Long-Term Evaluation of Spinal Cord Stimulation in Patients With Painful Diabetic Polyneuropathy: An Eight-to-Ten–Year Prospective Cohort Study

Zuidema, Xander; Daal, Elke van; Geel, Iris van; Geus, Thomas J de; Kuijk, Sander M J van; Galan, Bastiaan E. de; Meij, Nelleke de; Zundert, Jan Van

doi:10.1016/j.neurom.2022.12.003

Cited by 11 publications

(11 citation statements)

References 24 publications

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“…The most consistent objective finding is that PDPN is associated with more profound sensory loss than DPN. 4 Risk factors for developing PDPN include: (1) longer disease duration; (2) female gender; (3) dyslipidemia; (4) existence of other complications of DM; (5) obesity; (6) older age; (7) smoking; (8) high alcohol intake; (9) HbA1C levels; (10) sensory phenotype and severity of neuropathy; (11) genotype (tetrodotoxin sensitive sodium channels NaV1.3, NaV 1.7, NaV 1.8, and NaV1.9, elevated levels of miR-146a, miR-98, and miR-155); (12) increased serum levels of TNF-alpha and other inflammatory cytokines and chemokines; (13) increased methylglyoxal (MGO) (activation TRPA1 and NaV1.8); (14) decreased serum Vitamin D; (15) decreased blood flow (increased hypoxia-inducible factor 1-alpha (HIF 1α) and von Willebrand factor (vWF). 6,21,[23][24][25][26][27] Although the complex pathogenesis of PDPN is not fully understood, different pathophysiological mechanisms have been hypothesized (Figures 1 and 2).…”

Section: E Pi De M Iology a N D Pat Hoph Ysiologymentioning

confidence: 99%

“…In paresthesia-based SCS, 65% of responders are likely to still benefit from this therapy even after 8-10 years of treatment. 7 Long-term treatment failure was associated with greater severity of neuropathy. 89 In 10 kilohertz SCS (HF-10) stimulation, 63.6% and 85% of patients experienced ≥50% pain reduction after 1 year of treatment in intention to treat (ITT) and modified intention to treat (mITT) analyses, respectively.…”

Section: Minimal Invasive Treatmentmentioning

confidence: 99%

“…102 Hardware failure (eg, lead fractures, implanted pulse generator (IPG), and lead migrations), pocket pain, and loss of therapeutic effect are frequently reported complications related to SCS treatment and have been reported up to 10 years of follow-up. 7,103 Infection at the IPG site occurs in around 5-10% of cases and can usually be treated with antibiotics and removal of the implant. 1 Technical adverse events can be solved by lead replacement, repositioning of the pulse generator, or reprogramming of stimulation parameters.…”

Section: Complications Of Interventional Managementmentioning

confidence: 99%

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4. Painful diabetic polyneuropathy

Zuidema,

de Galan,

Brouwer

et al. 2023

Pain Practice

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IntroductionPain as a symptom of diabetic polyneuropathy (DPN) significantly lowers quality of life, increases mortality and is the main reason for patients with diabetes to seek medical attention. The number of people suffering from painful diabetic polyneuropathy (PDPN) has increased significantly over the past decades.MethodsThe literature on the diagnosis and treatment of diabetic polyneuropathy was retrieved and summarized.ResultsThe etiology of PDPN is complex, with primary damage to peripheral nociceptors and altered spinal and supra‐spinal modulation. To achieve better patient outcomes, the mode of diagnosis and treatment of PDPN evolves toward more precise pain‐phenotyping and genotyping based on patient‐specific characteristics, new diagnostic tools, and prior response to pharmacological treatments. According to the Toronto Diabetic Neuropathy Expert Group, a presumptive diagnosis of “probable PDPN” is sufficient to initiate treatment. Proper control of plasma glucose levels, and prevention of risk factors are essential in the treatment of PDPN. Mechanism‐based pharmacological treatment should be initiated as early as possible. If symptomatic pharmacologic treatment fails, spinal cord stimulation (SCS) should be considered. In isolated cases, where symptomatic pharmacologic treatment and SCS are unsuccessful or cannot be used, sympathetic lumbar chain neurolysis and/or radiofrequency ablation (SLCN/SLCRF), dorsal root ganglion stimulation (DRGs) or posterior tibial nerve stimulation (PTNS) may be considered. However, it is recommended that these treatments be applied only in a study setting in a center of expertise.ConclusionsThe diagnosis of PDPN evolves toward pheno‐and genotyping and treatment should be mechanism‐based.

