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
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 kH...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-10-01
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| Series: | Biomedicines |
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| Online Access: | https://www.mdpi.com/2227-9059/10/10/2630 |
| _version_ | 1827651398142001152 |
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| author | Bryan C. Hoelzer Deborah Edgar Shiao-Ping Lu Rod S. Taylor |
| author_facet | Bryan C. Hoelzer Deborah Edgar Shiao-Ping Lu Rod S. Taylor |
| author_sort | Bryan C. Hoelzer |
| collection | DOAJ |
| description | 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 (<i>N</i> = 216, 90 implanted) and 2 others that examined LF-SCS (<i>N</i> = 36, 17 implanted; <i>N</i> = 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 (<i>p</i> < 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 (<i>p</i> = 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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| id | doaj.art-a334c12b5fe840d89365e345c7e7a5d4 |
| institution | Directory Open Access Journal |
| issn | 2227-9059 |
| language | English |
| last_indexed | 2024-03-09T20:38:06Z |
| publishDate | 2022-10-01 |
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| spelling | doaj.art-a334c12b5fe840d89365e345c7e7a5d42023-11-23T23:06:13ZengMDPI AGBiomedicines2227-90592022-10-011010263010.3390/biomedicines10102630Indirect 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 TrialsBryan C. Hoelzer0Deborah Edgar1Shiao-Ping Lu2Rod S. Taylor3Medical Director, Southwest Spine and Pain Center, Provo, UT 84059, USACommexus Ltd., Dunblane FK15 0DF, UKLucid Consulting, Los Altos, CA 94024, USAMRC/CSO Social and Public Health Sciences Unit & Robertson Centre for Biostatistics, School of Health and Well Being, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow G12 8QQ, UKSpinal 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 (<i>N</i> = 216, 90 implanted) and 2 others that examined LF-SCS (<i>N</i> = 36, 17 implanted; <i>N</i> = 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 (<i>p</i> < 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 (<i>p</i> = 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.https://www.mdpi.com/2227-9059/10/10/2630painful diabetic neuropathyperipheral neuropathyspinal cord stimulation10 kHz SCSdiabetesneuropathic pain |
| spellingShingle | Bryan C. Hoelzer Deborah Edgar Shiao-Ping Lu Rod S. Taylor 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 Biomedicines painful diabetic neuropathy peripheral neuropathy spinal cord stimulation 10 kHz SCS diabetes neuropathic pain |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | painful diabetic neuropathy peripheral neuropathy spinal cord stimulation 10 kHz SCS diabetes neuropathic pain |
| url | https://www.mdpi.com/2227-9059/10/10/2630 |
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