<?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>IRCT20190626044015N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-04</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy of shock wave therapy in the treatment of tennis elbow in athletes using sonography</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of extracorporeal shock wave therapy in the treatment of lateral epicondylitis in athletes using ultrasonography</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>25</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40627</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Examples include athletes who are brought to the attention of sports federations, who will begin treatment with the approval of the center, Randomization description: Simple randomization by lottery means that at the beginning of the study and in the first referring patient, the group names are written in 2 pieces of paper and placed in one of two intervention or control groups by the patient operator's removal. By identifying the first patient's treatment group, the next patient will be assigned to the other group and thus the patients will be divided into groups. In this study, the researcher, evaluator, and participants are unaware of the study group allocation and only the operator is aware of the group assignment, Blinding description: Participants enter the research after completing the informed consent form and are divided into two groups. From this stage, only the operator of the device has been informed from the medical group and the participants, the resarcher and the evaluator to avoid the bias in the study from the subjects of the study groups No information is available.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Lateral Epicondylitis or Tennis Elbow.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: a 4 Hz frequency shock wave,  an energy flux density of 0.08 j/mm ², 2000 Shock, once a week for 3 weeks. Physical therapy is then performed with stretching exercise, 3 times a day and 4-5 repetitions. Shock wave unit:  ESM /SWISS DOLORCLAST/ Switzerland. Intervention 2: Control group: Sham group,  a 4 Hz frequency shock wave, an energy flux density of 0.04 j/mm ², 1500 shocks, once a week and for 3 weeks with foam mediator in the area. Also physiotherapy with stretching exercises for 3 times Performs 4-5 repetitions per day.</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>Dr. Atefeh Aminianfar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of rehabilitation,  Semnan University of Medical Sciences,  5 km of Semnan-Damghan road</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513138111</zip>
        <telephone>+98 23 3365 4180</telephone>
        <email>aminfar@semums.ac.ir</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Atefeh Aminianfar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of rehabilitation,  Semnan University of Medical Sciences,  5 km of Semnan-Damghan road</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513138111</zip>
        <telephone>+98 23 3365 4180</telephone>
        <email>aminfar@semums.ac.ir</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosed lateral epicondylitis
At least 3 month of pain on lateral epicondyle
Treatment to the affected area within the previous 3 month
VAS above 4
Age between 2 and 4 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>36 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>&lt; 18 year of age
Contraindications for shockwave therapy ( malignancy, history of infected area involved, epilepsy, epilepsy, use of pacemaker, pregnancy)
History of  lateral epicondylitis surgery
Elbow deformity
Cervical radiculopathy
History of rheumatology or polyarthritis
The history of vasculitis
The history of treatment with Shakviou in the last 12 months
History of injection in the last 3 months (Corticosteroid, Autologous blood injection, PRP, Mesotherapy)
Congenital or acquired deformities of the upper extremity</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: a 4 Hz frequency shock wave,  an energy flux density of 0.08 j/mm ², 2000 Shock, once a week for 3 weeks. Physical therapy is then performed with stretching exercise, 3 times a day and 4-5 repetitions. Shock wave unit:  ESM /SWISS DOLORCLAST/ Switzerland</i_keyword>
      <i_keyword>Control group: Sham group,  a 4 Hz frequency shock wave, an energy flux density of 0.04 j/mm ², 1500 shocks, once a week and for 3 weeks with foam mediator in the area. Also physiotherapy with stretching exercises for 3 times Performs 4-5 repetitions per day.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Measurement of tendon thickness. Timepoint: Before the intervention begins and one month after the end of the intervention. Method of measurement: Ultrasonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain score. Timepoint: At the beginning of the study (before the intervention), after the end of the intervention and one month after the end of the intervention. Method of measurement: Visual Analogue Scale.</sec_outcome>
      <sec_outcome>Performance score. Timepoint: Before the intervention begins, after the intervention and one month after the end of the intervention. Method of measurement: Disabilities of the Arm, Shoulder, and Hand Questionnaire.</sec_outcome>
      <sec_outcome>Hand strength score. Timepoint: Before the intervention begins, after the intervention and one month after the end of the intervention. Method of measurement: Dynamometer.</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-12</approval_date>
        <contact_name>Ethics committee of shiraz university of medical science</contact_name>
        <contact_address>No. 10, Payvand 21., Payam Blvd., Paknejad Bvd., Saadatabad Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
