<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20190419043319N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-30</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>The effect of ozone-oxygen gas on pain and activity in patients with lumbar spinal stenosis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of ozone-oxygen gas injection and high power laser in paravertebral muscles on pain and activity in patients with lumbar spinal stenosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39191</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After selecting the sample, they were randomly divided into three groups. In this study, individuals were assigned to three groups using permutation block method. In this method, A represents the person receiving the first intervention, B represents the person receiving the second intervention, and C represents the person receiving the placebo. Considering blocks of size 6, they were categorized into the desired permutations and patients were classified by random selection from the permutation envelope, Blinding description: For the double blinding process, after selecting patients, they are told that in all groups, the treatment methods are uncomplicated and could reduce pain. The treatment can be placebo (normal saline), ozone-oxygen or high power laser. The patient and the treating physician are not aware of the nature of the treatment. Each patient and the drug used for him is identified by the same number. For example, patient number 8 and drug number 8.</study_design>
      <phase>N/A</phase>
      <hc_freetext>lumbar spinal stenosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: intramuscular paravertebral injection of oxygen –ozone with 10 microgram/cc - 3 times at week for 5 weeks. Intervention 2: Intervention group 2: high intensity laser 30 W; dose 100 J / cm². 5 15-minute sessions per week for 2 weeks. Intervention 3: Control group: Exercises included lower trunk rotation; knee to chest; pelvic tilt, which strengthens and stabilizes the muscles of the abdomen, back and pelvis. All treatment groups were instructed to exercise three times a day for 2 weeks.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samira Shahabi Rabori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baqaei Pour Clinic; Shahid Sadoughi Hospital; Ibn Sina Blvd; Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916884818</zip>
        <telephone>+98 35 3822 6575</telephone>
        <email>shahabi.867@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samira Shahabi Rabori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baqaei Pour Clinic; Shahid Sadoughi Hospital; Ibn Sina Blvd; Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916884818</zip>
        <telephone>+98 35 3822 6575</telephone>
        <email>shahabi.867@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Informed consent to participate in the study
Existence of neurological pain and lameness in the last six months
Age between 35-75 years
Absence of any spinal or musculoskeletal disease
No response to drug treatment for more than 3 months</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Diabetes mellitus
Body mass index more than 41
History of fracture of the spine
History of bleeding disorders
Rheumatic diseases
Neuropathy
Psychological diseases
Brucellosis
Genetic diseases such as galactose intolerance or lactase deficiency
Congenital heart diseases
Allergic reactions to bovine proteins
Inability to communicate
History of significant liver, kidney and heart disorders
Injections in or around the affected joint in the last six months
Pregnancy
Cancer
People who are taking anticoagulants
People with Favism
Vascular claudication
History of previous spinal surgery
Indication of emergency surgery
Any ban on ozone treatment
Any ban on acetaminophen
People consuming codeine</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M48.06</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Spinal stenosis, lumbar region</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: intramuscular paravertebral injection of oxygen –ozone with 10 microgram/cc - 3 times at week for 5 weeks</i_keyword>
      <i_keyword>Intervention group 2: high intensity laser 30 W; dose 100 J / cm². 5 15-minute sessions per week for 2 weeks</i_keyword>
      <i_keyword>Control group: Exercises included lower trunk rotation; knee to chest; pelvic tilt, which strengthens and stabilizes the muscles of the abdomen, back and pelvis. All treatment groups were instructed to exercise three times a day for 2 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before treatment, immediately after treatment, and at weeks 4 and 8 after treatment. Method of measurement: Somatic symptom scale questionnaire.</prim_outcome>
      <prim_outcome>Physical activity. Timepoint: Before treatment, immediately after treatment, and at weeks 4 and 8 after treatment. Method of measurement: Somatic symptom scale questionnaire.</prim_outcome>
      <prim_outcome>Satisfaction. Timepoint: Before treatment, immediately after treatment, and at weeks 4 and 8 after treatment. Method of measurement: Somatic symptom scale questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-26</approval_date>
        <contact_name>Ethics Committee of Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>8915887856; Baqaei Pour Clinic; Shahid Sadoughi Hospital; Ibn Sina Blvd; Yazd yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
