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Advances in Neuromodulation for Pain Management

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

Deadline for manuscript submissions: closed (15 January 2022) | Viewed by 39417

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Special Issue Editor

Prof. Dr. Maarten Moens

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Universitair Ziekenhuis Brussel, Brussels, Belgium
Interests: SCS; mechanisms of action; holistic response; prediction models

Special Issue Information

Dear Colleagues,

Chronic pain has a devastating impact on our society, not only economically and financially, but also on the well-being and happiness of mankind.

Neuromodulation as a last resort treatment for chronic pain conditions underwent, over the last decade, an enormous technical and innovative change. New spinal cord stimulation paradigms, combined therapies, and digital platforms are the new standard.

Despite these new technologies, patients are still suffering from chronic pain and are difficult to treat.

This Special Issue invites researchers in the field of neuromodulation to contribute to the state of art in five fields, related to neuromodulation, which are important to the patient.

The first topic concerns the ethical issues and medico-legal aspects of neuromodulation as a continuum in patients’ lives. Does the choice of implanting a neuromodulation device limit opportunities? What kind of “bias” does a patient undergo unconsciously, prior to implantation?

A second and relevant item is the use and feasibility of predicting models prior to implantation. Implementation research of available predicting models and new models is of special interest.

Related to the need of a chronic pain patient, research on the relevance of patient outcomes and measurements in order to detect, define, and determine treatment success will be promoted. The fourth pillar of this Special Issue will focus on the optimalisation of the neuromodulation trajectory prior, during, and after implantation of a device. And in relation to this topic, algorithms, practical guidelines, and flowcharts in patients’ salvation techniques will be the fifth field of interest.

This Special Issue will be an open access publication of the Journal of Clinical Medicine; (ISI Web of Knowledge impact factor 3.303 (2019); ranked 36/165 (Q1) for General & Internal Medicine).

Prof. Dr. Maarten Moens
Guest Editor

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Keywords

Chronic pain
Spinal cord stimulation
Prediction models
Ethics
Medico legal issues
Patient-related outcome measurements
Salvage therapy
Algorithms
Implementation research

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Published Papers (11 papers)

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Editorial

Jump to: Research, Review

2 pages, 159 KiB

Open AccessEditorial

Advances in Neuromodulation for Chronic Pain

by Maarten Moens and Lisa Goudman

J. Clin. Med. 2022, 11(3), 874; https://doi.org/10.3390/jcm11030874 - 7 Feb 2022

Viewed by 1782

Abstract

In the past decade, neuromodulation as a treatment option for pain took a huge interest in innovating and developing more effective paradigms to conquer chronic pain syndromes [...] Full article

(This article belongs to the Special Issue Advances in Neuromodulation for Pain Management)

Research

Jump to: Editorial, Review

9 pages, 1017 KiB

Open AccessArticle

Hospital at Home for Intrathecal Pump Refills: A Prospective Effectiveness, Safety and Feasibility Study

by Lisa Goudman, Ann De Smedt, René Huygens, Marc Noppen, Maria Vanschoenwinkel, Samar M. Hatem and Maarten Moens

J. Clin. Med. 2021, 10(22), 5353; https://doi.org/10.3390/jcm10225353 - 17 Nov 2021

Cited by 7 | Viewed by 2581

Abstract

Continuous Intrathecal Drug Delivery through an implanted pump is a well-known therapeutic option for the management of chronic pain and severe disabling spasticity. To have a successful therapy, pump refills need to be performed at regular time intervals after implantation. In line with the increased applications of Hospital at Home, these refill procedures might be performed at the patient’s home. The aim of this pilot study is to evaluate the feasibility, safety, and effectiveness of intrathecal pump refill procedures at home. Twenty patients were included whereby pump refill procedures were conducted at the patient’s home. To enable contact with the hospital, a video connection was set-up. Tele-ultrasound was used as post-refill verification. All procedures were successfully performed with complete patient satisfaction. Ninety-five percent of the patients felt safe during the procedure, and 95% of the procedures felt safe according to the physician. All patients indicated that they preferred their next refill at home. The median time consumption for the physician/nurse at the patient’s home was 26 min and for the researcher at the hospital 15 min. In light of quality enhancement programs and personalized care, it is important to continue urgent pain management procedures in a safe way, even during a pandemic. Full article

