<p>Retrospective Assessment of Salvage to 10 kHz Spinal Cord Stimulation (SCS) in Patients Who Failed Traditional SCS Therapy: RESCUE Study</p>

Abstract

Background and Objectives A randomized clinical trial demonstrated that 10 kHz SCS (10kHz-SCS) therapy is superior to traditional low-frequency SCS (LF-SCS) at 12- and 24-month clinical follow-ups and led to Food and Drug Administration (FDA) approval of the therapy. The results of the study led our practices to trial 10kHz-SCS in patients who had not maintained pain relief with LF-SCS therapy. Here, we report a large set of data from two clinical sites to assess if 10kHz-SCS is an effective salvage modality when LF-SCS fails. Methods We conducted a retrospective chart review of 120 patients across two clinical sites who had LF-SCS implants and were salvaged with 10kHz-SCS. Results Data were analyzed from 105 patients between 28 and 90 years old (median 60) with chronic pain for 13.6 years. The mean duration of LF-SCS therapy was 4.66±3.9 years. The average Visual Analog Scale (VAS) decreased from 8.30±1.4 (median of 8) cm to 3.32±2.0 (median of 3) cm at 12 months and 3.36±2.0 (median of 3) cm at the most recent clinic visit (p<0.001) following salvage therapy. Pain relief of 50% or more was obtained in 85 out of 105 (81%) patients. Opioid usage decreased from 60.3±77.1 mg to 32.1±44.0 mg MSO4 equivalents (p = 0.001) at 12 months after salvage therapy. Conclusion Eighty-one percent of patient cases reviewed, where LF-SCS had failed, achieved >50% pain relief with 10kHz-SCS, and almost all exhibited some clinical improvement. Therefore, 10kHz-SCS should be considered an appropriate option to rescue failed LF-SCS.

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

“…Over the past two decades, in summary, research studies have demonstrated the clinical and statistical efficacy of high-frequency 10 kHz SCS in patients with chronic refractory low back pain with neuropathic pain and post-laminectomy syndrome [49,68], in addition to painful diabetic neuropathy [64,65,69], non-surgical refractory back pain [55,70,71], chronic neck pain [57,58,62,[72][73][74]], chronic regional pain syndrome (CRPS) [75][76][77][78][79], thoracic pain [67], chronic post-surgical pain [66], chronic pelvic pain [63,80], chronic abdominal pain [81], migraine [82,83], as an adjunctive treatment do decrease opioid utilization [54,59,84], and as salvage therapy [85,86]. Among other painful syndromes in which 10 kHz SCS has been studied, painful diabetic neuropathy (PDN) and chronic neck and upper extremity pain have continued to gain clinical and research interest, as well as the use of 10 kHz SCS as a salvage therapy.…”

“…Amirdelfan et al reproduced similar positive outcomes in a prospective design with 10 kHz SCS, reporting 89.2% of subjects with neck pain and 95% of subjects with upper limb pain had at least 50% pain relief from baseline at 12-month follow-up [57]. Recently, Kapural et al conducted a retrospective data review of two clinical sites to access the utilization of 10 kHz SCS as a salvage therapy and found that 81% of the cases reviewed reported at least 50% pain relief upon utilization of 10 kHz SCS as salvage therapy with significantly decrease in opioid utilization at 12 months post-procedure [85].…”

Multisystem Spinal Cord Stimulation Trialing: A Single Center, Retrospective, Observational Study

“…However, there have been salvage reports looking into different therapies, such as 10‐kHz high‐frequency therapy (HF‐10) and dorsal root ganglion (DRG). One study showed that out of 105 patients that failed traditional SCS, 81% achieved greater than 50% pain relief with HF‐10, and almost all exhibited some clinical improvement 8 . Another case report showed sustained pain improves after 8 months when using DRG spinal stimulation in patients with complex regional pain syndrome (CRPS) that had failed traditional SCS 9 .…”

“…One study showed that out of 105 patients that failed traditional SCS, 81% achieved greater than 50% pain relief with HF-10, and almost all exhibited some clinical improvement. 8 Another case report showed sustained pain improves after 8 months when using DRG spinal stimulation in patients with complex regional pain syndrome (CRPS) that had failed traditional SCS. 9 The popularized trialing strategy should be more patient centric and this investigation serves as the foundational work.…”

Advances in Neuromodulation for Chronic Pain

“…The first step towards the holy grail is to walk the extra mile for every patient, even for those who do not respond anymore to the initial paradigm. Salvage strategies and algorithms are gaining interest from researchers and clinicians [8][9][10][11][12][13]. Salvage therapy should not only consist of converting patients towards new paradigms but also introducing extra tools to regain freedom and independence in terms of patient empowerment.…”