Spinal Cord Stimulation Procedure Research Articles

An assessment of the treatment of spinal cord stimulation: Postlaminectomy pain or neuropathic pain

Neuromodulation has a significant place, among the interventional methods, in the treatment of chronic pain. Spinal Cord Stimulation (SCS) is the most applied treatment method among neuromodulation methods. SCS procedure is a neuromodulation method used in the failed back surgery syndrome, neuropathic pain, and cancer pain. The 102 patients who applied SCS were included in the retrospective study from 2017-2022 in the University Algology Department. We asked about pain scores in line with visual analog scale degrees (VAS) before and after the SCS procedure, opioid use and compared the patient satisfaction with the procedure. We divided the patients into two groups as those with a diagnosis of post-laminectomy syndrome (Group 1) and those with a diagnosis of neuropathic pain (Group 2). VAS before SCS was 9.11±0.75 in Group 1 and 8.45±0.77 in Group two. After SCS, the decrease in pain intensity was much more distinct in post-laminectomy patients (Group 1), compared to the neuropathic pain patients (Group 2). The results were as follows: Group 1- 1.98±1.40, Group 2-4.08±0.71, p<0.001. The decrease in using analgesics was observed to be much more significant in Group 2. (P<0.05) Patient satisfaction was higher in Group 1 as well (p<0.05). We hold the opinion that post-laminectomy patients benefit more from the SCS procedure than neuropathic pain patients. We observed that the decrease both in pain intensity and the use of opioid analgesics was statistically and overwhelmingly distinct in post-laminectomy patients. According to the results of our study, we think that SCS is an effective and safe treatment method both for post-laminectomy and neuropathic pain patients.

Incidence and risk factors of spinal cord stimulation for persistent or recurrent pain after lumbar spine surgery: a population-based study

PurposeThis study aims to elucidate the incidence of and independent risk factors for spinal cord stimulator implantations for patients who underwent lumbar spine surgery.MethodsThe PERFormance, Effectiveness, and Cost of Treatment (PERFECT) episodes database, which was established for selected diseases and procedures in Finland, includes all patients who underwent lumbar spine surgery for degenerative spine conditions or spinal cord stimulation (SCS) in Finland from 1986 to 2018. The data on age, sex, hospital diagnoses, surgical procedures, and causes of death were imported from the Finnish national registers into the PERFECT database.ResultsBetween 1986 and 2018, 157,824 patients had their first lumbar spine procedure and for 1769 (1.1%) of them, a subsequent SCS procedure was observed during the follow-up. The cumulative incidence of SCS for persistent or recurrent pain after lumbar disk herniation, spinal stenosis, degenerative disk disease, and spondylolysis and spondylolisthesis surgery at 15 years was 1.2%, 1.0%, 2.7%, and 2.6% respectively. At 15 years, the cumulative incidence of SCS for persistent or recurrent pain after lumbar spine surgery after five or more lumbar spinal operations was 11.9%.ConclusionRepeated surgery was the most prominent significant risk factor for SCS for persistent or recurrent pain after lumbar spine surgery. The risk of SCS for persistent or recurrent pain after lumbar spine surgery increases significantly along with the number of lumbar spine procedures. When considering repeated lumbar spine surgery, careful evaluation of treatment options should take place to ensure good patient outcomes.

A case series of new radicular pain following the insertion of spinal cord stimulator.

Although spinal cord stimulation (SCS) is a safe procedure, equipment-related, biological and neurological complications have been observed in previous research, particularly case reports. No reports of new neuropathic pain in the absence of neurological deficit or positive MRI findings have been described. We detail three cases of new-onset radicular pain in the L5/S1 dermatome following insertion of SCS. This was a retrospective case series of three patients. Details of clinical background, indications for SCS and events occurring during insertion and further management were recorded. All three cases were technically difficult and required multiple epidural entry levels, with repeated passage of the electrode into and within the epidural space. All cases involved accessing epidural space T12/L1 and L1/L2. A possible explanation for the new-onset radicular pain could concern oedema to the conus medullaris, resulting from repeated passage of the electrode at the T12/L1 level. Alternative explanations could be direct trauma to transiting nerve roots, neuroplastic changes resulting in peripheral and central sensitisation and immune-mediated nerve injury. MRI imaging should be analysed prior to the SCS procedure to identify the level of the conus medullaris, with the aim of avoiding repeated passage of electrodes at that level. Unintended neurological adverse events should be discussed with patients during the consent process. Careful patient selection and psychological screening may also help identify patients who may be unlikely to respond to SCS therapy. Further reporting of new radiculopathic pain following SCS insertion is required to strengthen understanding of its potential causes.

