Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain

2015 ◽  
Vol 123 (4) ◽  
pp. 851-860 ◽  
Author(s):  
Leonardo Kapural ◽  
Cong Yu ◽  
Matthew W. Doust ◽  
Bradford E. Gliner ◽  
Ricardo Vallejo ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Back Pain ◽  
Spinal Cord Stimulation ◽  
Pain Treatment ◽  
Low Frequency ◽  
Leg Pain ◽  
Intractable Pain ◽  
Limited Effectiveness ◽  
Provide Pain Relief

Abstract Background: Current treatments for chronic pain have limited effectiveness and commonly known side effects. Given the prevalence and burden of intractable pain, additional therapeutic approaches are desired. Spinal cord stimulation (SCS) delivered at 10 kHz (as in HF10 therapy) may provide pain relief without the paresthesias typical of traditional low-frequency SCS. The objective of this randomized, parallel-arm, noninferiority study was to compare long-term safety and efficacy of SCS therapies in patients with back and leg pain. Methods: A total of 198 subjects with both back and leg pain were randomized in a 1:1 ratio to a treatment group across 10 comprehensive pain treatment centers. Of these, 171 passed a temporary trial and were implanted with an SCS system. Responders (the primary outcome) were defined as having 50% or greater back pain reduction with no stimulation-related neurological deficit. Results: 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 < 0.001 for both back and leg pain comparisons). The relative ratio for responders was 1.9 (95% CI, 1.4 to 2.5) for back pain and 1.5 (95% CI, 1.2 to 1.9) for leg pain. The superiority of HF10 therapy over traditional SCS for leg and back pain was sustained through 12 months (P < 0.001). HF10 therapy subjects did not experience paresthesias. Conclusion: HF10 therapy promises to substantially impact the management of back and leg pain with broad applicability to patients, physicians, and payers.

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 Long-term quality of life improvement for chronic intractable back and leg pain patients using spinal cord stimulation: 12-month results from the SENZA-RCT

2018 ◽  
Vol 27 (8) ◽  
pp. 2035-2044 ◽  
Author(s):  
Kasra Amirdelfan ◽  
Cong Yu ◽  
Matthew W. Doust ◽  
Bradford E. Gliner ◽  
Donna M. Morgan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
Leg Pain ◽  
Life Improvement ◽  
Pain Patients

scholarly journals High-Frequency Spinal Cord Stimulation at T9/10 in Patients With Failed Back Surgery Syndrome

Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Naoki Higashiyama ◽  
Takuro Endo ◽  
Taku Sugawara
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
High Frequency ◽  
Low Frequency ◽  
The Elderly ◽  
Failed Back Surgery Syndrome ◽  
Leg Pain ◽  
Effective Treatment Option ◽  
Failed Back Surgery ◽  
Back Surgery

Abstract INTRODUCTION Spinal cord stimulation (SCS) is an effective treatment option for low back pain and radicular leg pain of failed back surgery syndrome (FBSS). In a recent study, high-frequency spinal cord stimulation (HFSCS) was found to be more effective in treating chronic pain than traditional paresthesia-based low-frequency SCS (paresthesia SCS). The purpose of this study is to evaluate the efficacy of paresthesia SCS and HFSCS in improving outcomes. METHODS We retrospectively reviewed the outcomes of patients who underwent paresthesia SCS or HFSCS between September 2016 and January 2019. Paresthesia SCS is generally characterized by programming stimulation parameters such that the patient experiences paresthesia, and the paresthesia topography overlaps the pain topography as much as possible. The patient in HFSCS had a placement of cylindrical lead at levels T9-10. Patients were programmed with the electrode overlying the inferior endplate of T9 (+) and the electrode overlying the superior endplate of T10 (–). RESULTS A total of 14 patients (4 males, 10 females) underwent paresthesia SCS implantation. Mean age was 77.2 ± 9.6 yr. A total of 5 patients (2 males, 3 females) underwent HFSCS implantation. Mean age was 78.2 ± 7.5 yr. Operative time was shorter for the HFSCS group compared to the paresthesia SCS group (53.4 ± 4.8 min vs 82.9 ± 20.3 min, respectively; P < .001). A total of 5 out of 5 patients in the HFSCS group (100%) and 10 out of 14 patients in the paresthesia SCS group (71.4%) achieved the outcome of 50% pain relief (P = .25) CONCLUSION To confirm paresthesia during the procedure in the elderly may be complicated by hearing/language difficulties or by sedative-related confusion. Compared to paresthesia SCS, HFSCS allows for lower operative times and a more efficient and accurate positioning of the electrodes.

