<?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>IRCT20220622055252N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-29</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>comparison of telephysicaltherapy with in-clinic physical therapy</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of telephysicaltherapy with physicaltherapy in clinic based on exercise therapy and self- release on pain, range of motion, function and satisfaction in  patients with subacromial pain syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>33</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64616</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: randomisation will be done by putting separate papers in a bag with A , B ,C letters are written on them . a volunteer who pick A paper enter in the first intereventional group . then who pick B letter will be categorized in second interventional group. at last who pick C letter will be in control group, Blinding description: his single-blinded study has been blinded at the level of the assessor to conceal treatment group identity after randomization. the assessor is also a physical therapist and will do the assessments at the 1st, 5th, and 10th sessions. We will request from the assessor colleagues to not ask patients about their intervention group and patients not reveal their treatment plan.</study_design>
      <phase>3</phase>
      <hc_freetext>Shoulder subacromial pain syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: this group is going to recieve 2 methods of physical therapy including :exercise therapy(stretching and strengthing exercises) and self-release(treatment of trigger points and painful spots by using a tennis ball) via video call by common applications in smartphones (such as whatsapp or skype) and laptops for 3 weeks . it will be 10 sessions in this approach and patients will have 3 to 4 sessions every week in order to apply them on their own at home. Intervention 2: Intervention group 2: this group is going to recieve 2 methods of physical therapy including :exercise therapy(stretching and strengthing exercises) and self-release(treatment of trigger points and painful spots by using a tennis ball) via getting educational videos by common applications in smartphones and laptops for 3 weeks . it will be 10 sessions in this approach and patients will have 3 to 4 sessions every week in order to apply them on their own at home. Intervention 3: Control group: Intervention group 1: this group is going to recieve 2 methods of physical therapy including :exercise therapy and tissue release in physiotherapy clinic by therapist for 3 weeks . it will be 10 sessions in this approach and patients will have 3 to 4 sessions every week.</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Ehteshami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>aseman block, omid alley, meghdad alley,jaber ansari st</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8138986860</zip>
        <telephone>+98 31 3436 9369</telephone>
        <email>fateme.ehteshami94@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>khadije otadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>physical therapy department, school of rehabilitation of the university of tehran , shemiran turning , enghelab st</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965111</zip>
        <telephone>+98 21 7753 3939</telephone>
        <email>k_otadi@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>internet accessibilty
to be literate
suffering from subacromial pain syndrome
patients have to consent to participate in this study
aged between 20-50 years</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>history of shoulder pain less than 3 months
history of unsteadiness and dizziness
history of falling
blurred vision
history of new disease or an acute relapse
history recent shoulder surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M75.40</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Impingement syndrome of unspecified shoulder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: this group is going to recieve 2 methods of physical therapy including :exercise therapy(stretching and strengthing exercises) and self-release(treatment of trigger points and painful spots by using a tennis ball) via video call by common applications in smartphones (such as whatsapp or skype) and laptops for 3 weeks . it will be 10 sessions in this approach and patients will have 3 to 4 sessions every week in order to apply them on their own at home.</i_keyword>
      <i_keyword>Intervention group 2: this group is going to recieve 2 methods of physical therapy including :exercise therapy(stretching and strengthing exercises) and self-release(treatment of trigger points and painful spots by using a tennis ball) via getting educational videos by common applications in smartphones and laptops for 3 weeks . it will be 10 sessions in this approach and patients will have 3 to 4 sessions every week in order to apply them on their own at home.</i_keyword>
      <i_keyword>Control group: Intervention group 1: this group is going to recieve 2 methods of physical therapy including :exercise therapy and tissue release in physiotherapy clinic by therapist for 3 weeks . it will be 10 sessions in this approach and patients will have 3 to 4 sessions every week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Measuring percentage of telehealth patient satisfaction. Timepoint: measuring patient satisfaction after session 5th and 10th in telehealth group. Method of measurement: The modified Telehealth Satisfaction Scale: the purpose for using this questionnaire is to measure the quality of care for patients in the telerehabilitation group.it has many questions to survey how much a patient is satisfied with different aspects of this method for example the ease of use or manner of therapists.</prim_outcome>
      <prim_outcome>Measuring patient satisfaction from in-clinic physical therapy care. Timepoint: measuring patient satisfaction after session 5th and 10th in-clinic(conventional)group. Method of measurement: The Patient Satisfaction with Physical Therapy care: it will be used specifically to measure the quality of care at clinic by therapist .for example investigates different aspects of commuting to rehabilitation center or survey the quality of hands-on treatment.</prim_outcome>
      <prim_outcome>Measuring patient pain scale. Timepoint: measurment of patient's pain at the basement(before beginning) , and after 5th and 10th sessions. Method of measurement: The Visual Analogue Scale (VAS).</prim_outcome>
      <prim_outcome>Measurment of patient's pain and function. Timepoint: measurment of patient's pain and function at the basement(before beginning) , and after 5th and 10th( last)sessions. Method of measurement: The Shoulder Pain and Disability Index questionnaire(SPADI).</prim_outcome>
      <prim_outcome>Measurment of shoulder joint range of motion angle. Timepoint: measurment of patient's shoulder range of motion at the basement(before beginning) , and after 5th and 10th( last)sessions. Method of measurement: Goniometery.</prim_outcome>
      <prim_outcome>Measuring the rate of patients change after intervention. Timepoint: measuring patient's rate of change after session 5th and 10th sessions. Method of measurement: The Global Rating of Change (GRC):this scale is designed to assess the patient's level of change and wellness after intervention . if a patient marks a number between -1 to -5 indicates worsening of his/her condition. in contrast if someone say a number between +1 to +5 represent getting better.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-02</approval_date>
        <contact_name>ethics committee of Tehran University of Medical Science</contact_name>
        <contact_address>room 605,Secretariat of the Ethics Committee in Biomedical Research of the University, Research and Technology Vice-ChancellorوCentral Organization of the University, 6th Floor,Keshavarz Blvd., Quds St Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
