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

Philippe Rigoard; Amine Ounajim; Lisa Goudman; Benedicte Bouche; Manuel Roulaud; Philippe Page; Bertille Lorgeoux; Sandrine Baron; Kevin Nivole; Mathilde Many; Nihel Adjali; Elodie Charrier; Delphine Rannou; Laure Poupin; Chantal Wood; Romain David; Dylan Héraud; Maartens Moens; Maxime Billot

doi:10.3390/jcm10215094

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

J Clin Med. 2021 Oct 29;10(21):5094. doi: 10.3390/jcm10215094.

Authors

Philippe Rigoard^{1

2

3}, Amine Ounajim¹, Lisa Goudman^{4

5}, Benedicte Bouche¹, Manuel Roulaud¹, Philippe Page⁵, Bertille Lorgeoux¹, Sandrine Baron¹, Kevin Nivole¹, Mathilde Many¹, Nihel Adjali¹, Elodie Charrier⁶, Delphine Rannou⁶, Laure Poupin⁶, Chantal Wood¹, Romain David^{1

7}, Dylan Héraud¹, Maartens Moens^{4

5}, Maxime Billot¹

Affiliations

¹ PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France.
² Department of Spine Surgery & Neuromodulation, Poitiers University Hospital, 86021 Poitiers, France.
³ Pprime Institute UPR 3346, CNRS, ISAE-ENSMA, University of Poitiers, 86360 Chasseneuil-du-Poitou, France.
⁴ Department of Neurosurgery, Universitair Ziekenhuis Brussel, 1090 Brussels, Belgium.
⁵ STIMULUS Research Group, Vrije Universiteit Brussel, 1090 Brussels, Belgium.
⁶ Pain Evaluation and Treatment Centre, Poitiers University Hospital, 86021 Poitiers, France.
⁷ Physical and Rehabilitation Medicine Unit, Poitiers University Hospital, University of Poitiers, 86021 Poitiers, France.

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: Failed Back Surgery Syndrome (FBSS); Failed Spinal Cord Stimulation Syndrome (FSCSS); Hybrid Stimulation; Multidimensional Pain assessment; Pain Mapping; Spinal Cord Stimulation; SubQ-stimulation; salvage therapy.