scholarly journals Long-Term Improvements in Chronic Axial Low Back Pain Patients Without Previous Spinal Surgery: A Cohort Analysis of 10-kHz High-Frequency Spinal Cord Stimulation over 36 Months

Pain Medicine ◽  
2017 ◽  
Vol 19 (6) ◽  
pp. 1219-1226 ◽  
Author(s):  
Adnan Al-Kaisy ◽  
Stefano Palmisani ◽  
Thomas E Smith ◽  
Roy Carganillo ◽  
Russell Houghton ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Low Back Pain ◽  
Back Pain ◽  
Spinal Cord Stimulation ◽  
High Frequency ◽  
Spinal Surgery ◽  
Cohort Analysis ◽  
Low Back ◽  
Pain Patients

New Trends in Neuromodulation for the Management of Neuropathic Pain

Neurosurgery ◽  
2002 ◽  
Vol 50 (4) ◽  
pp. 690-704 ◽  
Author(s):  
Kenneth M. Aló ◽  
Jan Holsheimer
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
Clinical Results ◽  
Intractable Pain ◽  
Long Term Effects ◽  
Long Term Outcomes ◽  
Dorsal Columns ◽  
Painful Area ◽  
Electronic Field

Abstract SINCE ITS FIRST application in 1967, the methodology and technology of spinal cord stimulation for the management of chronic, intractable pain have evolved continuously. Despite these developments and improved knowledge of the effects of spinal anatomy and epidural contact configuration on paresthesia coverage, the clinical results of spinal cord stimulation—particularly the long-term effects—are still unsatisfactory in many patients. This dissatisfaction has come primarily from the failure of single-electrode configurations to provide consistent paresthesia coverage of the entire painful area. Therefore, new approaches were developed during the late 1990s that attempted to selectively cover one or more dermatomes with paresthesia as well as to provide sequential stimulation of different anatomic sites. These approaches have been applied both intraspinally and extraspinally by stimulating either the spinal nerves or the dorsal columns. To target parts of the latter, different methods have been developed and tested using either two-dimensional contact configurations or electronic field steering. These developments hold promise for improving long-term outcomes as well as increasing the number of pain conditions that can be treated with neuromodulation therapy. In this review, the history, theoretical basis, and evolution of these methodologies, as well as the ways in which they represent new trends in neuromodulation, are discussed.

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 Is Impedance a Parameter to be Taken into Account in Spinal Cord Stimulation?

2007 ◽  
Vol 4;10 (7;4) ◽  
pp. 533-540
Author(s):  
David Abejon
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
Pain Treatment ◽  
Energy Requirement ◽  
Age Groups ◽  
Primary Objective ◽  
Intractable Pain ◽  
Perception Threshold ◽  
Implanted Electrodes ◽  
Significant Difference

Background: Over the last few decades, spinal cord stimulation (SCS) has become one of the main treatments in the therapeutic arsenal available to pain treatment units. New stimulation systems have been developed and the indications of neurostimulation have been expanded. The premises for a successful technique remain the same; good patient selection, good surgical technique, and good management of electrical parameters when programming. Design: An observational report. Objectives: The primary objective of the study was to determine the relationship between changes in impedance (R) and energy requirement (E) elicited by changes in patients posture. The postures analyzed were supine (S), sitting (SI), standing (ST), and walking (W). As a second objective, the difference produced in the energy requirement when changing posture was analyzed. Methods: A study was carried out in 70 patients with chronic intractable pain implanted with a neurostimulation system between January 2000 and March 2006. We define the perception threshold (Tp); the discomfort threshold (Td); and the therapeutic threshold (Tt). The amplitude of perception was measured in mA. With the resulting data, the therapeutic range (TR) was determined. After performing all measurements with the patient in the ST position, the neurostimulation system was shut off and the patient maintained in the other position for 5 minutes before performing the measurements. The variables R and E were compared by age groups, sex, implant duration, and the time since implant placement. Patients were divided into groups according to whether the location of the implanted electrodes was cervical or thoracic. The full analysis by age, sex, and implant duration was performed in the cervical and thoracic implant groups. Results: No correlation was found between impedance and posture. When the results for R and E were analyzed by sex and age, no statistical differences were found in any of the values in any position. The analysis of time since implant greater than or less than 6 months did not find differences in the energy requirement, although there was a significant difference in the impedance value when patients were in the S position. No significant differences were observed in the analysis by age groups. Key words: Impedance, posture change, spinal cord stimulation

scholarly journals High Frequency Spinal Cord Stimulation for Complex Regional Pain Syndrome: A Case Report

