Implantable Pulse Generator Site May Be Associated With Spinal Cord Stimulation Revision Surgeries

2019 ◽  
Author(s):  
Shyle H. Mehta ◽  
Christian M. Hoelscher ◽  
Ashwini D. Sharan ◽  
Sara Thalheimer ◽  
Chengyuan Wu
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
Pulse Generator ◽  
Implantable Pulse Generator

scholarly journals The Challenge of Converting “Failed Spinal Cord Stimulation Syndrome” Back to Clinical Success, Using SCS Reprogramming as Salvage Therapy, through Neurostimulation Adapters Combined with 3D-Computerized Pain Mapping Assessment: A Real Life Retrospective Study

2022 ◽  
Vol 11 (1) ◽  
pp. 272
Author(s):  
Philippe Rigoard ◽  
Amine Ounajim ◽  
Lisa Goudman ◽  
Tania Banor ◽  
France Héroux ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Pain Intensity ◽  
Spinal Cord Stimulation ◽  
Pulse Generator ◽  
Clinical Success ◽  
Real Life ◽  
Intensity Rating ◽  
Pain Mapping

While paresthesia-based Spinal Cord Stimulation (SCS) has been proven effective as treatment for chronic neuropathic pain, its initial benefits may lead to the development of “Failed SCS Syndrome’ (FSCSS) defined as decrease over time related to Loss of Efficacy (LoE) with or without Loss of Coverage (LoC). Development of technologies associating new paresthesia-free stimulation waveforms and implanted pulse generator adapters provide opportunities to manage patients with LoE. The main goal of our study was to investigate salvage procedures, through neurostimulation adapters, in patients already implanted with SCS and experiencing LoE. We retrospectively analyzed a cohort of patients who were offered new SCS programs/waveforms through an implanted adapter between 2018 and 2021. Patients were evaluated before and at 1-, 3-, 6- and 12-month follow-ups. Outcomes included pain intensity rating with a Visual Analog Scale (VAS), pain/coverage mappings and stimulation preferences. Last follow-up evaluations (N = 27) showed significant improvement in VAS (p = 0.0001), ODI (p = 0.021) and quality of life (p = 0.023). In the 11/27 patients with LoC, SCS efficacy on pain intensity (36.89%) was accompanied via paresthesia coverage recovery (55.57%) and pain surface decrease (47.01%). At 12-month follow-up, 81.3% preferred to keep tonic stimulation in their waveform portfolio. SCS conversion using adapters appears promising as a salvage solution, with an emphasis on paresthesia recapturing enabled via spatial retargeting. In light of these results, adapters could be integrated in SCS rescue algorithms or should be considered in SCS rescue.

scholarly journals Spinal cord stimulation for chronic intractable trunk or limb pain: study protocol for a Chinese multicenter randomized withdrawal trial (CITRIP study)

2020 ◽  
Author(s):  
Yang Lu ◽  
Peng Mao ◽  
Guihuai Wang ◽  
Wei Tao ◽  
Donglin Xiong ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Visual Analog Scale ◽  
Spinal Cord Stimulation ◽  
Pulse Generator ◽  
Short Form ◽  
Control Group ◽  
Withdrawal Period ◽  
Analog Scale ◽  
Limb Pain ◽  
Vas Score

Abstract Background: Although effective results of many studies support the use of spinal cord stimulation in the chronic pain patients, no randomized controlled trial has been undertaken in China to date. CITRIP is a multicenter, prospective, randomized, withdrawal study designed to evaluate the clinical effectiveness and safety of spinal cord stimulation plus remote programming management in patients with intractable trunk or limb pain.Method：Participants will be recruited in approximately 10 centers across China. Eligible participants with intractable trunk or limb and an average Visual Analog Scale (VAS) score ≥ 5 will undergo spinal cord stimulation test. Participants with VAS score reduction ≥ 50% could move forward to receive implantation of an implanted pulse generator. In the withdrawal period at 3-months follow-up visit, participants randomized to the experimental group (EG) will undergo continuous stimulation while ceasing the stimulation in the control group (CG). The outcome assessment will occur at baseline and at 1, 3 (pre and post randomization) and 6 months. The primary outcome is the difference of maximal visual analog scale (VAS) score between EG and CG in the withdrawal period compared with baseline before the withdrawal period. Additional outcomes include VAS score change at 1, 3 and 6-month follow-ups, responder rate (VAS score improving by 50%), achievement rate of a desirable pain state (VAS score ≤ 4), awake times during sleep, Beck Depression Inventory for depression evaluation, short-form 36 for quality of life evaluation, drug usage, satisfaction rating of the device. Adverse events will be collected. The primary analysis will follow the intention-to-treat principle. Discussion：The CITRIP study seeks to evaluate the effectiveness and safety of a randomized withdrawal trial of spinal cord stimulation for patients with intractable trunk or limb pain.Trial registration: NCT03858790, clinicaltrials.gov, registered on March 1st, 2019, retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03858790

