Spinal Cord Stimulation Implantation Research Articles

Evaluation of thoracic sympathetic ganglion block as a predictor for response to ketamine infusion therapy and spinal cord stimulation in patients with chronic upper extremity pain.

To investigate the predictive value of thoracic sympathetic ganglion block (TSGB) in response to ketamine infusion therapy (KIT) and spinal-cord stimulation (SCS) in patients with chronic upper-extremity pain including complex regional pain syndrome (CRPS). Retrospective. Tertiary hospital single-center. Patients who underwent TSGB receiving KIT or SCS within a 3-year window. Positive TSGB outcomes were defined as ≥ 2 0-10 Numerical Rating Scale (NRS) score reduction at 2 weeks post-procedure. Positive KIT and SCS outcomes were determined by ≥ 2 NRS score reduction at 2-4 weeks post-KIT and ≥4 NRS score reduction at 2-4 weeks post-SCS implantation, respectively. Among 207 patients who underwent TSGB, 38 received KIT and 34 underwent SCS implantation within 3 years post-TSGB; 33 patients receiving KIT and 32 patients receiving SCS were included. Among 33 patients who received KIT, 60.6% (n = 20) reported a ≥ 2 0-10 NRS pain-score reduction. Positive response to TSGB occurred in 70.0% (n = 14) KIT responders, significantly higher than that in 30.8% (n = 4) KIT non-responders. Multivariable analysis revealed a positive association between positive responses to TSGB and KIT (OR 7.004, 95% CI 1.26-39.02). Among 32 patients who underwent SCS implantation, 68.8% (n = 22) experienced short-term effectiveness. Positive response to TSGB was significantly higher in SCS responders (45.5%, n = 10) than in non-responders (0.0%). However, there were no associations between pain reduction post-TSGB and that post-KIT or post-SCS. A positive response to TSGB is a potential predictor for positive KIT and SCS outcomes among patients with chronic upper-extremity pain, including CRPS.

Relationship between number of prior lumbar spine surgeries and outcomes following spinal cord stimulator implantation: A multisite, retrospective pooled analysis.

Lumbar spine surgery is a common procedure for treating disabling spine-related pain. In recent decades, both the number and cost of spine surgeries have increased despite technological advances and modification in surgical technique. For those patients that have continued uncontrolled back and/or lower extremity pain following lumbar spine surgery, spinal cord stimulation (SCS) has emerged as a viable treatment option. However, the impact of lumbar spine surgical history remains largely unstudied. Specifically, the current study considers the impact of number of prior lumbar spine surgeries on pain relief outcomes following SCS implantation. We queried the electronic medical record of five separate pain practices for all patients who have undergone a SCS implant between January 1, 2017, and March 1, 2020. Inclusion criteria consisted of any patients with an SCS implant who underwent a prior lumbar spine surgery. The primary outcome was the mean calculated percentage pain relief in patients based on number of prior lumbar spine surgeries. There was a total of 1974 total SCS implant cases identified across five separate pain clinics. There was no difference in mean calculated pain relief in patients with one prior spine surgery versus those with two or more prior spine surgeries (28.2% vs. 25.8%, adjusted β-coefficient -3.1, 95% CI -8.9 to 2.7, p = 0.290). Similarly, when analyzing number of spine surgeries as a continuous variable, there was no association between number of spine surgeries and calculated pain relief (adjusted β-coefficient -1.5, 95% CI -4.0 to 1.1, p = 0.257). Additionally, after patients were stratified based on waveform, there was no association between number of prior lumbar spine surgeries (analyzed both as a categorical and continuous variable) and calculated percentage pain relief. This multicentered retrospective study found that there was no significant difference in pain scores in individuals who received SCS following one or more lumbar spine surgeries. Additionally, the waveform of the SCS device had no statistically significant impact on post-operative pain scores following one or more lumbar spine surgeries.

The effect of COVID-19 on pain control in patients with a neurostimulator in situ- a retrospective study.

