Spinal cord stimulation for the management of painful diabetic neuropathy: a systematic review and meta-analysis of individual patient and aggregate data

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.

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

“…In addition, the necessity for data conversion in the LF-SCS studies may have impacted the fidelity of data pooling and between-study comparisons. Notably, Slangen et al, did not measure overall pain but instead assessed separate day and night pain in anticipation of a potential diurnal effect [ 39 ]; thus, we used the averaged pain intensity in our analysis, as per the Duarte et al, meta-analysis [ 55 ]. However, we cannot interpret whether individual patients in the Slangen study responded both during the day and night, nor how they would have rated their overall pain.…”

“…Next, we determined the mITT mean pain intensity reductions with 95% CI at 6 months for each of the 4 groups, including data conversion as needed to allow consistent comparison between studies (as per the Duarte et al, meta-analysis [ 55 ]). The mean pain intensity reduction for the 10 kHz SCS group was derived from the mITT individual patient data (IPD), which allowed the calculation of individual absolute pain intensity reduction at 6 months.…”

“…A recent systematic review and meta-analysis assessed the effectiveness of SCS for the management of PDN [ 55 ]. At the time of the analysis, data were only available from RCTs that compared LF-SCS with CMM.…”

Application and future trends of spinal cord stimulation

“…About one in every three diabetic patients is affected by painful diabetic neuropathy (PDN) [21], which is defined as pain arising from peripheral somatosensory system abnormalities in diabetic people. PDN is characterized by various sorts of pain feelings occurring with paresthesias or allodynia and significantly impairs quality of life.…”

No Zero Sum in Opioids for Chronic Pain: Neurostimulation and the Goal of Opioid Sparing, Not Opioid Eradication

“…Not only do the newer units provide paresthesia-free or minimal-paresthesia analgesia, but they have been demonstrated through myriad systematic reviews to be safe, clinically effective, and even cost-effective in treating neuropathic pain of axial spine or radicular origin, as well as radicular symptoms, in addition to other types of neuropathic pain across different populations. [10][11][12][13][14][15][16][17][18][19][20][21][22] While SCS has been a treatment option for chronic pain for only half a century, accounts of the use of opioids date back to at least 1550 BC, when an ancient Egyptian pharmacopoeia contained prescriptions for uses of opium. 23 Although effective as analgesics for many types of pain, opioids' efficacy for neuropathic pain has been determined to be extremely limited, at best.…”