Spinal Cord Stimulation Therapy Research Articles

Outcomes of ECAP-controlled closed-loop spinal cord stimulation therapy in JAPAN: how to increase patient satisfaction with spinal cord stimulation

Objective: Orthopedic surgeons commonly encounter patients with low back pain and leg pain. Despite conservative treatment, which may involve the use of weak opioids or NSAIDs, some patients do not experience improvement and may require increased dosages, contributing to concerns about opioid overuse overseas. Spinal cord stimulation (SCS) therapy, which can be trialed without surgical intervention, offers a potential treatment option. We evaluated Inceptiv (Medtronic), a generator that allows new stimulation settings using evoked compound action potentials (ECAPs)-controlled Closed-Loop technology. Methods: We evaluated six patients (four females, two males) who underwent implantation of the Inceptiv generator for SCS therapy. The average walking time (seconds) during a 2.1-meter walk and pain assessment using the Numerical Rating Scale (NRS) were conducted. Patient satisfaction was assessed using a 5-point scale: very satisfied (5), somewhat satisfied (4), neutral (3), somewhat dissatisfied (2), very dissatisfied. (1). Results: The average walking time improved from 11.8 seconds to 6.6 seconds, and the NRS score decreased from 7.6 to 4.2. Patient satisfaction was high, with four patients being very satisfied (5), one somewhat satisfied (4), and one neutral (3). Discussion: SCS therapy with Closed-Loop technology using the Inceptiv generator offers the potential to adjust electrical stimulation to minimize discomfort in daily activities and provide pain relief. It is considered a new treatment option for patients with common orthopedic conditions such as thoracolumbar compression fractures and lumbar spinal stenosis who suffer from chronic refractory pain in routine clinical practice.

Distinct Functional Connectivity Patterns for Intermittent Vs Constant Neuropathic Pain Phenotypes in Persistent Spinal Pain Syndrome Type 2 Patients.

Chronic low backpain (cLBP) has been associated with alterations in brain functional connectivity (FC) butbased upon heterogeneous populations and single network analyses. Our goal is to study a more homogeneous cLBP population and focus on multiple cross-network (CN) connectivity analysis. We hypothesize that within this population: 1) altered CNFC, involving emotion and reward/aversion functions are related to their pain levels and 2) altered relationships are dependent upon pain phenotype (constant neuropathic vs intermittent pain). In this case series, resting state fcMRI scans were obtained over a study duration of 60 months from 23 patients (13 constant neuropathic and 10 intermittent pain) with Persistent Spinal Pain Syndrome (PSPS Type 2) being considered for spinal cord stimulation (SCS) therapy at a single academic center. Images were acquired using a Discovery MR750 GE scanner. During the resting state acquisitions, they were asked to close their eyes and relax. The CNanalysis was performed on 7 brain networksand compared to age-matched controls. Linear regression was used to test the correlation between CN connectivity and pain scores. CNFCinvolving emotion networks (STM: striatum network index) was significantly lower than controls in all patients, regardless of pain phenotype (P < 0.003). Pain levels were positively correlated with emotional FCfor intermittent painbut negatively correlated for constant pain. This is thefirst report of 1) altered CN FCinvolving emotion/reward brain circuitry in 2) a homogeneous population of cLBPpatients with 3) two different pain phenotypes (constant vs intermittent) in PSPS Type 2 patients being considered for SCS. FC patterns were altered in cLBPpatients as compared to controls and were characteristic for each pain phenotype. Thesedata supportfcMRI as a potential and objective tool in assessing pain levels in cLBP patients with different painphenotypes.

Healthcare Utilization (HCU) Reduction with High-Frequency (10 kHz) Spinal Cord Stimulation (SCS) Therapy.

