scholarly journals Sustained Long-Term Outcomes With Closed-Loop Spinal Cord Stimulation: 12-Month Results of the Prospective, Multicenter, Open-Label Avalon Study

Neurosurgery ◽  
2020 ◽  
Vol 87 (4) ◽  
pp. E485-E495 ◽  
Author(s):  
Marc Russo ◽  
Charles Brooker ◽  
Michael J Cousins ◽  
Nathan Taylor ◽  
Tillman Boesel ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Pain Relief ◽  
Spinal Cord Stimulation ◽  
Closed Loop ◽  
Leg Pain ◽  
Therapeutic Window ◽  
Long Term Outcomes ◽  
Open Label ◽  
Stimulus Pulse

Abstract BACKGROUND Spinal cord stimulation (SCS) activates the dorsal column fibers using electrical stimuli. Current SCS systems function in fixed-output mode, delivering the same stimulus regardless of spinal cord (SC) activation. OBJECTIVE To present long-term outcomes of a novel closed-loop SCS system that aims to maintain the SC activation near a set target level and within a therapeutic window for each patient. SC activation is measured through the evoked compound action potential (ECAP) generated by each stimulus pulse. METHODS Fifty patients with lower back and/or leg pain who were successfully trialed received a permanent system (Evoke; Saluda Medical, Sydney, Australia). Ratings of pain (visual analog scale), quality of life, function, sleep, and medication use were collected at baseline and at each visit. SC activation levels were reported in summary statistics. The therapeutic window for each individual patient was defined as the range of ECAP amplitudes between sensation threshold and uncomfortably strong stimulation. RESULTS At 12 mo, the proportion of patients with ≥50% relief was 76.9% (back), 79.3% (leg), and 81.4% (overall), and the proportion with ≥80% pain relief was 56.4% (back), 58.6% (leg), and 53.5% (overall). Patients spent a median of 84.9% of their time with stimulation in their therapeutic window, and 68.8% (22/32) eliminated or reduced their opioid intake. Statistically significant improvements in secondary outcomes were observed. CONCLUSION The majority of patients experienced more than 80% pain relief with stable SC activation, as measured by ECAP amplitude at 12 mo, providing evidence for the long-term effectiveness of the Evoke closed-loop SCS system.

scholarly journals Sustained Long-Term Outcomes With Closed-Loop Spinal Cord Stimulation: 12-Month Results of the Prospective, Multicenter, Open-Label Avalon Study

Neurosurgery ◽  
2021 ◽  
Vol 89 (Supplement_2) ◽  
pp. S24-S24
Author(s):  
Marc Russo ◽  
Charles Brooker ◽  
Michael J Cousins ◽  
Nathan Taylor ◽  
Tillman Boesel ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
Closed Loop ◽  
Long Term Outcomes ◽  
Open Label

scholarly journals 10 kHz spinal cord stimulation for the treatment of chronic back and/or leg pain: Summary of clinical studies

2020 ◽  
Vol 8 ◽  
pp. 205031212095136
Author(s):  
Thorsten Luecke ◽  
Deborah Edgar ◽  
Daniel Huse
Keyword(s):  
Quality Of Life ◽  
Spinal Cord ◽  
Pain Relief ◽  
Spinal Cord Stimulation ◽  
Clinical Studies ◽  
Response To Therapy ◽  
Leg Pain ◽  
Pubmed Database

Chronic pain has a major impact on sufferers and their families. The associated health care costs are substantial. In the context of increasing prevalence, effective treatment options are ever more important. 10 kHz spinal cord stimulation has been shown to effectively provide pain relief, aid in opioid reduction, and improve quality of life in patients with chronic intractable pain. The present review aims to summarize the clinical evidence related to the use of 10 kHz SCS in chronic back and/or leg pain. We searched the PubMed database between 2009 and 2 June 2020 for articles reporting clinical studies that included at least 10 human subjects permanently treated with a 10 kHz SCS system (Senza® system) for chronic back and/or leg pain for a minimum of 3 months. A randomized controlled trial (SENZA-RCT), as well as several prospective and retrospective studies, reported clinical outcomes in subjects with chronic back and leg pain treated with 10 kHz SCS. A high proportion of subjects (60%–80%) reported long-term response to therapy. Pain relief was provided without paresthesia. Other studies showed promising pain relief outcomes in subjects with back pain ineligible for spinal surgery, neuropathic limb pain, and in those with previously failed traditional low-frequency SCS. Most studies reported improved quality of life metrics and/or reduced opioid intake. Level 1 evidence has already been established for the use of 10 kHz SCS in treating chronic back and leg pain, corroborated by real-world, clinical experience. Exploratory studies also show the potential of the therapy in other refractory pain syndromes, although larger studies are desired to validate their findings. Overall, the literature suggests that 10 kHz SCS provides long-term pain relief in a high proportion of patients, along with improved quality of life and reduced opioid consumption.

scholarly journals Comparison of 10-kHz High-Frequency and Traditional Low-Frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain

