Clinical ResearchParesthesia-Based Versus High-Frequency Spinal Cord Stimulation: A Retrospective, Real-World, Single-Center Comparison
Introduction
The utilization of spinal cord stimulation (SCS) for the treatment of various chronic pain conditions has become increasingly common over the past two decades. Fueled by expanding indications, an increased prevalence of population-wide chronic pain, and studies describing the negative repercussions of chronic opioid use, SCS therapy has evolved dramatically.1,2 The past decade has seen the introduction of new waveforms and changes in electrical dosing, and, arguably, one of the most important advancements has been the introduction of high-frequency, 10 kHz SCS (Nevro Corp, Redwood City, CA).3, 4, 5, 6 Approved for use in Europe in 2010, Australia in 2011, and the United States in 2015, 10 kHz SCS is paresthesia-free, allows for anatomical lead placement, and permits usage while driving.7
Multiple publications have reported improved pain relief outcomes with 10 kHz SCS when compared to historical data and in head-to-head studies with traditional SCS.3,8, 9, 10, 11, 12 The 24-month SENZA-RCT reported a responder rate (≥50% visual analog scale [VAS] improvement) of 76.5% for back pain and 72.9% for leg pain with 10 kHz SCS, and 49.3% for both back pain and leg pain with traditional SCS.13 At 24-months with 10 kHz SCS, the authors reported a mean decrease in back pain VAS of 66.9% and leg pain VAS of 65.1%. The authors reported the 24-month traditional SCS mean decrease in back pain VAS was 41.1% and leg pain VAS was 46.0%. Results from an industry-maintained registry of 1660 patients reported retrospective real-world patient reported percentage improvement in pain scale (PR-PIPS) results with 10 kHz SCS.14 A total of 1660 patients were trialed and/or permanently implanted with a high-frequency SCS device. At 12 months, outcome data from 326 patients were available and showed a 77.6% responder rate (≥50% PR-PIPS).
However, other studies have described conflicting findings and suggest comparable outcomes to other stimulation paradigms.15,16 In 2017, De Andres et al published results of a blinded, prospective, randomized controlled trial comparing conventional frequency SCS with high-frequency SCS in a failed back surgery syndrome (FBSS) patient population.15 Sixty patients met eligibility criteria and were randomized to either conventional frequency SCS or high-frequency SCS. Fifty-five patients followed up at 12 months. The authors reported no difference in patient outcomes between the two stimulation settings. It is noteworthy that neither group had expected post-implant pain reduction when compared to historical data. A year later, Thomson et al reported on 33 patients who underwent a successful paresthesia-based SCS trial and were implanted with a permanent system.16 Then, these 33 patients underwent a “sweet spot” search with 10 kHz stimulation to find the optimal stimulation location, and 21 patients (63.6%) found at least 30% pain relief during this process. Next, these 21 patients had a double-blind rate randomization phase where each patient experienced 1, 4, 7, and 10 kHz stimulation in randomized order, all at the “sweet spot” location. A washout phase of a few days to one week was allowed between the different frequency settings to minimize overlap of stimulation settings. Each frequency was utilized for four weeks, and pulse width and amplitude were adjusted during the first three weeks to find optimal pain relief. Twenty patients completed this portion of the study. The mean back pain numeric rating scale (NRS) scores decreased between 48.5% and 52.9% across frequencies and results were reported to be equivalent (p = 0.00002). The mean leg pain NRS scores decreased between 47.3% and 52.7% across frequencies and results were reported to be equivalent (p = 0.003). This is difficult to interpret from the physician standpoint, and equally confusing for patients seeking optimal pain relief outcomes.
Given the current published evidence continues to show discrepancies in efficacy and our experienced neuromodulation practice uses multiple technologies regularly in daily clinical practice, we performed a retrospective data collection and analysis to assess patient outcomes following implantation of traditional SCS (Medtronic, Fridley, MN) and 10 kHz SCS. The primary objective was to report site-collected real-world PR-PIPS with traditional SCS and 10 kHz SCS from a single, academic medical center. The secondary objective was to report an explantation rate with each stimulation design.
