<?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>IRCT20220701055331N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-06-11</date_registration>
      <primary_sponsor>Rashid Latif Medical College</primary_sponsor>
      <public_title>Effects of post isometric relaxation and Bruegger's exercises on pain, range of motion and disability in patients with mechanical neck pain</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Post Isometric Relaxation and Bruegger's Exercises on Pain, Range of Motion and Disability in patients with Mechanical Neck Pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-06-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77229</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random computer number generator will be used for randomization. Assign unique identification numbers to participants, then use a reliable software tool to generate a list of random numbers. Match these numbers to participant IDs and allocate individuals to different study groups based on the sorted random numbers. Ensure that the randomization process is concealed and documented for transparency and integrity, Blinding description: Single blinding in a study involves keeping the outcome assessor blind to the intervention received by the participants. This helps to minimize bias in assessing the study outcomes. To achieve single blinding, the outcome assessor is not informed about the treatment allocation of the participants and remains unaware of which group received the intervention being studied.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Mechanical neck pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group A:  Post isometric relaxation exercise: Total 20 sessions will be given to each patient in 4 weeks with 3 sessions per week. Intervention 2: Intervention group B: Bruegger’s exercise: 	Total 20 sessions will be given to each patient in 4 weeks with 3 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>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 concerns about patient confidentiality and privacy, uncertainty about the legal and ethical implications of sharing sensitive data, lack of resources or infrastructure to manage and share the data securely, and potential risks of misinterpretation or misuse of the data by third parties</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rouman Naseer</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rashid Latif Medical College 35-km Ferozpur Road Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54600</zip>
        <telephone>+92 333 4975431</telephone>
        <email>ifra.awan@rlmc.edu.pk</email>
        <affiliation>Rashid Latif Medical College</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ifra Zulqarnain Awan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rashid Latif Medical College 35-km Ferozpur Road Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54600</zip>
        <telephone>+92 333 4975431</telephone>
        <email>ifra.awan@rlmc.edu.pk</email>
        <affiliation>Rashid Latif Medical College</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Both male and female patients
Age ranged from 20-40 years and suffering from Mechanical neck pain for at least three months</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any orthopedic or neurological condition surgery in the cervical spine or shoulder
Patients having Inflammation, malignancy and metabolic disorder will be excluded
Patients with neck pain radiating into arms and upper extremity will be excluded from this study
Neck pain associated with headache and facial pain, recent surgery, Vertebrobasiliar insufficiency (VBI) positive will be excluded
History of recent trauma and fractures of cervical spine will be excluded</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group A:  Post isometric relaxation exercise: Total 20 sessions will be given to each patient in 4 weeks with 3 sessions per week.</i_keyword>
      <i_keyword>Intervention group B: Bruegger’s exercise: 	Total 20 sessions will be given to each patient in 4 weeks with 3 sessions per week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Numeric pain rating scale to measure pain.</prim_outcome>
      <prim_outcome>Range of motion. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Range of motion will be measured by Universal goniometer.</prim_outcome>
      <prim_outcome>Disability. Timepoint: before intervention and 4 weeks after intervention. Method of measurement: Neck disability index (NDI) will be used to measure disability.</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>Rashid Latif Medical College</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-25</approval_date>
        <contact_name>Institutional Review Board of Rashid Latif Medical College, Lahore.</contact_name>
        <contact_address>35-KM Ferozepur Road Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
