<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/NCT01709058</url>
  </required_header>
  <id_info>
    <org_study_id>INRCA-02-2011</org_study_id>
    <secondary_id>2011-003185-33</secondary_id>
    <nct_id>NCT01709058</nct_id>
  </id_info>
  <brief_title>Study on the Effects of Oxygen-ozone Therapy on Back Pain in Subjects Aged 65 or Older</brief_title>
  <acronym>O2-O3</acronym>
  <official_title>Prospective, Randomized, Single Blind Trial on the Effects of Paravertebral Intramuscular Oxygen-ozone Therapy on Back Pain in Subjects Aged 65 or Older</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Nazionale di Ricovero e Cura per Anziani</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Regione Marche</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Istituto Nazionale di Ricovero e Cura per Anziani</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to evaluate the efficacy of the oxygen-ozone therapy in the treatment of back&#xD;
      pain in subjects aged 65 or older. In particular, the intramuscular injection&#xD;
      technique/paravertebral of oxygen-ozone mixture, a minimal invasive treatment with respect to&#xD;
      intradiscal infiltration/intraforaminal technique, will be used.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Back pain is a leading cause of disability, including impairment in activities of daily&#xD;
      living. In particular, the persistence of low back pain is more frequent in the elderly,&#xD;
      associated with functional limitations and difficulties to perform tasks in everyday life. In&#xD;
      addition to pharmacological treatments, various non-surgical interventional procedures are&#xD;
      used for the treatment of low back pain. Some recent studies have evaluated the&#xD;
      interventional oxygen-ozone (O2-O3) therapy in the treatment of back pain. However, these&#xD;
      results are based on the technique of intradiscal infiltration / intraforaminal of O2-O3,&#xD;
      while the intramuscular injection technique / paravertebral is the most widely used in&#xD;
      clinical practice in Italy. In general, minimally invasive treatments such as percutaneous&#xD;
      infiltration, are well tolerated and have been shown to produce clinical results, although&#xD;
      the number of controlled studies is still scarce and the studies are often not comparable.&#xD;
      Taking into account the above considerations, it seems appropriate to try to broaden the&#xD;
      knowledge on the use of O2-O3 in the treatment of low back pain, using the technique of&#xD;
      intramuscular injection / paravertebral, with particular reference to the elderly population.&#xD;
&#xD;
      The primary objective of this trial is therefore to evaluate the effects of O2-O3 therapy in&#xD;
      the treatment of back pain associated with lumbar disc disease using the technique of&#xD;
      intramuscular injection/paravertebral. These effects will be evaluated after a 6 weeks&#xD;
      treatment period and after a 3 months follow-up period.&#xD;
&#xD;
      The project will include 130 subjects aged 65 or older who will be randomly enrolled in two&#xD;
      different types of intervention:&#xD;
&#xD;
        -  Oxygen-ozone therapy&#xD;
&#xD;
        -  Simulated treatment&#xD;
&#xD;
      fully described below in the section: Interventions&#xD;
&#xD;
      In addition to clinical evaluations, the trial will contribute to the study of biological&#xD;
      bases of the O2-O3 therapy as the levels of trace elements, oxidative status and antioxidant&#xD;
      capacity in plasma will be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">August 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2014</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oswestry Disability Index(ODI)</measure>
    <time_frame>6 weeks</time_frame>
    <description>The Oswestry Disability Index (ODI) is used to investigate the functional impairment in activities of daily living related to low back pain. The ODI is one of the main measuring instruments necessary for the evaluation of disability from pain and is considered the gold standard for evaluation of disability in low back pain. It consists of 10 questions with multiple answers in which the patient chooses the answer that comes closest to its current state or to that of the last 2 weeks.&#xD;
Response to treatment is considered as a binary classification: &quot;success&quot; if the Oswestry Disability Index is between 0 and 20% (minimal disability) and &quot;failure&quot; in the other cases.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oswestry Disability Index (ODI)</measure>
    <time_frame>3 months follow-up</time_frame>
    <description>The Oswestry Disability Index (ODI) is used to investigate the functional impairment in activities of daily living related to low back pain. The ODI is one of the main measuring instruments necessary for the evaluation of disability from pain and is considered the gold standard for evaluation of disability in low back pain. It consists of 10 questions with multiple answers in which the patient chooses the answer that comes closest to its current state or to that of the last 2 weeks.&#xD;
Response to treatment is considered as a binary classification: &quot;success&quot; if the Oswestry Disability Index is between 0 and 20% (minimal disability) and &quot;failure&quot; in the other cases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comprehensive geriatric assessment by INTERRAI-MDS-HC/VAOR-ADI instrument</measure>
    <time_frame>6 weeks</time_frame>
    <description>identification information, personal data at admission, assessment date, cognitive function, communication and vision, mood and behaviour, physical function, incontinence, diagnosis of the disease, health conditions, oral and nutrition status, skin conditions, medications, treatment and procedures, advanced directives, discharge potential, discharge, assessment information, anamnestic-clinical data, standardised clinical assessment, physical performance tests</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intake of paracetamol</measure>
    <time_frame>6 weeks</time_frame>
    <description>The use of paracetamol is allowed during the study period for the treatment of low back pain, at a dose of no more than 4 grams a day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oxidative stress</measure>
