<?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>IRCT20171030037093N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-06</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of shockwave therapy on pain of patient with post stroke hemiplegic shoulder pain</public_title>
      <acronym></acronym>
      <scientific_title>The effect of shockwave therapy on pain of patient with post stroke hemiplegic shoulder pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39179</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: Patients are randomly assigned to one of the two groups by selecting the cards named A and B, Blinding description: In this study, the principal executor is considered to be medical doctors who are fully aware of the goals of the study and the types of treatments. Patients will not be aware of statistical research goals and how to compare treatments. However, they are fully aware of the fact that they are treated with different treatments in one of the two groups and that they receive treatment for their illness and have been studying satisfactorily. Patients will not be aware of shock or vision shock therapy. The counselor for statistics and information analytics, about treatment (shockwave and shock sham) and the name of the patients is not known.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Shoulder pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Under treatment with shockwave, the number of sessions is 5 sessions, which consists of 3 sessions of focus with intervals and 5 radial sessions with intervals of two days per week. The SHAKEVIEW protocol is in this form. Shockwave focus is expressed as the number of shocks of 1,000 at any point with a J2 / 0-3 / 0 energy of ZH 4 and a radial to 1000 shocks per point with an energy of 1.33 j3 and a frequency of 15Hz. Intervention 2: Control group: Sham treatment was used with zero energy.</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 I will decide untill finishing the study</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shila Haghighat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Physical Medicine and Rehabilitation, School of Medicine, Kashani Hospital, Isfahan University of Medical Sciences</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174675731</zip>
        <telephone>+98 31 3670 0666</telephone>
        <email>Haghighatshila@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shila Haghighat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Physical Medicine and Rehabilitation, School of Medicine, Kashani Hospital, Isfahan University of Medical Sciences</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174675731</zip>
        <telephone>+98 31 3670 0666</telephone>
        <email>Haghighatshila@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Satisfaction to participate in the study
Age group 20-80 years
At least 3 months have passed since the stroke occurred.
Shoulder pain and shoulder paralysis have started after ischemic stroke.
The severity of the shoulder pain is based on the vas criterion of at least 4 or more for at least 3 months.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Not being able to express the severity of pain
Surgical history on the shoulder
Use of oral hives 3 days before the study
Intraocular infusion or other interventions affecting shoulder in the past month
Taking high dose warfarin (INR above 4)
Trauma history on shoulders
Patients receiving a cardiac pacemaker
Moderate to severe depression
crps based on patient examination
History of shoulder pain before a stroke
Based on the examinations, no mechanical causes for pain should be noted.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M25.51</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pain in shoulder</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: Under treatment with shockwave, the number of sessions is 5 sessions, which consists of 3 sessions of focus with intervals and 5 radial sessions with intervals of two days per week. The SHAKEVIEW protocol is in this form. Shockwave focus is expressed as the number of shocks of 1,000 at any point with a J2 / 0-3 / 0 energy of ZH 4 and a radial to 1000 shocks per point with an energy of 1.33 j3 and a frequency of 15Hz.</i_keyword>
      <i_keyword>Control group: Sham treatment was used with zero energy</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severe shoulder pain. Timepoint: The beginning of the study, the end of treatment, and weeks 4 and 8 after treatment. Method of measurement: Vas questionnaire.</prim_outcome>
      <prim_outcome>Shoulder performance. Timepoint: The beginning of the study, the end of treatment, and weeks 4 and 8 after treatment. Method of measurement: Examination and questionnaire.</prim_outcome>
      <prim_outcome>The range of shoulder motion. Timepoint: The beginning of the study, the end of treatment, and weeks 4 and 8 after treatment. Method of measurement: Goniometer.</prim_outcome>
      <prim_outcome>Time to start shoulder pain. Timepoint: The beginning of the study, the end of treatment, and weeks 4 and 8 after treatment. Method of measurement: Information Form.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-07</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahn University of Medical Sciences, Hezar jarib st, Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
