<?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>IRCT20210908052416N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-21</date_registration>
      <primary_sponsor>The University of lahore</primary_sponsor>
      <public_title>Effects of core stability with dynamic stretching in addition to routine physical therapy in patients with chronic low back pain.</public_title>
      <acronym>Tanvir</acronym>
      <scientific_title>Effects of core stability with dynamic stretching in addition to routine physical therapy in patients with chronic low back pain.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-10-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58731</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Parallel group, double blinded, randomized controlled trial, Randomization description: Participants were allocated to either to group A or group B by lottery method. Researcher had taken paper chits equal in number to sample size and wrote numbers from 1 to 48 on each paper chit separately. The paper chits are folded, put in box and well shuffled the box. Each participant was requested to draw a paper chit from the box and give to the researcher. Odd numbers were allocated to group A and even numbers were allocated to group B .Participants were recruited into either group A or group B. Each group consists of 24 participants, Blinding description: This was a single blinded study as the assessor was not disclosed about the study group .Assessor was another physical therapist who measured the pre-trial and post-trial readings of pain, range of motion and physical disability. The data collected by the assessor was provided to the researcher.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Patients in intervention group were treated with core stability exercises (squats, crunches, front plank, plank with alternating leg lift, supine 2 leg bridge exercise), dynamic stretching (Slum stretch, cat and camel stretch, child pose stretch, overhead lateral stretch, and side leg swings), and routine physical therapy (Experimental Group). For six weeks, both groups received two sessions per week. All of the exercises are performed in two sets of 10-15 repetitions during each session. Intervention 2: Control group: Patients in Group-A (Control Group) receive Routine physical therapy, which involves 20 minutes of hot pack superficial moist heat and 20 minutes of traditional transcutaneous electrical nerve stimulation (TENS) to the pain site utilising a dual-channel portable TENS unit with an 80-100 pulses per second frequency. In addition, abdominal curl ups in supine, back extensor exercises in prone, hip extensor exercises in prone andlumber rotation.</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 CORE STABILITY WITH DYNAMIC STRETCHING IN ADDITION TO ROUTINE PHYSICAL THERAPY IN PATIENTS WITH CHRONIC LOW BACK PAIN and all collected deidentiﬁed IPD will be shared.

When:
Afetr publication

To whom:
people working in academic institutions and researchers

Conditions:
It could be used on request

Where to obtain:
Through phone and Email drtanvirhussain212@@gmail.com

How to obtain:
Through Email and phone 00923024646625

Comments:
data can bee provided on request but after publication</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tanvir hussain</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sagian Wala Bypass, Data Gunj Buksh Town, Lahore</address>
        <city>lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 37147265</telephone>
        <email>drtanvirhussain212@gmail.com</email>
        <affiliation>Govt.Mian Munshi Dhq teaching hospital lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tanvir hussain</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sagian Wala Bypass, Data Gunj Buksh Town, Lahore,</address>
        <city>lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 37147265</telephone>
        <email>drtanvirhussain212@gmail.com</email>
        <affiliation>Govt.Mian Munshi Dhq teaching hospital Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with the history of non-specific chronic low back pain, both male and female patients, age ranges from 20 to 50 years will include in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>•Any neurological symptoms Any pathology of spine like Spondylosis, Spondylolisthesis Patients with other comorbidity such as systemic disorders                                            •Patients with sociopsychatric disorders, Pregnancy,fracture</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>Patients in intervention group were treated with core stability exercises (squats, crunches, front plank, plank with alternating leg lift, supine 2 leg bridge exercise), dynamic stretching (Slum stretch, cat and camel stretch, child pose stretch, overhead lateral stretch, and side leg swings), and routine physical therapy (Experimental Group). For six weeks, both groups received two sessions per week. All of the exercises are performed in two sets of 10-15 repetitions during each session.</i_keyword>
      <i_keyword>Control group: Patients in Group-A (Control Group) receive Routine physical therapy, which involves 20 minutes of hot pack superficial moist heat and 20 minutes of traditional transcutaneous electrical nerve stimulation (TENS) to the pain site utilising a dual-channel portable TENS unit with an 80-100 pulses per second frequency. In addition, abdominal curl ups in supine, back extensor exercises in prone, hip extensor exercises in prone andlumber rotation</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: Before intervention and then on 2nd, 4th and 6th week. Method of measurement: Numeric pain rating scale.</prim_outcome>
      <prim_outcome>Range of motion. Timepoint: Before intervention and then on 2nd, 4th and 6th week. Method of measurement: Universal goniometer.</prim_outcome>
      <prim_outcome>Functional disability. Timepoint: Before intervention and then on 2nd, 4th and 6th week. Method of measurement: Oswetry Low Back Pain Disability Questionnaire.</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>The university of Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-04</approval_date>
        <contact_name>Ethics Committee of The University of Lahore "Institutional Review Board"</contact_name>
        <contact_address>defence road campus,new campus ,The University of Lahore lahore punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
