Stimwave Technologies said it’s launching a new clinical trial for its miniature, wireless neuromodulation anti-pain device for treating chronic, non-specific-origin lower back pain.
The multi-center, randomized, double-blind, placebo-controlled Tsunami study is slated to enroll 45 patients in a comparison of spinal nerve simulation and a sham device, according to a press release.
The trial is designed to be un-blinded after 90 days, when the sham devices will enabled to allow the control cohort to receive therapy, according to Stimwave. The primary endpoint is overall pain score using visual analog scoring measurements, with secondary endpoints of quality of life, patients global impression of change and opioid use reduction, the Miami-based company said.
"The unique Stimwave technology platform allows, for the 1st 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," chairman & CEO Laura Tyler Perryman said in prepared remarks.
“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," added principal investigator Dr. Adnan Al-Kaisy of London’s Pain Management & Neuromodulation Centre at Guy’s and St. Thomas’ Hospital NHS Trust.
Earlier this month the FDA granted 510(k) clearance to Stimwave’s Freedom device, a spinal cord stimulation system with a tiny injectable microchip small enough – between 2cm and 11cm – to be implanted through a standard needle.
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