BACKGROUND:Persistent spinal pain syndrome Type 2 (PSPS-T2) is a long-lasting condition that consists of persistent pain following spinal surgery. Although this condition has long-term effects, it is currently studied at a given time point or over a limited period of time, which does not reflect the true impact of pain patients. To bridge this gap, we used latent class trajectory models to extract clusters with different trajectories of patients with PSPS-T2. MATERIALS AND METHODS:Data from the PREDIBACK study, an observational, multicentric, and longitudinal investigation carried out prospectively, were used. This study focuses on patients with PSPS-T2, tracking their outcomes at 3-month intervals over a one-year period. Health status was evaluated using a novel multidimensional clinical response index (MCRI). The trajectories of patients' health status were extracted using mixture of mixed effect models. RESULTS:Two hundred (200) PSPS-T2 patients were included. Two clusters were identified, including 'persistent low health' trajectories (63.1%) and 'improving health' trajectories (36.9%). Regarding the factors associated with these trajectories, our results showed that lower age, lower body mass index, lower pain intensity, lower functional disability, lower anxiety and less extended pain surface were associated with improving health status. CONCLUSION:Clustering methods provide an opportunity to identify two distinct clusters of pain-related health trajectories of PSPS-T2 patients. Persistence of the symptoms was not observed in one third of the PSPS-T2 study patients, who belong to the improving pain-related health cluster, while the other two thirds did not achieve improved health over a 1-year follow-up. SIGNIFICANCE STATEMENT:Our study findings suggest that the use of trajectory-based methods could improve patient evaluation and pain management as it allows for obtaining a global view of patients during their care pathway compared to conventional methods, which only focus on specific visits. Our study also advocates for multidimensional assessment and management of pain by targeting not only pain intensity but also the psychological distress, functional capacity and pain surface at an early stage of pain onset after spine surgery.

Background: Peripheral nerve stimulation (PNS) has emerged as a minimally invasive percutaneous procedure addressing neuropathic pain. However, the percutaneous cylindrical lead ultrasound-guided implantation procedure requires expertise that limits widespread PNS utilization. To overcome these challenges, a microinvasive endoscopy device has very recently been developed, enhancing the precision of PNS implantation by providing accurate visualization of the targeted nerve. We aimed to determine the feasibility, safety, clinical effectiveness, and energy consumption of PNS therapy by means of ultrasound guidance combined with microendoscopy. Materials and Methods: This is a retrospective, single-center, single-arm study. Patient recruitment was performed in February and March 2023. Patients with >12 months of upper or lower limb pain presenting with pain >5 of 10 that was refractory to conventional treatments were eligible. Safety was assessed by collecting adverse events and complications related to the PNS implantation with microendoscopy. The Multidimensional Clinical Response Index (MCRI), pain intensity (visual analog scale [VAS]), pain surface (PRISMap Software, PRISMATICS lab, CHU de Poitiers, Poitiers, France), quality of life (EuroQoL 5 dimensions 5 levels [EQ5D-5L]), functional disability (Oswestry Disability Index [ODI]), anxiety and depression (Hospital Anxiety and Depression Scale), and energy consumption were assessed at baseline and at one and three months. Results: Six patients received PNS, which was implanted through ultrasound guidance combined with microendoscopy. No adverse event was reported during the three-month follow-up. Clinical outcomes (MCRI, VAS, ODI, EQ5D-5L) significantly increased at one- and three-month follow-up. Energy consumption was, on average, 2.6 +/- 1.1 mu C.s(-1) at one-month and 3.3 +/- 2.0 mu C.s(-1) at three-month follow-up. Conclusions: Implanted PNS by means of ultrasound combined with microendoscopy was safe and provided clinical benefits with very low energy consumption (15-440 times less than spinal cord stimulation) in patients with upper or lower limb neuropathic pain. Microendoscopy would offer extended PNS indications, overcoming limitations associated with ultrasound alone. Future research is nonetheless needed to provide stronger evidence through randomized controlled trial design.

