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      Comparison of 10-kHz High-Frequency and Traditional Low-Frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: 24-Month Results From a Multicenter, Randomized, Controlled Pivotal Trial

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          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.

          ABBREVIATIONS:

          IPG, implantable pulse generator

          MCID, minimal clinically important difference

          PI, permanent implant

          ODI, Oswestry Disability Index

          SCS, spinal cord stimulation

          VAS, Visual Analog Scale

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          Most cited references18

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          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: The SENZA-RCT Randomized Controlled Trial.

          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.
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            • Record: found
            • Abstract: not found
            • Article: not found

            Electrical inhibition of pain by stimulation of the dorsal columns: preliminary clinical report.

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              • Record: found
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              Is Open Access

              Sustained Effectiveness of 10 kHz High-Frequency Spinal Cord Stimulation for Patients with Chronic, Low Back Pain: 24-Month Results of a Prospective Multicenter Study

              Objective The aim of this study was to investigate the long-term efficacy and safety of paresthesia-free high-frequency spinal cord stimulation (HF10 SCS) for the treatment of chronic, intractable pain of the low back and legs. Design Prospective, multicenter, observational study. Method Patients with significant chronic low back pain underwent implantation of a spinal cord stimulator capable of HF10 SCS. Patients' pain ratings, disability, sleep disturbances, opioid use, satisfaction, and adverse events were assessed for 24 months. Results After a trial period, 88% (72 of 82) of patients reported a significant improvement in pain scores and underwent the permanent implantation of the system. Ninety percent (65 of 72) of patients attended a 24-month follow-up visit. Mean back pain was reduced from 8.4 ± 0.1 at baseline to 3.3 ± 0.3 at 24 months (P < 0.001), and mean leg pain from 5.4 ± 0.4 to 2.3 ± 0.3 (P < 0.001). Concomitantly to the pain relief, there were significant decreases in opioid use, Oswestry Disability Index score, and sleep disturbances. Patients' satisfaction and recommendation ratings were high. Adverse Events were similar in type and frequency to those observed with traditional SCS systems. Conclusions In patients with chronic low back pain, HF10 SCS resulted in clinically significant and sustained back and leg pain relief, functional and sleep improvements, opioid use reduction, and high patient satisfaction. These results support the long-term safety and sustained efficacy of HF10 SCS.
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                Author and article information

                Journal
                Neurosurgery
                Neurosurgery
                neu
                Neurosurgery
                Neurosurgery
                0148-396X
                1524-4040
                6 September 2016
                November 2016
                : 79
                : 5
                : 667-677
                Affiliations
                [* ]Center for Clinical Research and Carolina's Pain Institute, Winston-Salem, North Carolina;
                []Swedish Pain Center, Seattle, Washington;
                [§ ]The Pain Center of Arizona and HOPE Research Institute, Phoenix, Arizona;
                []Clinical and Regulatory Affairs, Nevro Corp., Menlo Park, California;
                []Millennium Pain Center, Bloomington, Illinois;
                [# ]Advanced Pain Therapy, PLLC, Hattiesburg, Mississippi;
                [** ]IPM Medical Group, Inc., Walnut Creek, California;
                [‡‡ ]Pain Consultants of Oregon, Eugene, Oregon;
                [§§ ]Comprehensive Pain & Rehabilitation, Pascagoula, Mississippi;
                [¶¶ ]Coastal Orthopedics and Pain Medicine, Bradenton, Florida
                Author notes
                Correspondence: Leonardo Kapural, MD, PhD, Carolinas Pain Institute, 145 Kimel Park Drive,Winston-Salem, NC 27103. E-mail: lkapural@ 123456ccrpain.com
                Article
                NEU-D-15-01398 00009
                10.1227/NEU.0000000000001418
                5058646
                27584814
                a6e94b6d-54fb-44dc-906b-fbbaf80d0a22
                Copyright © 2016 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the Congress of Neurological Surgeons

                This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CC BY-NC-ND), which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially.

                History
                : 12 October 2015
                : 09 July 2016
                Categories
                Research—Human—Clinical Trials
                Custom metadata
                TRUE

                back pain,chronic pain,leg pain,paresthesia,spinal cord stimulation

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