MIAMI--(BUSINESS WIRE)--Stimwave Technologies Incorporated, a privately held medical device manufacturer and research institute, today announced initiation of a multi-center, randomized, double-blind, placebo-controlled clinical study of its wireless high frequency stimulator for the treatment of chronic, non-specific origin low back pain, the “TsunamiTM” study.
The study is designed to compare a sham device to stimulation of spinal nerves at settings that are not perceived by the patient, thus allowing for a true, blinded patient experience. The study un-blinds the patients after 90 days, after which time the sham group devices are enabled to allow the sham participants to benefit from the therapy long-term. Overall pain scores utilizing visual analog score VAS measurements are the primary endpoints. Quality of Life (QoL), Patients Global Impression of Change (PGIC) and reduction in the use of opioids are the secondary endpoints.
“The unique Stimwave technology platform allows, for the first time, a true scientific study of neuromodulation therapy that can have no observational bias since all of the products are provided by the same manufacturer. It is truly blinded in order to finally enable accurate measurement of the effectiveness of the therapy,” said Stimwave Chairman and Chief Executive Officer Laura Tyler Perryman. It is the hope that the outcome of the study will provide proper evidence-based research to encourage utilization of electroceutical devices to replace or reduce dependence on pain medications and bring forth a new era in medicine with potentially fewer side effects than medications.
The Stimwave device is introduced through a needle procedure, eliminating the need for more complicated surgical intervention and reducing the risks of infection and adverse events associated with implantable pulse generators. The device classically delivers what are called “tonic” stimulation pulses, where the sensory and motor nerves react to the stimulation energy, producing a perceived tingling feeling. Optionally, the Stimwave platform includes the ability to program various settings of pulse waveforms and high frequencies that eliminate the perception feeling, enabling, for the first time in pain management, the ability to perform a placebo RCT.
“The medical community at large has long awaited the ability to conduct placebo controlled RCT for the treatment of chronic axial lower back pain patients without prior back surgery. This technology platform allows for flexibility in treatment to conduct this research that will benefit the field of neuromodulation immensely,” said Dr. Adnan Al-Kaisy, Director of The Pain Management and Neuromodulation Centre at Guy's and St. Thomas' Hospital NHS Trust, London/UK, and principal investigator of the trial.
The study will enroll a minimum of 45 patients throughout 2015 in centers throughout United Kingdom, The Netherlands, Switzerland and Belgium.
Stimwave Technologies Incorporated is a privately held medical device company engaged in the development, manufacture, and commercialization of wirelessly powered, injectable, microtechnology neurostimulators, providing patients with a convenient, safe, minimally invasive, and highly cost-effective pain management solution that is easily incorporated into their daily lives. Stimwave’s goal is to evolve its patented, cutting-edge platform into the default for neuromodulation, increasing the accessibility for patients worldwide while lowering the economic impact of pain management.