Spinal Cord Stimulation Implantation Research Articles

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.

ID: 219777 Neuromodulation in a 10-Year-Old With Chronic Abdominal Pain: A Case Report

Chronic abdominal pain in the pediatric population is complex, and identifiable causes may be difficult to elucidate. Median arcuate ligament syndrome is a rare disease in which diagnosis has been controversial in the medical community. Patients typically present with chronic postprandial abdominal pain accompanied with nausea, vomiting and weight loss. It is a diagnosis of exclusion with unclear pathophysiology typically thought to have both a structural component via compression of the celiac artery by the median arcuate ligament, as well as a neuropathic component mediated by the celiac ganglia. Optimal treatment is also debated but generally involves surgical intervention to decompress the celiac artery with or without neurolysis of the celiac plexus. We present the case of a 10-year-old female with chronic abdominal pain refractory to aggressive medical and surgical treatments, who found relief with spinal cord stimulator implantation. Before evaluation in the pain clinic, the patient received extensive gastroenterological workup and treatments including arcuate ligament release with neurolysis of the celiac ganglion that provided relief for nearly two months. She had increasing abdominal pain since five years of age and required a feeding tube for adequate nutritional intake.

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.

ID: 206245 Relationship Between Prior Spine Surgeries and Outcomes Following Spinal Cord Stimulation: A Pooled Analysis

Lumbar spine surgery is a common procedure for treating disabling spine-related pain. Ten to 40% of patients undergoing lumbar spine surgery experience persistent pain following the operation. Spinal cord stimulation (SCS) is a treatment indicated for failed back surgery syndrome (FBSS) with or without radiculopathy. The purpose of this review is to retrospectively determine the average pain relief felt from SCS implants after one or more failed lumbar spine surgeries.

ID: 205124 Paddle Lead Spinal Cord Stimulation in Patients With Morbid Obesity – Outcomes and Complications

Prior studies have shown morbidly obese patients face worse post-operative outcomes. This retrospective case series aims to report outcomes of morbidly obese patients following paddle lead spinal cord stimulation (SCS) implantation by a single surgeon.

ID: 207794 Hematoma Complications After Spinal Cord Stimulation Trials and Implantations: A Meta-Analysis

Spinal cord stimulation (SCS) has been successful in the treatment of many chronic pain disorders, including failed back surgery syndrome, angina pectoris, complex regional pain syndrome, peripheral vascular disease, diabetic neuropathy, and nonsurgical low back pain. Although major complications are rare, the consequences can be devastating. For example, epidural hematomas can result in paralysis and typically require urgent surgery to prevent permanent neurologic damage. The aim of this study was to perform a meta-analysis to identify the incidence of neuraxial and non-neuraxial hematomas after SCS trials and implantations.

ID: 204123 Surgical Site Infection Risk In Diabetes Patients Undergoing Spinal Cord Stimulation: A Literature Review

Spinal cord stimulation (SCS) has become increasingly utilized for the treatment of various chronic pain conditions over the past two decades. However, despite these improvements, the same complications that were encountered in early SCS implantation surgery continue today, including postoperative surgical site infection (SSI). This literature review was conducted to review the surgical literature regarding the relationship between hemoglobin A1c (HbA1c), diagnosis of diabetes mellitus (DM), and risk of postoperative SSI.

ID: 212212 Use of Micro-Implantable Pulse Generators for Chronic Pain Conditions: A Case Series

Spinal cord stimulators (SCS) are a viable treatment option for chronic pain. Two common primary indications for SCS implantation are failed Back Surgery Syndrome (FBSS) and Complex Regional Pain Syndrome Type 1 (CRPS-1) (1). Studies have shown that patients with FBSS have better response to SCS over conservative management or repeat surgery (2) and CRPS-1 patients reported significant improvement in perceived effect and pain relief long term (3). A known reason for explant of SCS systems is due to pocket pain at the site where the implanted pulse generator (IPG) is placed. To circumvent this complication, new technology known as micro-implantable pulse generator has been efficacious in providing analgesia and resolving pocket pain (4).

ID: 214658 First-in-Human Experience With an Implantable SCS System With Automated Daily Remote Monitoring and Remote Programming

The BENEFIT-03 Study (NCT04683718) is designed to evaluate the safety and effectiveness of an implantable spinal cord stimulation (SCS) system with multiphase stimulation and remote device management. While results of an SCS teleprogramming pilot study have been reported previously,1 to our knowledge, BENEFIT-03 is the world’s first long-term study of an SCS system with automated remote device monitoring and remote programming capabilities.

ID: 222362 3-Month Study Results for an Implantable SCS System With Multiphase Stimulation and Remote Device Management

Patients receiving spinal cord stimulation (SCS) therapy require frequent reprogramming following device implantation to achieve optimal pain management and commonly encounter therapy disruptions.1-3 Delays scheduling in-clinic visits are common and may extend periods of pain relapse and contribute to worsening outcomes.4,5 Further, evidence suggests pain intensity reported during in-clinic assessments may be inconsistent with at-home daily reports, and may not fully reflect SCS patient experience in real-world settings.6,7 The BENEFIT-03 Study (NCT04683718) is designed to evaluate the safety and effectiveness of an implantable SCS system with automated remote device monitoring, remote programming and multiphase stimulation.