Outcomes of a Multicenter, Prospective, Crossover, Randomized Controlled Trial Evaluating Subperception Spinal Cord Stimulation at ≤1.2 kHz in Previously Implanted Subjects

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

“…These results suggest that SCS patients may benefit when provided with a single device that can deliver multiple waveform types, delivered in a sequential or simultaneous manner, and with capability for high precision targeting of neurostimulation fields. The results of this study align with previous studies suggesting that the use of various stimulation paradigms among different patients may be necessary for achieving the most effective pain relief outcomes, even within a select population displaying the same or similar pain conditions or symptoms [1][2][3][4][5][6]. For example, a crossover RCT (WHISPER) assessing ≤1.2 kHz sub-perception SCS versus supra-perception in previously implanted subjects recently provided evidence supporting the clinical benefit of sub-perceptive neurostimulation when provided as an option(s) for selective use, even in those who were implanted with and previously utilized tonic-based SCS for several years prior [6].…”

“…The results of this study align with previous studies suggesting that the use of various stimulation paradigms among different patients may be necessary for achieving the most effective pain relief outcomes, even within a select population displaying the same or similar pain conditions or symptoms [1][2][3][4][5][6]. For example, a crossover RCT (WHISPER) assessing ≤1.2 kHz sub-perception SCS versus supra-perception in previously implanted subjects recently provided evidence supporting the clinical benefit of sub-perceptive neurostimulation when provided as an option(s) for selective use, even in those who were implanted with and previously utilized tonic-based SCS for several years prior [6]. Additionally, the SUNBURST RCT showed that 12-weeks of either burst or tonic stimulation reduced Visual Analog Scale scores versus Baseline, and that notable proportions of study participants preferred one paradigm over the other, though most preferred burst [27].…”

“…A growing body of evidence suggests that optimal pain relief achieved in one Spinal Cord Stimulation (SCS) patient using a specific paradigm of stimulation may fail to render the same outcome in another patient with the identical diagnosis and symptom complaint [1,2,3,6]. This includes the use of SCS at higher frequencies (e.g.…”

“…This includes the use of SCS at higher frequencies (e.g. 1.2-10 kHz) for chronic pain as strikingly different preferences and/or variable treatment satisfaction data have been reported by various studies [1,[4][5][6][7]. Moreover, pain relief outcomes described by real-world, observational studies assessing 10 kHz stimulation have not consistently reproduced results that match those reported by a large, multicenter randomized controlled trial using 10 kHz [7,8,9,10,11].…”

Sub-Perception and Supra-Perception Spinal Cord Stimulation in Chronic Pain Syndrome: A Randomized, Semi-Double-Blind, Crossover, Placebo-Controlled Trial

“…The information about comparative efficiency of different modes of stimulation is scanty despite several published reports in this area [ 14 , 15 , 16 , 17 ]. Sensation-free modes of SCS provide a unique opportunity to conduct a placebo-controlled trial in a crossover design and to assess the power of sham stimulation [ 18 ].…”