Efficacy and Safety of 10 kHz Spinal Cord Stimulation for the Treatment of Chronic Pain: A Systematic Review and Narrative Synthesis of Real-World Retrospective Studies

Abstract

10 kHz spinal cord stimulation (SCS) is increasingly utilized globally to treat chronic pain syndromes. Real-world evidence complementing randomized controlled trials supporting its use, has accumulated over the last decade. This systematic review aims to summarize the retrospective literature with reference to the efficacy and safety of 10 kHz SCS. We performed a systematic literature search of PubMed between 1 January 2009 and 21 August 2020 for English-language retrospective studies of ≥3 human subjects implanted with a Senza® 10 kHz SCS system and followed-up for ≥3 months. Two independent reviewers screened titles/abstracts of 327 studies and 46 full-text manuscripts. In total, 16 articles were eligible for inclusion; 15 reported effectiveness outcomes and 11 presented safety outcomes. Follow-up duration ranged from 6–34 months. Mean pain relief was >50% in most studies, regardless of follow-up duration. Responder rates ranged from 67–100% at ≤12 months follow-up, and from 46–76% thereafter. 32–71% of patients decreased opioid or nonopioid analgesia intake. Complication incidence rates were consistent with other published SCS literature. Findings suggest 10 kHz SCS provides safe and durable pain relief in pragmatic populations of chronic pain patients. Furthermore, it may decrease opioid requirements, highlighting the key role 10 kHz SCS can play in the medium-term management of chronic pain.

High-frequency (10 kHz) Spinal Cord Stimulation for the Treatment of Focal, Chronic Postsurgical Neuropathic Pain: Results from a Prospective Study in Belgium

“…In the past several years, high-frequency SCS delivered at 10 kHz has been shown to provide superior pain relief to conventional SCS in subjects with chronic low back and leg pain [10][11][12][13] as well as effectiveness in treating chronic peripheral polyneuropathy (PPN) [14,15]; high-frequency SCS offers the advantage of paresthesia-independent pain relief. This prospective study was undertaken in order to evaluate the efficacy and safety of 10-kHz SCS for treating subjects with CPSP.…”

Management of Chronic and Neuropathic Pain with 10 kHz Spinal Cord Stimulation Technology: Summary of Findings from Preclinical and Clinical Studies

“…Data suggested that the HF-SCS group had a greater response rate relative to LF-SCS and greater pain reduction in both back and leg regions at 24-month follow-up (8). The SENZA series of trials introduced robust data regarding the use of high-frequency 10 kHz SCS and provides substantial evidence that √ is not only safe, but also statistically and clinically effective with demonstrated superiority of high-frequency 10 kHz SCS in contrast to LF-SCS in the treatment of chronic back and neuropathic pain, with level I evidence supported by real-world data studies and clinical experience [67,68,70,84,[109][110][111].…”

Concept of the Number Needed to Treat for the Analysis of Pain Relief Outcomes in Patients Treated with Spinal Cord Stimulation

“…Over the last decade, SCS technology has developed rapidly, resulting in the emergence and adoption of several new stimulation paradigms, including high-frequency 10 kHz SCS (10 kHz SCS), burst stimulation, dorsal root ganglion (DRG) stimulation, and closed-loop SCS [ 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 ]. Never has more choice been available in the field of SCS since the inception of the technology.…”