Medical device manufacturer Stimwave Technologies has commenced a multi-center, randomized, double-blind and placebo-controlled clinical trial of its wireless high frequency stimulator to treat chronic and non-specific origin low back pain, the Tsunami study.
The trial has been 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 company plans to enroll a minimum of 45 patients throughout 2015 in centers across the UK, The Netherlands, Switzerland and Belgium.
According to the company, the trial unbinds 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.
Stimwave Technologies chairman and CEO Laura Tyler Perryman said: "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 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."
Stimwave develops and markets wirelessly powered and injectable, microtechnology neurostimulators.