<?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>IRCT2016072828310N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-08-25</date_registration>
      <primary_sponsor>Vice Chancellor for Research and Technology</primary_sponsor>
      <public_title>Effect of  Lumbosacral orthosis on low back pain management</public_title>
      <acronym></acronym>
      <scientific_title>Effect of  Lumbosacral orthosis on the gait dynamics in chronic non-specific low back pain patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22992</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization was performed blindly by a permuted block randomization in which block sizes were randomly varied from two to four and allocation ratio was 1:1. An independent person performed the allocation via sealed, opaque envelopes numbered consequently to ensure the allocation concealment, Blinding description: The assessor and participants were blind to group assignment. While the data analysis was blindly conducted, due to the nature of the intervention (PT, LSO) in both groups, the blinding of the participants and outcome assessor during the test procedure was impossible and it didn't take place.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic non-specific low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group will receive physical therapy (exercises and electrotherapy) as well as a semirigid lumbosacral orthosis for 6 weeks, 8 hour a day. Intervention 2: The control subjects will receive physical therapy (exercises and electrotherapy) for 6 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Individual Participant Data collected for the primary and secondary outcome measures will be shared after de-identification.

When:
If there is a request from researchers, the data will become available after paper publication.

To whom:
The data will be available for researchers working at the academic institutions.

Conditions:
More analyses on the data should be performed under supervision of the researchers of this study.

Where to obtain:
The data would be available through email: ma.hekmat@yahoo.com per requests received from academic researchers.

How to obtain:
Whenever a request is received, first the researcher should be identified. Second, the aims of the study should be clarified. Further, all ethics related to recruitment of the subjects should be passed. The process will be clarified through email by details.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohammad Ali Sanjari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 17, School of Rehabilitation Sciences, Iran University of Medical Sciences,  Madadkaran  ave., Shahnazari St., Madar Sq., Mirdamad Blvd.,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>sanjarima@alum.sharif.edu</email>
        <affiliation>School of Rehabilitation Sciences, Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammad Ali Sanjari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 17, School of Rehabilitation Sciences, Iran University of Medical Sciences, Madadkaran ave., Shahnazari St., Madar Sq., Mirdamad Blvd.,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>sanjarima@alum.sharif.edu</email>
        <affiliation>School of Rehabilitation Sciences, Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Low back pain intensity from 1 to 6
Low back pain for at least 6 months
3 months from the last treatment session
There should be acute exacerbation periods of low back pain
Age between 18 to 50 years
Subjects could be able to walk with preferred walking speed for 10 minutes so that pain is not barrier for walking</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Specific low back pain such as disk herniation, fracture, spondylolisthesis
Referral pain in the lower limbs
History of spinal surgery
History of trauma resulted in sprain, dislocation and fracture in spinal area
Using drugs that interfere with walking
Any previous use of lumbar supports
gait imbalance and use of assistive devices</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dorsalgia, unspecified , Backache NOS</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group will receive physical therapy (exercises and electrotherapy) as well as a semirigid lumbosacral orthosis for 6 weeks, 8 hour a day.</i_keyword>
      <i_keyword>The control subjects will receive physical therapy (exercises and electrotherapy) for 6 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: before intervention, 3 weeks aftter intervention, 6 weeks after intervention, 1 month after the stop of intervention. Method of measurement: numerical pain rating scale.</prim_outcome>
      <prim_outcome>Disability. Timepoint: before intervention, 3 weeks aftter intervention, 6 weeks after intervention, 1 month after the stop of intervention. Method of measurement: Oswestry disability index questionnaire.</prim_outcome>
      <prim_outcome>Fear avoidance. Timepoint: before intervention, 3 weeks aftter intervention, 6 weeks after intervention, 1 month after the stop of intervention. Method of measurement: fear avoidance belief questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fractal scaling index. Timepoint: before intervention, 3 weeks aftre intervention, 6 weeks after intervention, 1 month after the stop of the intervention. Method of measurement: motion analysis system, power law relationship between stride to stride fluctuations and time as measuring the slope of log/log-fluctuations plot.</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 Chancellor for Research and Technology</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-05-25</approval_date>
        <contact_name>Iran University of Medical Sciences</contact_name>
        <contact_address>Hemmat highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
