Spinal Cord Stimulation and Other Neuromodulation Therapies for the Treatment of Refractory Chronic Pain: What’s New? What’s Good? What’s Better?

A special issue of Journal of Clinical Medicine (ISSN 2077-0383). This special issue belongs to the section "Clinical Neurology".

Deadline for manuscript submissions: closed (25 March 2022) | Viewed by 11055

Special Issue Editor


E-Mail Website1 Website2
Guest Editor
1. Department of Spine Surgery and Neuromodulation, Poitiers University Hospital, Poitiers, France
2. PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, Poitiers, France
3. Pprime Institue UPR 3346, CNRS, University of Poitiers, Poitiers, ISAE-ENSMA, France
Interests: chronic pain; neuromodulation; spinal cord stimulation; dorsal root ganglion; peripheral nerve; prediction models; data-mining; algorithms; artificial intelligence

Special Issue Information

Dear Colleagues,

Chronic refractory pain (CRP) is a major, worldwide health problem that generates considerable expenses for healthcare systems.  On top of this, post-operative back and/or leg pain, previously known as “Failed Back Surgery Syndrome / FBSS” and recently renamed “Persistent Spinal Pain Syndrome / PSPS”, represent one of its most disabling syndromes.

Ultimately, this devastating condition can become the substrate of potential indications for implanted neuromodulation therapy, once two crucial criteria have been fulfilled: (1) Optimal Medical Management has previously failed and, (2) Therapeutical strategies are to be discussed based on a Multidisciplinary team assessment.  Notwithstanding the existence of these recommendations and published guidelines, a number of controversial issues concerning the invasive management of PSPS are regularly debated worldwide at spine, pain and neuromodulation conferences, and no clear consensus has been reached.

Any lasting relief solution to failed back syndrome will be due to the physician who not only masters the pathology and the technical aspects, but who also understands the patient. Solutions to great problems usually come from men and women who are passionate, observing and skillful.

In CRP treatment, current practice in neurostimulation varies, from one center to another, and most clinical decisions are based on an individual diagnosis.

Given this context, neurostimulation evaluation tools and pain relief assessment are of major concern, especially insofar as they now constitute one of the main biases of clinical trials. Moreover, the proliferation of technological devices, in a promising yet unsettling market, fosters and furthers confusion.

At the epicenter of the refractory chronic pain enigma, this technological earthquake now underway can be considered as either a rare opportunity to better help the patient or a major source of opaqueness for physicians. 

There are three options available for scientific debates on our daily neurostimulation practice: intentional ignorance, standardized evidence-based practice or an alternative data mining approach.

With this Special Issue of JCM, our intent is to bridge the existing scientific gap and to fruitfully address these topics.

Aims

The articles of this Special Issue will be arranged according to four fields of discussion concerning:

  1. Novel modalities of outcome assessment, with a focus on technological-clinical transfers to connect the potential mechanisms of action of newly available technologies to the patient and daily practice. Because pain is a physical sensation involving a psychological dimension, its assessment justifies the use of multidimensional and global evaluation scales. Given the formidable ongoing expansion of neurostimulation techniques and available devices, implanters and patients may remain confused when selecting the right tool for the right indication. To evaluate and objectively compare patient outcomes, depending on therapeutical strategies, it appears essential to develop a rational and quantitative approach to pain assessment for patients undergoing neurostimulation implantation.
  2. New technological solutions (incl. spinal ganglion and peripheral nerve stimulation, novel waveforms, adaptors)
  3. New targets and potential indications (incl. vegetative nervous system, conus medullaris, etc…)
  4. The need for robust rational, network-based multicentric research and data collection. The future of SCS: will it come from prospective trials? This would probably be overly restrictive. There is a need for objective evaluation tools (“transducers”) to transpose electrical signals into clinical effects and to guide therapeutic choices. This will result from collective commitment and will illustrate how Artificial Intelligence can create a differentiator in the decision-making process, which is of paramount importance to the medical community.

Methodology

We are expecting original articles from internationally renowned orthopaedic, spine and neurosurgeons, anaesthesiologists, rheumatologists, psychiatrists and rehabilitation physicians, as well as health system experts and pain physicians. The manuscripts will be selected according to the following criteria:

-  Insofar as they provide a comprehensive and clearly outlined overview of neuromodulation management in a difficult context,

-  For their originality and their high scientific quality in the field of permanent innovation,

-  For their philosophical and ethical approach based on a patient-centric vision.

While this Special Issue does not claim to put an end to all current controversies, we hope it will provide implanters and pain physicians with a clearer understanding of the issues involved and will enable them to provide the best available treatment guided by an evidence-based medicine approach.

