<?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>IRCT20190717044238N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-23</date_registration>
      <primary_sponsor>The University of Lahore</primary_sponsor>
      <public_title>The effects of  non-surgical decompression in addition to routine physical therapy in patients with lumber radiculopathy; A Randomized Controlled Trial</public_title>
      <acronym>RCT</acronym>
      <scientific_title>The effects of  non-surgical decompression in addition to routine physical therapy in patients with lumber radiculopathy; A Randomized Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40978</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: no, Randomization description: By using computer generated random number table, patients will be randomly assigned into two groups. All those random numbers will be enclosed in sealed envelopes. A third person (who will further not be the part of research) will open envelops and the patients will be allocated to the mentioned group accordingly, Blinding description: An independent assessor,  who will be a senior and experienced physiotherapist and further will not be the part of study will perform the assessment of patients.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Lumber Radiculopathy.</hc_freetext>
      <i_freetext>Intervention 1: Control group: The control group will receive conventional physiotherapy including electrotherapy and trunk stability exercises. The treatment will be performed as follows:1) Electrotherapy components will consist of 5 minutes of therapeutic ultrasound and 15 minutes of continuous transcutaneous electrical nerve stimulation with concurrent hot pack 2) Trunk stability Exercises. Intervention 2: Intervention group: In addition to the interventions given in control group, participants in the experimental group will also receive spinal decompression therapy. The treatment session of 20 minutes will be given three days a week, for a total of 4 weeks. For non-surgical spinal decompression therapy of lumbar spine, the patient will be in supine lying position on a motorized table, which has movable lower half. A harness is placed around the hips and is attached to the lower table near the feet. The upper part of the table remains in a fixed position while the lower part, to which the patient is harnessed, slides back and forth to provide the traction and relaxation. Decompression isolates the distraction forces to a specific motor unit of the spine and affects a specific disc level.</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 identified IPD

When:
Data will be available after the completion of study and will remain available till 6 months

To whom:
Data will be available for other people almost 6 months after the completion of study

Conditions:
The data/document could be used by communicating with the principle investigator "Fareeha Amjad" on email address:  fari_fairy22@yahoo.com

Where to obtain:
Fareeha Amjad,  fari_fairy22@yahoo.com

How to obtain:
Data/document can be accessed through communicating with principle investigator "Fareeha Amjad" on institutional email address: fari_fairy22@yahoo.com

Comments:
N/A</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fareeha Amjad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The University of Lahore,Pakistan</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 99200600</telephone>
        <email>fari_fairy22@yahoo.com</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fareeha Amjad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The University of Lahore,Pakistan</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 99200600</telephone>
        <email>fari_fairy22@yahoo.com</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Both male and female patients
Age between 25-55 years
Clinically and radiologically diagnosed patients (by neuro-surgeon) of lumbar radiculopathy
Radiating Low Back Pain for at least 3 months
Willing to participate in the study</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Recent fracture or dislocation of lumber vertebra
History of surgery on lumber spine, hip or pelvis
Spinal tumors or infections in the intervertebral disc
Inflammatory diseases such as rheumatism
Spinal deformity such as scoliosis
Spondylolysthesis
Osteoporosis below L1
Patients taking medications e.g NSAIDS for pain
Severe disc degeneration
Pregnant females
Having three or more herniation</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 - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: The control group will receive conventional physiotherapy including electrotherapy and trunk stability exercises. The treatment will be performed as follows:1) Electrotherapy components will consist of 5 minutes of therapeutic ultrasound and 15 minutes of continuous transcutaneous electrical nerve stimulation with concurrent hot pack 2) Trunk stability Exercises</i_keyword>
      <i_keyword>Intervention group: In addition to the interventions given in control group, participants in the experimental group will also receive spinal decompression therapy. The treatment session of 20 minutes will be given three days a week, for a total of 4 weeks. For non-surgical spinal decompression therapy of lumbar spine, the patient will be in supine lying position on a motorized table, which has movable lower half. A harness is placed around the hips and is attached to the lower table near the feet. The upper part of the table remains in a fixed position while the lower part, to which the patient is harnessed, slides back and forth to provide the traction and relaxation. Decompression isolates the distraction forces to a specific motor unit of the spine and affects a specific disc level.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain Intensity. Timepoint: before intervention and after 4 weeks of intervention. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Lumber range of motion. Timepoint: before intervention and after 4 weeks of intervention. Method of measurement: Clinical Test (Modified-Modified Schober's Test).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of Life. Timepoint: before intervention and after 4 weeks of intervention. Method of measurement: SF 36 scoring calculator will be used.</sec_outcome>
      <sec_outcome>Level of disability. Timepoint: before intervention and after 4 weeks of intervention. Method of measurement: ODI scoring calculator.</sec_outcome>
      <sec_outcome>Endurance. Timepoint: before intervention and after 4 weeks of intervention. Method of measurement: Stop Watch will be used to calculate the endurance time.</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>2018-09-20</approval_date>
        <contact_name>Institutional Review Board</contact_name>
        <contact_address>The University of Lahore,Pakistan Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
