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

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.

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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

Journal of Clinical Medicine ◽

10.3390/jcm11010272 ◽

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.

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Improving Limb Salvage for Chronic Limb-Threatening Ischemia With Spinal Cord Stimulation: A Retrospective Analysis

Vascular and Endovascular Surgery ◽

10.1177/1538574420985765 ◽

2021 ◽

pp. 153857442098576

Author(s):

Anna E. Cyrek ◽

Nora Henn ◽

Fabian Meinhardt ◽

Martin Lainka ◽

Arkadius Pacha ◽

...

Keyword(s):

Quality Of Life ◽

Spinal Cord ◽

Pain Intensity ◽

Skin Temperature ◽

Limb Salvage ◽

Spinal Cord Stimulation ◽

Stage Iii ◽

Fontaine Stage

Introduction: Chronic limb-threatening ischemia (CLTI) represents the most severe form of peripheral artery disease (PAD). Up to a third of CLTI patients are not eligible to receive first-line treatments such as bypass surgery or endovascular interventions. Epidural spinal cord stimulation (SCS) has been used as a method to improve microcirculatory blood flow and relieve ischemic pain in CTLI patients. The aim of the study was to evaluate limb salvage, ulcer closure, and clinical changes of SCS implanted CTLI patients at 1-year follow-up. Methods: Eligible patients had end-stage lower limb PAD unresponsive to medical therapy and not amenable to surgical reconstruction. Patients were candidates for amputation, but limb loss was not inevitable (Fontaine stage III and IV). Pain intensity and skin temperature in the ischemic area (visual analogue scale), quality of life (WHOQoL-BREF), and ankle/brachial blood pressure index (ABI) were recorded at routine follow-up visits. Data were analyzed retrospectively. Results: 29 patients underwent SCS implantation at one vascular center. The minimum follow-up period was 30 months. Limb survival at 1-year follow-up was 97% (28/29) and 73% (11/15) had complete closure of limb ulcers. Pain intensity, skin temperature, and quality of life progressively improved up to 12 months after implant, with Fontaine stage III patients improving more substantially than Fontaine stage IV patients. SCS therapy did not affect ABI measurement. No complications related to the device or procedure occurred. Conclusions: SCS is a valid alternative in patients unsuitable for revascularization. The quality of results depends on both a strict selection of patients by vascular specialists and the frequency of follow-up controls. The therapy may be more beneficial in patients classified as Fontaine stage III.

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

Traumatology and Orthopedics of Russia ◽

10.21823/2311-2905-2010-0-2-68-71 ◽

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.

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Burst Spinal Cord Stimulation

Neurosurgery ◽

10.1227/01.neu.0000368153.44883.b3 ◽

2010 ◽

Vol 66 (5) ◽

pp. 986-990 ◽

Cited By ~ 201

Author(s):

Dirk De Ridder ◽

Sven Vanneste ◽

Mark Plazier ◽

Elsa van der Loo ◽

Tomas Menovsky

Keyword(s):

Spinal Cord ◽

Neuropathic Pain ◽

Visual Analog Scale ◽

Spinal Cord Stimulation ◽

Short Form ◽

Burst Stimulation ◽

Analog Scale ◽

Tonic Stimulation ◽

Better Than

Abstract INTRODUCTION Spinal cord stimulation is commonly used for neuropathic pain modulation. The major side effect is the onset of paresthesia. The authors describe a new stimulation design that suppresses pain as well as, or even better than, the currently used stimulation, but without creating paresthesia. METHODS A spinal cord electrode (Lamitrode) for neuropathic pain was implanted in 12 patients via laminectomy: 4 at the C2 level and 7 at the T8–T9 level for cervicobrachialgia and lumboischialgia, respectively (1 at T11 at another center). During external stimulation, the patients received the classic tonic stimulation (40 or 50 Hz) and the new burst stimulation (40-Hz burst with 5 spikes at 500 Hz per burst). RESULTS Pain scores were measured using a visual analog scale and the McGill Short Form preoperatively and during tonic and burst stimulation. Paresthesia was scored as present or not present. Burst stimulation was significantly better for pain suppression, by both the visual analog scale score and the McGill Short Form score. Paresthesia was present in 92% of patients during tonic stimulation, and in only 17% during burst stimulation. Average follow-up was 20.5 months. CONCLUSION The authors present a new method of spinal cord stimulation using bursts that suppress neuropathic pain without the mandatory paresthesia. Pain suppression seems as good as or potentially better than that achieved with the currently used stimulation. Average follow-up after nearly 2 years (20.5 months) suggests that this stimulation design is stable.

