Actively Recruiting

Phase Not Applicable
Age: 60Years +
All Genders
NCT07198750

"Bimodal vs Unimodal High-Intensity Pulsed Electromagnetic Field Therapy in Older Adults With Knee Osteoarthritis"

Led by Hospital Civil de Guadalajara · Updated on 2025-09-30

64

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This randomized, double-blind clinical trial aims to evaluate the effect of high-intensity pulsed electromagnetic field therapy (HI-PEMF) applied either exclusively on the knee joint or bimodally on the knee and quadriceps, in older adults with knee osteoarthritis. Both groups will also receive a structured home-based exercise program. The primary outcome is pain reduction, and secondary outcomes include functional performance.

CONDITIONS

Official Title

"Bimodal vs Unimodal High-Intensity Pulsed Electromagnetic Field Therapy in Older Adults With Knee Osteoarthritis"

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Guadalajara, Jalisco, Mexico, 44280

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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