De-novo chronic neuropathic pain following COVID-19 is widely recognised. However, there are currently no published studies investigating the effect of SARS-CoV-2 infection on patients with pre-existing neuropathic pain who have required spinal cord stimulator (SCS) implantation. Here, the authors aimed to analyse outcomes in their institution's patients who had spinal cord stimulator (SCS) implantation or revision procedures to the system over a 5-year period. Specifically, the short-term and long-term outcomes of patients who contracted COVID-19 during the follow-up period were compared to the control group of patients who did not. Patients included in this study had spinal cord stimulator implantation (de-novo and revision procedures) between 1 January 2017 and 31 January 2022, for neuropathic pain of any aetiology. Patients deemed eligible for the study were invited to participate in a telephone survey through which clinical outcome data were collected. Pain scores were assessed with a modified form of the Brief Pain Inventory (BPI). Of 91 patients, 48 (52.7%) had contracted COVID-19 by the time of the survey. Patients who contracted COVID-19 had significantly worse BPI scores in the 'Least pain' domain following their infection and at time of the survey, when compared to their score 6 months after the operation. 22.9% (n = 11) of the patients who contracted COVID-19 experienced a change in their symptoms following their infection. Within this sub-group, there was a statistically significant deterioration in BPI scores in 10/11 domains following their infection and in 2/11 domains at time of the survey. Worsening severity of COVID-19 symptoms was not associated with worse BPI scores. Infection with SARS-CoV-2, in a significant proportion of patients with an SCS in situ, causes at least a transient deterioration in pain control. Further prospective multicentre studies are indicated to establish the prevalence of this phenomenon.

349 Brain Functional Imaging of Pain States Using Resting-State fMRI and Multi-Delay PCASL in Chronic Low-Back Pain Patients Implanted With Thoracic Spinal Cord Stimulation

INTRODUCTION: A treatment of chronic low-back pain is implantation of a thoracic spinal cord stimulator (tSCS), which has been shown to reduce pain. The functional changes in pain processing regions of the brain as assessed by resting-state fMRI and multi-delay pseudocontinuous arterial spin labeling (PCASL) have never been studied. METHODS: PCASL data based on 5 post-label delays (0.5–2.5s) as well as rsfMRI were acquired in five patients (1F) post-tSCS with cLBP and five healthy subjects (2F). Patient MRI scans were taken post-implantation with the SCS device turned off. Three PCASL measures and four rsfMRI measures were derived and normalized into MNI space and smoothed. Averaged values for each measure from the pain ROI atlas were extracted and compared between patients and controls. Statistics were conducted following Box-Cox transformation of data. RESULTS: Arterial transit time derived from PCASL showed a significant difference in the OFC, SMA, and PSG of patients, but other ASL measures showed no effect. Several regions across the rs-fMRI measures showed significant differences, including those involved in cognition (DLPFC, PCC), and pain processing (PSG) and sensation (S2). CONCLUSIONS: Functional imaging showed that cLBP patients treated with SCS display differences in resting-state function and brain perfusion across several pain regions of the brain. These areas are mainly part of the cognitive and behavioral components of the pain circuitry.

Conversion of a medical implant into a versatile computer-brain interface

BackgroundInformation transmission into the human nervous system is the basis for a variety of prosthetic applications. Spinal cord stimulation (SCS) systems are widely available, have a well documented safety record, can be implanted minimally invasively, and are known to stimulate afferent pathways. Nonetheless, SCS devices are not yet used for computer-brain-interfacing applications. ObjectiveHere we aimed to establish computer-to-brain communication via medical SCS implants in a group of 20 individuals who had been operated for the treatment of chronic neuropathic pain. MethodsIn the initial phase, we conducted interface calibration with the aim of determining personalized stimulation settings that yielded distinct and reproducible sensations. These settings were subsequently utilized to generate inputs for a range of behavioral tasks. We evaluated the required calibration time, task training duration, and the subsequent performance in each task. ResultsWe could establish a stable spinal computer-brain interface in 18 of the 20 participants. Each of the 18 then performed one or more of the following tasks: A rhythm-discrimination task (n = 13), a Morse-decoding task (n = 3), and/or two different balance/body-posture tasks (n = 18; n = 5). The median calibration time was 79 min. The median training time for learning to use the interface in a subsequent task was 1:40 min. In each task, every participant demonstrated successful performance, surpassing chance levels. ConclusionThe results constitute the first proof-of-concept of a general purpose computer-brain interface paradigm that could be deployed on present-day medical SCS platforms.

