<?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>IRCT20200226046623N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-17</date_registration>
      <primary_sponsor>University of Lahore</primary_sponsor>
      <public_title>Breathing reeducation in neck pain</public_title>
      <acronym></acronym>
      <scientific_title>Effects of   breathing Reeducation on clinical  outcomes in non specific chronic neck pain.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-02-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46240</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Randomization description: simple randomization by sealed envelop method, Blinding description: participants in the study are blind to the treatement to which they are exposed to.The assessor who is measuring the outcome measures is unaware of the treatment the patient has gone through.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Non specific Neck pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group will receive supervised breathing exercises focusing on proper inhalation, exhalation and chest expansion for 15 minutes with routine physical therapy treatment in form of infrared  for 10 minutes, isometric exercises for flexor, extensor and side flexor of cervical spine in supine lying 20 repetitions with 10 seconds hold. Patients will undergo the intervention twice a week for consecutive 8 weeks. Outcome measures will be taken for musculoskeletal and respiratory elements on baseline and at 4th and 8th week respectively. For musculoskeletal element Pain and ROM will be assessed by using visual Analogue scale and CROM (deluxe), Functional disability will be measured through Neck disability index. Cervical muscle strength and endurance will be measured through isometric neck dynamometer and craniocervical flexion test respectively. For respiratory element Spirometer will be used for assessing pulmonary volumes, flows and maximal voluntary ventilation. Intervention 2: Control group: Control group will receive routine physical therapy treatment in form of infrared  for 10 minutes, isometric exercises for flexor, extensor and side flexor of cervical spine in supine lying 20 repetitions with 10 seconds hold. Patients will undergo the intervention twice a week for consecutive 8 weeks. Outcome measures will be taken for musculoskeletal and respiratory elements on baseline and at 4th and 8th week respectively. For musculoskeletal element Pain and ROM will be assessed by using visual Analogue scale and CROM (deluxe), Functional disability will be measured through Neck disability index. Cervical muscle strength and endurance will be measured through isometric neck dynamometer and craniocervical flexion test respectively. For respiratory element Spirometer will be used for assessing pulmonary volumes, flows and maximal voluntary ventilation.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Mainly due to institutional policy</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sahreen Anwar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Street#2, canal park, Vip block</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 8750106</telephone>
        <email>sahreenanwar@yahoo.com</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sahreen Anwar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Street#2, canal park, Vip block</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 8750106</telephone>
        <email>sahreenanwar@yahoo.com</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients having non specific neck pain for more than 3 months•
Patients having no history of respiratory disease•
Patients having FEV1/FVC ratio=0.7 or 70% of the predicted value•
Patients having no history of antidepressant drug treatment•
Both genders
Age between 25-50 years</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Smokers•
Known history of depression•
Patients having any sort of Asthma•
Patients with upper cervical signs and symptoms•
Prolong sitting.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group will receive supervised breathing exercises focusing on proper inhalation, exhalation and chest expansion for 15 minutes with routine physical therapy treatment in form of infrared  for 10 minutes, isometric exercises for flexor, extensor and side flexor of cervical spine in supine lying 20 repetitions with 10 seconds hold. Patients will undergo the intervention twice a week for consecutive 8 weeks. Outcome measures will be taken for musculoskeletal and respiratory elements on baseline and at 4th and 8th week respectively. For musculoskeletal element Pain and ROM will be assessed by using visual Analogue scale and CROM (deluxe), Functional disability will be measured through Neck disability index. Cervical muscle strength and endurance will be measured through isometric neck dynamometer and craniocervical flexion test respectively. For respiratory element Spirometer will be used for assessing pulmonary volumes, flows and maximal voluntary ventilation.</i_keyword>
      <i_keyword>Control group: Control group will receive routine physical therapy treatment in form of infrared  for 10 minutes, isometric exercises for flexor, extensor and side flexor of cervical spine in supine lying 20 repetitions with 10 seconds hold. Patients will undergo the intervention twice a week for consecutive 8 weeks. Outcome measures will be taken for musculoskeletal and respiratory elements on baseline and at 4th and 8th week respectively. For musculoskeletal element Pain and ROM will be assessed by using visual Analogue scale and CROM (deluxe), Functional disability will be measured through Neck disability index. Cervical muscle strength and endurance will be measured through isometric neck dynamometer and craniocervical flexion test respectively. For respiratory element Spirometer will be used for assessing pulmonary volumes, flows and maximal voluntary ventilation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before intervention and at 4th ,8th week. Method of measurement: Visual Analogue scale (VAS).</prim_outcome>
      <prim_outcome>Range of motion neck. Timepoint: Before intervention,at 4th and 8th week. Method of measurement: CROM device.</prim_outcome>
      <prim_outcome>Cervical muscle strength. Timepoint: Before intervention,and at 4th week and 8th week. Method of measurement: Dynamometer.</prim_outcome>
      <prim_outcome>Neck muscles endurance. Timepoint: Before intervention,4th week and 8th week. Method of measurement: Craniocervical Flexion test, Biopressure feedback.</prim_outcome>
      <prim_outcome>Neck disability. Timepoint: Before intervention,at 4th and 8th week. Method of measurement: Neck disability index questionire.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before intervention and at 4th and 6th week. Method of measurement: NOOS Questioire.</prim_outcome>
      <prim_outcome>Pulmonary Function Test. Timepoint: Before intervention, at 4th and 6th week. Method of measurement: Spirometry.</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>University of Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-16</approval_date>
        <contact_name>Ethics committee of university of Lahore</contact_name>
        <contact_address>1km, Defence Road, Bhobatian chowk Lahore Pakistan Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