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Section: E Pi De M Iology a N D Pat Hoph Ysiologymentioning

confidence: 99%

Section: Minimal Invasive Treatmentmentioning

confidence: 99%

Section: Complications Of Interventional Managementmentioning

confidence: 99%

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4. Painful diabetic polyneuropathy

Zuidema,

de Galan,

Brouwer

et al. 2023

Pain Practice

Self Cite

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“…4 Spinal cord stimulation (SCS) is such an alternative treatment option, and has been shown to be an effective therapy for PDPN patients. [5][6][7][8][9][10] The use of SCS with conventional settings (conventional SCS [Con-SCS]) typically results in approximately 50% pain reduction in 50% to 70% of PDPN patients. 11 Besides Con-SCS, new SCS paradigms like High-Frequency (HF) and Differential Target Multiplexed (DTM)-SCS have recently emereged.…”

Section: Introductionmentioning

confidence: 99%

Conventional, high frequency and differential targeted multiplexed spinal cord stimulation in experimental painful diabetic peripheral neuropathy: Pain behavior and role of the central inflammatory balance

de Geus,

Franken,

Joosten

2023

Mol Pain

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Spinal cord stimulation (SCS) is a last resort treatment for pain relief in painful diabetic peripheral neuropathy (PDPN) patients. However, the effectivity of SCS in PDPN is limited. New SCS paradigms such as high frequency (HF) and differential target multiplexed (DTM) might improve responder rates and efficacy of SCS-induced analgesia in PDPN patients, and are suggested to modulate the inflammatory balance and glial response in the spinal dorsal horn. The aim of this study was to research the effects of Con-, HF- and DTM-SCS on pain behavior and the spinal inflammatory balance in an animal model of PDPN. Streptozotocin-induced PDPN animals were stimulated for 48 hours with either Con-SCS (50Hz), HF-SCS (1200Hz) or DTM-SCS (combination of Con- and HF-SCS). Mechanical hypersensitivity was assessed using Von Frey (VF) test and the motivational aspects of pain were assessed using the mechanical conflict avoidance system (MCAS). The inflammatory balance and glial response were analyzed in the dorsal spinal cord based on RNA expression of pro- and anti-inflammatory cytokines (Tnf-α, Il-1ß, Il-4, Il-10), a microglia marker (Itgam), an astrocyte marker (Gfap), a T-cell marker (Cd3d), microglia proliferation markers (Irf8, Adgre1) and P2X4, p13-MAPK, BDNF signaling markers (P2x4, Mapk14, Bdnf). The results show that Con-, HF-, and DTM-SCS significantly decreased hypersensitivity after 48 hours of stimulation compared to Sham-SCS in PDPN animals, but at the same time did not affect escape latency in the MCAS. At the molecular level, Con-SCS resulted in a significant increase in spinal pro-inflammatory cytokine Tnf-α after 48 hours compared to DTM-SCS and Sham-SCS. In summary, Con-SCS showed a shift of the inflammatory balance towards a pro-inflammatory state whilst HF- and DTM-SCS shifted the balance towards an anti-inflammatory state. These findings suggest that the underlying mechanism of Con-SCS induced pain relief in PDPN differs from that induced by HF- and DTM-SCS.

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“…Additionally, long-term outcome data were not considered in this analysis, which is an important determinant of overall treatment success. To date, the longest period of published follow-up data for HF-SCS is 12 months ( 6 ), whereas LF-SCS has been demonstrated to provide continued pain relief for DPN patients up to 10 years postimplant ( 7 ).…”

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confidence: 99%