intervention name: 40 mg Triamcinolone acetate 1 cc
description: 40 mg Triamcinolone acetate 1 cc
arm group label: epidural steroid injection
intervention type: Drug
intervention name: Placebos
description: no injected agent
arm group label: placebo injection
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Ramathibodi Hospital
investigator full name: Jatupon Kongtharvonskul
investigator title: principle investigator
mesh term: Intervertebral Disc Displacement
mesh term: Triamcinolone
sharing ipd: No