Pain relief and improvement in quality of life with 10 kHz SCS therapy: Summary of clinical evidence

Abstract

Objective Chronic pain is a prevalent condition which has a significant effect on the lives of those it impacts. High‐frequency 10 kHz spinal cord stimulation (10 kHz SCS) has been shown to provide paresthesia‐free pain relief for a wide variety of pain indications. This article summarizes the current and emerging data as they relate to the clinical use of the therapy in various pain syndromes. Methods A literature search was conducted using the PubMed electronic database using keywords related to 10 kHz SCS. The database was queried from 2013 to May 2019. Articles reporting clinical studies that included human subjects permanently treated with 10 kHz SCS (Senza® system) were included in the review. Recent and relevant conference proceedings known to the authors were also included. Results The selected literature demonstrated significant evidence for the efficacy of 10 kHz SCS in treating chronic back and leg pain (CBLP), including a randomized, controlled trial as well as prospective and retrospective studies. One‐year follow‐up responder rates (pain relief ≥50%) ranged from 60% to 80%. Other studies and case series showed promising outcomes in specific conditions, including nonsurgical refractory back pain, neuropathic limb pain, complex regional pain syndrome, chronic widespread pain, chronic pelvic pain, and intractable headache. Subgroup analyses also pointed toward the potential of 10 kHz SCS being successful when low‐frequency SCS has failed. The vast majority of these studies reported improved quality of life (QOL) metrics and/or reduced opioid consumption. Conclusions Level I evidence already exists for the efficacy of 10 kHz SCS in treating CBLP, supported by real‐world clinical experience. Other studies demonstrate the potential of the therapy across a range of chronic pain etiologies, although larger confirmatory studies are recommended. Overall, the literature suggests that the therapy is associated with improved QOL as well as reduced opioid consumption.

10‐kHz Spinal Cord Stimulation for Chronic Postsurgical Pain: Results From a 12‐Month Prospective, Multicenter Study

“…Pain intensity showed rapid and continued improvement throughout the study period, and the responder rate compares favorably to previous studies of 10‐kHz SCS in other pain conditions, including the SENZA‐RCT randomized controlled trial, which reported response rates of 84.5% for back pain and 83.1% for leg pain, and other real‐world and prospective studies 15–17,28–35 . The remission rate was 62.1% (18 subjects) after 1 year of treatment, which is very similar to the rate from SENZA‐RCT, which was about 60%.…”

High-frequency 10 kHz Spinal Cord Stimulation for Chronic Back and Leg Pain

“…The SENZA-RCT and other published studies of 10 kHz-SCS have demonstrated that a substantial proportion of patients experience sustained pain relief considerably greater than 50%, with sustained pain scores of ≤3.0 (on a 0 to 10 VAS)—so-called “remitter” state. 9 , 10 , 20 , 33 , 35 , 37 – 42 This contrasts with the assumption in the model that treatment had been successful if patients achieved ≥50%: the real-world outcomes with use of 10 kHz-SCS are better than this. 38 Research into the HRQoL and health care costs of remitters would enable an update of the existing SCS economic model.…”

A Prospective, Multi‐Center, Clinical Trial of a 10‐kHz Spinal Cord Stimulation System in the Treatment of Chronic Pelvic Pain

“…The evidence for the efficacy of 10‐kHz SCS relieving chronic pain in multiple contexts, improving patients’ quality of life, and reducing opioid consumption, 20,21 and its efficacy in treating CPP is supported by a small case series 13 . Unlike SCS at lower frequencies, animal models suggest 10‐kHz SCS selectively activates inhibitory interneurons in the spinal dorsal horn at low intensities below the threshold activating the dorsal column 22 .…”