(This article belongs to the Special Issue Advances in Neuromodulation for Pain Management)

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20 pages, 3119 KiB

Open AccessArticle

The Added Value of Subcutaneous Peripheral Nerve Field Stimulation Combined with SCS, as Salvage Therapy, for Refractory Low Back Pain Component in Persistent Spinal Pain Syndrome Implanted Patients: A Randomized Controlled Study (CUMPNS Study) Based on 3D-Mapping Composite Pain Assessment

by Philippe Rigoard, Amine Ounajim, Lisa Goudman, Benedicte Bouche, Manuel Roulaud, Philippe Page, Bertille Lorgeoux, Sandrine Baron, Kevin Nivole, Mathilde Many, Nihel Adjali, Elodie Charrier, Delphine Rannou, Laure Poupin, Chantal Wood, Romain David, Dylan Héraud, Maartens Moens and Maxime Billot

J. Clin. Med. 2021, 10(21), 5094; https://doi.org/10.3390/jcm10215094 - 29 Oct 2021

Cited by 16 | Viewed by 2779

Abstract

While Spinal Cord Stimulation (SCS) provides satisfaction to almost 2/3 of Persistent Spinal Pain Syndrome-Type 2 (PSPS-T2) patients implanted for refractory chronic back and/or leg pain, when not adequately addressed the back pain component, leaves patients in a therapeutic cul-de-sac. Peripheral Nerve field Stimulation (PNfS) has shown interesting results addressing back pain in the same population. Far from placing these two techniques in opposition, we suggest that these approaches could be combined to better treat PSPS-T2 patients. We designed a RCT (CUMPNS), with a 12-month follow-up, to assess the potential added value of PNfS, as a salvage therapy, in PSPS-T2 patients experiencing a “Failed SCS Syndrome” in the back pain component. Fourteen patients were included in this study and randomized into 2 groups (“SCS + PNfS” group/n = 6 vs. “SCS only” group/n = 8). The primary objective of the study was to compare the percentage of back pain surface decrease after 3 months, using a computerized interface to obtain quantitative pain mappings, combined with multi-dimensional SCS outcomes. Back pain surface decreased significantly greater for the ”SCS + PNfS” group (80.2% ± 21.3%) compared to the “SCS only” group (13.2% ± 94.8%) (p = 0.012), highlighting the clinical interest of SCS + PNfS, in cases where SCS fails to address back pain. Full article

(This article belongs to the Special Issue Advances in Neuromodulation for Pain Management)

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14 pages, 653 KiB

Open AccessArticle

Professional Status of Persistent Spinal Pain Syndrome Patients after Spinal Surgery (PSPS-T2): What Really Matters? A Prospective Study Introducing the Concept of “Adapted Professional Activity” Inferred from Clinical, Psychological and Social Influence

by Nicolas Naiditch, Maxime Billot, Lisa Goudman, Philippe Cornet, Manuel Roulaud, Amine Ounajim, Philippe Page, Bertille Lorgeoux, Sandrine Baron, Kevin Nivole, Pierre Pries, Yassine Abdollah Moufid, Cécile Swennen, Simon Teyssedou, Tanguy Vendeuvre, Elodie Charrier, Laure Poupin, Delphine Rannou, Géraldine Brumauld de Montgazon, Pierre François Descoins, Brigitte Roy-Moreau, Nelly Grimaud, Romain David, Maarten Moens and Philippe Rigoard Show full author list Hide full author list

