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

gonarthrosis 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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called HI-PEMF - Knee (Chronic Pain Protocol), a medical device called HI-PEMF - Quadriceps (Muscle Strengthening Protocol), and others for people with knee osteoarthritis, osteo arthritis of the knee, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 60 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.