<?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>IRCT20200228046639N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-22</date_registration>
      <primary_sponsor>Riphah International University</primary_sponsor>
      <public_title>Effects of Lumbar Sustained Natural Appophyseal Glide and Muscle energy technique in Low Back Pain.</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Lumbar Sustained Natural Appophyseal Glide versus Muscle energy techniques on pain, Range of Motion and function in chronic Nonspecific Low Back Pain.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-07-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49370</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Written informed consent will be taken. After enrollment into study, patient will be allocated either to group A or Group B by lottery method. No. of Chits will be equal to total sample size, odd Numbers will be allocated to Group A and even number will be allocated to Group B.Each patient will be requested to draw a chit from the box and after that patient will be recruited into either Group A or Group B, Blinding description: Participant, Assessor Blind: Data safety will be ensured by assigning
Specific Identity numbers and all consent, readings forms
will be placed in locker to blind Assessors.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic nonspecific low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Lumber sustained natural appophyseal glide SNAG on Lumber L4/L5 vertebrae.	The subjects will receive mulligan concept SNAG (sustained natural Appophyseal glide) position of subject: sitting on the edge of table and both feet will be support on footstep. The therapist must be standing behind the subject and place a belt around the subject’s lower abdomen (below the anterior superior illac spine) also the therapist below hips. The Ulnar border of therapist right hand will be placed under the spinous process of vertebra above the suspected spinal segment. The other hand will be placed on the bed to the left of subject. The mobilizing force will be parallel to the facet joint plan in cephalic direction and asked the subject to lean forward. Sustained the flexed position for few seconds and maintain the facet glide until the subject erect. Intervention 2: Intervention group:The subject will receive METS on Quadrates lumborum (post isometric relaxation technique) position of subject: side lying and the physiotherapist behind the subject at waist level. the subject will  extend uppermost arm over the head to grasp the top end of the table and on inhalation subject will abduct his uppermost leg until the therapist palpates quadrates activity(elevated around 30◦).the subject is asked to hold the leg isometricaly in this state and allowing gravity to provide resistance. After 10 sec the subject let the leg to fall toward the floor.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Muhammad Salman Bashir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>28-M Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 35126110</telephone>
        <email>chistisalman@yahoo.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Muhammad Salman Bashir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>28-M Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 35126110</telephone>
        <email>chistisalman@yahoo.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Subject between the ages 25 to 60.
Both male and female patients with low back pain.
Subject with history of 3 months continues or intermittent symptoms of low back pain.
The flexion of trunk at least 40-degree ROM.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient with history of pathology of spine (spine tumors,spinal infections, spondylosis, neurological deficit, pregnant women).
Patient pain will radiate down to the knee.
History of spinal 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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Lumber sustained natural appophyseal glide SNAG on Lumber L4/L5 vertebrae.	The subjects will receive mulligan concept SNAG (sustained natural Appophyseal glide) position of subject: sitting on the edge of table and both feet will be support on footstep. The therapist must be standing behind the subject and place a belt around the subject’s lower abdomen (below the anterior superior illac spine) also the therapist below hips. The Ulnar border of therapist right hand will be placed under the spinous process of vertebra above the suspected spinal segment. The other hand will be placed on the bed to the left of subject. The mobilizing force will be parallel to the facet joint plan in cephalic direction and asked the subject to lean forward. Sustained the flexed position for few seconds and maintain the facet glide until the subject erect.</i_keyword>
      <i_keyword>Intervention group:The subject will receive METS on Quadrates lumborum (post isometric relaxation technique) position of subject: side lying and the physiotherapist behind the subject at waist level. the subject will  extend uppermost arm over the head to grasp the top end of the table and on inhalation subject will abduct his uppermost leg until the therapist palpates quadrates activity(elevated around 30◦).the subject is asked to hold the leg isometricaly in this state and allowing gravity to provide resistance. After 10 sec the subject let the leg to fall toward the floor.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: First (pre/post) and third and sixth week. Method of measurement: Numeric Pain Rating Scale.</prim_outcome>
      <prim_outcome>Range of motion for flexion and extension. Timepoint: First (pre/post) and third and sixth week. Method of measurement: Lumber inclinometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Function. Timepoint: First (pre/post) and third and sixth week. Method of measurement: Modified Oswestry disability index.</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</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-08</approval_date>
        <contact_name>Research Ethical Committee (REC), Riphah College of Rehabilitation Sciences,Lahore campus</contact_name>
        <contact_address>28-M, Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
