Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain.

Aim: The availability of long-term (>2 years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global SCS registry for chronic pain. Methods: Participants were prospectively enrolled globally at 79 implanting centers and followed out to 3 years after device implantation. Results: Of 1881 participants enrolled, 1289 received a permanent SCS implant (1776 completed trial). The annualized rate of device explant was 3.5% (all causes), and 1.1% due to inadequate pain relief. Total incidence of device explantation >3 years was 7.6% (n = 98). Of these, 32 subjects (2.5%) indicated inadequate pain relief as cause for removal. Implant site infection (11 events) was the most common device-related serious adverse event (<1%). Conclusion: This prospective, global, real-world study demonstrates a high-level of safety for SCS with low rate of explant/serious adverse events. Clinical Trial Registration: NCT01719055 (ClinicalTrials.gov).

Exploration of High- and Low-Frequency Options for Subperception Spinal Cord Stimulation Using Neural Dosing Parameter Relationships: The HALO Study.

OBJECTIVES: Subperception spinal cord stimulation (SCS) is described mostly utilizing waveforms that require high energy. However, the necessity of these waveforms for effective subperception has not been established. We aimed to explore whether effective subperception pain relief can be achieved using frequencies below 1 kHz. MATERIALS AND METHODS: Thirty chronic pain patients implanted with SCS were enrolled as part of a multicenter, real-world, consecutive, observational case series. An effective stimulation location was determined using a novel electric field shape designed to preferentially modulate dorsal horn elements. Subsequently, programs at lower frequencies (600, 400, 200, 100, 50, and 10 Hz) were provided with pulse-width and amplitude adjusted to optimize response. RESULTS: All tested frequencies (1 kHz down to 10 Hz) provided effective subperception relief, yielding a mean of 66-72% reduction in back, leg, and overall pain. It was found that to maintain analgesia, as frequency was decreased, the electrical or "neural" dose had to be adjusted according to parameter relationships described herein. With the reduction of frequency, we observed a net reduction of charge-per-second, which enabled energy savings of 74% (200 Hz) and 97% (10 Hz) relative to 1 kHz. Furthermore, pain reduction was sustained out to one year, with 85% of patients reporting a preference for frequencies of 400 Hz or below. CONCLUSIONS: We have derived an electric field configuration and, along with previous learnings in the kHz range, a set of neural dosing parameter relationships (10-10,000 Hz), which enable the expansion of effective subperception SCS to low frequency and achieve major energy savings.

Real-World Outcomes Using a Spinal Cord Stimulation Device Capable of Combination Therapy for Chronic Pain: A European, Multicenter Experience.

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 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.

A novel fast-acting sub-perception spinal cord stimulation therapy enables rapid onset of analgesia in patients with chronic pain.

Background: Treating chronic pain using sub-perception Spinal Cord Stimulation (SCS) does not elicit paresthesia but is associated with long analgesic 'wash-in' (i.e. duration until maximum pain relief) and prolonged assessment of therapy. We describe the attainment of clinically meaningful and rapid-onset analgesic outcomes using a novel sub-perception SCS approach.Methods: This observational case-series evaluated patients implanted with an SCS device for chronic pain, who underwent re-programming utilizing a new methodology in which paresthesia was used to guide sub-perception stimulation field targeting at specific parameters including charge-balanced symmetrical pulses at 90 Hz (termed Fast-Acting Sub-Perception Therapy, FAST). Pain scores (NRS) were collected as reported per standard-of-care from patient charts.Results: Mean overall pain score at baseline was 8.4 ± 0.2 (n = 41). After activation of FAST, a 7.1-point reduction in overall pain score was (1.3 ± 0.2, p < 0.0001) reported within 11.2 ± 1.9 minutes (n = 34). This decrease in pain score was sustained out to 3-month (1.6 ± 0.3, n = 26) and 6-month follow-up (1.7 ± 0.4, n = 18). At last follow up (mean = 223 ± 132 days), a pain score of 1.6 ± 0.3, n = 30 was determined.Conclusions: After FAST implementation, a profound analgesic response, requiring substantially less energy than conventional sub-perception methodologies, was observed. This rapid analgesic onset achieved with the novel FAST technique suggests the potential for an alternative mechanism of action(s) of sub-perception SCS.

Occipital Nerve Stimulation for Pain Modulation in Drug-Resistant Chronic Cluster Headache.

Occipital nerve stimulation (ONS) is a surgical treatment proposed for drug-resistant chronic cluster headache (drCCH). Long-term series assessing its efficacy are scarce. We designed a retrospective observational study with consecutive sampling, evaluating the follow-up of 17 drCCH patients who underwent ONS. Our main endpoint was the reduction the rate of attacks per week. We also evaluated the pain intensity through the Visual Analogue Scale (VAS), patient overall perceived improvement and decrease in oral medication intake. After a median follow-up of 6.0 years (4.5-9.0), patients decreased from a median of 30 weekly attacks to 22.5 (5.6-37.5, p = 0.012), 7.5 at 1 year (p = 0.006) and 15.0 at the end of follow-up (p = 0.041). The VAS decreased from a median of 10.0 to 8.0 (p = 0.011) at three months, to 7.0 (p = 0.008) at twelve months and 7.0 (p = 0.003) at the end of the follow-up. A total of 23.5% had an overall perceived improvement of ≥70% at 3 months, 41.2% at 1 year and 27.8% at the end of follow-up. Reducing prophylactic oral medication was possible in 76.5% and it was stopped in 17.7%. Triptan use decreased in all the responder patients and 17.7% stopped its intake. A total of 41.2% presented mild adverse events. In conclusion, our long-term experience suggests that ONS could be an interesting option for drCCH-selected patients, as it is a beneficial and minimally invasive procedure with no serious adverse events.

