Comparison of conventional, burst and high-frequency spinal cord stimulation on pain relief in refractory failed back surgery syndrome patients: study protocol for a prospective randomized double-blinded cross-over trial (MULTIWAVE study)

Abstract

Background: While the evolution of technology provides new opportunities to manage chronic refractory pain using different waveform modalities of spinal cord stimulation in failed back surgery syndrome (FBSS), there is no randomized controlled trial available to compare the efficacy of these different stimulations waveforms to date. MULTIWAVE is a prospective, randomized, double-blinded, crossover trial study designed to compare the clinical efficacy of tonic conventional stimulation (TCS), burst stimulation (BURST) and high-frequency stimulation (HF) in FBSS patients over a 15-month period in SCS implanted patients.

The Challenge of Converting “Failed Spinal Cord Stimulation Syndrome” Back to Clinical Success, Using SCS Reprogramming as Salvage Therapy, Through Neurostimulation Adapters Combined with 3D-Computerized Pain Mapping Assessment. A Real-Life Retrospective Cohort Analysis

“…Although Karri and al (2020) [24] showed the superiority of burst over tonic in reduction of pain through a meta-analysis of 5 studies comparing burst versus tonic, our study demonstrates that patients seem to still appreciate paresthesia-based stimulation. These results need to be confirmed on a larger cohort with long-term follow-up [25].…”

“…While SCS is effective to manage pain in about 50% of implanted patients, and by extension improve quality of life [26] one of the more challenging conditions is to find solutions in case of SCS pain relief failure [27,28] or LoE over time [12,29,30]. While the ultimate decision in SCS failure could be IPG and lead(s) explantation [11,27,28] alternative could nowadays be proposed to the patient with introduction of a device adapter to switch from conventional to independent source spatial targeting [31] and from tonic to new paresthesia-free waveforms, such as Burst or HF [20,25,[32][33][34].…”

“…Indeed, over the last 15 years, new SCS paradigms have been developed, relying on different mechanisms of action [38,39] and offering new ways to shape the electrical field, both spatially and temporally. Thanks to these recent advances in SCS hardware and programming technologies, patients can have access to various waveforms (standard rate, high frequency (HF), burst, high dose (HD)) [17,25,31,[40][41][42] and tailored advanced targeting (multisource IPG) [17,18] of the chronic pain experienced by SCS-implanted patients [43,44].…”

The Added Value of Subcutaneous Peripheral Nerve Field Stimulation Combined with SCS, as Salvage Therapy, for Refractory Low Back Pain Component in Persistent Spinal Pain Syndrome Implanted Patients: A Randomized Controlled Study (CUMPNS Study) Based on 3D-Mapping Composite Pain Assessment

“…Indeed, after having spent four decades of SCS trying to find the best spatial neural target to stimulate [1,2,[51][52][53][54][55], with an emphasis on lead design [53] and electrical field modeling [56,57], around 2014 neuromodulation philosophy adopted a radically different direction, due to innovations in the temporal resolution of the signal, thereafter focusing on new waveforms. Burst stimulation appeared in 2013 [58], paresthesia free-high frequency techniques were developed contemporarily and it took about 5 years for our community to publish counter-studies, counterbalancing the "overly promising" initial results of some of these techniques [59][60][61][62], the objective being to orient us toward the right compromise for our patients, mixing the two approaches as complementary tools: (i) Spatial resolution can be adjusted by the choice of the neural target and new programing capabilities, based on electrical fragmentation of the current; and (ii) temporal resolution can be adjusted by the IPG, as an alternative to tonic conventional SCS or a combination of several waveforms delivered to the patient, the objective being to enhance our ability to personalize SCS therapies [2,63]. As a consequence, some recently marketed adapters play on the temporal resolution of SCS and give the patient the opportunity to extensively test the different existing waveforms with promising results [64][65][66].…”

The Added Value of Subcutaneous Peripheral Nerve Field Stimulation Combined with SCS, as Salvage Therapy, for Refractory Low Back Pain Component in Persistent Spinal Pain Syndrome Implanted Patients: A Randomized Controlled Study (CUMPNS Study) Based on 3D-Mapping Composite Pain Assessment

“…Indeed, after having spent four decades of SCS trying to find the best spatial neural target to stimulate [1,2,[49][50][51][52][53], with an emphasis on lead design [51] and electrical field modeling [54,55], around 2014 neuromodulation philosophy adopted a radically different direction, due to innovations in the temporal resolution of the signal, thereafter focusing on new waveforms. Burst stimulation appeared in 2013 [56], paresthesia freehigh frequency techniques were developed contemporarily and it took about 5 years for our community to publish counter-studies, counterbalancing the "overly promising" initial results of some of these techniques [57][58][59][60], the objective being to orient us toward the right compromise for our patients, mixing the two approaches as complementary tools: (i) Spatial resolution can be adjusted by the choice of the neural target and new programing capabilities, based on electrical fragmentation of the current; and (ii) temporal resolution can be adjusted by the IPG, as an alternative to tonic conventional SCS or a combination of several waveforms delivered to the patient, the objective being to enhance our ability to personalize SCS therapies [2,61]. As a consequence, some recently marketed adaptors play on the temporal resolution of SCS and give the patient the opportunity to extensively test the different existing waveforms with promising results [62][63][64].…”