10-kHz Spinal Cord Stimulation Treatment for Painful Diabetic Neuropathy: Results from Post-Hoc Analysis of the SENZA-PPN Study

Abstract

Aim: Previous studies of 10 kHz spinal cord stimulation demonstrated its safety and efficacy for treatment of neuropathic pain of the trunk and/or limbs. This study analyzed data from a subset of subjects with painful diabetic neuropathy enrolled in a prospective, multicenter study of peripheral polyneuropathy with various etiologies. Materials & methods: Of the eight subjects that had permanent devices, seven attended the 12-month follow-up assessment. Results & conclusion: At 12 months, 6/7 subjects were treatment responders (≥50% pain relief) and had pain remission (visual analog scale ≤ 3.0 cm). Worsening of neurologic deficits was not reported in any subject. Instead, 5/7 subjects showed improvements in sensory testing and/or reflexes. These results support further investigation of 10 kHz spinal cord stimulation as a safe and effective treatment for intractable painful diabetic neuropathy.

Amelioration of lower limb pain and foot drop with 10 kHz spinal cord stimulation: A case series

“…In addition, an analysis of patients with painful diabetic neuropathy enrolled in a prospective, multicentre study of peripheral polyneuropathy found that five out of seven patients showed improvements in sensory perception and reflexes. 25 Similarly, a case series involving patients with painful diabetic polyneuropathy reported either preservation or improvement in sensory perception in their lower limbs following treatment with 10 kHz SCS. 26 These results together with our findings suggest that 10 kHz SCS may have beneficial effects in addition to pain relief.…”

10 kHz spinal cord stimulation for the treatment of chronic back and/or leg pain: Summary of clinical studies

“…Spinal cord stimulation at 10 kHz is associated with improved clinical outcomes in patients with various chronic pain etiologies, while also improving QOL and reducing opioid intake. 34,57,[62][63][64][65][66][67][68][69][72][73][74][75][76][77][78][79][80][81][82][83] The primary aim of this review was to summarize the existing clinical evidence for the use of 10 kHz SCS to treat chronic back and/or leg pain.…”

Treatment of Painful Diabetic Neuropathy—A Narrative Review of Pharmacological and Interventional Approaches

“…Moreover, paresthesia itself is a limiting factor for a substantial number of patients, particularly paresthesia affecting areas outside of the painful region and carrying intensity variations resulting from postural changes [86]. Alternative waveforms have been developed with the aim of addressing some of these limitations and have been studied in patients with PDN, including burst SCS and high-frequency SCS [62][63][64]87,88].…”

“…In contrast to conventional and burst SCS, evidence from a multicenter RCT has shown that high-frequency SCS delivered at 10 kHz (10 kHz SCS) produces deep and durable paresthesia-free pain relief for chronic neuropathic pain [44,[62][63][64]88,[91][92][93][94][95][96][97]. The specific benefits and unique physiological responses associated with 10 kHz SCS may be attributed to its unique mechanism of action [98][99][100][101][102][103][104][105], although the precise mechanism of action is not yet understood [106].…”

“…A prospective trial, SENZA-PPN, was the first to test 10 kHz SCS in 26 subjects with peripheral polyneuropathy (PPN) refractory to conventional management, including 18 who got a permanently implanted device [62]. A sub-analysis of subjects in SENZA-PPN showed 6 of 7 subjects who had PDN were responders (≥50% pain relief) and pain remitters (VAS ≤ 3.0 cm) after 12 months of 10 kHz stimulation, and 5 subjects demonstrated improvements in sensory and/or reflex testing, suggesting 10 kHz SCS could be associated with beneficial neurological effects beyond simple analgesia [63]. All study-related AEs were mild or moderate and resolved without sequalae.…”