<?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>IRCT20190818044558N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-12</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Manual therapy techniques in low back pain</public_title>
      <acronym></acronym>
      <scientific_title>Investigating immediate effects of posterior-anterior lumbar mobilization with different amplitude on pressure pain threshold of patients with chronic non specific low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>25</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41679</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic non-specific low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: Fourth lumbar vertebra posterior-anterior mobilization with low amplitude (150-200 N). Patient were asked to go in prone position and after that the mobilization technique was applied to forth lumbar vertebrae.  There was three different session of therapy.To prevent the carry-over effect, we implemented 48 hours rest between each session. To calculate precise amount of force applied, we placed a digital weight gauge below the abdomen of patients. We used Pisiform grip technique for lumbar mobilization in this study. Intervention 2: Intervention group2:  Fourth lumbar vertebra posterior-anterior mobilization with high amplitude ( 50-200 N). Patient were asked to go in prone position and after that the mobilization technique was applied to forth lumbar vertebrae.  There was three different session of therapy.To prevent the carry-over effect, we implemented 48 hours rest between each session.To calculate precise amount of force applied, we placed a digital weight gauge below the abdomen of patients. We used Pisiform grip technique for lumbar mobilization in this study. Intervention 3: Intervention group3:  Fourth lumbar vertebra posterior-anterior mobilization with static amplitude (200 N). Patient were asked to go in prone position and after that the mobilization technique was applied to forth lumbar vertebrae.  There was three different session of therapy. To prevent the carry-over effect, we implemented 48 hours rest between each session. To calculate precise amount of force applied, we placed a digital weight gauge below the abdomen of patients. We used Pisiform grip technique for lumbar mobilization in this study. Intervention 4: Control group: Sustaining prone position for five 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Only a portion of the data such as main outcomes information would be shared.

When:
Start of access period from March 2020.

To whom:
Scholars working in academic and scientific institutes that have scientific merit.

Conditions:
All statistical analysis on the data should be done under my authority.

Where to obtain:
Mohammad Reza Khanmohammadi
Email:
m.reza_khanmohamadi@yahoo.com

How to obtain:
They should email Mr. Khanmohammadi. After evaluating their scientific competency, the data will send to them during less than a week.

Comments:
Nothing</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Reza Khanmohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mohammad Reza Khanmohammadi, No 33, Mirghaderi alley, Gozalkhoue Street, south Mehr-abad district, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1385666161</zip>
        <telephone>+98 21 6662 4672</telephone>
        <email>mr-khanmohammadi@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Reza Khanmohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mohammad Reza Khanmohammadi, No 33, Mirghaderi alley, Gozalkhoue Street, south Mehr-abad district, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1385666161</zip>
        <telephone>+98 21 6662 4672</telephone>
        <email>mr-khanmohammadi@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>suffering chronic nonspecific low back pain
Pain at the beginning of study between: 3-6 according to visual analog scale
age ranges between 18 to 45 years
Male participants only
experiencing back pain for more than 3 months
Body mass index below 28</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Existence of deviation in alignment of vertebral column
Radiating pain from low back region to lower extremity</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: Fourth lumbar vertebra posterior-anterior mobilization with low amplitude (150-200 N). Patient were asked to go in prone position and after that the mobilization technique was applied to forth lumbar vertebrae.  There was three different session of therapy.To prevent the carry-over effect, we implemented 48 hours rest between each session. To calculate precise amount of force applied, we placed a digital weight gauge below the abdomen of patients. We used Pisiform grip technique for lumbar mobilization in this study.</i_keyword>
      <i_keyword>Intervention group2:  Fourth lumbar vertebra posterior-anterior mobilization with high amplitude ( 50-200 N). Patient were asked to go in prone position and after that the mobilization technique was applied to forth lumbar vertebrae.  There was three different session of therapy.To prevent the carry-over effect, we implemented 48 hours rest between each session.To calculate precise amount of force applied, we placed a digital weight gauge below the abdomen of patients. We used Pisiform grip technique for lumbar mobilization in this study.</i_keyword>
      <i_keyword>Intervention group3:  Fourth lumbar vertebra posterior-anterior mobilization with static amplitude (200 N). Patient were asked to go in prone position and after that the mobilization technique was applied to forth lumbar vertebrae.  There was three different session of therapy. To prevent the carry-over effect, we implemented 48 hours rest between each session. To calculate precise amount of force applied, we placed a digital weight gauge below the abdomen of patients. We used Pisiform grip technique for lumbar mobilization in this study.</i_keyword>
      <i_keyword>Control group: Sustaining prone position for five minutes</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pressure pain threshold. Timepoint: Before and immediately after performing the therapy procedure. Method of measurement: Pressure algometry according to newton scale.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-11-25</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran University of Medical Science main building, Kehavarz Blvd, Qods Ave,Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
