<?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>IRCT20191127045528N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-23</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effects of high intensity laser therapy on rotator cuff tendinitis</public_title>
      <acronym></acronym>
      <scientific_title>Effects of high intensity laser therapy on clinical and sonogeraphy findings in patients with rotator cuff tendinitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45004</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 32 patients will be selected by simple non-probability sampling.
After completing the informed consent form, the research will be randomly blocked with forth blocked size will be divided into two groups of 16; treatment and control groups, Blinding description: Participants will be empowered with placebo without the knowledge of a  kind of powerful laser.The respected colleague evaluates in which group, without knowing the people in the group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>People with rotator cuff tendinitis.</hc_freetext>
      <i_freetext>Intervention 1: 16 patients participating in the study who were selected by simple non-probability sampling. Before using the modalities, the pain scale with "VAS scale" and the degree of disability by the "Pain and Shoulder Disability Questionnaire" were administered to patients. The data will be evaluated. Also, the range of motion of the shoulder in the directions of flexion, abduction and external and internal rotation by "goniometry" and the amount of subacromial fluid accumulation around the rotator cuff tendon will be measured by "sonography"  treatment  groups will receive 1 tablet of diclofenac 100 mg daily for the first 10 days after rotator cuff tendonitis. After the 10 day treatment period, diclofenac will be administered.Intervention group: In addition to the conventional physiotherapy, the 808 nm pulsed laser pulse laser with an average power of 4 watts and a power density of 20 joule / cm2 and frequency of 20 Hz will be used at 10 painful points  and  ROM exercises including WAND exercises to increase range of motion,flexion, external rotation, abduction, internal rotation and pendular training in the first 6 sessions and rotator cuff muscles strengthening and scapular stabilizers in the final 6 sessions. No pain was given.Marinate will initially be trained in a 3 set of 10 sets at the clinic to evaluate the proper performance under the supervision of a physiotherapist. If pain is reported during each exercise, the exercise will be stopped and re-examined after a few sessions.These exercises will be performed once a day, with 3 sessions of 10 sessions per day as a home exercise. (12 sessions in total). At the end of physiotherapy sessions, pain and range of motion، Shoulder pain and disability questionnaireare measured by a physiotherapist who is unaware of the treatment and The amount of fluid accumulation around the tendon will also be monitored by a physician. Intervention 2: Control group:16 patients participating in the study who were selected by simple non-probability sampling. Before using the modalities, the pain scale with "VAS scale" and the degree of disability by the "Pain and Shoulder Disability Questionnaire" were administered to patients. The data will be evaluated. Also, the range of motion of the shoulder in the directions of flexion, abduction and external and internal rotation by "goniometry" and the amount of subacromial fluid accumulation around the rotator cuff tendon will be measured by "sonography"  control  group will receive 1 tablet of diclofenac 100 mg daily for the first 10 days after rotator cuff tendonitis. After the 10 day treatment period, diclofenac will be administeredIn addition to the conventional physiotherapy,placebo high power laser therapy be used for them and ROM exercises including WAND exercises to increase range of motion flexion, external rotation, abduction, internal rotation and pendular training in the first 6 sessions and rotator cuff muscles strengthening and scapular stabilizers in the final 6 sessions. No pain was given.At the end of physiotherapy sessions, pain and range of motion، Shoulder pain and disability questionnaire are measured by a physiotherapist who is unaware of the control and The amount of fluid accumulation around the tendon will also be monitored by a physician.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Morteza Beyrami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Next to Imam Reza Hospital School of Medicine / Golgasht Street /Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>514777346</zip>
        <telephone>+98 41 3337 6923</telephone>
        <email>info@medfac.tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Morteza Beyrami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Next to Imam Reza Hospital School of Medicine / Golgasht Street /Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>514777346</zip>
        <telephone>+98 41 3337 6923</telephone>
        <email>info@medfac.tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis for rotator cuff tendinitis
Range of motion restriction
Pain range 3-7 in visual analog scale
Increase liquid in subacromial space
Age between 20-60 years old</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Shoulder surgery
Neoplastic disease
