<?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>IRCT20151017024572N17</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-12</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Comparing local injection of ozone, corticosteroid and prolotherapy under ultrasound guidance in the treatment of  inflammation of shoulder tendons</public_title>
      <acronym></acronym>
      <scientific_title>Comparing ultrasound guided injection of oxygen-ozone vs. corticosteroid vs. prolotherapy in the treatment of shoulder tendinopathy : a randomized, prospective, multicenter randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20698</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple random method for randomization will be used and individuals (patients) will form random units. A random sequence will be generated using RAS software. A central randomization method will be used to conceal random allocation. The random sequence will be created by the statistician and will be available to her. The doctor will be connected to the statistician by telephone or text message and will ask him or her about the random allocation of the participant to the specific group, Blinding description: In order to blind the patient, the doctor will prepare the injection material in the syringe, and will cover the syringes with an aluminum sheet to avoid being aware of the type of injection. It should be noted that dilution of corticosteroid and normal salin will be done to equalize the volume of all three injectable solutions.
Patients in each group will be evaluated by a physical medicine and rehabilitation specialist, who is not aware of the type of injection, before the injection, two week , two months and six months after the injection.</study_design>
      <phase>3</phase>
      <hc_freetext>Inflammation of the shoulder tendons.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group (ozone therapy): 5cc ozone 20μg / L, in subacromial space with lateral aperture under ultrasound guidance. Intervention 2: Intervention group (porlotherapy): 5cc dextrose 20%, in subacromial space with lateral aperture under ultrasound guidance. Intervention 3: Control group (corticosteroid therapy ): 1cc triamcinolone 40mg + 1cc lidocaine , in subacromial space with lateral aperture under ultrasound guidance.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Arash Babaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physical medicine and rehabilitation ward, Firoozgar Hospital, Behafarin Avenue, Valiasr Square, Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۴۹۶۱۴۵۳۵</zip>
        <telephone>+98 21 86701</telephone>
        <email>arashbabaie@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Arash Babaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1593747811</zip>
        <telephone>+98 21 8214 1229</telephone>
        <email>babaei-ghazani.a@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The presence of tandinopathy in patients as a positive one in a special shoulder test, including: Neer test, Hawkins test
Visual Analog Scale (VAS) above 4
Patient's desire to attend research project</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Existence of a history and examination of rotator cuff tears, diabetes, coagulation disorders, fractures, rheumatologic diseases, tumors and infection
Receiving injection in the shoulder joint in the last 3 months
Frozen Shoulder
Presence of c6-c5 synchronous radiculopathy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G59</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mononeuropathy in diseases classified elsewhere</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group (ozone therapy): 5cc ozone 20μg / L, in subacromial space with lateral aperture under ultrasound guidance.</i_keyword>
      <i_keyword>Intervention group (porlotherapy): 5cc dextrose 20%, in subacromial space with lateral aperture under ultrasound guidance.</i_keyword>
      <i_keyword>Control group (corticosteroid therapy ): 1cc triamcinolone 40mg + 1cc lidocaine , in subacromial space with lateral aperture under ultrasound guidance.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score based on Visual Analogue Scale. Timepoint: Before injection, two weeks  , two months and six months after the injection. Method of measurement: Visual Analog Scale (VAS).</prim_outcome>
      <prim_outcome>Shoulder pain and disability. Timepoint: Before injection, two weeks  , two months and six months after the injection. Method of measurement: Shoulder pain and disability index (SPADI).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Clinical Global Impression. Timepoint: Before injection, two weeks  , two months and six months after the injection. Method of measurement: Clinical Global Impression Questionnaire.</sec_outcome>
      <sec_outcome>Patient Global Impression of Improvement. Timepoint: Before injection, two weeks  , two months and six months after the injection. Method of measurement: Patient Global Impression of Improvement Questionnaire.</sec_outcome>
      <sec_outcome>Shoulder  rang of motiom. Timepoint: Before injection, two weeks  , two months and six months after the injection. Method of measurement: goniometer.</sec_outcome>
      <sec_outcome>Subacromial bursaThickness. Timepoint: Before injection, two weeks  , two months and six months after the injection. Method of measurement: sonography.</sec_outcome>
      <sec_outcome>Constant Score. Timepoint: Before injection, two weeks  , two months and six months after the injection. Method of measurement: Constant Score Questionnaire.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Iran University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Iran University of Medical Sciences</source_name>
      <source_name>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-08</approval_date>
        <contact_name>Ethics Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences,Hemat Highway next to Milad Tower,Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
