A spinal cord stimulation system that delivered 10-kHz high-frequency therapy was nearly twice as effective at relieving pain as traditional low-frequency spinal cord stimulation, according to research published in Anesthesiology.
The SENZA-RCT study demonstrated that 10-kHz high-frequency (HF10) therapy was superior to traditional spinal cord stimulation (SCS) in the long-term treatment of both back and leg pain, but followed the pattern of results from previous studies.
These findings could influence the way back and leg pain is managed in the future. “Unfortunately, currently available treatments have limited effectiveness for most people with severe chronic pain,” wrote study researcher Leonardo Kapural, MD, PhD, clinical director of Wake Forest University Health Sciences Center Chronic Pain Center, Carolinas Pain Institute and Center for Clinical Research in Winston-Salem, North Carolina. “Opioid analgesics are frequently prescribed despite the lack of clinical evidence supporting their long-term use to treat chronic pain.”
SCS delivers electrical pulses via spinal electrode arrays (leads) to treat chronic intractable pain of the back and limbs.Traditional devices deliver pulse frequencies from 2 to 1200 Hz in order to produce paresthesias, a tingling sensation that is intended to mask pain perception.This requires physicians to perform intraoperative paresthesia mapping on patients; however, it is difficult to achieve adequate and stable paresthesia coverage in some regions of the body. Therefore, finding an SCS treatment approach that does not rely on paresthesias has the potential to improve back and leg pain treatment. HF10 therapy delivers short-duration pulse frequencies at 10 kHz and does not produce paresthesia.
For the SENZA-RCT trial, researchers randomly assigned 171 participants to receive either HF10 therapy or standard SCS. After a trial phase of 14 days, participants with a 40% or greater response to their respective treatment proceeded to permanent device implantation.