Evaluation of Patient's Quality of Life before and after Implantation of Abbott's Proclaim™ XR Spinal Cord Stimulator with BurstDR™ Stimulation in Chronic Pain Syndrome.

Background and Objectives: In case of the ineffectiveness of pharmacological and non-pharmacological treatments in managing chronic neuropathic pain, spinal cord stimulation (SCS) with BurstDR™ stimulation may reduce pain and increase the quality of life. The term "burst" refers to a series of stimulation impulses that are compressed into small packets and separated by intervals of latency. Materials and Methods: A group of 30 consecutive patients who received the BurstDR™ stimulator using the minimally invasive percutaneous method was selected. Patients selected for our study underwent numerous spinal surgeries before SCS implantation. In the study, analgesics and co-analgesics and their doses used by patients before and 6 months after SCS implantation were examined and compared. Using the visual analogue scale (VAS), pain was compared before and after the procedure. Patients` quality of life was assessed using the Oswestry Disability Index (ODI). Results: We observed a significant reduction in opioid daily doses by an average of 32.4% (±36.1%) and a reduction in paracetamol daily doses by an average of 40% (±33.4%). There was a reduction in pregabalin doses as well. Ketoprofen daily dose reduction was 85.4 mg. The mean VAS difference before and after procedure was 3.9 (±2.3), and the mean difference in ODI was 12.9 (±9), which benefits operative treatment. The VAS and ODI results were statistically significant as well. Conclusions: According to our research, BurstDR™ stimulation improves the quality of life by reducing doses of analgesics and the level of pain.

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.

EEG Changes during Propofol Anesthesia Induction in Vegetative State Patients Undergoing Spinal Cord Stimulation Implantation Surgery.

To compare the EEG changes in vegetative state (VS) patients and non-craniotomy, non-vegetative state (NVS) patients during general anesthesia with low-dose propofol and to find whether it affects the arousal rate of VS patients. Seven vegetative state patients (VS group: five with traumatic brain injury, two with ischemic-hypoxic VS) and five non-craniotomy, non-vegetative state patients (NVS group) treated in the Department of Neurosurgery, Peking University International Hospital from January to May 2022 were selected. All patients were induced with 0.5 mg/kg propofol, and the Bispectral Index (BIS) changes within 5 min after administration were observed. Raw EEG signals and perioperative EEG signals were collected and analyzed using EEGLAB in the MATLAB software environment, time-frequency spectrums were calculated, and EEG changes were analyzed using power spectrums. There was no significant difference in the general data before surgery between the two groups (p > 0.05); the BIS reduction in the VS group was significantly greater than that in the NVS group at 1 min, 2 min, 3 min, 4 min, and 5 min after 0.5 mg/kg propofol induction (p < 0.05). Time-frequency spectrum analysis showed the following: prominent α band energy around 10 Hz and decreased high-frequency energy in the NVS group, decreased high-frequency energy and main energy concentrated below 10 Hz in traumatic brain injury VS patients, higher energy in the 10-20 Hz band in ischemic-hypoxic VS patients. The power spectrum showed that the brain electrical energy of the NVS group was weakened R5 min after anesthesia induction compared with 5 min before induction, mainly concentrated in the small wave peak after 10 Hz, i.e., the α band peak; the energy of traumatic brain injury VS patients was weakened after anesthesia induction, but no α band peak appeared; and in ischemic-hypoxic VS patients, there was no significant change in low-frequency energy after anesthesia induction, high-frequency energy was significantly weakened, and a clear α band peak appeared slightly after 10 Hz. Three months after the operation, follow-up visits were made to the VS group patients who had undergone SCS surgery. One patient with traumatic brain injury VS was diagnosed with MCS-, one patient with ischemic-hypoxic VS had increased their CRS-R score by 1 point, and the remaining five patients had no change in their CRS scores. Low doses of propofol cause great differences in the EEG of different types of VS patients, which may be the unique response of damaged nerve cell residual function to propofol, and these weak responses may also be the basis of brain recovery.