Real-world evidence on spinal cord neuromodulation and pain: Long-term effectiveness analysis in a single-center cohort.

Introduction: Chronic pain inflicts damage in multiple spheres of patient's life and remains a challenge for health care providers. Real-world evidence derived from outcome registries represents a key aspect of the ongoing systematic assessment and future development of neurostimulation devices. Research question: The objective of the present study was to assess the long-term effectiveness of neurostimulation as a treatment for spinal chronic pain. Material and methods: The patients analyzed in the present study represent a singlecenter cohort of 52 individuals. Primary outcome measures included numeric pain rating scale, Beck depression index II and Oswestry disability index variation from baseline to 36-month visits. Secondary outcomes included its evaluation at 6-month, 12-month and 24-month visits. Results: A significant improvement in targeted pain, depression and disability values were observed at 36-month follow-up (P â€‹< â€‹0.001, P â€‹= â€‹0.009 and P â€‹< â€‹0.001 respectively). Those results were consistent in the leg and back pain subgroup but not in the neck, chest and arm pain subgroup. The decrease in pain, depression and disability values happened progressively through time, with the exception of the 12-month visit, where a mild stagnation was observed. Discussion and conclusion: Our results suggest that spinal cord stimulation is an effective long-term treatment for spinal chronic pain in real-world conditions when applied to a variety of patients and conditions usually seen in routine practice. Nevertheless, some fluctuations may occur during treatment so prolonged follow-up periods should be considered before rendering an unsuccessful therapy diagnosis.

Tumor fibroso solitario extra-intramedular de localización dorsal / Solitary fibrous tumor: A clinical case

Introducción: El tumor fibroso solitario (TFS) es un tumor poco frecuente de origen mesenquimal, que se localiza principalmente en pleura. De extraordinaria infrecuencia es su localización a nivel intraespinal, siendo la región torácica la más frecuente. Presentación del caso: Presentamos el caso de una paciente de 48 años con hipoestesia ascendente progresiva en miembros inferiores y mielopatía de un mes de evolución, que se diagnosticó de un tumor intraespinal en segmento D3-D4. Fue intervenida quirúrgicamente mediante abordaje dorsal posterior y laminoplastia D3-D4, hallándose un tumor intradural con componente intramedular, de 18×12mm, aproximadamente. La resección fue completa y la anatomía patológica resultó el diagnóstico de tumor fibroso solitario. La paciente, tras 7 meses de seguimiento se encuentra asintomática. Discusión: La resección completa tumoral junto con las características histopatológicas son los principales factores pronósticos, teniendo la cirugía un papel protagonista en este tipo de neoplasia. Conclusión: Son muy pocos los casos publicados en la literatura de tumor fibroso solitario con localización intraespinal. Con este artículo aportamos un nuevo caso a la misma

Introduction: Solitary fibrous tumor (TFS) is a rare tumor of mesenchymal origin, located mainly in the pleura. It is extraordinarily infrequent find it at the intraespinal level, being the thoracic region the most frequent. Case presentation: We present the case of a 48-year-old patient with progressive ascending lower limb and myelopathy of one month of evolution, with intraspinal location at the D3-D4 level. It was surgically operated by posterior dorsal approach and D3-D4 laminoplasty, with an intradural tumor with an intramedullary component of approximately 18×12mm. The resection was complete and the pathological anatomy gave the diagnosis of solitary fibrous tumor. The patient is currently asymptomatic. Discussion: Complete tumor resection and histopathological features are the main prognostic factors. Surgery have a main role in this type of neoplasia. Conclusion: There are few case published of solitary fibrous tumor with intraspinal localization. We apport another case to the literature

Solitary fibrous tumor: A clinical case. / Tumor fibroso solitario extra-intramedular de localización dorsal.

INTRODUCTION: Solitary fibrous tumor (TFS) is a rare tumor of mesenchymal origin, located mainly in the pleura. It is extraordinarily infrequent find it at the intraespinal level, being the thoracic region the most frequent. CASE PRESENTATION: We present the case of a 48-year-old patient with progressive ascending lower limb and myelopathy of one month of evolution, with intraspinal location at the D3-D4 level. It was surgically operated by posterior dorsal approach and D3-D4 laminoplasty, with an intradural tumor with an intramedullary component of approximately 18×12mm. The resection was complete and the pathological anatomy gave the diagnosis of solitary fibrous tumor. The patient is currently asymptomatic. DISCUSSION: Complete tumor resection and histopathological features are the main prognostic factors. Surgery have a main role in this type of neoplasia. CONCLUSION: There are few case published of solitary fibrous tumor with intraspinal localization. We apport another case to the literature.