High‐frequency spinal cord stimulation as rescue therapy for chronic pain patients with failure of conventional spinal cord stimulation

Abstract

Background: This study aims to evaluate the efficacy of 10-kHz high-frequency (HF10) devices as a rescue treatment in patients with failure of conventional spinal cord stimulation (SCS) therapy for chronic pain without the need to change the spinal hardware. Methods: In this real-world prospective study, patients with neuropathic pain treated with conventional tonic SCS in whom the therapy had failed, either during the trial phase or after a period of optimal functioning, were recruited throughout 2 years for HF10-SCS therapy. Data on analgesia, functionality, analgesics use and treatment safety were collected 12 months after treatment. Results: Eleven of the 18 (61%) patients included in the study were successfully rescued with HF10-SCS. Of them, 5 out of 12 (45%) were in the trial phase and six out of six (100%) had previously functioning implants. A significant improvement in low-back and limb pain was obtained (p = 0.003 and p = 0.0001, respectively).Treatment success was significantly associated with gender (p = 0.037), weight (p = 0.014), body mass index (BMI) (p = 0.007) and time of rescue (p = 0.015). A linear regression test confirmed a significant association between treatment failure and BMI and gender (p = 0.004). Conclusions: Our results suggest that analgesic rescue with HF10-SCS is an effective therapeutic option for non-responders to conventional SCS, although obesity might be a limiting factor for treatment success. Nevertheless, more comprehensive studies are needed to corroborate our findings. Significance: This study shows that high-frequency stimulation may be useful in patients with failure of conventional tonic stimulation for chronic pain, both in the trial phase and in previously implanted subjects. The novelty of this study lies in the use of the implanted epidural electrodes, which avoids the need for further surgery.The results in terms of pain control and recovery of functionality are satisfactory. In addition, variables such as male gender and high body mass index could be predictors of therapy failure.

High‐frequency (10 kHz) spinal cord stimulation (SCS) as a salvage therapy for failed traditional SCS: A narrative review of the available evidence

“…In the remaining study, trial details were not reported 23 . Overall, 4 of the 10 studies provided details of whether new leads or pre‐existing t‐SCS leads were used during salvage therapy 14,17–19 . Of these, 2 patient populations were salvaged with their pre‐existing t‐SCS leads, 14,19 1 group with new leads, 18 and 1 cohort with either type (but no granular detail was provided) 17 …”

“…Among the 10 included records, 3 reported studies with prospective designs, [14][15][16] and 7 presented retrospective reviews [17][18][19][20][21][22][23] (Table 1). Records were published between 2014 and 2021, either as peer-reviewed journal articles (8/10) 14,[16][17][18][20][21][22][23] or conference proceedings (2/10) 15,19 (Table 2). Across the 10 studies, follow-up duration ranged from 6 to 26 months.…”

“…Although mixed diagnoses were included, the predominant location of pain was in the back and/or legs (in at least 60% of participants). In addition, 4 study patient populations comprised only failed t-SCS patients, 14,[17][18][19] while 6 cohorts had subgroups of failed t-SCS patients, representing between 8% and 64% of the full study populations. 15,16,[20][21][22][23]…”

“…Three studies that met our eligibility criteria reported 10 kHz SCS salvage outcomes in exclusive populations of failed t-SCS patients following a repeat trial. 14,18,19 The largest of the 3 studies by Ghosh et al 18 retrospectively reviewed the medical records of 31 such patients. Of these, 5 patients underwent salvage due to an unsuccessful t-SCS trial (≤ 50% pain relief from baseline), and 26 due to failed permanent implant.…”

French guidelines for neuropathic pain: An update and commentary

“…Another neuromodulation technique of major interest for some refractory neuropahtic pain conditions is spinal cord stimulation. Newer stimulation paradigms using very high frequency (10 KHz) now appear highly effective and have the advantage of being free of paresthesia [29][30][31]. Regarding the potential relevance of a screening trial before permanent implantation, a recent study showed that although it may have diagnostic utility, there was no evidence that a screening trial strategy provided superior patient outcomes or was cost-effective compared to a no trial screening approach [32].…”