<?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>IRCT138812113470N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2010-06-05</date_registration>
      <primary_sponsor>Research Deputy of Tehran  University of Medical Sciences and Health Services</primary_sponsor>
      <public_title>Comparison between effects of abdomino lumbo pelvic belt and exercise therapy  in low back pain in pregnancy.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison between two types of treatment in pelvic girdle pain in pregnancy: Abdomino lumbo pelvic belt and exercise therapy.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3584</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Prescribtion of an abdomino lumbo pelvic belt in  group1 of trial with educational pamphlete consists of usual care in prevention and treatment of low back pain in pregnancy for 6 weeks. Intervention 2: Exercise prescribtion in group 2 of trial consist of stretching and strenghtening of abomen, lumbar and pelvic muscles and core stability exercises with one booklet consists  of guidelines for these exercises and educational pamphlete consists of usual care in treatment and prevention of low back pain in pregnancy for 6 weeks. Intervention 3: An educational pamphlete in control group consists of usual care for treatment and prevention of low back pain in pregnancy for 6 weeks.</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 Abolhasani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 7, Jalal Al Ahmad Highway, opposite of Shariatei Hospital's clinic, sports medicine research center</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21886302278</telephone>
        <email>m_abolhasani@razi.tums.ac.ir</email>
        <affiliation>Sports medicine research center.</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ramin Kordi.</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 7, Jalal Al Ahmad Highway, opposite of SHariatei Hospital's clinic, sports medicine research center</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21886302278</telephone>
        <email>ramin_kordi@tums.ac.ir</email>
        <affiliation>Assistant professor of Tehran University of Medical Sciences and Health Services. MD. PHD of sports </affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
1- Healthy pregnant women with pain in lumbar region.&#13;
2- Pregnancy age: 20-32 weeks of pregnancy.&#13;
3- The consent will be received from all participants.&#13;
4- Mono fetus pregnancy.&#13;
5- Pelvic girdle pain had been diagnosed with history, physical examination and       specific tests.&#13;
6- Contraindications of exercise in pregnancy should not be existed in participants such as: vaginal bleeding, preeclampsia, IURG, placenta previa, preterm labor, cervix insufficiency, rupture of membrane in recent pregnancy.&#13;
7- Systemic diseases should not be existed in participants such as: restrictive lung diseases, heart diseases.&#13;
Exclusion criteria:&#13;
1- If contraindications of exercise in pregnancy happened during study.&#13;
2- If participants don’t refer after 3 and 6 weeks of intervention.&#13;
3- If participants don’t use belt and exercise regularely.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Low back pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Prescribtion of an abdomino lumbo pelvic belt in  group1 of trial with educational pamphlete consists of usual care in prevention and treatment of low back pain in pregnancy for 6 weeks.</i_keyword>
      <i_keyword>Exercise prescribtion in group 2 of trial consist of stretching and strenghtening of abomen, lumbar and pelvic muscles and core stability exercises with one booklet consists  of guidelines for these exercises and educational pamphlete consists of usual care in treatment and prevention of low back pain in pregnancy for 6 weeks.</i_keyword>
      <i_keyword>An educational pamphlete in control group consists of usual care for treatment and prevention of low back pain in pregnancy for 6 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Back pain. Timepoint: 3 and 6 weeks after interventions. Method of measurement: Visual Analogue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life. Timepoint: 3 and 6 weeks after interventions. Method of measurement: WHO quality of life questionnaire.</sec_outcome>
      <sec_outcome>Patient's ability in implementation of daily activities. Timepoint: 3 and 6 weeks after interventions. Method of measurement: OSWESTRY disability questionnaire.</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 Deputy of Tehran  University of Medical Sciences and Health Services</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date></approval_date>
        <contact_name>Research Deputy of Tehran University of Medical Sciences and Health Services</contact_name>
        <contact_address>Keshavarz Blvd., GHods Avenue crossing. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
