Permanent Spinal Cord Stimulation Research Articles

894 Comparison of Intraoperative Neural Changes During Tonic Versus High-Frequency Spinal Cord Stimulation in Chronic Pain Patients

INTRODUCTION: Chronic pain is a prevalent issue that may affect up to 34% of US adults, and spinal cord stimulation (SCS) is a promising therapy. However, SCS device selection remains a challenge because there are currently no objective biomarkers to evaluate chronic pain, or to predict which patients will be responders. METHODS: Intraoperative EEG signals were recorded in 24 chronic pain patients (14 women) during permanent SCS electrode placement surgery. Neural responses were captured with respect to tonic (60 Hz/300 µs) and high-frequency (1 kHz/30 µs) SCS paradigms in a randomized manner and correlated to Numeric Rating Scale (NRS) scores. All data were analyzed offline in MATLAB and SPSS v28.0.1.1. RESULTS: Our analyses for the main effects demonstrated a significant difference between cortical regions (F(2.88,57.7) = 7.60 , p < 0.001) and a marginal difference between stimulation conditions (F(2,40) = 2.970, p = 0.063). The post hoc analysis for these factors revealed that alpha/theta peak power ratio was significantly different between in central regions (C3-C4) between tonic and HF stimulation (p = 0.006) and temporal regions (T3-T4) between baseline and HF stimulation (p = 0.049). The comparison of NRS scores before and 3 months after surgery indicated a significant improvement in pain intensity (p < 0.001) at the group level. The neural features found to be significantly correlated with preoperative NRS scores in PFC (p = 0.036 and p = 0.025) and temporal regions (p = 0.041 and p = 0.012) under both stimulations. CONCLUSIONS: Our preliminary results support the possibility that different stimulation patterns affect the electrophysiological activity differently in various cortical regions. Such differences might account for the variability in pain suppression in patients with chronic pain treated with SCS. Future work will utilize this dataset to develop a machine learning classifier to support objective device selection strategies.

Spinal cord stimulation for chronic pain treatment following sacral chordoma resection: illustrative case.

Cancer-related or postoperative pain can occur following sacral chordoma resection. Despite a lack of current recommendations for cancer pain treatment, spinal cord stimulation (SCS) has demonstrated effectiveness in addressing cancer-related pain. A 76-year-old female with a sacral chordoma underwent anterior osteotomies and partial en bloc sacrectomy. She subsequently presented with chronic pain affecting both buttocks and posterior thighs and legs, significantly impeding her daily activities. She underwent a staged epidural SCS paddle trial and permanent system placement using intraoperative neuromonitoring. The utilization of percutaneous leads was not viable because of her history of spinal fluid leakage, multiple lumbosacral surgeries, and previous complex plastic surgery closure. The patient reported a 62.5% improvement in her lower-extremity pain per the modified Quadruple Visual Analog Scale and a 50% improvement in the modified Pain and Sleep Questionnaire 3-item index during the SCS trial. Following permanent SCS system placement and removal of her externalized lead extenders, she had an uncomplicated postoperative course and reported notable improvements in her pain symptoms. This case provides a compelling illustration of the successful treatment of chronic pain using SCS following radical sacral chordoma resection. Surgeons may consider this treatment approach in patients presenting with refractory pain following spinal tumor resection.

Spinal Cord Stimulation (SCS) reduces Morphine Milligram Equivalents (MME) in patients using Opioid analgesics for Chronic Non-Cancer Pain

