Abstract Details

Title A Prospective Clinical Trial to Assess High Frequency Spinal Cord Stimulation (HF-SCS) at 10 kHz in the Treatment of Chronic Intractable Pain from Peripheral Polyneuropathy

Topic Pain

Presentation(s) P2 - Poster Session 2 (5:30 PM-6:30 PM)

Poster/Presentation
Number 7-065

Objective

To document the safety and effectiveness of 10kHz high frequency SCS (HF-SCS) in treatment of chronic intractable pain from peripheral polyneuropathy (PPN).

Background Current treatment options for neuropathic pain are primarily pharmacological with limited effectiveness and sometimes intolerable side effects¹. Based on documented long-term pain relief seen in previous studies, we hypothesized that paresthesia-independent, 10 kHz HF-SCS may provide effective pain relief for neuropathic pain^2,3.

Design/Methods Subjects with chronic, intractable pain of ≥5 cm (on a 0-10 cm visual analog scale) of the upper/lower limb from PPN were enrolled in a prospective, multi-center study following IRB approval. Subjects with successful trial stimulation were implanted with a Senza system (Nevro Corp., Redwood City, CA) with two epidural leads spanning C2-C6 or T8-T11 vertebral bodies for upper limb pain and lower limb pain, respectively. Interim 12-month results are presented as mean±95% CI.

Results

Twenty-two of the 26 subjects (84.6%) trialed had a successful trial and 18 received a permanent implant . Five procedure related adverse events or serious adverse events were reported.

In addition to improvements in pain and disability (Table 1), neurological assessment demonstrated either sensory, motor or reflex improvements in 12, and 14 subjects at end of trial and 3 months, respectively.

Baseline

3 months

6 months

12 months

All subjects

Pain score

(N; Responder rate)

7.5±0.7

(18, N/A)

1.9±0.3

(18; 78%)

2.2±0.8

(18, 78%)

2.8±1.5

(16, 69%)

PDN subjects

8.1±0.8

(8, N/A)

1.9±0.9

(8; 100%)

2.0±0.8

(8; 87%)

2.1±1.7

(7; 86%)

Pain disability index

38.7±7.9

(18)

21.6±6.6

(18)

18.4±7.5

(18)

22.0±7.7

(14)

Pain interference (McGill Pain Questionnaire)

4.8±0.7

(18)

1.8±0.7

(18)

N/A

2.1±0.9

(15)

Table 1. Pain and disability outcomes for study subjects (mean±95% CI). Responders had at least 50% pain relief from baseline.

Conclusions

10 kHz HF-SCS resulted in long-term clinically meaningful improvements with concomitant improvements in subjects’ neurological status.

Authors/Disclosures
PRESENTER	No disclosure on file
Paul C. Chang, MD (Ruttonjee Hospital)	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file

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