<?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>IRCT20250308064979N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-03-30</date_registration>
      <primary_sponsor>Combined Military Hospital Kohat</primary_sponsor>
      <public_title>Effectiveness of Kinesiotaping on Pain Management in Lower Back: A Randomized Controlled Trial</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the Role of Kinesiotaping as an Adjunct to Medication, Physiotherapy, and Exercises in on Low Back Pain: Clinical Outcomes from 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/82577</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Other Design Features are:, Randomization description: his study employs a randomized controlled trial (RCT) design using a sample randomization method. Participants will be randomly assigned to either the Kinesio taping + standard care group or the standard care only group.

Method of Randomization
Type: Simple randomization
Unit of Randomization: Individual participants
Stratification
Participants will be stratified based on:
Age range: 20–60 years
Pain severity level: Moderate and severe
Randomization Process
Software Used: SPSS
Random Sequence Generation: Computer-generated randomization
Random Allocation Process: Allocation will be conducted using a random sequence to ensure unbiased group assignment.
Outcome Measures
Numerical Rating Scale (NRS) will be utilized to assess pain levels.
OSWESTRY Disability Index (ODI).</study_design>
      <phase>2-3</phase>
      <hc_freetext>Low Back Pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Description Intervention group: Participants will receive Kinesio Taping (K Tape) applied to the Lower Back The tape will be worn continuously for 24 hours and functional improvements will be assessed at baseline, 24 hours, 3 days. and 1week post-application using the Numeric Rating Scale (NRS) and ODI. Intervention 2: Control group: Participants will receive standard care (without KinesioTaping). Pain and functional improvements will be assessed at baseline 24hours, 3 days. and 1-week post-application using the Numeric Rating Scale (NRS) and ODI.</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 lower back. This datasheet consists of Demographics (age, gender), and grade of baseline assessment (ODI and NRS Scores) follow up results at 24 hours, 3 days and 1 week.

When:
This dataset will be made available upon request after study completion and publications of findings.

To whom:
The deidentified data will be available to researchers, clinicians and academic institutions conducting studies related to low back pain management, or rehabilitation interventions. Access will be granted upon formal request 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 purposes of patient re-identification.

Where to obtain:
Dataset is obtainable through formal request through emails

How to obtain:
A formal request is needed by official email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Syed Tameem ul Hassan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kohat Cantt</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>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Syed Tameem ul Hassan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kohat Cantt</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 20-60 years diagnosed with chronic low back pain (non-specific)No recent back surgery or significant spinal abnormalities both genders</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with inflammatory diseases (e.g., rheumatoid arthritis, ankylosing spondylitis)Pregnant women Skin allergies, wounds, or infections in the back area Neurological deficits (e.g., sciatica, herniated disc) Obesity (BMI &gt; 30)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Low back pain</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: Description Intervention group: Participants will receive Kinesio Taping (K Tape) applied to the Lower Back The tape will be worn continuously for 24 hours and functional improvements will be assessed at baseline, 24 hours, 3 days. and 1week post-application using the Numeric Rating Scale (NRS) and ODI</i_keyword>
      <i_keyword>Control group: Participants will receive standard care (without KinesioTaping). Pain and functional improvements will be assessed at baseline 24hours, 3 days. and 1-week post-application using the Numeric Rating Scale (NRS) and ODI</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain Reduction by applying Kinesio Taping on Lower Back. 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 (NFS) from 010 where 0 indicates no pain and 10 indicates the worst pain imaginableParticipants will report their pain levels at baseline, 24 hours. 3 days and 1week post-application of Kinesio tape.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Improvement in functional ability of individuals with lower back pain. 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 Oswestry Disability Index (ODI) to measure functional disability due to everyday activities such as standing, walking and lifting. Assessments will be conducted at baseline 24 hours 8days, 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 Kohat, Pakistan</contact_name>
        <contact_address>Kohat Cantt Kohat Khyber Pukhtunkhwa Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