Success of lateral cervical spinal cord stimulation for the treatment of chronic neuropathic refractory pain.

Background: Spinal cord stimulation (SCS) is traditionally performed by implanting surgical leads along the midline of the spinal cord, over the dorsal columns. Here, we present a patient who successfully underwent lateral cervical SCS to treat chronic refractory neuropathic pain.Methods: A 46-year-old female, with a schwannoma involving the right axillary nerve, presented with a chronic refractory right upper extremity pain syndrome. The tumor was located between the fibers of the teres minor and the posterior deltoid, and measured 2.2 cm in diameter. After 8 months of analgesics, opioids, physiotherapy, and acupuncture, the patient underwent surgery; however, the tumor was unresectable (i.e., due to significant adjacent vascular/neural structures). Three months later, she had a midline C6-C7 laminectomy for placement of a right-sided epidural SCS lead (i.e., containing 16 electrode contacts).Results: Within 4 days following this SCS procedure, the patient’s pain completely resolved; at 10 postoperative months, she still remains pain free.Conclusion: Lateral SCS at the C6-C7 level provided a safe and effective option for the relief of chronic neuropathic pain attributed to an unresectable schwannoma of the right axillary nerve in a 46-year-old female.

Benefit of spinal cord stimulation for patients with central poststroke pain: a retrospective multicenter study.

Spinal cord stimulation (SCS) has been considered an ineffective procedure for patients with central poststroke pain (CPSP). However, recent case series that included small numbers of patients reported the possible efficacy of SCS as a treatment of CPSP. This multicenter retrospective study aimed to examine the outcomes of using SCS to treat patients with CPSP and to explore factors related to outcomes. The authors reviewed the medical records of patients with CPSP who underwent SCS to collect data regarding their background, surgical information, and outcomes of SCS at trial stimulation and last follow-up after long-term implantation in six study centers. Outcomes were evaluated with a pain score for intensity (range 0-10) and the Patient Global Impression of Changes (PGIC) scale. Factors associated with outcomes were explored with univariable and multivariable analyses. The authors collected data from a total of 166 patients (mean age 63.4 years; mean pain score at baseline 8.2). Of these patients, 163 underwent trial stimulation. The mean pain score decreased by 42.0%, 104 (64%) patients had ≥ 30% decrease in pain score, and 96 (59%) reported much or very much improved condition on the PGIC scale at trial stimulation. Moreover, 106 (64%) patients underwent long-term implantation of SCS devices. The mean decrease in pain score was 41.4%, 63 (59%) patients continued to show ≥ 30% decrease in pain score at last follow-up, and 60 (56%) reported much or very much improved condition on the PGIC scale at last follow-up (median [range] follow-up period 24 [24-63] months). Eleven device-related complications and 10 permanent explantations were observed. Univariable and multivariable analyses suggested that young age, less sensory disturbance, implantation of cervical leads, treatment of upper-limb pain, and extensive treated regions were associated with satisfactory outcomes at last follow-up after long-term implantation. These findings indicate that SCS may modestly benefit patients with CPSP. SCS has therapeutic potential for patients with intractable CPSP owing to the lower invasiveness of the SCS procedure and refractory nature of CPSP. Nevertheless, trial stimulation is necessary because of the high initial failure rate.

Retrospective evaluation of 16 patients who underwent spinal cord stimulation

The aim of this study was to examine the outcomes of patients who underwent Spinal Cord Stimulation (SCS) in our clinic. In this study, records of 16 patients who underwent SCS in the Algology and Neurosurgery Clinic of the Ministry of Health, Health Sciences University, Samsun Training and Research Hospital between 2015 and 2018 were retrospectively analysed. The pain levels of the patients before and after the procedure were evaluated with the Visual Analogue Scale (VAS). The mean age of the patients was 54.25 ± 11.45 years. After the SCS procedure, it was found that pain levels determined by the VAS decreased significantly (p < 0.001). Eleven (68.7%) patients reported that they were quite satisfied or partially satisfied after SCS, and seven patients (43.8%) underwent revision due to hardware malfunctions and post-surgical complications. Based on our study results, we believe that SCS is an effective treatment method that can be used to reduce pain.