Download This Paper Open PDF in Browser Add Paper to My Library Share: Permalink Using these links will ensure access to this page indefinitely Copy URL Copy DOI

Objectives: Spinal cord stimulation (SCS) and dorsal root ganglion stimulation (DRGS) have individually shown efficacy in relieving pain in patients with persistent spinal pain syndrome after spinal surgery (PSPS-T2). Combining SCS and DRGS simultaneously, along with Burst stimulation programming, may enhance the responder rate of patients with PSPS-T2. Material and Methods: This study aimed to compare the pain relief (>= 50%) responder rates in SCS, DRGS, and SCS+DGRS (DUAL) through a three-month randomized cross-over trial in patients with PSPS-T2. After the cross-over period, stimulation programming was switched to Burst. Secondary objectives included evaluating the clinical efficacy at three-, four-, six-, and 12-month follow-ups, assessing pain intensity, area of pain, area of paresthesia coverage, quality of life, functional disability, psychologic distress, medication intake, and the Multidimensional Clinical Response Index (MCRI). Results: The responder rate of pain relief was similar in SCS, DRGS, and DUAL (60%, p = 0.84) at the end of the cross-over period, increasing to 80% with the ability to switch between stimulation possibilities. Burst programming did not provide additional pain relief at the four-month follow-up (p = 0.99). Clinical outcomes significantly improved until 12-month follow-up compared with baseline. Considering a clinically significant fi cant increase of 1.05 of the MCRI, all patients were responders at three-, four-, and six- month follow-up, and 80% were responders at 12 months compared with baseline. Conclusions: The full option to stimulate different neural structures, separately or simultaneously, led to improved responder rates, allowing patients to personalize treatment. A multidimensional assessment is essential to reveal the full potential benefits fi ts of neuromodulation in patients with chronic pain.

Given the multidimensional aspect of pain, the assessment of treatment efficacy is challenging. The prospective observational multicenter PREDIBACK study aimed to assess, compare, and predict the effectiveness of different treatments for persistent spinal pain syndrome type 2 (PSPS-T2) using a digital tool and the Multidimensional Clinical Response Index (MCRI) including pain intensity, functional disability, quality of life, anxiety and depression, and pain surface. Results indicated that neurostimulation was the most effective treatment at 3-, 6-, 9-, and 12-month follow-up compared to baseline, leading to significant improvements in pain, function, and quality of life, whereas optimized medical management (OMM) and spinal reoperation showed no significant benefits. Additionally, the study identified pain surface, BMI, and smoking status as predictors of treatment outcomes. These findings highlight the potential of digital medicine to improve patient care by providing data-driven insights and personalized treatment recommendations for PSPS-T2.

Les lombo-radiculalgie postopératoire (LRPO) se caractérisent par des douleurs impactant les capacités fonctionnelles, l’état psychologique, les facteurs sociaux [1], et détériorent de façon dramatique la qualité de vie liée à la santé (QVLS) des patients. Le poids de chaque composante (intensité de la douleur, capacités fonctionnelles, détresse émotive) sur la QVLS n’est pas clairement établi dans la littérature. Dès lors, l’objectif principal de notre étude était d’identifier des sous-groupes de patients LRPO en se basant sur l’impact de l’intensité de la douleur, de l’incapacité fonctionnelle et de la dépression sur la QVLS. L’objectif secondaire était de caractériser les sous-groupes de patients selon des variables psycho-sociales. Cette étude multicentrique observationnelle inclue 200 patients avec des LRPO suivis sur une durée de 12 mois. Les patients sont évalués tous les 3 mois à partir des questionnaires suivants : – Euro-Quol-5 Dimensions (EQ-5D_5L) : mesure la QVLS ; – Échelle visuelle analogique (EVA) : intensité de la douleur ; – Oswestry Disability Index (ODI) : incapacité fonctionnelle ; – Hospital Anxiety and Depression Scale (HADS) : score de dépression. Pour identifier les différents clusters de patients, nous avons utilisé un mélange de modèles mathématiques à effets mixtes. Ces modèles permettent d’identifier des groupes de patients pour qui les effets de plusieurs variables explicatives (ODI, EVA, HAD) sur une variable cible (EQ5D-5L) sont différents. Au total, 198 patients avec des données complètes ont été inclus dans l’analyse. Deux sous-groupes de patients ont été identifiés. Alors que l’intensité de la douleur et l’état psychologique apparaissent impacter principalement la QVLS chez 31,3 % (n = 62) patients LRPO, l’incapacité fonctionnelle et l’état psychologique impactaient de façon principale la QVLS de 68,7 % (n = 136) des patients, pour les patients du deuxième groupe (n = 62 ; 31,3 %). Les hommes percevant leur travail comme physique sont plus affectés par l’incapacité fonctionnelle que par l’intensité de la douleur. Un niveau d’éducation plus faible, l’absence de stratégies d’adaptation et une intensité de la douleur plus élevée sont associés à une QVLS plus influencée par la perception de la douleur. L’identification de ces groupes permet de mieux comprendre les dimensions de la QVLS et ouvre la voie à une évaluation optimisée du patient douloureux chronique afin d’améliorer son parcours de soin par une prise en charge personnalisée.

