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      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

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          Abstract

          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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          Most cited references 14

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          High-frequency spinal cord stimulation for the treatment of chronic back pain patients: results of a prospective multicenter European clinical study.

          The objective of this prospective, open-label, multicenter European clinical trial was to quantify the efficacy and safety of a spinal cord stimulation (SCS) system that utilizes high-frequency (up to 10 kHz) waveforms, which do not produce paresthesia, for the treatment of chronic, intractable pain of the back and/or limbs. Eighty-three patients, with significant back pain, were recruited for a trial of high-frequency stimulation through two percutaneous eight-contact epidural leads. Patients' pain ratings, disability, sleep disturbances, and satisfaction, as well as complication rates, were assessed for up to six months. After a trial period, 88% (72 out of 82) of patients reported a significant improvement in visual analog scale (VAS) scores and underwent permanent implantation of the high-frequency SCS system. Mean back pain VAS of 8.4 was reduced to 2.7 at six months (p< 0.001). Mean leg pain VAS of 5.4 was reduced to 1.4 at six months (p< 0.001). Seventy-four percent of patients had greater than 50% back pain relief at six months. There were significant improvements in Oswestry disability score and sleep, and reductions in pain medication use. Adverse events observed were those seen with conventional SCS therapy--lead migration, wound infection, and pain around implant site. In a cohort of patients with difficult-to-treat chronic back pain, high-frequency SCS provided significant and sustained low back pain and leg pain relief to more than 70% of treated subjects. Notably, this was achieved without paresthesia. Patients also experienced significant improvement in disability and sleep. Overall, the results confirm a favorable safety and efficacy profile of the high-frequency SCS system. © 2012 International Neuromodulation Society.
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            Analgesic efficacy of high-frequency spinal cord stimulation: a randomized double-blind placebo-controlled study.

            Spinal cord stimulation is a recognized treatment of chronic neuropathic and vascular pain. Recent data suggest that the use of very high-frequency (HF) stimulation modes does produce analgesia without paresthesia. To compare the efficacy of HF stimulation (HF spinal cord stimulation [HFSCS]) and sham stimulation on the patient's global impression of change (PGIC), pain intensity, and quality of life. Forty patients who have achieved stable pain relief with conventional SCS have been recruited. After randomization, HFSCS and sham are initiated in a double-blind randomized two-period-crossover design. Complete data were available from 33 patients. The primary outcome was a minimal improvement in the PGIC. The proportion of patients responding under HFSCS was 42.4% (14/33 patients) vs. 30.3% (10/33 patients) in the sham condition. The mean benefit of HF vs. sham was not statistically significant with a proportion of 11.2% in favor of HFSCS (p = 0.30). There was a highly statistically significant "period effect," irrespective of treatment received, with 51.5% of patients (N = 17) improving at visit 3 vs. 21.2% (N = 7) at visit 5 (p = 0.006). The mean pain visual analog scale (VAS) on sham was 4.26 vs. 4.35 on HFSCS (p = 0.82) and the mean EuroQol five-dimensional (EQ-5D) index with HFSCS was 0.480 vs. 0.463 with sham (p = 0.78). This is the first randomized double-blind study on SCS. HFSCS was equivalent to sham for the primary outcome (improvement of PGIC) as well as for both the secondary outcomes (VAS and EQ-5D index). There was a highly statistically significant "period effect" (p = 0.006) with improved PGIC scores in the first study period regardless of the treatment. The same trend was seen for VAS and EQ-5D. It appears that the effect of HFSCS and sham is equal and only the order in the sequence, not the nature of the treatment, seems to dictate the effect. © 2013 International Neuromodulation Society.
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              Novel spinal cord stimulation parameters in patients with predominant back pain.

              To examine the feasibility of novel high-frequency spinal cord stimulation therapy in a cohort of patients with chronic predominant back pain during a four day, percutaneous trial. Prospective, multicenter open label pilot trial.  Twenty-four patients with back pain greater than leg pain who were candidates for spinal cord stimulation were trialed at five U.S. centers. Patients completed a percutaneous trial with a commercially available spinal cord stimulator. The implanted leads were then connected to the novel external stimulation device and patients were trialed for an additional four days. Pain intensity ratings, subjective descriptions, and patients' preference. There was significant improvement from baseline in overall pain scores (8.68 to 2.03, [p < 0.001]) and back pain scores (8.12 to 1.88, [p < 0.001]) with the investigational stimulation. The investigational stimulation was preferred to the commercially available systems in 21 of 24 patients (88%). Patients with predominant back pain reported a substantial reduction in overall pain and back pain when trialed with high-frequency spinal cord stimulation therapy. © 2013 International Neuromodulation Society.
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                Author and article information

                Journal
                Pain Med
                Pain Med
                pme
                Pain Medicine (Malden, Mass.)
                Wiley Periodicals, Inc (Oxford, UK )
                1526-2375
                1526-4637
                March 2014
                05 December 2013
                : 15
                : 3
                : 347-354
                Affiliations
                [* ]The Pain Management and Neuromodulation Centre, Guy's and St. Thomas' Hospital London, UK
                []Multidisciplinary Pain Centre, AZ Nikolaas St Niklaas, Belgium
                Author notes
                Reprint requests to: Adnan Al-Kaisy, MD, The Pain Management and Neuromodulation Centre, Guy's and St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK. Tel: +44 (0) 20-71883237; Fax: +44 (0) 20-7188-4719; E-mail: Adnan.Al-Kaisy@ 123456gstt.nhs.uk .

                Disclosure and Conflicts of Interest: AA and TS have received travel sponsorship and speaker fees from Nevro Corp and Medtronic; JPVB and IS have received travel sponsorship and speaker fees from Nevro Corp, Medtronic, Spinal Modulation, and Mainstay; SP has received travel reimbursement from Nevro Corp and Medtronic; DP does not declare any conflict of interest.

                [1]

                Both authors contributed equally to the conduct, analyses, and writing of this study.

                Article
                10.1111/pme.12294
                4282782
                24308759
                © 2013 The Authors. Pain Medicine published by Wiley Periodicals, Inc.

                This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

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                Original Research Articles

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