Section snippets
Study Design
This study was a single-center retrospective review to determine PR-PIPS of traditional SCS and high-frequency SCS (10 kHz) of those patients implanted for at least 12 months. The study was approved by the corresponding author's institutional review board and the need for patient consent was waived. There was no funding for this study.
Data Collection
This study retrospectively reviewed medical records of all consecutive traditional SCS and 10 kHz SCS implants between January 1, 2016, and March 1, 2020 (Fig. 1
Baseline Characteristics
The patient selection process for inclusion in our final quantitative analysis and sensitivity analysis is displayed in Fig. 1. There was a total of 163 implanted patients (traditional stimulation, n = 85; high-frequency stimulation, n = 78). Twenty-two explants (traditional stimulation, n = 10; high-frequency stimulation, n = 12) were identified (overall 13.5%, traditional stimulation 11.8%, and high-frequency stimulation 15.4%). Seventy-five total remaining SCS implants utilizing traditional
Discussion
Our results suggest 24-month real-world PR-PIPS between traditional SCS and high-frequency SCS is comparable. We found no difference in mean PR-PIPS between traditional stimulation and high-frequency stimulation (50.6% vs 47.6% and p = 0.399 with explants excluded; 44.6% vs 40.3% and p = 0.391 with explants included). Additionally, there was no significant difference when stratified by various PR-PIPS threshold levels. When using the prior definition of “responder” status (≥50% PR-PIPS) and
Conclusion
This study adds further evidence to the published literature that successful long-term results can be achieved with SCS. Better mechanisms of capturing patient response, functional improvement, and overall satisfaction are required to understand the long-term effects and differences between the SCS systems currently available. This retrospective analysis did not find a statistically significant difference in PR-PIPS between traditional stimulation and high-frequency stimulation in a variety of
Authorship Statement
Jonathan M. Hagedorn was involved with study inception. Joshua Romero and Chris Thuc Ha performed the data collection. Ryan S. D'Souza and Jonathan M. Hagedorn performed the statistical analysis. All authors contributed to manuscript preparation and agreed on the final version.
References (31)
- et al.
Success using neuromodulation with BURST (SUNBURST) study: results from a prospective, randomized controlled trial using a novel Burst waveform
Neuromodulation
(2018) - et al.
Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomised, controlled trial
Lancet Neurol
(2020) - et al.
Outcomes of a multicenter, prospective, crossover, randomized controlled trial evaluating subperception spinal cord stimulation at ≤1.2 kHz in previously implanted subjects
Neuromodulation
(2020) - et al.
Effects of rate on analgesia in kilohertz frequency spinal cord stimulation: results of the PROCO randomized controlled trial
Neuromodulation
(2018) - et al.
Explantation of 10kHzspinal cord stimulation devices :a retrospective review of 744 patients followed for at least 12 months
Neuromodulation
(2021) - et al.
Therapy-related explants after spinal cord stimulation: results of an international retrospective chart review study
Neuromodulation
(2017) - et al.
Spinal stimulation for the treatment of intractable spine and limb pain: a systematic review of RCTs and meta-analysis
Mayo Clin Proc
(2019) - et al.
Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome
Pain
(2007) - et al.
Pain trends among American adults, 2002-2018: patterns, disparities, and correlates
Demography
(2021) - et al.
A review of potential adverse effects of long-term opioid therapy: a practitioner's guide
Prim Care Companion CNS Disord
(2012)
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
Overview of HF10 spinal cord stimulation for the treatment of chronic pain and an introduction to the Senza Omnia™ system
Pain Manag
High-frequency spinal cord stimulation at 10 kHz for the treatment of combined neck and arm pain: results from a prospective multicenter study
Neurosurgery
10-kHz spinal cord stimulation for chronic postsurgical pain: results from a 12-month prospective, multicenter study
Pain Pract
A prospective, multi-center, clinical trial of a 10-kHz spinal cord stimulation system in the treatment of chronic pelvic pain
Pain Pract
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Source(s) of financial support: None.
Conflict of Interest: Jonathan M. Hagedorn is a consultant for Abbott, Boston Scientific, Nevro, and Speranza Therapeutics. Markus A. Bendel has funded research with Nevro. All other authors have no conflicts to report.