Prof. Philippe Rigoard
Guest Editor

Manuscript Submission Information

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Keywords

  • chronic pain
  • neuromodulation
  • spinal cord stimulation
  • dorsal root ganglion
  • peripheral nerve
  • prediction models
  • data-mining
  • algorithms
  • artificial intelligence

Published Papers (5 papers)

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Research

19 pages, 8580 KiB  
Article
“Neuro-Fiber Mapping”: An Original Concept of Spinal Cord Neural Network Spatial Targeting Using Live Electrostimulation Mapping to (Re-)Explore the Conus Medullaris Anatomy
by Philippe Rigoard, Maarten Moens, Lisa Goudman, Tom Le Tutour, Michel Rochette, Jonathan Dany, Mohamed Et Talby, Manuel Roulaud, Rémi Hervochon, Amine Ounajim, Kévin Nivole, Romain David and Maxime Billot
J. Clin. Med. 2023, 12(5), 1747; https://doi.org/10.3390/jcm12051747 - 22 Feb 2023
Cited by 2 | Viewed by 1397
Abstract
Spinal cord (SC) anatomy is often assimilated to a morphologically encapsulated neural entity, but its functional anatomy remains only partially understood. We hypothesized that it could be possible to re-explore SC neural networks by performing live electrostimulation mapping, based on “super-selective” spinal cord [...] Read more.
Spinal cord (SC) anatomy is often assimilated to a morphologically encapsulated neural entity, but its functional anatomy remains only partially understood. We hypothesized that it could be possible to re-explore SC neural networks by performing live electrostimulation mapping, based on “super-selective” spinal cord stimulation (SCS), originally designed as a therapeutical tool to address chronic refractory pain. As a starting point, we initiated a systematic SCS lead programming approach using live electrostimulation mapping on a chronic refractory perineal pain patient, previously implanted with multicolumn SCS at the level of the conus medullaris (T12-L1). It appeared possible to (re-)explore the classical anatomy of the conus medullaris using statistical correlations of paresthesia coverage mappings, resulting from 165 different electrical configurations tested. We highlighted that sacral dermatomes were not only located more medially but also deeper than lumbar dermatomes at the level of the conus medullaris, in contrast with classical anatomical descriptions of SC somatotopical organization. As we were finally able to find a morphofunctional description of “Philippe–Gombault’s triangle” in 19th-century historical textbooks of neuroanatomy, remarkably matching these conclusions, the concept of “neuro-fiber mapping” was introduced. Full article
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22 pages, 1680 KiB  
Article
Combining Awake Anesthesia with Minimal Invasive Surgery Optimizes Intraoperative Surgical Spinal Cord Stimulation Lead Placement
by Philippe Rigoard, Amine Ounajim, Lisa Goudman, Chantal Wood, Manuel Roulaud, Philippe Page, Bertille Lorgeoux, Sandrine Baron, Kevin Nivole, Mathilde Many, Emmanuel Cuny, Jimmy Voirin, Denys Fontaine, Sylvie Raoul, Patrick Mertens, Philippe Peruzzi, François Caire, Nadia Buisset, Romain David, Maarten Moens and Maxime Billotadd Show full author list remove Hide full author list
J. Clin. Med. 2022, 11(19), 5575; https://doi.org/10.3390/jcm11195575 - 22 Sep 2022
Cited by 3 | Viewed by 1647
Abstract
Spinal cord stimulation (SCS) is an effective and validated treatment to address chronic refractory neuropathic pain in persistent spinal pain syndrome-type 2 (PSPS-T2) patients. Surgical SCS lead placement is traditionally performed under general anesthesia due to its invasiveness. In parallel, recent works have [...] Read more.
Spinal cord stimulation (SCS) is an effective and validated treatment to address chronic refractory neuropathic pain in persistent spinal pain syndrome-type 2 (PSPS-T2) patients. Surgical SCS lead placement is traditionally performed under general anesthesia due to its invasiveness. In parallel, recent works have suggested that awake anesthesia (AA), consisting of target controlled intra-venous anesthesia (TCIVA), could be an interesting tool to optimize lead anatomical placement using patient intra-operative feedback. We hypothesized that combining AA with minimal invasive surgery (MIS) could improve SCS outcomes. The goal of this study was to evaluate SCS lead performance (defined by the area of pain adequately covered by paraesthesia generated via SCS), using an intraoperative objective quantitative mapping tool, and secondarily, to assess pain relief, functional improvement and change in quality of life with a composite score. We analyzed data from a prospective multicenter study (ESTIMET) to compare the outcomes of 115 patients implanted with MIS under AA (MISAA group) or general anesthesia (MISGA group), or by laminectomy under general anesthesia (LGA group). All in all, awake surgery appears to show significantly better performance than general anesthesia in terms of patient pain coverage (65% vs. 34–62%), pain surface (50–76% vs. 50–61%) and pain intensity (65% vs. 35–40%), as well as improved secondary outcomes (quality of life, functional disability and depression). One step further, our results suggest that MISAA combined with intra-operative hypnosis could potentialize patient intraoperative cooperation and could be proposed as a personalized package offered to PSPS-T2 patients eligible for SCS implantation in highly dedicated neuromodulation centers. Full article
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23 pages, 3849 KiB  
Article
