<?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>IRCT20210630051741N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-01</date_registration>
      <primary_sponsor>The University of Faisalabad</primary_sponsor>
      <public_title>COMPARATIVE EFFECT OF UPPER THORACIC SPINE MOBILIZATION WITH MOBILITY EXERCISES AND UPPER CERVICAL SPINE MOBILIZATION WITH STABILIZATION EXERCISES IN MECHANICAL NECK PAIN</public_title>
      <acronym>MNP</acronym>
      <scientific_title>COMPARATIVE EFFECT OF UPPER THORACIC SPINE MOBILIZATION WITH MOBILITY EXERCISES AND UPPER CERVICAL SPINE MOBILIZATION WITH STABILIZATION EXERCISES IN MECHANICAL NECK PAIN</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57757</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Non-probability purposive sampling technique will be utilized for collecting sample and sample will be allocated to treatment group A and B by using online randomization generator. 
2 sets of 18 unique numbers per set
Range: From 1 to 36— Sorted from Least to Greatest
Group A: Thoracic Mobilization and Mobility Exercise
[1,2,6,7,10,11,15,17,18,19,20,22,23,24,29,32,33,35]
Group B: Cervical Mobilization and Stabilization Exercise
[3,4,5,8,9,12,13,14,16,21,25,26,27,28,30,31,32,34, 36], Blinding description: Patients will be kept blind through allocation concealment to treatment group. Patients will be unaware of their respective group treatment plans.</study_design>
      <phase>3</phase>
      <hc_freetext>Mechanical neck pain can be defined as pain in neck or shoulder area aggravated by prolonged posture and movement of neck and palpation of neck musculature..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:. Intervention 2: Intervention group:.</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 It will be decided later on as per the advice of supervisor and the requirements of the journal in which the article will be sent for publication.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Ramesha Tahir; PT</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>9-Y-B, Block Madina Town, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 8502460</telephone>
        <email>ramisha.alvi@gmail.com</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ramesha Tahir; PT</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>9-Y-B, Block Madina Town, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 8502460</telephone>
        <email>ramisha.alvi@gmail.com</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>•	Male and female both genders
•	Age ranging from 20-40 years
•	Primary complaint of neck pain from past 12 weeks
•	Pain rating of more than 2 on NPRS
•	Reduced cervical ROM in extension, rotation and side bending
•	Neck Disability Index score of 20% or more i.e. 10 points or more on 0 to 50 scale
•	Commitment to comply with treatment plans</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>•	Previous history of trauma or surgery to cervical or thoracic spine, whiplash injury
•	Presence of neurological deficits
•	Presence of bilateral upper extremity symptoms
•	Cervical myelopathy or nerve root pathology
•	Patients with positive Lhermitte’s sign
•	Vascular diseases of head and neck
•	Presence of any red flags e.g. fracture, tumor, osteoporosis, rheumatoid arthritis, metabolic diseases, blood pressure at rest more than 140/90 mm Hg, chronic history of corticosteroid use
•	Any symptoms of central nervous system (CNS) involvement e.g. hyperreflexia, sensory deficits and muscle atrophy in hands, nystagmus, unsteadiness in gait, loss of visual acuity, abnormal facial sensation, dysgeusia, positive pathological reflexes
•	Patients with psychological disorders or those who can’t comprehend given instructions.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54. 2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Code M54. 2 is the diagnosis code used for Cervicalgia (Neck Pain). A disorder characterized by marked discomfort sensation in the neck area.Discomfort or more intense forms of pain that are localized to the cervical region. This term generally refers to </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:</i_keyword>
      <i_keyword>Intervention group:</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The numerical pain rating scale was utilized to measure intensity of pain. Pain Intensity was rated on 0-10 scale at a horizontal bar.  NPRS consists of 11 points, which range from 0= no pain, 1-4= mild pain, 4-7= moderate pain 7-10= severe pain. Timepoint: 5 timepoints including Baseline, 1st week post treatment, 2nd week post treatment, 3rd week post treatment, 4th week post treatment. Method of measurement: Numerical Pain Rating Scale will be utilized to assess pain.</prim_outcome>
      <prim_outcome>Universal Goniometer will be used to measure Cervical ROM. Timepoint: 5 timepoints including Baseline, 1st week post treatment, 2nd week post treatment, 3rd week post treatment, 4th week post treatment. Method of measurement: Universal Goniometer will be used to measure Cervical ROM.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>It is a questionnaire which measures the functional ability of the patient. Each item is scored on a 0 to 5 rating scale, in which zero means no pain and 5 means worst imaginable pain. All the points are summed to give a total score, which can be interpreted as 0 points= no activity limitations,0-4 points = no disability, 5-14 points = mild disability, 15-24 points = moderate disability, 25-34 points = severe disability, 35-50 points = complete disability 50 points =complete activity limitation. Timepoint: 2 timepoints including Baseline and 4th week post treatment. Method of measurement: Neck Disability Index will be used to measure neck disability.</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>Self financed</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-17</approval_date>
        <contact_name>Ethical Committee of The University of Faisalabad</contact_name>
        <contact_address>Sargodha Rd, University Town, Faisalabad, Punjab 38000 Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
