<?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>IRCT20210813052161N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-28</date_registration>
      <primary_sponsor>Yasmin physiotherapy center</primary_sponsor>
      <public_title>Comparison of neural mobilization with mulligan mobilization for low back pain</public_title>
      <acronym></acronym>
      <scientific_title>Butler’s neural tissue mobilization in comparison with sustained natural apophyseal glide (SNAG) mulligan mobilization for sub-acute and chronic low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58115</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Randomization of the participants was accomplished by using simple random sampling by means of lottery method, Blinding description: Participants will be aware of the existence of both groups. Participants will have complete information about the description of treatment being performed in both groups but will not be aware which treatment will be performed on them. 
All the participants will be masked in the study.
This will be carried out by keeping the anonymous by study period.</study_design>
      <phase>3</phase>
      <hc_freetext>Low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For group A baseline treatment will be TENS and hot pack (10 min) and then Butler's neural mobilization will be applied as patients will be supine and therapist will be in foot standing position. Therapist will place one hand under ankle without putting pressure on patient’s patella or peripheral nerves.  Hip will be flexed and knee extended in one plane and will move the leg to the position where patients will feel symptoms. Sustained stretch or slow oscillations will be provided for 10 seconds. Then returned to neutral position and it will contains 3 sets. Exercise will perform 3 times a day; regularly for 4 weeks duration. Device used will be plinth. Intervention 2: Intervention group: For group B baseline treatment will be same including TENS and hot pack (10 min) and then SNAG mulligan's mobilization will be applied as patients will be sitting while facing away from the therapist. Pelvis will be stabilized by belt that will surround patient’s ASIA and around the physiotherapist ischial tuberosity. Therapist will put thumb on spinous process and palpate it. Patient will flex and then extend lumbar spine to neutral position. Belt tension will be maintained by PT. Technique will be applied on lumbar spinal levels of pain. Therapist ask patient to move into flexion and at the same time will apply sustained posteroanterior force throughout the movement on the painful spinous process. Oscillation amplitude and depth will depend upon patient pain and other symptoms. If patient’s major complaint will be pain, then oscillation depth will be in pain fee range and not deep. Exercises were performed with 10 repetitions, 3 sets. It will be performed three times a week for 4 weeks duration. Devices used will be Mulligan belts and plinths.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is As we have signed and assured the participants that their data will not be shared anywhere else other than the current study</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Iqra Ibrar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Town, Sargodha Road</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 8401315</telephone>
        <email>dr.iqraibrar@gmail.com</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Iqra Ibrar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Town, Sargodha Road</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 8401315</telephone>
        <email>dr.iqraibrar@gmail.com</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 35-55 years.
Both genders
Low back pain with radiation to lower extremity (above knee)
Diagnosed patients of non-contained disc herniation.
Patients who are not on analgesics.
Patients with minimal 6 weeks history of subacute and chronic low back pain
Unilateral SLR is positive in between 35 and 70 degrees.</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients of cauda equina syndrome.
Diagnosed patients of non-contained disc herniation.
Patient with LBP due to fracture, spine structural deformities like scoliosis, spinal fusion or osseous stenosis.
Patient with history of any recent surgery, spinal surgery or artificial disc.
Patient with saddle anesthesia.
Patient with bowel and bladder symptoms.
Patient having pregnancy.
Patient with cancer, infection or inflammatory disease, bladder, kidney, uterus issues, injury, other severe medical or psychiatric illness
Patients on any other medical or therapeutic intervention within last 3 months.
Patient who are unable to participate in study due to any abnormality or refusal for consent.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Low back pain</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: For group A baseline treatment will be TENS and hot pack (10 min) and then Butler's neural mobilization will be applied as patients will be supine and therapist will be in foot standing position. Therapist will place one hand under ankle without putting pressure on patient’s patella or peripheral nerves.  Hip will be flexed and knee extended in one plane and will move the leg to the position where patients will feel symptoms. Sustained stretch or slow oscillations will be provided for 10 seconds. Then returned to neutral position and it will contains 3 sets. Exercise will perform 3 times a day; regularly for 4 weeks duration. Device used will be plinth.</i_keyword>
      <i_keyword>Intervention group: For group B baseline treatment will be same including TENS and hot pack (10 min) and then SNAG mulligan's mobilization will be applied as patients will be sitting while facing away from the therapist. Pelvis will be stabilized by belt that will surround patient’s ASIA and around the physiotherapist ischial tuberosity. Therapist will put thumb on spinous process and palpate it. Patient will flex and then extend lumbar spine to neutral position. Belt tension will be maintained by PT. Technique will be applied on lumbar spinal levels of pain. Therapist ask patient to move into flexion and at the same time will apply sustained posteroanterior force throughout the movement on the painful spinous process. Oscillation amplitude and depth will depend upon patient pain and other symptoms. If patient’s major complaint will be pain, then oscillation depth will be in pain fee range and not deep. Exercises were performed with 10 repetitions, 3 sets. It will be performed three times a week for 4 weeks duration. Devices used will be Mulligan belts and plinths.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Low back pain. Timepoint: Before intervention, 2nd week and 4th week. Method of measurement: Visual analogue scale.</prim_outcome>
      <prim_outcome>Straight leg raise. Timepoint: Before intervention, 2nd week and 4th week. Method of measurement: Goniometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Low back disability. Timepoint: Before intervention and 4th week. Method of measurement: Oswestry disability index.</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>Yasmin physiotherapy center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-21</approval_date>
        <contact_name>Ethics and Technical committee of The University of Faisalabad</contact_name>
        <contact_address>University Town, Sargodha Road Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
