Durability of High-Frequency 10-kHz Spinal Cord Stimulation for Patients With Painful Diabetic Neuropathy Refractory to Conventional Treatments: 12-Month Results From a Randomized Controlled Trial

Petersen, Erika; Stauss, Thomas; Scowcroft, James; Brooks, Elizabeth S.; White, Judith L.; Sills, Shawn; Amirdelfan, Kasra; Guirguis, Maged; Xu, Jijun; Yu, Cong; Nairizi, Ali; Patterson, Denis; Tsoulfas, Kostandinos C; Creamer, Michael; Galan, Vincent; Bundschu, Richard; Mehta, Neel; Sayed, Dawood; Lad, Shivanand P.; DiBenedetto, David J; Sethi, Khalid A.; Goree, Johnathan; Bennett, Matthew T.; Harrison, Nathan; Israel, Atef F; Chang, P; Wu, Paul; Argoff, Charles E.; Nasr, Christian; Taylor, Rod S; Caraway, David; Mekhail, Nagy

doi:10.2337/dc21-1813

Cited by 26 publications

(33 citation statements)

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“…After a full-text assessment of the remaining 18 citations, 6 articles met the eligibility criteria. These included 3 individual RCT reports by Petersen et al [ 38 ], Slangen et al [ 39 ], and de Vos et al [ 40 ], and 3 additional publications of extended follow-up data from the Petersen and Slangen RCTs [ 41 , 42 , 50 ].…”

Section: Resultsmentioning

confidence: 99%

“…However, long-term follow-up data (5 years) suggest that the effectiveness of LF-SCS diminishes over time [ 39 , 41 , 42 ], a phenomenon also documented in other neuropathic pain conditions [ 12 , 27 , 43 , 44 , 45 , 46 , 47 , 48 , 49 ]. More recently, analyses of 6- and 12-month follow-up data from the SENZA-PDN trial showed that 10 kHz SCS provided sustained pain relief over time compared with CMM [ 50 ]. Studies in other chronic pain syndromes also suggest that the therapy is effective and durable after several years [ 11 , 16 , 51 , 52 , 53 , 54 ].…”

Section: Introductionmentioning

confidence: 99%

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Indirect Comparison of 10 kHz Spinal Cord Stimulation (SCS) versus Traditional Low-Frequency SCS for the Treatment of Painful Diabetic Neuropathy: A Systematic Review of Randomized Controlled Trials

Hoelzer¹,

Edgar²,

et al. 2022

Biomedicines

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Spinal cord stimulation (SCS) is increasingly used to treat painful diabetic neuropathy (PDN). At the time of a recent meta-analysis in this field, data were only available from randomized controlled trials (RCTs) of traditional low-frequency SCS (LF-SCS). However, outcomes from high-frequency 10 kHz SCS treatment are now available. Our study aimed to systematically review the contemporary evidence for SCS in patients with lower limb pain due to PDN and include an indirect comparison of the high- and low-frequency modalities. We searched the PubMed/CENTRAL databases up to 18 August 2022, for peer-reviewed RCTs of SCS that enrolled PDN patients with lower limb pain symptoms. The quality of the evidence was assessed with the Cochrane Risk of Bias tool. Using SCS treatment arm data from the RCTs, we indirectly compared the absolute treatment effect of 10 kHz SCS and LF-SCS. Results are presented in tables and forest plots. This systematic review was reported according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) 2020 guidelines. Three RCTs met our eligibility criteria, including the recent 10 kHz SCS RCT (N = 216, 90 implanted) and 2 others that examined LF-SCS (N = 36, 17 implanted; N = 60, 37 implanted). Our analysis of 6-month data found clinically meaningful pain relief with each SCS modality. However, significantly greater pain reduction was identified for 10 kHz SCS over LF-SCS: average pain reduction in the 10 kHz SCS cohort was 73.7% compared with 47.5% in the pooled LF-SCS group (p < 0.0001). In the permanent implant subset, the 50% pain reduction responder rate was 83.3% in the 10 kHz SCS cohort versus 63.0% in the pooled LF-SCS group (p = 0.0072). The overall risk of bias of each included RCT was deemed high, mainly due to the absence of patient blinding. Our analysis indicates that paresthesia-free 10 kHz SCS can provide superior pain relief and responder rate over LF-SCS for managing PDN patients refractory to conventional medical management.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Indirect Comparison of 10 kHz Spinal Cord Stimulation (SCS) versus Traditional Low-Frequency SCS for the Treatment of Painful Diabetic Neuropathy: A Systematic Review of Randomized Controlled Trials

Hoelzer¹,

Edgar²,

et al. 2022

Biomedicines

View full text Add to dashboard Cite

show abstract

“…The detailed neurologic examination has been previously described. 27 , 28 Although care was taken to standardize the examination, interassessor variability should be considered a limitation. Further studies with more objective metrics for neurologic testing are needed to better understand and substantiate these findings.…”

Section: Discussionmentioning

confidence: 99%

“…Methods have been described previously. 27 , 28 , 30 This study was designed to be a pragmatic clinical trial 31 with 18 US sites. The patients recruited reflect typical clinical practice as do the interventions used in the comparator arm.…”

Section: Methodsmentioning

confidence: 99%