Summary of background dataChronic Pain is a prevalent condition that affects many people in the United States. Spinal Cord Stimulation (SCS) has been documented to help reduce perceived pain; however, few studies have analyzed the impact of perceived pain on opioid consumption before and after SCS. ObjectivesThis retrospective cohort study aimed to evaluate the impact of spinal cord stimulation on opioid consumption after permanent SCS implant. MethodsThis IRB-approved retrospective single-center study investigated the opioid consumption of 26 adults at three different times: (1) Initial date of service-baseline- (2) SCS implant date, and (3) 6 months post-SCS implant date. Mean opioid consumption was calculated over the month prior and after to visit of (1), (2), and (3) to generate 3 separate month averages. Opioid consumptions were measured using Morphine Milligram Equivalents (MME). To determine the difference in MME consumption from baseline to permanent SCS implantation, we conducted a series of paired-sample t-tests. ResultsPatients' MME significantly decreased from baseline (M = 52.63, SD = 45.07) to 6-months post-SCS implantation (M = 24.64, SD = 31.97, t (25) = 4.29, p < .001). The effect of this difference was large (d = 0.84). Whereas patients’ morphine equivalents decreased from date of SCS implantation (M = 35.73, SD = 52.78) to 6-months post-SCS implantation (M = 24.64, SD = 31.97), this difference was not significant (t (25) = 1.66, p = .11) but yielded a small effect size (d = 0.34). Discussions/conclusionIn our study, patients using opioids for non-cancer pain management, SCS moderated the perception of pain neurocircuitry and noxious stimuli-manifestation, resulting in a reduced sense of pain and decreased opioid usage.

Real World Characterization of Chronic Pain, Success Rates and Implant Rates: Evidence from a Digital Health Platform of Patients Undergoing Spinal Cord Stimulation Evaluations

Spinal cord stimulation is an effective treatment for those experiencing chronic back and leg pain but requires a temporary evaluation period (SCSeval) before permanent implantation. We present real-world data from 7,000 patients who underwent SCSeval while utilizing a mobile digital health platform for education, feedback, and outcomes collection during their surgical journey. We analyzed preoperative patient demographics, characterized patient pain profiles using the patient-reported outcomes measurement information system-29 surveys, and calculated the rates of conversion from temporary to permanent spinal cord stimulation (SCS) implantation. Between August 1, 2021, and March 2, 2023, 7,000 patients (mean age 59.1, 59.6% female) underwent SCSeval procedures while utilizing a mobile application. Patients commonly experienced aching, sharp, stabbing, tingling, numb, and burning pain. Patients had tried multiple prior therapies and wanted to reduce their use of opioids and pain medications. Overall, 90.1% of the patients had a successful SCSeval, and 80.4% of those converted to permanent implant, with the highest rates among those who underwent SCSeval in a hospital setting. There was a significant improvement in all domains of pain as evaluated by pre and postoperative patient-reported outcomes measurement information system-29 surveys. This study supports the use of digital health technology as part of the SCS journey to improve the patient experience and allow for robust patient-reported outcomes collection. The overall rate of SCSeval to permanent SCS in our study of 72.4% was higher than national rates of 64%, suggesting that an app may allow clinicians to better quantify changes in chronic pain and provide more insight into choosing to implant SCS permanently. PerspectiveThis article presents real-world evidence from a digital health platform for therapy education and outcomes collection from patients undergoing spinal cord stimulation evaluation procedures. Such tools could allow for better pain characterization and allow for more nuanced tracking of patient outcomes among those with chronic pain.

ID: 216932 High-Frequency Spinal Cord Stimulation Salvages Therapy in Failed Low-Frequency Treatment of Failed Back Surgery Syndrome

Spinal cord stimulator (SCS) is a Federal Drug Administration-approved treatment modality for treating failed back surgery syndrome (FBSS), complex regional pain syndrome (CRPS), and diabetic neuropathy (DN). Patients first must undergo an SCS trial by placing electrodes in the epidural space with a temporary external power source to determine if the patient achieves pain relief. The pulses generated by the SCS create paresthesias to interfere with the pain. If the trial is successful, a permanent SCS is implanted. Despite using paresthesias in low-frequency SCS treatment, many patients find this uncomfortable. To avoid using paresthesias with low frequency, a newer, higher frequency version using a waveform of 10 kHz at a subthreshold level can provide superior pain relief without paresthesias. Additionally, high-frequency SCS may be used to salvage therapy where low-frequency SCS has failed. Here, we present a case where we switched mid-trial from low-frequency to high-frequency SCS with lead placement revision salvaging the trial and improving the patient’s overall pain.

