<?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>IRCT20250303064920N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-03-06</date_registration>
      <primary_sponsor>Combined Military Hospital Kohat</primary_sponsor>
      <public_title>"Effectiveness of Kinesio Taping on Pain Management in knee Osteoarthritis : A Randomized Controlled Trial"</public_title>
      <acronym></acronym>
      <scientific_title>"Assessment of enhanced impact of Kinesio taping on Pain management in Knee Osteoarthritis - A Randomized controlled trial with standard care approaches"</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/82205</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study employs a randomized controlled trial (RCT) design using a simple randomization method. Participants will be randomly assigned to either the Kinesio taping + standard care group or the standard care-only group.

Method of randomization: Simple randomization 

Unit of randomization: Individual participants.

Stratification: Participants will be stratified based on age ranging (40-80 years) and pain severity level ( moderate and severe).

Tools used: software (e.g., SPSS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) post-application, and NRS for pain.

Random sequence generation: Random Allocation process.</study_design>
      <phase>3</phase>
      <hc_freetext>Knee osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants will receive Kinesio Taping (K Tape) applied to the knee joint. The tape will be worn continuously for 24 hours. Pain and functional improvements will be assessed at baseline, 24 hours, 3 days, and 1 week post-application using the Numeric Rating Scale (NRS) and WOMAC index.". Intervention 2: Control group: Participants will receive standard care (without Kinesio Taping). Pain and functional improvements will be assessed at baseline, 24 hours, 3 days, and 1 week post-application using the Numeric Rating Scale (NRS) and WOMAC 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 deidentified individual patient data (IPD) from a randomized controlled trial assessing the impact of Kinesio taping on pain management in knee osteoarthritis. The data consists of:
Patient demographics (age, gender)
Grade of knee OA
Baseline assessment (WOMAC and NRS scores)
Follow-up results at 24 hours, 3 days and 1 week post-application periods
On excel sheet

When:
The dataset will be made available upon request after the study’s completion and publication of findings.

To whom:
The deidentified data will be available to researchers, clinicians, and academic institutions conducting studies related to knee osteoarthritis, pain management, or rehabilitation interventions. Access will be granted upon formal request and approval.

Conditions:
Under Which Criteria the Data/Document Could Be Used:
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 purposes or patient re-identification.
Proper citation of the original study is required in any resulting publication.

Where to obtain:
The dataset is available from [Combined Military Hospital ]. Interested researchers can request access via email or official institutional request.

Contact Information:03368885877
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 approved, access will be granted via secure data transfer.

Comments:
For any clarifications or additional information regarding data access, please contact [Nimra Naeem] at nimranaeem2020@gmail.com</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nimra Naeem</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Combined Military Hospital Kohat</address>
        <city>Kohat</city>
        <country1>Pakistan</country1>
        <zip>26000</zip>
        <telephone>+92 321 5770860</telephone>
        <email>nimranaeem2020@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>Age between 40-80 years
Clinically Diagnosed with knee osteoarthritis (Grade 2-4)
Chronic knee pain( On NRS)
Consent to participate
BMI limit
Intact skin on knees
Functional Limitations</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Severe knee deformities
Inflammatory diseases
Chronic skin conditions
Neurological disorders
Overweight
Pregnancy
Skin Allergies
Trauma
Acute pain
Open wounds</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M19.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Primary osteoarthritis of other joints</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</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 knee joint. The tape will be worn continuously for 24 hours. Pain and functional improvements will be assessed at baseline, 24 hours, 3 days, and 1 week post-application using the Numeric Rating Scale (NRS) and WOMAC index."</i_keyword>
      <i_keyword>Control group: Participants will receive standard care (without Kinesio Taping). Pain and functional improvements will be assessed at baseline, 24 hours, 3 days, and 1 week post-application using the Numeric Rating Scale (NRS) and WOMAC index.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain reduction by application of kinesio taping on knee joint. 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 a Numeric Rating Scale (NRS) from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Participants will report their pain levels at baseline, 24 hours, 3 days, and 1 week post-application of Kinesio tape.".</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Improvement in functional ability of the knee in individuals with osteoarthritis. Timepoint: Baseline( pre-intervention), 24 hours, 3 days, and 1 week post application of kinesio taping. Method of measurement: "Functional improvement will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC score evaluates pain, stiffness, and physical function, with higher scores indicating worse symptoms. Assessments will be conducted at baseline, 24 hours, 3 days, and 1 week post-application."(Provides a more detailed explanation of the WOMAC index and how it will be used.).</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 Kohat, Pakistan</contact_name>
        <contact_address>Combined Military Hospital Kohat Kohat Khyber Pakhtunkhwa Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
