<?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>IRCT20210730052018N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-09</date_registration>
      <primary_sponsor>Mola Bakhsh hospital Sargodha</primary_sponsor>
      <public_title>Effects of Pelvic Clock vs Pelvic Tilt Exercises on pregnant women with low back pain during their third trimester</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Pelvic Clock vs Pelvic Tilt Exercises on pregnant women with low back pain during their third trimester</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>26</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57867</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Non-probability purposive sampling will be used to recruit the individual for the study and then randomization will be done by lottery method to allocate the individual to two interventional groups. Sealed envelops will be used for allocation concealment, Randomization description: Written informed consent will be taken. After enrollment into study, patients will be allocated either to Group 1 or Group 2 by lottery method. No. of chits will be equal to total sample size, odd no. will be allocated to Group 1 and even no. will be allocated to Group 2. Each patient will be requested to draw a chit from the box and after that patient will be recruited into either Group 1 or Group 2.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Low back pain is leading health problem in lumbosacral region. It is defined by muscle tension, or stiffness localized below the costal margin and above the inferior gluteal folds. The symptoms of low back pain occurs in people of all ages .The low back pain symptoms may be short lasting but frequent occurrence is common , the acute episode lasts from few days to four weeks while sub-acute phase of low back pain lasts for four to twelve weeks and chronic low back pain persists from months and  years. It is a composite condition with several contributing factors involving psychological factors, social factors and biophysical factors.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: After taking baseline measures group A patients will receive hot pack for 10 minutes and pelvic tilt exercise for 15 minutes. 5 sessions/ week will be given for 4 weeks. Intervention 2: Intervention group 2: After taking baseline measures group B patients will receive hot pack for 10 minutes and pelvic clock exercise for 15 minutes. 5 sessions/week will be given for 4 weeks. Treatment time of each session will be approximately 25 minutes.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further decision and information decided yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Bushra Mustaq</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House no 1428 Mohallah Qazian Wala khushab.</address>
        <city>Khushab</city>
        <country1>Pakistan</country1>
        <zip>41000</zip>
        <telephone>+92 48 3726938</telephone>
        <email>bushaamushtaq213@gmail.com</email>
        <affiliation>Sargodha Institute of Health Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Bushra Mushtaq</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House no 1428 Mohallah Qazian Wala Khushab</address>
        <city>Khushab</city>
        <country1>Pakistan</country1>
        <zip>41000</zip>
        <telephone>+92 48 3726938</telephone>
        <email>bushaamushtaq213@gamil.com</email>
        <affiliation>Sargodha Institute of Health Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age limit 25 to 35
Pregnant women with low back pain in 3rd trimester</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Any systemic illness
Gestational diabetes
Urinary tract infection
Multiple pregnancy
Complication during pregnancy
First and second trimester
Traumatic injury
Any previous surgery</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: After taking baseline measures group A patients will receive hot pack for 10 minutes and pelvic tilt exercise for 15 minutes. 5 sessions/ week will be given for 4 weeks</i_keyword>
      <i_keyword>Intervention group 2: After taking baseline measures group B patients will receive hot pack for 10 minutes and pelvic clock exercise for 15 minutes. 5 sessions/week will be given for 4 weeks. Treatment time of each session will be approximately 25 minutes</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: before treatment, after treatment (4th week). Method of measurement: Visual analogue scale (VAS).</prim_outcome>
      <prim_outcome>Functional performance. Timepoint: before treatment, after treatment (4th week). Method of measurement: Oswestry Disability Index (ODI).</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>Mola Bakhsh Hospital, Sargodha</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-17</approval_date>
        <contact_name>Sargodha Institute of Health Sciences (SIHS), Research Ethical Committe (REC)</contact_name>
        <contact_address>117-C, Zafar Ullah Road, Satellite Town, Sargodha. Sargodha Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