Correlation between spinal cord stimulation analgesia and cortical dynamics in pain management.

Spinal cord stimulation (SCS) is an effective method to treat neuropathic pain. It is necessary to identify the responders of SCS analgesia before implantation. The aim of this study is to investigate the relationship between the cortical dynamics and SCS analgesia responders in pain management. Resting-state EEG recording was performed in patients who underwent short-term implantation of spinal cord stimulation for pain therapy. We then did spectral analysis to capture the pattern of cortical oscillation between neuromodulation therapy analgesia responders and nonresponders. About 58.3% (14 out of 24) of participants were considered as analgesia responders, with average visual analogue scores reduction of 4.8 ± 1.0 after surgery, and 2.1 ± 0.7 for the nonresponder subgroup, respectively. The alpha oscillation was significantly enhanced in responder cohort compared with nonresponders. We also observed an increasing spectral power of gamma band in responders. Furthermore, the attenuation of pain severity was significantly correlated with the global alpha oscillation activity (r = 0.60, P = 0.002). Likely, positive and significant correlation was found between the pain relief and gamma activity (r = 0.58, P = 0.003). Distinct pattern of neural oscillation is associated with the analgesic effect of spinal cord stimulation in pain management, enhancement of cortical alpha and gamma oscillation may be a predictor of analgesia responders.

Complications of Spinal Cord Stimulators-A Comprehensive Review Article.

Spinal cord stimulation has been increasing in influence as an option to regulate pain, especially in the chronic pain patient population. However, even with the numerous changes made to this technology since its inception, it is still prone to various complications such as hardware issues, neurological injury/epidural hematoma, infections, and other biological concerns. The purpose of this article is to thoroughly review and evaluate literature pertaining to the complications associated with percutaneous spinal cord stimulation. Lead migration is generally the most common complication of percutaneous spinal cord stimulation; however, recent utilization of various anchoring techniques has been discussed and experienced clinical success in decreasing the prevalence of lead migration and lead fractures. With newer high-frequency systems gaining traction to improve pain management and decrease complications as compared to traditional systems, rechargeable implantable pulse generators have been the preferred power source. However, recent findings may suggest that these rechargeable implantable pulse generators do not significantly increase battery life as much as was proposed. Intraoperative neuromonitoring has seen success in mitigating neurological injury postoperatively and may see more usage in the future through more testing. Though the occurrence of infection and biological complications, including dural puncture and skin erosion, has been less frequent over time, they should still be treated in accordance with established protocols. While many complications can arise following percutaneous spinal cord stimulator implantation, the procedure is less invasive than open implantation and has seen largely positive patient feedback. Hardware complications, the more common issues that can occur, rarely indicate a serious risk and can generally be remedied through reoperation. However, less common cases such as neurological injury, infections, and biological complications require prompt diagnosis to improve the condition of the patient and prevent significant damage.

Quantitative assessment of painful diabetic peripheral neuropathy after high-frequency spinal cord stimulation: a pilot study.

