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Article

Real-World Outcomes Using a Spinal Cord Stimulation Device Capable of Combination Therapy for Chronic Pain: A European, Multicenter Experience

by
Jan Willem Kallewaard
1,*,
Jose Francisco Paz-Solis
2,
Pasquale De Negri
3,
Maria Angeles Canós-Verdecho
4,
Hayat Belaid
5,
Simon J. Thomson
6,
David Abejón
7,
Jan Vesper
8,
Vivek Mehta
9,
Philippe Rigoard
10,
Paolo Maino
11,
Sarah Love-Jones
12,
Isaac F. Peña
13,
Simon Bayerl
14,
Christophe Perruchoud
15,
Renaud Bougeard
16,
Cleo Mertz
17,
Yu Pei
18 and
Roshini Jain
18
1
Department of Anesthesiology and Pain Medicine, Rijnstate Hospital, 6815 Arnhem, The Netherlands
2
Department of Neurosurgery, University Hospital La Paz, 28046 Madrid, Spain
3
AORN S. Anna & S. Sebastiano, 81100 Caserta, Italy
4
Multidisciplinary Unit for Pain Treatment, University and Polytechnic Hospital La Fe, 46026 Valencia, Spain
5
Fondation Adolphe de Rothschild, 75019 Paris, France
6
Pain Management, Mid and South Essex University Hospitals NHSFT, Basildon SS16 5NL, UK
7
Pain Unit, Hospital Universitario Quirónsalud, 28223 Madrid, Spain
8
Department of Functional Neurosurgery and Stereotaxy, University Medical Center Heinrich Heine University, 40225 Düsseldorf, Germany
9
Pain & Anaesthesia Research Centre, St. Bartholomew’s Hospital, Bart’s Health, London EC1A 7BE, UK
10
Prismatics Lab & Spine Surgery and Neuromodulation Department, Poitiers University Hospital, 86021 Poitiers, France
11
Pain Management Center, Neurocenter of Southern Switzerland, 6900 Lugano, Switzerland
12
Anaesthetics and Pain Management, Southmead Hospital, Bristol FCW5 P9, UK
13
Pain Unit, Virgen Del Rocio University Hospital, 41013 Sevilla, Spain
14
Neurosurgery, Charité—Universitätsmedizin Berlin, 13353 Berlin, Germany
15
Pain Clinic, La Tour Hospital, 1217 Meyrin, Switzerland
16
Clinique du Val d’Ouest, 69130 Écully, France
17
Boston Scientific Neuromodulation, 1861 Brussels, Belgium
18
Boston Scientific Neuromodulation, Valencia, CA 91355, USA
 
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*
Author to whom correspondence should be addressed.
J. Clin. Med. 2021, 10(18), 4085; https://doi.org/10.3390/jcm10184085
Submission received: 4 August 2021 / Revised: 31 August 2021 / Accepted: 7 September 2021 / Published: 10 September 2021
(This article belongs to the Special Issue Spinal Cord Stimulation and Other Neuromodulation Therapies for the Treatment of Refractory Chronic Pain: What’s New? What’s Good? What’s Better?)
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Abstract

Given the differing mechanisms thought to underlie therapeutic sub- and supra-perception-based neurostimulative modalities, Spinal Cord Stimulation (SCS) systems designed for combined delivery of these approaches may help improve analgesic outcomes and quality of life, and reduce treatment failures. This multicenter, observational case-series evaluated 188 patients with chronic back and/or leg pain implanted with an SCS device capable of sequential or simultaneous delivery of sub-perception and supra-perception stimulation programming (i.e., combination therapy) at 16 sites in Europe. Following implantation, patients were provided with an array of advanced supra-perception programs (e.g., paresthesia-based SCS using multiple independent current sources), and a custom set of sub-perception programs optimized with specific waveforms and/or field shapes. A mean overall pain score of 7.9 ± 1.7 (Standard Deviation (SD)) was reported pre-trial (Baseline). Overall pain was reduced by 4.4 ± 2.8 points (NRS) at 3-months (n = 117) and at 12 months post-implant (n = 90), respectively (p < 0.0001). Substantial quality-of-life (EQ-5D-5L) improvement as assessed at last follow-up was also observed (n = 60). These results suggest that an implanted SCS device capable of combination therapy, while also enabled with patient-specific waveform optimization and stimulation field targeting capabilities, can enable highly effective pain relief and improve quality of life in patients suffering with chronic pain.
Keywords: chronic pain; combination therapy; customized stimulation field targeting; spinal cord stimulation; SCS chronic pain; combination therapy; customized stimulation field targeting; spinal cord stimulation; SCS

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MDPI and ACS Style

Kallewaard, J.W.; Paz-Solis, J.F.; De Negri, P.; Canós-Verdecho, M.A.; Belaid, H.; Thomson, S.J.; Abejón, D.; Vesper, J.; Mehta, V.; Rigoard, P.; et al. Real-World Outcomes Using a Spinal Cord Stimulation Device Capable of Combination Therapy for Chronic Pain: A European, Multicenter Experience. J. Clin. Med. 2021, 10, 4085. https://doi.org/10.3390/jcm10184085

AMA Style

Kallewaard JW, Paz-Solis JF, De Negri P, Canós-Verdecho MA, Belaid H, Thomson SJ, Abejón D, Vesper J, Mehta V, Rigoard P, et al. Real-World Outcomes Using a Spinal Cord Stimulation Device Capable of Combination Therapy for Chronic Pain: A European, Multicenter Experience. Journal of Clinical Medicine. 2021; 10(18):4085. https://doi.org/10.3390/jcm10184085

Chicago/Turabian Style

Kallewaard, Jan Willem, Jose Francisco Paz-Solis, Pasquale De Negri, Maria Angeles Canós-Verdecho, Hayat Belaid, Simon J. Thomson, David Abejón, Jan Vesper, Vivek Mehta, Philippe Rigoard, and et al. 2021. "Real-World Outcomes Using a Spinal Cord Stimulation Device Capable of Combination Therapy for Chronic Pain: A European, Multicenter Experience" Journal of Clinical Medicine 10, no. 18: 4085. https://doi.org/10.3390/jcm10184085

APA Style

Kallewaard, J. W., Paz-Solis, J. F., De Negri, P., Canós-Verdecho, M. A., Belaid, H., Thomson, S. J., Abejón, D., Vesper, J., Mehta, V., Rigoard, P., Maino, P., Love-Jones, S., Peña, I. F., Bayerl, S., Perruchoud, C., Bougeard, R., Mertz, C., Pei, Y., & Jain, R. (2021). Real-World Outcomes Using a Spinal Cord Stimulation Device Capable of Combination Therapy for Chronic Pain: A European, Multicenter Experience. Journal of Clinical Medicine, 10(18), 4085. https://doi.org/10.3390/jcm10184085

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