| CTRI Number |
CTRI/2025/12/099134 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
12/12/2025 |
| 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
|
To study the effect of TECAR therapy on patients with knee osteoarthritis. |
|
Scientific Title of Study
|
Effects of TECAR, Sham TECAR and Conventional Physiotherapy in Patients with Knee Osteoarthritis on physical function , disability and quality of life: A Randomized Control 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 |
Alisha Paudel |
| Designation |
PG student |
| Affiliation |
Amity Institute of Health and Allied Science |
| Address |
Amity university Noida, Amity Institute of Health and Allied Science,F block, first floor, room no. 101
Amity university Noida, Amity Institute of Health and Allied Science,F block, first floor, room no. 101
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9263827016 |
| Fax |
|
| Email |
alisha.paudel0000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Kumar Malik |
| Designation |
Assistant professor III |
| Affiliation |
Amity Institute of Health and Allied Science |
| Address |
Amity university Noida, Amity Institute of Health and Allied Science,F block, first floor, room no. 101
Amity university Noida, Amity Institute of Health and Allied Science,F block, first floor, room no. 101
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9899274238 |
| Fax |
|
| Email |
pkmalik@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Kumar Malik |
| Designation |
Assistant professor III |
| Affiliation |
Amity Institute of Health and Allied Science |
| Address |
Amity university Noida, Amity Institute of Health and Allied Science,F block, first floor, room no. 101
Amity university Noida, Amity Institute of Health and Allied Science,F block, first floor, room no. 101
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9899274238 |
| Fax |
|
| Email |
pkmalik@amity.edu |
|
|
Source of Monetary or Material Support
|
| Amity University,Noida,Amity Institute of Health and Allied Science |
|
|
Primary Sponsor
|
| Name |
Alisha Paudel |
| Address |
Amity University Noida Sector 125 India
Pin 201301 |
| 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 |
| Dr Pakaj kumar Malik |
Amity University |
Amity Institute of Health and Allied Science,Noida
201301,Uttar Pradesh, Sector 125, Department of Physiotherapy ,F block ,first floor,room no.101
Gautam Buddha Nagar
UTTAR PRADESH |
9899274238
pkmalik@amity.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amity University Noida |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional physiotherapy |
exercises and modalities other than TECAR for 4 weeks. |
| Comparator Agent |
Sham TECAR |
Sham TECAR for 4 weeks |
| Intervention |
TECAR |
TECAR for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients with knee pain aged between 40 to 75 years both male and female.
Clinically diagnosed cases with knee OA Grade 2 and 3 according to Kellgren Lawrence classification from X ray.
Patients with pain duration of more than 3 months.
Participants expressing voluntary participation and providing informed consent. |
|
| ExclusionCriteria |
| Details |
History of recent knee injury operation and intraarticular injection within the last 6 months
to 1 year
Patients with any obvious knee deformity and limb length descrepency
Known history of neurological infectious inflammatory or systemic diseases affecting
lower limbs
Patients with known history of cardiac pacemakers malignancies or contraindications for
TECAR therapy
Patients reported to undergo other physiotherapy treatments during the study period
Chronic pharmacological treatment with corticosteroids or NSAIDs for 6 month
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain
Disability
Quality of life |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Range of Motion
Muscle strength
Functional performance |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/01/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study is a randomized controlled trial designed to compare the effects of TECAR therapy, sham TECAR, and conventional physiotherapy in patients with Grade 2–3 knee osteoarthritis. The aim is to determine whether adding TECAR therapy provides additional benefits in terms of pain reduction, improved joint mobility, functional ability, disability, and quality of life.
A total of 72 participants will be randomly assigned into three groups:
-
TECAR + Conventional Physiotherapy
-
Sham TECAR + Conventional Physiotherapy
-
Conventional Physiotherapy only
The intervention will last 4 weeks (12 sessions). Outcome measures include VAS for pain, ROM (goniometer), strength (isokinetic dynamometer), WOMAC, and WHO-QOL. Data will be analyzed using One-way ANOVA.
The study addresses a major research gap because few previous studies used a sham group and the evidence regarding TECAR’s effectiveness in knee OA is still conflicting. By including a placebo group, this trial aims to clearly evaluate if improvements are due to the actual TECAR effect or placebo.
The findings are expected to guide physiotherapists in making evidence-based decisions regarding TECAR therapy in knee OA management.
|