Bimodal vs Unimodal High-Intensity Pulsed Electromagnetic Field Therapy for Older Adults with Knee Osteoarthritis
Effect of High-Intensity Pulsed Electromagnetic Field Therapy as a Bimodal Intervention for Analgesia and Strengthening in Older Adults With Knee Osteoarthritis: A Randomized Double-Blind Controlled Clinical Trial
This trial will test whether applying high-intensity pulsed electromagnetic fields to both the knee and quadriceps reduces pain and improves function more than applying it only to the knee in adults 60 and older with knee osteoarthritis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Hospital Civil de Guadalajara Academic / other |
| Locations | 1 site (Guadalajara, Jalisco) |
| Trial ID | NCT07198750 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, parallel-group trial will enroll 64 older adults with moderate to severe knee osteoarthritis and randomize them 1:1 to receive HI-PEMF applied either to the symptomatic knee alone or to both the knee and the quadriceps. Treatments are delivered with a BTL-6000 Super Inductive System across nine HI-PEMF sessions over about five weeks, and all participants follow a standardized home-based strengthening and mobility exercise program. The primary outcome is pain reduction measured from baseline to post-intervention, with secondary outcomes including functional performance and muscle-related measures. Outcomes are measured at baseline and after the intervention period to compare the two application approaches.
Who should consider this trial
Good fit: Ideal candidates are adults aged 60 or older with radiographic knee osteoarthritis (Kellgren-Lawrence grade I–IV), chronic knee pain ≥3/10 for over six months, able to walk and follow instructions, and available for nine treatment sessions and home exercises.
Not a fit: Patients with pacemakers or implantable defibrillators, active inflammatory rheumatic disease, prior total knee replacement, recent corticosteroid use, neurological disorders affecting motor function, or open wounds near the treatment area are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could reduce knee pain and improve quadriceps activation and function, offering a noninvasive treatment option that may delay more invasive interventions.
How similar studies have performed: Previous PEMF studies have reported promising pain relief and some muscle activation benefits, but high-intensity bimodal (knee plus quadriceps) application in a randomized, double-blind design remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 60 * Clinical and radiological diagnosis of knee OA grade I-IV * Pain ≥ 3 on Numeric Analog Scale for \>6 months * Can walk (with/without aid) * Cognitive ability to follow instructions * Signed informed consent * Availability for 9 treatment sessions and home exercise Exclusion Criteria * Prior total knee arthroplasty (unilateral or bilateral) * Neurological disorders affecting motor function or cognition (e.g., Parkinson's disease, stroke, moderate to severe dementia) * Active inflammatory rheumatic diseases (e.g., rheumatoid arthritis, lupus) * Presence of pacemakers, implantable defibrillators, or metallic implants near the treatment area * Current use of other physical therapy modalities for pain (e.g., electrotherapy, ultrasound, TENS) outside the study protocol * Participation in another clinical trial within the past 3 months * Current use of NSAIDs or systemic/local corticosteroids (including intra-articular injections) * Open wounds or active infections at the treatment site * Decompensated cardiac conditions or medical contraindication to exercise * Vestibular disorders that affect balance and interfere with functional assessments * Uncorrected visual impairment interfering with gait or balance (visual acuity worse than 20/60 in the better eye, assessed by Snellen chart) Withdrawal Criteria: * Participants who complete fewer than 7 out of the 9 planned intervention sessions (i.e., less than 80% adherence) * Occurrence of serious adverse events related to the intervention that contraindicate continuation * Repeated non-compliance with the home exercise program, documented in at least two consecutive weekly follow-up reports * Voluntary withdrawal of consent at any time during the study
Where this trial is running
Guadalajara, Jalisco
- Hospital Civil de Guadalajara "Fray Antonio Alcalde" — Guadalajara, Jalisco, Mexico (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.