<?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>IRCT20220301054160N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-08</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Adding Tecartherapy On routine physicalTherapy On Pain And Kinetic Changes In Runners With Medial Tibial Stress Syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Adding Tecartherapy On routine physicalTherapy On Pain And Kinetic Changes In Runners With Medial Tibial Stress Syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62733</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients are randomly assigned to intervention and control groups by the block method. Random numbers 1 and 2 are produced using www. randomization.com, then are placed in sealed envelopes in order. When patients are referred, one envelope is opened in order. If the number in the envelope is 1, the patient enters the intervention group with  tecartherapy  and routine physiotherapy, and if the number is 2,  patient enters the control group, which includes only routine physiotherapy.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Medial Tibial Stress Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Tecar  treatment group, 9 sessions of tecar therapy, the total time of treatment with tecar intervention in this study will be 15 minutes, which will be used as 5 minutes in capacitive mode and 10 minutes in resistance mode, and with the usual physiotherapy treatment that is exactly the same. Intervention 2: Control group: The routine physiotherapy treatment group consists of nine treatment sessions including sessions on a daily basis. 20 minutes of high frequency tens with a frequency of 100 Hz and a pulse duration of 40 microseconds will be used at the site of pain, followed by 3 minutes of 1MHz ultrasound with a 20% diode cycle at the site of pain.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>saeideh Babaeitabar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Semnan University of Medical Science.Basij Blv</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3514799442</zip>
        <telephone>+98 23 3344 8999</telephone>
        <email>saeidehbabaei66@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>saeideh Babaeitabar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Semnan Univesity of Medical Science,Basij Blv</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3514799442</zip>
        <telephone>+98 23 3344 8999</telephone>
        <email>saeidehbabaei66@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Subjects of any gender
People aged 20-40 years.
Have a history of pain during exercise in the inner-posterior part of the tibia bone and the pain spreads by touching the posterior-inner edge of the tibia about 5 cm in place
Existence of pain that occurs with exercise and occurs during and after exercise
The presence of pain in the affected leg is predominan
Have this pain for at least a week</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with current or previous radiological symptoms of stress fractures or other types of fractures
Local infection or osteomyelitis in the same foot
Tumor in the area
Previous surgery on the same leg
Previous use of tecartherapy to treat tibial internal stress syndrome.
Pregnancy
Disorder and numbness in the area
Patients with balance disorders, patients with middle ear disorder</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S86.89</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other injury of other muscles and tendons at lower leg level</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Tecar  treatment group, 9 sessions of tecar therapy, the total time of treatment with tecar intervention in this study will be 15 minutes, which will be used as 5 minutes in capacitive mode and 10 minutes in resistance mode, and with the usual physiotherapy treatment that is exactly the same.</i_keyword>
      <i_keyword>Control group: The routine physiotherapy treatment group consists of nine treatment sessions including sessions on a daily basis. 20 minutes of high frequency tens with a frequency of 100 Hz and a pulse duration of 40 microseconds will be used at the site of pain, followed by 3 minutes of 1MHz ultrasound with a 20% diode cycle at the site of pain.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: In the first session and after the completion of 9 treatment sessions. Method of measurement: Visual scale of pain.</prim_outcome>
      <prim_outcome>Measurement of ground reaction force. Timepoint: In the first session and after the completion of 9 treatment sessions. Method of measurement: Force plate.</prim_outcome>
      <prim_outcome>Measuring the average displacement velocity. Timepoint: In the first session and after the completion of 9 treatment sessions. Method of measurement: Force plate.</prim_outcome>
      <prim_outcome>Measure the amount of displacement. Timepoint: In the first session and after the completion of 9 treatment sessions. Method of measurement: Force plate.</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>saeideh Babaeitabar</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-13</approval_date>
        <contact_name>Ethics committee of Semnan University of Medical sciences</contact_name>
        <contact_address>No5,Dehkade Olmpic Ave.Zibadasht Blv,Tehran Town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
