<?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>IRCT20170117032020N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-04</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison the efficacy of two manual therapy methods (postro-anterior &amp; Mulligan sustained natural apophyseal glide) on low back pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of immediate effects following postro-anterior mobilization technique and Mulligan sustained natural apophyseal glide on chronic nonspecific low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25044</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block balanced randomization, Blinding description: Block balances randomization set before trial starting and was wrote in closed envelopes and sort them by number. Every participant that entered in study, therapist opened one envelope to find participant's grouping, but assessor was not aware about patient's group, because assessment was done in another room. Our sham treatment was very similar to Mulligan technique. therefore, No patient found that this was not real treatment, therefore patients and assessor were not aware about groups and only therapist was aware.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Low Back Pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 1: Mulligan Sustained natural apophyseal glide technique as intervention with 6 repetition during 4 sets and using mulligan belt. Intervention 2: Intervention 2: Posterior-anterior mobilization technique as intervention30 seconds at 4 sets and 30 seconds rest between them. Intervention 3: Control group: Sham technique of SNAG4 repetition of 3 sets forward flexion with caudal direction touch.</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>Mohammad Javaherian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.336, Corner of Safi-Ali-Shah street, Enghelab street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>111551683</zip>
        <telephone>+98 21 7753 3939</telephone>
        <email>Javaherian_m@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Siamak Bashardoust Tajali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.336, Corner of Safi-Ali-Shah street, Enghelab street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>111551683</zip>
        <telephone>+98 21 7753 3939</telephone>
        <email>S_Bashardoust@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>age between 20 to 50
Low back pain for more than 12 weeks
Pain at center of lumbar region (with or without radiating to distal of buttock(s) region which intensify with forward flexion, but firs half flexion in painless
Pain is equal to or greater than three by VAS
Can understand the commands
willingness to participate in the study</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Disorders like malignancy, hemorrhagic, wound, infection, sensory-motor deficits or any other pathology
Surgery or injection at lumbar region
Osteoporosis or history of fracture at lumbar or lower extremity
Any factor which prevents patient to lie prone (such as asthma or pacemaker) or limited range of motion in knee or ankle
Diabetes melitus
Any contraindication of mobilization
Sever mental disorder
Pregnancy
Spondylolisthesis and sacralization
Patient withdrawal of cooperation
Patient discomfort and intolerance</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>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention 1: Mulligan Sustained natural apophyseal glide technique as intervention with 6 repetition during 4 sets and using mulligan belt</i_keyword>
      <i_keyword>Intervention 2: Posterior-anterior mobilization technique as intervention30 seconds at 4 sets and 30 seconds rest between them.</i_keyword>
      <i_keyword>Control group: Sham technique of SNAG4 repetition of 3 sets forward flexion with caudal direction touch</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain Pressure threshold. Timepoint: Before and immediately after intervention. Method of measurement: By pressure algometer at 3 cm right to L4 vertebrae, L3-L4-S1 dermatome of right lower extremity and left mid-deltoid.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain. Timepoint: Before and immediately after intervention. Method of measurement: Visual analog scale.</sec_outcome>
      <sec_outcome>Forward flexion. Timepoint: Before and immediately after intervention. Method of measurement: Inclinometery.</sec_outcome>
      <sec_outcome>Backward extension. Timepoint: Before and immediately after intervention. Method of measurement: Inclinometery.</sec_outcome>
      <sec_outcome>Right and Left side bending. Timepoint: Before and immediately after intervention. Method of measurement: Goniometry.</sec_outcome>
      <sec_outcome>Right and left trunk rotation. Timepoint: Before and immediately after intervention. Method of measurement: Goniometry.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-04-20</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Conrner of Quds street- Keshavarz Street- Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
