<?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>IRCT20230731058990N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-27</date_registration>
      <primary_sponsor>UOL, Lahore</primary_sponsor>
      <public_title>Quantum movement technique on pain and functional disability in patients with chronic low back pain</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Quantum movement technique on pain and functional disability in patients with chronic low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>78</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72214</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Straight leg raise test, numeric pain rating scale, Mckenzie lumbar extension, Randomization description: participants were randomized using gold fish bowl method into two groups. one is control group and the other is experimental group. Treatment allocation were done by using concealed envelope method. In this, sealed opaque envelops with treatment regimen written were provided to the participants. Once a patient had consented to enter a trial an envelope was opened and the patient was then offered the allocated treatment regimen , Blinding description: The study was single blinded. The participants did not know while they were receiving experimental or routine physical therapy treatment. and yes intervention is similar enough for blinding participants.</study_design>
      <phase>3</phase>
      <hc_freetext>Low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Regular physical therapy for low back pain was included hot packs, bridging exercises, lumbar extension, and prone leg lifts. A maximum of three sessions of this was given on alternate days. Each session was included ten minutes of heating. Three repetitions of the bridging, lumbar extension, and prone leg lift exercises was given. Each therapy session were last 25 to 30 minutes. Intervention 2: Intervention group: Along with standard physical therapy like hot packs, bridging exercises, lumbar extension, and prone leg lifts, Group B was also received quantum movement technique. This will be administered on different days. Each session was included ten minutes of thermotherapy. Three repetitions of the quantum movement technique, which includes the McKenzie lumbar extension, stabilization drills, and proprioceptive neuromuscular facilitation, was given. Each treatment session was last for 40 to 45 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Demographic data and data related to final outcome will be shared by maintaining the confidentiality.

When:
data will be available from April 2024 to June 2024 after the 6 months of publication. the data sharing plan for a controlled trial (i.e., what data will be shared when and under what conditions) will be publicly available at a third party site that shares data with and meets the data requirements of WHO's International Clinical Trial Registry platforms this occurs before the first participant is enrolled.

To whom:
Dr Iqra Islam (corresponding author) professor at UOL, Lahore

Conditions:
for research purpose

Where to obtain:
To the corresponding author of the study, Dr iqra Islam and can contact on +92 313 4260161 iqrawislam@gamail.com can visit these search engines you can find my study easily here https://scholar.google.com/ https://www.researchgate.net/

How to obtain:
Open-access and there is the traditional public data release where anyone can get access to the data with no registration or conditions. The request will be reviewed by Director in charge and in case of eligibility, it would be shared in two weeks.

Comments:
I want randomized controlled trial registration.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Sania Naz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1-Km defense road Lahore, Pakistan</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 304 4407035</telephone>
        <email>sania.naz642@gmail.com</email>
        <affiliation>UOL, Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Kashaf Faraz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1-Km defense road Lahore, Pakistan</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 304 6541357</telephone>
        <email>kashaffraz@gmail.com</email>
        <affiliation>UOL, Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who had a complaint of Low Back Pain for over 12-weeks
A score greater than or equal to 4/10 on Numeric Pain Rating Scale (NPRS)
Evidence of Low Back Pain induced limitations during daily activities.
Patients who had a positive straight leg raise test (SLRT) and received no physiotherapy for at least 6-months
Region involved of back from L1-L5 and S1
Pre-diagnosed patients of low back pain
Age is between 25-55 years
Both gender</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who were unable to walk independently
Spinal cord infection like Cauda equina syndrome.
Patients who had difficulties in exercise performance due to mental problems
Neurological disorders like cerebral palsy, epilepsy</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>Regular physical therapy for low back pain was included hot packs, bridging exercises, lumbar extension, and prone leg lifts. A maximum of three sessions of this was given on alternate days. Each session was included ten minutes of heating. Three repetitions of the bridging, lumbar extension, and prone leg lift exercises was given. Each therapy session were last 25 to 30 minutes.</i_keyword>
      <i_keyword>Intervention group: Along with standard physical therapy like hot packs, bridging exercises, lumbar extension, and prone leg lifts, Group B was also received quantum movement technique. This will be administered on different days. Each session was included ten minutes of thermotherapy. Three repetitions of the quantum movement technique, which includes the McKenzie lumbar extension, stabilization drills, and proprioceptive neuromuscular facilitation, was given. Each treatment session was last for 40 to 45 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Baseline and 4th, 8th and 12th week of treatment. Method of measurement: Numeric Pain Rating Scale (NPRS).</prim_outcome>
      <prim_outcome>Functional Disability. Timepoint: Baseline and 4th, 8th and 12th week of treatment. Method of measurement: Oswestry Disability Scale (ODI).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Functional abilities. Timepoint: Baseline and 4th, 8th and 12th week after treatment. Method of measurement: Oswestry Disability Scale (ODI).</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, Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-26</approval_date>
        <contact_name>Research Ethics Committee (REC)</contact_name>
        <contact_address>1-Km defense road Lahore, Pakistan Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
