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"Assessment of enhanced impact of Kinesio taping on Pain management in Knee Osteoarthritis - A Randomized controlled trial with standard care approaches"

Protocol summary

Study aim
the study aims to evaluate the short-term effects of Kinesio taping on pain reduction and functional improvement using the Numerical Rating Scale (NRS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Design
Randomized controlled trial (RCT), parallel-group design, comparing the effects of Kinesio taping with standard care versus standard care alone in patients with knee OA. A total of 100 participants randomly assigned to either the intervention group (Kinesio taping + standard care) or the control group (standard care alone) using concealed allocation. The study will follow up participants at 24 hours, 3 days, and 1 week post-intervention to assess outcomes.
Settings and conduct
conducted in clinical setting, patients randomly allocated and patients are not blinded
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 1. Aged 40 to 80 years 2. Chronic knee pain 3. Ability to provide informed consent 4.Intact skin over knee Exclusion Criteria: 1. Presence of skin allergies, open wounds, or infections at the application site. 2. Diagnosed with inflammatory joint diseases. 3. Patients with neurological disorders 4. Pregnant
Intervention groups
Intervention group will receive Kinesio taping (K-tape) application on the affected knee joint in addition to standard care. Tape strip (5 cm wide, length adjusted to knee size) placed medially from the tibial tuberosity to the rectus femoris muscle and another strip laterally. At middle portion 30-40% tension, at ends 0% tension. The tape will remain in place for 24 hours, unless discomfort or skin irritation occurs, in which case it will be removed.
Main outcome variables
NRS and western Ontario and McMaster Universities Osteoarthritis Index( WOMAC)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250303064920N1
Registration date: 2025-03-06, 1403/12/16
Registration timing: retrospective

Last update: 2025-03-06, 1403/12/16
Update count: 0
Registration date
2025-03-06, 1403/12/16
Registrant information
Name
Nimra Naeem
Name of organization / entity
Combined Military Hospital Kohat, Pakistan
Country
Pakistan
Phone
+92 321 5770860
Email address
nimranaeem2020@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
2024-11-01, 1403/08/11
Actual recruitment end date
2025-01-01, 1403/10/12
Trial completion date
2025-01-01, 1403/10/12
Scientific title
"Assessment of enhanced impact of Kinesio taping on Pain management in Knee Osteoarthritis - A Randomized controlled trial with standard care approaches"
Public title
"Effectiveness of Kinesio Taping on Pain Management in knee Osteoarthritis : A Randomized Controlled Trial"
Purpose
Treatment
Inclusion/Exclusion 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
Exclusion criteria:
Severe knee deformities Inflammatory diseases Chronic skin conditions Neurological disorders Overweight Pregnancy Skin Allergies Trauma Acute pain Open wounds
Age
From 40 years old to 80 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 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
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 Kohat, Pakistan
Street address
Combined Military Hospital Kohat
City
Kohat
Postal code
26000
Approval date
2024-09-20, 1403/06/30
Ethics committee reference number
E-2005/A/1

Health conditions studied

1

Description of health condition studied
Knee osteoarthritis
ICD-10 code
M19.0
ICD-10 code description
Primary osteoarthritis of other joints

Primary outcomes

1

Description
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."

Secondary outcomes

1

Description
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.)

Intervention groups

1

Description
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."
Category
Rehabilitation

2

Description
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.
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
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
Nimra Naeem
Position
Physiotherapy Intern
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Combined Military Hospital Kohat
City
Kohat
Province
Khyber Pakhtunkhwa
Postal code
26000
Phone
+92 321 5770860
Email
nimranaeem2020@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
Khyber Pkhtunkhwa
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 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 data will become available and for how long
The dataset will be made available upon request after the study’s completion and publication of findings.
To whom data/document is available
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.
Under which criteria data/document could be used
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.
From where data/document is obtainable
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
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 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
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