Neurosurgery ◽  
2016 ◽  
Vol 79 (5) ◽  
pp. 667-677 ◽  
Author(s):  
Leonardo Kapural ◽  
Cong Yu ◽  
Matthew W. Doust ◽  
Bradford E. Gliner ◽  
Ricardo Vallejo ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Back Pain ◽  
Pain Relief ◽  
Spinal Cord Stimulation ◽  
High Frequency ◽  
Low Frequency ◽  
Leg Pain ◽  
Long Term Results ◽  
End Point

Abstract BACKGROUND: Pain relief with spinal cord stimulation (SCS) has focused historically on paresthesias overlapping chronically painful areas. A higher level evidence supports the use of SCS in treating leg pain than supports back pain, as it is difficult to achieve adequate paresthesia coverage, and then pain relief, in the low back region. In comparison, 10-kHz high-frequency (HF10 therapy) SCS therapy does not rely on intraoperative paresthesia mapping and remains paresthesia-free during therapy. OBJECTIVE: To compare long-term results of HF10 therapy and traditional low-frequency SCS. METHODS: A pragmatic randomized, controlled, pivotal trial with 24-month follow-up was conducted across 11 comprehensive pain treatment centers. Subjects had Visual Analog Scale scores of ≥5.0/10.0 cm for both back and leg pain, and were assigned randomly (1:1) to receive HF10 therapy or low-frequency SCS. The primary end point was a responder rate, defined as ≥50% back pain reduction from baseline at 3 months with a secondary end point at 12 months (previously reported). In this article, 24-month secondary results are presented. Non-inferiority was first assessed, and if demonstrated the results were tested for superiority. RESULTS: In the study, 198 subjects were randomized (101 HF10 therapy, 97 traditional SCS). One hundred seventy-one subjects (90 HF10 therapy, 81 traditional SCS) successfully completed a short-term trial and were implanted. Subjects averaged 54.9 ± 12.9 years old, 13.6 ± 11.3 years since diagnosis, 86.6% had back surgery, 88.3% were taking opioid analgesics. At 3 months, 84.5% of implanted HF10 therapy subjects were responders for back pain and 83.1% for leg pain, and 43.8% of traditional SCS subjects were responders for back pain and 55.5% for leg pain (P <.001 for both back and leg pain comparisons, non-inferiority and superiority). At 24 months, more subjects were responders to HF10 therapy than traditional SCS (back pain: 76.5% vs 49.3%; 27.2% difference, 95% CI, 10.1%-41.8%; P <.001 for non-inferiority and superiority; leg pain: 72.9% vs 49.3%; 23.6% difference, 95% CI, 5.9%-38.6%; P <.001 for non-inferiority and P =.003 for superiority). Also at 24 months, back pain decreased to a greater degree with HF10 therapy (66.9% ± 31.8%) than traditional SCS (41.1% ± 36.8%, P <.001 for non-inferiority and superiority). Leg pain also decreased to a greater degree with HF10 therapy (65.1% ± 36.0%) than traditional SCS (46.0% ± 40.4%, P <.001 for non-inferiority and P =.002 for superiority). CONCLUSION: This study demonstrates long-term superiority of HF10 therapy compared with traditional SCS in treating both back and leg pain. The advantages of HF10 therapy are anticipated to impact the management of chronic pain patients substantially.

scholarly journals Defining the Therapeutic Window (TW) for Spinal Cord Stimulation (SCS) Using Evoked Compound Action Potential (ECAP) Recordings: Results From the Evoke Study

Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Robert M Levy
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
Closed Loop ◽  
Compound Action Potential ◽  
Open Loop ◽  
Therapeutic Window ◽  
Perception Threshold ◽  
Electrical Field Strength ◽  
Evoked Compound Action Potential

Abstract INTRODUCTION Spinal cord stimulation (SCS) is an established treatment for chronic pain; however, long-term success remains suboptimal. Current SCS therapies are fixed-output and do not account for large variation in electrical field strength due to changes in distance between the electrode and spinal cord (SC). METHODS In Avalon, 50 subjects were implanted and programmed in closed-loop; in Evoke, 134 subjects were randomized into open-loop (OL-SCS) or closed-loop (CL-SCS). ECAPs, a measure of SC activation, are recorded following each stimulation pulse in both groups. Each subject's therapeutic window (TW) is determined individually as the ECAP amplitude range between sensation perception threshold and discomfort. Without a measure of SC activation (eg, ECAPs), TW can only be based on perception of intensity; however, stimulation can produce variable SC activation (ECAP amplitude) as the electrode to SC distance varies with movement. RESULTS In the Evoke Study, each subjects' TW was determined in the clinic, along with the clinician prescribed level. There was no statistical difference between the 2 groups' TWs; however, CL-SCS subjects spent significantly more time in the TW despite having equivalent therapeutic ranges. Long-term data showed a similar percentage of stimuli in the TW (83%-97%). CONCLUSION TW can be individually defined by ECAP amplitudes (measure of SC activation), removing the need to rely on subjective reports of intensity, which can vary over time and with movement.

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.

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