<?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>IRCT201608154104N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-09-25</date_registration>
      <primary_sponsor>Research center of Physical Medicine and Rehabilitation,Tabriz university of medical sciences</primary_sponsor>
      <public_title>Comparison of the effects of ShockWave Therapy and physiothreapy in teratment of muscular pain of shoulder.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effects of Extracorporeal ShockWave Therapy and conventional physiotherapy in improvement of patients with shoulder girdle myofascial pain syndrome.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4299</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The patients will divide randomly into 3 groups (A,B,C).For randomization we will use computerized randomization with Excel software and we will write this sequence in separate pockets and put them in a box. The patients will treat with sequence of this box.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Muscular pain syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Shockwave therapy with shockwave instrument(2000 impulses,5Hz,EFD=0.1 mj/mm2) for 3 sessions(  1 session per week) with stretch exercises of shoulder muscles at home for 20 days(twice a day). Intervention 2: Routine physiothrapy for 10 sessions( 3 sessions per week) with  stretch exercises of shoulder muscles at home for 20 days(twice a day).physiotherapy includes: hot pack for 20 minutes with heat of 74.5 degrees celsius. Electrical nerve stimulation with frequencies of 70 to 80 hertz for 25 minutes. Continuous ultrasonography with dose of 1.25 to 1.5 w/cm2. Intervention 3: The third group will do stretch exercises of shoulder for 20 days( twice a day).</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>Maryam Samandarian</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>dr.marsam17@gmail.com</email>
        <affiliation>Tabriz university of medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammad Rahbar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golgasht Ave.,Imam Reza Hospital,Department of Physical Medicine and rehabilitation</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 3337 3967</telephone>
        <email>rahbarm@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria: age between 20 to 55 years old,at physical examination presence of palpable taut bands along that there are one or more trigger points that pressure on them causese pain , pain at least for 2 months, severity of pain at least 30 millimeters in Visual Analogue Scale, normal neurologic examination, absence of other diseases( such as radiculopathy,severe osteoarthritis, rheumatic disese) that will be ruled out with blood tests, simple graphy,MRI and electrodiagnostic studies, Absence of recent accident and recent surgery and fracture of spinal column, absence of shoulder injection in recent 2-3 months, absence of dry needling injection, absence of shockwave contraindications( hemorrhagic disorders, use of anticoagulants,thrombosis, tumors, cardiac pacemaker, pregnancy, diabetic polyneuropathy), Exclusion criteria: absence of inclusion criteria and patients with psychotic disorders such as depression and anxiety that take treatment and patients that do not finish the course of teratment or do not refer for follow up.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M75.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Shoulder lesion, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Shockwave therapy with shockwave instrument(2000 impulses,5Hz,EFD=0.1 mj/mm2) for 3 sessions(  1 session per week) with stretch exercises of shoulder muscles at home for 20 days(twice a day).</i_keyword>
      <i_keyword>Routine physiothrapy for 10 sessions( 3 sessions per week) with  stretch exercises of shoulder muscles at home for 20 days(twice a day).physiotherapy includes: hot pack for 20 minutes with heat of 74.5 degrees celsius. Electrical nerve stimulation with frequencies of 70 to 80 hertz for 25 minutes. Continuous ultrasonography with dose of 1.25 to 1.5 w/cm2</i_keyword>
      <i_keyword>The third group will do stretch exercises of shoulder for 20 days( twice a day).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: before treatment, immediately after treatment and one month after treatment. Method of measurement: Visual Analogue Scale with grading from zero to 100 millimeters.</prim_outcome>
      <prim_outcome>Pain Pressure Treshold. Timepoint: before treatment, immediately after treatment and one month after treatment. Method of measurement: Algometer device.</prim_outcome>
      <prim_outcome>Ability to manage in erveryday life. Timepoint: before treatment, immediately after treatment and one month after treatment. Method of measurement: Neck Disability index questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Range of motion of shoulder joints. Timepoint: before treatment, immediately after treatment and one month after treatment. Method of measurement: Goniometer.</sec_outcome>
      <sec_outcome>Range of motion of neck. Timepoint: before treatment, immediately after treatment and one month after treatment. Method of measurement: Inclinometer device.</sec_outcome>
      <sec_outcome>Shoulder muscle forces. Timepoint: before treatment, immediately after treatment and one month after treatment. Method of measurement: Physical examination.</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>Research center of Physical Medicine and Rehabilitation,Tabriz university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-07-04</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>
