<?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>IRCT20230107057073N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-21</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>the effect of shockwave therapy on pain and performance in runners with iliotibial band syndrome.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Shockwaves Therapy on Lower Extremity Pain, Function and Torque Ratio of Abductors to Hip Adductors in Runners with Iliotibial Band Syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68569</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>ITBS.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: It will be applied with 500 pulses with a frequency of 15 Hz in the selected area. Depending on the level of pain tolerance, it will increase up to 2000 pulses. Finally, 3 trigger points in the outer thigh area with 700 pulses and 15 Hz, twice a week for 4 weeks. Shockwave device: ESM, Swiss Dolorclast model, Swiss along with routine physiotherapy. Intervention 2: Control group: Sham shock therapy along with routine physical therapy. All people in the control group will receive the shockwave in the same position with the device turned on but in such a way that it does not shock their body. First, a few shocks below the receiving threshold and then the device turns off.</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 further 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>Age between 18 and 50 years old
A runner with experience of more than one year and regular weekly training and participating in cross-country competitions and running at least 20 km per week
Having pain for at least 4 weeks in the lateral area of the knee
ITBS diagnosis based on history Clinical examination and modified treadmill test •
Pain intensity: grade 1 - pain after running, but does not limit the distance or speed of running. Grade 2 - pain while running but no limitation of running distance or speed. Grade 3 - Pain during running severe enough to limit distance or speed. and grade 4 - the pain is severe enough to prevent running. To continue with the baseline assessment, subjects had to report a pain grade of 3 or 4.
Positive Noble's test, if pain was present at 30 to 40 degrees of flexion when a finger was held on the lateral condyle of the knee during flexion/extension. It is experienced.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Symptoms of knee injury
Previous treatment of ITBS in the last 6 months
Use of painkillers or NSAIDs in the past two weeks
Use of hot pack and icepack
Stretching or weight lifting two days before
History of knee surgery
pregnancy
Using a heart battery
Taking anticoagulants
Fracture of damaged leg bones in the last 12 months
History of treatment with shock wave
infection
tumor
diabetes
Rheumatic disease
Severe heart disease
Psychiatric illness
Other severe systemic diseases
Unwillingness to accept any of the interventions in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M76.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Iliotibial band syndrome</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: It will be applied with 500 pulses with a frequency of 15 Hz in the selected area. Depending on the level of pain tolerance, it will increase up to 2000 pulses. Finally, 3 trigger points in the outer thigh area with 700 pulses and 15 Hz, twice a week for 4 weeks. Shockwave device: ESM, Swiss Dolorclast model, Swiss along with routine physiotherapy</i_keyword>
      <i_keyword>Control group: Sham shock therapy along with routine physical therapy. All people in the control group will receive the shockwave in the same position with the device turned on but in such a way that it does not shock their body. First, a few shocks below the receiving threshold and then the device turns off.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before starting the study, immediately after treatment. Method of measurement: VAS.</prim_outcome>
      <prim_outcome>Lower Extremity Function. Timepoint: Before starting the study, immediately after treatment. Method of measurement: modified treadmill.</prim_outcome>
      <prim_outcome>Torque Ratio of Abductors to Hip Adductors. Timepoint: Before starting the study, immediately after treatment. Method of measurement: Isokinetic.</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-06</approval_date>
        <contact_name>Ethics committee of Semnan University of Medical Sciences</contact_name>
        <contact_address>No. 10, Payvand 21., Payam Blvd., Paknejad Bvd., Saadatabad Seman Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
