<?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>IRCT20190618043932N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-25</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>PRP in frozen shoulder</public_title>
      <acronym>PRP in FS</acronym>
      <scientific_title>A COMPARISON OF THE CLINICAL OUTCOMES OF PRP INJECTION AND ARTHROSCOPIC RELEASE FOR THE TREATMENT OF FROZEN SHOULDER BASED ON CLINICAL TESTS</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>126</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40457</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Other design features: No spesefic design, Randomization description: 126 patient with frozen shoulder that refer to orthopedic clinic in 1398 will enrolled in  an easy non-probable way.Patients were randomly allocated into three groups of 42 people. The first person was treated with PRP followed by physiotherapy and the second one was treated by arthroscopy followed by physiotherapy and the third one was physiotherapy alone, and this trend continued until 42 subjects Arrived Finally.</study_design>
      <phase>N/A</phase>
      <hc_freetext>frozen shoulder.</hc_freetext>
      <i_freetext>Intervention 1: intervention group: PRP group: all the patients will be fill questioneries preinterventation.  then will be received 2 cc PRP  in posterior portal of shoulder arthroscopy. patient receive physiotherapy after injection. patient will be fallowed by questioneries after 6weeks, 6months and 12 months later. Intervention 2: Intervention group: arthroscopic release group: all the patients will be fill questioneries preinterventation.  then will be under shoulder arthroscopy under general anestesia. then  patient receive physiotherapy after surgury. patient will be fallowed by questionarys after 6weeks, 6months and 12 months later. Intervention 3: Control group: physioterapic group. all the patients will be fill questioneries preinterventation. then  patients receive physiotherapy. patient will be fallowed by questioneries after 6weeks, 6months and 12 months later.</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:
all data can be available for all the people who interest in PRP.

When:
when the research finished.

To whom:
all data can be available for all the people who interest in PRP.

Conditions:
for PRP development

Where to obtain:
dr amirreza sadeghifar.
a.sadeghifar.kmu.ac.ir

How to obtain:
with one call and email address

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr amirreza sadeghifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qarani Ave, bahonar hospital</address>
        <city>kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7613747181</zip>
        <telephone>+98 34 3132 5700</telephone>
        <email>a.sadeghifar@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr amirreza sadeghifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Besate2 clinic, Qrani ave, shariati Ave</address>
        <city>kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7613747181</zip>
        <telephone>+98 34 3132 5700</telephone>
        <email>A.sadeghifar@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All of the patient with frozen shoulder that refer to orthopedic clinic for treatment.
Patient most be have 30 to 70 years old</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Iess than 30 years old
More than 70 years old
Patient who had any operation in same shoulder to treat frozen shoulder.
Any fracture aroun the shoulder (acromion,clavicle,coracoied,scapulla)
Shoulder joint septic arteritis.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M75.00</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Adhesive capsulitis of unspecified shoulder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention group: PRP group: all the patients will be fill questioneries preinterventation.  then will be received 2 cc PRP  in posterior portal of shoulder arthroscopy. patient receive physiotherapy after injection. patient will be fallowed by questioneries after 6weeks, 6months and 12 months later.</i_keyword>
      <i_keyword>Intervention group: arthroscopic release group: all the patients will be fill questioneries preinterventation.  then will be under shoulder arthroscopy under general anestesia. then  patient receive physiotherapy after surgury. patient will be fallowed by questionarys after 6weeks, 6months and 12 months later.</i_keyword>
      <i_keyword>Control group: physioterapic group. all the patients will be fill questioneries preinterventation. then  patients receive physiotherapy. patient will be fallowed by questioneries after 6weeks, 6months and 12 months later.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>1. patient score in AMERICAN SHOULDER AND ELBOW QUESTIONARY 2. patient score in SIMPLE SHOULDER TEST 3. patient score in Oxford shoulder score final. Timepoint: patients will be followed preintervention, in the next 6 weeks, 6 months and 12 months. Method of measurement: 1. AMERICAN SHOULDER AND ELBOW QUESTIONARY 2. SIMPLE SHOULDER TEST 3. OXFORD SHOULDER SCORE FINAL.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-02-22</approval_date>
        <contact_name>Ethics committee of kerman University of Medical Sciences</contact_name>
        <contact_address>Qarani ave, shariati ave, bahonar hospital, kerman kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
