<?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>IRCT20190707044128N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-13</date_registration>
      <primary_sponsor>The University of Lahore</primary_sponsor>
      <public_title>Low Level Laser Therapy in Discogenic Lumber Radiculopathy</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of Low Level Laser Therapy in Discogenic Lumber Radiculopathy; A Double Blind Randomized Controlled Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-02-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>140</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46417</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be allocated into two groups i.e. an Experimental Group and a Control Group by Randomization through Sealed Envelope Method. The Experimental Group patients will be treated with Low Level Laser Therapy along with Conventional Physical Therapy while those in the Control Group will be given Conventional Physical Therapy alone, Blinding description: Participants and the outcome assessor will be kept blind. Allocation of patients into the Experimental and Control group will be random through Sealed Envelope Method.</study_design>
      <phase>2</phase>
      <hc_freetext>Lumbar disc herniation is a displacement / protrusion of disc material (nucleus pulposus or annulus fibrosis) beyond the intervertebral disc space. The prolapsed nucleus pulposus will often come in contact with the nearby spinal nerves, results in the compression of these nerves which in turn results in severe radicular pain. Herniated discs are the common cause of lower back pain (LBP), hip and leg pain. The onset of pain may begin suddenly or gradually after injury. Typically, the pain is located bilaterally at the posterior belt line. The pain pattern is usually referred rather than radicular with a sharp, shooting pain running down the lower back, buttocks and down the thigh along with numbness or tingling sensations. The pain is aggravated by prolonged sitting, standing, forward bending or twisting movements and is relieved by walking, lying down, rest and a recumbent position..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group-A of 70 patients will be treated with Low level Laser Therapy (LLLT) -830nm, 0.67 W/cm2 or 300 mW/cm2 at (Lumber-4,5 and Sacral-1 area) and Conventional Physical Therapy – McKenzie technique (1 set of 5 repetitions ), Hot Pack (10 mins), Hold Relax with sustained stretch (1 set of 5 repetitions with 15 seconds hold), Sciatic nerve mobilizations in 1 set of 5 repetitions. Intervention 2: Control group: Group-B of 70 patients will be treated with Conventional Physical Therapy alone – McKenzie technique (1 set of 5 repetitions ), Hot Pack (10 mins), Hold Relax with sustained stretch (1 set of 5 repetitions with 15 seconds hold), Sciatic nerve mobilizations in 1 set of 5 repetitions.</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:
Consent form, Clinical Study Report, Statistical Plan files can be shared

When:
2 months after Publication

To whom:
People working in academic institutions or people working in businesses can also apply to receive it

Conditions:
Intervention Purpose

Where to obtain:
ishaqpt786@gmail.com

How to obtain:
Full description about the purpose/aim of using the documents, Insight about the disorder and Intervention of the research

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Ishaq Ahmed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>6.7-Km, Japan Road, Sihala, Zone-5</address>
        <city>Islamabad</city>
        <country1>Pakistan</country1>
        <zip>75500</zip>
        <telephone>+92 51 4486422-6</telephone>
        <email>ishaqpt786@gmail.com</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ishaq Ahmed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Japan Road, Sihala</address>
        <city>Islamabad</city>
        <country1>Pakistan</country1>
        <zip>75500</zip>
        <telephone>+92 42 37592112</telephone>
        <email>ishaqpt786@gmail.com</email>
        <affiliation>The university of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age group between 25- 50 years
Both male and female patients
Newly diagnosed cases of discogenic lumbar radiculopathy
Patients with at least moderate score (21%-40%) in Oswestry Disability Index
Patients with positive SLR or Lasegue's test</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients receiving treatment by other methods like vapocoolants, dry needling, laser acupuncture, subdural steroid injections etc. for the last 3 months
Lumbar spine surgery within the past year
Spondylolisthesis
Ankylosing spondylitis
Vascular, neurological or rheumatic disorders
Clinical evidence of any myelopathy or joint disorders
Recent fracture of the lumbar vertebral spine
Cauda equina syndrome
Osteoporosis
Clinical evidence of any tumor or any space occupying lesion.
Any co-morbid diseases</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: Group-A of 70 patients will be treated with Low level Laser Therapy (LLLT) -830nm, 0.67 W/cm2 or 300 mW/cm2 at (Lumber-4,5 and Sacral-1 area) and Conventional Physical Therapy – McKenzie technique (1 set of 5 repetitions ), Hot Pack (10 mins), Hold Relax with sustained stretch (1 set of 5 repetitions with 15 seconds hold), Sciatic nerve mobilizations in 1 set of 5 repetitions.</i_keyword>
      <i_keyword>Control group: Group-B of 70 patients will be treated with Conventional Physical Therapy alone – McKenzie technique (1 set of 5 repetitions ), Hot Pack (10 mins), Hold Relax with sustained stretch (1 set of 5 repetitions with 15 seconds hold), Sciatic nerve mobilizations in 1 set of 5 repetitions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain Intensity. Timepoint: At the start of treatment and then after 18 treatment sessions for each patient. Method of measurement: Visual Analogue Scale (VAS).</prim_outcome>
      <prim_outcome>Functional Disability. Timepoint: At the start of treatment and then after 18 treatment sessions for each patient. Method of measurement: ODI (Oswestry Disability Index).</prim_outcome>
      <prim_outcome>Lumber Range of Motion. Timepoint: At the start of treatment and then after 18 treatment sessions for each patient. Method of measurement: Dual Inclinometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sciatic Nerve mobility. Timepoint: At the start of treatment and then after 18 treatment sessions for each patient. Method of measurement: Straight Leg Raise  or Lasegue's Test.</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>The University of Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-05</approval_date>
        <contact_name>Board of Advanced Studies and Research, The University of Lahore</contact_name>
        <contact_address>1-km Defence Road, Off Bhobatian Chowk Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