J. Clin. Med. 2021, 10(21), 5055; https://doi.org/10.3390/jcm10215055 - 29 Oct 2021

Cited by 15 | Viewed by 2986

Abstract

Persistent Spinal Pain Syndrome Type 2 (PSPS-T2) represents a main cause of work disruption. Beyond its societal consequences, occupational inactivity is responsible for a major decrease in physical/mental health in individuals but remains poorly analyzed. We designed a study to prospectively examine Professional Status (PS) evolution and its association with key bio-psychological markers. Data from 151 consecutively included working-age PSPS-T2 patients were analyzed to determine the proportion of professional inactivity and the relationships between PS and Social Gradient of Health (SGH), Numeric Pain Rating Scale (NPRS), EuroQol 5-Dimensional 5-Level (EQ-5D-5L), Oswestry Disability Index (ODI), Hospital Anxiety and Depression Scale (HADS), and Fear-Avoidance Belief Questionnaire work subscale (FABQ-W). Despite optimized medical management, 73.5% of PSPS-T2 patients remained inactive after 1 year of follow-up/p = 0.18. Inactive patients presented a low SGH/p = 0.002, higher NPRS/p = 0.048, lower EQ-5D-5L/p < 0.001, higher ODI/p = 0.018, higher HADS-D/p = 0.019 and higher FABQ-W/p < 0.001. No significant mediation effect of FABQ-W on SGH consequences regarding PS was observed in our structural model/p = 0.057. The link between unemployment and bio-psycho-social pain dimensions appears bidirectional and justifies intense collaboration with social workers. Optimizing therapeutical sequencing towards personalized professional plans implies restoring “Adapted Physical Function” as an initial goal, and tailoring an “Adapted Professional Activity”, matching with patient expectations and capabilities, as a final objective. Full article

(This article belongs to the Special Issue Advances in Neuromodulation for Pain Management)

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20 pages, 1137 KiB

Open AccessArticle

A Novel Multi-Dimensional Clinical Response Index Dedicated to Improving Global Assessment of Pain in Patients with Persistent Spinal Pain Syndrome after Spinal Surgery, Based on a Real-Life Prospective Multicentric Study (PREDIBACK) and Machine Learning Techniques

by Philippe Rigoard, Amine Ounajim, Lisa Goudman, Pierre-Yves Louis, Yousri Slaoui, Manuel Roulaud, Nicolas Naiditch, Bénédicte Bouche, Philippe Page, Bertille Lorgeoux, Sandrine Baron, Elodie Charrier, Laure Poupin, Delphine Rannou, Géraldine Brumauld de Montgazon, Brigitte Roy-Moreau, Nelly Grimaud, Nihel Adjali, Kevin Nivole, Mathilde Many, Romain David, Chantal Wood, Raphael Rigoard, Maarten Moens and Maxime Billot Show full author list Hide full author list

J. Clin. Med. 2021, 10(21), 4910; https://doi.org/10.3390/jcm10214910 - 24 Oct 2021

Cited by 24 | Viewed by 10516

Abstract

The multidimensionality of chronic pain forces us to look beyond isolated assessment such as pain intensity, which does not consider multiple key parameters, particularly in post-operative Persistent Spinal Pain Syndrome (PSPS-T2) patients. Our ambition was to produce a novel Multi-dimensional Clinical Response Index (MCRI), including not only pain intensity but also functional capacity, anxiety-depression, quality of life and quantitative pain mapping, the objective being to achieve instantaneous assessment using machine learning techniques. Two hundred PSPS-T2 patients were enrolled in the real-life observational prospective PREDIBACK study with 12-month follow-up and received various treatments. From a multitude of questionnaires/scores, specific items were combined, as exploratory factor analyses helped to create a single composite MCRI; using pairwise correlations between measurements, it appeared to more accurately represent all pain dimensions than any previous classical score. It represented the best compromise among all existing indexes, showing the highest sensitivity/specificity related to Patient Global Impression of Change (PGIC). Novel composite indexes could help to refine pain assessment by informing the physician’s perception of patient condition on the basis of objective and holistic metrics, and also by providing new insights regarding therapy efficacy/patient outcome assessments, before ultimately being adapted to other pathologies. Full article

