<?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>IRCT20190802044411N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-26</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Gluteal trigger point injection in lumbosacral canal stenosis patients</public_title>
      <acronym></acronym>
      <scientific_title>A comparison between effectiveness of gluteal trigger injection with epidural steroid injection in lumbosacral canal stenosis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42805</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Complete randomized block design with random allocation software was used for randomization and  the list of patients was prepared by a computer with the same block length and the secretary divided the patients based on the list of patients, Blinding description: clinical caregiver: we taught the caregiver how to complete the questionnaire. this person was not aware of the allocation to groups. 
The outcome assessor who completed the questionnaires was not aware of the group allocation. 
Data analyzer: Questionnaires were finally given to a person to review the information. This person does not know any of the steps of the work, how groups were classified and the intervention performed.</study_design>
      <phase>3</phase>
      <hc_freetext>lumbosacral canal stenosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The group that received 80 mg  Amp Methylprednisolon and 4 cc Amp Marcaine epidural injection with fluoroscopic guidance and  then two weeks , four weeks, eight weeks  after first dose injection , VAS, Oswestry, Quebec , RMQ was filled. Intervention 2: Control group: The group that received injection of 80 mg Methylprednisolon amp and 5 cc of lidocaine amp in gluteal trigger points, then two weeks, four weeks and eight weeks after first dose, VAS, Oswestry, Quebec, RMQ questionnaires were filled.</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:
All available data can be shared after making people unidentifiable

When:
start access period one year after publishing the results

To whom:
everyone can access to this information

Conditions:
if the information in this study helps to improve the science process

Where to obtain:
khoshnazar31@yahoo.com 
00989131434549

How to obtain:
after sending the desired message, all authors of the study will be consulted all information will be sent within a maximum of the three weeks if permited.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sana Sadat Khoshnazar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO 6,Baharan Aveno ,  Maaliabad Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7184747811</zip>
        <telephone>+98 71 3648 6787</telephone>
        <email>Khoshnazar31@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sana Sadat Khoshnazar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO 6, Baharan Ave , Maaliabad Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7184747811</zip>
        <telephone>+98 71 3648 6787</telephone>
        <email>khoshnazar31@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age : 40 to75 years old
Being diagnosis with lumbar canal stenosis according to mri or edx
Complaining low back pain , psudoclaudication , parestesia that no responsed to conservative treatment
Gender: male or female</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Infection involving lumbar spinal (brucella)
Diabetes mellitus
Rhumatological disorder(lupuse, gout)
BMI more than 42
Pregnancy
Malignancy
Liver disease
sensitivity reaction to test drug
Malnutrition
Peripheral neuropathy
Bleeding disorder
Galactosemia
Radiculopathy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M99.53</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Intervertebral disc stenosis of neural canal of lumbar region</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The group that received 80 mg  Amp Methylprednisolon and 4 cc Amp Marcaine epidural injection with fluoroscopic guidance and  then two weeks , four weeks, eight weeks  after first dose injection , VAS, Oswestry, Quebec , RMQ was filled.</i_keyword>
      <i_keyword>Control group: The group that received injection of 80 mg Methylprednisolon amp and 5 cc of lidocaine amp in gluteal trigger points, then two weeks, four weeks and eight weeks after first dose, VAS, Oswestry, Quebec, RMQ questionnaires were filled.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Radicular low back pain. Timepoint: two weeks, four weeks, eight weeks. Method of measurement: Visual Analogue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Function of patient. Timepoint: two weeks, four weeks , eight weeks. Method of measurement: The Quebec Back Pain Disability Scale.</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>2019-06-22</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>No.6, Baharan Ave , Maali abad Blvd shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
