Pain relief outcomes using an SCS device capable of delivering combination therapy with advanced waveforms and field shapes

Abstract

Background: Given the range of subjective experiences reported by patients with chronic pain, Spinal Cord Stimulation (SCS) systems designed for tailored delivery of analgesic therapy may help improve treatment effectiveness and satisfaction. Research design and methods: This case-series evaluated 420 patients with chronic back and/or leg pain implanted with an SCS device capable of sequential or simultaneous delivery of neurostimulation (i.e. combination therapy) as well as multiple waveforms and/or field shapes. Following implantation, an array of standard programs (e.g. paresthesia-based SCS), and a custom set of sub-perception programs were provided per patient feedback. Pain scores (Numeric Rating Scale, NRS) were collected at baseline and during follow-up. Results: In this multicenter, observational series (n = 420, 53.1% female; Age: 64.2 ± 13.4 years), a mean overall pain score of 7.2 ± 1.8 (SD) was reported pre-trial (Baseline). At a mean follow-up duration of 208 ± 200 (SD) days, the mean overall pain score reduced to 2.4 (p < 0.0001). Overall pain was reduced by 5.1 ± 2.4 and 4.5 ± 2.4 points (NRS) at 3-months (N = 256) and at 12-months post-implant (N = 122) respectively (p < 0.0001). Conclusions: These results suggest that highly 'customizable' SCS approaches may allow for highly effective pain relief within the real-world clinical setting.

Improved Pain Control with Combination Spinal Cord Stimulator Therapy Utilizing Sub-perception and Traditional Paresthesia Based Waveforms: A Pilot Study

“…to show a significant reduction in chronic pain from preimplantation NRS of 7.2 by 5.2 (+/-2.4) points at 3 and 12 months of follow up (16). The COMBO RCT is actively researching this, but results are not yet available (17).…”

“…A new advancement is an (IPG) capable of a simultaneous combination of waveforms, traditional paresthesia based, and sub perception based to modulate the spinal cord (7). Recent studies provide evidence for the efficacy of sub-perception SCS and have set forth to evaluate the ef-ficacy of an SCS system capable of providing multiple combined waveforms (14)(15)(16)(17). These studies focus primarily on subperception SCS in patients who were achieving suboptimal results with SCS therapy or evaluated the effects of various frequencies on pain relief (9, 10).…”

Real-World Outcomes Using a Spinal Cord Stimulation Device Capable of Combination Therapy for Chronic Pain: A European, Multicenter Experience

“…As described in detail in previous work [19], the SCS system utilized by patients included in this study (Spectra WaveWriter, Boston Scientific, Marlborough, MA, USA) uses anatomically guided neural targeting to deliver paresthesia-based SCS therapy using a three-dimensional finite element model of the spinal cord as well as an algorithm that has been designed to determine the exact amount of current needed at each relevant contact of interest, per a user-specified central point of stimulation on the dorsal column [27]. Patients included in this study were implanted with either an 8-contact percutaneous lead with 1, 4, or 6 mm edge-to-edge spacing and 31, 62, or 66 mm span (Linear or Linear ST, Boston Scientific, Marlborough, MA, USA) or a 16-contact percutaneous lead (Infinion CX, Boston Scientific, Marlborough, MA, USA) with 1 mm edge-to-edge spacing and 67 mm span.…”

“…Although distinct mechanisms that underlie both of these SCS approaches have not been definitively identified, an assortment of reported studies and clinical observations seem to suggest that differences likely do exist with regard to how the analgesic outcomes induced by sub-and supra-perception SCS are manifested [15][16][17][18]. Given this probability and the dynamic nature of the chronic pain experience, there is now a growing interest in the clinical application of sub-and supra-perception SCS as a combination therapy versus the exclusive use of either subor supra-perception SCS alone [6,19,20]. The commonly observed variable experience of chronic pain from patient-to-patient is thought to derive, at least in part, from the differing mechanisms that underlie the array of chronic pain syndromes and symptom complaints diagnosed in and imparted by SCS-implanted patients [21][22][23].…”

“…To date, only a very limited number of peer-reviewed clinical studies have published outcomes in patients who have been implanted with devices designed to integrate suband supra-perception modalities. However, as these types of devices offering this capability become increasingly available to patients, we surmise that it will be important to monitor and track how these systems are used to treat pain as well as associated clinical outcomes [19,[24][25][26]. To that end, we chose to embark on a multicenter, consecutive, observational, case-series consisting of a cohort of patients who used an SCS system engineered to provide patients with multiple waveform type and/or field shape programming options that also can simultaneously or sequentially deliver different neurostimulative modalities (i.e., sub-and supra-perception approaches) in combination.…”