Spinal cord stimulation (SCS) is a well-established treatment for patients with chronic pain. With increasing healthcare costs, it is important to determine the benefits of SCS in healthcare utilization (HCU). This retrospective, single-center observational study involved 160 subjects who underwent implantation of a high-frequency (10 kHz) SCS device. We focused on assessing trends in HCU by measuring opioid consumption in morphine milligram equivalents (MME), as well as monitoring emergency department (ED) and office visits for interventional pain procedures during the 12-month period preceding and following the SCS implant. Our results revealed a statistically significant reduction in HCU in all domains assessed. The mean MME was 51.05 and 26.52 pre- and post-implant, respectively. There was a 24.53 MME overall decrease and a mean of 78.2% statistically significant dose reduction (p < 0.0001). Of these, 91.5% reached a minimally clinically important difference (MCID) in opioid reduction. Similarly, we found a statistically significant (p < 0.01) decrease in ED visits, with a mean of 0.12 pre- and 0.03 post-implant, and a decrease in office visits for interventional pain procedures from a 1.39 pre- to 0.28 post-10 kHz SCS implant, representing a 1.11 statistically significant (p < 0.0001) mean reduction. Our study reports the largest cohort of real-world data published to date analyzing HCU trends with 10 kHz SCS for multiple pain etiologies. Furthermore, this is the first and only study evaluating HCU trends with 10 kHz SCS by assessing opioid use, ED visits, and outpatient visits for interventional pain procedures collectively. Preceding studies have individually investigated these outcomes, consistently yielding positive results comparable to our findings.

Large-scale real-world data on a multidisciplinary approach to spinal cord stimulation for persistent spinal pain syndromes: first evaluation of the Neuro-Pain® nationwide screening and follow-up interactive register.

Spinal cord stimulation is a common treatment option for neuropathic pain conditions. Despite its extensive use and multiple technological evolutions, long term efficacy of spinal cord stimulation is debated. Most studies on spinal cord stimulation include a rather limited number of patients and/or follow-ups over a limited period. Therefore, there is an urgent need for real-world, long-term data. In 2018, the Belgian government initiated a nationwide secure platform for the follow-up of all new and existing spinal cord stimulation therapies. This is a unique approach used worldwide. Four years after the start of centralized recording, the first global extraction of data was performed. Herein, we present the findings, detailing the different steps in the centralized procedure, as well as the observed patient and treatment characteristics. Furthermore, we identified dropouts during the screening process, the reasons behind discontinuation, and the evolution of key indicators during the trial period. In addition, we obtained the first insights into the evolution of the clinical impact of permanent implants on the overall functioning and quality of life of patients in the long-term. Although these findings are the results of the first data extraction, some interesting conclusions can be drawn. The long-term outcomes of neuromodulation are complex and subject to many variables. Future data extraction will allow us to identify these confounding factors and the early predictors of success. In addition, we will propose further optimization of the current process.

First evidence of a biomarker-based dose-response relationship in chronic pain using physiological closed-loop spinal cord stimulation

Background and objectivesIn spinal cord stimulation (SCS) therapy, electricity is the medication delivered to the spinal cord for pain relief. In contrast to conventional medication where dose is determined by...

Neurophysiological outcomes that sustained clinically significant improvements over 3 years of physiologic ECAP-controlled closed-loop spinal cord stimulation for the treatment of chronic pain

IntroductionA novel, spinal cord stimulation (SCS) system with a physiologic closed-loop (CL) feedback mechanism controlled by evoked compound action potentials (ECAPs) enables the optimization of physiologic neural dose and the...

Prospective Six-Month Analysis of Multiarea Burst Spinal Cord Stimulation: Correlating Intraoperative Neuromonitoring With Postoperative Programming and Clinical Outcomes

