<?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>IRCT20201031049207N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-25</date_registration>
      <primary_sponsor>University of Sargodha, Lyallpur Campus Faisalabad</primary_sponsor>
      <public_title>Sciatic Nerve Mobilization in  Lumbar Radicular Pain.</public_title>
      <acronym>Sciatic Nerve Mobilization Trial</acronym>
      <scientific_title>Effects of Sciatic Nerve Mobilization versus Conventional physiotherapy Treatment in Patients with Lumbar Radicular Pain” A Randomized Control Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-03-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52923</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients who met eligibility criteria's and signed the informed consent document were enrolled in the study. They were divided into two groups by using lottery method. Chits were prepared  equal to total sample size, odd Numbers were  allocated to Group A and even number were allocated to Group B. Each patient was requested to draw a chit from the box and after that patients were recruited into either Group A or Group B, Blinding description: Data safety was ensured by assigning Specific Identity numbers and all consent forms, data collection charts were placed in locker to blind Assessors.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Normal Healthy Individuals with Lumber radicular Pain. The compression of any of  the lumber nerve route can results in severe radicular pain. The onset of pain may begin suddenly or gradually after injury. The pain pattern is usually 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 In the beginning patients were given conventional baseline treatment according to North American spine society clinical guidelines and Sciatic nerve mobilization was added as an intervention. Sciatic nerve mobilization techniques were given in the form of 3 sets of 10 oscillatory movements at the ankle that were rhythmic ankle dorsiflexion and plantarflexion with a gap of 10 seconds between each set for 3 times a week for 2 weeks on alternate days. Intervention 2: Group B: Control group. Patients were given only conventional baseline treatment according to North American spine society clinical guidelines. It included moist hot pack for 15 minutes in prone lying position, and supervised back strengthening exercises consisting of pelvic tilts, bridging, quadruped alternate arm and leg activities, abdominal bracing exercises. Patients were asked to perform 2 sets of 10 repetitions of each exercise 3 times a week for 2 weeks on alternate days.</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 Sciatic Nerve Mobilization versus Conventional physiotherapy Treatment in Patients with Lumbar Radicular Pain” A Randomized Control Trial. Consent form, Clinical Study Report, Statistical Plan files can be shared.

When:
after Publication for one year

To whom:
People working in academic institutions or people working in businesses can also contact Principal Investigator to receive it.

Conditions:
the data can be included in meta analysis and systematic reviews. Person responsible for scientific inquiry will cater the other requests personally, review them on predefined criteria and respond accordingly.

Where to obtain:
zainab.48@hotmail.com

How to obtain:
by formal email request Full description about the purpose/aim of using the documents, Insight about the disorder and Intervention of the research can be obtained.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sahreen Anwar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jinnah Colony</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 2618283</telephone>
        <email>sahreenanwar@yahoo.com</email>
        <affiliation>Physiotherpay Department, Independent Medical College.</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>ZAinab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Satiana Road</address>
        <city>Fisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 8792050</telephone>
        <email>zainab.48@hotmail.com</email>
        <affiliation>University of Sargodha Layallpur Campus</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age: 25 -55 years
Both genders
Positive Lasegue Sign
Pain radiation to Unilateral limb.
Pain Since more than 2 months.</inclusion_criteria>
      <agemin>22 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Age less than 22 or more than 55 years.
Presence of any Red Flag signs.
Infection –Tuberculosis.
Lumbar Instability/ subluxation/ Fracture/ spondylolisthesis
Joint Hyper mobility.
Inability to comply with the study protocol due to cognitive impairment
Osteoporosis.
Tumors around the back
Inflammation around the lumbar spine.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Radiculopa</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>M54.16</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 In the beginning patients were given conventional baseline treatment according to North American spine society clinical guidelines and Sciatic nerve mobilization was added as an intervention. Sciatic nerve mobilization techniques were given in the form of 3 sets of 10 oscillatory movements at the ankle that were rhythmic ankle dorsiflexion and plantarflexion with a gap of 10 seconds between each set for 3 times a week for 2 weeks on alternate days.</i_keyword>
      <i_keyword>Group B: Control group. Patients were given only conventional baseline treatment according to North American spine society clinical guidelines. It included moist hot pack for 15 minutes in prone lying position, and supervised back strengthening exercises consisting of pelvic tilts, bridging, quadruped alternate arm and leg activities, abdominal bracing exercises. Patients were asked to perform 2 sets of 10 repetitions of each exercise 3 times a week for 2 weeks on alternate days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before 1st session and after last session. Method of measurement: pain will be measured using numeric pain rating scale subjectively.</prim_outcome>
      <prim_outcome>Functional disability. Timepoint: Before 1st session and after last session. Method of measurement: Measured subjectively using Modified Oswestry Disability Index.</prim_outcome>
      <prim_outcome>Range of Motion-Straight Leg Raise (SLR). Timepoint: Before 1st session and after last session. Method of measurement: measured using Standard Goniometer.</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>None</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-02-10</approval_date>
        <contact_name>SCPT-IRB</contact_name>
        <contact_address>Umer Street Sialkot Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
