<?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>IRCT20220115053712N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-19</date_registration>
      <primary_sponsor>GCUF Layyah campus</primary_sponsor>
      <public_title>Core stability  with and without stretching exercises on pain and functional disability in non specific low back pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of effects of Core Stability with and without Stretching Exercises on pain and functional disability  in Non-Specific Low Back Pain.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>21</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70910</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: toe-tuch test,fair test and ober test used for flexibilty assessment, Randomization description: Participants were randomly allocated into two groups through drawing a number, Blinding description: The study was single blinded. The participants didn't know while they were receiving experimental or conventional treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Non specific low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: participants performed Core stabilization exercises with stretching for 30 min, 3 times/week, for 6 weeks. Core stabilization consisted of abdominal hollowing, straight leg raise from prone, supine extension bridge and prone bridge and stretching in hip muscle (Hamstrings, Tensor fasciae lata, Piriformis and Gluteus Maximus). All study participants received a total of 18 treatments sessions over a six-week period, which consisted of 3 treatment sessions per week. Intervention 2: Control group: they performed core stabilization exercises i.e abdominal hollowing, straight leg raise from prone, supine extension bridge and prone bridge, for 20 minutes 3 times a week. All exercises were repeated 3 times. All study participants received a total of 18 treatments sessions over a six-week period, which consisted of 3 treatment sessions per week.</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 clinical 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 Trials Registry Platform; this occur before the first participant is enrolled.

To whom:
dr.Sania Naz (corresponding author) professor at GCUF layyah campus.

Conditions:
for research purpose

Where to obtain:
To the corresponding author of the study; dr sania naz  and can contact on +923044407035saaniaanaz@gmail.com can visit these search engines, you can find my study easily here https://www.researchgate.net/ https://scholar.google.com/

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 clinical trial registration.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Sania Naz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Near  layyah sugar mills; Layyah</address>
        <city>Layyah</city>
        <country1>Pakistan</country1>
        <zip>31200</zip>
        <telephone>+92 304 4407035</telephone>
        <email>saaniaanaz@gmail.com</email>
        <affiliation>GCUF layyah campus</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Noshaba Kanwal</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Near  layyah sugar mills   layyah</address>
        <city>Layyah</city>
        <country1>Pakistan</country1>
        <zip>31200</zip>
        <telephone>+92 309 9709093</telephone>
        <email>zuhahadeed786@gmail.com</email>
        <affiliation>GCUF layyah campus</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 25 – 65 years
Both genders
Non-specific low back pain for at least 3 months
Pain intensity of 3 or higher based on Numeric Pain Rating Scale (NPRS)</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of spinal surgery
History of ankylosing spondylitis or rheumatoid arthritis
History of spondylolisthesis or spondylolysis
History of spinal or pelvic fracture
History of spinal inflammation or tumor
History of osteoporosis
Continuous use of pain medications
History of respiratory disease or heart disease
History of stroke</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: participants performed Core stabilization exercises with stretching for 30 min, 3 times/week, for 6 weeks. Core stabilization consisted of abdominal hollowing, straight leg raise from prone, supine extension bridge and prone bridge and stretching in hip muscle (Hamstrings, Tensor fasciae lata, Piriformis and Gluteus Maximus). All study participants received a total of 18 treatments sessions over a six-week period, which consisted of 3 treatment sessions per week.</i_keyword>
      <i_keyword>Control group: they performed core stabilization exercises i.e abdominal hollowing, straight leg raise from prone, supine extension bridge and prone bridge, for 20 minutes 3 times a week. All exercises were repeated 3 times. All study participants received a total of 18 treatments sessions over a six-week period, which consisted of 3 treatment sessions per week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Please write: Before and 6 weeks after treatment. Method of measurement: Numerical pain rating scale (NPRS).</prim_outcome>
      <prim_outcome>Disability. Timepoint: Before and 6 weeks after treatment. Method of measurement: Modified oswestry disability index.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Functional activities. Timepoint: Before and 6 weeks after  treatment. Method of measurement: Modified oswestry disabilty index (MODI).</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>GCUF Layyah campus</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-10</approval_date>
        <contact_name>Institutional ethics committee of GCUF layyah campus</contact_name>
        <contact_address>Near layyah sugar mills; Layyah Layyah Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