Les lomboradiculalgies postopératoires (LRPO), comme d’autres types de douleur, sont considérées comme une expérience sensorielle et émotionnelle désagréable influencée par des facteurs biologiques, psychologiques et sociaux [1], [2], [3]. Malgré l’innovation constante de la technologie numérique et de l’intelligence artificielle, la douleur est toujours évaluée par des « outils de référence » tels que l’échelle visuelle analogique de la douleur (EVA) [4]. La principale limite de cet outil est qu’il ne tient pas compte des nombreuses dimensions de la douleur, comme les incapacités fonctionnelles, la détresse psychologique ou de la qualité de vie [3]. En pratique, les évaluations de ces dimensions sont considérées indépendamment, même si l’expérience clinique souligne l’imbrication de ces dimensions les unes avec les autres. Notre objectif était de développer un nouvel indice multidimensionnel de réponse clinique (MCRI), incluant l’intensité de la douleur, la capacité fonctionnelle, l’anxiété/dépression, la qualité de vie et la cartographie de la douleur, l’objectif étant une évaluation multidimensionnelle des douleurs. C’est une étude observationnelle, prospective, multicentrique (PREDIBACK) incluant 200 patients avec des LRPO avec un suivi de 12 mois. L’intensité de la douleur, la surface de la douleur corporelle (en cm2 via une interface tactile), l’incapacité fonctionnelle (Oswestry Disability Index), l’anxiété/dépression (Hospital Anxiety and Depression scale), la qualité de vie (EuroQol-5 dimensions). Ces résultats ont été combinés à l’aide d’une analyse factorielle pour créer l’indice composite MCRI. Le MCRI a été comparé aux autres mesures par des tests de corrélations. La capacité du MCRI à détecter la satisfaction du patient après une thérapie a également été analysée. Le MCRI représentait de façon plus pertinente toutes les dimensions de la douleur comparée aux autres scores classiques (corrélation avec les autres critères > 0,603). De plus, comparé aux autres critères, le MCRI a montré la plus grande sensibilité (77,4 %) et spécificité (79,8 %) pour détecter de la satisfaction du patient par rapport aux autres scores. Ce nouvel indice composite MCRI pourrait contribuer à affiner l’évaluation de l’état de santé général du patient douloureux chronique sur la base de paramètres objectifs. Ce nouvel indice MCRI doit être éprouvé en milieu clinique afin de déterminer l’efficacité des thérapies.

Refractory persistent spinal pain syndrome after surgery (PSPS-T2) can be successfully addressed by spinal cord stimulation (SCS). While conventional stimulation generates paresthesia, recent systems enable the delivery of paresthesia-free stimulation. Studies have claimed non-inferiority/superiority of selected paresthesia-free stimulation compared with paresthesia-based stimulation, but the comparative efficacy between different waveforms still needs to be determined in a given patient. We designed a randomized controlled 3-month crossover trial to compare pain relief of paresthesia-based stimulation versus high frequency versus burst in 28 PSPS-T2 patients implanted with multiwave SCS systems. Our secondary objectives were to determine the efficacy of these 3 waveforms on pain surface, quality of life, functional capacity, psychological distress, and validated composite multidimensional clinical response index to provide holistic comparisons at 3-, 6-, 9-, and 15-month post-randomization. The preferred stimulation modality was documented during the follow-up periods. No difference between the waveforms was observed in this study (P = .08). SCS led to significant pain relief, quality of life improvement, improvement of multidimensional clinical response index, and of all other clinical outcomes at all follow-up visits. Forty-four percent of the patients chose to keep the paresthesia-based stimulation modality after the 15-month follow-up period. By giving the possibility to switch and/or to combine several waveforms, the overall rate of SCS responders further increased with 25%. In this study, high frequency or burst do not appear superior to paresthesia-based stimulation, wherefore paresthesia-based stimulation should still be considered as a valid option. However, combining paresthesia-based stimulation with paresthesia-free stimulation, through personalized multiwave therapy, might significantly improve SCS responses.Perspective: This article assesses clinical SCS efficacy on pain relief, by comparing paresthesia-based stimulation and paresthesia-free stimulation (including high frequency and burst) modalities in patient presenting with PSPS-T2. Switching and/or combining waveforms contribute to increasing the global SCS responders rate.(c) 2023 The Author(s). Published by Elsevier Inc. on behalf of United States Association for the Study of Pain, Inc This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

