Bimodal vs Unimodal High-Intensity Pulsed Electromagnetic Field Therapy for Older Adults with Knee Osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital Civil de Guadalajara "Fray Antonio Alcalde"
  Guadalajara, Jalisco, Mexico Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.