National Pain Report has been reporting on many advancements in the spinal cord stimulation (SCS) industry. You can read some of the articles here. Now there is a clinical study just published in the journal, Anesthesiology, that’s putting some muscle behind why these advancement smatter.
The study, Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: The SENZA-RCT Randomized Controlled Trial, showed that high frequency spinal cord stimulation is almost twice as effective as low frequency stimulation for treating back pain. For treating leg pain, high frequency stimulation was considerably more effective.
The system tested is called Senza and is made by Nevro (NYSE: NEVRO). The system delivers what is called HF10 therapy, which means it delivers stimulation at a rate of 10,000 Hz, compared to 40 to 60 HZ with traditional SCS therapy.
“This is the first long-term study to compare the safety and effectiveness of high frequency and traditional SCS therapy for back and leg pain,” said Dr. Leonardo Kapural, a professor of anesthesiology at Wake Forest University School of Medicine, in a press release. “Chronic back and leg pain have long been considered difficult to treat and current pain relief options such as opioids have limited effectiveness and commonly known side effects. Given the prevalence of chronic pain, high frequency SCS is an exciting advance for our patients.”
A total of 198 subjects with both back and leg pain were randomized into a treatment group of 10 comprehensive pain management clinics. Then, 171 passed a temporary trial and were implanted with the HF10 system. “Responders” to therapy were defined as having 50% or greater back pain reduction.
At 3 months, 84.5% of those who used HF10 therapy had 50% or greater back pain relief, and 83.1% had 50% or greater leg pain relief. For those who used low frequency stimulation, only 43.8% gained at least 50% back pain relief, and only 55.5% gained at least 50% leg pain relief, which is statistically significant (P < 0.001 for both back and leg pain comparisons).
The study concluded, “The superiority of HF10 therapy over traditional SCS for leg and back pain was sustained through 12 months (P < 0.001).”
SCS therapy is used by about 400,000 people to treat back and leg pain. SCS is also known as nerve stimulation, and involves having a small pulse generator placed in the body which produces electrical signals to mask the perception of pain traveling from the painful area to the brain.