<?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>IRCT20210821052245N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-07</date_registration>
      <primary_sponsor>University of Lahore</primary_sponsor>
      <public_title>Effect of hamstring flexibility in patients with chronic non-specific low back pain.</public_title>
      <acronym></acronym>
      <scientific_title>Comparative effects of mulligan two-leg rotation technique and muscle energy technique on hamstring flexibility, pain and functional disability in patients with chronic non-specific low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-11-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>116</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58400</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients who were eligible were randomly assigned, using the simple random sampling technique by lottery method. Out of the screened patients, 108 patients who fulfill the inclusion criteria were assigned a number. The walk-in patients were assigned by even numbers and odd numbers. Patients coming at the even numbers were included in Group A (Two Leg Rotation) and those with odd numbers were included in Group B (Muscle Energy Technique). 54 patients were included in Group A and 54 patients were assigned to Group B, Blinding description: The double blinding technique was used. The assessor and participants both were blinded to the given technique. In the end, the study was unblinded and researchers and participants was made aware of the treatment groups in which they were allocated.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic Low Back Pain with decreased hamstring flexibility.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group (Mulligan Two Leg Rotation): After giving the moist hot pack for 20 minutes at the low back area and hamstrings, the therapist stands at the limited hamstrings flexibility side of the patient lying in a supine position. Both legs were flexed to a level that feet are off the table. After stabilizing the patient shoulders on the bed, the patient’s leg was fully flexed and slowly taken to the side of the limited hamstring muscle flexibility. When the limit was reached, the position was sustained for 30 seconds with overpressure applied by the therapist, and then the legs were lowered to the plinth. Three repetitions were repeated, and 1 minute rest time was given between each stretch. And the same procedure was done for the other side of limited hamstrings flexibility. Total time duration for this technique was 10 minutes. Intervention 2: Intervention group (Muscle Energy Technique): Post Isometric Relaxation (PIR) of muscle energy technique was used. After applying the moist hot pack for 20 minutes at the low back and hamstrings the patient was instructed to lie in a supine position with the non-treated leg straight on the table. The therapist passively flexed the treated leg at the hip and the patient knee was straightened on the therapist's shoulder until the primary resistance was felt. The patient was instructed to apply pressure for 7-10 seconds on the therapist's shoulder against resistance by using no more than 25% of their strength during isometric contractions. The contraction period was followed by a relaxation period and then the therapist passively straightened the knee towards its new barrier and held it for 30 seconds. The procedure was repeated 4 times with a 10-second rest interval between them. Total time duration for this technique was 10 minutes.</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 Because patient consent was taken only for this study, so I cannot share the data without their permission.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Razzaq</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House number 486, MDA officers co-operative housing society, Multan</address>
        <city>MULTAN</city>
        <country1>Pakistan</country1>
        <zip>60000</zip>
        <telephone>+92 61 6524875</telephone>
        <email>maryam.raazq@gmail.com</email>
        <affiliation>Bakhtawar Amin Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Razzaq</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House number 486, MDA officers co-operative housing society, Multan</address>
        <city>MULTAN</city>
        <country1>Pakistan</country1>
        <zip>60000</zip>
        <telephone>+92 61 7524875</telephone>
        <email>maryam.raazq@gmail.com</email>
        <affiliation>Bakhtawar Amin Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Both male and female
Age group eighteen to thirty years of age
Non-specific low back pain for more than three months.
Patients with hamstrings tightness measured by Active Knee Extension (AKE) test with measurement having greater than the thirty-degree loss of knee.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Low back pain with active systemic or spine pathology.
Upper motor neuron lesion and lower motor neuron lesion
Pregnancy, psychological risk factor or subjects apprehensive for the stretching techniques
History of fracture or surgery of spine, pelvis, hip or knee.</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group (Mulligan Two Leg Rotation): After giving the moist hot pack for 20 minutes at the low back area and hamstrings, the therapist stands at the limited hamstrings flexibility side of the patient lying in a supine position. Both legs were flexed to a level that feet are off the table. After stabilizing the patient shoulders on the bed, the patient’s leg was fully flexed and slowly taken to the side of the limited hamstring muscle flexibility. When the limit was reached, the position was sustained for 30 seconds with overpressure applied by the therapist, and then the legs were lowered to the plinth. Three repetitions were repeated, and 1 minute rest time was given between each stretch. And the same procedure was done for the other side of limited hamstrings flexibility. Total time duration for this technique was 10 minutes.</i_keyword>
      <i_keyword>Intervention group (Muscle Energy Technique): Post Isometric Relaxation (PIR) of muscle energy technique was used. After applying the moist hot pack for 20 minutes at the low back and hamstrings the patient was instructed to lie in a supine position with the non-treated leg straight on the table. The therapist passively flexed the treated leg at the hip and the patient knee was straightened on the therapist's shoulder until the primary resistance was felt. The patient was instructed to apply pressure for 7-10 seconds on the therapist's shoulder against resistance by using no more than 25% of their strength during isometric contractions. The contraction period was followed by a relaxation period and then the therapist passively straightened the knee towards its new barrier and held it for 30 seconds. The procedure was repeated 4 times with a 10-second rest interval between them. Total time duration for this technique was 10 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: Before the intervention and 2,4 weeks. Method of measurement: Numeric Pain Rating Scale.</prim_outcome>
      <prim_outcome>Hamstring flexibility. Timepoint: Before intervention, 2,4 week. Method of measurement: Active knee extension test.</prim_outcome>
      <prim_outcome>Functional Disability. Timepoint: Before intervention and 2,4 week. Method of measurement: Modified Oswestary 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>UOL</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-19</approval_date>
        <contact_name>Ethics' committee of The University of Lahore, Faculty of Allied health Science</contact_name>
        <contact_address>Defence Road Campus, Bhobatian Chowk, Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
