Paresthesia-free spinal cord stimulation (SCS) with 10-kHz high-frequency (HF10) therapy was superior to traditional SCS for long-term treatment of intractable back and leg pain, according to a study published earlier this month in Neurosurgery.1
Achieving pain relief with traditional SCS relies on producing stimulation-induced paresthesias that overlap with chronically painful areas.
Careful electrode positioning and programming is required, and and manual adjustments to device parameters are often required , as changes in body position may lead to under- or overstimulation 1,2 In addition, while SCS treatment of leg pain has been well-studied, efforts to provide adequate paresthesia coverage for back pain have not been successful.1
In contrast to traditional SCS which delivers low-frequency (50 Hz) pulses of electrical stimulation, HF10 therapy produces electrical stimulation pulses at high frequency (10,000 Hz) that are shorter in duration, lower in amplitude, and do not induce paresthesias.3
The SENZA-RCT randomized controlled trial showed that HF10 therapy was more effective than traditional SCS at reducing intractable back and leg pain by more than 50% from baseline through a period of 12 months.3 Leonardo Kapural, MD, PhD, of Wake Forest Baptist Health, and colleagues sought to compare the long-term efficacy of HF10 therapy with that of traditional SCS by reporting 24-month results from SENZA-RCT.
Of 171 participants, a greater proportion of patients treated with HF10 therapy achieved the primary endpoint, ≥50% back pain reduction from baseline at 3 months, than those treated with traditional SCS (84.5% vs 43.8%; P <.001 for non-inferiority and superiority).
More HF10 patients than traditional SCS patients also demonstrated treatment response (≥50% pain reduction from baseline) with leg pain at 3 months (83.1% vs 55.5%; P <.001 for non-inferiority and superiority).
At 24 months, HF10 therapy continued to elicit superior treatment response rates compared with traditional SCS for back pain (76.5% vs 49.3%; P <.001 for superiority) and leg pain (72.9% vs 49.3%; P = .003 for superiority). Rates of remission were also higher in the HF10 therapy group than in the traditional SCS group for back pain (65.9% vs 31.0%; P = .003 for superiority) and leg pain (65.9% vs 39.4%; P = .001 for superiority).
Back pain and leg pain were also reduced to a greater extent with HF10 therapy than traditional SCS at 24 months (66.9% vs 41.1% for back pain and 65.1% vs 46.0% for leg pain; P <.001 and P = .002 for superiority, respectively).
Serious adverse events had similar incidence in both groups, were uncommon, were not related to stimulation, and did not result in neurological deficits. Implant site pain was the most common adverse event in both groups. Significantly more traditional SCS patients had uncomfortable paresthesias than HF10 therapy patients (11.3% vs 0.0%; P <.001).
Summary and Clinical Applicability
HF10 therapy, a high-frequency, short-duration, and low-amplitude delivery method of SCS, treats chronic back and leg pain without producing paresthesias and has been shown to be superior to traditional SCS in the SENZA-RCT trial. The 24-month results of SENZA-RCT indicate that HF10 therapy retains long-term, superior efficacy over traditional SCS.
“The advantages of HF10 therapy are anticipated to impact the management of patients with chronic back and leg pain substantially, and possibly other pain conditions,” the authors concluded. “The superior and durable results demonstrated in this study are anticipated to lead to improved long-term cost effectiveness and payer acceptance, making this therapy broadly available to patients suffering from chronic pain.”
Limitations and Disclosures
Investigators and subjects were not blinded to treatment assignment due to differences in stimulator lead placement, device programming, and paresthesias produced between the HF10 therapy and traditional SCS groups
The study populations for both groups were heterogeneous, with many patients carrying more than 1 pain diagnosis
The study was funded by Nevro Corp. Several of the authors report financial relationships with Nevro Corp.
- Kapural L, Yu C, Doust MW, Gliner BE, et al. Comparison of 10-kHz High-Frequency and Traditional Low-Frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: 24-Month Results From a Multicenter, Randomized, Controlled Pivotal Trial. Neurosurgery. Published online: Sep 6, 2016. doi: 10.1227/NEU.0000000000001418.
- Schultz DM, Webster L, Kosek P, Dar U, Tan Y, Sun M. Sensor-driven position-adaptive spinal cord stimulation for chronic pain. Pain Physician. 2012;15(1):1-12.
- Kapural L, Yu C, Doust MW, Gliner BE, et al. 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. Anesthesiology. 2015;123(4):851-860.