<?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>IRCT20231121060129N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-11</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Laser therapy in lumbar discopathy</public_title>
      <acronym></acronym>
      <scientific_title>Investigation of the clinical effects of percutaneous laser disc decompression in the treatment of Lumbar Intervertebral Disc</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73885</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: The target population includes all patients referred to the Imam Reza Hospital clinic with radicular pain caused by intervertebral disc herniation. Subjects are included in the study by considering the entry and exit criteria through non-random sampling. Then they are divided into intervention and control groups using RAS software using random block method with 2 and 4 blocks. Flow chart (Loss to follow up) will be mentioned.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Lumbar discopathy.</hc_freetext>
      <i_freetext>Patients in the intervention group, after determining the affected areas of the lumbar spine, taking a history, physical examination, imaging such as MRI, CT scan and electromyography - nerve conduction velocity (EMG-NCV), in an outpatient setting, with injection A one-step needle into the disc space will be treated. Disc material is not removed. Instead, the nucleus pulposus will be vaporized by laser. Patients are treated with a 1000 J 980 nm diode laser (a product of LaserStar Technologies Corp, manufactured in Germany with a 200 micron fiber) at a power of 5 watts. After sterile skin preparation and dressing, the disc space is identified with the help of a C-arm fluoroscope. The craniocaudal movement of the fluoroscope tube defines the margin of the disc. The fluoroscope tube is rotated obliquely to bring the superior articular process to the midline, and a 7-inch 18-gauge needle is inserted immediately anterior to the superior articular process and superior to the transverse process through a triangular safe zone. Advancement with the C-fluoroscope arm is observed to be strong enough and of good quality to provide an overview of the area. When finished, the tip of the needle should be in the center of the disc..</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Agamohammadi Davood</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Reza hospital, Golgasht Str., Azadi Ave.</address>
        <city>tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614756</zip>
        <telephone>+98 41 3334 7054</telephone>
        <email>daghamohamadi@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Agamohammadi Davood</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Reza hospital, Golgasht Str., Azadi Ave.</address>
        <city>tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614756</zip>
        <telephone>+98 41 3334 7054</telephone>
        <email>daghamohamadi@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1) Age 35-70 years
2) Symptoms of radicular pain in the lower limbs
3) Confirmation of lumbar disc herniation with CT scan, magnetic resonance imaging (MRI) or myelogram
4) No improvement after 3 months of conservative treatment</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1) Patients with a history of previous spinal surgery
2) cauda equina syndrome
3) Bone disorders
4) Generalized disc bulging
5) Nervous disorders (movement disorders, urinary and fecal incontinence)
6) Pregnancy
7) Any history of coagulopathy
8) reducing the height of the disc by more than 50%</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M51.16</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Intervertebral disc disorders with radiculopathy, lumbar region</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Patients in the intervention group, after determining the affected areas of the lumbar spine, taking a history, physical examination, imaging such as MRI, CT scan and electromyography - nerve conduction velocity (EMG-NCV), in an outpatient setting, with injection A one-step needle into the disc space will be treated. Disc material is not removed. Instead, the nucleus pulposus will be vaporized by laser. Patients are treated with a 1000 J 980 nm diode laser (a product of LaserStar Technologies Corp, manufactured in Germany with a 200 micron fiber) at a power of 5 watts. After sterile skin preparation and dressing, the disc space is identified with the help of a C-arm fluoroscope. The craniocaudal movement of the fluoroscope tube defines the margin of the disc. The fluoroscope tube is rotated obliquely to bring the superior articular process to the midline, and a 7-inch 18-gauge needle is inserted immediately anterior to the superior articular process and superior to the transverse process through a triangular safe zone. Advancement with the C-fluoroscope arm is observed to be strong enough and of good quality to provide an overview of the area. When finished, the tip of the needle should be in the center of the disc.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The Persian version of the Roland-Morris Disability Questionnaire and Oswestry Disability Index is one of the main assessment tools used in the assessment of spinal disabilities. The RDQ has been validated and extensively evaluated in a variety of clinical studies and has been reported to exhibit good psychometric properties. 1 The questions in this questionnaire are designed to provide the physician with information about how Pacemaker pain affects the patient's ability to perform daily tasks. Timepoint: Investigations are conducted and recorded before the intervention, immediately after the intervention and one week after the intervention. Method of measurement: The amount of pain is determined using the VAS tool. The VAS tool is in the form of a graduated ruler from 0 to 10, and the patient indicates one of the numbers listed on the ruler according to the intensity of pain from the lowest to the highest.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-10-04</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Research Vice Chancellor, Tabriz University of Medical Sciences, Daneshgah Ave. tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