    <time_frame>6 weeks</time_frame>
    <description>The evaluation of oxidative stress by the d-ROMs test and total antioxidant capacity by the anti-ROMs test will be performed.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Back Pain</condition>
  <arm_group>
    <arm_group_label>Intramuscular/paravertebral injections of Oxygen-Ozone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will be treated with &quot;Intramuscular/paravertebral injections of Oxygen-Ozone&quot; twice a week for six weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Simulated treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The &quot;Simulated intramuscular/paravertebral injections&quot; will mimic the Oxygen-Ozone injections in the area to be treated by pricking the skin with the needle without drilling. These simulated injections will be performed twice a week for six weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intramuscular/paravertebral injections of Oxygen-Ozone</intervention_name>
    <description>Medical Oxygen will be used as a part of the injected mixture (100% oxygen, 200 bar compressed gas in steel cylinder with valve 14 with an integrated reductive). For the generation of the Oxygen-Ozone mixture a certified equipment OZONOSAN alpha plus will be used according to the D.L. 46/97, EEC Directive 93/42, class 2A with a photometer. The mixture of O2-O3 is produced through a method called &quot;silent discharge&quot;. Intramuscular/paravertebral injections to 3 cm from the spinal medial line will be performed introducing 5-20 mL of oxygen-ozone to each point, at a concentration of 10-20 micrograms/mL, for a total volume of 40 mL</description>
    <arm_group_label>Intramuscular/paravertebral injections of Oxygen-Ozone</arm_group_label>
    <other_name>oxygen-ozone treatment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Simulated intramuscular/paravertebral injections</intervention_name>
    <description>The simulated treatment administration will mimic the treatment in the area to be treated by pricking the skin with the needle without drilling. A light massage will be practice by hand and the application area will be covered with a bandage adhesive leaving the patient in the prone position for 10-15 minutes.</description>
    <arm_group_label>Simulated treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients aged 65 or older&#xD;
&#xD;
          -  intervertebral disc degeneration&#xD;
&#xD;
          -  back pain persistent for at least 6 weeks&#xD;
&#xD;
          -  painkillers and anti-inflammatory drugs&#xD;
&#xD;
          -  ODI score at baseline between 30 and 80%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  heart failure&#xD;
&#xD;
          -  favism&#xD;
&#xD;
          -  clinically hyperthyroidism&#xD;
&#xD;
          -  cancer and concomitant chemo-or radio-therapy&#xD;
&#xD;
          -  epilepsy&#xD;
&#xD;
          -  asthma&#xD;
&#xD;
          -  life expectancy of 6 months or less&#xD;
&#xD;
          -  psychotic drugs&#xD;
&#xD;
          -  clinical signs of radiculopathy&#xD;
&#xD;
          -  polyradiculopathy&#xD;
&#xD;
          -  progressive neurological deficit&#xD;
&#xD;
          -  lumbar stenosis&#xD;
&#xD;
          -  spondylolisthesis&#xD;
&#xD;
          -  diabetic neuropathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Oriano Mercante, MD</last_name>
    <phone>39 071 8003276</phone>
    <email>O.MERCANTE@inrca.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>INRCA Hospital, via della Montagnola, 81</name>
      <address>
        <city>Ancona</city>
        <zip>I-60131</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Oriano Mercante, MD</last_name>
      <email>O.MERCANTE@inrca.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <last_update_submitted>October 17, 2012</last_update_submitted>
  <last_update_submitted_qc>October 17, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 18, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Back Pain</keyword>
  <keyword>Therapeutics</keyword>
  <keyword>Aged</keyword>
  <keyword>Injections, Intramuscular</keyword>
  <keyword>Oxygen</keyword>
  <keyword>Ozone</keyword>
  <keyword>Geriatric Assessment</keyword>
  <keyword>Trace Elements</keyword>
  <keyword>Oxidative stress</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
  </condition_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/NCT01709058
org study id: INRCA-02-2011
secondary id: 2011-003185-33
nct id: NCT01709058
lead sponsor: 
collaborator: 
has dmc: No
This study aims to evaluate the efficacy of the oxygen-ozone therapy in the treatment of back
      pain in subjects aged 65 or older. In particular, the intramuscular injection
      technique/paravertebral of oxygen-ozone mixture, a minimal invasive treatment with respect to
      intradiscal infiltration/intraforaminal technique, will be used.
Back pain is a leading cause of disability, including impairment in activities of daily
      living. In particular, the persistence of low back pain is more frequent in the elderly,
      associated with functional limitations and difficulties to perform tasks in everyday life. In
      addition to pharmacological treatments, various non-surgical interventional procedures are
      used for the treatment of low back pain. Some recent studies have evaluated the
      interventional oxygen-ozone (O2-O3) therapy in the treatment of back pain. However, these
      results are based on the technique of intradiscal infiltration / intraforaminal of O2-O3,
      while the intramuscular injection technique / paravertebral is the most widely used in
      clinical practice in Italy. In general, minimally invasive treatments such as percutaneous
      infiltration, are well tolerated and have been shown to produce clinical results, although
      the number of controlled studies is still scarce and the studies are often not comparable.
      Taking into account the above considerations, it seems appropriate to try to broaden the
      knowledge on the use of O2-O3 in the treatment of low back pain, using the technique of
      intramuscular injection / paravertebral, with particular reference to the elderly population.

