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Clinical Trials in Mexico / NCT07198750
Recruiting Not applicable

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

NCT07198750 · tracked via the Priya Life Science Mexico tracker
Sponsor
Hospital Civil de Guadalajara
Phase
Not applicable
Started
2025-09-15
Last updated
2025-09-30

Condition(s) studied

Knee OsteoarthritisOsteoarthritisOsteo Arthritis of the KneeGonarthrosis

Investigational drug(s) / intervention(s)

HI-PEMF - Knee (Chronic Pain Protocol)HI-PEMF - Quadriceps (Muscle Strengthening Protocol)Home-Based Exercise Program

HI-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.

HI-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.

Home-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.

Study 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

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in pain intensity measured by the Numeric Analog Scale (NAS) — Baseline, end of intervention (week 5), and 2-month follow-up
    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.

Trial sites (1)

FacilityCityRegionStatus
Hospital Civil de Guadalajara "Fray Antonio Alcalde" Guadalajara Jalisco Recruiting

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Other trials for the same condition

Persona Ti-Nidium Post-Market Clinical Follow-up Active, not recruiting
A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee Active, not recruiting
Persona Partial Knee Clinical Outcomes Study Active, not recruiting
Efficacy and Safety of Celecoxib/Acetaminophen Versus Celecoxib for Diagnosed Osteoarthritis in Acute Exacerbation Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07198750 on ClinicalTrials.gov ↗ ← All trials in Mexico