"Bimodal vs Unimodal High-Intensity Pulsed Electromagnetic Field Therapy in Older Adults With Knee Osteoarthritis"
Recruiting · NCT07198750 · Interventional (participants receive a specific treatment) · Lead sponsor: Hospital Civil de Guadalajara
View the official record on ClinicalTrials.gov →Interventions studied
HI-PEMF - Knee (Chronic Pain Protocol)HI-PEMF - Quadriceps (Muscle Strengthening Protocol)Home-Based Exercise Program
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.
Who can take part
Age range
60 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Hospital Civil de Guadalajara "Fray Antonio Alcalde" - Guadalajara, Jalisco, Mexico