"Bimodal vs Unimodal High-Intensity Pulsed Electromagnetic Field Therapy in Older Adults With Kne… (NCT07198750) | Clinical Trial Compass
RecruitingNot Applicable
"Bimodal vs Unimodal High-Intensity Pulsed Electromagnetic Field Therapy in Older Adults With Knee Osteoarthritis"
Mexico64 participantsStarted 2025-09-15
Plain-language 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 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.
Who can participate
Age range60 Years
SexALL
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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 adver…
What they're measuring
1
Change in pain intensity measured by the Numeric Analog Scale (NAS)
Timeframe: Baseline, end of intervention (week 5), and 2-month follow-up