ID:16585 RCT: Ultra-Low-Frequency (ULF™) Waveform vs Traditional SCS in Temporary Trial for Nociceptive and Neuropathic Pain

Abstract

SCS has been shown to be effective in treating an increasing array of neuropathic pain conditions, however nociceptive pain conditions remain largely recalcitrant to currently available SCS options. We hypothesized that a treatment that could directly inhibit neural function may enable effective relief for both neuropathic and nociceptive pain. While the neuromodulation field was built on the pioneering work of Hodgkin and Huxley detailing the mechanisms of how action potentials are initiated or inhibited, existing neurostimulation devices are designed only to directly activate neural tissue, using short duration pulses. Technologies to directly inhibit the activity of the nervous system have not been well developed to-date. A method to inhibit neural tissue required application of static electrical currents had been unfeasible due to technological constraints. The constraints have been alleviated with the creation of a proprietary Ultra-Low Frequency (ULFTM) waveform coupled to a novel trial stimulator. This randomized, controlled trial builds on the success of a pilot clinical study.