<?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>IRCT20151026024729N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-24</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of dry needling technique on walking in subjects with piriformis syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The effect of dry needling technique on pain, disability and lower extremity kinematics during walking in patient with piriformis syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32305</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization using random block method is performed individually using sealed envelopes, Blinding description: In this study, evaluator do not know allocation and treatment effects.</study_design>
      <phase>N/A</phase>
      <hc_freetext>piriformis syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Control group: In this group, patients will not receive treatment for a week and after a week they will receive physiotherapy for the release of piriformis muscle. Intervention 2: Intervention group: In this group, people will be treated with dry needling. In this method, the needle is inserted into the piriformis muscle simultaneously with the help of an ultrasound apparatus, and it is rotated and returned for 60 seconds.</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:
The total data from this study, including demographic information, primary and secondary outcomes are shared after participant being unidentified.

When:
The start of the access period will be without a time limit from March of 2019.

To whom:
The data from this study will only be available to researchers at academic institutions.

Conditions:
The data from this study will be available for use in secondary or review articles.

Where to obtain:
It will be possible for the researchers to access the documentation by email with a personal page on the site
.E-mail address: pt.taba.a@gmail.com
Researchgate address: https://www.researchgate.net/profile/Abbas_Tabatabaiee

How to obtain:
All requests will be reviewed and answered within a maximum of 3 weeks.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abbas tabatabaiee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of rehabilitation sciences., Madadkaran St., shahnazari St., Madar Squar, Mirdamad, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۳۴۸۷ - ۱۵۴۵۹</zip>
        <telephone>+98 21 2222 2059</telephone>
        <email>pt.taba.a@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ismail ebrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of rehabilitation sciences., Madadkaran St., shahnazari St., Madar Squar, Mirdamad, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۳۴۸۷ - ۱۵۴۵۹</zip>
        <telephone>+98 21 2222 2059</telephone>
        <email>dr_i_ebrahimi@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>buttock pain or radicular pain of sciatic nerve
increase symptoms with sitting
tenderness in piriformis muscle
increase symptoms with tension-generated maneuver</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>contraindication of dry needling
history of vertebral or lower extremity surgery
pregnancy
hip arthritis or pain
lumbar discopathy or instability</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S74.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Injury of sciatic nerve at hip and thigh level</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: In this group, patients will not receive treatment for a week and after a week they will receive physiotherapy for the release of piriformis muscle.</i_keyword>
      <i_keyword>Intervention group: In this group, people will be treated with dry needling. In this method, the needle is inserted into the piriformis muscle simultaneously with the help of an ultrasound apparatus, and it is rotated and returned for 60 seconds.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before first intervention, 72 hours and 7th days after the last treatment session. Method of measurement: visual analog scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Lower extremity kinematic. Timepoint: before first intervention and 72 hours after last treatment session. Method of measurement: motion analysis instrument.</sec_outcome>
      <sec_outcome>Pain pressure threshold. Timepoint: Before first intervention, 72 hours and 7th days after the last treatment session. Method of measurement: algometery.</sec_outcome>
      <sec_outcome>Disability. Timepoint: Before first intervention, 72 hours and 7th days after the last treatment session. Method of measurement: oswestry questionnaire.</sec_outcome>
      <sec_outcome>Internal and external range of motion of hip joint. Timepoint: Before first intervention, 72 hours and 7th days after the last treatment session. Method of measurement: by goniometry.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-20</approval_date>
        <contact_name>Ethics Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Shahid Hemmat Highway tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
