<?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>IRCT20200825048515N52</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-12</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of high-power laser in the recovery of patients with rotator cuff tendinopathy</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of high-power laser and Meloxicam in improving shoulder joint function and pain of patients with rotator cuff tendinopathy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63210</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method is permuted block randomization. In this way, at first using online software (sealedenvelope), a sequence of random numbers will be created and by the same software, the generated numbers will be divided into 7 blocks of size 6. Which is an equal number in each block will be 3 items from the intervention group and 3 items from the control group. So by using each block, 3 patients (equally) will be assigned to each group, Blinding description: Due to the different nature of the intervention in the two groups, the Care provider is aware of the type of intervention in each group. But the patient is not aware of the difference in treatment between the two groups. Also, the Outcome assessor and data analyzer of the two groups will not have information.</study_design>
      <phase>3</phase>
      <hc_freetext>Rotator cuff tendinopathy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After reducing the patient's pain, the patient is taught the exercises that strengthen the rotator cuff muscles and the shoulder girdle by repeating 3 times a day and 3 sets each time for 20 seconds. Patients are then treated with a high-power laser. So that, in the first stage, a slow scan (100 square cm2/minute) is performed along the rotator cuff tendons with an average of 10-15 J/cm2, which is the maximum energy received in this stage is 3000 J. In the second stage, on the painful points of the muscles around the shoulder and the joint line in the front, back, and outside of the joint, and on the patient's acromioclavicular joint, 10-15 J/cm2 are applied at each point and the maximum energy received in this stage is 2000 J. The output power of each wavelength will be set to 810 by 3 watts and output by 1.5 W, wavelength 910 by 300 Wand output by 0.1 W, wavelength 1064 by 2 watts and output by 1 W. The pulse frequency is set to 6,000 and the duty cycle to 50%, with a total output power of 2.6 W. The number of laser sessions for each patient will be 10 alternating sessions of 3 sessions per week. Intervention 2: Control group: After reducing the patients' pain, the patient is taught the exercises that strengthen the rotator cuff muscles and the shoulder girdle by repeating 3 times a day and 3 sets each time for 20 seconds. Patients will then be given 15 mg of meloxicam tablets with food once daily for 2 weeks.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Razieh Maghroori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physical and Rehabilitation Department, Kashani Hospital, Kashani St., Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8183983434</zip>
        <telephone>+98 31 3233 0091</telephone>
        <email>maghroori@mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Razieh Maghroori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physical and Rehabilitation Department, Kashani Hospital, Kashani St., Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8183983434</zip>
        <telephone>+98 31 3233 0091</telephone>
        <email>maghroori@mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with unilateral rotator cuff tendonitis
Previous normal radiograph of the shoulder
Age between 18 and 65 years
Symptoms last less than 3 months
Failure to perform any other therapeutic intervention during the last 3 months such as steroid injection into the shoulder joint or physiotherapy
No contraindications to performing lasers
Satisfaction to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of surgery
Having a fracture near the shoulder
Severe direct or indirect injuries following traction
Generalized disorders of the musculoskeletal system or nervous disorders
Having underlying diseases (including hypertension, coagulation disorders, heart disease, liver disease, kidney disease, cancer)
drug abuse
Inability to communicate and cognitive impairment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M75.11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Incomplete rotator cuff tear or rupture not specified as traumatic</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After reducing the patient's pain, the patient is taught the exercises that strengthen the rotator cuff muscles and the shoulder girdle by repeating 3 times a day and 3 sets each time for 20 seconds. Patients are then treated with a high-power laser. So that, in the first stage, a slow scan (100 square cm2/minute) is performed along the rotator cuff tendons with an average of 10-15 J/cm2, which is the maximum energy received in this stage is 3000 J. In the second stage, on the painful points of the muscles around the shoulder and the joint line in the front, back, and outside of the joint, and on the patient's acromioclavicular joint, 10-15 J/cm2 are applied at each point and the maximum energy received in this stage is 2000 J. The output power of each wavelength will be set to 810 by 3 watts and output by 1.5 W, wavelength 910 by 300 Wand output by 0.1 W, wavelength 1064 by 2 watts and output by 1 W. The pulse frequency is set to 6,000 and the duty cycle to 50%, with a total output power of 2.6 W. The number of laser sessions for each patient will be 10 alternating sessions of 3 sessions per week.</i_keyword>
      <i_keyword>Control group: After reducing the patients' pain, the patient is taught the exercises that strengthen the rotator cuff muscles and the shoulder girdle by repeating 3 times a day and 3 sets each time for 20 seconds. Patients will then be given 15 mg of meloxicam tablets with food once daily for 2 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before, immediately and three months after the intervention. Method of measurement: Visual Analog Scale (VAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Shoulder joint function. Timepoint: Before, immediately and three months after the intervention. Method of measurement: Disabilities of the Arm, Shoulder and Hand outcome Measure (DASH).</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>Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-07</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