ID: 218213 Successful Spinal Cord Stimulator Trial in the Visually Impaired

A 72-year-old gentleman was referred to the chronic pain clinic after being deemed a non-surgical candidate for a multilevel lumbar fusion per orthopedic spine surgery. His past medical history is notable for coronary artery disease, diabetes mellitus, obstructive sleep apnea, and blindness in bilateral eyes. The patient has been suffering for years from lower back pain, without red flag symptoms, and had failed multiple treatment modalities, including bilateral sacroiliac joint injections, L3-4, L4-5, and L5-S1 facet blocks. Although he is capable of performing most of his activities of daily living, his blindness unfortunately has been a barrier to both surgical interventions and pain management therapy. After consultation with a chronic pain physician, he was offered a spinal cord stimulator trial. With direct communication between the patient and the spinal cord stimulator company representative, a remote-less algorithm was able to be programmed that allowed for successful mapping of target nerves generating 80% efficacy in pain therapy. A thorough literature review demonstrated a lack of research focus in neuromodulation for patients with disabilities. With tailored guidance this patient achieved adequate pain relief which significantly improved his quality of life during the trial phase. The patient is determined to undergo a permanent spinal cord stimulator placement soon. This case report outlines a successful neuromodulation trial in a visually impaired patient. Ultimately, there is still work to be done to ensure advancements in pain medicine are accessible to all patients regardless of disabilities.

ID: 204233 Patient Centered Neuromodulation Trial: Shared Decision Making in the Era of Multiple Neuromodulation Paradigms

Spinal cord stimulation (SCS) has a well-established role for chronic, intractable neuropathic low back and leg pain. There are a wide variety of SCS stimulation paradigms, broadly categorized into paresthesia-based (i.e., conventional) and paresthesia-free (i.e., high-frequency) systems. However, the current literature remains unclear as to which system is the most effective and lacks evidence-based standards to optimize matching to a given patient. While less than two thirds of patients receiving trials undergo permanent SCS implantation, nearly half of patients with SCS implantation experience eventual loss of pain relief without clear etiology despite initial screening trials.1-5 This relatively poor translation of pain relief reveals the limited sensitivity of current trials. Crossover trials, allowing patients to experience both paresthesia-based and paresthesia-free SCS systems, may serve as a patient-centered alternative strategy to identify the most effective mode of stimulation for individual patients.

Paddle-Lead Spinal-Cord Stimulation Surgeries for Chronic Neuropathic Pain: A Single Surgeon Case-Series Outcome Analysis in Indian Population.

Background Spinal-cord stimulation (SCS) for relief of chronic neuropathic pain is well established. Objective The inherent limitations with conventional percutaneous lead SCS are lead migration, positional variations in stimulation, as well as possible nonreplication of benefits after permanent SCS implantation, which were experienced during a positive trial period. To circumvent these limitations, we analyzed five consecutive cases of chronic intractable neuropathic pain who underwent direct SCS paddle lead placement during the trial period for pain relief. In addition, during the process of placing a permanent paddle lead, the impediment created by prior epidural scarring in such chronic patients can be obviated mechanically thereby increasing the efficacy of the procedure. Material and Methods The demographic details, diagnosis, preoperative visual analogue scale score (VAS), and follow-up VAS were recorded. Surgical procedure consisted of a standard dorsal laminotomy followed by placement of permanent paddle leads. Results All patients reported significant improvement in their VAS scores. Mean duration of follow-up was 23.6 months (9-35 months). Mean preoperative VAS was 9.4 and 1.4 at the last follow-up. No major complications were found. Conclusion With careful patient selection and appropriate surgical strategy, it was possible to implant permanent paddle leads during SCS trial itself in our five patients thereby replicating and sustaining the trial period pain relief. We argue that this can be a new cost-effective and reliable technique for the placement of SCS leads achieving excellent and sustained pain relief.

Long-term Safety of Spinal Cord Stimulation Systems in A Prospective, Global Registry of Patients With Chronic Pain

Aim: The availability of long-term (>2years) 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 3yearsafter device implantation. Results: Of 1881 participants enrolled, 1289 received a permanent SCS implant(1776completed 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 >3years was 7.6% (n=98). Of these, 32subjects (2.5%) indicated inadequate pain relief as cause for removal. Implantsite 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).

Changes in quantitative sensory testing and patient perspectives following spinal cord stimulation for persistent spinal pain syndrome: An observational study with long-term follow-up.

