<?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>IRCT20191130045554N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-20</date_registration>
      <primary_sponsor>Riphah International University QIE Campus</primary_sponsor>
      <public_title>EFFECTS OF GRASTON INSTRUMENT SOFT TISSUE MOBILIZATION IN PATIENTS WITH SCIATIC NERVE ENTRAPMENT</public_title>
      <acronym>EOGISTMIPWSNE</acronym>
      <scientific_title>EFFECTS OF GRASTON INSTRUMENT SOFT TISSUE MOBILIZATION IN PATIENTS WITH SCIATIC NERVE ENTRAPMENT</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>18</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43884</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patient will be recruited into Group A and Group B by lottery method (without replacement), Blinding description: Single Blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sciatic Nerve Entrapment.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group A: Graston technique with help of graston instrument is applied (3 sessions per week for 4 weeks). Intervention 2: Intervention group B: Graston technique along with lumber traction (Mechanical) and neural mobilization. (3 sessions per week for 4 weeks).</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 plan</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Muhammad Shahzad Qadree</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>13-14-C-Civic Centre Near Hamdard Chowk Township Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 35126110</telephone>
        <email>shhzdqadree@gmail.com</email>
        <affiliation>Riphah International University QIE Campus</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Prof. Dr. Syed Shakeel ur Rehman</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>13-14-C-Civic Centre Near Hamdard Chowk Township Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 35126110</telephone>
        <email>shakil.urrehman@riphah.edu.pk</email>
        <affiliation>Riphah International University QIE Campus</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Onset of radicular low back pain of less than 12 weeks.
Pain upon active SLR in 30-70̊. Sensitivity: 0.67(11)  Specificity: 0.26 (12)
Age group in range of 30-60 years.
Male only.
Sciatic nerve entrapment diagnosed on MRI.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Spinal Fracture.
Spinal tumor or any malignancy.
Psychiatric Disorder.
History of Osteoporosis.
Rheumatologic disorders.
Pain beyond 70̊ or below 30̊ on active SLR.
Positive compression and distraction test of SI joint.
Positive gaenslen’s test
Any red flags.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.30</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sciatica, unspecified side</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 A: Graston technique with help of graston instrument is applied (3 sessions per week for 4 weeks)</i_keyword>
      <i_keyword>Intervention group B: Graston technique along with lumber traction (Mechanical) and neural mobilization. (3 sessions per week for 4 weeks)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Treatment will be given to both groups for 4 weeks, 3 sessions per week and post treatment evaluation will be done after two weeks and follow up evaluation after one month by NPRS. Method of measurement: Numeric Pain Rating Scale.</prim_outcome>
      <prim_outcome>Functional Disability. Timepoint: Treatment will be given to both groups for 4 weeks, 3 sessions per week and post treatment evaluation will be done after two weeks and follow up evaluation after one month by MODI. Method of measurement: Modified Oswestry Disability Index.</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>Riphah International University QIE Campus</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-29</approval_date>
        <contact_name>Riphah College of Rehabilitation and Allied Health Sciences</contact_name>
        <contact_address>13-14-C-Civic centre , Near Hamdard Chowk, Township Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
