The study aims to evaluate the short-term effects of Kinesio Taping on pain intensity and neck functional status using the Numerical Rating scale (NRS) and the Oswestry Neck Disability Index (ONDI).
Design
A randomized controlled trial (RCT) with a parallel-group design will compare Kinesio Taping + standard care vs. standard care alone in 100 neck pain patients. Randomization will be concealed. Assessments will be conducted at 24 hours, 3 days, and 1 week post-intervention.
Settings and conduct
The trial will be conducted in clinical settings. Participants will be randomly allocated to the intervention or control group. This is an open-label study; therefore, blinding will not be applied to participants, investigators, or outcome assessors.
Participants/Inclusion and exclusion criteria
-Inclusion Criteria: Adults aged 18-70 years.Chronic neck pain.Trauma or injury to the neck or Cervical spine.Informed consent and participate in the study.
-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 Neck trauma.
Intervention groups
The intervention group will receive Kinesio Taping (K-tape) on the neck based on standard KT guidelines. Taping will be applied for three consecutive days and reapplied over one week. Physiotherapy, exercises, and NSAIDs will be provided as needed.
Main outcome variables
Numeric pain rating scale(NRS) and Oswestry neck disability index(ONDI).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250308064984N1
Registration date:2025-04-13, 1404/01/24
Registration timing:retrospective
Last update:2025-04-13, 1404/01/24
Update count:0
Registration date
2025-04-13, 1404/01/24
Registrant information
Name
Hafsa Alam
Name of organization / entity
Combined Military Hospital Kohat Pakistan
Country
Pakistan
Phone
+92 333 3515751
Email address
alamhafsa131@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-01, 1403/08/11
Expected recruitment end date
2025-01-01, 1403/10/12
Actual recruitment start date
2024-01-01, 1402/10/11
Actual recruitment end date
2025-01-01, 1403/10/12
Trial completion date
2025-01-01, 1403/10/12
Scientific title
"Assessing the effectiveness of Kinesio Taping in Enhancing Conventional Therapies for Chronic Neck Pain - A Randomized Controlled Trial"
Public title
Assessing the effectiveness of Kinesio Taping for Chronic Neck Pain
Purpose
Treatment
Inclusion/Exclusion 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
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
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board, Combined Military Hospital
Street address
Kohat KPK Pakistan
City
Kohat
Postal code
26000
Approval date
2024-09-20, 1403/06/30
Ethics committee reference number
E-2005/A/102
Health conditions studied
1
Description of health condition studied
Neck or Cervical spine pain
ICD-10 code
M54.2
ICD-10 code description
Cervicalgia
Primary outcomes
1
Description
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.
Secondary outcomes
1
Description
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.
Intervention groups
1
Description
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.
Category
Other
2
Description
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.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Physical Medicine and Rehabilitation CMH Kohat KPK, Pakistan
Full name of responsible person
Dr Syed Tameem-UL-Hassan
Street address
Combined Military Hospital Kohat, KPK, Pakistan
City
Kohat
Postal code
26000
Phone
+92 336 8885877
Email
drtameem2@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Combined Military Hospital Kohat
Full name of responsible person
Dr Syed Tameem-UL-Hassan
Street address
CMH kohat
City
Kohat
Postal code
26000
Phone
+92 336 8885877
Email
drtameem2@gmail.com
Grant name
Government Institute
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Combined Military Hospital Kohat
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Combined Military Hospital Kohat
Full name of responsible person
Hafsa Alam
Position
Physiotherapy Intern
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Combined Military Hospital Kohat
City
Kohat
Province
KPK
Postal code
26000
Phone
+92 333 3515751
Email
alamhafsa131@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Combined Military Hospital Kohat
Full name of responsible person
Dr Syed Tameem-UL-Hassan
Position
Major
Latest degree
Specialist
Other areas of specialty/work
Physiotherapy
Street address
Combined Military Hospital Kohat
City
Kohat
Province
KPK
Postal code
26000
Phone
+92 336 8885877
Email
drtameem2@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Combined Military Hospital Kohat
Full name of responsible person
Dr Syed Tameem-UL-Hassan
Position
Major
Latest degree
Specialist
Other areas of specialty/work
Physiotherapy
Street address
CMH Kohat
City
Kohat
Province
Khyber Pakhtunkhwa
Postal code
26000
Phone
+92 336 8885877
Email
drtameem2@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
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 the data will become available and for how long
This data will be made avaliable upon request after the study's completion and publication of findings.
To whom data/document is available
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.
Under which criteria 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 purpose or patient re-identification.Proper citation of the original study is required in any resulting publication.
From where data/document is obtainable
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
What processes are involved for a request to access data/document
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.