The Challenge of Converting “Failed Spinal Cord Stimulation Syndrome” Back to Clinical Success, Using SCS Reprogramming as Salvage Therapy, through Neurostimulation Adapters Combined with 3D-Computerized Pain Mapping Assessment: A Real Life Retrospective Study
by Philippe Rigoard, Amine Ounajim, Lisa Goudman, Tania Banor, France Héroux, Manuel Roulaud, Etienne Babin, Bénédicte Bouche, Philippe Page, Bertille Lorgeoux, Sandrine Baron, Nihel Adjali, Kevin Nivole, Mathilde Many, Elodie Charrier, Delphine Rannou, Laure Poupin, Chantal Wood, Romain David, Maarten Moens and Maxime Billotadd Show full author list remove Hide full author list
J. Clin. Med. 2022, 11(1), 272; https://doi.org/10.3390/jcm11010272 - 5 Jan 2022
Cited by 10 | Viewed by 2620
Abstract
While paresthesia-based Spinal Cord Stimulation (SCS) has been proven effective as treatment for chronic neuropathic pain, its initial benefits may lead to the development of “Failed SCS Syndrome’ (FSCSS) defined as decrease over time related to Loss of Efficacy (LoE) with or without [...] Read more.
While paresthesia-based Spinal Cord Stimulation (SCS) has been proven effective as treatment for chronic neuropathic pain, its initial benefits may lead to the development of “Failed SCS Syndrome’ (FSCSS) defined as decrease over time related to Loss of Efficacy (LoE) with or without Loss of Coverage (LoC). Development of technologies associating new paresthesia-free stimulation waveforms and implanted pulse generator adapters provide opportunities to manage patients with LoE. The main goal of our study was to investigate salvage procedures, through neurostimulation adapters, in patients already implanted with SCS and experiencing LoE. We retrospectively analyzed a cohort of patients who were offered new SCS programs/waveforms through an implanted adapter between 2018 and 2021. Patients were evaluated before and at 1-, 3-, 6- and 12-month follow-ups. Outcomes included pain intensity rating with a Visual Analog Scale (VAS), pain/coverage mappings and stimulation preferences. Last follow-up evaluations (N = 27) showed significant improvement in VAS (p = 0.0001), ODI (p = 0.021) and quality of life (p = 0.023). In the 11/27 patients with LoC, SCS efficacy on pain intensity (36.89%) was accompanied via paresthesia coverage recovery (55.57%) and pain surface decrease (47.01%). At 12-month follow-up, 81.3% preferred to keep tonic stimulation in their waveform portfolio. SCS conversion using adapters appears promising as a salvage solution, with an emphasis on paresthesia recapturing enabled via spatial retargeting. In light of these results, adapters could be integrated in SCS rescue algorithms or should be considered in SCS rescue. Full article
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11 pages, 1246 KiB  
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, Jose Francisco Paz-Solis, Pasquale De Negri, Maria Angeles Canós-Verdecho, Hayat Belaid, Simon J. Thomson, David Abejón, Jan Vesper, Vivek Mehta, Philippe Rigoard, Paolo Maino, Sarah Love-Jones, Isaac F. Peña, Simon Bayerl, Christophe Perruchoud, Renaud Bougeard, Cleo Mertz, Yu Pei and Roshini Jain
J. Clin. Med. 2021, 10(18), 4085; https://doi.org/10.3390/jcm10184085 - 10 Sep 2021
Cited by 13 | Viewed by 2381
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 [...] Read more.
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. Full article
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12 pages, 1979 KiB  
Article
Electrochemical Skin Conductance Alterations during Spinal Cord Stimulation: An Experimental Study
by Lisa Goudman, Nieke Vets, Julie Jansen, Ann De Smedt, Maxime Billot, Philippe Rigoard, Ann Cordenier, Sebastiaan Engelborghs, Aldo Scafoglieri and Maarten Moens
J. Clin. Med. 2021, 10(16), 3565; https://doi.org/10.3390/jcm10163565 - 13 Aug 2021
Cited by 1 | Viewed by 2009
Abstract
Despite the well-known clinical effects of spinal cord stimulation (SCS), the mechanisms of action have not yet been fully unraveled. The primary aim of this study was to measure whether electrochemical skin conductance, as a measure of peripheral sympathetic autonomic function, is altered [...] Read more.
Despite the well-known clinical effects of spinal cord stimulation (SCS), the mechanisms of action have not yet been fully unraveled. The primary aim of this study was to measure whether electrochemical skin conductance, as a measure of peripheral sympathetic autonomic function, is altered by SCS. A second aim was to compare skin conductance levels of patients with failed back surgery syndrome (FBSS) with age- and sex-matched healthy controls. Twenty-three patients with FBSS treated with SCS participated in this study. Sudomotor function was measured with the SudoscanTM instrument on the hands and feet during SCS on and off states. Difference scores in skin conductance between patients and age- and sex-matched healthy controls were calculated. Normal sudomotor function at the painful lower limb was revealed for 61% of the patients when SCS was activated. Skin conductance levels were not altered between on and off states of SCS. Differences in scores between patients and healthy controls were significantly different from zero. This study showed that SCS does not influencing the sympathetic nervous system in patients with FBSS, as measured by skin conductance levels. Moreover, it suggested that there is no normalization of the functioning of the sympathetic nervous system, despite the effectiveness of SCS to reduce pain intensity. Full article
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