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

Sponsor
Hospital Civil de Guadalajara
Study ID
NCT07198750
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HI-PEMF - Knee (Chronic Pain Protocol) — DEVICE
    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.
  • HI-PEMF - Quadriceps (Muscle Strengthening Protocol) — DEVICE
    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.
  • Home-Based Exercise Program — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Sep 30, 2025
Start date
Sep 15, 2025
Status verified
Sep 2025
Primary completion
Feb 5, 2026
Completion
Apr 15, 2026

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A - Unimodal HI-PEMF
    Participants in Group A will receive high-intensity pulsed electromagnetic field therapy (HI-PEMF) applied exclusively to the symptomatic knee (femorotibial joint) for 10 minutes per session, twice a week over 5 weeks, completing a total of 9 sessions. The intervention will use the "Chronic Pain" protocol of the BTL-6000 Super Inductive System. A standardized home-based exercise program will be provided to all participants.
  • Experimental: Group B - Bimodal HI-PEMF
    Participants in Group B will receive high-intensity pulsed electromagnetic field therapy (HI-PEMF) applied to both the symptomatic knee (femorotibial joint) and the quadriceps muscle (rectus femoris), with 10 minutes per site, twice a week over 5 weeks, completing a total of 9 sessions. The knee application will follow the "Chronic Pain" protocol, and the quadriceps application will follow the "Muscle Strengthening" protocol, both using the BTL-6000 Super Inductive System. A standardized home-based exercise program will be provided to all participants.

Primary Outcome Measure

Change in pain intensity measured by the Numeric Analog Scale (NAS) [ Time Frame: Baseline, end of intervention (week 5), and 2-month follow-up ]

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