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

NCT07198750 | Recruiting

• 1 other identifier: CEI-151-25
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis; Osteoarthritis; Osteo Arthritis of the Knee; Gonarthrosis

Keywords

High-Intensity Pulsed Electromagnetic Fields; HI-PEMF; Super Inductive System; Knee Osteoarthritis; Gonarthrosis; Geriatric Rehabilitation; Chronic Pain; Functional Mobility

Outcome Measures

Primary Outcomes (1)

• Change in pain intensity measured by the Numeric Analog Scale (NAS)

  Pain intensity will be assessed using the 11-point Numeric Analog Scale (0 = no pain, 10 = worst possible pain), reported by the patient at rest and related to the most symptomatic knee. The primary endpoint is the change in NAS score from baseline to end of the 5-week intervention and at 2-month follow-up (approximately week 13). This will allow evaluation of both immediate and sustained effects of the intervention.

  Baseline, end of intervention (week 5), and 2-month follow-up

Secondary Outcomes (2)

• Change in functional mobility measured by the Timed Up and Go (TUG) test

  Baseline, end of intervention (week 5), and 2-month follow-up

• Change in lower-limb functional strength measured by the 5-times Sit-to-Stand (5STS) test

  Baseline, end of intervention (week 5), and 2-month follow-up

Study Arms (2)

Group A - Unimodal HI-PEMF

EXPERIMENTAL

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.

Device: HI-PEMF - Knee (Chronic Pain Protocol); Behavioral: Home-Based Exercise Program

Group B - Bimodal HI-PEMF

EXPERIMENTAL

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.

Device: HI-PEMF - Quadriceps (Muscle Strengthening Protocol); Behavioral: Home-Based Exercise Program

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.

Group A - Unimodal HI-PEMF

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.

Group B - Bimodal HI-PEMF

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.

Group A - Unimodal HI-PEMF; Group B - Bimodal HI-PEMF

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Civil de Guadalajara: lead

Study Sites (1)

Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Guadalajara, Jalisco, 44280, Mexico

RECRUITING

Related Publications (3)

• Iannitti T, Fistetto G, Esposito A, Rottigni V, Palmieri B. Pulsed electromagnetic field therapy for management of osteoarthritis-related pain, stiffness and physical function: clinical experience in the elderly. Clin Interv Aging. 2013;8:1289-93. doi: 10.2147/CIA.S35926. Epub 2013 Sep 26.

  PMID: 24106421 BACKGROUND

• Ong MT, Man GC, Lau LC, He X, Qiu J, Wang Q, Chow MC, Choi BC, Yu M, Yung PS. Effect of pulsed electromagnetic field as an intervention for patients with quadriceps weakness after anterior cruciate ligament reconstruction: a double-blinded, randomized-controlled trial. Trials. 2022 Sep 12;23(1):771. doi: 10.1186/s13063-022-06674-2.

  PMID: 36096886 BACKGROUND

• Bagnato GL, Miceli G, Marino N, Sciortino D, Bagnato GF. Pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial. Rheumatology (Oxford). 2016 Apr;55(4):755-62. doi: 10.1093/rheumatology/kev426. Epub 2015 Dec 24.

  PMID: 26705327 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Chronic Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants were informed that the intervention would be applied to the lower limb without specifying the anatomical region. The HI-PEMF equipment produces no perceptible sensations, aiding participant blinding. Outcome assessors were independent and unaware of group assignment. Care providers administering the intervention were not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician Specialist, Department of Physical and Rehabilitation Medicine

Model Details: Two-arm parallel design: Group A receives HI-PEMF applied to the knee only (unimodal), while Group B receives HI-PEMF applied to both the knee and quadriceps (bimodal). Both groups also perform the same home-based exercise program.

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 30, 2025
• Study Start: September 15, 2025
• Primary Completion: February 5, 2026
• Study Completion: April 15, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)