The study’s abstract is posted on the website of the conference website of the European League Against Rheumatism (EULAR).
of the study was to evaluate the efficacy of a wearable PEMF device on
pain intensity reduction in patients affected by knee osteoarthritis.
Secondary aim is to evaluate the effect on stiffness, function, quality
of life and pressure pain threshold.
Knee osteoarthritis is the
most common form of joint disease and the major cause of pain and
physical disability among elderly people, the study abstract said.
is the major cause of disability in the U.S. affecting 52.5 million
adults. Osteoarthritis of the knee is the most common musculoskeletal
pain and disability condition. Therefore, we are extremely pleased by
the results of Dr. Gianluca Bagnato's clinical study," said Ian Rawe,
Ph.D., director of research at BioElectronics.
manufactures over-the-counter wearable PEMF devices called ActiPatch
Therapy, and other devices for drug-free musculoskeletal pain relief.
study involved randomized, double-blind, placebo-controlled clinical
trial, with equal randomization (1:1) and parallel group. Knee
osteoarthritis (OA) patients, enrolled according to the ACR criteria,
with age >40 years, persistent pain, defined as a minimum mean score
of 40 on a 100 mm visual analog scales (VAS), symptomatic disease for at
least six months prior to enrollment have been recruited to be randomly
assigned to wear active (n=20) or placebo (n=20) device for 12 hours
daily for four weeks. Patients affected by secondary causes of OA or by
diabetes mellitus have been excluded.
Patients in the active
group showed a statistically significant improvement in visual analogue
pain scores (VAS) (p<0.005) and WOMAC (Western Ontario and McMaster
Universities Osteoarthritis Index) pain scores (p<0.001) at four
weeks compared to baseline.
Patients in the active group assessed
for function and disability showed statistically significant
improvement for WOMAC function (p<0.002) and WOMAC stiffness
(p<0.02) at four weeks compared to baseline.
Patients in the
active group also demonstrated statistically significant (p<0.04)
improved physical and mental health as assessed by the SF-36 (36-item
Medical Outcomes Study Short-Form 36 version 2) at four weeks compared
No statistically significant results were recorded in the placebo group. No adverse events have been observed during the study.
study concluded that given the low risk of adverse events, wearable
PEMF therapy “appears to be a promising and effective therapy in
reducing pain intensity, modulating pain threshold and increasing
quality of life in OA patients.”
Proponents of the study also
called for larger human studies to confirm the long-term effect on pain
intensity and on the modulation of pain threshold.
Wearable therapy device shows promise for pain management: study
May 14, 2014 — A new study from the University of Messina in Italy and University of Louisville in Kentucky shows wearable pulsed electromagnetic fields (PEMF) device may help reduce pain for patients with osteoarthritis.
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