In honour of September Pain Awareness Month, Stimwave has announced the launch of a new randomised clinical trial treating painful peripheral neuropathy, known as the “SMOOTH” study.
Painful peripheral neuropathy resulting from damage to the peripheral nervous system affects an estimated 20 million people in the USA alone according to the Centers for Disease Control and Prevention.
Nerve stimulation is a well-established treatment for chronic neuropathic pain. However, according to a press release, 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 spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS) therapy versus sham (device off state) in a prospective, randomised controlled trial with a 12-month endpoint. The study will take place at over 20 sites throughout the USA in conjunction with neuropathy diagnostic testing centres.
“Utilising the innovative Stimwave wireless technology for pain associated with peripheral neuropathy has proven effective for many patients in my practice,” said Ryan Pollina, 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 SCS and 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 USA who endure daily chronic back and leg pain.