| 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
|
|
|
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
|
|
|
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. |