BackgroundSpinal cord stimulation (SCS) can impact sensory, pain and tolerance thresholds in various ways, which can be accessed via quantitative sensory testing (QST). The objectives of this study were to (1) assess the subjective sensory responses using QST in patients following SCS therapy for PSPS and (2) to get a clinical impression of the results of SCS during an interview of these patients with PSPS and SCS during long term follow‐up.MethodsForty patients with PSPS who received SCS treatment underwent QST via electrical and mechanical pressure stimuli. QST was performed at four different moments (1) pre‐implantation SCS, (2) two weeks postoperatively, (3) three months after permanent SCS implantation and (4) six months after permanent SCS implantation. Patients’ perspectives on pain, use of drugs and quality of life were assessed via semi‐structured interviews during a follow‐up between 5 and 11 years.ResultsWe found statistical significant differences in the changes of sensory, pain and tolerance thresholds. A decrease in pain complaints and analgesics use were reported by the patients during follow‐up. The quality of life in patients increased from three to eight (NRS 0 [worst QoL imaginable] ‐10 [best QoL imaginable]) after receiving SCS.ConclusionsThe increased thresholds on areas without pain or being covered by the SCS induced paresthesias may indicate that there are central changes contributing to these deviations in thresholds. The overall QoL in patients improved greatly after receiving SCS.SignificanceThis study provides an overview of the effect of SCS on sensory, pain and tolerance thresholds in patients with PSPS throughout the SCS treatment process. In addition, this study presents data from 40 patients with PSPS treated with SCS, analysing several long‐term patient‐reported outcome measures. The results serve to give more insight into the mechanism of SCS and document SCS as a possible treatment for PSPS.

IDF21-0081 Effect of High-Frequency 10 kHz Spinal Cord Stimulation in Painful Diabetic Neuropathy – A Randomized Controlled Trial

Background: The World Health Organization estimates 422 million persons with diabetes globally and approximately 20% with painful diabetic neuropathy (PDN). Current treatment options are ineffective for many patients; however, previous results suggest high-frequency (10kHz) spinal cord stimulation (SCS) relieves pain and may improve sensation in patients with refractory symptoms. Aim: Prospective, multicenter RCT to evaluate the effectiveness of 10 kHz SCS (Nevro Corp.) plus conventional medical management (CMM) compared with CMM alone for persons with refractory PDN. Method: Participants had PDN symptoms ≥12 months, lower limb pain ≥5 cm (10 cm visual analog scale), hemoglobin A1c ≤10%, and were randomized 1:1 between treatment arms. Outcomes included pain, neurological function, and quality of life over 12 months. Patients could opt to crossover to the alternative treatment at 6 months if they had insufficient pain relief (<50%), were dissatisfied, and their physician deemed it was medically appropriate. Results: Baseline characteristics were similar between groups. The mean age of participants was 60.8 years (SD 10.7) with mean hemoglobin A1c of 7.4% (SD 1.2%). Median duration of diabetes was 10.9 years (IQR 6.3-16.4) with median 5.6 years (IQR 3.0-10.1) of peripheral neuropathy symptoms. At 6 months, 82% of the CMM group crossed over to SCS treatment and none in the 10 kHz SCS group crossed over to CMM. In total, 154 patients underwent permanent SCS device implant; 5 (3.2%) were explanted, all due to infection. Participants originally randomized to 10 kHz SCS as well as those who crossed over demonstrated clear, sustained benefits in lower limb pain, pain interference with daily living, sleep quality, and improvement on neurological examination at 12-month follow-up (Table). TableData shown as mean (95% CI) or proportions.CMM Pre- and Post-crossover to 10 kHz SCS10 kHz SCSBaseline6 Months (CMM only)12 Months (6 mo CMM, 6 mo SCS)Baseline6 Months12 MonthsLower Limb Pain VAS17.2 cm (6.8-7.6 cm)7.4 cm (7.0-7.8 cm)2.0 cm (1.6-2.4 cm)7.6 cm (7.2-7.9 cm)1.7 cm (1.3-2.1 cm)1.7 cm (1.3-2.1 cm)Pain relief from baseline--6.7% (-15.0-1.7%)70.3% (63.4-77.1%)-76.3% (70.7-81.9%)77.1% (71.8-82.3%)Pain interference with mood & daily activities (BPI-DPN)25.9 (5.4-6.4)6.2 (5.6-6.8)2.1 (1.6-2.6)6.2 (5.8-6.7)2.2 (1.7-2.6)1.9 (1.5-2.3)Impact of pain on sleep VAS (PSQ-3)36.7 cm (6.1-7.2 cm)7.0 cm (6.3-7.6 cm)2.7 cm (2.0-3.3 cm)5.9 cm (5.4-6.5 cm)2.1 cm (1.6-2.5 cm)2.1 cm (1.6-2.6 cm)Participants with improvement on neurological examination-0/52 (0%)32/52 (62%)-43/73 (59%)52/76 (68%)110 cm visual analog scale. 2Brief Pain Inventory for Diabetic Peripheral Neuropathy questionnaire. 3Pain and Sleep Questionnaire Three-Item index. Open table in a new tab 110 cm visual analog scale. 2Brief Pain Inventory for Diabetic Peripheral Neuropathy questionnaire. 3Pain and Sleep Questionnaire Three-Item index. Discussion: This is the largest RCT to date of SCS management in PDN. Substantial improvements with high-frequency (10kHz) SCS were sustained over 12 months and support this treatment for PDN patients with refractory symptoms.

