Avacen Medical announced promising results from a clinical trial investigating the AVACEN Thermal Exchange System for fibromyalgia treatment, with findings of reduced pain across a widespread index of measures in study participants.
The study, performed by researchers at the University of California, San Diego, and the Department of Veterans Affairs, involved 22 participants with fibromyalgia according to the 2010 ACR diagnostic criteria. The primary outcome evaluated was the Widespread Pain Index (WPI) score after four weeks of treatment, defined as pain occurring in at least two contralateral body quadrants, in addition to the axial skeleton, for at least three consecutive months.
Findings indicated that patients, after a 28-day follow-up, showed a statistically significant reduction of more than 40% in WPI and a decrease in tender point count to a level below the value normally used for the clinical disease evaluation.
Treatment in the clinical trial consisted of the AVACEN Thermal Exchange System, a noninvasive means of continuous heat transfer from the palm into the circulatory system while the body stays at normal temperature (98.6 degrees F; 37 degrees C). According to the company, this heat acts as a catalyst to decrease blood thickness, with the body dissipating the unwanted heat infusion by pumping warmed blood through deep tissue until it reaches the capillary network, where it can be cooled by the air. The heat system induces an increase in microvascular circulation that can be of significant benefit.
“Our patented AVACEN Treatment Method is an entirely new concept in chronic pain treatment through whole-body muscular relaxation. This is accomplished by bathing the skeletal muscles with warm oxygenated and nutritious blood. Our FDA-Cleared AVACEN 100 uses the AVACEN Treatment Method,” Thomas Muehlbauer, Avacen’s medical CEO and the method’s inventor, said in a press release. “These results can significantly improve the quality of life for fibromyalgia sufferers worldwide. We have submitted this data to the FDA and are eager to receive approval to market our device for relief of widespread pain associated with fibromyalgia. This disease affects approximately 10 million people in the U.S. and an estimated 3-6% of the global population.”
The company also notes that while a number of medicines have been approved for the treatment of pain associated with fibromyalgia, there are currently no known FDA-approved or -cleared medical devices. The AVACEN 100 uses the same method as the heat exchange system and has a record of some 500,000 treatments for conditions such as arthritis without any reported negative side effects, according to the release.