<?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>IRCT138711151637N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2010-12-11</date_registration>
      <primary_sponsor>Vice-Deen for Research of Faculty of Basic of Medical Science of Tarbiat Modares University (TMU)</primary_sponsor>
      <public_title>Effect of stabilization Exercise on Low Back Pain (LBP) patients</public_title>
      <acronym></acronym>
      <scientific_title>The short-term effects of of stabilization Exercise on the stability index of Biodex system, abdominal and back muscle electromyography (EMG) and lumbar curvature in men with non-specific low back pain (NS.CLBP)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1095</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Non- Specific  Chronic Low Back Pain.</hc_freetext>
      <i_freetext>Intervention 1: First Intervention: Abdominal Hollowing exercise&#13;
&#13;
"Drawing in" or "Abdominal Hollowing" training: The subject was placed in crock lying position and was taught special and isolate contraction of Transversus Abdominis muscle based on Richardson concepts. Training will continue until the patient was quite remembering the correct contraction. The subject was instructed to pull him navel in (toward spinal column) and up (less than 10 percent maximum voluntary contraction MVC). When ideal contraction of Transversus Abdominus was obtained (best activation with minimal other muscle activation), was asked them to hold contraction with breathing and Imprisonment not their breath. Pressure BoiFeedback Unit was used for control of muscle contraction. 3 set each one with10 repetitions while 2 minutes as a rest period between each set and keeping contraction of muscle for 10 seconds was the ultimate goal.&#13;
Time of training, depends on correct learning of Abdominal Hallowing and was different between patients. Intervention 2: Second intervention: "Abdominal Bracing exercise&#13;
"Co-contraction" or "Abdominal Bracing training. ّFirst, a natural waist position (slight lordosis) was investigated ,then subject must contract all muscles as 360º around the trunk(area of lumbar spine), such as someone pressure to his waist but he can resist while he had normal breathing , at beginning of this maneuvers ,therapist would give touch feedback with her hands to the patient and after learning, patients would do it himself Pressure Bio Feedback Unit Was used to control of correct contraction of abdominal wall muscle. Patient must reach a stage that can do this maneuvers simultaneously with normal breathing and maintain this state about 10 seconds. This exercise in supine crook lying mode is done. Llike the first intervention, achieving to 3 set each one with10 repetitions while 2 minutes as a rest period between each set and keeping contraction of muscle for 10 seconds was the ultimate goal. Intervention 3: Control group: &#13;
For subjects of this group was not performed any intervention and the mean duration of time equivalent to the intervention training group, were given  to  them instead of  intervention  period  between data recording  because for the real effects of the intervention in the treatment group is determined .</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Sedighe Kahrizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physical Therapy Department, Medical Sciences Faculty, Tarbiat Modares University</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14117113116</zip>
        <telephone>+98 21 8288 4511</telephone>
        <email>kahrizis@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University (T.M.U)</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Sedighe Kahrizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physical Therapy Department, Medical Sciences  faculty, Tarbiat Modares University.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8288 4511</telephone>
        <email>kahrizis@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University (T.M.U)</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age 25- 35 years, no history of exercise therapy (especially in the abdominal area) or professional exercise.; abdominal skin fold thickness no greater than 25 mm.&#13;
Exclusion criteria: having history of major heart problem, cardiovascular, respiratory or neuorological problems, having radicular pain in single or both feet, pain exacerbation during the intervention process, history of major spinal surgery, using depression drug in the month prior to the study, addiction to drugs and alcohol</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>35 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M40.4 ,M40</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Kyphosis and lordosis, Other deforming dorsopathies, Other intervertebral disc disorders, Other dorsopathies, not elsewhere classified, Dorsalgia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First Intervention: Abdominal Hollowing exercise&#13;
&#13;
"Drawing in" or "Abdominal Hollowing" training: The subject was placed in crock lying position and was taught special and isolate contraction of Transversus Abdominis muscle based on Richardson concepts. Training will continue until the patient was quite remembering the correct contraction. The subject was instructed to pull him navel in (toward spinal column) and up (less than 10 percent maximum voluntary contraction MVC). When ideal contraction of Transversus Abdominus was obtained (best activation with minimal other muscle activation), was asked them to hold contraction with breathing and Imprisonment not their breath. Pressure BoiFeedback Unit was used for control of muscle contraction. 3 set each one with10 repetitions while 2 minutes as a rest period between each set and keeping contraction of muscle for 10 seconds was the ultimate goal.&#13;
Time of training, depends on correct learning of Abdominal Hallowing and was different between patients.</i_keyword>
      <i_keyword>Second intervention: "Abdominal Bracing exercise&#13;
"Co-contraction" or "Abdominal Bracing training. ّFirst, a natural waist position (slight lordosis) was investigated ,then subject must contract all muscles as 360º around the trunk(area of lumbar spine), such as someone pressure to his waist but he can resist while he had normal breathing , at beginning of this maneuvers ,therapist would give touch feedback with her hands to the patient and after learning, patients would do it himself Pressure Bio Feedback Unit Was used to control of correct contraction of abdominal wall muscle. Patient must reach a stage that can do this maneuvers simultaneously with normal breathing and maintain this state about 10 seconds. This exercise in supine crook lying mode is done. Llike the first intervention, achieving to 3 set each one with10 repetitions while 2 minutes as a rest period between each set and keeping contraction of muscle for 10 seconds was the ultimate goal.</i_keyword>
      <i_keyword>Control group: &#13;
For subjects of this group was not performed any intervention and the mean duration of time equivalent to the intervention training group, were given  to  them instead of  intervention  period  between data recording  because for the real effects of the intervention in the treatment group is determined .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>EMG of abdomen and back muscles. Timepoint: Before and immediatly after interventions. Method of measurement: EMG muscle activity with electromyography system  as  Root Mean Square value or RMS  and Intensity of muscle activity as microvolt value.</prim_outcome>
      <prim_outcome>Lumbar Curve. Timepoint: Before and immediatly after interventions. Method of measurement: by Inclinometer system as degree value.</prim_outcome>
      <prim_outcome>Biodex stability Indexes. Timepoint: Before and immediatly after interventions. Method of measurement: By Biodex Stability System, as Anterior-posterior , Lateral stability  and Limit of Stability indexes.</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>Vice-Deen for Research of Faculty of Basic of Medical Science of Tarbiat Modares University (TMU)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2008-04-11</approval_date>
        <contact_name>Tarbiat Modares University (T.M.U)</contact_name>
        <contact_address>Medical Ethics Committee, Faculty of Medical Sciences,Tarbiat Modares University, Jalal Al Ahmad Highway Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