IntroductionDeRidder burst spinal cord stimulation (SCS) has shown superior relief from overall pain to traditional tonic neurostimulation therapies and a reduction in back and leg pain. However, nearly 80% of patients have two or more noncontiguous pain areas. This affects the ability to effectively program stimulation and deliver long-term efficacy of the therapy. Multiple DeRidder burst region programming is an option to treat multisite pain by interleaving stimulation at multiple areas along the spinal cord. Previous intraoperative neuromonitoring studies have shown that DeRidder burst stimulation provides broader myotomal coverage at a lower recruitment threshold. The goal of this study is to correlate intraoperative electromyogram (EMG) threshold and postsynaptic excitability with postoperative paresthesia thresholds and optimal burst stimulation programming. Materials and MethodsNeuromonitoring was performed during permanent implant of SCS leads in ten patients diagnosed with chronic intractable back and/or leg pain. Each patient underwent the surgical placement of a Penta Paddle electrode through laminectomy at the T8–T11 spinal levels. Subdermal electrode needles were placed into lower extremity muscle groups, in addition to the rectus abdominis muscles, for EMG recording. Evoked responses were compared across multiple trials of burst stimulation in which the number of independent burst areas was varied. After intraoperative data collection, all patients were programmed with single- and multiarea DeRidder burst. Intermittent dosing was delivered at 30:90, 120:360, 120:720, and 120:1440 (seconds ON/OFF) intervals. Numerical rating scale (NRS) and Patient Global Impression of Change scores were evaluated at one, two, three, four, and six months after permanent implant. ResultsThe thresholds for EMG recruitment after DeRidder burst differed across all patients owing to anatomical and physiological variations. After a 30-second dose of stimulation, the average decrease in thresholds was 1.25 mA for two-area and 0.9 mA for four-area DeRidder burst. Furthermore, a 30-second dose of multisite DeRidder burst produced a 0.25 mA reduction in the postoperative paresthesia thresholds. Across all patients, the baseline NRS score was 6.5 ± 0.5, and the NRS score after single or multiarea DeRidder burst therapy was 2.87 ± 1.50. Eight of ten patients reported a ≥50% decrease in their pain scores through the six-month follow-up visit. Pain outcomes using intermittent multiarea stimulation with longer OFF times (120:360, 120:720, 120:1440) were comparable to those using single-area DeRidder burst at 30:90 up to six months after implant with patient preference being two-area DeRidder burst. ConclusionsThis study aims to evaluate the use of intraoperative neuromonitoring to optimize stimulation programming for multisite pain and correlate it with postoperative programming and efficacy. These results suggest that multisite programming can be used to further customize DeRidder burst stimulation to each individual patient and improve outcomes and quality of life for patients receiving SCS therapy for multisite pain.

Examining the Type, Quality, and Content of Web-Based Information for People With Chronic Pain Interested in Spinal Cord Stimulation: Social Listening Study.

The increased availability of web-based medical information has encouraged patients with chronic pain to seek health care information from multiple sources, such as consultation with health care providers combined with web-based information. The type and quality of information that is available on the web is very heterogeneous, in terms of content, reliability, and trustworthiness. To date, no studies have evaluated what information is available about neuromodulation on the web for patients with chronic pain. This study aims to explore the type, quality, and content of web-based information regarding spinal cord stimulation (SCS) for chronic pain that is freely available and targeted at health care consumers. The social listening tool Awario was used to search Facebook (Meta Platforms, Inc), Twitter (Twitter, Inc), YouTube (Google LLC), Instagram (Meta Platforms, Inc), blogs, and the web for suitable hits with "pain" and "neuromodulation" as keywords. Quality appraisal of the extracted information was performed using the DISCERN instrument. A thematic analysis through inductive coding was conducted. The initial search identified 2174 entries, of which 630 (28.98%) entries were eventually withheld, which could be categorized as web pages, including news and blogs (114/630, 18.1%); Reddit (Reddit, Inc) posts (32/630, 5.1%); Vimeo (Vimeo, Inc) hits (38/630, 6%); or YouTube (Google LLC) hits (446/630, 70.8%). Most posts originated in the United States (519/630, 82.4%). Regarding the content of information, 66.2% (383/579) of the entries discussed (fully discussed or partially discussed) how SCS works. In total, 55.6% (322/579) of the entries did not elaborate on the fact that there may be >1 potential treatment choice and 47.7% (276/579) did not discuss the influence of SCS on the overall quality of life. The inductive coding revealed 4 main themes. The first theme of pain and the burden of pain (1274/8886, 14.34% coding references) explained about pain, pain management, individual impact of pain, and patient experiences. The second theme included neuromodulation as a treatment approach (3258/8886, 36.66% coding references), incorporating the background on neuromodulation, patient-centered care, SCS therapy, and risks. Third, several device-related aspects (1722/8886, 19.38% coding references) were presented. As a final theme, patient benefits and testimonials of treatment with SCS (2632/8886, 29.62% coding references) were revealed with subthemes regarding patient benefits, eligibility, and testimonials and expectations. Health care consumers have access to web-based information about SCS, where details about the surgical procedures, the type of material, working mechanisms, risks, patient expectations, testimonials, and the potential benefits of this therapy are discussed. The reliability, trustworthiness, and correctness of web-based sources should be carefully considered before automatically relying on the content.

