This study will focus on comparing the commercially available SCS and PNS therapy versus sham (device off state) in a prospective, randomized controlled trial with a 12-month end point
Stimwave Technologies, the leading innovator of wireless medical device bioelectronic technology, in honor of September Pain Awareness Month, today announces the launch of a new randomized clinical trial treating painful peripheral neuropathy, the “SMOOTH” study.
Painful peripheral neuropathy resulting from damage to the peripheral nervous system affects an estimated 20 million people in the United States alone according the CDC.
Nerve stimulation is a well-established treatment for chronic neuropathic pain. However, traditional equipment has under served most of the patient population with pain distributions that are difficult to target.
This study will focus on comparing the commercially available SCS and PNS therapy versus sham (device off state) in a prospective, randomized controlled trial with a 12-month end point. The study will take place at over 20 sites throughout the US in conjunction with neuropathy diagnostic testing centers.
“Utilizing the innovative Stimwave wireless technology for pain associated with peripheral neuropathy has proven effective for many patients in my practice,” said Ryan Pollina, MD, the SMOOTH study Principal Investigator and Medical Director Blue Water Pain Specialists. “I look forward to conducting this prospective study to generate Level 1 evidence for the therapy and to widen the awareness of this novel, drug free, micro-technology option for patients suffering from the debilitating effects of peripheral neuropathy.”
Stimwave has the first FDA cleared wireless Freedom Stimulator devices for Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS). These devices are the world’s first wireless, fully programmable, stimulators for pain management and represent a life-changing technological breakthrough for the more than 90- million people in the U.S. who endure daily chronic back and leg pain.
Source: Company Press Release