<?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>IRCT20250308064984N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-04-13</date_registration>
      <primary_sponsor>Combined Military Hospital Kohat</primary_sponsor>
      <public_title>Assessing the effectiveness of Kinesio Taping for Chronic Neck Pain</public_title>
      <acronym></acronym>
      <scientific_title>"Assessing the effectiveness of Kinesio Taping in Enhancing Conventional Therapies for Chronic Neck Pain - A Randomized Controlled Trial"</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82423</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is a randomized controlled trial (RCT) using a simple randomization method. Participants will be randomly assigned to one of two groups:
(1) Kinesio Taping plus standard care, or
(2) Standard care only.

Method of randomization: Simple randomization.
Unit of randomization: Individual participants.
Stratification: Participants will be stratified based on age (18–70 years) and pain severity level (mild, moderate, or severe).
Tool used for randomization: SPSS software.
Random sequence generation: Computer-generated randomization sequence.
Random allocation process: Allocation will be conducted using a pre-generated random sequence to ensure unbiased assignment. Concealment will be maintained using sealed, opaque, sequentially numbered envelopes.
Outcome measures: Numeric Rating Scale (NRS) will be used to assess pain level, and the Oswestry Neck Disability Index (ONDI) will be used to evaluate neck disability.</study_design>
      <phase>3</phase>
      <hc_freetext>Neck or Cervical spine pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants will receive Kinesio Taping (K-Tape) applied to the cervical region. The tape will be worn continuously for 24 hours. Pain and functional improvemnets will be assessed at baseline, 24 hours, 3 days and 1 week post application using the Numerical Rating Scale (NRS) and ONDI scale. Intervention 2: Control group: Participants will recieve standard care (without kinesio taping).Pain and functional improvement will be assessed at baseline, 24 hours, 3 days, and 1 week post application using the Numeric rating scale(NRS) and Oswestry neck disability index.</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:
This dataset includes de-identified individual patient data (IPD) from a randomized controlled trial assessing impact of Kinesio Taping in the pain management of neck.This data consists of: Patient Demographics (age,gender), Baseline assessment (ONDI and NRS scores), Follow-up results at 24 hours, 3 days and 1 week post application periods on excel sheet.

When:
This data will be made avaliable upon request after the study's completion and publication of findings.

To whom:
The deidentified data will be avaliable to the researchers, clinicians and academic institutions conducting studies related to neck pain management, or rehabilitation interventions. Access will be granted upon formal requests and approval.

Conditions:
The data will be shared only for academic and research purposes. Researchers must submit a formal request with ethical approval for data usage. The dataset must not be used for commercial purpose or patient re-identification.Proper citation of the original study is required in any resulting publication.

Where to obtain:
The dataset is avaliable from (Combined Military Hospital). Interested researchers can request access via email or official institution request. Contact Information:0336 8885877 Email:drtameem2@gmail.com Address:Combined Military Hospital

How to obtain:
1. Submit a formal request via email or institutional portal, detailing the purpose of data usage. 2.Provide ethical approval from their respective institution if applicable. 3.Sign a data-sharing agreement ensuring compliance with ethical guidelines and non commercial usage. 4.Approval process: The request will be reviewed within [Specify time e.g 2-4 weeks], and if approval access will be granted via secure data tranfer.

Comments:
For any clarifications or additiona informtion regarding data access, please contact [Hafsa Alam] at alamhafsa131@gmail.com.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hafsa Alam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Combined Military Hospital Kohat</address>
        <city>Kohat</city>
        <country1>Pakistan</country1>
        <zip>26000</zip>
        <telephone>+92 333 3515751</telephone>
        <email>alamhafsa131@gmail.com</email>
        <affiliation>Combined Military Hospital Kohat</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Syed Tameem-UL-Hassan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Combined Military Hospital Kohat</address>
        <city>Kohat</city>
        <country1>Pakistan</country1>
        <zip>26000</zip>
        <telephone>+92 336 8885877</telephone>
        <email>drtameem2@gmail.com</email>
        <affiliation>Combined Military Hospital Kohat</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adults aged 18-70 years
Diagnosed with Chronic Neck Pain
No recent trauma or injury to the neck or Cervical spine
Ability to provide informed consent and participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Recent surgery of neck
History of neck or cervical spine fractures
Presence of cancer in neck or cervical spine
Pregnant or breast feeding women
Skin allergies, open wounds and infections in neck area
Patients with inflammatory diseases(e.g Rheumatoid arthritis,Ankylosing Spondylitis)
Neurological disorder and trauma to the neck</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Participants will receive Kinesio Taping (K-Tape) applied to the cervical region. The tape will be worn continuously for 24 hours. Pain and functional improvemnets will be assessed at baseline, 24 hours, 3 days and 1 week post application using the Numerical Rating Scale (NRS) and ONDI scale.</i_keyword>
      <i_keyword>Control group: Participants will recieve standard care (without kinesio taping).Pain and functional improvement will be assessed at baseline, 24 hours, 3 days, and 1 week post application using the Numeric rating scale(NRS) and Oswestry neck disability index.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain Reduction by applying Kinesio Taping on cervical pain. Timepoint: Baseline (Pre-Intervention) 24 hours, 3 days and 1 week post application of Kinesio Taping. Method of measurement: Pain reduction will be assessed using Numerical Rating Scale (NRS): An 11-point scale (0-10) where patients rate their pain intensity.                                                                                                                     Assessments will be conducted at baseline 24 hours, 3 days and 1 week post application of Kinesio tape.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Neck functional status in individuals with cervical pain. Timepoint: Baseline (pre-intervention), 24 hours, 3 days and 1 week post application of Kinesio taping. Method of measurement: Functional improvements will be assessed using Oswestry Neck Disability Index (ONDI). The ONDI scale evaluates pain, stiffness, and physical function with higher score indicating worse symptoms.                                                                                         Assessment will be conducted at baseline, 24 hours, 3 days and 1 week post application.</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>Combined Military Hospital Kohat</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-09-20</approval_date>
        <contact_name>Institutional Review Board, Combined Military Hospital</contact_name>
        <contact_address>Kohat KPK Pakistan Kohat KPK Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
