| CTRI Number |
CTRI/2025/07/091779 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Which Works Better for Early Knee Osteoarthritis: Kinesiology Taping or Mulligan’s Movement Therapy? |
|
Scientific Title of Study
|
A Single Blinded Randomized Controlled Trial to Compare the Effectiveness of Kinesiology Taping and Mulligan’s Mobilization with Movement in Patients with Early Knee Osteoarthritis |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
STPriya |
| Designation |
Student |
| Affiliation |
SRM Institute of Science and Technology Trichy |
| Address |
4th floor Medical college building
SRM Institute of Science and Technology
Irugalur
Tiruchirappalli SRM Institute of Science and Technology Tiruchirappalli TAMIL NADU 621105 India |
| Phone |
9360097765 |
| Fax |
|
| Email |
stpriya2712@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
S Selvin James |
| Designation |
Assistant Professor |
| Affiliation |
SRM Institute of Science and Technology, |
| Address |
4th floor , Medical college building,
Tiruchirappalli TAMIL NADU 621105 India |
| Phone |
9994437109 |
| Fax |
|
| Email |
rajinijames@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
S Selvin James |
| Designation |
Assistant Professor |
| Affiliation |
SRM Institute of Science and Technology, |
| Address |
4th floor , Medical college building,
Tiruchirappalli TAMIL NADU 621105 India |
| Phone |
9994437109 |
| Fax |
|
| Email |
rajinijames@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical college hospital & research centre Tiruchirappalli
Tamil nadu
India
621105
|
|
|
Primary Sponsor
|
| Name |
STPriya |
| Address |
4th floor Medical college building
SRM Institute of Science and Technology
Irugalur
Tiruchirappalli
Tamil nadu
India
621105 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Mr S Selvin James |
Trichy SRM Medical College Hospital and research centre |
Irungalur, Tiruchirapalli - 621105 Tiruchirappalli TAMIL NADU |
9994437109
rajinijames@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TRICHY SRM IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
osteoarthritis knee |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kinesiology Taping |
Group A will receive Kinesiology Taping will be applied for 3 session over 2 weeks |
| Intervention |
Mulligans Mobilization with Movement |
Group B will receive Mulligans Mobilization with Movement technique will be applied for 3 session over 2 weeks |
| Comparator Agent |
Standard Exercise Protocols |
Group C is Control Group will receive Standard Exercise Protocols for 3 sessions over 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Unilateral Knee Osteoarthritis and Kellgren Lawrence grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
Knee Infections and Knee Surgeries and Rheumatoid Arthiritis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reducing the Pain assessed by Numerical Pain Rating Scale (NPRS), Functional Activity assessed by Western Ontario McMaster Osteoarthritis Index (WOMAC) Scale |
The baseline assessed in 2 weeks for NPRS and WOMAC |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life assessed by Quality of Life Shortform - 36 |
The baseline assessment on 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
08/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Patients referred from various departments such as the Orthopedic department will be recruited and the written consent form will be obtained from the patients. The patients will randomly be allotted into three groups by computer generated random sampling method and each group consist of 30 patients. After which a baseline assessment will be done for everyone who are recruited by physiotherapist who will be blinded in this study. Then the intervention is 3 sessions over 2 weeks will be given to those in the intervention group, Either Kinesiology Taping and Exercises or (MWM) Mobilization with Movement and Exercises. Those in the controlled group will receive the conventional treatment for Knee Osteoarthritis. Once the treatment sessions are over a post assessment will be done by the physiotherapist who will be blinded in this study. After which the Statistical Analysis will be done and the results will be revealed. |