Should we Oppose or Combine Waveforms for Spinal Cord Stimulation in PSPS-T2 Patients? A Prospective Randomized Crossover Trial (MULTIWAVE Study)

Neuromodulation and Habituation: A Literature Review and Conceptional Analysis of Sustaining Therapeutic Efficacy and Mitigating Habituation

“…The MULTIWAVE study, a prospective, randomized, controlled, crossover, doubleblind trial, showed that allowing switching of waveforms and/or combining waveforms increased the rate of SCS responders by 25%. This study also found waveform versatility had a positive and sustained response in patients who had been salvaged from cSCS loss of efficacy [78]. Given the current evidence implicating the individual effectiveness of SCS microdosing [45], turning stimulation off for a designated period [61], pulse dosing, and cycling between different stimulation waveforms [45,46], we hypothesize that implementing all three strategies immediately after SCS implantation will prolong device efficacy and pain relief.…”

Neuromodulation and Habituation: A Literature Review and Conceptional Analysis of Sustaining Therapeutic Efficacy and Mitigating Habituation

“…The MULTIWAVE study, a prospective, randomized, controlled, crossover, double-blind trial showed that allowing switching or waveforms and/or combining waveforms increased the rate of SCS responders by 25%. The study also found waveform versatility had a positive and sustained response in patients who had been salvaged from cSCS loss of efficacy [77]. Given the current evidence implicating the individual effectiveness of SCS microdosing [44], turning stimulation off for a designated period [61], pulse dosing, and cycling between different stimulation waveforms [44,45] we hypothesize that implementing all three strategies immediately after SCS implantation will prolong device efficacy and pain relief.…”

Improved Outcomes and Therapy Longevity after Salvage Using a Novel Spinal Cord Stimulation System for Chronic Pain: Multicenter, Observational, European Case Series

“…Results from the WHISPER randomized controlled trial (RCT) demonstrated that a device capable of providing multiple neurostimulation therapies provided superior long-term outcomes when subjects were able to choose the most effective therapy [47]. In the MULTIWAVE crossover RCT, the responder rate increased by up to 25% when a device capable of such versatility was used [20,33], with a responder rate of 95% considering multidimensional index assessment [48]. Our own results demonstrated that in patients with LoE who converted to a new IPG (after more than five years of successful treatment with their previous SCS system), the mean NRS pain score decreased by 4.1 points (p < 0.0001) compared to pre-conversion, with a treatment responder rate of 58.5% (≥50% improvement in overall pain) at the last follow-up.…”

“…Since its first application in the late 1960s [6], spinal cord stimulation (SCS) using conventional paresthesia-based stimulation has proven to be an effective and efficient therapy for chronic low back and/or leg pain [7][8][9][10]. New SCS paradigms have been developed over the last 15 years, introducing neural-targeting algorithms, sub-perception therapies, and waveform combination capabilities supported by substantial clinical evidence [11][12][13][14][15][16][17][18][19][20].…”

“…Yet, it is possible to use a more versatile SCS device with advanced programming capabilities that provide full access to a wide range of therapeutic options. These modalities include supra-and sub-perception stimulation therapies that can be used either in isolation or in combination and enable the use of advanced temporal and spatial neural-targeting algorithms (e.g., customized field shapes using multiple independent current control, MICC) [14][15][16][17][18]20,33,34]. Simple, minimally invasive replacement of the IPG, using an adapter or not, can be performed, enabling access to multiple programmable solutions that allow stimulation to be tailored and adjusted over time.…”