      The primary objective of this trial is therefore to evaluate the effects of O2-O3 therapy in
      the treatment of back pain associated with lumbar disc disease using the technique of
      intramuscular injection/paravertebral. These effects will be evaluated after a 6 weeks
      treatment period and after a 3 months follow-up period.

      The project will include 130 subjects aged 65 or older who will be randomly enrolled in two
      different types of intervention:

        -  Oxygen-ozone therapy

        -  Simulated treatment

      fully described below in the section: Interventions

      In addition to clinical evaluations, the trial will contribute to the study of biological
      bases of the O2-O3 therapy as the levels of trace elements, oxidative status and antioxidant
      capacity in plasma will be evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Oswestry Disability Index(ODI)
time frame: 6 weeks
description: The Oswestry Disability Index (ODI) is used to investigate the functional impairment in activities of daily living related to low back pain. The ODI is one of the main measuring instruments necessary for the evaluation of disability from pain and is considered the gold standard for evaluation of disability in low back pain. It consists of 10 questions with multiple answers in which the patient chooses the answer that comes closest to its current state or to that of the last 2 weeks.
Response to treatment is considered as a binary classification: "success" if the Oswestry Disability Index is between 0 and 20% (minimal disability) and "failure" in the other cases.
measure: Oswestry Disability Index (ODI)
time frame: 3 months follow-up
description: The Oswestry Disability Index (ODI) is used to investigate the functional impairment in activities of daily living related to low back pain. The ODI is one of the main measuring instruments necessary for the evaluation of disability from pain and is considered the gold standard for evaluation of disability in low back pain. It consists of 10 questions with multiple answers in which the patient chooses the answer that comes closest to its current state or to that of the last 2 weeks.
Response to treatment is considered as a binary classification: "success" if the Oswestry Disability Index is between 0 and 20% (minimal disability) and "failure" in the other cases.
measure: Comprehensive geriatric assessment by INTERRAI-MDS-HC/VAOR-ADI instrument
time frame: 6 weeks
description: identification information, personal data at admission, assessment date, cognitive function, communication and vision, mood and behaviour, physical function, incontinence, diagnosis of the disease, health conditions, oral and nutrition status, skin conditions, medications, treatment and procedures, advanced directives, discharge potential, discharge, assessment information, anamnestic-clinical data, standardised clinical assessment, physical performance tests
measure: intake of paracetamol
time frame: 6 weeks
description: The use of paracetamol is allowed during the study period for the treatment of low back pain, at a dose of no more than 4 grams a day
measure: oxidative stress
time frame: 6 weeks
description: The evaluation of oxidative stress by the d-ROMs test and total antioxidant capacity by the anti-ROMs test will be performed.
arm group label: Intramuscular/paravertebral injections of Oxygen-Ozone
arm group type: Experimental
description: This group will be treated with "Intramuscular/paravertebral injections of Oxygen-Ozone" twice a week for six weeks
arm group label: Simulated treatment
arm group type: Other
description: The "Simulated intramuscular/paravertebral injections" will mimic the Oxygen-Ozone injections in the area to be treated by pricking the skin with the needle without drilling. These simulated injections will be performed twice a week for six weeks.
intervention type: Drug
intervention name: Intramuscular/paravertebral injections of Oxygen-Ozone
description: Medical Oxygen will be used as a part of the injected mixture (100% oxygen, 200 bar compressed gas in steel cylinder with valve 14 with an integrated reductive). For the generation of the Oxygen-Ozone mixture a certified equipment OZONOSAN alpha plus will be used according to the D.L. 46/97, EEC Directive 93/42, class 2A with a photometer. The mixture of O2-O3 is produced through a method called "silent discharge". Intramuscular/paravertebral injections to 3 cm from the spinal medial line will be performed introducing 5-20 mL of oxygen-ozone to each point, at a concentration of 10-20 micrograms/mL, for a total volume of 40 mL
arm group label: Intramuscular/paravertebral injections of Oxygen-Ozone
other name: oxygen-ozone treatment
intervention type: Other
intervention name: Simulated intramuscular/paravertebral injections
description: The simulated treatment administration will mimic the treatment in the area to be treated by pricking the skin with the needle without drilling. A light massage will be practice by hand and the application area will be covered with a bandage adhesive leaving the patient in the prone position for 10-15 minutes.
arm group label: Simulated treatment
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Oriano Mercante, MD
phone: 39 071 8003276
email: O.MERCANTE@inrca.it
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Sponsor
mesh term: Back Pain