Postsynaptic dorsal column pathway activation during spinal cord stimulation in patients with chronic pain.

Spinal cord stimulation (SCS) treatment for chronic pain relies on the activation of primary sensory fibres ascending to the brain in the dorsal columns. While the efficacy of SCS has been demonstrated, the precise mechanism of action and nature of the fibres activated by stimulation remain largely unexplored. Our investigation in humans with chronic neuropathic pain undergoing SCS therapy, found that post-synaptic dorsal column (PSDC) fibres can be activated synaptically by the primary afferents recruited by stimulation, and axonically by the stimulation pulses directly. Synaptic activation occurred in 9 of the 14 patients analysed and depended on the vertebral level of stimulation. A clear difference in conduction velocities between the primary afferents and the PSDC fibres were observed. Identification of PSDC fibre activation in humans emphasises the need for further investigation into the role they play in pain relief and the sensory response sensation (paraesthesia) experienced by patients undergoing SCS.

Defining the Boundaries of Patient Perception in Spinal Cord Stimulation Programming

ObjectivesRecent developments in spinal cord stimulation (SCS) programming have initiated new modalities of imperceptible stimulation. However, the boundaries of sensory perception are not well defined. The BEnchtop NEuromodulation Following endIng of Trial study aimed to create a map of perceptual threshold responses across a broad range of SCS parameters and programming to inform subperception therapy design. Materials and MethodsThis multicenter study was conducted at seven US sites. A total of 43 patients with low back and/or leg pain who completed a percutaneous commercial SCS trial were enrolled. Test stimulation was delivered through trial leads for approximately 90 minutes before removal. SCS parameters, including amplitude, frequency, pulse width (PW), electrode configuration, cycling, and multifrequency stimulation were varied during testing. Paresthesia threshold (PT), comfort level (CL), perceptual coverage area, and paresthesia quality (through patient selection of keywords) were collected. Differences were evaluated with analysis of variance followed by post hoc multiple comparisons using t-tests with Bonferroni correction. ResultsPT was primarily determined by PW and was insensitive to frequency for constant frequency stimulation (range: 20 Hz–10 kHz; F(1284) = 69.58, p < 0.0001). For all tests, CL was approximately 25% higher than PT. The dominant variable that influenced paresthesia quality was frequency. Sensations described as comfortable and tingling were most common for frequencies between 60 Hz and 2.4 kHz; unpleasant sensations were generally more common outside this range. Increasing distance between active electrodes from 7 mm to 14 mm, or cycling the SCS waveform at 1 Hz, decreased PT (p < 0.0001). Finally, PT for a low-frequency stimulus (ie, 60 Hz) was unaffected by mixing with a sub-PT high-frequency stimulus. ConclusionsIn contrast to previous work investigating narrower ranges, PW primarily influenced PT, independently of frequency. Paresthesia quality was primarily influenced by pulse frequency. These findings advance our understanding of SCS therapy and may be used to improve future novel neuromodulation paradigms.

