<?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>IRCT20190715044216N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-27</date_registration>
      <primary_sponsor>Riphah International University</primary_sponsor>
      <public_title>Effects of Mulligan Traction Leg Raise versus Slump Stretching on Pain, Passive Leg Raise, and Functional Disability in Lumbar Radiculopathy</public_title>
      <acronym>EMTLRSSSPPLRFDLR</acronym>
      <scientific_title>Effects of Mulligan Traction Leg Raise versus Slump Stretching on Pain, Passive Leg Raise, and Functional Disability in Lumbar Radiculopathy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60791</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done by lottery method through convenient sampling.
Unit of randomization is Individual. 
Tool used in randomization will be lottery method. 
Through lottery method each member of the population will be assigned a number, after which numbers will be selected at random.
Allocation concealment will carried out, Blinding description: 1. It will be a single blinded study
2. Participants of both groups will be kept unfamiliar to the treatment protocol by lottery method. 
3. Participants of both groups will be called for treatment on alternate days in a week.
4. Group A will receive Mulligan traction leg raise and lumbar stabilization exercises for 3 days a week and Group B will receive Slump stretching and lumbar stabilization exercises for next 3 days a week. 
5. The health care provider (physical therapist) will be aware to the whole treatment procedure that will be provided to the participants.</study_design>
      <phase>3</phase>
      <hc_freetext>lumbar radiculopathy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group A: Mulligan Traction Leg Raise : The subjects will receive Mulligan traction leg raise and and common treatment. Mulligan traction  leg raise at available end range will be hold for 10 seconds with max. 3 repetitions. The common treatment include lumbar stabilization exercises. Lumbar stabilization exercises includes static glutei, static back and static hamstring hold for 10 seconds with maximum 10 repetitions. Treatment session was given 3 times per week for 4 weeks. Total duration of each session will be of 20 minutes. Intervention 2: Intervention group B: Slump Stretching : The subjects will receive Slump stretching and common treatment. Slump Stretching position will be  maintained for ten seconds with each session following 3 repetition stretches according to patient’s response.  Lumbar stabilization exercises. The common treatment include lumbar stabilization exercises. Lumbar stabilization exercises includes static glutei, static back and static hamstring hold for 10 seconds with maximum 10 repetitions.  Treatment session includes 3 times per week for 4 weeks.  Total duration of each session will be of 20 minutes. Evaluation will be done before treatment and at the end of 4th week.</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:
Effects of Mulligan Traction Leg Raise versus Slump Stretching on Pain, Passive Leg Raise, and Functional Disability in Lumbar Radiculopathy

When:
30th June 2022

To whom:
people working in academic institutions

Conditions:
Author will review the requests

Where to obtain:
gmail address: aqsairshad958@gmail.com

How to obtain:
Requests will be entertained through email after which people working in academic institutions will be granted request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Aqsa Irshad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jubilee Town A Block House no 514</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 32525250</telephone>
        <email>aqsairshad958@gmail.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Aqsa Irshad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jubilee town A Block house no 514</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>042325252520</telephone>
        <email>aqsairshad958@gmail.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pre diagnosed with lumbar radiculopathy
Age group of 30-60 years
SLR test positive
All subjects with unilateral or bilateral radiation of pain in sciatic nerve distribution
Male and Female patients
Participants willing to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of spinal surgery in previous 6 months
Knee and ankle pathology causing limitation of movement
Clinical conditions such as over sensitive skin, patient with cardiac pacemaker,   pregnancy etc.
Serious spinal condition e.g. infection, tumors, osteoporosis, spinal fracture
Inability to hold slump stretching position, reproduction of symptoms on neck flexion part of slump test
Patients with cervicogenic headache, VBI, spinal deformities and ankylosing spondylitis</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group A: Mulligan Traction Leg Raise : The subjects will receive Mulligan traction leg raise and and common treatment. Mulligan traction  leg raise at available end range will be hold for 10 seconds with max. 3 repetitions. The common treatment include lumbar stabilization exercises. Lumbar stabilization exercises includes static glutei, static back and static hamstring hold for 10 seconds with maximum 10 repetitions. Treatment session was given 3 times per week for 4 weeks. Total duration of each session will be of 20 minutes.</i_keyword>
      <i_keyword>Intervention group B: Slump Stretching : The subjects will receive Slump stretching and common treatment. Slump Stretching position will be  maintained for ten seconds with each session following 3 repetition stretches according to patient’s response.  Lumbar stabilization exercises. The common treatment include lumbar stabilization exercises. Lumbar stabilization exercises includes static glutei, static back and static hamstring hold for 10 seconds with maximum 10 repetitions.  Treatment session includes 3 times per week for 4 weeks.  Total duration of each session will be of 20 minutes. Evaluation will be done before treatment and at the end of 4th week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Treatment session includes 3 times per week for 4 weeks for 20 minutes and outcomes will be measured before applying intervention in 1st week and after completion of treatment at 4th week. Method of measurement: NPRS.</prim_outcome>
      <prim_outcome>Straight leg raise range of motion. Timepoint: Treatment session includes 3 times per week for 4 weeks for 20 minutes and outcomes will be measured before applying intervention in 1st week and after completion of treatment at 4th week. Method of measurement: Goniometer.</prim_outcome>
      <prim_outcome>Disability. Timepoint: Treatment session includes 3 times per week for 4 weeks for 20 minutes and outcomes will be measured before applying intervention in 1st week and after completion of treatment at 4th week. Method of measurement: Oswestry disability index scale.</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>Nill</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-01</approval_date>
        <contact_name>Research Review Committee of Riphah College of Rehabilitation Sciences</contact_name>
        <contact_address>Jubilee town , A Block, House no 514 Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
