Real-world outcomes of single-stage spinal cord stimulation in chronic pain patients: A multicentre, European case series

P. de Negri; Jose F. Paz-Solis; Philippe Rigoard; S. Raoul; J.W. Kallewaard; Ashish Gulve; Simon Thomson; M. Angeles Canós Verdecho; Sarah Love-Jones; A. Williams; Fernando Rascón-Ramírez; Simon Bayerl; José Llopis-Calatayud; Isaac Peña Vergara; Georgios Matis; Jan Vesper; David Abejón; Paolo Maino; Alfonso Papa; Yu Pei; Roshini Jain

doi:https://doi.org/10.1016/j.inpm.2023.100263

Real-world outcomes of single-stage spinal cord stimulation in chronic pain patients: A multicentre, European case series

P. de Negri, Jose F. Paz-Solis, Philippe Rigoard, S. Raoul, J.W. Kallewaard, Ashish Gulve, Simon Thomson, M. Angeles Canós Verdecho, Sarah Love-Jones, A. Williams, Fernando Rascón-Ramírez, Simon Bayerl, José Llopis-Calatayud, Isaac Peña Vergara, Georgios Matis, Jan Vesper, David Abejón, Paolo Maino, Alfonso Papa, Yu PeiRoshini Jain

Anesthesiology (AMC)

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

Background: Spinal cord stimulation (SCS) is effective in treating chronic neuropathic pain. A screening trial is typically conducted prior to implantation to evaluate whether a patient is a good candidate for SCS. However, the need for a screening trial has been debated. We evaluated real-world clinical outcomes in patients who underwent a single-stage procedure to receive SCS therapy (i.e., no screening trial period) (SS-SCS).

Methods: This observational, multicentre, real-world consecutive case series evaluated SS-SCS chronic pain patients. Pain and other functional outcomes were collected as part of standard care by site personnel with no sponsor involvement. Assessments included Numerical rating scale (NRS), Percent Pain Relief (PPR) and EQ-5D-5L (EuroQol 5 Dimensions-5L), recorded prior to SCS and following implantation.

Results: A total of 171 chronic pain patients (mean age: 59.4; 53.2% females) underwent a single-stage procedure (mean last follow-up, 408 days) and were included in the analysis. A 5.0 ± 2.1-point improvement in overall pain was reported at 3 months and sustained until the last follow-up post-implantation (p < 0.0001). At last follow-up, 50.3% (86/171) of patients reported an NRS pain score ≤3. Additionally, quality of life also improved (46.1-point change, from 70.2 to 25) at the last follow-up, based on EQ-5D-5L scores.

Conclusions: In routine clinical practice, SS-SCS can provide significant long-term pain relief and improve quality of life in chronic pain patients. Our results suggest that effective long-term outcomes and success may be achieved without a trial period prior to permanent implantation of an SCS system.

Original language	English
Journal	Interventional Pain Medicine
Volume	2
Issue number	3
DOIs	https://doi.org/10.1016/j.inpm.2023.100263
Publication status	Published - Sept 2023

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https://doi.org/10.1016/j.inpm.2023.100263Licence: CC BY-NC-ND

Cite this

de Negri, P., Paz-Solis, J. F., Rigoard, P., Raoul, S., Kallewaard, J. W., Gulve, A., Thomson, S., Verdecho, M. A. C., Love-Jones, S., Williams, A., Rascón-Ramírez, F., Bayerl, S., Llopis-Calatayud, J., Peña Vergara, I., Matis, G., Vesper, J., Abejón, D., Maino, P., Papa, A., ... Jain, R. (2023). Real-world outcomes of single-stage spinal cord stimulation in chronic pain patients: A multicentre, European case series. Interventional Pain Medicine, 2(3). https://doi.org/10.1016/j.inpm.2023.100263

@article{c1b9fa6d27f540dd8912d1abe6b0b00f,

title = "Real-world outcomes of single-stage spinal cord stimulation in chronic pain patients: A multicentre, European case series",

abstract = "Background: Spinal cord stimulation (SCS) is effective in treating chronic neuropathic pain. A screening trial is typically conducted prior to implantation to evaluate whether a patient is a good candidate for SCS. However, the need for a screening trial has been debated. We evaluated real-world clinical outcomes in patients who underwent a single-stage procedure to receive SCS therapy (i.e., no screening trial period) (SS-SCS).Methods: This observational, multicentre, real-world consecutive case series evaluated SS-SCS chronic pain patients. Pain and other functional outcomes were collected as part of standard care by site personnel with no sponsor involvement. Assessments included Numerical rating scale (NRS), Percent Pain Relief (PPR) and EQ-5D-5L (EuroQol 5 Dimensions-5L), recorded prior to SCS and following implantation.Results: A total of 171 chronic pain patients (mean age: 59.4; 53.2% females) underwent a single-stage procedure (mean last follow-up, 408 days) and were included in the analysis. A 5.0 ± 2.1-point improvement in overall pain was reported at 3 months and sustained until the last follow-up post-implantation (p < 0.0001). At last follow-up, 50.3% (86/171) of patients reported an NRS pain score ≤3. Additionally, quality of life also improved (46.1-point change, from 70.2 to 25) at the last follow-up, based on EQ-5D-5L scores.Conclusions: In routine clinical practice, SS-SCS can provide significant long-term pain relief and improve quality of life in chronic pain patients. Our results suggest that effective long-term outcomes and success may be achieved without a trial period prior to permanent implantation of an SCS system.",

