Spinal Cord Stimulation for the Management of Painful Diabetic Neuropathy

A Systematic Review and Meta-analysis of Individual Patient and Aggregate Data

Rui V. Duarte; Sarah Nevitt; Michelle Maden; Kaare Meier; Rod S. Taylor; Sam Eldabe; Cecile C. de Vos

Disclosures

Pain. 2021;162(11):2635-2643. 

In This Article

Abstract and Introduction

Abstract

Spinal cord stimulation (SCS) has been suggested as a treatment option for patients with painful diabetic neuropathy (PDN). We conducted a systematic review and undertook a meta-analysis on individual patient data from randomised controlled trials (RCTs) to assess the effectiveness of SCS for the management of PDN. Electronic databases were searched from inception to May 2020 for RCTs of SCS for PDN. Searches identified 2 eligible RCTs (total of 93 patients with PDN) and 2 long-term follow-up studies of one of the RCTs. Individual patient data were obtained from the authors of one of these RCTs. Meta-analysis showed significant and clinically meaningful reductions in pain intensity for SCS compared with best medical therapy alone, pooled mean difference (MD) −3.13 (95% confidence interval [CI]: −4.19 to −2.08) on a 10-point scale at the 6-month follow-up. More patients receiving SCS achieved at least a 50% reduction in pain intensity compared with best medical therapy, pooled risk ratio 0.08 (95% CI: 0.02–0.38). Increases were observed for health-related quality of life assessed as EQ-5D utility score (pooled MD 0.16, 95% CI: 0.02–0.30) and visual analogue scale (pooled MD 11.21, 95% CI: 2.26–20.16). Our findings demonstrate that SCS is an effective therapeutic adjunct to best medical therapy in reducing pain intensity and improving health-related quality of life in patients with PDN. Large well-reported RCTs with long-term follow-up are required to confirm these results.

Introduction

Diabetes mellitus is the most common cause of peripheral neuropathy in the developed world and the most common complication of diabetes affecting up to 50% of people with diabetes.[11,34] Approximately one in 3 people with diabetes experience painful diabetic neuropathy (PDN).[1] Painful diabetic neuropathy is defined as pain arising as a result of abnormalities in the peripheral somatosensory system in people with diabetes[37] and has been found to significantly lower quality of life and substantially increase health costs associated with diabetes.[23] A recent cohort study reported that patients with PDN were 2 times more likely to use opioids and over 16 times more likely to have an amputation than patients with diabetes mellitus without neuropathy.[15]

Spinal cord stimulation (SCS) is a recognised option for the management of chronic neuropathic pain conditions, such as failed back surgery syndrome[16] and complex regional pain syndrome.[13] Several case series and case reports have suggested SCS as potentially effective for the management of PDN,[2,5,8,18,25,35] but higher-level evidence from randomised controlled trials (RCTs) is limited. A recent systematic review conducted a meta-analysis to evaluate change in pain severity based on 2 RCTs.[26] Pain severity is the only outcome evaluated in this systematic review. Health-related quality of life (HRQoL) that can be significantly affected by PDN has been shown to improve after SCS, which would be an important addition.[10]

Individual patient data (IPD) from RCTs allow to collect, check, and reanalyse individual-level data from all studies addressing a similar research question.[31] The aim of this systematic review was to identify and conduct a meta-analysis on IPD from RCTs of SCS for PDN to assess the effectiveness of SCS compared with usual care and other treatment alternatives for the management of PDN.

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