Annual Number of Spinal Cord Stimulation Procedures Performed in the State of Florida During 2018: Implications for Establishing Neuromodulation Centers of Excellence

To assess the volume of spinal cord stimulation procedures performed by physicians in the state of Florida in 2018. We obtained information from publicly available state databases for all patients undergoing procedures in 2018 at Florida hospitals, hospital-owned facilities, and independent ambulatory surgery centers. Cases in which a spinal cord stimulation procedure was performed were identified. We estimated for each physician office-based spinal cord stimulation trials (not subject to state reporting) based on the published Florida conversion factor of 25.6% of the total number of such procedures. The medical specialty of the listed performing physician was determined based on the national provider identifier. Counts of neurostimulation procedures performed by physician and within specialties were determined. The numbers of physicians and specialties performing various thresholds between 1 and ≥100 per year were determined, and the percentages of patients whose care was delivered by physicians below each threshold were determined. The data analyzed included 10,762 spinal cord stimulation cases. Among the 606 physicians who performed at least one spinal cord stimulation procedure, only nine performed at least 100 cases in 2018. During 2018, 78.4% of physicians performed, on average, <2 spinal cord stimulation procedures per month; there were 29.4% of spinal cord stimulation patients cared for by such physicians. Physicians performing less than four cases per month provided care for 56.9% of all cases. Few physicians performing spinal cord stimulation procedures in the state of Florida in 2018 would have been considered as "high volume." Although volume is only one among many criteria used to designate centers of excellence for other procedures, the potential impact on physician practice and patient access to care should be considered if a specific minimum number of annual cases by physician is to be established.

Spinal Cord Stimulation for Chronic Refractory Neuropathic Pain: A Technical Note Initial Experience of Two cases

AbstractSpinal cord stimulation is an established procedure for relieving chronic neuropathic pain conditions. Although it has been over five decades since the first spinal cord stimulation (SCS) was developed, it has only been used in a few cases in India. It is primarily based on the “Gate Theory” of pain. The mechanism of its action is not exactly clear, but reports have suggested that it plays the main role in selectively stimulating the large diameter pain fibers in the dorsal aspect of spinal cord. SCS procedure involves a very careful case selection, and current evidence suggests that only a few conditions of chronic refractory neuropathic pain are its established indications. In these patients too, the efficacy rate remains around 50 to 75%. The overall pain relief observed is around 50% decrease in visual analog scale (VAS) scores. It is a technically simple procedure involving placement of electrodes over the dorsal aspect of spinal cord in the epidural space. The procedure is a staged one in which trial lead electrodes are first implanted and stimulated with an external pulse generator (EPG). If the trial is successful and patient has acceptable pain relief over 1 week of stimulation at various settings, the patient undergoes the permanent implantation of electrodes at the same position. The permanent electrodes are then stimulated by an implantable pulse generator (IPG) in the subcutaneous pocket (abdominal or gluteal). Complications are rare and are more related to hardware like lead migration and breakage. Since it is does not damage the cord per se, its acceptance as a procedure for pain is known quite well in the Western world. Its availability and cost of implants is the major hurdle in its use in a developing nation like India. Here, we present a technical note and our experience of two cases of thoracic spinal cord stimulation for chronic neuropathic pain at our institution.

Management of Pulmonary Emboli During a Spinal Cord Stimulator Trial: A Case Report

Background: Neuromodulation has been used in the management of chronic pain for well over 30 years and is becoming increasingly relevant in the face of the ongoing opioid epidemic. Although this therapy continues to provide pain relief and improvement in function to patients with a wide variety of pathologies, several complications have been described ranging from lead migration to development of a granuloma causing cord compression. Although not described in the literature, a pulmonary embolism can be one of the rare complications of a spinal cord stimulation procedure, and when it happens during the trial period of spinal cord stimulation, it involves significant challenges in the clinical management of anticoagulation in the patient. Case Report: We present a case in which a patient developed bilateral pulmonary emboli (PE) during the trial phase of spinal cord stimulation. The patient did have a prior history of PE, had an inferior vena cava filter in place, and was on anticoagulation, which was held as per the current American Society of Regional Anesthesia guidelines prior to the spinal cord stimulator (SCS) trial. Conclusion: A pulmonary embolus is a possible complication from an SCS trial, especially in patients with preexisting thromboembolic risk factors. Management must involve multidisciplinary care focused on balancing the risks of thrombosis with those from a potential epidural hematoma at the time of lead removal. Key words: Spinal cord stimulation, pulmonary embolus, spinal cord stimulator complications, neuromodulation, venous thromboembolism, SCS trial, VTE, PE

Perioperative Outcomes of Spinal Cord Stimulator Placement in Patients with Complex Regional Pain Syndrome Compared with Patients without Complex Regional Pain Syndrome

