<?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>IRCT201602153217N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-07-16</date_registration>
      <primary_sponsor>Vice chancellor for research ,Tabriz university of Medical Sciences</primary_sponsor>
      <public_title>Electrical stimulation vs acupuncture for hemiplegic shoulder pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of electrical interferential current stimulation and electrical acupuncture in the management of hemiplegic shoulder pain and disability following ischemic stroke</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-07-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3280</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>hemiplegic shulder pain due to stroke.</hc_freetext>
      <i_freetext>Intervention 1: All patients in both groups undergone conventional physical therapy including superficial heat therapy (infra-red), faradic electrical stimulation (FES) for shoulder antigravity muscles and exercise programs such as range of motion and strengthening exercises for a total of ten-session period. Then, two groups will be separated and compared regarding the following agents: in group A, additional treatment including acupuncture concomitant electrical stimulation will be performed. Acupuncture needles with 25 *0.25 and 25*0.30 sizes will be inserted inside the these acu points: SI 10-12 (supraspinatus fossa), Du 14 (2cm lateral to C7 cervical spinus process), LI 14 (deltoid insertion), LI 10-11 (lateral epicondyl), Du 20( vertex of head), LI 4 (web of first dorsal intersooses of hand), GB20( top of upper trapezius) and two tender points  of each patient. Electrical acupuncture will be done for 20 minutes by expert physiatrist 2 times a week for 5 weeks. Intervention 2: In group B ( comparison group), interferential current therapy with (IFC) using carrier frequency of 100 HZ with four electrodes attached to infraspinatus and serratus anterior via one channel and attached to supraspinatus and deltoid muscles via second channel will be performed. Electrodes arrangement will be crossed shape and cloverleaf current will be applied 3 times a week for 3 weeks by an expert therapist.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parvin Darabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golgasht Ave,Imam Reza hospital,Physical medicine and rehabilitation department.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 3337 3967</telephone>
        <email>parvin2010d@gmail.com</email>
        <affiliation>Tabriz university of medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fariba Eslamian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golgasht Ave,Imam Reza Hospital, Physical medicine and rehabilitation department.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 3337 3967</telephone>
        <email>eslamiyanf@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of  Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: patients with hemiplegic shoulder pain due to Ischemic stroke, who have been affected within the one month to one year after stroke.&#13;
Exclusion criteria: 1-physiotherapy within the previous month ;2- history of local steroid/botox  injection into shoulder joint; 3-presence of pacemaker in heart; 4-local skin lesions in shoulder area; 5-intracerebral hemorrhage ; 6-impaired cognition.</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I69.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sequelae of stroke, not specified as haemorrhage or infarction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>All patients in both groups undergone conventional physical therapy including superficial heat therapy (infra-red), faradic electrical stimulation (FES) for shoulder antigravity muscles and exercise programs such as range of motion and strengthening exercises for a total of ten-session period. Then, two groups will be separated and compared regarding the following agents: in group A, additional treatment including acupuncture concomitant electrical stimulation will be performed. Acupuncture needles with 25 *0.25 and 25*0.30 sizes will be inserted inside the these acu points: SI 10-12 (supraspinatus fossa), Du 14 (2cm lateral to C7 cervical spinus process), LI 14 (deltoid insertion), LI 10-11 (lateral epicondyl), Du 20( vertex of head), LI 4 (web of first dorsal intersooses of hand), GB20( top of upper trapezius) and two tender points  of each patient. Electrical acupuncture will be done for 20 minutes by expert physiatrist 2 times a week for 5 weeks.</i_keyword>
      <i_keyword>In group B ( comparison group), interferential current therapy with (IFC) using carrier frequency of 100 HZ with four electrodes attached to infraspinatus and serratus anterior via one channel and attached to supraspinatus and deltoid muscles via second channel will be performed. Electrodes arrangement will be crossed shape and cloverleaf current will be applied 3 times a week for 3 weeks by an expert therapist.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Shoulder pain and disablity intensity. Timepoint: week0-week 5. Method of measurement: questionnaire of " shoulder pain and disablity Index".</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Shoulder range of motion. Timepoint: week 0-week 5. Method of measurement: Goniometry.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>ندارد</sec_id>
        <issuing_authority>ندارد</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice chancellor for research ,Tabriz university of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-02-02</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Daneshgah Ave., executive field of Tabriz University of Medical Sciences, vice chancellor for research of Tabriz university of medical Sciences,Ethics committee. Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
