Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

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

Version 1 : Received: 31 August 2021 / Approved: 1 September 2021 / Online: 1 September 2021 (18:16:10 CEST)

How to cite: Rigoard, P.; Ounajim, A.; Goudman, L.; Bouche, B.; Roulaud, M.; Page, P.; Lorgeoux, B.; Baron, S.; Nivole, K.; Many, M.; Adjali, N.; Charrier, E.; Rannou, D.; Poupin, L.; Wood, C.; David, R.; Héraud, D.; Moens, M.; Billot, M. 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. Preprints 2021, 2021090031 (doi: 10.20944/preprints202109.0031.v1). Rigoard, P.; Ounajim, A.; Goudman, L.; Bouche, B.; Roulaud, M.; Page, P.; Lorgeoux, B.; Baron, S.; Nivole, K.; Many, M.; Adjali, N.; Charrier, E.; Rannou, D.; Poupin, L.; Wood, C.; David, R.; Héraud, D.; Moens, M.; Billot, M. 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. Preprints 2021, 2021090031 (doi: 10.20944/preprints202109.0031.v1).

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.

Keywords

spinal cord stimulation (SCS); peripheral nerve field stimulation (PNfS); SubQ-stimulation; hybrid stimulation; multidimensional pain assessment; pain mapping; pain software; persistent spinal pain syndrome - T2 (PSPS-T2); failed back surgery syndrome; failed spinal cord stimulation syndrome (FSCSS); salvage therapy; salvage algorithm

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