<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/NCT03038529</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00009903</org_study_id>
    <nct_id>NCT03038529</nct_id>
  </id_info>
  <brief_title>Variable Approaches of Intradiscal O3-O2 Injection</brief_title>
  <official_title>Variable Approaches of Intradiscal O3-O2 Injection for Management of Low Back Pain: Could it Make a Difference? a Prospective Double Blind Randomized Clinical Trial.</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>
    <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>
      Cost Intradiscal injection of ozone-oxygen mixture (O3-O2) which offers a rapid onset&#xD;
      amelioration of symptoms, with a sustained duration pain relief in low back pain.&#xD;
&#xD;
      Does change of injection approach make a difference?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Low back pain (LBP) mostly is induced by disc herniation (DH), or degeneration and has a&#xD;
      burden upon social and economic aspects of life. Medical and or surgical interventions have&#xD;
      been used to resolve this problem, but one of the newly introduced is the minimally invasive&#xD;
      low cost Intradiscal injection of ozone-oxygen mixture (O3-O2) which offers a rapid onset&#xD;
      amelioration of symptoms, with a sustained duration pain relief.&#xD;
&#xD;
      A lot of injection approaches are available, but which offers the best results, is the&#xD;
      question.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Actual">November 30, 2016</completion_date>
  <primary_completion_date type="Actual">October 30, 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>Quality of pain alleviation (visual analog scale)</measure>
    <time_frame>one year</time_frame>
    <description>assessing visual analog scale (VAS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Analgesia reduction (percent)</measure>
    <time_frame>one year</time_frame>
    <description>the percent of analgesia reduction</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>A: Classic approach</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Intradiscal O3 injection through classic postrolateral extraarticular percutaneous approach.&#xD;
The participants will receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2. The ozone-oxygen mixture was produced in real-time by a medical ozone generator (Ozonline E 80, Medica srl, Bologna Italy).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B: Transforaminal approach (Yess approach )</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2 through postrolateral transforaminal approach (Yess approach).&#xD;
The ozone-oxygen mixture was produced in real-time by a medical ozone generator (Ozonline E 80, Medica srl, Bologna Italy).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Classic postrolateral extraarticular percutaneous approach for O3 injection</intervention_name>
    <description>Receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2 through the classic postrolateral extraarticular percutaneous approach</description>
    <arm_group_label>A: Classic approach</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Postrolateral transforaminal approach (Yess approach ) for O3 injection</intervention_name>
    <description>Group B receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2 through postrolateral transforaminal approach (Yess approach ).</description>
    <arm_group_label>B: Transforaminal approach (Yess approach )</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  radicular leg pain&#xD;
&#xD;
          -  low back pain&#xD;
&#xD;
          -  non-responsive to conservative treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient refusal&#xD;
&#xD;
          -  infection at injection site&#xD;
&#xD;
          -  coagulopathy&#xD;
&#xD;
          -  uncontrolled or degenerative spine disease&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  multilevel disk involvement&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abdelraheem Alawaamy, MD</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <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>December 2017</verification_date>
  <study_first_submitted>January 28, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>December 7, 2017</last_update_submitted>
  <last_update_submitted_qc>December 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 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>
  <keyword>low back pain , Ozone</keyword>
  <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>
  </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/NCT03038529
org study id: IRB00009903
nct id: NCT03038529
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Cost Intradiscal injection of ozone-oxygen mixture (O3-O2) which offers a rapid onset
      amelioration of symptoms, with a sustained duration pain relief in low back pain.

      Does change of injection approach make a difference?
Low back pain (LBP) mostly is induced by disc herniation (DH), or degeneration and has a
      burden upon social and economic aspects of life. Medical and or surgical interventions have
      been used to resolve this problem, but one of the newly introduced is the minimally invasive
      low cost Intradiscal injection of ozone-oxygen mixture (O3-O2) which offers a rapid onset
      amelioration of symptoms, with a sustained duration pain relief.

      A lot of injection approaches are available, but which offers the best results, is the
      question.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Quality of pain alleviation (visual analog scale)
time frame: one year
description: assessing visual analog scale (VAS)
measure: Analgesia reduction (percent)
time frame: one year
description: the percent of analgesia reduction
arm group label: A: Classic approach
arm group type: Other
description: Intradiscal O3 injection through classic postrolateral extraarticular percutaneous approach.
The participants will receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2. The ozone-oxygen mixture was produced in real-time by a medical ozone generator (Ozonline E 80, Medica srl, Bologna Italy).
arm group label: B: Transforaminal approach (Yess approach )
arm group type: Active Comparator
description: Participants will receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2 through postrolateral transforaminal approach (Yess approach).
The ozone-oxygen mixture was produced in real-time by a medical ozone generator (Ozonline E 80, Medica srl, Bologna Italy).
intervention type: Procedure
intervention name: Classic postrolateral extraarticular percutaneous approach for O3 injection
description: Receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2 through the classic postrolateral extraarticular percutaneous approach
arm group label: A: Classic approach
intervention type: Procedure
intervention name: Postrolateral transforaminal approach (Yess approach ) for O3 injection
description: Group B receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2 through postrolateral transforaminal approach (Yess approach ).
arm group label: B: Transforaminal approach (Yess approach )
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Abdelraheem Alawaamy, MD
role: Study Director
affiliation: Assiut University
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
sharing ipd: Undecided