scholarly journals A Fully Implantable Miniaturized Liquid Crystal Polymer (LCP)-Based Spinal Cord Stimulator for Pain Control

Sensors ◽  
2022 ◽  
Vol 22 (2) ◽  
pp. 501
Author(s):  
Seunghyeon Yun ◽  
Chin Su Koh ◽  
Jungmin Seo ◽  
Shinyong Shim ◽  
Minkyung Park ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Electrical Stimulation ◽  
Liquid Crystal ◽  
Mechanical Stimulation ◽  
Spinal Cord Stimulation ◽  
Pulse Generator ◽  
Spinal Cord Stimulator ◽  
Stimulation Threshold ◽  
Crystal Polymer ◽  
Stimulation Of

Spinal cord stimulation is a therapy to treat the severe neuropathic pain by suppressing the pain signal via electrical stimulation of the spinal cord. The conventional metal packaged and battery-operated implantable pulse generator (IPG) produces electrical pulses to stimulate the spinal cord. Despite its stable operation after implantation, the implantation site is limited due to its bulky size and heavy weight. Wireless communications including wireless power charging is also restricted, which is mainly attributed to the electromagnetic shielding of the metal package. To overcome these limitations, here, we developed a fully implantable miniaturized spinal cord stimulator based on a biocompatible liquid crystal polymer (LCP). The fabrication of electrode arrays in the LCP substrate and monolithically encapsulating the circuitries using LCP packaging reduces the weight (0.4 g) and the size (the width, length, and thickness are 25.3, 9.3, and 1.9 mm, respectively). An inductive link was utilized to wirelessly transfer the power and the data to implanted circuitries to generate the stimulus pulse. Prior to implantation of the device, operation of the pulse generator was evaluated, and characteristics of stimulation electrode such as an electrochemical impedance spectroscopy (EIS) were measured. The LCP-based spinal cord stimulator was implanted into the spared nerve injury rat model. The degree of pain suppression upon spinal cord stimulation was assessed via the Von Frey test where the mechanical stimulation threshold was evaluated by monitoring the paw withdrawal responses. With no spinal cord stimulation, the mechanical stimulation threshold was observed as 1.47 ± 0.623 g, whereas the stimulation threshold was increased to 12.7 ± 4.00 g after spinal cord stimulation, confirming the efficacy of pain suppression via electrical stimulation of the spinal cord. This LCP-based spinal cord stimulator opens new avenues for the development of a miniaturized but still effective spinal cord stimulator.

scholarly journals The Challenge of Converting “Failed Spinal Cord Stimulation Syndrome” Back to Clinical Success, Using SCS Reprogramming as Salvage Therapy, Through Neurostimulation Adapters Combined with 3D-Computerized Pain Mapping Assessment. A Real-Life Retrospective Cohort Analysis

2021 ◽  
Author(s):  
Philippe Rigoard ◽  
Amine Ounajim ◽  
Lisa Goudman ◽  
Tania Banor ◽  
France Héroux ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Pain Intensity ◽  
Spinal Cord Stimulation ◽  
Pulse Generator ◽  
Clinical Success ◽  
Cohort Analysis ◽  
Real Life ◽  
Intensity Rating ◽  
Pain Mapping

