<?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>IRCT20190527043730N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-16</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of lumbar stabilization exercise performed on stable versus unstable surfaces in chronic low back pain patient</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of exercise on stable surface versus unstable surface on cross section area of lumbar stabilizer muscle, pain, disability index, static and dynamic balance in patients with chronic low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40038</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals with block randomization and sealed opaque envelopes concealment take place in two groups, Blinding description: in this study evaluations and intervention are performed by two different physiotherapists.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1:  This group will receive the common physical therapy treatment and  exercise on unstable surface for 18 session during a period of 6 weeks. lumbar stabilization exercise program progressively  increase during the 6-week exercise program. The subjects will ask to perform three sets of 10 repetitions during the first and second week, progress to three sets of 15 repetitions during each session in the third and fourth weeks, and three sets of 20 repetitions during the fifth and sixth weeks. Intervention 2: Intervention group 2: This group will receive the common physical therapy treatment and  exercise on stable surface for 18 session during a period of 6 weeks. lumbar stabilization exercise program progressively  increase during the 6-week exercise program. The subjects will ask to perform three sets of 10 repetitions during the first and second week, progress to three sets of 15 repetitions during each session in the third and fourth weeks, and three sets of 20 repetitions during the fifth and sixth weeks.</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 without plane</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Shohreh Taghizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Abiverdi 1 Avenue, Chamran Boulvard</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71345-1733</zip>
        <telephone>+98 71 1626 1081</telephone>
        <email>TaghizSh@Sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Shohreh Taghizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Abiverdi 1 Avenue, Chamran Boulvard</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71345-1733</zip>
        <telephone>+98 71 1626 1081</telephone>
        <email>TaghizSh@Sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>18 to 40 years
mechanical low back pain(LBP) but no radicular symptoms such as radiating pain below the knee, loss of sensation, or loss of reflex
pain intensity of 3–6 in the Visual Analogue Scale (VAS)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
Spinal fractures
Herniated discs
Acute low back pain
spondylolisthesis and spondylolysis
lower limb length discrepancy
previous surgery on vertebral column
specific diseases causing back pain such as malignancy, rheumatologic conditions
severe osteoporosis
recent stabilization exercise performance (within last 6 weeks)
Athletes
Neurological diseases
body mass index(BMI) above 26
Disability more than 60% in the oswestry Disability index
Uncontrolled disorders of the liver, kidney and thyroid</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 - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1:  This group will receive the common physical therapy treatment and  exercise on unstable surface for 18 session during a period of 6 weeks. lumbar stabilization exercise program progressively  increase during the 6-week exercise program. The subjects will ask to perform three sets of 10 repetitions during the first and second week, progress to three sets of 15 repetitions during each session in the third and fourth weeks, and three sets of 20 repetitions during the fifth and sixth weeks.</i_keyword>
      <i_keyword>Intervention group 2: This group will receive the common physical therapy treatment and  exercise on stable surface for 18 session during a period of 6 weeks. lumbar stabilization exercise program progressively  increase during the 6-week exercise program. The subjects will ask to perform three sets of 10 repetitions during the first and second week, progress to three sets of 15 repetitions during each session in the third and fourth weeks, and three sets of 20 repetitions during the fifth and sixth weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Thickness of lumbar stabilizer muscle. Timepoint: Pre and post intervention (after 6 weeks). Method of measurement: ultrasound device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain. Timepoint: pre and post intervention (after 6 weeks) and fallow up (after 10 weeks). Method of measurement: visual analogue scale.</sec_outcome>
      <sec_outcome>Static balance. Timepoint: pre and post intervention (after 6 weeks). Method of measurement: open and close eye single leg stance.</sec_outcome>
      <sec_outcome>Dynamic balance. Timepoint: pre and post intervention (after 6 weeks). Method of measurement: modified star excursion balance test.</sec_outcome>
      <sec_outcome>Disability. Timepoint: pre and post intervention (after 6 weeks) and fallow up (after 10 weeks). Method of measurement: 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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-02-27</approval_date>
        <contact_name>Research Ethics committee of Shiraz School of Rehabilitation sciences</contact_name>
        <contact_address>School of Rehabilitation Sciences, Abiverdi 1 st., Chamran Blvd., Shiraz,Iran Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