2017 ◽  
Vol 1 (21;1) ◽  
pp. E177-E182
Author(s):  
Alan D. Kaye
Keyword(s):  
Spinal Cord ◽  
Case Report ◽  
Complex Regional Pain Syndrome ◽  
Spinal Cord Stimulation ◽  
High Frequency ◽  
Therapeutic Option ◽  
Low Frequency ◽  
Pain Syndrome ◽  
Leg Pain ◽  
Caucasian Woman

Complex regional pain syndrome (CRPS) is a chronic, debilitating, neuropathic pain condition which is often misdiagnosed, difficult to manage, and lacks proven methods for remission. Most available methods provide some relief to a small percentage of patients. Recent FDA approval and superiority of the Nevro Senza 10-kHz high frequency (HF10) spinal cord stimulation (SCS) therapy over traditional low-frequency spinal cord stimulation for treatment of chronic back and leg pain may provide a new interventional therapeutic option for patients suffering from CRPS. We provide a case report of a 53-year-old Caucasian woman who suffered with CRPS in the right knee and thigh for over 7 years. Implantation of the HF10 device provided over 75% relief of pain, erythema, heat, swelling, and tissue necrosis to the entire region within 1 month of treatment. Because the HP10 therapy provides pain relief without paresthesia typical of traditional low-frequency, this system may provide relief for patients suffering from chronic pain. Key words: Complex regional pain syndrome, spinal cord stimulation, Nevro Senza HF10, erythema, knee, thigh

scholarly journals Wireless High-Frequency Spinal Cord Stimulation (10 kHz) Compared with Multiwaveform Low-Frequency Spinal Cord Stimulation in the Management of Chronic Pain in Failed Back Surgery Syndrome Subjects: Preliminary Results of a Multicenter, Prospective Randomized Controlled Study

Pain Medicine ◽  
2019 ◽  
Vol 20 (10) ◽  
pp. 1971-1979 ◽  
Author(s):  
Robert Bolash ◽  
Michael Creamer ◽  
Richard Rauck ◽  
Payam Vahedifar ◽  
Aaron Calodney ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Chronic Pain ◽  
Spinal Cord Stimulation ◽  
High Frequency ◽  
Low Frequency ◽  
Failed Back Surgery Syndrome ◽  
Leg Pain ◽  
Trial Period ◽  
Failed Back Surgery ◽  
Back Surgery

Abstract Background This study aimed to evaluate the wireless Freedom Spinal Cord Stimulator (WSCS) System for the treatment of chronic back and/or leg pain associated with failed back surgery syndrome (FBSS) refractory to standard medical treatment utilizing 10-kHz stimulation (high-frequency [HF]) in comparison with 10–1,500-Hz stimulation (low-frequency [LF]) waveforms. Methods Ninety-nine subjects were randomized in a 1:1 ratio to receive either HF or LF stimulation waveforms utilizing the same Freedom WSCS System. All subjects were implanted with two 8-electrode arrays in the exact same anatomical positions within the dorsal epidural spinal column, with the top electrode positioned at the T8 and T9 vertebrae levels, respectively, and the wireless receiver placed under the skin in a subcutaneous pocket. Results Seventy-two (HF: N = 38; LF: N = 34) subjects had completed the six-month follow-up after an initial 30-day trial period at the time of this report. For both the HF and LF arms, mean visual analog scale (VAS) scores for back and leg pain decreased significantly: 77% and 76%, respectively, for the HF arm and 64% and 64%, respectively, for the LF arm. In addition, most subjects experienced significant improvements in VAS, Oswestry Disability Index, European Quality of Life 5 Dimension questionnaire, Patient Global Impression of Change, and sleep duration. Conclusions These preliminary results demonstrate that WSCS devices can reduce FBSS chronic pain substantially with both LF and HF stimulation waveforms over a seven-month period (30-day trial period and six-month post-trial evaluation).

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