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

10.21203/rs.2.20185/v2 ◽

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

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High-frequency spinal cord stimulation for treating pain in the lower limbs accompanied by bilateral para-anesthesia: A case report

Journal of Neurorestoratology ◽

10.26599/jnr.2020.9040012 ◽

2020 ◽

Vol 8 (3) ◽

pp. 132-137

Author(s):

Zhuqiang Cheng

Keyword(s):

Spinal Cord ◽

Spinal Cord Stimulation ◽

High Frequency ◽

Severe Pain ◽

Traffic Accident ◽

Lower Limbs ◽

Sensory Impairment ◽

Remarkable Effect ◽

Muscle Twitching

A 46-year-old female patient experienced severe pain in both lower limbs following a traffic accident in 2008. The pain mainly presented in her feet; she also experienced sensory impairment, convulsions, and exercise function disorders. She was diagnosed with neuropathic pain, and no medicine had any remarkable effect. Therefore, spinal cord stimulation (SCS) was performed in October 2019. Her pain did not reduce after the initial adoption of conventional SCS until the application of high frequency SCS (HF-SCS). At the 6-month follow-up, the pain in her lower limbs was considerably reduced, lower limb motor function was slightly improved, and muscle twitching in both feet disappeared.

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

Sensors ◽

10.3390/s22020501 ◽

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.

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Spinal Cord Stimulation in Treatment of Chronic Benign Pain: Challenges in Treatment Planning and Present Status, a 22-Year Experience

Neurosurgery ◽

10.1227/01.neu.0000192162.99567.96 ◽

2006 ◽

Vol 58 (3) ◽

pp. 481-496 ◽

Cited By ~ 264

Author(s):

Krishna Kumar ◽

Gary Hunter ◽

Denny Demeria

Keyword(s):

Quality Of Life ◽

Spinal Cord ◽

Pain Relief ◽

Success Rate ◽

Spinal Cord Stimulation ◽

Pain Clinic ◽

Axial Component

Abstract OBJECTIVE: To present an in-depth analysis of clinical predictors of outcome including age, sex, etiology of pain, type of electrodes used, duration of pain, duration of treatment, development of tolerance, employment status, activities of daily living, psychological status, and quality of life. Suggestions for treatment of low back pain with a predominant axial component are addressed. We analyzed the complications and proposed remedial measures to improve the effectiveness of this modality. METHODS: Study group consists of 410 patients (252 men, 58 women) with a mean age of 54 years and a mean follow-up period of 97.6 months. All patients were gated through a multidisciplinary pain clinic. The study was conducted over 22 years. RESULTS: The early success rate was 80% (328 patients), whereas the long-term success rate of internalized patients was 74.1% (243 patients) after the mean follow-up period of 97.6 months. Hardware-related complications included displaced or fractured electrodes, infection, and hardware malfunction. Etiologies demonstrating efficacy included failed back syndrome, peripheral vascular disease, angina pain, complex regional pain syndrome I and II, peripheral neuropathy, lower limb pain caused by multiple sclerosis. Age, sex, laterality of pain or number of surgeries before implant did not play a role in predicting outcome. The percentage of pain relief was inversely related to the time interval between pain onset and time of implantation. Radicular pain with axial component responded better to dual Pisces electrode or Specify-Lead implantation. CONCLUSION: Spinal cord stimulation can provide significant long-term pain relief with improved quality of life and employment. Results of this study will be effective in better defining prognostic factors and reducing complications leading to higher success rates with spinal cord stimulation.

