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 High Frequency Spinal Cord Stimulation at 10 kHz for the Treatment of Chronic Pain: 6-Month Australian Clinical Experience

2016 ◽  
Vol 4;19 (4;5) ◽  
pp. 267-280 ◽  
Author(s):  
Dr Marc A. Russo
Keyword(s):  
Spinal Cord ◽  
Pain Relief ◽  
Spinal Cord Stimulation ◽  
High Frequency ◽  
Leg Pain ◽  
Control Group ◽  
Intractable Pain ◽  
Positive Trial ◽  
Pain Clinics ◽  
Wide Range

Background: High frequency spinal cord stimulation at 10 kHz (HF10 therapy) represents a prominent advance in spinal cord stimulation (SCS) therapy, having demonstrated enhanced efficacy in patients with back and leg pain and pain relief without paresthesia that is sustained at 24 months post implant. Objective: To report on the effectiveness HF10 SCS therapy for a wide range of intractable pain conditions in clinical practice. Study Design: Retrospective investigation of 256 patients who trialed HF10 SCS for chronic intractable pain of various etiologies. Setting: Three Australian pain clinics. Methods: Two hundred fifty-six patients trialed HF10 SCS with view of a permanent implant if successful. Pain distributions included back + leg, back only, head ± neck, and neck ± arm/ shoulder. About 30% of patients had previously failed traditional low-frequency paresthesiabased stimulation, while the remaining cohort were either highly refractory to treatment or not recommended by the pain physician for traditional SCS. Pain scores (numerical pain rating scale – NPRS) and functional outcome measures (Oswestry Disability Index – ODI; and activity tolerance times) were assessed at baseline, post-trial, and at 3 and 6 months post-implant as available in the medical records. Results: Of the 256 patients, 189 (73%) reported a positive trial and were implanted. Patients with back + leg pain demonstrated the highest trial success rate (81%). A mean reduction in pain, among those for whom data were available, of 50% was sustained up to 6 months postimplant across the entire patient population. Sixty-eight percent of patients who failed traditional SCS reported a positive trial and mean pain relief at 6 months was 49% (P < 0.001). An 8.6 point reduction in ODI (21%) at 6 months and improved sitting, standing, and walking tolerances were also reported. Limitations: As data was collected retrospectively, missing data points were unavoidable; this was primarily due to inconsistent data collection and patients being lost to follow-up. Patient populations were diverse and a control group was not appropriate in this setting. Conclusions: These retrospective results demonstrate a significant advancement for patients suffering with chronic intractable pain and are consistent with recently published clinical results for HF10 SCS. HF10 SCS appears to be a viable, paresthesia-free alternative to traditional SCS, with high trial success rates, demonstrated effectiveness in a range of pain distributions including those typically difficult to treat with traditional SCS, and the possibility to restore pain control in patients who have previously failed traditional SCS. Key words: Spinal cord stimulation, high frequency stimulation, HF10, paresthesia-free stimulation, back pain, leg pain, cervical pain, neuromodulation

scholarly journals High Frequency Spinal Cord Stimulation in a Patient with Bilateral Cochlear Implants

2021 ◽  
pp. 189-191
Keyword(s):  
Spinal Cord ◽  
Chronic Pain ◽  
Pain Relief ◽  
Cochlear Implant ◽  
Cochlear Implants ◽  
Spinal Cord Stimulation ◽  
High Frequency ◽  
Pain Clinic ◽  
Bilateral Cochlear Implants ◽  
Patient Reported

BACKGROUND: High-frequency spinal cord stimulation (HF-SCS) has become very popular in the management of chronic pain worldwide. As it relies on generating high-frequency electrical impulses, there is a risk of interference with other devices such as cochlear implants that utilize similar principles. A literature search did not reveal any case reports of HF-SCS implantation in a patient with cochlear implants. CASE REPORT: A 75-year-old White woman with a history of bilateral cochlear implants (Cochlear Americas Nucleus® with cp910 processor) for severe sensorineural hearing loss presented to our chronic pain clinic with lumbosacral radiculopathy. The patient underwent a HF-SCS trial with entry point at the L1-L2 space and the leads positioned at the top and bottom of T8. The patient did not experience any auditory interference with her Cochlear implant at triple the average SCS stimulation strength. During the follow-up visit the next week, the patient reported nearly 80% symptomatic pain relief and significant functional improvement. There was no change in her hearing and no evidence of interference. The patient ultimately underwent percutaneous SCS paddle electrode placement and at 3 months, continues to have excellent pain relief without any auditory interactions. CONCLUSION: We successfully implanted a HF-SCS at the thoracic level in a patient with bilateral cochlear implants without any auditory interference. KEY WORDS: Cochlear implant, lumbar radiculopathy, spinal cord stimulation

