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CTRI Number  CTRI/2024/07/070843 [Registered on: 18/07/2024] Trial Registered Prospectively
Last Modified On: 26/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A controlled trial to study the effect of Kinesio Taping and Sham Taping on Pain and Functional Mobility in knee osteoarthritis patients  
Scientific Title of Study   Comparative Efficacy of Kinesio Taping and Sham Taping on Pain and Functional Mobility in patients with Knee Osteoarthritis: A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aida Priyanka 
Designation  Post Graduate Student 
Affiliation  National Institute For Locomotor Disabilities(Divyangjan) 
Address  Room Number 117, Department Of Physiotherapy National Institute For Locomotor Disabilities (Divyangjan) BT Road, Bonhooghly, Kolkata North Twentyfour Parganas West Bengal 700090 India

North Twentyfour Parganas
WEST BENGAL
700090
India 
Phone  8008530487  
Fax    
Email  apriyanka2111@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Amrita Mukherjee 
Designation  Lecturer 
Affiliation  National Institute For Locomotor Disabilities(Divyangjan) 
Address  Room Number 117, Department Of Physiotherapy National Institute For Locomotor Disabilities (Divyangjan) BT Road, Bonhooghly, Kolkata North Twentyfour Parganas West Bengal 700090 India

North Twentyfour Parganas
WEST BENGAL
700090
India 
Phone  7384361511  
Fax    
Email  m.amrita007@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Aida Priyanka 
Designation  Post Graduate Student 
Affiliation  National Institute For Locomotor Disabilities(Divyangjan) 
Address  Room Number 117, Department Of Physiotherapy National Institute For Locomotor Disabilities (Divyangjan) BT Road, Bonhooghly, Kolkata North Twentyfour Parganas West Bengal 700090 India

North Twentyfour Parganas
WEST BENGAL
700090
India 
Phone  8008530487  
Fax    
Email  apriyanka2111@gmail.com  
 
Source of Monetary or Material Support  
National Institute For Locomotor Disabilities (Divyangjan) 
 
Primary Sponsor  
Name  Aida Priyanka 
Address  National Institute For Locomotor Disabilities (Divyangjan) 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Aida Priyanka  National Institute For Locomotor Disabilities (Divyangjan)  Room Number 117, Department Of Physiotherapy National Institute For Locomotor Disabilities (Divyangjan) BT Road, Bonhooghly, Kolkata North Twentyfour Parganas West Bengal 700090 India
North Twentyfour Parganas
WEST BENGAL 
8008530487

apriyanka2111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kinesio Taping  The intervention group will receive Kinesio Taping (4 sessions for 2 weeks-1st ,3rd ,5th and 8th day) along with Standardized Exercise Program (5 sessions per week for 2 weeks).Patient will perform the Home Exercise Program once a day in home during 2 weeks of treatment period. 
Comparator Agent  Sham Taping  This group will receive Sham Taping (4sessions for 2 weeks – 1st,3rd,5th and 8th day) along with Standardized Exercise Program (5 sessions per week for 2 weeks).Patient will perform the Home Exercise Program once a day in home during 2 weeks of treatment period.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Both male and female patients willing to participate.
2. Patients aged between 40-65 years.
3. Pain duration of more than 3 months.
4. Numerical Pain Rating Scale (NPRS) Score between 3-8.
5. Patients with Knee Osteoarthritis grade III according to Kellgren and Lawrence classification.

 
 
ExclusionCriteria 
Details  1. History of acrylic allergy or positive patch test.
2. Active localised skin infection, irritated or fragile skin around the knee, open traumatic wound, recent scars.
3. Musculoskeletal conditions like ligament sprains, meniscus injury, fracture, any surgery of lower extremity and deformity of lower extremities etc.
4. Rheumatological diseases like rheumatoid arthritis and ankylosing spondylosis or any infective arthritis.
5. Systemic disorders involving lower extremity like deep vein thrombosis, venous insufficiency and lymphatic disorders etc.
6. Diagnosed neurological conditions like stroke, cerebral palsy, muscle dystrophies, peripheral neuropathies, spinal cord and brain injury etc.
7. Patients who are using knee orthosis.
8. Patients on oral steroid within 1 month or intra-articular corticosteroid over knee joint within 3 months.
9. Non-cooperative patients.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Pain intensity by -Numerical Pain Rating Scale (NPRS).
2. Functional mobility by - Timed Up and Go (TUG) Test.
3. Function by - WOMAC Osteoarthritis Index.
 