Discrepancy Between Reported and Calculated Pain Reduction in Patients With Spinal Cord Stimulation Therapy and Lack of Agreement Between Patient Satisfaction and Degree of Pain Relief

ObjectivesThis study aimed to determine agreement between reported percentage pain reduction (RPPR) and calculated percentage pain reduction (CPPR) in patients with percutaneous spinal cord stimulation (SCS) implants, and to correlate RPPR and CPPR with patient satisfaction. We also sought to determine which patient-reported outcome measures are most improved in patients with SCS. Materials and MethodsFifty patients with percutaneous spinal cord stimulator implants with a mean follow-up of 51.1 months were interviewed and surveyed to assess their pain level, impression of degree of pain relief, satisfaction with the therapy, and desire to have the device again. Baseline pain level was obtained from their preimplant records. ResultsOverall, RPPR was found to be 53.3%, whereas CPPR was 44.4%. Of all patients, 21 reported <50% pain reduction; however, most of these (12/21, 57%) were satisfied with the outcome of therapy. In terms of individual improvement in outcomes, activities of daily life was the most improved measure at 82%, followed by mood, sleep, medication use, and health care utilization at 74%, 62%, 50%, and 48%, respectively. ConclusionsRPPR appears to be a complex outcome measure that may not agree with CPPR. Overall RPPR is greater than the CPPR. On the basis of our data, these independently valid measures should not be used interchangeably. A 50% pain reduction threshold is not a requisite for patient satisfaction and desire to have the device again. Activities of daily living was the most improved measure in this cohort, followed by mood, sleep, medication usage, and decrease in health care utilization.

Treatment of pain in length-dependent peripheral neuropathy with the use of spinal cord stimulation: a systematic review.

Chronic intractable pain from peripheral neuropathy is a debilitating condition that might not respond to conventional medical management and pharmacotherapy. The primary objective of this systematic review was to assess change (or reduction) in pain intensity in patients with length-dependent peripheral neuropathy after spinal cord stimulation (SCS) therapy. This systematic review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. The primary outcome was change (or reduction) in pain intensity after 12 months of SCS therapy compared with baseline in participants with length-dependent peripheral neuropathy. Secondary outcomes included change in pain intensity after 6 months and change in opioid consumption after 12 months. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) guidelines were used to appraise the quality of evidence. Nineteen studies consisting of 376 participants who underwent SCS implantation met the inclusion criteria. Qualitative synthesis revealed that all eligible studies reported a significant improvement in pain intensity after 12 months of SCS therapy as compared with baseline. Mean differences with 95% confidence intervals were calculated for 4 studies, all of which achieved the minimal clinically important difference for change in pain intensity at 12 months. The GRADE quality of evidence for this outcome was appraised as very low quality. This systematic review highlights that SCS could lead to significant improvement in pain intensity for length-dependent peripheral neuropathy, although future well-powered randomized controlled trials are warranted to increase the certainty of evidence in this finding. PROSPERO (https://www.crd.york.ac.uk/PROSPERO/) ID: CRD42022377572.

ECAP-controlled closed-loop versus open-loop SCS for the treatment of chronic pain: 36-month results of the EVOKE blinded randomized clinical trial

IntroductionThe evidence for spinal cord stimulation (SCS) has been criticized for the absence of blinded, parallel randomized controlled trials (RCTs) and limited evaluations of the long-term effects of SCS in...

Multiphase Spinal Cord Stimulation in Participants With Chronic Back or Leg Pain: Results of the BENEFIT-02 Randomized Clinical Trial

ObjectiveThis study aimed to assess the safety and effectiveness of a new charge-distributed multiphase stimulation paradigm during an extended spinal cord stimulation (SCS) trial. Materials and MethodsThis prospective, multicenter, randomized, single-blind, feasibility study included participants with chronic low back and/or leg pain and baseline numerical rating scale (NRS) for overall pain intensity ≥6. After a successful commercial SCS trial, participants were randomized to multiphase SCS therapy A (approximately 600–1500 Hz) or B (approximately 300–600 Hz), delivered via an investigational external pulse generator and existing leads during an 11-to-12–day testing period. Primary end points were mean NRS change from baseline to final in-office visit for each multiphase therapy and between therapies. Secondary end points included mean NRS change from end of commercial trial to final study visit and incidence of device-related adverse events (AEs). Additional measures included patient-reported outcomes collected at home through electronic watches and written diaries. Power usage was compared between multiphase and commercial therapies. ResultsA total of 122 participants initiated a commercial trial; 77 were randomized to a multiphase arm, and 65 completed the study. Reductions in mean NRS scores from baseline to final study visit were significant for multiphase therapy A and B (−4.3 and −4.7, respectively; both p < 0.0001). There was no statistically significant difference in mean NRS reduction or percent pain relief between multiphase therapies. In an additional analysis, 63.9% of participants reported greater pain relief with multiphase than with commercial SCS therapy in the at-home setting. On average, multiphase required less power than did commercial devices. One non–serious device-related AE was reported, and no infections occurred during the extended trial. ConclusionsMultiphase SCS effectively reduced pain in participants with chronic low back and/or leg pain during a trial, with no unanticipated device-related AEs reported. Future studies should evaluate long-term effectiveness of multiphase stimulation. Clinical Trial RegistrationThe Clinicaltrials.gov registration number for the study is NCT03594266.

