Dataset Information

10-kHz Spinal Cord Stimulation for Chronic Postsurgical Pain: Results From a 12-Month Prospective, Multicenter Study.

ABSTRACT:

Background

Chronic postsurgical pain (CPSP) can be caused by peripheral nerve injury (PNI) resulting from surgical procedures and has a significant neuropathic component. This prospective, single-arm study was conducted to document the effectiveness of 10-kHz spinal cord stimulation (10-kHz SCS) as a treatment for patients with CPSP.

Methods

Subjects with CPSP who were refractory to conventional medical interventions and reported pain scores of ?5 cm on a 10-cm VAS underwent trial stimulations lasting up to 14 days. Epidural leads were implanted at locations appropriate for the primary area of pain, and trials resulting in ?40% pain relief were considered successful. Subjects with successful trials underwent implantation with a permanent 10-kHz SCS system and were followed for 12 months after implantation.

Results

Of the 34 subjects who underwent trial stimulation, 1 was withdrawn early and 29 (87.9%) had a successful trial and received a permanent implant. After 12 months of treatment, the mean VAS score decreased by 6.5 cm, the response rate was 88.0% (22/25), and 18 subjects (62.1%) were remitters with VAS scores sustained at ?3.0 cm. Scores for all components of the short-form McGill Pain Questionnaire 2 were significantly reduced, including affective descriptors of pain. Pain catastrophizing and vigilance, patient function, physical and mental well-being, and sleep quality all improved over the course of the study. No neurologic deficits reported in the study.

Conclusions

10-kHz SCS is effective and tolerated in patients with CPSP, and further study of its clinical application in this population is warranted.

SUBMITTER: Gupta M

PROVIDER: S-EPMC7754504 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Publications

10-kHz Spinal Cord Stimulation for Chronic Postsurgical Pain: Results From a 12-Month Prospective, Multicenter Study.

Gupta Mayank M Scowcroft James J Kloster Daniel D Guirguis Maged M Carlson Jonathan J McJunkin Tory T Chaiban Gassan G Israel Atef A Subbaroyan Jeyakumar J

Pain practice : the official journal of World Institute of Pain 20200723 8

<h4>Background</h4>Chronic postsurgical pain (CPSP) can be caused by peripheral nerve injury (PNI) resulting from surgical procedures and has a significant neuropathic component. This prospective, single-arm study was conducted to document the effectiveness of 10-kHz spinal cord stimulation (10-kHz SCS) as a treatment for patients with CPSP.<h4>Methods</h4>Subjects with CPSP who were refractory to conventional medical interventions and reported pain scores of ≥5 cm on a 10-cm VAS underwent trial ...[more]

PMID: 32585742

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Project description: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 generatorMCID, minimal clinically important differencePI, permanent implantODI, Oswestry Disability IndexSCS, spinal cord stimulationVAS, Visual Analog Scale.

Project description:To compare pragmatic real-world 10-kHz high-frequency spinal cord stimulation (HF-SCS) outcomes at a single academic center to the industry-sponsored SENZA-RCT and Stauss et al. study. This single-center retrospective study included patients with refractory back or limb pain trialed and/or permanently implanted with the Nevro HF-SCS system from 2016 to 2021. Demographic and outcome data were obtained from the electronic medical record (EMR) and real-world global database maintained by Nevro Corp. Data obtained from the global database were confirmed using the EMR. Main outcome measures included positive responder status (≥50% patient-reported percentage pain reduction (PRPPR)), improvement in function, improvement in sleep, and reduction in pain medication usage. Comparison groups included patient outcomes from the SENZA-RCT and Stauss et al. study. Patients (N = 147) trialed with HF-SCS were reviewed, with data available for 137. Positive trialed patient responder rate (≥50% PRPPR) was 77% (106/137, 95CI 70-84%) vs. 87% (1393/1607, 95CI 85-89%) Stauss et al. vs. 93% (90/97, 95CI 88-98%) SENZA-RCT HF-SCS. At the last available follow-up, positive implanted patient responder rate was 73% (58/80, 95CI 63-82%) vs. 78% (254/326, 95CI 73-82%) Stauss et al. vs. 79% (71/90, 95CI 70-87%) SENZA-RCT HF-SCS. Sixty-seven percent (59/88, 95CI 57-77%) reported improved function vs. 72% (787/1088, 95CI 70-75%) Stauss et al.; 45% (31/69, 95CI 33-57%) reported improved sleep vs. 68% (693/1020, 95CI 65-71%) Stauss et al. and 16% (9/56, 95CI 6-26%) reported decrease in medication use vs. 32% (342/1070, 95CI 29-35%) Stauss et al. Patient responder rates in this retrospective pragmatic real-world study of HF-SCS are consistent with previous industry-sponsored studies. However, improvements in quality-of-life measures and reduction in medication usage were not as robust as reported in industry-sponsored studies. The findings of this non-industry-sponsored, independent study of HF-SCS complement those of previously published studies by reporting patient outcomes collected in the absence of industry sponsorship.

Dataset Information

10-kHz Spinal Cord Stimulation for Chronic Postsurgical Pain: Results From a 12-Month Prospective, Multicenter Study.

Background

Methods

Results

Conclusions

Publications

10-kHz Spinal Cord Stimulation for Chronic Postsurgical Pain: Results From a 12-Month Prospective, Multicenter Study.

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