<?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>IRCT20240503061634N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-09-23</date_registration>
      <primary_sponsor>EGE</primary_sponsor>
      <public_title>Cervical Epidural İnjection</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Epidural Needle Placement and Reliability in Interlaminar Epidural Steroid İnjection in the Cervical Region with the Hanging Drop and Loss of Resistance Methods Accompanied by Fluoroscopy in the Prone Position - Prospective Randomized Controlled Clinical Study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-06-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77238</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization will be provided as follows. Patients will be processed consecutively, one with the LOR method and the other with the HD method. The number of patients to be included will be determined at the study time by performing a power analysis, Blinding description: The patient does not know which method will be used.</study_design>
      <phase>N/A</phase>
      <hc_freetext>cervical disc displacement.</hc_freetext>
      <i_freetext>Intervention group1: Steroid injection will be made into the cervical epidural area with the LOR technique. If the contrast given without pressure loss is in the epidural space, it is considered unsuccessful, and if the contrast given despite pressure loss is not in the epidural space, or even if it is suspicious epidural, it is considered unsuccessful. If there is a pressure loss, if the contrast given is in the epidural space, the procedure will be considered successful. Post-procedure complications will also be examined. Intervention group2: Steroid injection will be made into the cervical epidural space with the HD technique. If the fluid in the Hub part of the needle falls with negative pressure in the HD technique and we see the given contrast in the epidural area with fluoroscopy, the procedure will be considered successful. If the contrast spreads into the epidural space without falling or if the contrast does not spread into the epidural space while falling or if it is suspicious epidural, the procedure will be considered unsuccessful.Post-procedure complications will also be examined..</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:
Comparison of Epidural Needle Placement and Reliability in Interlaminar Epidural Steroid İnjection in the Cervical Region with the Hanging Drop and Loss of Resistance Methods Accompanied by Fluoroscopy in the Prone Position - Prospective Randomized Controlled Clinical Study

When:
Made available (starting 3 months after publication)

To whom:
This only available for people working in academic institutions

Conditions:
Prospective Randomized Controlled Clinical Study

Where to obtain:
shahinazizov1@gmail.com

How to obtain:
The data will be officially available after sending a message to the e-mail

Comments:
-</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sahin Azizov</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mosun senani</address>
        <city>Baku</city>
        <country1>Azerbaijan</country1>
        <zip>1005</zip>
        <telephone>+994 51 435 79 75</telephone>
        <email>shahinazizov1@gmail.com</email>
        <affiliation>Ege</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sahin Azizov</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mohsun Senani</address>
        <city>Baku</city>
        <country1>Azerbaijan</country1>
        <zip>1007</zip>
        <telephone>+994 70 660 19 19</telephone>
        <email>shahinazizov1@gmail.com</email>
        <affiliation>Azerbaijan Medical University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Azerbaijan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>cervical disc herniation</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Operated cervical disc herniation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M50.20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other cervical disc displacement, unspecified cervical region</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: Steroid injection will be made into the cervical epidural area with the LOR technique. If the contrast given without pressure loss is in the epidural space, it is considered unsuccessful, and if the contrast given despite pressure loss is not in the epidural space, or even if it is suspicious epidural, it is considered unsuccessful. If there is a pressure loss, if the contrast given is in the epidural space, the procedure will be considered successful. Post-procedure complications will also be examined. Intervention group2: Steroid injection will be made into the cervical epidural space with the HD technique. If the fluid in the Hub part of the needle falls with negative pressure in the HD technique and we see the given contrast in the epidural area with fluoroscopy, the procedure will be considered successful. If the contrast spreads into the epidural space without falling or if the contrast does not spread into the epidural space while falling or if it is suspicious epidural, the procedure will be considered unsuccessful.Post-procedure complications will also be examined.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Whether the tip of the needle is in the epidural area. Timepoint: At the time of the procedure and after 3 weeks. Method of measurement: Will be evaluated by spreading the contrast over the required area.</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>Ege</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-06-07</approval_date>
        <contact_name>Ethics committee of  Azerbaijan Medical University</contact_name>
        <contact_address>9RWM+64M Samad Vurgun Baku Nesimi Azerbaijan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
