<?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>IRCT20180406039203N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-03</date_registration>
      <primary_sponsor>Tarbiat modares university</primary_sponsor>
      <public_title>Evaluation of high power and low power laser with tape and in shoulder impingement</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation and comparison of two therapeutic physiotherapy protocols of high power or low power lasers combined with kinesio taping on shoulder function and musculoskeletal sonography parameters in patients with subacromial impingement syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>37</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30534</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Precise assessment of changes before and after treatment with ultrasound, Randomization description: Simple and individual randomization will be done through sealed envelopes, Blinding description: Individuals participating in the study are blind to what kind of laser they receive or are in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Subacromial impingement syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: A high power laser with a power of 4 watts for 9 minutes will be used on a sub-acromicl space of 10 centimeters in area, and the total energy received will be 2050 jul. Per square centimeter. Treatment will be performed three times a week for seven sessions. Intervention 2: Intervention group: A low power laser with a power of 200 MW for 16 minutes will be used on a sub-acromicl space of 10 cm2. The total energy received will be 200 jules per square centimeter. Treatment is performed three times a week for seven sessions. Intervention 3: Control group: A placebo laser will be given for 10 minutes. The patient's position and therapist will be treated in the same way as the treatment group. The device is switched on and the radiation does not start.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Unidentifiable people can share all the data

When:
Start the access period 6 months after printing the results

To whom:
Data will be available to researchers working in academic and scientific institutes in the industry

Conditions:
To carry out scientific projects

Where to obtain:
zohre zaki , zaki_zohre@yahoo.com

How to obtain:
Submitting the project plan and the full review of the individuals and the organization carrying out the project and will be sent upon confirmation

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zohre Zaki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jala Ale Ahmad street , Tarbiat modares university</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115-111</zip>
        <telephone>+98 21 8288 0000</telephone>
        <email>zaki_zohre@yahoo.com</email>
        <affiliation>Tarbiat modares university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zohre Zaki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jalal Ale Ahmad street , Tarbiat modares university</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115-111</zip>
        <telephone>+98 21 8288 0000</telephone>
        <email>zaki_zohre@yahoo.com</email>
        <affiliation>Tarbiat modares university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>BMI 25-30 , Right shoulder pain
Stage I,II in Neer Classification
The presence of tendonitis and inflammation in the MRI that is being examined by a doctor
Painful arch 40-120 of shoulder abduction
Positive Yocum , Neer and Hawkins - kennedy tests
Weakness or pain in resistence external rotation , internal rotation and abduction
VAS 4-8</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Presence : pregnancy , shoulder surgery , G.H joint dislocation , corticostroid and heyaloronic acid injection from 6 month befor
Presence: Frozen shoulder ، Acromioclavicular joint arthritis , Rottator cuff ruptur , shoulder instability
Tscore lower than -2
Radicular pain
Use anti-inflammatory and drugs since the onset of evaluation and participation in the study
Unwillingness to continue treatment for any reason</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M75.41</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Impingement syndrome of right shoulder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: A high power laser with a power of 4 watts for 9 minutes will be used on a sub-acromicl space of 10 centimeters in area, and the total energy received will be 2050 jul. Per square centimeter. Treatment will be performed three times a week for seven sessions</i_keyword>
      <i_keyword>Intervention group: A low power laser with a power of 200 MW for 16 minutes will be used on a sub-acromicl space of 10 cm2. The total energy received will be 200 jules per square centimeter. Treatment is performed three times a week for seven sessions.</i_keyword>
      <i_keyword>Control group: A placebo laser will be given for 10 minutes. The patient's position and therapist will be treated in the same way as the treatment group. The device is switched on and the radiation does not start</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before and after treatmant. Method of measurement: Visual analogue scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Range of motion. Timepoint: Before and after treatmant. Method of measurement: Goniometer.</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>Tarbiat modares university</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-28</approval_date>
        <contact_name>National Ethics Committee for Biomedical Research</contact_name>
        <contact_address>Jala al ahmad street , Tarbiat modares university Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