(This article belongs to the Special Issue Advances in Neuromodulation for Pain Management)

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11 pages, 889 KiB

Open AccessArticle

The Influence of Missing Data on Disabilities in Patients Treated with High-Dose Spinal Cord Stimulation: A Tipping Point Sensitivity Analysis

by Lisa Goudman, Geert Molenberghs, Rui V. Duarte and Maarten Moens

J. Clin. Med. 2021, 10(21), 4897; https://doi.org/10.3390/jcm10214897 - 24 Oct 2021

Cited by 1 | Viewed by 1990

Abstract

New waveforms have changed the field of Spinal Cord Stimulation (SCS) to optimize therapy outcomes, among which is High-Dose SCS (HD-SCS). Missing observations are often encountered when conducting clinical trials in this field. In this study, different approaches with varying assumptions were constructed to evaluate how conclusions may be influenced by these assumptions. The aim is to perform a tipping point sensitivity analysis to evaluate the influence of missing data on the overall conclusion regarding the effectiveness of HD-SCS on disability. Data from the Discover study were used, in which 185 patients with Failed Back Surgery Syndrome were included. Disability was evaluated before SCS and after 1, 3 and 12 months of HD-SCS. During the second, third and fourth visit, data from 130, 114 and 90 patients were available, respectively. HD-SCS resulted in a significant decrease in disability scores based on the analysis of observed data and with multiple imputations. The tipping point sensitivity analysis revealed that the shift parameter was 17. Thus, the conclusion concerning the time effect under a “missing at random” mechanism is robust when the shift parameter for the disability score is 17. From a clinical point of view, a shift of 17 points on disability is not very plausible. Therefore we tend to consider the conclusions drawn under “missing at random” as being robust. Full article

(This article belongs to the Special Issue Advances in Neuromodulation for Pain Management)

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17 pages, 521 KiB

Open AccessArticle

Machine Learning Algorithms Provide Greater Prediction of Response to SCS Than Lead Screening Trial: A Predictive AI-Based Multicenter Study

by Amine Ounajim, Maxime Billot, Lisa Goudman, Pierre-Yves Louis, Yousri Slaoui, Manuel Roulaud, Bénédicte Bouche, Philippe Page, Bertille Lorgeoux, Sandrine Baron, Nihel Adjali, Kevin Nivole, Nicolas Naiditch, Chantal Wood, Raphaël Rigoard, Romain David, Maarten Moens and Philippe Rigoard

J. Clin. Med. 2021, 10(20), 4764; https://doi.org/10.3390/jcm10204764 - 18 Oct 2021

Cited by 16 | Viewed by 2481

Abstract

Persistent pain after spinal surgery can be successfully addressed by spinal cord stimulation (SCS). International guidelines strongly recommend that a lead trial be performed before any permanent implantation. Recent clinical data highlight some major limitations of this approach. First, it appears that patient outco mes, with or without lead trial, are similar. In contrast, during trialing, infection rate drops drastically within time and can compromise the therapy. Using composite pain assessment experience and previous research, we hypothesized that machine learning models could be robust screening tools and reliable predictors of long-term SCS efficacy. We developed several algorithms including logistic regression, regularized logistic regression (RLR), naive Bayes classifier, artificial neural networks, random forest and gradient-boosted trees to test this hypothesis and to perform internal and external validations, the objective being to confront model predictions with lead trial results using a 1-year composite outcome from 103 patients. While almost all models have demonstrated superiority on lead trialing, the RLR model appears to represent the best compromise between complexity and interpretability in the prediction of SCS efficacy. These results underscore the need to use AI-based predictive medicine, as a synergistic mathematical approach, aimed at helping implanters to optimize their clinical choices on daily practice. Full article

(This article belongs to the Special Issue Advances in Neuromodulation for Pain Management)

