<?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>IRCT20200608047700N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-22</date_registration>
      <primary_sponsor>The University of lahore</primary_sponsor>
      <public_title>Acute Non- Specific Low Back Pain</public_title>
      <acronym>Dileep Kumar</acronym>
      <scientific_title>Comparison of McKenzie Extension Exercise versus Mulligan Sustained Natural Apopheseal Glides on Pain, Range of Motion and Functional Disability in Patients with Acute Non- Specific Low Back Pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49754</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization will be performed by selection of a participant place odd and even number in two different groups, Blinding description: This will be double blind study as the assessor and participant will not be disclosed about the study group. The data will be collected by assessor and will be provided to the researcher.</study_design>
      <phase>N/A</phase>
      <hc_freetext>acute low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants will receive routine physical therapy (10 minutes hot pack, 5 minutes TENS, 5 minutes soft tissue massage) along with McKenzie Extension Exercises in prone position with repeated movements. Patient will have 5 repetitions of every set of exercise with 20 seconds of pause in per session. Intervention 2: Control group: Participants will receive routine physical therapy (10 minutes hot pack, 5 minutes TENS, 5 minutes soft tissue massage) along with Mulligan’s SNAGs in sitting and prone position by applying antereo cranial glide in the direction of treatment plane over the spinous process at 8 repetitions per session.</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:
Comparison of McKenzie Extension Exercise versus Mulligan Sustained Natural Apopheseal Glides on Pain, Range of Motion and Functional Disability in  Patients with Acute Non- Specific Low Back Pain and all collected deidentiﬁed IPD will be shared.

When:
After Publication

To whom:
people working in academic institutions and researchers

Conditions:
it could be used on request

Where to obtain:
Through Email and phone drdileeplumhs@gmail.com

How to obtain:
Through Email and phone drdileeplumhs@gmail.com 0092 331 3837764

Comments:
data can bee provided on request but after publication</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dileep Kumar Lohana</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>759-A Block Gulshan-e-Ravi, Lahore</address>
        <city>lahore</city>
        <country1>Pakistan</country1>
        <zip>54500</zip>
        <telephone>+92 42 37413842</telephone>
        <email>info@grwtust.org</email>
        <affiliation>Gosha e shifa Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dileep Kumar Lohana</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>759-A Block Gulshan-e-Ravi, Lahore</address>
        <city>lahore</city>
        <country1>Pakistan</country1>
        <zip>54500</zip>
        <telephone>+92 42 37413842</telephone>
        <email>info@grwtrust.org</email>
        <affiliation>Gosha e Shifa Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>•Patient with history of acute non specific Low Back Pain
Either gender
age ranges from 20-50 years
only Married people will include in study</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>•Any neurological symptoms
Any pathology of spine like Spondylosis, Spondylolisthesis
Patients with other comorbidity such as systemic disorders
•Patients with sociopsychatric disorders
Pregnancy</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Participants will receive routine physical therapy (10 minutes hot pack, 5 minutes TENS, 5 minutes soft tissue massage) along with McKenzie Extension Exercises in prone position with repeated movements. Patient will have 5 repetitions of every set of exercise with 20 seconds of pause in per session.</i_keyword>
      <i_keyword>Control group: Participants will receive routine physical therapy (10 minutes hot pack, 5 minutes TENS, 5 minutes soft tissue massage) along with Mulligan’s SNAGs in sitting and prone position by applying antereo cranial glide in the direction of treatment plane over the spinous process at 8 repetitions per session.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain Intensity. Timepoint: before intervention and then on 4th and 8th week. Method of measurement: Visual analogue scale.</prim_outcome>
      <prim_outcome>Lumbar Range of motion. Timepoint: before intervention and then on 4th and 8th week. Method of measurement: Back Performance Scale.</prim_outcome>
      <prim_outcome>Functional Disability. Timepoint: before intervention and then on 4th and 8th week. Method of measurement: Oswetry Low Back Pain Disability Questionnaire.</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>The University of Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-04</approval_date>
        <contact_name>Ethics Committee of The University of Lahore "Institutional Review Board"</contact_name>
        <contact_address>defence road campus,new campus ,The University of Lahore lahore punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
