Real-world outcomes of single-stage spinal cord stimulation in chronic pain patients: A multicentre, European case series.
Chronic pain
Neuromodulation
Single-stage procedure
Spinal cord stimulation
Trial screening
Journal
Interventional pain medicine
ISSN: 2772-5944
Titre abrégé: Interv Pain Med
Pays: Netherlands
ID NLM: 9918591886006676
Informations de publication
Date de publication:
Sep 2023
Sep 2023
Historique:
received:
05
04
2023
revised:
31
05
2023
accepted:
01
06
2023
medline:
24
6
2023
pubmed:
24
6
2023
entrez:
6
9
2024
Statut:
epublish
Résumé
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). 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. 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. 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.
Sections du résumé
Background
UNASSIGNED
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
UNASSIGNED
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
UNASSIGNED
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
UNASSIGNED
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.
Identifiants
pubmed: 39238903
doi: 10.1016/j.inpm.2023.100263
pii: S2772-5944(23)00095-X
pmc: PMC11372901
doi:
Types de publication
Journal Article
Langues
eng
Pagination
100263Informations de copyright
© 2023 The Authors.
Déclaration de conflit d'intérêts
The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Pasquale De Negri reports administrative support, statistical analysis, and writing assistance were provided by Boston Scientific Neuromodulation. Pasquale De Negri reports a relationship with Boston Scientific Neuromodulation that includes: non-financial support. This study was sponsored by 10.13039/100008497Boston Scientific, and personnel from the Clinical Research Department within Boston Scientific’s Division of Neuromodulation were involved in the study design (RJ), analysis (RJ, YP), interpretation of the data (RJ), writing of the manuscript (RJ) and overall decision to submit the article for publication. 10.13039/100008497Boston Scientific also funded the services of the medical writer (Deborah Nock, Medical WriteAway, Norwich, UK). Drs. Jose F. Paz-Solis, Philippe Rigoard, Sylvie Raoul, Simon Thomson and Georgios K. Matis declare active consulting agreements with Boston Scientific. Dr. Abejón is a consultant and speaker for Boston Scientific, Saluda Médical, Medtronic and Abbott, Devonlabs, Cardiva2 and Grünenthal. Yu Pei and Roshini Jain are employees of Boston Scientific. This study is sponsored by 10.13039/100008497Boston Scientific.