<?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>IRCT20230907059376N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-06-08</date_registration>
      <primary_sponsor>Khyber Medical University, Peshawar</primary_sponsor>
      <public_title>Effectiveness of Mckenzie neck exercise and conventional physical therapy in patients with chronic non-specific neck pain</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Mckenzie neck exercise and conventional physical therapy in patients with chronic non-specific neck pain: A randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-06-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>26</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77211</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants will be randomly allocated to groups using the sealed envelope method. This technique ensures that the assignment is unbiased and that neither the participants nor the researchers can influence the group allocation. Each participant will draw an envelope containing their group assignment, maintaining the randomness and confidentiality of the process. This method is commonly used in clinical trials and research studies to ensure the integrity of the experimental design, Blinding description: Only the assessor, who will assess pre and post scores, will be blind in current study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic non specific neck pain.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Participants in this group will receive conventional therapy. Conventional physical therapy protocol will include active neck exercises, which consists of functional exercises, postural exercises, stretching, relaxation exercises and isometric neck exercises to increase strength or range of motion.  Exercise therapy may also be preceded by massage (such as soft tissue release for 5 minutes), stretching, or physical therapy techniques like heat applications (such as hot pack for 10-15 minutes), interferential current, and transcutaneous electrical nerve stimulation (TENS) application. This protocol will be done thrice a week, with thirty-minute therapy sessions, with an overall of maximum of twelve sessions. Intervention 2: Intervention group: This group will receive McKenzie exercise for neck pain.  The patient will be asked to keep their head as forward-facing as possible while moving it backward as much as they can. Making the movement as large as possible is crucial. After finishing, the patient goes back to their neutral rest position. Four sets of ten to fifteen repetitions of the exercise are to be performed, with a one-to-two-minute break in between.First Week of applying McKenzie Protocol:The patient will be supine with their head retracted or their chin thrust in. Under the occiput, a tiny pillow will be positioned to sustain a small amount of flexion. The patient will be instructed to position their head so that it was squarely over the girdle of their shoulders by pulling the neck and head posteriorly. After holding the final position for a brief moment, the subject will be free to settle into a resting position. Frequency: Four sets of ten to fifteen repetitions of this procedure will be performed, with one to three minutes of rest in between.Second Week of applying McKenzie Protocol:The therapist will progress the patient while they were seated by adding neck extension and applying overpressure with their chin at the end of the range of motion. Frequency: Four sets of this procedure will be performed, with a one to two minute break in between.Third Week of applying McKenzie Protocol:The patient will be positioned in such a way that their head will keep off the couch while lying supine. The therapist will apply the traction exercise of retraction and extension. All along the range of motion, the traction and extension will be maintained. Fourth Week of applying McKenzie Protocol:The patient will be instructed to get into short sitting. The therapist will then apply retraction with lateral flexion, neck rotation, and then pair the retraction and flexion of the neck with overpressure. Frequency: Four sets of 10 to 15 repetitions of this procedure will be performed, with a 1- to 2-minute rest period in between.</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:
Management of non specific neck pain through Mckenzie protocol will be the provided data title.

When:
After the completion of research data will be available for one year of time.

To whom:
Document will be available for the rehabilitation researchers, physiotherapy faculty and students.

Conditions:
The participants registered with IRCT will have access to the data.

Where to obtain:
Document will be available by contacting principal author Muhammad Salman Khan through email salmankhan9412@gmail.com

How to obtain:
The person registered with IRCT have to email the principal author.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atik Arsh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>F1 Phase-6 Rd, Phase 5 Hayatabad, Peshawar, Khyber Pakhtunkhwa 25100, Pakistan</address>
        <city>Peshawar</city>
        <country1>Pakistan</country1>
        <zip>25000</zip>
        <telephone>+92 91 5862514</telephone>
        <email>aatikarsh@kmu.edu.pk</email>
        <affiliation>Khyber Medical University, Peshawar</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Muhammad Salman Khan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>XCRP+W7C, 5-B/2 Shaukat Khanum Rd, Phase 5 Hayatabad, Peshawar, Khyber Pakhtunkhwa 25000, Pakistan</address>
        <city>Peshawar</city>
        <country1>Pakistan</country1>
        <zip>25000</zip>
        <telephone>+92 91 5838666</telephone>
        <email>salmankhan9412@gmail.com</email>
        <affiliation>Rehman Medical Institute, Peshawar</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Male and female individuals•
Age 18 to 65 years
Having localized chronic, non-specific neck pain from ≥ 3 months</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Cervical radiating pain
History of the neck surgery in the past 12 months
History of spinal cord lesion
Diagnosed cases of serious pathologies like infection, inflammation or malignancy
Individuals who have been clinically diagnosed with psychological disorders</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Participants in this group will receive conventional therapy. Conventional physical therapy protocol will include active neck exercises, which consists of functional exercises, postural exercises, stretching, relaxation exercises and isometric neck exercises to increase strength or range of motion.  Exercise therapy may also be preceded by massage (such as soft tissue release for 5 minutes), stretching, or physical therapy techniques like heat applications (such as hot pack for 10-15 minutes), interferential current, and transcutaneous electrical nerve stimulation (TENS) application. This protocol will be done thrice a week, with thirty-minute therapy sessions, with an overall of maximum of twelve sessions.</i_keyword>
      <i_keyword>Intervention group: This group will receive McKenzie exercise for neck pain.  The patient will be asked to keep their head as forward-facing as possible while moving it backward as much as they can. Making the movement as large as possible is crucial. After finishing, the patient goes back to their neutral rest position. Four sets of ten to fifteen repetitions of the exercise are to be performed, with a one-to-two-minute break in between.First Week of applying McKenzie Protocol:The patient will be supine with their head retracted or their chin thrust in. Under the occiput, a tiny pillow will be positioned to sustain a small amount of flexion. The patient will be instructed to position their head so that it was squarely over the girdle of their shoulders by pulling the neck and head posteriorly. After holding the final position for a brief moment, the subject will be free to settle into a resting position. Frequency: Four sets of ten to fifteen repetitions of this procedure will be performed, with one to three minutes of rest in between.Second Week of applying McKenzie Protocol:The therapist will progress the patient while they were seated by adding neck extension and applying overpressure with their chin at the end of the range of motion. Frequency: Four sets of this procedure will be performed, with a one to two minute break in between.Third Week of applying McKenzie Protocol:The patient will be positioned in such a way that their head will keep off the couch while lying supine. The therapist will apply the traction exercise of retraction and extension. All along the range of motion, the traction and extension will be maintained. Fourth Week of applying McKenzie Protocol:The patient will be instructed to get into short sitting. The therapist will then apply retraction with lateral flexion, neck rotation, and then pair the retraction and flexion of the neck with overpressure. Frequency: Four sets of 10 to 15 repetitions of this procedure will be performed, with a 1- to 2-minute rest period in between.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Neck Pain intensity. Timepoint: Outcome measures will be used/measured at baseline and after the intervention. Method of measurement: Numeric Pain rating scale.</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>Khyber Medical University, Peshawar</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-05-30</approval_date>
        <contact_name>KMU AS&amp;RB</contact_name>
        <contact_address>5-B/2 Shaukat Khanum Rd, Phase 5 Hayatabad, Peshawar, Khyber Pakhtunkhwa Peshawar Khyber Pakhtunkhwa Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
