<?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>IRCT20230829059295N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-20</date_registration>
      <primary_sponsor>Combined military hospital</primary_sponsor>
      <public_title>Transforaminal epidural versus intra-articular facet joint injection for treatment of lumbar radiculopathy</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of transforaminal epidural versus intra-articular facet joint injection for treatment of lumbar radiculopathy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73631</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was done by non probability consecutive sampling via lottery method. Patients were divided in to facet joint group (Group F) and epidural group (Group E). Allocation concealment was not done.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Lower backache and hip pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Facet-joint group ( Group F), The procedure was carried out under fluoroscopic guidance with the patient in the prone position under strict aseptic measures. The site of needle insertion was anesthetized using 1% lignocaine on the skin and subcutaneous tissue. Spinal needle (22 G) was inserted, and sequential fluoroscopic views taken. Once appropriate position was reached, 2.5 ml contrast was injected through minibore tubing attached to the needle to confirm correct placement and rule out intravascular placement. One confirmed, 2 ml of 1% preservative-free lignocaine (20mg) with 60 mg of methylprednisolone was injected at the facet-joint site. Intervention 2: Intervention group: Epidural group ( Group E) patients were placed in the prone position with the targeted site away from the interventionist. An Anteroposterior scout was done at vertebral level T12-S1 to confirm position and level before the procedure. Under fluoroscopic guidance, 2 ml of 1% preservative-free lignocaine (20mg) with 60 mg of methylprednisolone was injected once the needle was in the correct placement after confirmation with 2.5 ml of iodinated contrast.</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 collected data could be provided

When:
Data will be available for 2 years starting from December 2023 till December 2025

To whom:
Academic institutions

Conditions:
Interventional studies being done on the same topic

Where to obtain:
haroontariq299@gmail.com

How to obtain:
Please contact the email provided above to ask for the detailed data.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Haroon Tariq</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House No 318, Street 5, Sector B1, DHA Phase 1, Rawalpindi</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 323 7399976</telephone>
        <email>haroontariq299@gmal.com</email>
        <affiliation>Combined Military Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Haroon Tariq</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House 318 ,Street 5, sector B1 , DHA phase one Rawalpindi</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 323 7399976</telephone>
        <email>haroontariq299@gmail.com</email>
        <affiliation>Combined military hospital Rawalpindi</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All male and female patients between ages 30-60 years
Confirmed  case of lumbar radiculopathy diagnosed by standard MRI imaging studies</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with debilitating cardiac or respiratory disease
Tumors of the spine with or without metastatic disease
Patients with known allergy to lignocaine, bupivacaine or steroids
Patients with a regional block done for pain in the last one year</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.16</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Radiculopathy, lumbar region</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Facet-joint group ( Group F), The procedure was carried out under fluoroscopic guidance with the patient in the prone position under strict aseptic measures. The site of needle insertion was anesthetized using 1% lignocaine on the skin and subcutaneous tissue. Spinal needle (22 G) was inserted, and sequential fluoroscopic views taken. Once appropriate position was reached, 2.5 ml contrast was injected through minibore tubing attached to the needle to confirm correct placement and rule out intravascular placement. One confirmed, 2 ml of 1% preservative-free lignocaine (20mg) with 60 mg of methylprednisolone was injected at the facet-joint site.</i_keyword>
      <i_keyword>Intervention group: Epidural group ( Group E) patients were placed in the prone position with the targeted site away from the interventionist. An Anteroposterior scout was done at vertebral level T12-S1 to confirm position and level before the procedure. Under fluoroscopic guidance, 2 ml of 1% preservative-free lignocaine (20mg) with 60 mg of methylprednisolone was injected once the needle was in the correct placement after confirmation with 2.5 ml of iodinated contrast.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Patient satisfaction regarding pain relief  after interventional procedure in lumbar radiculopathy. Timepoint: 4 weeks and then 3 months post intervention. Method of measurement: Numerical rating scale (NRS) , Visual analog scale (VAS) , Oswestry disability index (ODI).</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>Combined military hospital</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-29</approval_date>
        <contact_name>Ethical committee of combined military hospital</contact_name>
        <contact_address>Tamizudin road , lalkurti rawalpindi Rawalpindi Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