While paresthesia-based spinal cord stimulation (SCS) has been proven effective to treat chronic neuropathic pain, initial benefits may lead to the development of “Failed SCS Syndrome’ (FSCSS) defined as decrease over time related to Loss of Efficacy (LoE) with or without Loss of Coverage (LoC). Development of technologies associating new paresthesia-free stimulation waveforms and implanted pulse generator adapters provide opportunities to manage patients with LoE. The main goal of our study was to investigate salvage procedures, through neu-rostimulation adapters, in patients already implanted with SCS and experienced LoE. We retro-spectively analyzed a cohort of patients who were offered new SCS programs/waveforms through an implanted adapter between 2018 and 2021. Patients were evaluated before, and at 1, 3, 6 and 12-month follow-up. Outcomes included pain intensity rating with Visual Analog Scale (VAS), pain/coverage mappings and stimulation preferences. Last follow-up evaluations (N=27) showed significant improvement in VAS (p = 0.0001), ODI (p = 0.021) and Quality of Life (p=0.023). In the 11/27 patients with LoC, SCS efficacy on pain intensity (36.89%) was accompa-nied by paresthesia coverage recovery (55.57%) and pain surface decrease (47.01%). At 12-month follow-up, 81.3% preferred to keep tonic stimulation in their waveform portfolio. SCS conver-sion using adapters appears promising as a salvage solution, with an emphasis on paresthesia recapturing enabled by spatial retargeting. In light of these results, adapters could be integrated to SCS rescue algorithms or should be considered in SCS rescue.

scholarly journals Paresthesia-Independence: An Assessment of Technical Factors Related to 10 kHz Paresthesia-Free Spinal Cord Stimulation

2017 ◽  
Vol 4 (20;4) ◽  
pp. 331-341
Author(s):  
Kerry Bradley
Keyword(s):  
Spinal Cord ◽  
Pain Relief ◽  
Study Design ◽  
Spinal Cord Stimulation ◽  
Pulse Generator ◽  
Pain Clinic ◽  
Leg Pain ◽  
Controlled Study ◽  
Intractable Pain ◽  
Technical Factors

Background: Spinal cord stimulation (SCS) has been successfully used to treat chronic intractable pain for over 40 years. Successful clinical application of SCS is presumed to be generally dependent on maximizing paresthesia-pain overlap; critical to achieving this is positioning of the stimulation field at the physiologic midline. Recently, the necessity of paresthesia for achieving effective relief in SCS has been challenged by the introduction of 10 kHz paresthesia-free stimulation. In a large, prospective, randomized controlled pivotal trial, HF10 therapy was demonstrated to be statistically and clinically superior to paresthesia-based SCS in the treatment of severe chronic low back and leg pain. HF10 therapy, unlike traditional paresthesia-based SCS, requires no paresthesia to be experienced by the patient, nor does it require paresthesia mapping at any point during lead implant or post-operative programming. Objectives: To determine if pain relief was related to technical factors of paresthesia, we measured and analyzed the paresthesia responses of patients successfully using HF10 therapy. Study Design: Prospective, multicenter, non-randomized, non-controlled interventional study. Setting: Outpatient pain clinic at 10 centers across the US and Italy. Methods: Patients with both back and leg pain already implanted with an HF10 therapy device for up to 24 months were included in this multicenter study. Patients provided pain scores prior to and after using HF10 therapy. Each patient’s most efficacious HF10 therapy stimulation program was temporarily modified to a low frequency (LF; 60 Hz), wide pulse width (~470 μs), paresthesiagenerating program. On a human body diagram, patients drew the locations of their chronic intractable pain and, with the modified program activated, all regions where they experienced LF paresthesia. Paresthesia and pain drawings were then analyzed to estimate the correlation of pain relief outcomes to overlap of pain by paresthesia, and the mediolateral distribution of paresthesia (as a surrogate of physiologic midline lead positioning). Results: A total of 61 patients participated across 11 centers. Twenty-eight men and 33 women with a mean age of 56 ± 12 years of age participated in the study. The average duration of implantable pulse generator (IPG) implant was 19 ± 9 months. The average predominant pain score, as measured on a 0 – 10 visual analog scale (VAS), prior to HF10 therapy was 7.8 ± 1.3 and at time of testing was 2.5 ± 2.1, yielding an average pain relief of 70 ± 24%. For all patients, the mean paresthesia coverage of pain was 21 ± 28%, with 43% of patients having zero paresthesia coverage of pain. Analysis revealed no correlation between percentage of LF paresthesia overlap of predominant pain and HF10 therapy efficacy (P = 0.56). Exact mediolateral positioning of the stimulation electrodes was not found to be a statistically significant predictor of pain relief outcomes. Limitations: Non-randomized/non-controlled study design; short-term evaluation; certain technical factors not investigated.Conclusion: Both paresthesia concordance with pain and precise midline positioning of the stimulation contacts appear to be inconsequential technical factors for successful HF10 therapy application. These results suggest that HF10 therapy is not only paresthesia-free, but may be paresthesia-independent. Key words: Spinal cord stimulation, paresthesia, high frequency, 10kHz, pain relief, physiologic midline, paresthesia-free

