| CTRI Number |
CTRI/2025/07/091317 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study on Use of Pulsed Electromagnetic Therapy and Targeted Muscle Exercises in Osteoarthritis Patients |
|
Scientific Title of Study
|
Effect of Pulsed Electromagnetic Field Therapy Combined with Vastus Medialis Oblique Muscle Strengthening Exercises in Osteoarthritis Patients-A Randomized Control Trail. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Archita Mahavir Suriya |
| Designation |
MPT Student |
| Affiliation |
Abhinav Bindra Sports Medicine And Research Institute |
| Address |
Abhinav Bindra Sports Medicine Research And Institute,Plot 273 NH-16, Pahala, Bhubaneswar.
Khordha ORISSA 752101 India |
| Phone |
|
| Fax |
|
| Email |
architasuriya@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Priyadarshini Mishra |
| Designation |
Associate Professor, ABSMARI |
| Affiliation |
Abhinav Bindra Sports Medicine Research And Institute |
| Address |
Abhinav Bindra Sports Medicine Research And Institute,Plot 273, NH-16, Pahala, Bhubaneswar.
Khordha ORISSA 752101 India |
| Phone |
9438150665 |
| Fax |
|
| Email |
priyadarshinimishra@absmari.com |
|
Details of Contact Person Public Query
|
| Name |
Archita Mahavir Suriya |
| Designation |
MPT Student |
| Affiliation |
Abhinav Bindra Sports Medicine Research And Institute |
| Address |
Abhinav Bindra Sports Medicine Research And Institute,Plot 273 NH-16, Pahala, Bhubaneswar.
Khordha ORISSA 752101 India |
| Phone |
8652017015 |
| Fax |
|
| Email |
architasuriya@gmail.com |
|
|
Source of Monetary or Material Support
|
| My Physio Spot
Pushpak Chs, Opposite Gomantak Hall, Malviya Road, Vile Parle East-400057 |
|
|
Primary Sponsor
|
| Name |
Archita Mahavir Suriya |
| Address |
My Physio Spot Pushpak Chs, Opposite Gomantak Hall, Malviya Road, Vile Parle East-400057 |
| 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 Rajkumar Varma |
My Physio Spot |
My Physio Spot 52/2 Pathak Building,Nehru Road, Vile Parle East,Mumbai-400057 Mumbai MAHARASHTRA |
81607 03823
contact@myphysiospot.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ABSMARI Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Knee Osteoarthritis |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group-Pulsed Electromagnetic Field Therapy |
This group will be given PEMF for 40 mins for 5 days a week for 4 weeks |
| Intervention |
Experimental group-Pulsed Electromagnetic Field Therapy with Vastus Medialis Oblique muscle strengthening exercises |
This Group Patients will be given PEMF for 30 mins and Exercises for VMO strengthening. for 5 days a week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients diagnosed with OA Knee by an orthopedician or rheumatologist.
2)Patients showing GRADE 1,2, & 3 according to Kellgren & Lawrence classification of OA.
3)Patients with age 35 to 65
4)Patients with unilateral or bilateral OA.
5)Patients with primary or secondary OA |
|
| ExclusionCriteria |
| Details |
1)Patients with history of any knee surgery.
2) Patient with or a possibility of pregnancy.
3)Patients with any infection of the area being treated.
4) Patients with pacemaker.
5) Patients taking any analgesics. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Digital Vernier Calliper for measuring Joint Space Narrowing |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="56" Sample Size from India="56"
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)
|
24/07/2025 |
| 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="1" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Background - Knee osteoarthritis (KOA) is a common degenerative joint disease causing pain, swelling, and reduced function, especially in adults aged 30–65. It is the most prevalent form of osteoarthritis globally and a leading cause of disability. Diagnosis often involves radiographic evaluation of joint space narrowing and osteophyte formation, with methods like digital caliper measurements.Pulsed Electromagnetic Field Therapy (PEMF) is emerging as a safe, non-invasive, and effective treatment for KOA. It helps reduce inflammation, preserve joint structures, and improve physical function, and is supported by European and Dutch clinical guidelines for conditional use.VMO weakness is common in knee osteoarthritis (KOA) and often appears before pain. It plays a key role in patellar stability due to its oblique alignment and medial pull. Studies show that painful knees have reduced quadriceps mass, especially in the VMO, while other thigh muscles remain unaffected. Therefore, rehabilitation often targets the VMO to restore joint mechanics and improve knee function. Objective- To check effect of PEMF therapy on pain, stiffness and physical function of OA patients in Indian population. and To check how PEMF therapy combined with VMO strengthening exercises will be beneficial for patients with OA.
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