<?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>IRCT20220829055825N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-01</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of focused shock wave on chronic supraspinatus tendinopathy</public_title>
      <acronym></acronym>
      <scientific_title>The effects of focused shock wave on pain, range of motion, muscle strength and quality of life in non-professional athletes with chronic  supraspinatus tendinopathy.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67394</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: AABB; BBAA; ABAB; BABA; ABBA; BAAB. Write these items on six paper and put in the six packets. Draw eight times until eight envelopes are selected, provided that the envelopes are repeated; each characteristics of the specification of the four allocations of the individual, Blinding description: The main researcher in this study won't aware of the randomization of the patients and the patients will treat by another therapist who will  aware of the treatment groups. At the end, the data analyst will analyze the data without knowing what treatment package groups 1 and 2 received.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic supraspinatus tendinopathy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:4 session ( one session per week)  Extracorporeal Shockwave Therapy(ESWT) Focused Storz ( Swiss 2019) . Protocol: 1000-2000 plus, frequency 4 Hz, intensity 0.1 mj/mm2. Intervention 2: Control group:4 session ( one session per week) Friction massage for 10 minutes on supraspinatus tendon, myofacsial tissue of supraspinatus, deltoid and upper trapezius.</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>Alireza Karimiahmadabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 19., First Boostan street., Fakharmoghadam Ave., Dadman Blvd., Qods Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1981619420</zip>
        <telephone>+98 21 2676 7708</telephone>
        <email>Karimi.AR@iums.ac.ir</email>
        <affiliation>Oxin physiotherapy Clinic</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soheil_Mansour Sohani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physical Therapy Dept., 3rd floor, school of rehabilitation sciences, Madadkaran Ave., Shah nazari St., Maadar Sq.,Mirdamaad Blv., Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 2059</telephone>
        <email>mansorsohani.s@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Non-professional athletes ( 2 to 3 hours per week)
Pain in sport activities in last 3 month
Age limitation 20-45 years old
Body mass index below 30
Being positive at least 2 of these test: empty can, painful arc, Hawkins</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>All contraindication of shock wave
History of surgery, fracture or osteoarthritis in the treatment areas</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M75.80</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other shoulder lesions, unspecified shoulder</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:4 session ( one session per week)  Extracorporeal Shockwave Therapy(ESWT) Focused Storz ( Swiss 2019) . Protocol: 1000-2000 plus, frequency 4 Hz, intensity 0.1 mj/mm2</i_keyword>
      <i_keyword>Control group:4 session ( one session per week) Friction massage for 10 minutes on supraspinatus tendon, myofacsial tissue of supraspinatus, deltoid and upper trapezius.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Range of motion of flexion, abduction, external rotation of the shoulder. Timepoint: At the first and end of treatment program. Method of measurement: Range of motion with inclinometer.</prim_outcome>
      <prim_outcome>Strength of the supraspinatus muscle. Timepoint: At the first and end of treatment program. Method of measurement: Muscle strength with dynamometer.</prim_outcome>
      <prim_outcome>Pain  pressure  threshold of the muscles of the supraspinatus, middle deltoid, and upper trapezius. Timepoint: At the first and end of treatment program. Method of measurement: Pain pressure threshold with algometer.</prim_outcome>
      <prim_outcome>Amount  of Visual Analog Scale. Timepoint: Before and after each session. Method of measurement: Visual Analog Scale (VAS) questionnaire.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: At the first and end of treatment program. Method of measurement: SF-36 questionner.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-28</approval_date>
        <contact_name>Ethic Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Next to Milad Tower, Hemat Highway, Iran University of Medical Sciences. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
