Health Condition 1: M170- Bilateral primary osteoarthritis of knee
Conditions
Interventions
Intervention1: SWA-KNEE (Proposed PEMF-based Medical Device): Participants in the intervention group receive the SWA-KNEE PEMF device for 45 minutes daily over 45 days in addition to standard care. Th
Sponsors
Swayogya Rehab Solutions Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age and Gender: Participants aged 40-70 Years, including males and females 2) Diagnosis of Osteoarthritis (OA): Participants must be diagnosed with OA knee 3) Symptom Duration: Experiencing symptomatic OA for at least 3 months before enrolment. 4) Inadequate Relief from Conventional Therapy: Persistent pain despite maximal tolerated doses of conventional medical treatment. 5) VAS Pain Score Range: Participants must have a Visual Analog Scale (VAS) pain score between 4 and 8, indicating moderate to severe pain levels. 6) Pressure Pain Threshold (PPT): participants should have a PPT score of less than or equal to 4kg per centimetres square when measured at specific knee joint sites (e.g. medial and lateral joint lines) using a calibrated algometer. This score reflects moderate to severe knee osteoarthritis. 7) Participants must show evidence of knee osteoarthritis on standing knee X-rays, with Kellgren-Lawrence (K-L) grade II to IV and alignment parameters as follows: - Medial Compartmental OA: Varus alignment less than equal to 5 degrees. - Lateral Compartmental OA: Valgus alignment less than equal to 5 degrees. 8) Willing to give written informed consent 9) Willing to comply with the trial protocol
Exclusion criteria
Exclusion criteria: 1) Pacemaker or Metallic Implants: Individuals with pacemakers or any metallic implants 2) Previous Knee Surgery: History of any prior knee surgery. 3) Patients with specific findings such as meniscus root tear, severe complex meniscus injuries, or gross osteochondral defects, as these conditions are unlikely to improve with the therapy proposed. 3) Other Medical Conditions: Presence of any medical condition that might impact the efficacy of the intervention. 4) Knee Deformities: Presence of any knee deformities. 5) Need for Alternative Treatments: Patients requiring other interventions besides standard conservative measures, such as intra-articular corticosteroid injections, or those resistant to conservative management. 6) Non-consent: Persons who do not consent to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Both pre and post data related to pain and functionality from each and individual subjects on 1st, 5th, 15th, 30th and 45th day will be recorded using following methodologies in the experimental group: a. Pain Monitoring using VAS and Pain Pressure Threshold device b. Functionality Monitoring using Knee Injury and Osteoarthritis Outcome Score (KOOS) and joint Angular movement measurement using Goniometers. c. life style measurement by KOOS. d. Effect (if any) on articular using MRITimepoint: Outcomes will be assessed at baseline (Day 1) and then on Days 5, 15, 30, and 45. These time points allow us to capture both the immediate and short-term effects of the intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the effect on articular cartilageTimepoint: 6 Months | — |
Countries
India
Contacts
Public ContactPooja Kumari Jha
Swayogya Rehab Solutions Pvt Ltd
Outcome results
None listed