A case of subacute postherpetic neuralgia leading to permanent spinal cord stimulation implantation

A case of subacute postherpetic neuralgia leading to permanent spinal cord stimulation implantation

Percutaneous Spinal Cord Stimulation Lead Placement Under Deep Sedation and General Anesthesia.

IntroductionSpinal cord stimulation (SCS) is a commonly utilized therapy for the treatment of neuropathic pain conditions. The Neurostimulation Appropriateness Consensus Committee (NACC) has recommended that the placement of percutaneous SCS leads be performed in an awake patient capable of providing feedback. It is not currently known how commonly this recommendation is adhered to by physicians in clinical practice. This article presents the findings of a survey designed to answer this important question.MethodsWe conducted a survey of the active membership of the American Society of Regional Anesthesia and Pain Medicine (ASRA) and the Spine Intervention Society (SIS) regarding practice patterns with SCS therapy. We analyzed the percent of respondents who indicated that they use deep sedation and general anesthesia during SCS placement as well as any reported complications.ResultsMany practitioners frequently utilize deep sedation as well as general anesthesia when performing SCS implants. Our findings demonstrate that 77% of physicians reported that they utilize deep sedation for permanent SCS implants at times, and 45% of physicians reported the use of general anesthesia for 10 kHz implants. Additionally, 94% of physicians reported that they have never had a complication related to the use of general anesthesia for a spinal cord stimulator placement.ConclusionsThis survey provides initial data on SCS practices among a large cohort of clinicians who utilize SCS. SCS lead placement under deep sedation and general anesthesia appears to be common practice for many physicians who perform implants. This survey should stimulate further research on this topic, given that the current safety guidelines and the rate of physicians reporting the use of deep sedation and general anesthesia for spinal cord stimulator placement remain at odds.

The Role of Vancomycin Powder During Spinal Cord Stimulator Implantation: A Case Series and Review of the Literature

We examined the role of intrawound vancomycin powder as prophylaxis against postoperative surgical site infection (SSI) after spinal cord stimulator (SCS) implantation. We performed a retrospective analysis of 153 consecutive patients who had undergone permanent SCS implantation surgery via open laminectomy between 2014 and 2020. We queried the patients' medical records for patient age, sex, relevant medical history, and whether intrawound vancomycin had been administered. We compared the rates of SSI (primary outcome) and seroma (secondary outcome) within 3 months after surgery between the vancomycin and no-vancomycin groups. Finally, we conducted multivariable logistic regression analyses to identify independent predictors of postoperative SSI or seroma. Of the 153 patients, 59% were women, and the average age was 65.4 years. Overall, 3 patients (2%) had developed an SSI: 2 (methicillin-resistant Staphylococcus aureus, Klebsiella) in the vancomycin group and 1 (methicillin-sensitive Staphylococcus aureus) in the no-vancomycin group. This difference in SSI rate between the 2 groups was insignificant (P= 0.73). Three seromas, all in the no-vancomycin group, accounted for a statistically significant difference in seroma formation between the 2 groups (P= 0.04). Multivariate logistic regression failed to identify any perioperative characteristics as independent predictors of postoperative SSI or seroma. Our experience suggests open laminectomy for SCS implantation surgery can be performed with a low postoperative SSI rate, with or without the use of powdered vancomycin. We found no evidence suggesting that the use of powdered vancomycin is unsafe or related to postoperative seroma formation. We failed to draw any definitive conclusions regarding its efficacy, despite referencing the largest single case series of SCS implantation to date.