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16 pages, 875 KiB

Open AccessArticle

Finite Mixture Models Based on Pain Intensity, Functional Disability and Psychological Distress Composite Assessment Allow Identification of Two Distinct Classes of Persistent Spinal Pain Syndrome after Surgery Patients Related to Their Quality of Life

by Amine Ounajim, Maxime Billot, Pierre-Yves Louis, Yousri Slaoui, Denis Frasca, Lisa Goudman, Manuel Roulaud, Nicolas Naiditch, Bertille Lorgeoux, Sandrine Baron, Kevin Nivole, Mathilde Many, Nihel Adjali, Philippe Page, Bénédicte Bouche, Elodie Charrier, Laure Poupin, Delphine Rannou, Géraldine Brumauld de Montgazon, Brigitte Roy-Moreau, Chantal Wood, Raphaël Rigoard, Romain David, Maarten Moens and Philippe Rigoard Show full author list Hide full author list

J. Clin. Med. 2021, 10(20), 4676; https://doi.org/10.3390/jcm10204676 - 13 Oct 2021

Cited by 21 | Viewed by 3192

Abstract

Persistent Spinal Pain Syndrome Type 2 (PSPS-T2), (Failed Back Surgery Syndrome), dramatically impacts on patient quality of life, as evidenced by Health-Related Quality of Life (HRQoL) assessment tools. However, the importance of functioning, pain perception and psychological status in HRQoL can substantially vary between subjects. Our goal was to extract patient profiles based on HRQoL dimensions in a sample of PSPS-T2 patients and to identify factors associated with these profiles. Two classes were clearly identified using a mixture of mixed effect models from a clinical data set of 200 patients enrolled in “PREDIBACK”, a multicenter observational prospective study including PSPS-T2 patients with one-year follow-up. We observed that HRQoL was more impacted by functional disability for first class patients (n = 136), and by pain perception for second class patients (n = 62). Males that perceive their work as physical were more impacted by disability than pain intensity. Lower education level, lack of adaptive coping strategies and higher pain intensity were significantly associated with HRQoL being more impacted by pain perception. The identification of such classes allows for a better understanding of HRQoL dimensions and opens the gate towards optimized health-related quality of life evaluation and personalized pain management. Full article

(This article belongs to the Special Issue Advances in Neuromodulation for Pain Management)

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9 pages, 1003 KiB

Open AccessArticle

Exhaled-Breath Testing Using an Electronic Nose during Spinal Cord Stimulation in Patients with Failed Back Surgery Syndrome: An Experimental Pilot Study

by Lisa Goudman, Julie Jansen, Nieke Vets, Ann De Smedt and Maarten Moens

J. Clin. Med. 2021, 10(13), 2921; https://doi.org/10.3390/jcm10132921 - 29 Jun 2021

Viewed by 1804

Abstract

The increased awareness of discrepancies between self-reporting outcome measurements and objective outcome measurements within the field of neuromodulation has accelerated the search towards more objective measurements. The aim of this study was to evaluate whether an electronic nose can differentiate between chronic pain patients in whom Spinal Cord Stimulation (SCS) was activated versus deactivated. Twenty-seven patients with Failed Back Surgery Syndrome (FBSS) participated in this prospective pilot study. Volatile organic compounds in exhaled breath were measured with electronic nose technology (Aeonose™) during SCS on and off states. Random forest was used with a leave-10%-out cross-validation method to determine accuracy of discriminating between SCS on and off states. Our random forest showed an accuracy of 0.56, with an area under the curve of 0.62, a sensitivity of 62% (95% CI: 41–79%) and a specificity of 50% (95% CI: 30–70%). Pain intensity scores were significantly different between both SCS states. Our findings indicate that we cannot discriminate between SCS off and on states based on exhaled breath with the Aeonose™ in patients with FBSS. In clinical practice, these findings imply that with a noninvasive electronic nose, exhaled breath cannot be used as an additional marker of the effect of neuromodulation. Full article

(This article belongs to the Special Issue Advances in Neuromodulation for Pain Management)

