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. 2023 Jun 24;2(3):100263.
doi: 10.1016/j.inpm.2023.100263. eCollection 2023 Sep.

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

Pasquale De Negri  1 , Jose Francisco Paz-Solis  2 , Philippe Rigoard  3   4 , Sylvie Raoul  5 , Jan-Willem Kallewaard  6   7 , Ashish Gulve  8 , Simon Thomson  9 , Maria Angeles Canós-Verdecho  10 , Sarah Love-Jones  10 , Adam Williams  11 , Fernando J Rascón-Ramírez  12 , Simon Bayerl  13 , José Emilio Llopis-Calatayud  14 , Isaac Peña Vergara  15 , Georgios K Matis  16 , Jan Vesper  17 , David Abejón  18 , Paolo Maino  19 , Alfonso Papa  20 , Yu Pei  21 , Roshini Jain  21
Affiliations

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

Pasquale De Negri et al. Interv Pain Med. .

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.

Keywords: Chronic pain; Neuromodulation; Single-stage procedure; Spinal cord stimulation; Trial screening.

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Conflict of interest statement

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.

Figures

Fig. 1
Fig. 1
Overall pain, low back and leg pain scores at baseline and up to 12 months post-implant (mean ​± ​standard error).
Fig. 2
Fig. 2
Overall pain, low back, and leg pain scores at baseline and up to last follow-up (mean ​= ​408 days) (mean ​± ​standard error).
Fig. 3
Fig. 3
Distribution of overall pain scores at last follow-up (mean ​= ​408 days). 50.3% (86 of 171 patients) reported a pain score ≤3.
Fig. 4
Fig. 4
Mean quality of life at last follow-up (mean ​= ​408 days), assessed using the EQ-5D-5L (0 ​= ​‘the worst health you could imagine’ to 100 ​= ​‘the best health you could imagine’). A 46.1-point improvement in EQ-5D-5L was noted.
Fig. 5
Fig. 5
Distribution of lead location (lead tip shown) among n ​= ​171 patients. Information related to 11 patients was not provided.
See this image and copyright information in PMC

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