Results of a clinical trial comparing high frequency spinal cord stimulation and low frequency spinal cord stimulation show that people with intractable back or leg pain benefit most from high frequency stimulation. The SENZA-RCT multi-center study was published in the September issue of Neurosurgery.
High frequency stimulation (10 – kHz) delivers pulses of electrical stimulation to the spinal cord at a rate of 10 kHz, which is significantly higher than the 50 Hz rate traditional low frequency stimulation devices deliver.
The study enrolled 241 patients across 11 U.S. clinical trial sites (171 patients received SCS implants at 10 sites), making it the largest prospective randomized spinal cord stimulation (SCS) study to assess the treatment of chronic back and leg pain. The measure of effectiveness was having participants achieve greater than or equal to 50% reduction in back pain compared to their baseline after 3 months, compared to those treated with traditional SCS therapy.
For those in the study with back pain, more than 84% using high frequency SCS therapy achieved the endpoint, while only 43% of people using low frequency SCS therapy did (P <.001 for non-inferiority and superiority).
For those in the study with leg pain, after three months, 83% of those using high frequency SCS therapy had a reduction of pain that was greater than or equal to 50% better than baseline. For low frequency SCS therapy, only 55% met the endpoint (P <.001 for non-inferiority and superiority).
After 24 months of using the two therapies, the differences held true for both back pain and leg pain. More than 66% of people with back pain using high frequency SCS therapy continued to experience more than 50% reduction compared to baseline. Slightly more than 41% of those using low frequency SCS therapy experienced similar outcomes. For those with leg pain, the figures were 65% for high frequency SCS therapy, and 46% for low frequency SCS therapy.
“Chronic pain is a significant public health problem that impacts an estimated 100 million American adults. More Americans are impacted by chronic pain than diabetes, heart disease and cancer combined and innovative, non-opioid treatments that work over a longer period of time are needed,” said Leo Kapural, M.D., Ph.D, the Principal Investigator of the study.
“By demonstrating a significant and durable decrease in back and leg pain over a two-year period, Nevro’s HF10 therapy represents an important and evidence-based advance in pain medicine. As we read in the paper every day and hear mounting concern from regulatory agencies, treating chronic pain conditions with opioids is fraught with risks. HF10 therapy is a non-opioid, reversible therapy that may represent a compelling option for many of these suffering patients.”
The Senza HF10 spinal cord stimulation system provides high frequency electrical pulses to the spinal cord to alleviate pain. The electrical pulses are delivered by small electrodes on leads that are placed near the spinal cord and are connected to a compact, battery-powered generator implanted under the skin. HF10 therapy is the only SCS therapy indicated to provide pain relief without paresthesia (a stimulation-induced sensation, such as tingling or buzzing, which is the basis of traditional SCS).