<?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>IRCT20190717044238N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-05-06</date_registration>
      <primary_sponsor>Riphah International University Lahore</primary_sponsor>
      <public_title>Effects of Pilates versus McGill exercises on pain, flexibility, core stability and functional disability in patients with chronic mechanical low back pain</public_title>
      <acronym>mlbp</acronym>
      <scientific_title>Effects of Pilates versus McGill exercises on pain, flexibility, core stability and functional disability in patients with chronic mechanical low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-05-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76577</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization will be done by use of sealed envelops which involves assigning participants to different groups by randomly selecting an envelope that contains their group assignment. This will ensure reduce biasness in allocation of interventions. Simple randomization method is used to allocate participants to different groups, Blinding description: In the trial the participant( who are willing to participate)  is blinded by not knowing or being unaware which intervention they are receiving , but the researcher (physiotherapist) know. This trial will be single blinded. Researcher will be responsible for care for participants during the trial, data collectors, outcome assessors, and with lessor importance Data Safety .</study_design>
      <phase>N/A</phase>
      <hc_freetext>chronic mechanical low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1 : The Pilates group in the study will follow a six-week exercise regimen, where they will participate in Pilate’s sessions twice a week. Pilates is a form of exercise that focuses on core strength, flexibility, and controlled movements. As the weeks progress, the intensity and complexity of the Pilates exercises will be increased, aiming to gradually build the participants' physical capabilities and enhance their health outcomes. This structured approach will allow the patients to adapt to the exercise difficulty over time, potentially improving their effectiveness.: Pilate’s exercises emphasize core muscle activation :⦁	Single leg lower⦁	Straight-leg bicycle⦁	Oblique double knee tucks ⦁	Oblique tucks⦁	Kneeling side bending. Intervention 2: Intervention group 2 :The Mc Gill group in the study will engage in a six-week exercise protocol specific to the Mc Gill method, attending sessions twice a week. With 10 minutes of heating pad This program is expected to concentrate on exercises that promote back health and core stability. With each passing week, the exercises will become more challenging, with the goal of methodically enhancing the participants' endurance, strength, and overall well-being. This progressive strategy will be designed to allow participants to gradually adjust to the increasing demands of the exercises, which is anticipated to improve the efficiency and benefits of the intervention .The Big Three: McGill has popularized three specific exercises that are often included in his approach. These exercises are the McGill ⦁	Curl-Up, ⦁	Bird-Dog,⦁	Side Plank.</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 confidentiality of participants</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sabra Ghulam Rasool</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Riphah International University Lahore Gulberg green campus</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 310 4143346</telephone>
        <email>sabra.ksr@gmail.com</email>
        <affiliation>Riphah International University Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fareeha Amjad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Riphah International University Lahore Gulberg green campus</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 334 3372779</telephone>
        <email>fari_fairy22@yahoo.com</email>
        <affiliation>Riphah International University Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Both male and Female
Age between 20 and 40 years .
Having mechanical low back pain without radiation to lower limbs, for more than 6 weeks were enrolled in the study.
Participants should obtain clearance from their primary healthcare provider or a physician to participate in a physical activity program like Pilates or McGill’s Protocol.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with any systemic disorder or who were undergoing intervention
Patients having a history of spine surgery were also not included
Have a pacemaker or a history of serious cardiac event or of cardiorespiratory dysfunction
Severe cognitive impairment or aphasia leading to difficulty in communication,
Participants who have any significant musculoskeletal or orthopedic problems that would interfere with their ability to participate in the physical therapy program.
Participants who have a history of uncontrolled hypertension or arrhythmias.</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 1 : The Pilates group in the study will follow a six-week exercise regimen, where they will participate in Pilate’s sessions twice a week. Pilates is a form of exercise that focuses on core strength, flexibility, and controlled movements. As the weeks progress, the intensity and complexity of the Pilates exercises will be increased, aiming to gradually build the participants' physical capabilities and enhance their health outcomes. This structured approach will allow the patients to adapt to the exercise difficulty over time, potentially improving their effectiveness.: Pilate’s exercises emphasize core muscle activation :⦁	Single leg lower⦁	Straight-leg bicycle⦁	Oblique double knee tucks ⦁	Oblique tucks⦁	Kneeling side bending.</i_keyword>
      <i_keyword>Intervention group 2 :The Mc Gill group in the study will engage in a six-week exercise protocol specific to the Mc Gill method, attending sessions twice a week. With 10 minutes of heating pad This program is expected to concentrate on exercises that promote back health and core stability. With each passing week, the exercises will become more challenging, with the goal of methodically enhancing the participants' endurance, strength, and overall well-being. This progressive strategy will be designed to allow participants to gradually adjust to the increasing demands of the exercises, which is anticipated to improve the efficiency and benefits of the intervention .The Big Three: McGill has popularized three specific exercises that are often included in his approach. These exercises are the McGill ⦁	Curl-Up, ⦁	Bird-Dog,⦁	Side Plank</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before intervention, 6 weeks. Method of measurement: Numeric pain rating scale (NPRS).</prim_outcome>
      <prim_outcome>Flexibility. Timepoint: Before intervention, 6 week. Method of measurement: Sit and reach test score.</prim_outcome>
      <prim_outcome>Core stability. Timepoint: Before intervention ,6 week. Method of measurement: Sahrmann core stability test.</prim_outcome>
      <prim_outcome>Funtional disability. Timepoint: Before intervention, 6 week. Method of measurement: Urdu version of Oswestry Disability index (ODI).</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>Riphah International University Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-04-03</approval_date>
        <contact_name>Research and ethics Commitee Riphah College of Rehabilitation and Allied Health Sciences</contact_name>
        <contact_address>Riphah International University Gulberg campus lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
