<?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>IRCT20190717044238N14</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-05-18</date_registration>
      <primary_sponsor>Riphah International University Lahore</primary_sponsor>
      <public_title>Effects of Mcgill versus Lee Stabilization Exercises on Pain, Disability, Range of motion, Quality of life and Endurance in Patient with Chronic Nonspecific Low Back Pain</public_title>
      <acronym>nlbp</acronym>
      <scientific_title>Effects of Mcgill versus Lee Stabilization Exercises on Pain, Disability, Range of motion, Quality of life and Endurance in Patient with Chronic Nonspecific Low Back Pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-05-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76688</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization will be done by using sealed envelops which involves assigning participants to different groups by randomly selecting an envelope that contains their group assignment. This will ensure reduced bias in allocation of interventions. Simple randomization method is used to allocate participants to different groups, Blinding description: In the trial the participant( who are willing to participate)  is blinded by not knowing or being unaware which intervention they are receiving , but the researcher (physiotherapist) know. This trial will be single blinded. Researcher will be responsible for care for participants during the trial, data collectors, outcome assessors, and with lessor importance Data Safety .</study_design>
      <phase>N/A</phase>
      <hc_freetext>chronic non specific low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Mc Gill group. Intervention 2: Control group: Lee Stabilization.</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 confidentiality of participants</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hafiza Sumbal Liaqat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Riphah International University Lahore Gulberg green campus</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 332 0459833</telephone>
        <email>sumballiaqat10@gmail.com</email>
        <affiliation>Riphah International University Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fareeha Amjad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Riphah International University Lahore Gulberg green campus</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 334 3372779</telephone>
        <email>fari_fairy22@yahoo.com</email>
        <affiliation>Riphah International University Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient with a history of 3 months nonspecific low back pain
Pain intensity (3–7) according to NPRS score
Age: 30–50 years
Both male and female patients</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any lumbar surgery
Spinal stenosis
Neurological dysfunction
Systemic disease
Pregnancy
Infections
Carcinoma
Any fracture or deformity</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Low Back P</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>M54.5</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Mc Gill group</i_keyword>
      <i_keyword>Control group: Lee Stabilization</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before intervention, 6 weeks. Method of measurement: Numeric pain rating scale (NPRS).</prim_outcome>
      <prim_outcome>Functional disability. Timepoint: Before intervention, 6 weeks. Method of measurement: Urdu version of Oswestry Disability index (ODI).</prim_outcome>
      <prim_outcome>Range of motion. Timepoint: Before intervention, 6 weeks. Method of measurement: Inclinometer.</prim_outcome>
      <prim_outcome>Endurance. Timepoint: Before intervention, 6 weeks. Method of measurement: Sorensen Test.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before intervention, 6 weeks. Method of measurement: SF-36 Urdu version.</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>Riphah International University Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-04-03</approval_date>
        <contact_name>Research and ethics Commitee Riphah College of Rehabilitation and Allied Health Sciences</contact_name>
        <contact_address>Riphah International University Gulberg campus lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