scholarly journals Spinal Cord Stimulation Trends of Utilization and Expenditures in Fee-For-Service (FFS) Medicare Population from 2009 to 2018

2021 ◽  
pp. 293-308
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
Pulse Generator ◽  
Facet Joint ◽  
Spinal Pain ◽  
Fee For Service ◽  
Annual Increase ◽  
Medicare Population ◽  
Utilization Patterns ◽  
Facet Joint Interventions

BACKGROUND: Spinal cord stimulation has been utilized with increasing frequency in managing chronic intractable spinal pain and complex regional pain syndrome (CRPS) in addition to other neuropathic pain states. The literature has shown the effectiveness of spinal cord stimulation in managing chronic pain with improvement in quality of life and cost utility. There have not been any reviews performed in the fee-for-service (FFS) Medicare population in reference to utilization and expenditure patterns of spinal cord stimulators. OBJECTIVES: This investigation was undertaken to assess the utilization and expenditures for spinal cord stimulation in the FFS Medicare population from 2009 to 2018. STUDY DESIGN: The present study was designed to assess the utilization patterns and expenditures in all settings, for all providers in the FFS Medicare population from 2009 to 2018 in the United States. A standard 5% national sample of the Centers for Medicare and Medicaid Services (CMS) physician outpatient billing claims data. All the expenditures were presented with allowed costs and adjusted to inflation to 2018 US dollars only trials and implants were included. RESULTS: Utilization patterns showed that spinal cord stimulation trials increased from 12,680 in 2009 to 36,280 in 2018, a 186% increase with an annual increase of 12.4%. The rate of trials per 100,000 population increased from 28 in 2009 to 61 in 2018 with a 120% increase, or an annual increase of 9.1%. The pulse generator implants increased from 7,640 in 2009 to 22,960 in 2018, an increase of 201%, with an annual increase of 13%. In addition, percutaneous placement with pulse generator implants increased from 4,080 in 2009 to 14,316 in 2018, a 252% increase, or 15% annual increase. In contrast, implantation of neurostimulator electrodes with paddle leads with laminectomy and placement of spinal pulse generator increased from 3,560 in 2009 to 8,600 in 2018, a 142% increase or an annual increase of 10.3%. Analysis of expenditures showed total inflation-adjusted expenditures increased from $292,153,701 in 2009 to $1,142,434,137 in 2018, a 291% increase from 2009 to 2018 and 16.4% annual increase. These expenditures were 125% higher than facet joint interventions and 138% higher than epidural interventions in 2018. In contrast, these expenditures were 55% below the expenditures of facet joint interventions and 66% lower than epidural injections in 2009. Trial to implant ratio improved from 42.5% in 2009 to 63.6% in 2018. An overwhelming majority of trials (90%) were performed by nonsurgical physicians, whereas, 56% of implants were performed by non-surgeons. LIMITATIONS: This assessment includes only FFS Medicare population, thus eliminating approximately 30% of the population with Medicare Advantage plans. In addition, this study has not taken into consideration various revisions not included in 3 specific codes. CONCLUSIONS: The analysis of spinal cord stimulators in the FFS Medicare population from 2009 to 2018 showed explosive increases of trials, implants and overall costs. KEY WORDS: Chronic pain, spinal pain, spinal cord stimulation, spinal cord stimulation trial, pulse generator implant, paddle leads with laminectomy, utilization trends of expenditures

scholarly journals Unexpected extrusion of the implantable pulse generator of the spinal cord stimulator - A case report -

