Pulsed electromagnetic field therapy for management of osteoarthritis-related pain, stiffness and physical function: clinical experience in the elderly.
Tommaso Iannitti, Gregorio Fistetto, Anna Esposito...
https://pubmed.ncbi.nlm.nih.gov/24106421Actively Recruiting
Phase Not Applicable
Age: 60Years +
All Genders
ID07198750
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
Led by Hospital Civil de Guadalajara · Updated on 2025-09-30
64
Participants Needed
1
Research Sites
9 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the effects of high-intensity pulsed electromagnetic field therapy (HI-PEMF) in older adults with moderate to severe knee osteoarthritis (OA). This randomized, double-blind clinical trial compares two treatment methods: HI-PEMF applied only to the knee joint versus HI-PEMF applied both to the knee and the quadriceps muscles. The study aims to understand pain reduction and improvement in functional performance in this population, addressing common issues such as muscle weakness and frailty associated with knee OA. Participants will be randomly assigned to one of two groups. Group A will receive HI-PEMF therapy focused exclusively on the symptomatic knee for 10 minutes per session, twice weekly for 5 weeks, totaling 9 sessions. Group B will receive HI-PEMF therapy applied to both the knee and the quadriceps muscle, with each site treated for 10 minutes per session under the same schedule. Both groups will also follow a standardized, home-based exercise program involving five specific strengthening and mobility exercises performed three times per week during the 5-week treatment period. The BTL-6000 Super Inductive System device is used for all HI-PEMF treatments. During the study, participants will be assessed at the start, after the 5-week intervention, and at a 2-month follow-up. Researchers will measure changes in pain using the Numeric Analog Scale (NAS), functional mobility through the Timed Up and Go (TUG) test, and lower-limb strength with the 5-times Sit-to-Stand (5STS) test. Additional evaluations include monitoring paracetamol use, frailty, sarcopenia, and radiological OA grade. Adherence to treatment sessions and exercises will be closely followed, and safety monitored throughout the study, which lasts a total of about three months including follow-up.
CONDITIONS
Brief Title
"Bimodal vs Unimodal High-Intensity Pulsed Electromagnetic Field Therapy in Older Adults With Knee Osteoarthritis"
Who Can Participate
Age: 60Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 60 years or older
- Clinical and radiological diagnosis of knee osteoarthritis grade I-IV
- Knee pain of 3 or more on the Numeric Analog Scale lasting more than 6 months
- Ability to walk with or without assistance
- Cognitive ability to understand and follow instructions
- Signed informed consent
- Availability to attend 9 treatment sessions and perform home exercises
You will not qualify if you...
- Prior total knee replacement surgery (unilateral or bilateral)
- Neurological disorders affecting movement or cognition such as Parkinson's disease, stroke, or moderate to severe dementia
- Active inflammatory rheumatic diseases like rheumatoid arthritis or lupus
- Presence of pacemakers, implantable defibrillators, or metal implants near the treatment area
- Current use of other physical therapy treatments for pain outside this study
- Participation in another clinical trial within the past 3 months
- Use of NSAIDs or corticosteroids including injections
- Open wounds or infections at the treatment site
- Unstable heart conditions or medical reasons preventing exercise
- Balance disorders affecting assessments
- Uncorrected poor vision interfering with walking or balance (worse than 20/60 vision)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 5 weeks
Participants receive high-intensity pulsed electromagnetic field therapy applied either to the symptomatic knee alone or to both the knee and quadriceps muscle, along with a standardized home-based exercise program. Therapy sessions occur twice a week over 5 weeks, totaling 9 sessions.
Twice weekly visits for a total of 9 sessions
Follow-up
Duration - 2 months
Participants are assessed for changes in pain intensity and functional mobility at 2 months after completing the treatment.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, Jalisco, Mexico, 44280
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Effect of pulsed electromagnetic field as an intervention for patients with quadriceps weakness after anterior cruciate ligament reconstruction: a double-blinded, randomized-controlled trial.
Michael Tim-Yun Ong, Gene Chi-Wai Man, Lawrence Chun-Man Lau...
https://pubmed.ncbi.nlm.nih.gov/36096886Pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial.
Gian Luca Bagnato, Giovanni Miceli, Natale Marino...
https://pubmed.ncbi.nlm.nih.gov/26705327