Improvement In Neuropathic Pain,Proprioception, And Gait Stability After Spinal Cord Stimulator Implantation For Chemotherapy-Induced Peripheral Neuropathy

BACKGROUND: We present a patient with gait instability and pain due to chemotherapy-induced peripheral neuropathy (CIPN) who experienced marked improvement in motor function, proprioception, and pain following placement of a spinal cord stimulator (SCS). CASE REPORT: A 62-year-old woman underwent placement of a permanent SCS after failing conservative therapy to manage her severe CIPN. Preoperatively, she reported significant gait instability in addition to her pain, typically suffering 10 falls per month. Postoperatively, she experienced a pronounced reduction in her pain level from 8 of 10 to 2 of 10 and in her number of falls from 10 to 0 per month. Furthermore, we formally assessed gait speed and function, Timed Up and Go (TUG) testing, postural control, and lower extremity function before and after SCS placement, and we found a profound improvement in all measurements. CONCLUSIONS: For patients with CIPN, SCS devices represent an increasingly viable treatment option. Our patient demonstrated significant improvements in not only pain, but also surprisingly in her motor function and gait stability with SCS therapy. This case highlights a potential additional benefit of neuromodulation in patients suffering from CIPN. KEY WORDS: Balance, cancer pain, chemotherapy-induced peripheral neuropathy, gait speed, neuromodulation, neuropathic pain, paresthesia, proprioception, spinal cord stimulation

Deep Learning Versus Logistic Regression to Predict Opioid Dose Reduction After Spinal Cord Stimulation

Abstract INTRODUCTION Opioid misuse persists as a public health crisis affecting approximately one in four Americans.1 Spinal cord stimulation (SCS) is a neuromodulation strategy to treat chronic pain, with one goal being decreased opioid consumption. Accurate prognostication about SCS success is key in optimizing surgical decision making for both physicians and patients. Deep learning, using neural network models such as the multilayer perceptron (MLP), enables accurate prediction of non-linear patterns and has widespread applications in healthcare. METHODS The IBM MarketScan® (IBM) database was queried for all patients ≥ 18 years old undergoing SCS from January 2010 to December 2015. Patients were categorized into opioid dose groups as follows: No Use, ≤ 20 morphine milligram equivalents (MME), 20–50 MME, 50–90 MME, and &amp;gt;90 MME. We defined “opiate weaning” as moving into a lower opioid dose group (or remaining in the No Use group) during the 12 months following permanent SCS implantation. After pre-processing, there were 62 predictors spanning demographics, comorbidities, and pain medication history. We compared an MLP with four hidden layers to the LR model with L1 regularization. Model performance was assessed using area under the receiver operating characteristic curve (AUC) with 5-fold nested cross-validation. RESULTS Ultimately, 6,124 patients were included, of which 77% had used opioids for &amp;gt;90 days within the 1-year pre-SCS and 72% had used &amp;gt;5 types of medications during the 90 days prior to SCS. The mean age was 56 ± 13 years old. Collectively, 2,037 (33%) patients experienced opiate weaning. The AUC was 0.74 for the MLP and 0.73 for the LR model. CONCLUSION To our knowledge, we present the first use of deep learning to predict opioid weaning after SCS. Model performance was slightly better than regularized LR. Future efforts should focus on optimization of neural network architecture and hyperparameters to further improve model performance. Models should also be calibrated and externally validated on an independent dataset. Ultimately, such tools may assist both physicians and patients in predicting opioid dose reduction after SCS.

Effectiveness of interventional procedures for post-laminectomy syndrome: A retrospective study.

