<?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>IRCT20200825048515N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-21</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of kinesiotype and corrective movements on pain and shoulder function in impingement syndrome of shoulder</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study of the effect of kinesiotype and corrective movements on pain and shoulder function in impingement syndrome of shoulder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50716</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, eligible patients will be selected using non-probability consecutive.Then, all patients are coded using computer randomization method using random allocation software and the codes will be randomly assigned to the intervention and control groups according to the order, Blinding description: Given that the two methods of intervention are different, the researcher and the patient are aware of the two groups, but the person evaluating the patient's outcomes and the data analyst will not know the type of intervention.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Impingement syndrome of shoulder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For all patients, meloxicam 15 mg tablets daily, as well as baclofen tablets, half a tablet on the first night and on the following nights, one tablet every night will be recommended, which will be used for 3 weeks. Exercise intervention will also prescribe exercises for increasing range of motion three times a day for both groups and five times each time following the exercise instructions. This exercise may be unique to each patient depending on the patient's condition and the amount of pain. For patients in the intervention group, in addition to medication and exercise, the kinesiotype tape will be used once a week during four weeks. Intervention 2: Control group: For all patients, meloxicam 15 mg tablets daily, as well as baclofen tablets, half a tablet on the first night and on the following nights, one tablet every night will be recommended, which will be used for 3 weeks. Exercise intervention will also prescribe exercises for increasing range of motion three times a day for both groups and five times each time following the exercise instructions. This exercise may be unique to each patient depending on the patient's condition and the amount of pain. Patients in the control group do not receive any other intervention.</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>Parisa Taheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Office of Physical Medicine, Al-Zahra Hospital, Sefeh St., Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174675731</zip>
        <telephone>+98 31 3668 5555</telephone>
        <email>Prs_taheri@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parisa Taheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Office of Physical Medicine, Al-Zahra Hospital, Sefeh St., Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174675731</zip>
        <telephone>+98 31 3668 5555</telephone>
        <email>Prs_taheri@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 18 years
Diagnosis of impingement syndrome of shoulder by a physical therapist
Satisfaction to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1. History of dislocation and traumatic injury and history of surgery on the shoulder joint
Deformity of the scapula and hunched back with the diagnosis of a physician specializing in physical medicine
Rotator cuff muscle rupture
Shoulder joint instability
Neurological problems of the neck, such as neck radiculopathy
Rheumatic diseases and destructive changes in the joints
History of shoulder injection or shoulder or neck physiotherapy in the last six months by reviewing the patient's medical record
History of neurological diseases such as stroke, multiple sclerosis
The presence of any skin disease around the shoulder and scapula</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M75.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Impingement syndrome of shoulder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For all patients, meloxicam 15 mg tablets daily, as well as baclofen tablets, half a tablet on the first night and on the following nights, one tablet every night will be recommended, which will be used for 3 weeks. Exercise intervention will also prescribe exercises for increasing range of motion three times a day for both groups and five times each time following the exercise instructions. This exercise may be unique to each patient depending on the patient's condition and the amount of pain. For patients in the intervention group, in addition to medication and exercise, the kinesiotype tape will be used once a week during four weeks.</i_keyword>
      <i_keyword>Control group: For all patients, meloxicam 15 mg tablets daily, as well as baclofen tablets, half a tablet on the first night and on the following nights, one tablet every night will be recommended, which will be used for 3 weeks. Exercise intervention will also prescribe exercises for increasing range of motion three times a day for both groups and five times each time following the exercise instructions. This exercise may be unique to each patient depending on the patient's condition and the amount of pain. Patients in the control group do not receive any other intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Shoulder pain. Timepoint: Before and three weeks after the intervention. Method of measurement: Visual analog scale(VAS).</prim_outcome>
      <prim_outcome>Shoulder function. Timepoint: Before and three weeks after the intervention. Method of measurement: By criteria Disabilities of the Arm, Shoulder and Hand (DASH).</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>Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-08</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar Jarib Ave, Azadi Square. Isfaha Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