Objective wearable measures correlate with self-reported chronic pain levels in people with spinal cord stimulation systems

Spinal Cord Stimulation (SCS) is a well-established therapy for treating chronic pain. However, perceived treatment response to SCS therapy may vary among people with chronic pain due to diverse needs and backgrounds. Patient Reported Outcomes (PROs) from standard survey questions do not provide the full picture of what has happened to a patient since their last visit, and digital PROs require patients to visit an app or otherwise regularly engage with software. This study aims to assess the feasibility of using digital biomarkers collected from wearables during SCS treatment to predict pain and PRO outcomes. Twenty participants with chronic pain were recruited and implanted with SCS. During the six months of the study, activity and physiological metrics were collected and data from 15 participants was used to develop a machine learning pipeline to objectively predict pain levels and categories of PRO measures. The model reached an accuracy of 0.768 ± 0.012 in predicting the pain intensity of mild, moderate, and severe. Feature importance analysis showed that digital biomarkers from the smartwatch such as heart rate, heart rate variability, step count, and stand time can contribute to modeling different aspects of pain. The results of the study suggest that wearable biomarkers can be used to predict therapy outcomes in people with chronic pain, enabling continuous, real-time monitoring of patients during the use of implanted therapies.

Immediate Effects of Anti-Spastic Epidural Cervical Spinal Cord Stimulation on Functional Connectivity of the Central Motor System in Patients with Stroke- and Traumatic Brain Injury-Induced Spasticity: A Pilot Resting-State Functional Magnetic Resonance Imaging Study.

Spinal cord stimulation (SCS) is one approach to the potential improvement of patients with post-stroke or post-traumatic spasticity. However, little is known about whether and how such interventions alter supraspinal neural systems involved in the pathogenesis of spasticity. This pilot study investigated whether epidural spinal cord stimulation at the level of the C3-C5 cervical segments, aimed at reducing spasticity, alters the patterns of functional connectivity of the brain. Eight patients with spasticity in the right limbs as a result of left cerebral hemisphere damage (due to hemorrhagic and ischemic stroke or traumatic and anoxic brain injury) were assessed with fMRI immediately before and immediately after short-term (1 to 6 days) test cervical epidural SCS therapy. Eight demographically and clinically comparable patients with spasticity in the right extremities due to a left hemisphere ischemic stroke and brain injury who received conventional therapy were examined as a control group. All patients also had paresis of one or two limbs and hyperreflexia. After the SCS therapy, there were three main findings: (1) higher functional connectivity of the brainstem to the right premotor cortex and changes in functional connectivity between cortical motor areas, (2) increased functional connectivity between the right and left lateral nodes of the sensorimotor network, and (3) a positive correlation between decreased spasticity in the right leg and increased functional connectivity within the right hemisphere sensorimotor cortex. All these changes in functional connectivity occurred with a statistically significant decrease in spasticity, as assessed using the modified Ashworth scale. The control group showed no decrease in spasticity or increase in functional connectivity in any of the seeds of interest. On the contrary, a decrease in functional connectivity of the brainstem and right postcentral gyrus was observed in this group during the observation period. We were thus able to detect intrinsic brain connectivity rearrangements that occurred during spasticity mitigation following short epidural SCS therapy. The clinical results obtained confirmed the efficacy of short-term anti-spastic SCS therapy. The obtained data on functional rearrangements of the central motor system may shed light on the mechanism of antispastic action of this procedure.