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14 pages, 707 KiB

Open AccessArticle

Persistent Spinal Pain Syndrome Type 2 (PSPS-T2), a Social Pain? Advocacy for a Social Gradient of Health Approach to Chronic Pain

by Nicolas Naiditch, Maxime Billot, Maarten Moens, Lisa Goudman, Philippe Cornet, David Le Breton, Manuel Roulaud, Amine Ounajim, Philippe Page, Bertille Lorgeoux, Kevin Nivole, Pierre Pries, Cecile Swennen, Simon Teyssedou, Elodie Charrier, Géraldine Brumauld de Montgazon, Pierre François Descoins, Brigitte Roy-Moreau, Nelly Grimaud, Romain David, Tanguy Vendeuvre and Philippe Rigoard Show full author list Hide full author list

J. Clin. Med. 2021, 10(13), 2817; https://doi.org/10.3390/jcm10132817 - 25 Jun 2021

Cited by 28 | Viewed by 4653

Abstract

The Social Gradient of Health (SGH), or position in the social hierarchy, is one of the major determinants of health. It influences the development and evolution of many chronic diseases. Chronic pain dramatically affects individual and social condition. Its medico-economic impact is significant and worldwide. Failed Back Surgery Syndrome or Persistent Spinal Pain Syndrome type 2 (PSPS-T2) represents one of its most fascinating and disabling conditions. However, the influence of SGH on PSPS-T2 has been poorly explored. We designed a prospective multicentric study (PREDIBACK study) to assess the SGH prevalence, and to examine its association with medical and psychological variables, in PSPS-T2 patients. This study included 200 patients to determine the SGH association with pain (NPRS), Quality of life (EQ-5D-5L), kinesiophobia (FABQ-Work), catastrophism (CSQ), and functional capacity (ODI). Around 85.3% of PSPS-T2 patients in our study had low SGH. Low SGH patients had a higher FABQ-Work and CSQ-Catastrophizing score than high SGH patients (p < 0.05). High SGH patients have a higher ODI score than low SGH patients (p < 0.10). Our results suggest that SGH is a relevant factor to guide prevention, research, and ultimately intervention in PSPS-T2 patients and could be more widely transposed to chronic pain. Full article

(This article belongs to the Special Issue Advances in Neuromodulation for Pain Management)

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Review

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18 pages, 680 KiB

Open AccessReview

Exploration of the Supraspinal Hypotheses about Spinal Cord Stimulation and Dorsal Root Ganglion Stimulation: A Systematic Review

by Lisa Goudman, Sander De Groote, Bengt Linderoth, Ann De Smedt, Sam Eldabe, Rui V. Duarte and Maarten Moens

J. Clin. Med. 2021, 10(13), 2766; https://doi.org/10.3390/jcm10132766 - 23 Jun 2021

Cited by 21 | Viewed by 3068

Abstract

Despite the established efficacy and effectiveness of Spinal Cord Stimulation (SCS), there is still no consensus on the supraspinal mechanisms of action of this therapy. The purpose of this study was to systematically review previously raised hypotheses concerning supraspinal mechanisms of action of SCS based on human, animal and computational studies. Searches were conducted using four electronic databases (PubMed, EMBASE, SCOPUS and Web of Science), backward reference searching and consultation with experts. The study protocol was registered prior to initiation of the review process (PROSPERO CRD42020161531). A total of 54 publications were included, 21 of which were animal studies, and 33 were human studies. The supraspinal hypotheses (n = 69) identified from the included studies could be categorized into six groups concerning the proposed supraspinal hypothesis, namely descending pathways (n = 24); ascending medial pathway (n = 13); ascending lateral pathway (n = 10); affective/motivational influences (n = 8); spinal–cerebral (thalamic)-loop (n = 3) and miscellaneous (n = 11). Scientific support is provided for the hypotheses identified. Modulation of the descending nociceptive inhibitory pathways, medial and lateral pathways were the most frequently reported hypotheses about the supraspinal mechanisms of action of SCS. These hypotheses were mainly supported by studies with a high or moderate confidence in the body of evidence. Full article

(This article belongs to the Special Issue Advances in Neuromodulation for Pain Management)

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