<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/NCT03023969</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00009908</org_study_id>
    <nct_id>NCT03023969</nct_id>
  </id_info>
  <brief_title>Implication of Two Doses of O2-O3 Upon the Pain Alleviation in Patients With Low Back Pain</brief_title>
  <official_title>Implication of Two Different Doses of Intradiscal O2-O3 Injection Upon the Pain Alleviation in Patients With Low Back Pain: A Randomized, Single-blind Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Low back pain is very common problem, variable modalities have been introduced to control&#xD;
      such problem. One of the emerging modalities is the ozone - oxygen (O2-O3 ) mixture that&#xD;
      could reduce the herniation disk size and inflammation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intervertebral disc herniation is the most common problem which induces low back pain LBP.&#xD;
      The number of patients seek surgical and or alternative therapy increases. The rate of&#xD;
      re-operation is between 7-9% at 2 years and increases up to 10-25% at ten years&#xD;
      postoperative.&#xD;
&#xD;
      Epidural injections with local anesthetics and steroids are one of the most commonly used&#xD;
      interventions in managing chronic low back pain and lower extremity pain of various causes.&#xD;
      However, despite their extensive use, debate continues on this medications effectiveness due&#xD;
      to the lack of well-designed, randomized, controlled studies to determine the effectiveness&#xD;
      of epidural injections in general, and caudal epidural injections in particular.&#xD;
&#xD;
      Ozone in mixture with oxygen has been justified in multiple studies have been done, this&#xD;
      study aims to evaluate variable doses of this mix upon patient satisfaction, pain alleviation&#xD;
      over 12 month follow up period .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2015</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>N/A</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain alleviation by visual analogue scale (VAS)</measure>
    <time_frame>12 months</time_frame>
    <description>assessing pain alleviation by visual analogue scale (VAS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction of disk herniation by MRI</measure>
    <time_frame>6 months</time_frame>
    <description>evaluation of disk herniation by MRI 6 month after injection, in comparison to the pre-injection MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain alleviation using Oswestry Low Back Pain Questionnaire</measure>
    <time_frame>12 months</time_frame>
    <description>using Oswestry Low Back Pain Questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Pain, Chronic</condition>
  <arm_group>
    <arm_group_label>group A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>percutaneous ozone intradiscal injection group A receive 10 ml of ozone oxygen mixture 40 ug O3/ ml O2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>percutaneous ozone intradiscal injection group receive 10 ml of ozone oxygen mixture 30 ug O3/ ml O2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ozone oxygen mixture</intervention_name>
    <description>receive 10 ml of ozone oxygen mixture under variable dosing</description>
    <arm_group_label>group A</arm_group_label>
    <arm_group_label>group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients Suffered radicular leg pain and some reported additional back pain.&#xD;
&#xD;
          -  All patients are non-responsive to conservative treatment modalities with VAS more&#xD;
             than 7.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  presence of bleeding disorder&#xD;
&#xD;
          -  local infection&#xD;
&#xD;
          -  uncontrolled or degenerative spine disease&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  multilevel disk involvement&#xD;
&#xD;
          -  patient refusal.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Emad Zarief Kamel Said</name>
      <address>
        <city>Assiut</city>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>February 5, 2017</last_update_submitted>
  <last_update_submitted_qc>February 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Emad Zarief , MD</investigator_full_name>
    <investigator_title>Lecturer of Anesthesia and ICU</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
  </condition_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/NCT03023969
org study id: IRB00009908
nct id: NCT03023969
lead sponsor: 
has dmc: No
Low back pain is very common problem, variable modalities have been introduced to control
      such problem. One of the emerging modalities is the ozone - oxygen (O2-O3 ) mixture that
      could reduce the herniation disk size and inflammation.
Intervertebral disc herniation is the most common problem which induces low back pain LBP.
      The number of patients seek surgical and or alternative therapy increases. The rate of
      re-operation is between 7-9% at 2 years and increases up to 10-25% at ten years
      postoperative.

      Epidural injections with local anesthetics and steroids are one of the most commonly used
      interventions in managing chronic low back pain and lower extremity pain of various causes.
      However, despite their extensive use, debate continues on this medications effectiveness due
      to the lack of well-designed, randomized, controlled studies to determine the effectiveness
      of epidural injections in general, and caudal epidural injections in particular.

      Ozone in mixture with oxygen has been justified in multiple studies have been done, this
      study aims to evaluate variable doses of this mix upon patient satisfaction, pain alleviation
      over 12 month follow up period .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Pain alleviation by visual analogue scale (VAS)
time frame: 12 months
description: assessing pain alleviation by visual analogue scale (VAS)
measure: Reduction of disk herniation by MRI
time frame: 6 months
description: evaluation of disk herniation by MRI 6 month after injection, in comparison to the pre-injection MRI
measure: Pain alleviation using Oswestry Low Back Pain Questionnaire
time frame: 12 months
description: using Oswestry Low Back Pain Questionnaire
arm group label: group A
arm group type: Active Comparator
description: percutaneous ozone intradiscal injection group A receive 10 ml of ozone oxygen mixture 40 ug O3/ ml O2
arm group label: group B
arm group type: Active Comparator
description: percutaneous ozone intradiscal injection group receive 10 ml of ozone oxygen mixture 30 ug O3/ ml O2.
intervention type: Drug
intervention name: ozone oxygen mixture
description: receive 10 ml of ozone oxygen mixture under variable dosing
arm group label: group A
arm group label: group B
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Emad Zarief , MD
investigator title: Lecturer of Anesthesia and ICU
mesh term: Back Pain
mesh term: Low Back Pain
mesh term: Chronic Pain
sharing ipd: Undecided