<?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>IRCT20180421039375N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-12</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of Gliseryl trinitrate (GTN) in the treatment of localized Tennis elbow</public_title>
      <acronym>GTN</acronym>
      <scientific_title>A comparative study of Gliseryl trinitrate (GTN) in the treatment of localized Tennis elbow</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-10-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35391</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 84 patients with TE were selected from among the patients referred to the orthopedic and rheumatology clinics of Bou Ali Hospital in a randomized way. They were divided into two groups of case and control. In order to collect the data, eligible patients referred to orthopedic and rheumatology clinics of Bou-Ali Hospital who were willing to participate in the study were randomizedly and blinded by the secretary to two groups receiving drop containing glyceryl nitrate (in the treatment group ) And liquid paraffin (placebo in the control group). As these medications were given in two packages (package A, package B) and divided into 2 groups, Blinding description: In this study, four groups of Participant, Care provider, Outcome assessor, and data analysers were kept blind. None of these names knew which dishes contained contained drop glyceryl nitrate or liquid paraffin.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Tennis Elbow.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Glyceryl nitrate recipient group: Delivered to patients with patches of skin and drop containing glyceryl nitrate, and it is recommended that patients receive 20 drop drops per day in the place where the elbow has the highest tenderness, and within 12 hours in Use patches throughout the day in a position, then change the patches the next day and repeat the procedure according to the instructions. Patients were advised to use a wound extensor tendon rehabilitation program that includes 2 seconds of contraction, 10 seconds of rest and 10 seconds of elongation of the muscles for at least 3 treatments per day. Patient follow-up was performed 2, 4, and 6 weeks after the first visit in subsequent visits, and patients were assessed for pain during nocturnal rest and during daily activities, Mandsley test (presence or absence of pain during resistance to Doris flextion of the wrists and pronation of the forearm), epicondylar tenderness in the first visit and pain and tenderness of epicondylar in subsequent visits were evaluated and the relevant results were recorded in the questionnaires. Intervention 2: Control group: The placebo recipient group: Delivered to patients with patches of skin and drop containing liquid paraffin, and it is recommended that patients receive 20 drop drops per day in the place where the elbow has the highest tenderness, and within 12 hours in Use patches throughout the day in a position, then change the patches the next day and repeat the procedure according to the instructions. Patients were advised to use a wound extensor tendon rehabilitation program that includes 2 seconds of contraction, 10 seconds of rest and 10 seconds of elongation of the muscles for at least 3 treatments per day. Patient follow-up was performed 2, 4, and 6 weeks after the first visit in subsequent visits, and patients were assessed for pain during nocturnal rest and during daily activities, Mandsley test (presence or absence of pain during resistance to Doris flextion of the wrists and pronation of the forearm), epicondylar tenderness in the first visit and pain and tenderness of epicondylar in subsequent visits were evaluated and the relevant results were recorded in the questionnaires.</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:
All data can be shared after unidentifiable people. The effect of topical glyceryl trisitrate on the treatment of tennis elbows is shared.

When:
After publishing the manuscript in a for 1 year later

To whom:
All researchers - have no limits

Conditions:
Provided that the researcher wants to do the same

Where to obtain:
Person responsible for research

How to obtain:
Email to Person responsible - Checked by the responsible - Providing information

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Shahla Abolghasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bu'ali Hospital,Tehran, Imam Hossein Square, Damavand Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>17117</zip>
        <telephone>+98 21 3334 8036</telephone>
        <email>shahlamarmin@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Shahla Abolghasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bu'ali Hospital,Tehran, Imam Hossein Square, Damavand Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>17117</zip>
        <telephone>+98 21 3334 8036</telephone>
        <email>shahlamarmin@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients over 16 years of age with Tennis Elbow
Patients who have symptoms for less than 3 months</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with heart disease who have a history of TNG use
People with a history of fracture or dislocation of the joint of the elbow, or a wrist or ligament on these joints
People who have had a history of corticosteroid injection over the past three months
People who have distal neuronal symptoms to the elbow
People with Seronegative enteropathy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M77.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Lateral epicondylitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Glyceryl nitrate recipient group: Delivered to patients with patches of skin and drop containing glyceryl nitrate, and it is recommended that patients receive 20 drop drops per day in the place where the elbow has the highest tenderness, and within 12 hours in Use patches throughout the day in a position, then change the patches the next day and repeat the procedure according to the instructions. Patients were advised to use a wound extensor tendon rehabilitation program that includes 2 seconds of contraction, 10 seconds of rest and 10 seconds of elongation of the muscles for at least 3 treatments per day. Patient follow-up was performed 2, 4, and 6 weeks after the first visit in subsequent visits, and patients were assessed for pain during nocturnal rest and during daily activities, Mandsley test (presence or absence of pain during resistance to Doris flextion of the wrists and pronation of the forearm), epicondylar tenderness in the first visit and pain and tenderness of epicondylar in subsequent visits were evaluated and the relevant results were recorded in the questionnaires.</i_keyword>
      <i_keyword>Control group: The placebo recipient group: Delivered to patients with patches of skin and drop containing liquid paraffin, and it is recommended that patients receive 20 drop drops per day in the place where the elbow has the highest tenderness, and within 12 hours in Use patches throughout the day in a position, then change the patches the next day and repeat the procedure according to the instructions. Patients were advised to use a wound extensor tendon rehabilitation program that includes 2 seconds of contraction, 10 seconds of rest and 10 seconds of elongation of the muscles for at least 3 treatments per day. Patient follow-up was performed 2, 4, and 6 weeks after the first visit in subsequent visits, and patients were assessed for pain during nocturnal rest and during daily activities, Mandsley test (presence or absence of pain during resistance to Doris flextion of the wrists and pronation of the forearm), epicondylar tenderness in the first visit and pain and tenderness of epicondylar in subsequent visits were evaluated and the relevant results were recorded in the questionnaires.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain and tenderness in patients with tennis elbow. Timepoint: Before the intervention and week 2, 4, 6 after intervention. Method of measurement: questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life Score. Timepoint: Before the start of the study and 2 months after the start of the study. 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>researcher</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-10-13</approval_date>
        <contact_name>Ethics Committee, Islamic Azad University of Medical Sciences, Tehran, Iran</contact_name>
        <contact_address>Tehran Medical Branch, Islamic Azad University, Khaghani st, Shari'ati Ave, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
