<?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>IRCT20170516034003N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-01</date_registration>
      <primary_sponsor>Guilan University of Medical Sciences</primary_sponsor>
      <public_title>The effects of laser therapy on pain and muscle thickness</public_title>
      <acronym></acronym>
      <scientific_title>The effects of laser therapy on pain, range of motion and muscle thickness in subjects with adhesive capslitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29068</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: Patients were assigned simple randomly by randomized numerical table  between 1 to52 numbers, Blinding description: Patients in both groups receive routine physiotherapy and laser therapy is performed in just one group. Treatment is done by health care staff who are not aware of the grouping and only implement the treatment protocol. The evaluation is done by one of the researchers who does not know about the treatment performed on patients.</study_design>
      <phase>3</phase>
      <hc_freetext>Adhesive capsulitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Interventions in this group include: 1) Infrared therapy for 20 minutes: The Infrared bulb is positioned at a distance of 50 cm from the shoulder of the individual. The patient will feel mild heat. 2- Treatment with TENS type brief for 20 minutes. In this method, four electrodes on the sides of the shoulder will be used. The frequency used varies from 3 to 120 Hz, and the patient will feel the electrical current, along with the muscle vibrations. 3- Exercise for strengthening muscle should include five exercises from the third to the tenth sessions twice daily. 4. Laser therapy: In this study, a laser with a wavelength of 905 nm, an energy density of 8 J / cm 2, a power of 50 mW in 10 points of the shoulder including 3 points on the anterior capsule, 3 points on the posterior capsule, 2 points on the root of the C5  nerve  and the two points on the axillary region. The radiation time will be  91s for each point. Intervention 2: Control group: Interventions in this group include: 1) Infrared therapy for 20 minutes: The Infrared bulb is positioned at a distance of 50 cm from the shoulder of the individual. The patient will feel mild heat. 2- Treatment with TENS type brief for 20 minutes. In this method, four electrodes on the sides of the shoulder will be used. The frequency used varies from 3 to 120 Hz, and the patient will feel the electrical current, along with the muscle vibrations. 3- Exercise for strengthening muscle should include five exercises from the third to the tenth sessions twice daily.</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:
Sharing is done after the end of the study. The total potential data can be shared after unidentifications of individuals.

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

To whom:
Researchers working in universities

Conditions:
Researchers working in universities

Where to obtain:
Adress: Physiotherapy section, Block 2, , Poursina hospital, Namjoo St, Rasht

How to obtain:
A written request for data from the relevant university with the name and academic degree of the researcher

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sosan Komaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Deputy of Research, Opposie to Azodi Stadium, Namjoo St, Rasht, Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۱۹۳۷۱۳۱۹۴</zip>
        <telephone>+98 13 3336 2639</telephone>
        <email>Research@gums.ac.ir</email>
        <affiliation>Guilan University of Medical Sciences, Deputy of Research</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Kamran Ezzati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Central Office of Guilan University of Medical Sciences, Parastar St., Rasht, I.R. Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۱۹۳۷۱۳۱۹۴</zip>
        <telephone>+98 13 3369 0099</telephone>
        <email>kamranezzati@gums.ac.ir</email>
        <affiliation>Guilan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adhesive capsulitis diagnosis: According to orthopedic physician assessment
Patients with pain duration between 3-9 month</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with adhesive capsulitis which shoulder range of motion not affected.
Patients with humerus, clavicle and scapula fractures
Patients with complete soft tissues tear such as tendons and labrum
Patients with history of diabetes and other inflammatory, articular and myofascial diseases
Patients that laser therapy is contraindicated due to tumor or hemorrhage</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M75.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Adhesive capsulitis of 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: Interventions in this group include: 1) Infrared therapy for 20 minutes: The Infrared bulb is positioned at a distance of 50 cm from the shoulder of the individual. The patient will feel mild heat. 2- Treatment with TENS type brief for 20 minutes. In this method, four electrodes on the sides of the shoulder will be used. The frequency used varies from 3 to 120 Hz, and the patient will feel the electrical current, along with the muscle vibrations. 3- Exercise for strengthening muscle should include five exercises from the third to the tenth sessions twice daily. 4. Laser therapy: In this study, a laser with a wavelength of 905 nm, an energy density of 8 J / cm 2, a power of 50 mW in 10 points of the shoulder including 3 points on the anterior capsule, 3 points on the posterior capsule, 2 points on the root of the C5  nerve  and the two points on the axillary region. The radiation time will be  91s for each point.</i_keyword>
      <i_keyword>Control group: Interventions in this group include: 1) Infrared therapy for 20 minutes: The Infrared bulb is positioned at a distance of 50 cm from the shoulder of the individual. The patient will feel mild heat. 2- Treatment with TENS type brief for 20 minutes. In this method, four electrodes on the sides of the shoulder will be used. The frequency used varies from 3 to 120 Hz, and the patient will feel the electrical current, along with the muscle vibrations. 3- Exercise for strengthening muscle should include five exercises from the third to the tenth sessions twice daily.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Visual Analogue Scale. Timepoint: Before intervention, After five sessions treatments, After ten sessions treatments, one month follow-up. Method of measurement: Visual Analogue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Shoulder range of motion with goniometer. Timepoint: Before intervention, After five sessions treatments, After ten sessions treatments, one month follow-up. Method of measurement: Goniometer.</sec_outcome>
      <sec_outcome>Muscle thickness by sonography. Timepoint: Before intervention, After five sessions treatments, After ten sessions treatments, one month follow-up. Method of measurement: sonography.</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>Guilan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-13</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>5th floor, Central office of Guilan University of Medical Sciences, Namjoo St., Rasht, Iran Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