Randomized trials have demonstrated efficacy of spinal cord stimulation (SCS) for treatment of painful diabetic neuropathy (PDN). Preliminary data suggested that treatment of PDN with high-frequency SCS resulted in improvements on neurological examination. The purpose of the present study was to explore whether patients with PDN treated with high-frequency SCS would have improvements in lower-extremity peripheral nerve function. Prospective cohort study in an outpatient clinical practice at a tertiary care center. Patients with PDN were treated with high-frequency SCS and followed up for 12 months after SCS implantation with clinical outcomes assessments of pain intensity, neuropathic symptoms, and neurological function. Small-fiber sudomotor function was assessed with the quantitative sudomotor axon reflex test (QSART), and large-fiber function was assessed with nerve conduction studies (NCS). Lower-extremity perfusion was assessed with laser Doppler flowmetry. Nine patients completed 12-month follow-up visits and were observed to have improvements in lower-extremity pain, weakness, and positive sensory symptoms. Neuropathy impairment scores were improved, and 2 patients had recovery of sensory responses on NCS. A reduction in sweat volume on QSART was observed in the proximal leg but not at other sites. No significant differences were noted in lower-extremity perfusion or NCS as compared with baseline. The improvement in pain relief was concordant with improvement in neuropathy symptoms. The findings from this study provide encouraging preliminary data in support of the hypothesis of a positive effect of SCS on peripheral neuropathy, but the findings are based on small numbers and require further evaluation. ClinicalTrials.gov ID NCT03769675.

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.

Postural Changes in Spinal Cord Stimulation Thresholds: Current and Voltage Sources

ObjectiveSpinal cord stimulation (SCS) thresholds are known to change with body position; however, these changes have not been fully characterized for both “constant-voltage” and “constant-current” pulse generators. This study aimed to evaluate and quantify changes in psychophysical thresholds resulting from postural changes that may affect both conventional paresthesia-based SCS and novel paresthesia-free SCS technologies. Materials and MethodsWe measured perceptual, usage, and discomfort thresholds in four body positions (prone, supine, sitting, standing) in 149 consecutive patients, with temporary lower thoracic percutaneous epidural electrodes placed for treating persistent low back and leg pain. We trialed 119 patients with constant-voltage stimulators and 30 patients with constant-current stimulators. ResultsMoving from supine to the sitting, standing, or prone positions caused all three thresholds (perceptual, usage, and discomfort) to increase by 22% to 34% for constant-voltage stimulators and by 44% to 82% for constant-current stimulators. Changing from a seated to a supine position caused stimulation to exceed discomfort threshold significantly more often for constant-current (87%) than for constant-voltage (63%) stimulators (p = 0.01). ConclusionsPosture-induced changes in SCS thresholds occurred consistently as patients moved from lying (supine or prone) to upright (standing or sitting) positions. These changes were more pronounced for constant-current than for constant-voltage pulse generators and more often led to stimulation-evoked discomfort. These observations are consistent with postural changes in spinal cord position measured in imaging studies, and with computer model predictions of neural recruitment for these different spinal cord positions. These observations have implications for the design, implantation, and clinical application of spinal cord stimulators, not only for conventional paresthesia-based SCS but also for paresthesia-free SCS.

EFFICACY AND PHARMACOECONOMICS STUDY OF SPINAL CORD STIMULATION (SCS) CONDUCTED AT THE PAIN THERAPY HUB, SAN GIULIANO HOSPITAL ASL NAPOLI 2

EFFICACY AND PHARMACOECONOMICS STUDY OF SPINAL CORD STIMULATION (SCS) CONDUCTED AT THE PAIN THERAPY HUB, SAN GIULIANO HOSPITAL ASL NAPOLI 2

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.

Rates and Causes of Reoperations Following Spinal Cord Stimulation Within a 2-12 year Period.

Retrospective study. Spinal cord stimulation has been mainly used for the management of postsurgical persistent neuropathic. The purpose of the study was to evaluate the rate and causes for reoperation following spinal cord stimulation, and to identify risk factors for reoperation. A retrospective study was conducted including patients who underwent surgical implantation of spinal cord stimulators within a 10-year period. The medical records of the included patients were reviewed for reoperations, demographics and certain clinical parameters. Demographics and clinical parameters were compared between patients with and without reoperations, and between patients with and without surgical site infections. Overall, 1014 index procedures and 175 reoperations were performed within the study period. At least 1 reoperation was performed in 97 (9.5%) cases. The most common cause for revision was lead migration or lead misplacement (n = 31, 3.0%). In 31 (3.1%) cases the stimulator was removed due to no pain relief. Surgical site infection that required reoperation developed in 30 cases (2.9%). Younger age was associated with a need for reoperation (Odds Ratio [OR]: .97,95% Confidence Interval [CI]:0.95-.99, P = .005), while higher Body Mass index and diabetes were associated with development of infection (OR: 1.05, 95% CI: 1.00-1.11, P = .036 and OR: 2.42, 95% CI: 1.05-5.47, P = .033 respectively). The results of this study indicate that certain measures could improve the overall reoperation rate after spinal cord stimulation, such as accurate positioning of the spinal cord stimulators and design of smaller generators. Moreover, preoperative optimization of patients could result in lower complication rate, lower reoperations rate, and subsequently better clinical outcomes.

