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

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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.

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Most cited references 38

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Cut-Off Points for Mild, Moderate, and Severe Pain on the Numeric Rating Scale for Pain in Patients with Chronic Musculoskeletal Pain: Variability and Influence of Sex and Catastrophizing

Anne M. Boonstra, Roy E. Stewart, Albère J. A. Köke … (2016)

Objectives: The 0–10 Numeric Rating Scale (NRS) is often used in pain management. The aims of our study were to determine the cut-off points for mild, moderate, and severe pain in terms of pain-related interference with functioning in patients with chronic musculoskeletal pain, to measure the variability of the optimal cut-off points, and to determine the influence of patients’ catastrophizing and their sex on these cut-off points. Methods: 2854 patients were included. Pain was assessed by the NRS, functioning by the Pain Disability Index (PDI) and catastrophizing by the Pain Catastrophizing Scale (PCS). Cut-off point schemes were tested using ANOVAs with and without using the PSC scores or sex as co-variates and with the interaction between CP scheme and PCS score and sex, respectively. The variability of the optimal cut-off point schemes was quantified using bootstrapping procedure. Results and conclusion: The study showed that NRS scores ≤ 5 correspond to mild, scores of 6–7 to moderate and scores ≥8 to severe pain in terms of pain-related interference with functioning. Bootstrapping analysis identified this optimal NRS cut-off point scheme in 90% of the bootstrapping samples. The interpretation of the NRS is independent of sex, but seems to depend on catastrophizing. In patients with high catastrophizing tendency, the optimal cut-off point scheme equals that for the total study sample, but in patients with a low catastrophizing tendency, NRS scores ≤ 3 correspond to mild, scores of 4–6 to moderate and scores ≥7 to severe pain in terms of interference with functioning. In these optimal cut-off schemes, NRS scores of 4 and 5 correspond to moderate interference with functioning for patients with low catastrophizing tendency and to mild interference for patients with high catastrophizing tendency. Theoretically one would therefore expect that among the patients with NRS scores 4 and 5 there would be a higher average PDI score for those with low catastrophizing than for those with high catastrophizing. However, we found the opposite. The fact that we did not find the same optimal CP scheme in the subgroups with lower and higher catastrophizing tendency may be due to chance variability.

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Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform

Ed Tavel, Thomas Yearwood, Allen Burton … (2018)

The purpose of the multicenter, randomized, unblinded, crossover Success Using Neuromodulation with BURST (SUNBURST) study was to determine the safety and efficacy of a device delivering both traditional tonic stimulation and burst stimulation to patients with chronic pain of the trunk and/or limbs.

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Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomised, controlled trial

Nagy Mekhail, Robert Levy, Timothy R Deer … (2019)

Spinal cord stimulation has been an established treatment for chronic back and leg pain for more than 50 years; however, outcomes are variable and unpredictable, and objective evidence of the mechanism of action is needed. A novel spinal cord stimulation system provides the first in vivo, real-time, continuous objective measure of spinal cord activation in response to therapy via recorded evoked compound action potentials (ECAPs) in patients during daily use. These ECAPs are also used to optimise programming and deliver closed-loop spinal cord stimulation by adjusting the stimulation current to maintain activation within patients' therapeutic window. We aimed to examine pain relief and the extent of spinal cord activation with ECAP-controlled closed-loop versus fixed-output, open-loop spinal cord stimulation for the treatment of chronic back and leg pain.

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Author and article information

Contributors

Pasquale De Negri

Journal

Journal ID (nlm-ta): Interv Pain Med

Journal ID (iso-abbrev): Interv Pain Med

Title: Interventional Pain Medicine

Publisher: Elsevier

ISSN (Electronic): 2772-5944

Publication date PMC-release: 24 June 2023

Publication date Collection: September 2023

Publication date (Electronic): 24 June 2023

Volume: 2

Issue: 3

Electronic Location Identifier: 100263

Affiliations

[a ]Department of Anesthesia, Sant’Anna and San Sebastiano Hospital, Caserta, Italy

[b ]Department of Neurosurgery, University Hospital La Paz, Madrid, Spain

[c ]Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery Lab, Poitiers University Hospital, Poitiers, France

[d ]Department of Neuro-Spine & Neuromodulation, Poitiers University Hospital, Poitiers, France

[e ]Department of Neurosurgery, Nantes University Hospital, Nantes, France

[f ]Department of Anesthesiology and Pain Medicine, Rijnstate Hospital, Arnhem, the Netherlands

[g ]Amsterdam University Medical Centre, Amsterdam, the Netherlands

[h ]Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK

[i ]Department of Pain Medicine and Neuromodulation, Mid and South Essex University Hospitals, Essex, UK

[j ]Multidisciplinary Unit for Pain Treatment, University and Polytechnic Hospital La Fe, Valencia, Spain

[k ]Department of Pain Medicine and Neuromodulation, Southmead Hospital, Bristol, United Kingdom

[l ]Neurosurgery Service, Hospital Clínico San Carlos, Madrid, Spain

[m ]Department of Neurosurgery, Charité - Universitätsmedizin Berlin, Berlin, Germany

[n ]Service of Anesthesiology, Resuscitation and Therapeutics of Pain, University Hospital La Ribera, Alzira, Valencia, Spain

[o ]Andalusian Health Service, University Hospital Virgen del Rocío, Seville, Spain

[p ]Department of Stereotactic and Functional Neurosurgery, University Hospital Cologne, Cologne, Germany

[q ]Department of Neurosurgery, University Hospital Düsseldorf, Düsseldorf, Germany

[r ]Multidisciplinary Pain Management Unit, University Hospital Quirónsalud, Madrid, Spain

[s ]Neurocenter of Southern Switzerland, Lugano Regional Hospital, Lugano, Switzerland

[t ]Pain Department, A.O. Dei Colli - V. Monaldi Hospital, Napoli, Italy

[u ]Division of Neuromodulation, Boston Scientific, Valencia, CA, USA

Author notes

[∗ ]Corresponding author. Via Palasciano, Caserta, Italy. pasquale.denegri@ 123456aorncaserta.it

[1]

No longer presently employed at the Division of Neuromodulation, Boston Scientific.

Article

Publisher Item ID: S2772-5944(23)00095-X Publisher ID: 100263

DOI: 10.1016/j.inpm.2023.100263

PMC ID: 11372901

PubMed ID: 39238903

SO-VID: 81c018d4-b9be-49ea-8c03-fa0accbe8a7f

License:

This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

History

Date received : 5 April 2023

Date revision received : 31 May 2023

Date accepted : 1 June 2023

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