<?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>IRCT138712101719N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2009-03-19</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences (Primary sponsor)</primary_sponsor>
      <public_title>Effects of combined physical therapy protocols on shoulder tendonitis</public_title>
      <acronym></acronym>
      <scientific_title>The beneficial effects of combined low level laser, ultrasound and exercise therapy on Iranian women with shoulder tendinitis: a randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2005-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>62</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1205</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Shoulder tendinitis.</hc_freetext>
      <i_freetext>Intervention 1: Low level Laser therapy(830nm,1 J/point) + Ultrasound (5 minutes per session at frequency of 1 MHZ and an intensity of 1 W/cm2 (Enraf sonopulse 434) + antigravity , strengthening exercise in involved muscles were administered for ten sessions. Intervention 2: Low level Laser therapy(780 nm,1 J/point) + Ultrasound (5 minutes per session at frequency of 1 MHZ and an intensity of 1 W/cm2 (Enraf sonopulse 434) + antigravity , strengthening exercise in involved muscles were administered for ten sessions. Intervention 3: Control :Ultrasound (5 minutes per session at frequency of 1 MHZ and an intensity of 1 W/cm2 (Enraf sonopulse 434) + antigravity , strengthening exercise in involved muscles were administered for ten sessions.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Khadije Otadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pich e shemiran- Enghlab st.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965141</zip>
        <telephone></telephone>
        <email>k-otadi@razi.tums.ac.ir</email>
        <affiliation>Faculty of Rehabilitation</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammad Reza Hadian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pich e shemiran- Enghlab st.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965141</zip>
        <telephone>+98 21 7753 6134</telephone>
        <email>hadianrs@sina.tums.ac.ir hadian_ras@yahoo.com</email>
        <affiliation>Faculty of Rehabilitation, Tehran University of Medical Sciences, TUMS</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Female patients with local pain in supraspinatus and /or long head of biceps tendons, painful arc in abduction movement, pain in isometric resistance and passive stretch in supraspinatus and biceps, tenderness over the involved tendons, and positive speed's sign or impingement test. &#13;
Exclusion criteria: Any history of steroid injection to the tendon, rupture of the tendons, calcification in the tendons,    bursitis, previous operation in shoulder region, neck and shoulder OA and Thoracic outlet</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M75.2,M75.</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Bicipital tendinitis,Impingement syndrome of shoulder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code></i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Low level Laser therapy(830nm,1 J/point) + Ultrasound (5 minutes per session at frequency of 1 MHZ and an intensity of 1 W/cm2 (Enraf sonopulse 434) + antigravity , strengthening exercise in involved muscles were administered for ten sessions</i_keyword>
      <i_keyword>Low level Laser therapy(780 nm,1 J/point) + Ultrasound (5 minutes per session at frequency of 1 MHZ and an intensity of 1 W/cm2 (Enraf sonopulse 434) + antigravity , strengthening exercise in involved muscles were administered for ten sessions</i_keyword>
      <i_keyword>Control :Ultrasound (5 minutes per session at frequency of 1 MHZ and an intensity of 1 W/cm2 (Enraf sonopulse 434) + antigravity , strengthening exercise in involved muscles were administered for ten sessions</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before intervention, and end of 10 sessions of treatment. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Tenderness. Timepoint: Before intervention, and end of 10 sessions of treatment. Method of measurement: Manual test and palpation.</prim_outcome>
      <prim_outcome>Functional movement. Timepoint: Before intervention, and end of 10 sessions of treatment. Method of measurement: Constant-Murley score.</prim_outcome>
      <prim_outcome>Muscle strength. Timepoint: Before intervention, and end of 10 sessions of treatment. Method of measurement: Manual Muscle Testing.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Satisfaction. Timepoint: 1 and 3 months after the end of 10 sessions treatment. Method of measurement: quetion by phone.</sec_outcome>
      <sec_outcome>Recovery of functional movement. Timepoint: 1 and 3 months after the end of 10 sessions treatment. Method of measurement: question by phone.</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>Tehran University of Medical Sciences (Primary sponsor)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2005-01-17</approval_date>
        <contact_name>Research Center for Medical Ethics</contact_name>
        <contact_address>No 21, 4th floor, Poorsina St. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