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Management of incidental lumboiliac hernia during spinal cord stimulator implant: a case report

Regional Anesthesia and Pain Medicine ◽

10.1136/rapm-2019-100794 ◽

2019 ◽

Vol 44 (11) ◽

pp. 1033-1034

Author(s):

David Hao ◽

Charles Odonkor ◽

Shane Volney ◽

Mihir Kamdar ◽

Shihab Ahmed

Keyword(s):

Spinal Cord ◽

Pulse Generator ◽

Incidental Finding ◽

Correct Diagnosis ◽

Synthetic Mesh ◽

Lumbar Hernia ◽

Spinal Cord Stimulator ◽

Operative Repair ◽

Lumbar Triangle

Lumboiliac or lumbar hernia is a rare defect in the posterolateral abdominal wall that may be inadvertently misidentified and interfere with the implantable pulse generator (IPG) portion of spinal cord stimulator (SCS) implants. We report the case of a 54-year-old Caucasian man with an incidental finding of a lumboiliac hernia in the inferior lumbar triangle of Petit with placement of an IPG in a SCS implant. With the assistance of surgical colleagues, the correct diagnosis was made intraoperatively. We describe the operative repair of the lumboiliac hernia with a synthetic mesh. A new IPG pocket was created above the mesh prior to proceeding with IPG placement. No recurrence of the hernia defect was observed on 2-month follow-up. It is important that pain physicians and neurosurgeons who perform SCS implants are aware of lumboiliac hernias to avoid potential diagnostic or management errors. Lumboiliac hernias should be included on the differential diagnosis of lumbar or flank masses. Confirmation with imaging may be necessary and definitive surgical treatment should be pursued.

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Spinal Cord Stimulation Is Effective in Management of Complex Regional Pain Syndrome I: Fact or Fiction

Neurosurgery ◽

10.1227/neu.0b013e3182181e60 ◽

2011 ◽

Vol 69 (3) ◽

pp. 566-580 ◽

Cited By ~ 71

Author(s):

Krishna Kumar ◽

Syed Rizvi ◽

Sharon Bishop Bnurs

Keyword(s):

Quality Of Life ◽

Spinal Cord ◽

Functional Status ◽

Complex Regional Pain Syndrome ◽

Spinal Cord Stimulation ◽

Pain Syndrome ◽

Sf 36

Abstract BACKGROUND: Complex regional pain syndrome (CRPS) I is a debilitating neuropathic pain disorder characterized by burning pain and allodynia. Spinal cord stimulation (SCS) is effective in the treatment of CRPS I in the medium term but its long-term efficacy and ability to improve functional status remains controversial. OBJECTIVE: To evaluate the ability of SCS to improve pain, functional status, and quality of life in the long term. METHODS: We retrospectively analyzed 25 patients over a mean follow-up period of 88 months. The parameters for evaluation were visual analog scale (VAS), Oswestry Disability Index (ODI), Beck Depression Inventory (BDI), EuroQoL-5D (EQ-5D) and Short Form 36 (SF-36), and drug consumption. Evaluations were conducted at point of entry, 3 months, 12 months, and last follow-up at 88 months (mean). RESULTS: At baseline, the mean scores were VAS 8.4, ODI 70%, BDI 28, EQ-5D 0.30, and SF-36 24. In general, maximum improvement was recorded at follow-up at 3 months (VAS 4.8, ODI 45%, BDI 15, EQ-5D 0.57, and SF-36 45). At last follow-up, scores were 5.6, 50%, 19, 0.57, and 40, respectively. Despite some regression, at last follow-up benefits were maintained and found to be statistically significant (P < .001) compared with baseline. Medication usage declined. SCS did not prevent disease spread to other limbs. Best results were achieved in stage I CRPS I, patients under 40 years of age, and those receiving SCS within 1 year of disease onset. CONCLUSION: SCS improves pain, quality of life, and functional status over the long term and consequently merits early consideration in the treatment continuum.

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