<?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>IRCT20190717044238N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-06</date_registration>
      <primary_sponsor>Riphah International University Lahore</primary_sponsor>
      <public_title>Sustained Natural Apophyseal Glides  and Thoracic Posture Correction Technique on Mechanical Neck Pain</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Sustained Natural Apophyseal Glides with and without Thoracic Postural Correction Techniques on Pain, Range of Motion and Disability in Patients with Mechanical Neck Pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>28</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68770</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be assigned to either control or treatment group by random selection using a computer-generated table of random numbers. These numbers will be placed inside sealed envelopes. Another individual, who is not involved in the research, will then open these envelopes and assign the patients to their respective groups based on the instructions provided, Blinding description: A skilled and experienced physiotherapist, who is not connected to the study, will making assessments on outcomes or gathering data on outcome variables.</study_design>
      <phase>3</phase>
      <hc_freetext>Mechanical neck pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group A will receive conventional therapy (Hot pack and Transcutaneous Electrical Nerve Stimulation) along sustained natural apophyseal glides. Sustained facet glide with movement will be applied at the facet joint between cervical C3 to C7. It will be performed in sitting or standing position of the patient. Sustained Natural Apophyseal Glides involves application of accessory passive glide to cervical vertebrae by a physiotherapist while the patient will simultaneously perform an active movement. Glide given is in the direction of the plane of facet joints, and technique is usually performed in weight-bearing position like standing, sitting etc. Patients in control group will receive treatment for alternate days, 3 days a week for 6 weeks. Intervention 2: Intervention group: Group B will receive conventional therapy same as group A with sustained natural apophyseal glides and thoracic posture correction technique. Thoracic postural correction technique includes active as well as therapist-facilitated stretches. Active stretches will be  thoracic extension in sitting, Wall angle stretch and Corner stretch, while the therapist-facilitated stretches will be seated mid-thoracic stretch and prone mid thoracic stretch. Stretches will be maintained for 15- 20 seconds with 10 repetitions of each stretch per session. Patients in control group will receive treatment for alternate days, 3 days a week 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Consent Form in its original format with no information about any participant study protocol- how the intervention was given to both groups

When:
Data would be available after the completion of the research at the end of 2023

To whom:
People working in an academic and clinical setting can have access to the above-mentioned information/documents

Conditions:
Data can only be used for Research Purposes

Where to obtain:
Data can be asked for at the following email address: rameenqayyum95@gmail.com

How to obtain:
One can ask for data at the given email address and it would be provided after knowing the general implications of sharing that particular data.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rameen Qayyum</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>26-D Architect Society Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54782</zip>
        <telephone>+92 322 4109195</telephone>
        <email>rameenqayyum95@gmail.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Fareeha Amjad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Riphah International University Madar e Millat Road, Quaid e Azam Industrial Estate Lahore, Punjab</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</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Individuals having localized pain or stiffness in spine or both combined b/w  C3 to C7 without upper limbs radiculopathy
Patients with chronic neck pain &gt;3 months
Pain reported on NPRS score ˃3 in neck region with limited or painful range of motion
Painful and limited cervical range of motion</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Tuberculosis, carcinoma, heart disease, osteoporosis
Neural disorders
Any trauma or localized infection in neck region, cervical stenosis, metabolic diseases in bone and joint
Hyper flexibility
Open sores
Ongoing radiotherapy, chemotherapy, steroid therapy or anticoagulants
Allergy to hot pack
Patients with history of surgery in cervical spine region with in a year</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 group: Group A will receive conventional therapy (Hot pack and Transcutaneous Electrical Nerve Stimulation) along sustained natural apophyseal glides. Sustained facet glide with movement will be applied at the facet joint between cervical C3 to C7. It will be performed in sitting or standing position of the patient. Sustained Natural Apophyseal Glides involves application of accessory passive glide to cervical vertebrae by a physiotherapist while the patient will simultaneously perform an active movement. Glide given is in the direction of the plane of facet joints, and technique is usually performed in weight-bearing position like standing, sitting etc. Patients in control group will receive treatment for alternate days, 3 days a week for 6 weeks</i_keyword>
      <i_keyword>Intervention group: Group B will receive conventional therapy same as group A with sustained natural apophyseal glides and thoracic posture correction technique. Thoracic postural correction technique includes active as well as therapist-facilitated stretches. Active stretches will be  thoracic extension in sitting, Wall angle stretch and Corner stretch, while the therapist-facilitated stretches will be seated mid-thoracic stretch and prone mid thoracic stretch. Stretches will be maintained for 15- 20 seconds with 10 repetitions of each stretch per session. Patients in control group will receive treatment for alternate days, 3 days a week for 6 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Functional disability. Timepoint: 6 weeks. Method of measurement: Neck Disability Index is a self-report questionnaire designed to determine how neck pain affects a patient’s daily life and the disability of patients with neck pain. It consists of 10 questions that ask about activities of daily living. More the score, the more significant the disability. The sample questionnaire is attached at the end. Four sections relate to subjective symptoms, and the remaining 6 sections relate to activities of daily living. Each unit is scored from 0 to 5 points, giving a maximum score of 50. The total score of the neck disability index ranges from 0 to 50 points.</prim_outcome>
      <prim_outcome>Pain. Timepoint: 6 weeks. Method of measurement: Patient level of pain will be assessed using this scale. This scale ranges from 0 to 10. 0 indicates “no pain” and 10 indicates “worst pain”.</prim_outcome>
      <prim_outcome>Range of motion. Timepoint: 6 weeks. Method of measurement: Changes from the Baseline ROM range of Motion of Cervical spine will be taken with the Help of Goniometer.</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>2023-01-02</approval_date>
        <contact_name>Riphah College of Rehabilitation and Allied Health Sciences Lahore</contact_name>
        <contact_address>F83G+V25, Madar-e-Millat Road, Quaid-e-Azam Industrial Estate Quaid e Azam Industrial Estate, Lahore, Punjab Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
