Skip to content

A clinical trial to study the effect of an appropriate pulsed electromagnetic field on knee pain, functionality, and cartilage (if any) in patients suffering from osteoarthritis

To establish manufacturing lines and to perform a pivotal clinical study of a Pulsed Electromagnetic Field based biophysically stimulated orthotic system for persons with knee osteoarthritis - NILL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/076385
Enrollment
150
Registered
2024-11-08
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M170- Bilateral primary osteoarthritis of knee

Interventions

Intervention1: Proposed PEMF based portable medical device named SWA-KNEE: To see the effect of proposed PEMF device on the OA patients by creating two groups namely experimental and control. Experime

Sponsors

Swayogya Rehab Solutions Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Primary OA Kellgren Lawrence Grade 1 -3 osteoarthritic patients. 2) Both male and female 3) Age 40-70 years 4) symptomatic disease for at least 6 months prior to enrolment 5) persistent pain despite receiving the maximal tolerated doses of conventional medical therapy

Exclusion criteria

Exclusion criteria: 1) Persons fitted with pacemaker. 2) Any prior knee surgery. 3) Persons fitted with any metallic implants. 4) Osteoarthritic patients having Kellgren Lawrence grade as 4. 5) Persons who do not provide consent for participation. 6) Presence of any medical condition that can impart effect on proposed intervention.

Design outcomes

Primary

MeasureTime frame
Both pre and post data related to pain and functionality from each and individual subjects on 1st, 5th, 15th, 30th, 45th and 60th day will be recorded using following methodologies in the experimental group (i.e., various data before and after the application of proposed medical device will be monitored): a. Pain Monitoring using Visual Analogue Scale (VAS) and Pain Pressure Threshold (PPT) device b. Functionality Monitoring using Knee Injury and Osteoarthritis Outcome Score (KOOS) and joint Angular movement measurement using Goniometers. c. Patient life style measurement using KOOS. d. Effect of Proposed PEMF device (i.e.Swaknee) on Knee Sound signals (Vibroarthrography) e. Effect of proposed device on articular (if any) using MRITimepoint: The proposed PEMF-based medical device will be applied daily to each patient in the experimental group for 45 minutes over a period of 45 days. The effects of the therapy will be assessed on the 1st, 5th, 15th, 30th, 45th, and 60th days. After completing the two-month treatment, patients will be monitored with follow-up assessments for an additional 4 months. Knee sound signals will also be collected to evaluate any changes in joint function related to the PEMF therapy.

Secondary

MeasureTime frame
To monitor the effect on articular cartilageTimepoint: 6 months

Countries

India

Contacts

Public ContactPooja Kumari Jha

Swayogya Rehab Solutions Pvt Ltd

swayogya19@gmail.com9310207675

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026