Protocol summary

Study aim
The primary objective of this study is to evaluate the clinical outcomes of adding Kinesio taping to standard treatment modalities (medication, physiotherapy, and exercises) in patients with LBP, specifically in terms of pain relief, functional improvement, and overall recovery.
Design
This RCT with a parallel-group design compares Kinesio taping + standard care vs. standard care alone in 100 patients with Low Back Pain. Randomization & Allocation Participants will be randomly assigned to either: Intervention: Kinesio taping + standard care Control: Standard care alone Allocation: Concealed randomization Follow-Up Assessments at 24 hours, 3 days, and 1 week post-intervention.
Settings and conduct
Conducted in Clinical Settings, patients randomly allocated, and patients are not blinded
Participants/Inclusion and exclusion criteria
Inclusion Criteria: • Adults aged 20-60 years • Diagnosed with chronic low back pain (non-specific) • Both genders • No recent back surgery or significant spinal abnormalities 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 > 30)
Intervention groups
The intervention group will have Kinesiotaping applied to the lumbar region based on standard KT methods for LBP. The tape will be applied for 3 consecutive days, following which it will be reapplied at regular intervals for one week. Physiotherapy and exercises will be administered as part of the treatment protocol for both groups. Medications, including nonsteroidal anti-inflammatory drugs (NSAIDs), will be prescribed based on individual needs.
Main outcome variables
NRS and ODI

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250308064979N1
Registration date: 2025-03-30, 1404/01/10
Registration timing: retrospective

Last update: 2025-03-30, 1404/01/10
Update count: 0
Registration date
2025-03-30, 1404/01/10
Registrant information
Name
Somaiya Ishaq
Name of organization / entity
Combined Military Hospital Kohat, Khyber Pukhtunkhwa, Pakistan
Country
Pakistan
Phone
+92 332 1946197
Email address
somaiyaishaq@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
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
Public title
Effectiveness of Kinesiotaping on Pain Management in Lower Back: A Randomized Controlled Trial
Purpose
Treatment
Inclusion/Exclusion 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
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 > 30)
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
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
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)
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Other Design Features are:

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Institutional Review Board, Combined Military Hospital Kohat, Pakistan
Street address
Kohat Cantt
City
Kohat
Postal code
26000
Approval date
2024-09-20, 1403/06/30
Ethics committee reference number
E-2005/A/3

Health conditions studied

1

Description of health condition studied
Low Back Pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain

Primary outcomes

1

Description
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

Secondary outcomes

1

Description
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

Intervention groups

1

Description
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
Category
Rehabilitation

2

Description
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
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
Kohat Cantt
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
Kohat Cantt
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
Dr. Syed Tameem ul Hassan
Position
Major
Latest degree
Specialist
Other areas of specialty/work
Physiotherapy
Street address
Kohat Cantt
City
Kohat
Province
Khyber Pukhtunkhwa
Postal code
26000
Phone
+92 336 8885877
Email
drtameem2@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
Kohat Cantt
City
Kohat
Province
Khyber Pukhtunkhwa
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
Somaiya Ishaq
Position
Physiotherapy Intern
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Kohat Cantt
City
Kohat
Province
Khyber Pukhtunkhwa
Postal code
26000
Phone
+92 332 1946197
Email
somaiyaishaq@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 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 the data will become available and for how long
This dataset will be made available upon request after study completion and publications of findings.
To whom data/document is available
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
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 purposes of patient re-identification.
From where data/document is obtainable
Dataset is obtainable through formal request through emails
What processes are involved for a request to access data/document
A formal request is needed by official email.
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