RecruitingNot ApplicableNCT07198750

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

Effect of High-Intensity Pulsed Electromagnetic Field Therapy as a Bimodal Intervention for Analgesia and Strengthening in Older Adults With Knee Osteoarthritis: A Randomized Double-Blind Controlled Clinical Trial

Sponsor

Hospital Civil de Guadalajara

Enrollment

64 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

Knee Osteoarthritis Osteoarthritis Osteo Arthritis of the Knee

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.

Eligibility

Min Age: 60 Years

Inclusion Criteria6

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

Exclusion Criteria16

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

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Interventions

DEVICEHI-PEMF - Knee (Chronic Pain Protocol)

High-intensity pulsed electromagnetic field (HI-PEMF) therapy applied to the symptomatic knee using the "Chronic Pain" protocol of the BTL-6000 Super Inductive System, 10-minute duration per session, applied twice per week over 5 weeks (total of 9 sessions). The applicator is positioned 2-3 cm above the patella, without skin contact, with the patient seated or in supine position.

DEVICEHI-PEMF - Quadriceps (Muscle Strengthening Protocol)

HI-PEMF therapy will be applied to both the symptomatic knee and the quadriceps muscle (rectus femoris). The knee application will follow the same procedure as in Group A, using the "Chronic Pain" protocol of the BTL-6000 Super Inductive System. In addition, the quadriceps will be treated using the "Muscle Strengthening" protocol. Each site will receive 10 minutes of therapy per session, twice per week over 5 weeks (total of 9 sessions). The applicator for the quadriceps will be positioned perpendicular to the muscle belly, without skin contact, with the patient lying supine and a cushion under the knee for slight flexion.

BEHAVIORALHome-Based Exercise Program

Standardized home-based exercise program prescribed to both groups. It includes five exercises: isometric quadriceps contractions, straight leg raises, seated knee extensions, sit-to-stand from chair, and stationary marching. Participants are instructed to perform the exercises three times per week during the 5-week intervention. Printed instructions and a video guide are provided. Adherence is reinforced via weekly follow-up.