2 times - on day 0 and after 2 weeks (10 sessions)
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/07/2024 
Date of Study Completion (India) 10/06/2025 
Date of First Enrollment (Global)  26/07/2024 
Date of Study Completion (Global) 10/06/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

PURPOSE OF THE STUDY:

 

There are various studies showing efficacy of Kinesio Taping in patients with Knee Osteoarthritis in Pain, Gait, Strength, Proprioception and Balance etc. However, to the best of our knowledge there are no studies which compared the efficacy of Kinesio Taping and Sham Taping on Pain and Functional Mobility in patients with Knee Osteoarthritis in Indian population.

Therefore, the purpose of the study is to find out the comparative efficacy of Kinesio Taping and Sham Taping on Pain and Functional Mobility in patients with Knee Osteoarthritis.


AIM: 

To compare the efficacy of Kinesio Taping and Sham Taping on pain and functional mobility in patients with Knee Osteoarthritis.


OBJECTIVES:

1.      To find out the efficacy of Kinesio Taping along with Standardized Exercise Program on pain and functional mobility in patients with Knee Osteoarthritis.

2.      To find out the efficacy of Sham Taping along with Standardized Exercise Program on pain and functional mobility in patients with Knee Osteoarthritis.

3.      To compare the efficacy of Kinesio Taping and Sham Taping along with Standardized Exercise Program on pain and functional mobility in patients with Knee Osteoarthritis.


NULL HYPOTHESIS :

There is no statistically significant difference between the efficacy of Kinesio Taping and Sham Taping on pain and functional mobility in patients with Knee Osteoarthritis.


ALTERNATIVE HYPOTHESIS :

There is statistically significant difference between the efficacy of Kinesio Taping and Sham Taping on pain and functional mobility in patients with Knee Osteoarthritis.


PROCEDURE:

Institutional Ethical Committee (IEC) approval will be taken before commencement of the study. All patients having Knee Pain or diagnosed with Knee Osteoarthritis are referred to the department of Physiotherapy from the Assessment clinic (ASC) of National Institute for Locomotor Disabilities (Divyangjan)  will be approached with the proposal of the study. Total 30 patients will be evaluated and screened according to inclusion and exclusion criteria along with radiological evaluation using x-ray for Kellgren and Lawrence classification .Patients meeting the exclusion criteria will not be included. Those fulfilling the inclusion criteria will be explained in details about the study in their preferred language. Written informed consent will be obtained from the patients agreeing to participate. Then the patients will be randomly divided into two groups by block randomization method by computer generated random blocks.

The demographic data and the outcome measure for Pain Intensity by Numerical Pain Rating Scale (NPRS), Functional Mobility by Timed Up and Go (TUG) Test and Function by WOMAC Osteoarthritis Index will be collected from each patient at Day 1 before starting the intervention and post-intervention at Day 10 i.e.at the end of 10th session (5 sessions per week for 2 weeks). All the patients in “Group A” (n=15) will be treated with Kinesio Taping along with Standardized Exercise Program for 10 sessions, whereas in “Group B” (n=15) patients will be treated with Sham Taping along with Standardized Exercise Program for 10 sessions.

Kinesio Taping and Sham Taping will be applied 4 sessions for 2 weeks on 1st ,3rd ,5th & 8th day and Standardized Exercise Program for 5 sessions per week for 2 weeks. The patient will be advised to contact the investigator incase the tape is dislodged or separated from the skin. After completion of 10 sessions (5 sessions per week) of intervention, all the patients will continue Home Exercise Program (HEP).

Rescue medication duly prescribed by the physician will be continued throughout the study, along with the standardized physiotherapeutic approach in both the groups.

 

 

 

 
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