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

Abstract

While Spinal Cord Stimulation (SCS) provides satisfaction to almost 2/3 of Persistent Spinal Pain Syndrome-Type 2 (PSPS-T2) patients implanted for refractory chronic back and/or leg pain when not adequately addressed the back pain component, leaves patients in a therapeutic cul-de-sac. Peripheral Nerve field Stimulation (PNfS) has shown interesting results addressing back pain in the same population. Far from placing these two techniques in opposition, we suggest that these approaches could be combined to better treat PSPS-T2 patients. We designed a RCT (CUMPNS), with a 12-month follow-up, to assess the potential added value of PNfS, as a salvage therapy, in PSPS-T2 patients experiencing a “Failed SCS Syndrome” in the back pain component. Fourteen patients were included in this study and randomized into 2 groups (“SCS + PNfS” group/n=6 vs “SCS only” group/n=8). The primary objective of the study was to compare the percentage of back pain surface decrease after 3 months, using a computerized interface to obtain quantitative pain mappings, combined with multi-dimensional SCS outcomes. Back pain surface decreased significantly greater for the ”SCS+PNfS” group (80.2% ± 21.3%) compared to the “SCS only” group (13.2% ± 94.8%) (p=0.012), highlighting the clinical interest of SCS+PNfS, in cases where SCS fails to address back pain.

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

“…(b) Should we change the target of neurostimulation (i.e. switching from SCS to Dorsal Root Ganglion (DRG) or Peripheral Nerve Field Stimulation (PNfS), as examples recently documented in the literature [36]? To take the best decision for the patient, one needs to put into the balance the potential drawbacks of the invasiveness of such procedures, given the risk of infection and total explantation.…”

“…), we could wonder if the potential new IPG, implanted following a positive lead trial, would not interfere with the other neurostimulation targets. Ongoing studies [54] and recent publications [36] consider this important question. We should note that one of the advantages of this new technology is to propose 4 channels of stimulation, with a multi-source generation of the current.…”

Patient Selection for Spinal Cord Stimulation in Treatment of Pain: Sequential Decision-Making Model — A Narrative Review

“…The application, efficacy, and safety of spinal cord stimulation (SCS) for the management of chronic pain are well known. 1–3 During the last decade, refinements and innovations have dominated the landscape of neuromodulation in the form of novel stimulation waveforms, 4 , 5 new anatomical targets, 6 , 7 and novel feedback-loop mechanisms. 8 , 9 Despite the widely accepted effects of SCS for obtaining pain relief, 1 increasing quality of life, 10 and decreasing pain-medication use, 11 clinicians are still faced with a lack of clear criteria for optimal patient selection for this treatment.…”