<?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>IRCT20180812040773N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-29</date_registration>
      <primary_sponsor>Gorgan University of Medical Sciences</primary_sponsor>
      <public_title>Role of exercise in elbow pain relief</public_title>
      <acronym></acronym>
      <scientific_title>The role of elbow exersices protocol in  treatment of patients with lateral epycodylitis(Tennis elbow)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33707</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A total of 40 patients with chronic lateral epicondylitis between the ages of 25 and 55 will be divided into two groups of 20, based on random blocks (Block Randomization).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Lateral Epicondylitis or Tennis Elbow.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For a 4-week course of treatment, meloxicam 15 mg twice daily with an elbow brace accompanied by moderating stimulant activities such as carrying objects, writing, driving, folding, twisting screwdrivers, etc. Intervention 2: Intervention group: In addition to the above, the following protocols are implemented:1. Stretch the wrist extensor muscles: With a healthy hand, bend the wrists while the elbows are located in the prosthesis and extension. Keep this movement for 10 seconds and repeat after a little rest.2. Slow and gradually tighten the wrist for 10 seconds and repeat it in 4 to 6 sets of 10 times a day.3. Active motion of the wrist in the form of flexion, extension, deviation to the radial and ulnar of the wrist for 10 seconds and repeat it.4. MassageAll movements are repeated in 4-6 sets of 10, and during exercises, when the pain is experienced, the person stops practicing, but mild pain does not prevent the training from being interrupted.</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:
In this study, all data are published after being unidentifiable, and will be available to researchers.

When:
Four months after the publication, data access is provided to researchers.

To whom:
Researchers and professors from the orthopedic and rheumatologic and physiotherapy group and the Student Research Committee can apply for data.

Conditions:
If data are used in studies and related articles by students of medical sciences, professors of orthopedic and rheumatologic and physiotherapy groups, etc., can be used.

Where to obtain:
To the Center for Rheumatology Student Research Committee Mr. Hanzale Balakheili, Head of Rheumatology Student Research Committee in Sayad Shirazi Hospital.
Phone:00989111789412

Dr. Afshin Sahebjamei, Assistant Professor of Orthopedics, 5th Azar Hospital, Gorgan
Phone: 00989155089335

Behfar Taziki, Medical Intern, Golestan University of Medical Science
Phone:00989375435045

How to obtain:
After requesting from trial investigators, the Rheumatology Research Committee and the University's Ethics Committee, if approved, data are available.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Behfar Taziki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dezziani clinic of orthopaedi, Shahid Beheshti Str</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4916655398</zip>
        <telephone>+98 17 3222 4848</telephone>
        <email>Behfartaziki@goums.ac.ir</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Afshin Sahebjamei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dezziani clinic of orthopaedi, Shahid Beheshti Str</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4916655398</zip>
        <telephone>+98 17 3222 4848</telephone>
        <email>sahebjameiafshin@yahoo.com</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pain in lateral side of elbow for at least 4-6 weeks
Lateral Epicondyle Tenderness
Elbow pain Due to wrist Extention against resistance
Elbow pain Due to fingers Tight flexion
Elbow pain Due to Wrist flexion
People at least 25 years of age and up to 55 years old</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Trauma History To Elbow
Surgical History Of Elbow
Injection or physiotherapy of the affected elbow in the last 6 months
The history of systemic inflammatory diseases or neurological skin diseases
The presence of pain at the same time in the shoulder or wrists of the side or the pain of the neck
Limit of shoulder Range Of Motion
Cases of chronic underlying disease such as diabetes or rheumatologic diseases
Hard Work
Failure to fill in the questionnaire
Failure to follow this course
People under the age of 25 or over 55 years</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M77.10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Lateral epicondylitis, unspecified elbow</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For a 4-week course of treatment, meloxicam 15 mg twice daily with an elbow brace accompanied by moderating stimulant activities such as carrying objects, writing, driving, folding, twisting screwdrivers, etc.</i_keyword>
      <i_keyword>Intervention group: In addition to the above, the following protocols are implemented:1. Stretch the wrist extensor muscles: With a healthy hand, bend the wrists while the elbows are located in the prosthesis and extension. Keep this movement for 10 seconds and repeat after a little rest.2. Slow and gradually tighten the wrist for 10 seconds and repeat it in 4 to 6 sets of 10 times a day.3. Active motion of the wrist in the form of flexion, extension, deviation to the radial and ulnar of the wrist for 10 seconds and repeat it.4. MassageAll movements are repeated in 4-6 sets of 10, and during exercises, when the pain is experienced, the person stops practicing, but mild pain does not prevent the training from being interrupted.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Improvement in the amount of pain. Timepoint: All patients are followed up on a weekly basis with Telephone and will be examined by the use of the Visual Analog Scale and Tennis Elbow Function Tests before and after intervention and one month after the start of the intervention. Method of measurement: Based On Tennis Elbow Function Test and Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Severity of difficulty in certain activities. Timepoint: All patients are followed up on a weekly basis with Telephone and will be examined by the use of the Visual Analogue Scale and Tennis Elbow Function Tests before and after intervention and one month after the start of the intervention. Method of measurement: Based On Tennis Elbow Function Test and Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Severity of difficulty in common activities. Timepoint: All patients are followed up on a weekly basis with Telephone and will be examined by the use of the Visual Analogue Scale and Tennis Elbow Function Tests before and after intervention and one month after the start of the intervention. Method of measurement: Based On Tennis Elbow Function Test and Visual Analogue Scale.</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>Gorgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-06</approval_date>
        <contact_name>Ethics committee of Golestan University of Medical Sciences</contact_name>
        <contact_address>Central Organization of Golestan University of Medical Sciences, Blvd. Hirkan, Gorgan Gorgan Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
