<?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>IRCT20210813052159N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-24</date_registration>
      <primary_sponsor>ABS Physiotherapy Clinic</primary_sponsor>
      <public_title>Comparison of Mulligan techniques in chronic low back pain patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparative effect of Mulligan two leg rotations and bend leg raise techniques in improving pain intensity and hamstring dynamics in subjects with chronic low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58270</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Eligible patients will be randomly assigned, using the simple random sampling technique by lottery method. Out of the screened patients, 34 patients those who fulfill the inclusion criteria were assigned a number. The walk-in patients will be assigned by even numbers and odd numbers. Patients coming at the even numbers will be included in Group A (Two Leg Rotation) and those with odd numbers will be included in the Group B (Bend Leg Raise). 17 patients will be included in the Group A and 17 patients will be assigned to the Group B, Blinding description: Information about the details of both programs will not be provided except for similarities across both groups (exercise regime). Both programs will be personalized to the patient’s abilities to ensure all eligible patients could complete the program. Patients will not be informed about the treatment protocols within the group they are enrolled in. Patient will not be aware whether they are included in the Group A or Group B and they will not be aware that they are receiving Two Leg Rotation or Bend Leg Raise technique within the group. Patient will not be aware of the maximum outcome measures possible after the treatment. Within two groups, the treatment will be given at the hospital or rehabilitation clinic during the one-hour therapy session.</study_design>
      <phase>3</phase>
      <hc_freetext>Chronic Low Back Pain patients with decreased hamstring flexibility.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group A (Mulligan Two Leg Rotation) Patient will be in supine lying and therapist will stand on the limited side of hamstring flexibility. Therapist will move both the legs into hip flexion and knee flexion to the maximum until both the feet are off the table. Upper extremity of the patient will fixed to the plinth by using the belt or assistant. Then both the legs will be moved to the limited hamstring flexibility side. Upon reaching the limit this position will be maintained for 30 seconds and over pressure may be applied. 3 repetitions will be given and same procedure will be applied on the other side. Devices used will be Mulligan belts and plinths. Intervention 2: Intervention group: Group B (Mulligan Bend Leg Raise) Patient will be in supine lying position. Knee will be placed on the therapist shoulder in 90-degree hip and knee flexion. Therapist would be standing on the patient side which is going to be treated. Both the hands will be placed on the lower end of thigh. Knee would rest on the therapist shoulder under the popliteal fossa and distraction will be added along the longitudinal axis of femur by using the both hands. Ask the patient to push against the shoulder with his leg and then asked to relax voluntarily. During this relaxation period bent knee will be pushed through its available range in the direction of shoulder in pain free range. Stretch will be maintained for 30 seconds and 3 repetitions will be given. If the pain is decreased and range of motion increased the hip will be moved into more flexion and procedure will be repeated. 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 patients that their data will not be shared and updated elsewhere other than the current study</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abdul Samad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Orchard Heights Plaza, Bahria Orchard phase 1, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>53720</zip>
        <telephone>+92 42 35475709</telephone>
        <email>abdulsamad2488@gmail.com</email>
        <affiliation>ABS Physiotherapy Clinic</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abdul Samad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Orchard Heights Plaza, Bahria Orchard phase 1, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>53720</zip>
        <telephone>+92 42 35475709</telephone>
        <email>abdulsamad2488@gmail.com</email>
        <affiliation>ABS Physiotherapy Clinic</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>•	Patients with age from 20 to 45 years
•	Both male and female were included
•	Subjects with pain above 3 on numeric pain rating scale.
•	Pain more than 12 weeks
•	Score more than 30% and less than 65% on the Modified Oswestry disability questionnaire</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>•	Subjects not willing to participate
•	Patients with Sciatica pain
•	Fracture of the Lumber, pelvic and all the spinal regions
•	Slipping of vertebra or complete tears of intervertebral disc
•	Recent history of trauma within six months
•	Surgical History
•	Radiating pain to the legs and buttocks
•	Spinal pathologies i.e. degenrative changes, spinal T.B, discitis, Osteoporosis and neoplasm
•	Disc herniation at any spinal region
•	Pregnancy</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: Group A (Mulligan Two Leg Rotation) Patient will be in supine lying and therapist will stand on the limited side of hamstring flexibility. Therapist will move both the legs into hip flexion and knee flexion to the maximum until both the feet are off the table. Upper extremity of the patient will fixed to the plinth by using the belt or assistant. Then both the legs will be moved to the limited hamstring flexibility side. Upon reaching the limit this position will be maintained for 30 seconds and over pressure may be applied. 3 repetitions will be given and same procedure will be applied on the other side. Devices used will be Mulligan belts and plinths.</i_keyword>
      <i_keyword>Intervention group: Group B (Mulligan Bend Leg Raise) Patient will be in supine lying position. Knee will be placed on the therapist shoulder in 90-degree hip and knee flexion. Therapist would be standing on the patient side which is going to be treated. Both the hands will be placed on the lower end of thigh. Knee would rest on the therapist shoulder under the popliteal fossa and distraction will be added along the longitudinal axis of femur by using the both hands. Ask the patient to push against the shoulder with his leg and then asked to relax voluntarily. During this relaxation period bent knee will be pushed through its available range in the direction of shoulder in pain free range. Stretch will be maintained for 30 seconds and 3 repetitions will be given. If the pain is decreased and range of motion increased the hip will be moved into more flexion and procedure will be repeated. Devices used will be Mulligan belts and plinths.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain Intensity. Timepoint: Before the Intervention, after 4 weeks of intervention. Method of measurement: Numeric Pain Rating Scale.</prim_outcome>
      <prim_outcome>Hamstring flexibility. Timepoint: Before the Intervention, after 4 weeks of intervention. Method of measurement: Active Knee Extension Test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Disability in Low back pain patients. Timepoint: Before the treatment, 4 weeks after the treatment. Method of measurement: Modified oswestary disability questionnaire.</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>ABS Physiotherapy Clinic</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-25</approval_date>
        <contact_name>Ethics and Technical committee of The University of Faisalabad</contact_name>
        <contact_address>University town, Sargodha road Faisalabad Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
