Status:
RECRUITING
"Bimodal vs Unimodal High-Intensity Pulsed Electromagnetic Field Therapy in Older Adults With Knee Osteoarthritis"
Lead Sponsor:
Hospital Civil de Guadalajara
Conditions:
Knee Osteoarthritis
Osteoarthritis
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
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 t...
Detailed Description
Knee osteoarthritis (OA) is a highly prevalent and disabling condition in older adults. It often coexists with quadriceps muscle weakness, sarcopenia, and frailty, all of which contribute to pain, fun...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 15 2026
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT07198750
Start Date
September 15 2025
End Date
April 15 2026
Last Update
September 30 2025
Active Locations (1)
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1
Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, Jalisco, Mexico, 44280