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

Neurosurgery ◽  
2006 ◽  
Vol 58 (3) ◽  
pp. 481-496 ◽  
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.

scholarly journals Options: A Prospective, Open-Label Study of HighDose Spinal Cord Stimulation in Patients with Chronic Back and Leg Pain

2020 ◽  
Vol 1;23 (1;1) ◽  
pp. 87-98 ◽  
Author(s):  
Ramsin Benyamin
Keyword(s):  
Spinal Cord ◽  
Pain Relief ◽  
Spinal Cord Stimulation ◽  
Pulse Width ◽  
Failed Back Surgery Syndrome ◽  
Leg Pain ◽  
High Dose ◽  
Failed Back Surgery ◽  
Global Impression Of Change

Background: Therapeutic approaches to spinal cord stimulation (SCS) continue to evolve and improve patient outcomes in patients receiving SCS therapy secondary to failed back surgery syndrome. Objectives: The aim of this study was to evaluate pain relief and other patient outcomes of SCS using selected high-dose programming parameters. Study Design: This was a prospective cohort study. Setting: This study took place at 11 centers in North America. Methods: Forty-four SCS-naive patients underwent trialing, starting with 1,000 Hz frequency, 90 µs pulse width followed by 300 Hz frequency, 800 µs pulse width, if pain relief was inadequate. Patients with 50% or greater pain relief were eligible for permanent implantation. Patient’s pain rating, global impression of change, health-related quality of life, functional disability, satisfaction/ recommendation, stimulation perception, device programming, and adverse events were assessed at 3 months postimplant. Results: There were significant improvements from baseline in mean Numeric Rating Scale (NRS11) pain scores for overall pain (7.5 to 3.8; P < 0.01), back pain (7.2 to 3.4; P < 0.01), leg pain (7.2 to 3.1; P < 0.01), Oswestry Disability Index (ODI) score (51.5 to 32.1; P < 0.01), and European Quality of Life–Five Dimensions, version 5L score (EQ-5D-5L) (0.58 to 0.74; P < 0.01). Twentyeight of 32 patients (88%) had significant, favorable improvement in Patient Global Impression of Change (PGIC). Eighty-four percent of patients were “satisfied,” and 78.1% would “definitely” recommend SCS. Eighteen patients (56%) used 1,000 Hz frequency and 90 µs pulse width exclusively; these patients experienced mean NRS-11 overall pain score improvement of 4.7 points. Device-, therapy-, or procedure-related adverse events were experienced in 19 patients (40%, 19 of 48), and all events resolved without reoperation and were similar to those observed with traditional SCS systems. Limitations: There was no active or sham comparator group, and therefore the reported effects may not be solely attributable to therapy effects and may be related to other, nonspecific effects of SCS. Conclusions: Improvements in pain relief, PGIC, EQ-5D-5L, ODI, and patient satisfaction were all clinically relevant and statistically significant. Future studies are needed to understand how these high-dose parameters perform versus a standard comparator. Key words: Spinal cord stimulation, high-frequency electrical stimulation, failed back surgery syndrome, neurostimulation, prospective, nonrandomized study

Spinal cord stimulation in the treatment of paraplegic pain

1995 ◽  
Vol 82 (1) ◽  
pp. 35-39 ◽  
Author(s):  
Beatrice Cioni ◽  
Mario Meglio ◽  
Luigi Pentimalli ◽  
Massimiliano Visocchi
Keyword(s):  
Spinal Cord ◽  
Pain Relief ◽  
Spinal Cord Stimulation ◽  
Neurological Status ◽  
Intractable Pain ◽  
Content Type ◽  
Number Of Patients ◽  
Status Level

✓ Twenty-five patients suffering from intractable pain due to a chronic spinal cord lesion underwent a percutaneous test of spinal cord stimulation. At the end of the test period, 40.9% of the patients reported a mean of 65% pain relief and these patients were selected for ongoing stimulation. At a mean follow-up time of 37.2 months the success rate, based on the number of patients with more than 50% pain relief, had fallen to 18.2%. Pain relief rates were analyzed in relation to quality of pain, neurological status, level and extent of the lesion, and electrode level to identify prognostic factors that could improve the clinical usefulness of spinal cord stimulation. Patients experiencing painful spasms or a constrictive type of pain and with incomplete thoracic lesions were found to be the best candidates for spinal cord stimulation.

scholarly journals Overview of HF10 spinal cord stimulation for the treatment of chronic pain and an introduction to the Senza Omnia™ system

