<?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>IRCT20210920052535N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-26</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effectiveness of ozone and corticosteroid injections in the treatment of CTS</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of local corticosteroid injection and local ozone injection in patients with carpal tunnel syndrome (CTS)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58846</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization was applied. In this method, patients were randomly divided into two groups using a table of random numbers by computer and online (using the site www.random.org/integres), Blinding description: Participants, the person who is completing the questionnaires and collecting the information, the person analyzing the information will be unaware of the group therapy and the type of injected substance.</study_design>
      <phase>3</phase>
      <hc_freetext>Carpal Tunnel Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: First Intervention group: corticosteroid (40mg Triamcinolone) injection under the ultrasound-guide around the median nerve. Intervention 2: Second Intervention group: ozone  (Ozone at a concentration of 10 micrograms per ml with 1 ml of 1% lidocaine) injection under the ultrasound-guide around the median nerve.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Information on the main outcome

When:
Start the access period 6 months after printing the results

To whom:
Only for researchers working in academic and scientific institutions

Conditions:
Confirming the responsible person

Where to obtain:
Dr Farnaz Hesam
f.hesam@rocketmail.com

How to obtain:
Request by email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farnaz Hesam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ebne Sina St, Shahid Ghandi Blvd, safaieh,Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۹۱۵۸۸۷۸۵۷</zip>
        <telephone>+98 35 3822 4000</telephone>
        <email>f.hesam@rocketmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amidodin khatibi Aghda</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ebne Sina St, Shahid Ghandi Blvd, Safaieh,Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۹۱۵۸۸۷۸۵۷</zip>
        <telephone>+98 35 3822 4000</telephone>
        <email>dr.khatibi_2@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients over 18 years with signs and symptoms of carpal tunnel syndrome confirmed by Electrodiagnostic study and have mild to moderate CTS according to it.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Age under 18 years
Severe carpal tunnel syndrome
Presence of underlying diseases such as diabetes, rheumatoid arthritis, thyroid disease and previous history of trauma
Presence of thenar atrophy and peripheral nerve lesions of the upper extremity, polyneuropathy and radiculopathy
Pregnancy, history of G6PD deficiency, thrombocytopenia, severe cardiovascular instability, people are receiving  ACE-I
History of injection or using a splint during the past 6 months or any previous surgery on the carpal tunnel</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G56.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Carpal tunnel syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First Intervention group: corticosteroid (40mg Triamcinolone) injection under the ultrasound-guide around the median nerve.</i_keyword>
      <i_keyword>Second Intervention group: ozone  (Ozone at a concentration of 10 micrograms per ml with 1 ml of 1% lidocaine) injection under the ultrasound-guide around the median nerve.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The severity of symptoms and functional limitations. Timepoint: Zero and 8th week. Method of measurement: Boston questionnaire was applied.</prim_outcome>
      <prim_outcome>The severity of symptoms. Timepoint: Zero and 8th week. Method of measurement: Visual Analog Scale(VAS).</prim_outcome>
      <prim_outcome>Electrodiagnostic criteria. Timepoint: Zero and 8th week. Method of measurement: EMG-NCS device was applied.</prim_outcome>
      <prim_outcome>Sonographic criteria. Timepoint: Zero and 8th week. Method of measurement: Sonographic device was applied.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Side effects. Timepoint: 8th week. Method of measurement: Questionnaire.</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>2021-05-19</approval_date>
        <contact_name>Research Ethics Committees of School of Medicine- Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>Central building of Yazd University of Medical Sciences, Bahonar Sq, Yazd Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