A Novel, Paresthesia-Free Spinal Cord Stimulation Waveform for Chronic Neuropathic Low Back Pain: Six-Month Results of a Prospective, Single-Arm, Dose-Response Study

ObjectivesThe aim of this prospective, single-blinded, dose-response study was to evaluate the safety and efficacy of a novel, paresthesia-free (subperception) spinal cord stimulation (SCS) waveform designed to target dorsal horn dendrites for the treatment of chronic neuropathic low back pain (LBP). Materials and MethodsTwenty-seven participants with chronic neuropathic LBP were implanted with a commercial SCS system after a successful trial of SCS therapy. Devices were programmed to deliver the investigative waveform (100 Hz, 1000 μs, T9/T10 bipole) at descending stimulation perception threshold amplitudes (80%, 60%, 40%). Programs were evaluated at six, ten, and 14 weeks, after which participants selected their preferred program, with more follow-up at 26 weeks (primary outcomes). Participants were blinded to the nature of the programming. Pain score (visual analog scale [VAS]), Brief Pain Inventory (BPI), quality of life (EQ-5D-5L), and health status (36-Item Short Form [SF-36]) were measured at baseline and follow-ups. Responder rate, treatment satisfaction, clinician global impression of change, and adverse events (AEs) also were evaluated. ResultsMean (± SD) baseline VAS was 72.5 ± 11.2 mm. At 26 weeks (n = 26), mean change from baseline in VAS was −51.7 mm (95% CI, −60.7 to −42.7; p < 0.001), with 76.9% of participants reporting ≥50% VAS reduction, and 46.2% reporting ≥80% VAS reduction. BPI, EQ-5D-5L, and SF-36 scores were all statistically significantly improved at 26 weeks (p < 0.001), and 100% of participants were satisfied with their treatment. There were no unanticipated AEs related to the study intervention, device, or procedures. ConclusionsThis novel, paresthesia-free stimulation waveform may be a safe and effective option for patients with chronic neuropathic LBP eligible for SCS therapy and is deliverable by all current commercial SCS systems. Clinical Trial RegistrationThis study is registered on anzctr.org.au with identifier ACTRN12618000647235.

ID: 216326 Improvement in Chronic Pain Induced Depression With Spinal Cord Stimulation Therapy

A detailed psychological evaluation is an important tool utilized by physicians to help predict the success of spinal cord stimulation (SCS) therapy. Psychological factors such as anxiety, depression and mood disorders may play a large predictive component in SCS failure. The high coexistence between depression and chronic pain, however, can complicate the picture. Recent studies have substantiated this complexity, and have started to place more value on the psychosocial and behavioral factors such as coping mechanisms, and social support. Herein, the authors present an interesting case of a 47 year old female with a significant psychiatric history that had significant improvement in her mood and overall mental health after SCS implant.

ID: 221663 High Frequency as Rescue in Failed Spinal Cord Stimulation Therapy

Conventional spinal cord stimulation therapy has been shown to be an effective tool in certain chronic pain syndromes. However, there are patients that fulfilling with traditional indications for this technique, the results are not as expected, or the efficacy is lost over time. Up to thirty percent of therapies are long-term failures, being the main cause of explanting the decreased efficacy of the stimulation system.

ID: 222688 Functional Ultrasound Imaging Reveals Activation Properties of Clinical Spinal Cord Stimulation Therapy

Spinal cord stimulation (SCS) therapy has long been established as an effective treatment for chronic neuropathic pain. However, methodological limitations have prohibited the detailed investigation of the activation patterns produced in the spinal cord during therapy. Functional ultrasound (fUS) is an emerging technology that monitors local hemodynamic changes in the brain that are tightly coupled to neural activity1-3. Previous studies have demonstrated that the high spatiotemporal resolution of fUS can be used to monitor activation in the spinal cord during SCS4,5. In this study, fUS was used to investigate neuromodulation patterns produced by clinical SCS paradigms in an ovine model that enabled testing with implanted clinical hardware.