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.

Intraoperative neurophysiological monitoring and spinal cord stimulator implantation

IntroductionSpinal cord injury (SCI) is one of the most dreaded complications after spinal cord stimulation (SCS) implantation surgery. As a result, intraoperative neurophysiological monitoring (IONM) has been proposed to avoid...

The contralateral oblique fluoroscopic view is associated with a lower incidence of postdural puncture headache in patients undergoing percutaneous spinal cord stimulation.

Spinal cord stimulation (SCS) is a minimally invasive therapy that is increasingly used to treat refractory neuropathic pain. Although this technique has a low incidence of serious long-term adverse sequelae, the risk of complications such as inadvertent dural puncture remains. The goal of this article was to determine the impact of the contralateral oblique (CLO) fluoroscopic view incidence of postdural puncture headache (PDPH) during spinal cord stimulator implantation as compared to lateral fluoroscopic view. This was a single academic institution retrospective analysis of electronic medical records spanning an approximate 20-year time period. Operative and postoperative notes were reviewed for details on dural puncture, including technique and spinal level of access, the development of a PDPH, and subsequent management. Over nearly two decades, a total of 1637 leads inserted resulted in 5 PDPH that were refractory to conservative measures but responded to epidural blood patch without long-term complications. The incidence of PDPH per lead insertion utilizing loss of resistance and lateral fluoroscopic guidance was 0.8% (4/489). However, adoption of CLO guidance was associated with a lower rate of PDPH at 0.08% (1/1148), p < 0.02. The incorporation of the CLO view to guide epidural needle placement can decrease the odds of a PDPH during percutaneous SCS procedures. This study further provides real-world data supporting the potential enhanced accuracy of epidural needle placement in order to avoid unintentional puncture or trauma to deeper spinal anatomic structures.

Paddle Lead Spinal Cord Stimulation in the Morbidly Obese Patient Population: Outcomes and Complications in a Single-Surgeon Cohort

Paddle lead spinal cord stimulation (SCS) is used to treat refractory chronic pain. Morbidly-obese patients seek SCS to reduce chronic pain. However, these patients face worse surgical outcomes, and the SCS literature has not evaluated safety and efficacy in this patient population. This study is the largest single-surgeon case series to date on morbidly obese patients with paddle lead SCS implantations. The primary objective is to report post-operative complication rates in morbidly-obese patients receiving SCS implants. The secondary objective is to report patient-reported pain scores and PROMIS Pain Interference and Physical Function scores in these patients. A retrospective chart review was conducted. The patient charts were reviewed from the day of procedure consent to 6 months post-op. Demographic information, pain scores, PROMIS scores, neurological complications, infections, and wound complications were documented. 67 patients were included. The mean pre-operative BMI was 44.47±4.02 kg/m2. The mean age was 58.9±11.4 years old. There were no neurological complications. 3/67 (4%) developed culture-positive infections. 9/67 (13%) patients developed superficial wound dehiscence without underlying infection. The mean post-op PROMIS PF score was 31.6±6.2 (n=16) and the mean post-op PROMIS PI score was 64.0±6.4 (n=16). There was a reduction in pain scores, from 7.9±1.7 pre-op to 5.7±2.5 post-op (n=22, p=0.004). Paddle lead SCS implantation is safe for morbidly-obese patients. The only minimal-risk complications present were post-operative infections and wound dehiscence. Surgical care can be modified to further reduce the rates of infection and dehiscence.