Complex regional pain syndrome (CRPS) is a multifaceted disorder resulting in an abnormal pain response to tissue injury. Among key CRPS features are neurogenic inflammation, maladaptive plasticity, and vasomotor dysfunction, which can result in severe pain and disability. Spinal cord stimulation (SCS) is an efficacious treatment for several chronic pain conditions and may improve pain and life quality in CRPS patients with CRPS. However, little information exists regarding perioperative outcomes of patients with CRPS undergoing surgical implantation of an SCS device. Patients were included if they underwent an SCS procedure at our institution between 2008 and 2016 for chronic pain. Cases were excluded if the procedure involved stimulator removal or if it was an outpatient procedure. Multivariate regression assessed the effect of CRPS and other clinical variables on perioperative outcomes. Eighty-one inpatient SCS implantation cases for chronic pain were included, with 9 patients (11.1%) having a CRPS diagnosis. The CRPS cohort received higher mean quantities of intraoperative opioids and had a lower proportion of patients reporting meaningful pain reduction (16.7%) in the 24-hour postoperative setting compared with patients without CRPS (35.9%), although this was not statistically significant. Multivariate regression modeling suggested that CRPS was a significant predictor of increased odds of extended time to the postanesthesia care unit discharge (P= 0.0406) and higher direct costs of hospitalization (P= 0.0326). Our data suggest that CRPS may pose several unique risks in the perioperative period after inpatient SCS implantation. These findings support the need for future prospective investigations examining risks and outcomes for SCS procedures in this population.

Utility of a Mobile Clinical Decision Support Application in Patients Undergoing Spinal Cord Stimulation.

Abstract INTRODUCTION Novel technologies to support real-time patient education, engagement and scalable outcomes monitoring to make clinically meaningful decisions are needed. The ManageMySurgery (MMS) Spinal Cord Stimulation (SCS) module is a mobile clinical decision support application that provides: (1) a mobile, patient-centered engagement tool for delivering pre-, peri- and postoperative SCS information; (2) scalable patient-reported outcomes collection; (3) a HIPAA-compliant 2-way messaging platform with a Clinical Specialist Educator for real-time support and goal setting. METHODS Prospective data was collected using the MMS mobile smartphone application in patients undergoing Medtronic SCS trial and permanent implant procedures. E-consent was obtained through the HIPAA compliant, mobile software platform. All data was de-identified, aggregated and analyzed. RESULTS A total of 20 patients (15-trial SCS and 5 permanent SCS patients) agreed to participate and logged onto the mobile software platform. For trial SCS patients, 100% of those that participated experienced &gt;50% pain relief as documented in their patient-reported outcomes. Furthermore, patients found various features of the software platform helpful for navigating different aspects of their SCS procedure, with 81% finding MMS helpful in preparing for their SCS procedure, 88% finding MMS helpful in recovering from their SCS procedure and 94% in communicating with their Clinical Specialist Educator. In addition, 95% of patients would recommend MMS to a friend or family member. CONCLUSION The MMS platform appears to have utility both during the SCS Trial and Permanent procedures. In patients with chronic pain, novel patient engagement and follow-up tools such as MMS may be a good option for keeping patients engaged with the therapy and ensuring patients stay on track during their procedural journey. Randomized, controlled trials with extended follow-up are in progress and needed to further evaluate the utility of MMS in patients with chronic pain undergoing SCS.

Implanter’s Integrated Information (I3) System: An Aid for Spinal Cord Stimulation Procedures

In spinal cord stimulation (SCS), the electrical stimulation of the spinal cord with an implanted lead evokes a tingling peripheral sensation known as paresthesias. Newer stimulation paradigms allow paresthesia-free treatment, but during the implantation of the lead, paresthesias must cover the painful area to achieve optimal treatment effect. The localization of the evoked paresthesias can be difficult to accurately describe for the patient, and furthermore depends on a complex and only partially predictable set of parameters that includes the anatomical localization and the programming of the electrical field. We aimed to optimize SCS implantation procedures by devising a way to aid the patient in making useful descriptions of the evoked paresthesias, then to visually convey the full set of information-anatomical position of the lead, programming parameters, and evoked paresthesias-directly to the implanting physician. To aid the patient in making accurate descriptions of the evoked paresthesia, we use an app dedicated to creating pain drawings on a tablet. We used Chromecast and Apple TV to project the information from the pain drawing tablet and the programming device to two monitors placed in the implanter's field of vision, right next to the fluoroscopy monitor. The three monitors combined provide a direct visual representation of the dynamic dataset used during SCS implantation: Position, Programming, and Paresthesias, essentially creating the equivalent of the dashboard of a car. We present an Implanter's Integrated Information (I3) system; a simple, inexpensive solution for gathering, integrating, and conveying the complex set of information necessary for a successful SCS procedure.

Epidural Spinal Stimulation to Improve Bladder, Bowel, and Sexual Function in Individuals With Spinal Cord Injuries: A Framework for Clinical Research.