In our study, we aimed to evaluate the change in numerical rating scale (NRS) score and interventional procedures performed on patients with post-laminectomy syndrome whose NRS score 7 and above according to the NRS. This study was carried out by examining the files of 107 patients, including 69 women and 38 men, aged 18 years and over who had applied between February 1, 2010, and February 1, 2015. Pain localization, post-operative periods, interventional procedures, and post-procedural pain status were determined using pain monitoring forms and hospital automation system in our clinic. Statistical significance of the obtained data was evaluated by Pearson Chi-square test, Kruskal-Wallis H test, Friedman test, and Mann-Whitney U-test. p>0.05 was not statistically significant, p<0.05 was considered statistically significant. With interventional procedures, 48.5% of patients had a reduction in pain of more than 50%. The success rate was 66.7% in patients with radicular pain. Pain palliation was achieved in 28.8% of patients who underwent transforaminal epidural steroid injection, whereas in patients undergoing dorsal root ganglion pulsed radiofrequency, this rate was 44.4%. When the pain scores of patients with permanent spinal cord stimulator (SCS) were compared with other patient groups, permanent SCS was found to be statistically and clinically significant (p<0.001). Post-laminectomy syndrome is not usually caused by a single pathology, and more than 1 intervention and recurrence are often needed. Post-laminectomy syndrome is a disease that requires a multidisciplinary approach and multiple treatment options must be decided according to the patient. More research is needed on treatment options.

An Observational Study of Intraoperative Neuromonitoring as a Safety Mechanism in Placement of Percutaneous Dorsal Root Ganglion Stimulation and Spinal Cord Stimulation Systems.

IntroductionPercutaneous neurostimulator device placement, specifically dorsal root ganglion (DRG) stimulation and spinal cord stimulation (SCS), involves the placement of thin wires within the spinal canal at specific locations, the DRG or dorsal column of the spinal cord, respectively, to provide an electrical current that modifies the pain signal as it enters the central nervous system from the periphery. Placement of neurostimulator devices is generally safe overall, but not without risk of major and minor complications. In this study, we assess the use of intraoperative neuromonitoring (IONM) as a tool to improve the safety of placing neurostimulator devices and subsequently minimizing postoperative complications.MethodsAfter IRB approval, an observational study was performed in 115 procedures to evaluate safety during placement of both temporary and permanent DRG and SCS systems and to document retrospectively any long-standing adverse events.ResultsThe rate of intraoperative neuromonitoring abnormal activity was 1.7% (n = 2), which allowed prompt recognition of nerve irritation and lead repositioning. Of the 115 consecutive implant cases performed with IONM, the postoperative minor adverse event rate was 1.7% (n = 2), which were transient and corrected with reprogramming. There were no long-standing neurological complications.ConclusionIn the largest observational study to date, we show that IONM creates a safe environment for patients undergoing SCS and DRG neurostimulator placement with the potential to decrease neurological complication rates. The use of IONM may be an alternative method to improve patient safety and outcomes as compared to monitor anesthesia care.

Do Thoracic Spinal Deformities Affect Outcomes of Spinal Cord Stimulators: A Retrospective Chart Review.

Retrospective chart review. The aim of this study was to ascertain whether the presence of structural thoracic deformities affects outcomes of permanent SCS placement. Neural modulation via spinal cord stimulators (SCSs) has become an accepted treatment option for various chronic pain syndromes. In most cases, the surgeon desires accurate midline positioning of the paddle lead, allowing for flexibility of unilateral or bilateral coverage of pain patterns. Structural spinal deformities (scoliosis or kyphosis) often result from coronal, sagittal, and rotatory deformity that can make midline placement more difficult. Between 2013 and 2017, two-hundred forty-one charts of patients who underwent permanent SCS placement at our suburban hospital were reviewed. Demographic information, numerical rating system (NRS) pain scores, Oswestry Disability Index (ODI) scores, and opioid medication usage were recorded at baseline and after permanent stimulator placement. Thoracic scoliosis and kyphosis angles were measured using spinal radiographs. The effect of each structural deformity on NRS, ODI, and narcotic medication usage changes from baseline was analyzed. Overall, 100 patients were included in our cohort. Fifty-six patients had measured thoracic spinal deformities (38% with scoliosis, 31% with kyphosis). There was no significant difference in NRS scores, ODI scores, or narcotic usage change between patients with scoliosis and those without (P = 0.66, P = 0.57, P = 0.75) or patients with kyphosis and those without (P = 0.51, P = 0.31, P = 0.63). Bivariate linear regression analysis showed that scoliotic and kyphotic angles were not significant predictors of NRS (P = 0.39, P = 0.13), ODI (P = 0.45, P = 0.07), and opioid usage (P = 0.70, P = 0.90) change, with multivariate regression analyses confirming these findings. SCSs can be effective options for treating lumbar back pain and radiculopathy. Our study suggests that the presence of mild structural deformities does not adversely affect outcomes of permanent SCS placement and as such should not preclude this population from benefiting from such therapies.Level of Evidence: 4.

