<?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>IRCT20200226046623N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-01-02</date_registration>
      <primary_sponsor>Lahore University of Biological and Applied Sciences</primary_sponsor>
      <public_title>role of Pilatese exercises with breathing reeducation in working women with chronic neck pain.</public_title>
      <acronym>PBNPS</acronym>
      <scientific_title>Effectiveness of pilates exercises with breathing re-education on pain, endurance, sleep and disability in working women with chronic non specific neck pain.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-10-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/79854</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: It was a single blinded parallel randomized clinical trial, Randomization description: Randomization was done using a computer generated block randomization scheme through "Random allocation" software. The blocks had different sizes(4,6,8) to ensure that the randomization process was unpredictable and to avoid selection bias. An automated randomization list was achieved with attrition rate included, Blinding description: In this study only participants were blinded. This meant that participants were unaware of whether they were in breathing re-education group or pilates group.</study_design>
      <phase>4</phase>
      <hc_freetext>Chronic Nack Pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1:The patients in the intervention group received baseline treatment in the form of hot pack and neck isometric exercises 10*10 for 10 minutes. After wards patients performed mat pilates exercises for 30 minutes including swan dive, neck rolls ,cervical spine retraction chin tucks ,nodding, shoulder shrugs followed by breathing exercises for 15 minutes, the intervention was applied on alternate days for 6 weeks. Intervention 2: Control group: The patients in the Pilates group received baseline treatment in the form of hot pack and neck isometric exercises 10*10 for 10 minutes. After wards patients performed mat Pilates exercises for 30 minutes including swan dive, neck rolls ,cervical spine retraction chin tucks ,nodding, shoulder shrugs . The intervention was applied on alternate days for 6 weeks.</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 Data will only be available upon request depending on the purpose of acquisition of the data.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sahreen Anwar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Street#2 Sajid Garden Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54300</zip>
        <telephone>+92 334 6591705</telephone>
        <email>Sahreenanwar@yahoo.com</email>
        <affiliation>Lahore, University of Biological And Applied Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sahreen Anwar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Street#2 Rizwan Garden Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54300</zip>
        <telephone>+92 334 6591705</telephone>
        <email>Sahreenanwar@yahoo.com</email>
        <affiliation>Lahore University of Biological And Applied Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 25-50 years old
Pain for more than 3 months
Females from white collar professions with daily 6 to 8 working hours per day •
Pain intensity of less than or equal to 6 on NPRS</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Cervical  radiculopathy
Rheumatological conditions
Neurological disorders
Pregnancy, as it can affect pain perception and exercise tolerance
Respiratory conditions like  COPD</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cervicalgia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1:The patients in the intervention group received baseline treatment in the form of hot pack and neck isometric exercises 10*10 for 10 minutes. After wards patients performed mat pilates exercises for 30 minutes including swan dive, neck rolls ,cervical spine retraction chin tucks ,nodding, shoulder shrugs followed by breathing exercises for 15 minutes, the intervention was applied on alternate days for 6 weeks.</i_keyword>
      <i_keyword>Control group: The patients in the Pilates group received baseline treatment in the form of hot pack and neck isometric exercises 10*10 for 10 minutes. After wards patients performed mat Pilates exercises for 30 minutes including swan dive, neck rolls ,cervical spine retraction chin tucks ,nodding, shoulder shrugs . The intervention was applied on alternate days for 6 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before intervention, and 3,6 weeks after intervention. Method of measurement: Numeric Pain rating Scale (NPRS).</prim_outcome>
      <prim_outcome>Neck Disability. Timepoint: Before intervention, and 3,6 weeks after intervention. Method of measurement: Neck Disability Index.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Endurance. Timepoint: Before intervention, and 3,6 weeks after intervention. Method of measurement: Craniocervical Flexion Test.</sec_outcome>
      <sec_outcome>Sleep. Timepoint: Before intervention, and 3,6 weeks after intervention. Method of measurement: Insomnia Severity Index (ISI).</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>Lahore University of Biological And Applied Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-07-24</approval_date>
        <contact_name>Ethical Committee,Faculty of Rehabilitation Sciences, Lahore university of Biological and Applied Sc</contact_name>
        <contact_address>Tulspura, Canal Bank ,North Lahore 53400 Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