author = "{de Negri}, P. and Paz-Solis, {Jose F.} and Philippe Rigoard and S. Raoul and J.W. Kallewaard and Ashish Gulve and Simon Thomson and Verdecho, {M. Angeles Can{\'o}s} and Sarah Love-Jones and A. Williams and Fernando Rasc{\'o}n-Ram{\'i}rez and Simon Bayerl and Jos{\'e} Llopis-Calatayud and {Pe{\~n}a Vergara}, Isaac and Georgios Matis and Jan Vesper and David Abej{\'o}n and Paolo Maino and Alfonso Papa and Yu Pei and Roshini Jain",

year = "2023",

month = sep,

doi = "https://doi.org/10.1016/j.inpm.2023.100263",

language = "English",

volume = "2",

journal = "Interventional Pain Medicine",

issn = "2772-5944",

publisher = "Elsevier",

number = "3",

}

de Negri, P, Paz-Solis, JF, Rigoard, P, Raoul, S, Kallewaard, JW, Gulve, A, Thomson, S, Verdecho, MAC, Love-Jones, S, Williams, A, Rascón-Ramírez, F, Bayerl, S, Llopis-Calatayud, J, Peña Vergara, I, Matis, G, Vesper, J, Abejón, D, Maino, P, Papa, A, Pei, Y & Jain, R 2023, 'Real-world outcomes of single-stage spinal cord stimulation in chronic pain patients: A multicentre, European case series', Interventional Pain Medicine, vol. 2, no. 3. https://doi.org/10.1016/j.inpm.2023.100263

TY - JOUR

T1 - Real-world outcomes of single-stage spinal cord stimulation in chronic pain patients

T2 - A multicentre, European case series

AU - de Negri, P.

AU - Paz-Solis, Jose F.

AU - Rigoard, Philippe

AU - Raoul, S.

AU - Kallewaard, J.W.

AU - Gulve, Ashish

AU - Thomson, Simon

AU - Verdecho, M. Angeles Canós

AU - Love-Jones, Sarah

AU - Williams, A.

AU - Rascón-Ramírez, Fernando

AU - Bayerl, Simon

AU - Llopis-Calatayud, José

AU - Peña Vergara, Isaac

AU - Matis, Georgios

AU - Vesper, Jan

AU - Abejón, David

AU - Maino, Paolo

AU - Papa, Alfonso

AU - Pei, Yu

AU - Jain, Roshini

PY - 2023/9

Y1 - 2023/9

N2 - Background: Spinal cord stimulation (SCS) is effective in treating chronic neuropathic pain. A screening trial is typically conducted prior to implantation to evaluate whether a patient is a good candidate for SCS. However, the need for a screening trial has been debated. We evaluated real-world clinical outcomes in patients who underwent a single-stage procedure to receive SCS therapy (i.e., no screening trial period) (SS-SCS).Methods: This observational, multicentre, real-world consecutive case series evaluated SS-SCS chronic pain patients. Pain and other functional outcomes were collected as part of standard care by site personnel with no sponsor involvement. Assessments included Numerical rating scale (NRS), Percent Pain Relief (PPR) and EQ-5D-5L (EuroQol 5 Dimensions-5L), recorded prior to SCS and following implantation.Results: A total of 171 chronic pain patients (mean age: 59.4; 53.2% females) underwent a single-stage procedure (mean last follow-up, 408 days) and were included in the analysis. A 5.0 ± 2.1-point improvement in overall pain was reported at 3 months and sustained until the last follow-up post-implantation (p < 0.0001). At last follow-up, 50.3% (86/171) of patients reported an NRS pain score ≤3. Additionally, quality of life also improved (46.1-point change, from 70.2 to 25) at the last follow-up, based on EQ-5D-5L scores.Conclusions: In routine clinical practice, SS-SCS can provide significant long-term pain relief and improve quality of life in chronic pain patients. Our results suggest that effective long-term outcomes and success may be achieved without a trial period prior to permanent implantation of an SCS system.

AB - Background: Spinal cord stimulation (SCS) is effective in treating chronic neuropathic pain. A screening trial is typically conducted prior to implantation to evaluate whether a patient is a good candidate for SCS. However, the need for a screening trial has been debated. We evaluated real-world clinical outcomes in patients who underwent a single-stage procedure to receive SCS therapy (i.e., no screening trial period) (SS-SCS).Methods: This observational, multicentre, real-world consecutive case series evaluated SS-SCS chronic pain patients. Pain and other functional outcomes were collected as part of standard care by site personnel with no sponsor involvement. Assessments included Numerical rating scale (NRS), Percent Pain Relief (PPR) and EQ-5D-5L (EuroQol 5 Dimensions-5L), recorded prior to SCS and following implantation.Results: A total of 171 chronic pain patients (mean age: 59.4; 53.2% females) underwent a single-stage procedure (mean last follow-up, 408 days) and were included in the analysis. A 5.0 ± 2.1-point improvement in overall pain was reported at 3 months and sustained until the last follow-up post-implantation (p < 0.0001). At last follow-up, 50.3% (86/171) of patients reported an NRS pain score ≤3. Additionally, quality of life also improved (46.1-point change, from 70.2 to 25) at the last follow-up, based on EQ-5D-5L scores.Conclusions: In routine clinical practice, SS-SCS can provide significant long-term pain relief and improve quality of life in chronic pain patients. Our results suggest that effective long-term outcomes and success may be achieved without a trial period prior to permanent implantation of an SCS system.

U2 - https://doi.org/10.1016/j.inpm.2023.100263

DO - https://doi.org/10.1016/j.inpm.2023.100263

M3 - Article

SN - 2772-5944

VL - 2

JO - Interventional Pain Medicine

JF - Interventional Pain Medicine

IS - 3

ER -