systemic inflammation disease
Complate tearing of rotator cuff
Cervical discopathy
Corticosteroids injection
Shoulder fracture
physical therapy in shoulder
Axillary lymphoedem
Myofasica syndrom
Pain killer user
Diabetic disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M75.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Rotator cuff syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>16 patients participating in the study who were selected by simple non-probability sampling. Before using the modalities, the pain scale with "VAS scale" and the degree of disability by the "Pain and Shoulder Disability Questionnaire" were administered to patients. The data will be evaluated. Also, the range of motion of the shoulder in the directions of flexion, abduction and external and internal rotation by "goniometry" and the amount of subacromial fluid accumulation around the rotator cuff tendon will be measured by "sonography"  treatment  groups will receive 1 tablet of diclofenac 100 mg daily for the first 10 days after rotator cuff tendonitis. After the 10 day treatment period, diclofenac will be administered.Intervention group: In addition to the conventional physiotherapy, the 808 nm pulsed laser pulse laser with an average power of 4 watts and a power density of 20 joule / cm2 and frequency of 20 Hz will be used at 10 painful points  and  ROM exercises including WAND exercises to increase range of motion,flexion, external rotation, abduction, internal rotation and pendular training in the first 6 sessions and rotator cuff muscles strengthening and scapular stabilizers in the final 6 sessions. No pain was given.Marinate will initially be trained in a 3 set of 10 sets at the clinic to evaluate the proper performance under the supervision of a physiotherapist. If pain is reported during each exercise, the exercise will be stopped and re-examined after a few sessions.These exercises will be performed once a day, with 3 sessions of 10 sessions per day as a home exercise. (12 sessions in total). At the end of physiotherapy sessions, pain and range of motion، Shoulder pain and disability questionnaireare measured by a physiotherapist who is unaware of the treatment and The amount of fluid accumulation around the tendon will also be monitored by a physician.</i_keyword>
      <i_keyword>Control group:16 patients participating in the study who were selected by simple non-probability sampling. Before using the modalities, the pain scale with "VAS scale" and the degree of disability by the "Pain and Shoulder Disability Questionnaire" were administered to patients. The data will be evaluated. Also, the range of motion of the shoulder in the directions of flexion, abduction and external and internal rotation by "goniometry" and the amount of subacromial fluid accumulation around the rotator cuff tendon will be measured by "sonography"  control  group will receive 1 tablet of diclofenac 100 mg daily for the first 10 days after rotator cuff tendonitis. After the 10 day treatment period, diclofenac will be administeredIn addition to the conventional physiotherapy,placebo high power laser therapy be used for them and ROM exercises including WAND exercises to increase range of motion flexion, external rotation, abduction, internal rotation and pendular training in the first 6 sessions and rotator cuff muscles strengthening and scapular stabilizers in the final 6 sessions. No pain was given.At the end of physiotherapy sessions, pain and range of motion، Shoulder pain and disability questionnaire are measured by a physiotherapist who is unaware of the control and The amount of fluid accumulation around the tendon will also be monitored by a physician.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Effects of high intensity laser therapy in increasing of shoulder range of motion. Timepoint: Measurement of shoulder range of motion in the first study and after 12 sessions of laser therapy. Method of measurement: Goniometry.</prim_outcome>
      <prim_outcome>The effect of high power laser on pain relief in people with shoulder tendonitis will be determined. Timepoint: Measurement of shoulder pain in the first study and after 12 sessions of laser therapy. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>The effect of high power laser on decreasing sub acromial fluid around the tendon in people with rotator cuff tendonitis will be determined based on ultrasound images. Timepoint: Measurement of subacromial fluid around the tendon in the first study and after 12 sessions of laser therapy. Method of measurement: Musculoskeletal ultrasound.</prim_outcome>
      <prim_outcome>The effect of a powerful laser on returning to the daily activities of people with shoulder tendonitis will be determined. Timepoint: Return to daily activity at baseline and after 12 sessions of laser therapy. Method of measurement: Shoulder pain and disability questionnaire.</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>Tabriz university of medical science.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-11-12</approval_date>
        <contact_name>Ethics committee of tabriz university of medical sciences</contact_name>
        <contact_address>Third Floor Vice Chancellor for Research and Technology, Building No. 2, Tabriz University of Medical Sciences, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
