High-Frequency Spinal Cord Stimulation Manages Back and Leg Pain Better than Low-Frequency Counterpart

Study earns the Congress of Neurological Surgery’s 2017 Paper of the Year award in the Pain subspecialty.

Peer Reviewed

Comparing the long-term outcomes of 10-kHz high-frequency (HF10 therapy) spinal cord stimulation (SCS) with traditional low-frequency SCS, researchers found HF10 therapy more effectively manages both back and leg pain better than its low-frequency counterpart—a major finding that could have significant impact for people suffering from chronic pain. The findings, originally published in September 2016 in Neurosurgery, earned one of the Congress of Neurological Surgeons’ (CNS) 2017 Paper of the Year awards.

In addition to earning the CNS honor, the paper was integral to securing regulatory approval of HF10 therapy and ensuring more people have access to the treatment.
Abstract 3d illustration of sound waves and spectrumThis is a major finding that could have significant impact for people suffering from chronic pain. Photo Source: 123RF.com.

“The study results led to U.S. Food and Drug Administration’s approval of this therapy,” said Leonardo Kapural, MD, PhD, Pain Physician at the Carolinas Pain Institute and Center for Clinical Research in Winston-Salem, NC. Dr. Kapural is the lead author of the study.

A Closer Look at the Results

This multicenter, prospective, randomized, controlled clinical trial provided Level 1 evidence evaluating the efficacy of HF10 therapy compared with traditional low-frequency SCS for patients with both chronic back and leg pain.

A total of 198 subjects (101 HF10 therapy, 97 traditional SCS) in 10 research centers with severe back and leg pain were randomized in a 1:1 ratio to treatment groups of traditional SCS (manufactured by Boston Scientific) and HF10 therapy (manufactured by Nevro Corp.).

HF10 therapy sustained better back and leg pain management over traditional low-frequency SCS through 12 months (P <0.001) and 24 months (P <0.001). At 24 months, more subjects were responders to HF10 therapy than traditional low-frequency SCS (back pain: 76.5% versus 49.3%; leg pain: 72.9% versus 49.3%) (P =0.003).

One of the surprising findings of the study, according to Dr. Kapural, was the attrition of positive clinical response of traditional, low-frequency stimulation that occurs 1-6 months after the start of the therapy (implantation of the device).

“Thus, despite the high proportion of patients with positive temporary testing trial (comparable to the HF10 therapy conversion rate), loss of the effectiveness of low frequency, traditional SCS is clearly documented in this study,” he stated.

“Namely, from about 80% of patients who responded to the 7-day trial, only about 50% maintained same pain relief two years later,” Dr. Kapural continues. “That was not the case for HF10 therapy stimulation, which essentially had the same number of responders.”

Other divides between the HF10 therapy and low-frequency traditional SCS groups involved presentation of paresthesias.

“In our study, none of the HF10 therapy subjects experienced paresthesias, while 46.5% of traditional low-frequency SCS subjects reported uncomfortable stimulation,” Dr. Kapural notes. “Based on the current clinical evidence, paresthesias during SCS are not essential to achieve pain relief and being uncomfortable—it limits acceptable time interval and amplitude of stimulation.”

“In addition, profound improvement in patient outcomes, particularly long-term decrease in pain scores and increase in functional capacity using HF10 therapy as a minimally invasive, low morbidity, reversible therapy, reinforces this approach as a necessary part of the algorithm for treatment of back and leg pain,” Dr. Kapural said.

The Future of High-Frequency Spinal Cord Stimulation

Dr. Kapural said several trials are currently exploring other important indications for HF10 therapy, including those for neck and arm pain.

“Initial data suggests that the better pain relief compared to low-frequency traditional SCS can be achieved when high-frequency stimulation is used for upper extremity, cervical radiculopathy, and axial neck pain, as well as peripheral neuropathy,” Dr. Kapural says.

About the CNS Paper of the Year Awards

This study is among the 10 winners of CNS’ first-ever Paper of the Year awards, which honor the best-in-class papers published in the organization’s journal, Neurosurgery. The winners were classified by neurosurgical subspecialty, and this study won in the Pain category.

Papers published in Neurosurgery between June 2016 and June 2017 were eligible to earn this year’s award.

“The selected authors are dedicated neurosurgeons [and pain medicine speciallists] who are improving our field through innovation; their accomplishments are remarkable and should be celebrated,” said Dr. Alan M. Scarrow, CNS president, in a news release.

The winning papers, which all underwent a scrupulous review process, will be recognized at the 2017 CNS Annual Meeting in Boston on October 7-11. 

Leonardo Kapural, MD, PhD, disclosed that he did research with Nevro, Medtronic, Boston Scientific, St. Jude Medical, Stimwave, Spinal Modulation, Halyard Health, Neuros Medical, and SPR Therapeutics. He received personal fees from GiMer Medical, Abbott, Nevro, Halyard Health, and Nalu Medical.

Updated on: 06/11/19
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Leonardo Kapural, MD, PhD
Pain Physician
Carolinas Pain Institute
Winston-Salem, NC

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