BioElectronics Technology More Effective Than Extra Strength Tylenol(R) in Reducing Muscle Soreness in Clinical Study
November 16 2009 - 4:10PM
Marketwired
BioElectronics Corp. (PINKSHEETS: BIEL) today announced that its
disposable drug-free anti-inflammatory devices proved to be
significantly more effective than acetaminophen in a clinical study
of Delayed Onset Muscle Soreness (DOMS).
The study tested the effectiveness of ActiPatch® Therapy versus
acetaminophen in reducing the pain of Delayed Onset Muscle
Soreness, a condition associated with increased physical
exertion.
"We now have an additional Institutional Review Board (IRB)
supervised and National Institutes of Health (NIH) registered
clinical study that demonstrates what our customers have been
saying for years," said Andrew Whelan, CEO, BioElectronics Corp.
"Our products give fast, localized relief from pain and swelling
without the danger of drug side effects. We plan to use this
additional study to further support our pending 510(K) applications
on file at FDA as well as possibly using them in additional
applications."
"In the study more than 100 healthy male and female college
athletes and trainers were given a vigorous resistance exercise
regimen to induce DOMS. They were then randomly divided into three
groups; a group that used ActiPatch for two days, a control group
that received no treatment, and a third group that was to be
treated with acetaminophen," commented Sheena Kong, M.D. the
principal investigator. "All participants returned approximately 48
hours after the exercise regime. Upon return those in the ActiPatch
and control groups immediately rated their levels of muscle pain
and soreness using the Visual Analogue Scale. Participants in the
acetaminophen group were given one gram of acetaminophen in the
form of Extra Strength Tylenol® and then 90 minutes later rated
their levels of muscle pain and soreness using the same scale."
Dr. Kong continued, "The study was conclusive showing that the
ActiPatch treated volunteers had significantly less pain than those
in either the acetaminophen or control groups. Also of note was the
fact that some of the participants assigned to the acetaminophen
group were eliminated from the results because they expressed
reservations about consuming the drug."
The report notes that there was a highly significant difference
between the control group and the group using the ActiPatch, with
the control group indicating an average VAS pain level of 3.179
compared to 1.500 for the ActiPatch group where lower numbers
indicate lower pain levels. This difference between the two groups
was found to be significant at the .001 level. The difference
between the acetaminophen group and the ActiPatch group was also
highly significant with the acetaminophen group indicating an
average pain level of 2.507, i.e., over one point higher than the
ActiPatch group. This difference was found to be significant at the
.05 level.
ActiPatch technology truncates the human body's natural
inflammatory response by breaking the cycle of chronic
inflammation. ActiPatch does this by delivering sensation-free
pulsed electromagnetic energy and RF waves directly to the affected
area and driving out the edematous fluid along with byproducts of
the damaged tissue. The effect is well documented and results in a
significant overall improvement in the restorative and recovery
process following a soft tissue injury. This speedier healing
results in a significant reduction in the pain associated with the
injury. ActiPatch has been used by thousands of people throughout
the world and maintains a 100% safety profile.
The study is Institutional Review Board (IRB) supervised and has
been registered with the National Institutes of Health. The
principal investigator, Sheena Kong, M.D. holds no financial
position in any form in the study's sponsor, BioElectronics Corp.,
and has not and will not receive financial compensation of any kind
for the administration or completion of the study. The
acetaminophen used in the study was Extra Strength Tylenol® in 1
gram doses.
A complete copy of the study results and protocol is available
on the BioElectronics Corp. web site:
http://www.bioelectronicscorp.com.
About BioElectronics Corporation
BioElectronics Corporation is the maker of ActiPatch® Therapy,
RecoveryRx(TM) Devices, HealFast® Therapy www.healfasttherapy.com
and the Allay(TM) family of inexpensive, disposable drug-free
anti-inflammatory devices. For more information please see
http://www.BioElectronicsCorp.com.
*Tylenol is a registered trademark of McNeil, PPC. Inc.
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For media enquiries, please contact: Joe Noel BioElectronics
Corp. (925) 922-2560
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