2021 ◽  
Vol 16 (1) ◽  
pp. 103-107
Author(s):  
Eun-Ji Choi ◽  
Hyun-Su Ri ◽  
Hyeonsoo Park ◽  
Hye-Jin Kim ◽  
Ji-Uk Yoon ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Pulse Generator ◽  
Pain Syndrome ◽  
Lower Abdomen ◽  
Local Pain ◽  
Implantable Pulse Generator ◽  
Technological Advances ◽  
Pressure Necrosis ◽  
The Right ◽  
Car Accident

Background: Despite significant technological advances in the implantable pulse generator (IPG), complications can still occur. We report a case that unexpected extrusion of the IPG of spinal cord stimulation (SCS) was promptly identified and successfully removed without any complications. Case: After a car accident 4 years ago, a 55-year-old man who was diagnosed with complex local pain syndrome in his right leg. The SCS was inserted with 2 leads, with the IPG being implanted in the right lower abdomen region. Four years later, he developed extrusion of the IPG from his abdominal region. This unexpected extrusion may have been related to pressure necrosis caused by continued compression of pocket site where a belt was frequently tied. The IPG and the leads were successfully removed without infection occurring. Conclusions: To prevent unexpected extrusion of IPG, it is necessary to consider in advance whether the pocket site is pressed against the belt.

scholarly journals SPINAL CORD STIMULATION IN TREATMENT OF THE NEUROPATHIC PAIN SYNDROMES: INITIAL EXPERIENCE

2010 ◽  
Vol 16 (2) ◽  
pp. 68-71
Author(s):  
D. A. Rzaev ◽  
V. V. Rudenko ◽  
I. L. Pudovkin ◽  
A. P. Tatarintsev ◽  
D. S. Godanyuk
Keyword(s):  
Spinal Cord ◽  
Chronic Pain ◽  
Neuropathic Pain ◽  
Spinal Cord Stimulation ◽  
Pulse Generator ◽  
Initial Experience ◽  
Pain Syndromes ◽  
Chronic Pain Syndromes

In the article initial experience of spinal cord stimulation for chronic pain syndromes is described. The trial was done for 62 patients, in 52 cases trial was successful and subcutaneous pulse generator were implanated. Maximal follow-up is 26 months. The level of pain evaluates at VAS. Permanent pain-relieve results were achieved in 46 patients (74,2%). These results correspond to literature data.

scholarly journals Minimally Invasive Wireless Spinal Cord Stimulation: A Novel Approach for Refractory Angina in Women

2019 ◽  
Vol 04 (04) ◽  
pp. 207-212
Author(s):  
Prasad S. S. V. Vannemreddy ◽  
Laura Tyler Perryman ◽  
Jyotsna Janaswamy ◽  
Konstantin V. Slavin
Keyword(s):  
Spinal Cord ◽  
Minimally Invasive ◽  
Spinal Cord Stimulation ◽  
Pulse Generator ◽  
Invasive Procedure ◽  
Anatomical Location ◽  
Surgical Trauma ◽  
Refractory Angina ◽  
Surgical Methods ◽  
Failed Back Surgery

AbstractRefractory angina (RA) persists even after thorough treatment for coronary artery disease. In such difficult situations, neuromodulation offers effective alternative management. One such minimally invasive procedure is spinal cord stimulation (SCS), a rapidly evolving therapy in the treatment of pain management. SCS has been in use to control RA and in some reports exhibited beneficiary results. However, several equipment-related complications have been reported, mainly attributed to the bulky implant material and the implantable pulse generator.Recent advancements in minimally invasive surgical methods and electronics resulted in implantable electrode coupled with nanotechnology-operated antenna. This is the smallest pulse generator in the field of neuromodulation at present.The equipment in this minimalistic approach involved percutaneous implantation of a single electrode (with embedded microelectronic sensors) at the required anatomical location, operated by means of wireless antenna placed in the vicinity of the implant and moderated by both the patient as well as the clinician. The advantage with the nanoeletrode stimulation include reduced surgical trauma/health care costs/surgical duration and improved cosmetic result, especially in women.This minimalistic wireless neuromodulation (WNM) has been successful in the management of chronic pain in failed back surgery syndrome (FBSS), herpetic neuralgia, complex regional pain syndrome (CRPS), and facial pain. SCS with WNM could increase the indications in RA and possibly improves the outcome of these patients.

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