<?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>IRCT20180406039203N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-28</date_registration>
      <primary_sponsor>Tarbiat Modares University</primary_sponsor>
      <public_title>The effect of high-power laser on supraspinatus tendon tear</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the Effects of High-Power Laser and Exercise Therapy on Supraspinatus Tendon Tear and Glenohumeral Joint Kinetics and Kinematics: Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>28</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75030</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Web-based randomization and masking through sealed envelopes will be used. First, the website http://www.graphpad.com/quickcalcs/index.cfm3 will be used to create a random sequence. Sealed opaque envelopes are used to hide the random allocation. Envelopes with aluminum wrappers (in order to make the contents of the envelopes unclear), preparation and each of the randomly created sequences are recorded on a card and the cards are placed inside the envelopes in order. Finally, the envelope door The letters are glued and placed in a box in order. At the time of registration of the participants, based on the order of entry of eligible participants into the study, one of the envelopes will be opened and the assigned group of that participant will be revealed, Blinding description: Data collection will be done by an experimenter who is not aware of the grouping.The participants were also blinded to the intervention groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Supraspinatus tendon partial thickness tear.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: K-laser will be used in this study. The treatment will be done 3 times a week for 10 sessions. In the first 3 sessions, the total energy will be 2478 joules, the average power will be 9 watts and the maximum power will be 20 watts. In the last 7 sessions, the total energy will be 4678 joules. Intervention 2: Control group: The treatment will be done 3 times a week for 10 sessions. Lasers are off in all meetings.</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 The publication schedule of this study is not yet known</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zohreh Zaki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jalal Al Ahmad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115-111</zip>
        <telephone>+98 21 82880</telephone>
        <email>zakizohre69@gmail.com</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roya Ravanbod</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tarbiat modares university Jalal Ale Ahmad street , Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115-111</zip>
        <telephone>+98 21 8288 3595</telephone>
        <email>rravanbod@hotmail.com</email>
        <affiliation>Tarbiat modares university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range: 40-60 years
Body mass index 25-30
The presence of an incomplete tear of 1-3 cm in the supraspinatus according to MRI
The positiveness of Drop Arm tests: empty can test, external rotation delay sign, champagne toast
Having reading and writing literacy at the cycle level
Moderate pain intensity based on Visual analogue scale 35-74 mm
Arm circumference size cm 1.28-4.29</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The unwillingness of people to continue treatment for any reason
Tears in other components of the rotator cuff with or without supraspinatus injury
Use of non-steroidal and steroidal anti-inflammatory drugs
Injection in the shoulder in 3 months before the study
Receiving physiotherapy treatments in 3 months before the study
Damage caused by exercise
The existence of a neurological disease that leads to muscle weakness or reduced range of motion
History of systemic diseases such as: rheumatoid arthritis, diabetes, severe cardiovascular disease, history of shoulder surgery
Presence of any shoulder pathology that leads to shoulder kinematic change
Contraindications for laser use: pregnancy, epilepsy, pacemaker, cancer
Dissemination of pain from the neck
More than 12 months have passed since the onset of their symptoms</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M75.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Rotator cuff tear or rupture, not specified as traumatic</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: K-laser will be used in this study. The treatment will be done 3 times a week for 10 sessions. In the first 3 sessions, the total energy will be 2478 joules, the average power will be 9 watts and the maximum power will be 20 watts. In the last 7 sessions, the total energy will be 4678 joules.</i_keyword>
      <i_keyword>Control group: The treatment will be done 3 times a week for 10 sessions. Lasers are off in all meetings.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Supraspinatus tendon tear size. Timepoint: Before and 48 hours after end of treatment. Method of measurement: The tear size is measured by ultrasound.</prim_outcome>
      <prim_outcome>Glenohumeral superior translation. Timepoint: Before and 48 hours after end of treatment. Method of measurement: Superior translation of the humeral head is measured by the motion analysis system.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain. Timepoint: pre-treatment, before 5th session and 48 hours post treatment. Method of measurement: By visual analogue scale.</sec_outcome>
      <sec_outcome>Muscle groups strength. Timepoint: pre and 48 hours post treatment. Method of measurement: By hand held dynamometer.</sec_outcome>
      <sec_outcome>Pain and function. Timepoint: pre and 48 hours post treatment. Method of measurement: By shoulder and pain disability index.</sec_outcome>
      <sec_outcome>EMG activity pattern, Root mean square. Timepoint: pre and 48 hours post treatment. Method of measurement: by electromyography system.</sec_outcome>
      <sec_outcome>Angular speed. Timepoint: pre and 48 hours post treatment. Method of measurement: by motion analysis system.</sec_outcome>
      <sec_outcome>Angular acceleration. Timepoint: pre and 48 hours post treatment. Method of measurement: by motion analysis system.</sec_outcome>
      <sec_outcome>Torque. Timepoint: pre and 48 hours post treatment. Method of measurement: by motion analysis system.</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>2023-10-22</approval_date>
        <contact_name>Tarbiat Modares University</contact_name>
        <contact_address>Jalal Al Ahmad Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