As with other types of pain, persistent spinal pain syndrome after surgery (PSPS-T2) is viewed as an unpleasant sensory and emotional experience influenced by biological, psychological, and social factors, leading to a decrease in health-related quality of life (QoL) [1–4]. A composite novel Multidimensional Clinical Response Index (MCRI) has been recently developed allowing to assess health status of PSPS-T2 patients including quality of life, functional disability, psychological distress, pain intensity and pain surface outcomes [5].

While Spinal Cord Stimulation (SCS) is a well-established therapy to address refractory Persistent Spinal Pain Syndrome after spinal surgery (PSPS-T2) [1-4], its lack of spatial selectivity and reported discomfort due to positional effects, can be considered as significant limitations. As alternatives, new waveforms, such as Burst stimulation [5] and different spatial neural targets, such as Dorsal Root Ganglion Stimulation (DRGS) [6,7], have shown promising results. Comparisons between DRGS and standard SCS, or their combination, have never been studied on the same patients.

A substantial fraction of spine surgery patients (10–50%) [1] develop new or persistent back and/or leg pain postoperatively [2] , recently classified as persistent spinal pain syndrome type 2 (PSPS-T2) [3]. PSPS-T2, such as other types of pain, is considered as an unpleasant sensory and emotional experience influenced by biological, psychological, and social factors, which leads to a decrease in health-related Quality of Life (QoL) [4–6]. Despite constantly innovative digital technology and Artificial Intelligence (AI), pain is still assessed by "gold-standard tools" such as the Numerical Pain Rating Scale (NRPS) score [7]. This tool major limitation is that it fails to consider more than one of the many dimensions of pain, such as functional disability [6] or psychological distress [2,6]. In daily practice, pain intensity, functional disability, psychological distress and quality of life assessments are considered independently, even though clinical experience emphasizes the massive interlaying of these different but permanently interconnected, pain dimensions. Our aim was to develop 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 multidimensional assessment.

Persistent Spinal Pain Syndrome Type 2 (PSPS-T2), known as Failed Back Surgery Syndrome, represents a major public health problem and a financial burden [1]. Besides pain perception, PSPS-T2 patients present major psychological distress and functional disability, which lead to an overall decrease in Health-Related Quality of Life (HRQoL). However, the importance of functioning, pain perception and psychological status in HRQoL can substantially vary between subjects [2]. Our goal was to identify different population subgroups based on the specific impact of pain intensity, functional disability and psychological distress on HRQoL in PSPS-T2 patients.

While spinal cord stimulation (SCS) is a well-established therapy to address refractory persistent spinal pain syndrome after spinal surgery (PSPS-T2), its lack of spatial selectivity and reported discomfort due to positional effects can be considered as significant limitations. As alternatives, new waveforms, such as burst stimulation and different spatial neural targets, such as dorsal root ganglion stimulation (DRGS), have shown promising results. Comparisons between DRGS and standard SCS, or their combination, have never been studied on the same patients. "BOOST DRG" is the first prospective, randomized, double-blinded, crossover study to compare SCS vs. DRGS vs. SCS+DRGS. Sixty-six PSPS-T2 patients will be recruited internationally in three centers. Before crossing over, patients will receive each stimulation modality for 1 month, using tonic conventional stimulation. After 3 months, stimulation will consist in switching to burst for 1 month, and patients will choose which modality/waveform they receive and will then be reassessed at 6 and 12 months. In addition to our primary outcome based on pain rating, this study is designed to assess quality of life, functional disability, psychological distress, pain surface coverage, global impression of change, medication quantification, adverse events, brain functional imaging and electroencephalography, with the objective being to provide a multidimensional insight based on composite pain assessment.