2020 ◽  
Vol 10 (6) ◽  
pp. 367-376 ◽  
Author(s):  
Jonathan M Hagedorn ◽  
Annie Layno-Moses ◽  
Daniel T Sanders ◽  
Daniel J Pak ◽  
Ashley Bailey-Classen ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Chronic Pain ◽  
Spinal Cord Stimulation ◽  
High Frequency ◽  
Pulse Generator ◽  
Intractable Pain ◽  
Worldwide Population ◽  
The Us ◽  
Us Fda ◽  
Chronic Pain Conditions

Chronic intractable pain affects a significant percentage of the worldwide population, and it is one of the most disabling and expensive health conditions across the globe. Spinal cord stimulation (SCS) has been used to treat chronic pain for a number of years, but high-frequency SCS was not the US FDA approved until 2015. In this review, we describe the history and development of high-frequency SCS and discuss the benefits of the Omnia™ implantable pulse generator. We also provide a thorough literature review of the published work, highlighting the efficacy and safety profiles of high-frequency SCS for the treatment of multiple chronic pain conditions. Lastly, we offer our outlook on future developments with the Omnia SCS system.

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

2021 ◽  
Author(s):  
Sanjeev Srivastava ◽  
Pawan Goyal ◽  
Anurag Sharma ◽  
Sanjay K. Rajan ◽  
Aditya Gupta
Keyword(s):  
Spinal Cord ◽  
Neuropathic Pain ◽  
Pain Relief ◽  
Spinal Cord Stimulation ◽  
Pulse Generator ◽  
Technical Note ◽  
Current Evidence ◽  
Chronic Neuropathic Pain ◽  
Thoracic Spinal Cord ◽  
Dorsal Aspect

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.

Waves of Pain Relief: A Systematic Review of Clinical Trials in Spinal Cord Stimulation Waveforms for the Treatment of Chronic Neuropathic Low Back and Leg Pain

2019 ◽  
Vol 131 ◽  
pp. 264-274.e3 ◽  
Author(s):  
Jeffery Head ◽  
Jacob Mazza ◽  
Victor Sabourin ◽  
Justin Turpin ◽  
Christian Hoelscher ◽  
...  
Keyword(s):  
Systematic Review ◽  
Spinal Cord ◽  
Clinical Trials ◽  
Pain Relief ◽  
Spinal Cord Stimulation ◽  
Leg Pain ◽  
Low Back

scholarly journals Pulse Width Programming in Spinal Cord Stimulation: A Clinical Study

2010 ◽  
Vol 4;13 (4;7) ◽  
pp. 321-335
Author(s):  
Thomas L. Yearwood
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
Pulse Width ◽  
Pulse Generator ◽  
Dorsal Column ◽  
Patient Choice ◽  
Leg Pain ◽  
Clinical Value ◽  
Number Of Patients ◽  
Wide Range

Background: With advances in spinal cord stimulation (SCS) technology, particularly rechargeable implantable, patients are now being offered a wider range of parameters to treat their pain. In particular, pulse width (PW) programming ranges of rechargeable implantable pulse generators now match that of radiofrequency systems (with programmability up to 1000µs). The intent of the present study was to investigate the effects of varying PW in SCS. Objective: To understand the effects of PW programming in spinal cord stimulation (SCS). Design: Single-center, prospective, randomized, single-blind evaluation of the technical and clinical outcomes of PW programming. Setting: Acute, outpatient follow-up. Methods: Subjects using fully-implanted SCS for > 3 months to treat chronic intractable low back and/or leg pain. Programming of a wide range (50-1000μs) of programmed PW settings using each patient’s otherwise unchanged ‘walk-in’ program. Outcome Measures: Paresthesia thresholds (perception, maximum comfortable, discomfort), paresthesia coverage and patient choice of tested programs. Results: We found strength-duration parameters of chronaxie and rheobase to be 295 (242 – 326) μs and 2.5 (1.3 – 3.3) mA, respectively. The median PW of all patients’ ‘walk-out’ programs was 400μs, approximately 48% higher than median chronaxie (P = 0.01), suggesting that chronaxie may not relate to patient-preferred stimulation settings. We found that 7/19 patients selected new PW programs, which significantly increased their paresthesia-pain overlap by 56% on average (P = 0.047). We estimated that 10/19 patients appeared to have greater paresthesia coverage, and 8/19 patients appeared to display a ‘caudal shift’ of paresthesia coverage with increased PW. Limitations: Small number of patients. Conclusions: Variable PW programming in SCS appears to have clinical value, demonstrated by some patients improving their paresthesia-pain overlap, as well as the ability to increase and even ‘steer’ paresthesia coverage. Key words: Spinal cord stimulation, pulse width, paresthesia, dermatome, implantable pulse generator, neurostimulation, chronic pain, neuropathic, dorsal column, dorsal root, chronaxie.

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