P51. The effect of structural spinal deformities on the effectiveness of spinal cord stimulators

BACKGROUND CONTEXT Neural modulation via spinal cord stimulators (SCS) has become an accepted technique for the treatment of a variety of chronic pain syndromes. A concept akin to the placement of these devices (regardless of manufacturer) in most cases is the desire to ensure accurate midline positioning of the paddle lead in the thoracic spine. Midline positioning allows for flexibility of unilateral or bilateral coverage of pain patterns in patients. The presence of structural spinal deformities such as scoliosis or kyphosis often implies some degree of coronal, sagittal and rotatory deformity. To date, no study has examined the relationship of thoracic scoliosis/kyphosis and outcomes after permanent SCS placement. PURPOSE This study looks to ascertain if the presence of structural thoracic deformities affects outcomes of permanent SCS placement. STUDY DESIGN/SETTING This retrospective chart review included patients who underwent permanent SCS placement at our suburban hospital. Spinal imaging for each patient was reviewed, and scoliosis and thoracic kyphosis angles were recorded. The effect of each structural deformity on the change in NRS, ODI, and narcotic medication usage from baseline was analyzed. PATIENT SAMPLE Only patients with lumbar radiculopathy who were treated with a SCS placed by a fellowship trained orthopedic surgeon or neurosurgeon were included in our study. Patients who had previous SCS placed, were having other surgeries while having their SCS placed, or did not have spinal imaging taken that allowed the angular measurement of structural curves were excluded. OUTCOME MEASURES For each patient, demographic information, numerical rating system (NRS) pain scores, Oswestry Disability Index (ODI) scores, and narcotic medication usage as reported by our online state narcotic drug monitoring program were recorded at baseline and after permanent stimulator placement. METHODS Spinal imaging for each patient was reviewed, and scoliosis and thoracic kyphosis angles were recorded. The effect of each structural deformity on the change in NRS, ODI, and narcotic medication usage from baseline was analyzed. RESULTS A total of 100 patient charts were included in our cohort. Sixty percent of our population was female, with a roughly even age distribution ranging from 37 to 90 years of age. The average scoliotic Cobb angle was 11.0 degrees and kyphotic scoliotic angle was 39.2 degrees. Overall, 43% of our cohort had scoliosis and 30% had thoracic kyphosis. There was no significant difference in change in NRS scores, ODI scores, or narcotic usage between patients with scoliosis and those without scoliosis (p=0.86, p=0.81, p=0.64) or patients with kyphosis and those without (p=0.71, p=0.31, p=0.62). Univariate linear regression analysis showed that scoliotic angle and kyphotic angle were not significant predictors of change in NRS score (p=0.46, p=0.12), ODI score (p=0.48, p=0.06), or narcotic usage (p=0.93, p=0.56). Multivariate linear regression also showed that scoliotic angle and kyphotic angle were not significant predictors of NRS (p=0.482, p=0.304), ODI (p=0.116, p=0.161), or narcotic pain usage (p=0.644, p=0.735) either. CONCLUSIONS Spinal cord stimulators can be effective options for treating lumbar back pain and radiculopathy, even in patients with structural deformities such as thoracic scoliosis or kyphosis. Our study suggests that the presence of structural deformities does not adversely affect outcomes of permanent SCS placement and as such should not preclude this population from benefiting from such therapies. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.