While some recent studies that apply epidural spinal cord stimulation (SCS) have demonstrated a breakthrough in improvement of the health and quality of the life of persons with spinal cord injury (SCI), the numbers of people who have received SCS are small. This is in sharp contrast to the thousands of persons worldwide living with SCI who have no practical recourse or hope of recovery of lost functions. Thus, the vision is to understand the full potential of this new intervention and to determine if it is safe and effective in a larger cohort, and if it is scalable so that it can be made available to all those who might benefit. To achieve this vision, the National Institute of Biomedical Imaging and Bioengineering called for and organized a consortium of multiple stakeholder groups: foundations addressing paralysis, federal and public agencies, industrial partners, academicians, and researchers, all interested in the same goal. Based on input from consortium participants, we have reasoned that a first step is to define a scalable SCS approach that is effective in restoring lost autonomic physiology, specifically bladder, bowel, and sexual function. These functions are most critical for improving the quality of life of persons living with SCI. This report outlines a framework for conducting the research needed to define such an effective SCS procedure that might seek Food and Drug Administration approval and be implemented at the population level.

Traumatic Sciatic Nerve Injury and Effectiveness of Spinal Cord Stimulation

Submit Manuscript | http://medcraveonline.com needle injury, neuritis, circumferential constriction around nerve fibre by scar tissue, direct nerve fibre damage by neurotoxic agents injected [4]. We had 2 patients with sciatic nerve injury following intramuscular injection. Patients had been injected analgesic intramuscularly to the left buttock region. They were admitted to our clinic with pain, paresthesia and burning sensation along the sciatic distribution and motor weakness at the left leg and also had a drop foot with loss of dorsiflexion of left foot. Patients’ electromygraphy was analysed on left lower extremity, there was nearly complete and complete axonal denervation on common peroneal and posterior tibial division of sciatic nerve respectively. VAS values were recorded 10 and 9 respectively. After the examination sacral 2-3-4 nerve block on left side was performed with fluoroscopy. Dexamethasone and lidocaine were used for block. Eker et al. performed the block to five patients with sciatic nerve injury following intramuscular injection without fluoroscopy. They observed significiant reduction in pain [5]. But we didn’t see any difference on visual analog scale (VAS) values. Anticonvulsant, antidepressant and analgesic agents were addedd to treatment. Despite the invasive procedure and medical treatments, pain persisted. Then it was decided to perform spinal cord stimulation (SCS) as an alternative treatment. SCS was applied between T8-T10 levels. Prior the procedure VAS values were recorded as 10 and 9. They were recorded 3 and 1, after performing SCS trial respectively. There were many clinical studies, reviews and case reports about sciatic nerve injury due to intramuscular injection. Most of them are about the management, surgical and conservative therapies, results of sciatic injection injury. When we checked out the literature, we could’t find any case report like this. Our cases may be first applied SCS for sciatic neuropathy following intramuscular injection. In this case report we present 2 cases who had neuropathic pain due to intramuscular injection which is resistant to invasive and medical theraphies. We observed that the SCS treatment was effective to relieve pain due to sciatic neuropathy. We did not observe any side effects and infection associated with SCS procedure. SCS should be considered as an alternative treatment method that can be used safely for sciatic neuropathy which has immediate response.

Short test-period spinal cord stimulation for failed back surgery syndrome.

The aim of this study was to investigate the effects of spinal cord stimulation (SCS) on patients with chronic pain due to failed back surgery syndrome and to evaluate selection criteria for predicting SCS success. Thirty-two patients were enrolled in the present study. Prior to test implantation, all of them have been screened with various plan questionnaires and were selected for the SCS procedure according to stringent criteria. The single-electrode neurostimulators Itrel II and Xtrel were used with percutaneously inserted leads. The leads were placed under X-ray image intensifier control, and position was modified until optimum paresthetic coverage of pain areas was achieved. Twenty-nine of the 32 test stimulation patients reported on a pain reduction of at least 50% and up to 90% of preimplantation values. After a test period of 24 to 72 hours, internalization of the whole SCS system followed. In 3 cases the lead was explanted after 3 days of test stimulation because of insufficient analgesic effect. No major complications were seen in this highly preselected group. Follow-ups of 2 to 3.5 years after lead implantation proved stable analgesia and good outcome in 25 patients. Further 4 patients experienced a late failure of the system due to decreased analgesic effects of SCS. In conclusion, if the selection of SCS candidate patients is performed very carefully and according to well defined criteria, test stimulation periods can be kept relatively short, thus reducing therapeutic failures, risk of infection, and costs of therapy.