<?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>IRCT20111102007984N29</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-05</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>A comparison of the effects of Triamcinolone and magnesium sulfate  in caudal neuroplasty</public_title>
      <acronym></acronym>
      <scientific_title>A comparison study of the effects of Triamcinolone and magnesium sulfate  in caudal neuroplasty in chronic low back pain.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35500</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: By using the randomize number table, the patients were divided into two equal groups (n=25), Blinding description: Both drugs are injectable and the injection site of both drugs in the patients' body is in the same area. Therefore, patients are not aware of the type of drug. Also, the outcome evaluator is unaware of the random allocation.</study_design>
      <phase>3</phase>
      <hc_freetext>low back pain.</hc_freetext>
      <i_freetext>Intervention 1: In intervention group 10 ml Ropivacaine 0.2% ( produced by Molteni, Italy) ,10 cc Nacl 5%(produced by Samen, Iran) ,50 mg Magnesium sulfate (produced by Shahid Ghazi,Iran) and 1500 unit Hyalase(produced by Darupakhsh,Iran )was injected in the caudal epidural space by a Racz catheter (produced by Epimed,USA) under fluoroscopic guidance . Intervention 2: Control group: In control group 10 ml Ropivacaine 0.2% (produced by Molteni, Italy) ,10 cc Nacl 5%(produced by Samen,Iran) ,80 mg Triamcinolone (produced by Caspian, IRAN) and 1500 unit Hyalase(produced by Darupakhsh,Iran )was injected in the caudal epidural space by a Racz catheter (produced by Epimed,USA) under fluoroscopic guidance .</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:
Some part of the clinical information of the patients will be shared

When:
6 months after the end of the project

To whom:
Faculty Members of Medical Sciences Universities

Conditions:
For further studies

Where to obtain:
Deputy of Research &amp; Technology
Pain Research Center, Iran University of Medical Sciences

How to obtain:
First, at the request of the university, she/he will be informed at the request of the university's deputy of the research department, and then she/he will be referred to the research center during the administrative process and the data will be received by the committee of the research center of the center with a commitment and acceptance.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farnad Imani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pain Research Center, Department of Anesthesiology and Pain Medicine, Rasool Akram Medical Center, Niayesh St. Sattar Khan St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613131</zip>
        <telephone>+98 21 6651 5758</telephone>
        <email>farnadimani@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Farnad Imani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pain Research Center, Department of Anesthesiology and Pain Medicine, Rasool Akram Medical Center, Niayesh St. Sattar Khan St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613131</zip>
        <telephone>+98 21 6651 5758</telephone>
        <email>farnadimani@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Chronic low back pain more than six months +/- radiculopathy
Moderate to severe pain score (&gt; 3, based on the Visual Analog Scale)
Being at the age of 40-70 years
Inadequate response to conservative and physiotherapy treatments after three months
American Anesthesiologists Classification (ASA) I-II
Disc protrusion in MRI</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Severe canal stenosis (more than two thirds in axial MRI view)
Sequestrated disc (fragmented)
Decreased disc height more than 60%
Sever spinal deformity
Spinal tumors
Vertebral fracture
Spondylolisthesis Grade&gt;2
Local or systemic infection
Taking anticoagulants
Drug abuse
History of drug reaction
Sever psychological disorders
Pregnancy and lactation
Severe or sudden neurological deficit such as urinary or fecal incontinence
Body Mass Index (BMI) &gt; 35
Patient's refusal
Diabetes mellitus
MRI contraindications (cardiac pacemaker, defibrillator, aortic aneurysm clips)
Impossible prone positioning</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 - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In intervention group 10 ml Ropivacaine 0.2% ( produced by Molteni, Italy) ,10 cc Nacl 5%(produced by Samen, Iran) ,50 mg Magnesium sulfate (produced by Shahid Ghazi,Iran) and 1500 unit Hyalase(produced by Darupakhsh,Iran )was injected in the caudal epidural space by a Racz catheter (produced by Epimed,USA) under fluoroscopic guidance .</i_keyword>
      <i_keyword>Control group: In control group 10 ml Ropivacaine 0.2% (produced by Molteni, Italy) ,10 cc Nacl 5%(produced by Samen,Iran) ,80 mg Triamcinolone (produced by Caspian, IRAN) and 1500 unit Hyalase(produced by Darupakhsh,Iran )was injected in the caudal epidural space by a Racz catheter (produced by Epimed,USA) under fluoroscopic guidance .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Low back pain. Timepoint: Before injection,two weeks,1,3 and 6 months after intervention. Method of measurement: pain score measured with visual analogue scale in Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Functional disability Index. Timepoint: Before injection, two weeks, 1,3 and 6 moth after intervention. Method of measurement: Oswestry Disability Index questionnaire (ODI).</sec_outcome>
      <sec_outcome>Raising straight leg, raising straight leg reversely. Timepoint: Before injection, two weeks, 1,3 and 6 moth after intervention. Method of measurement: straight leg raising test (SLR) ,Reverse straight leg raising test (RSLR).</sec_outcome>
      <sec_outcome>Bonnet. Timepoint: Before injection, two weeks, 1,3 and 6 moth after intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>FABER. Timepoint: Before injection, two weeks, 1,3 and 6 moth after intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Gaenslen. Timepoint: Before injection, two weeks, 1,3 and 6 moth after intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Tiptoe and Heel walking. Timepoint: Before injection, two weeks, 1,3 and 6 moth after intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Visual Analogue Pain scale. Timepoint: Before injection, two weeks, 1,3 and 6 moth after intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Analgesic consumption. Timepoint: Before injection, two weeks, 1,3 and 6 moth after intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Blood sugar. Timepoint: Blood sugar ,before injection,2 th day and 2th week after injection. Method of measurement: The result of the tests.</sec_outcome>
      <sec_outcome>HbA1C. Timepoint: injectionHbA1C, before injection,3 and 6 month after injection. Method of measurement: The result of the tests.</sec_outcome>
      <sec_outcome>Spinal canal diameter changes at MRI. Timepoint: MRI, before injection and 6 month after injection. Method of measurement: MRI report.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-07-24</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Hemmat Expressway corner Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
