BioElectronics Technology More Effective Than Extra Strength Tylenol(R) In Reducing Muscle Soreness In Clinical Study

Main Category: Pain / Anesthetics
Article Date: 17 Nov 2009 - 3:00 PST

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BioElectronics Corp. (PINKSHEETS: BIEL) 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.

Source
BioElectronics Corporation