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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
Session: MP-03a
Thurs, April 19, 1:15-3:00 pm
Shubert (Shubert Complex), 6th floor

Please note, medically challenging cases are removed three months after the meeting and scientific abstracts after three years.

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Introduction:

Peripheral neuropathy is caused by damage to or dysfunction of peripheral nerves, resulting in pain, numbness, and/or weakness. Damage may affect small (myelinated Ad and unmyelinated C) fibers along with injury to large myelinated fibers. The goal of this study is to document the safety and effectiveness of paresthesia-independent, high frequency SCS (HF-SCS) at 10 kHz in the treatment of chronic intractable pain from peripheral polyneuropathy.

Methods:

Subjects with chronic, intractable pain of ≥5 cm (on a 0-10 cm visual analog scale [VAS]) of the upper or the lower limb from peripheral polyneuropathy were enrolled in a prospective, multi-center study following Institutional Review Board approval. Mononeuropathies, significant spinal stenosis, epidural scarring or symptoms of myelopathy were causes for exclusion. Each subject was implanted with two epidural leads spanning C2-C6 or T8-T11 vertebral bodies for upper limb pain and lower limb pain, respectively. Subjects with successful trial stimulation (≥40% pain relief) were implanted with a Senza system (Nevro Corp., Redwood City, CA). Safety and effectiveness endpoints were captured up to 12 months post-implant. Interim three month results are presented as mean ± standard deviation in the permanent implant population.

Results:

A total 28 subjects were enrolled in the study, of whom two failed additional screening criteria. Majority of the subjects presented with lower limb pain (n=27). Common diagnoses include idiopathic polyneuropathy (n=15) and painful diabetic neuropathy (n=9).

Twenty-two of the 26 subjects trialed had a successful trial (84.6% trial success rate). Three subjects declined to proceed to the permanent implant despite a successful trial. One subject was withdrawn by the study investigator. Five procedure related adverse events (AE) or serious adverse events (SAEs) were reported (2 implant site extravasation, 1 implant site infection, 1 pain in extremity, 1 implant site dehiscence).

Results are summarized in Table 1. In the PDN sub-group, baseline pain score of 8.1 ± 1.0 cm (n=8) improved to 1.9 ± 1.4 cm (n=8, 88% responder rate), 2.0 ± 1.3 cm (n=8, 88% responder rate) and 2.2 ± 2.5 cm (n=6, 83% responder rate) at 3, 6 and 12 month follow-ups, respectively. Neurological assessment demonstrated either sensory, motor or reflex improvements in 12, 14 and 7 subjects at end of trial, 3 and 12 months, respectively.

 

 

Baseline
(n=18)

3 months (n=18)

6 months (n=17)

12 months (n=14)

Pain score (Responder rate)

8.2 ± 1.0 (NA)

1.8 ± 2.1 (78%)

2.7 ± 2.3 (76%)

3.1 ± 3.4 (64%)

Disability (Pain disability index)

38.7 ± 17.1

21.6 ± 14.2

19.1 ± 16.3

22.1 ± 14.6

Pain interference (McGill Pain Questionnaire)

4.86 ± 1.46

1.87 ± 1.62

N/A

2.30 ± 1.96

Table 1. Pain and disability outcomes for study subjects

Conclusions:

HF-SCS at 10 kHz resulted in clinically meaningful improvements in pain scores, disability and interference measures that were sustained over long-term follow-up. The concomitant improvement neurological status of many subjects suggests that the effect is broader than pain management with this therapy.

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