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MULTICENTER RANDOMIZED CONTROLLED PIVOTAL TRIAL COMPARING 10 KHZ AND TRADITIONAL SPINAL CORD STIMULATION: 24-MONTH RESULTS
ESRA Academy. Subbaroyan J. Sep 9, 2016; 138256
Topic: NEUROPATHIC PAIN
Disclosure(s): Employee of Nevro Corp.
Jeyakumar Subbaroyan
Jeyakumar Subbaroyan

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Abstract
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Background and Aims:

Effective pain relief with spinal cord stimulation (SCS) has historically been linked with paresthesias overlapping chronically painful areas (Schultz et al., 2012) (Parker et al., 2012). We report 24- month data from a study that compared a paresthesia-independent, 10 kHz SCS (HF10 therapy) to traditional low frequency SCS for the treatment of chronic back and leg pain.

Methods:

A randomized controlled pivotal trial was conducted across 11 comprehensive pain treatment centers (ClinicalTrials.gov NCT01609972).  Subjects with visual analog scale (VAS) scores of ≥5.0 of 10.0 cm for both back and leg pain were randomly assigned (1:1) to receive HF10 therapy or traditional low frequency SCS.  The primary endpoint was responder rate, defined as ≥50% pain reduction.

Results:

At 24 months, 85 (out of 90) test and 71 (out of 81) control subjects were followed-up.  Back pain decreased to a greater degree with HF10 therapy (7.5 cm±1.3 cm at baseline to 2.4 cm±2.3 cm, or 66.9%) than traditional SCS (7.8 cm±1.2 cm at baseline to 4.5 cm±.9 cm,or 41.1%%, p<0.001). Similarly, leg pain decreased to a greater degree with HF10 therapy (7.1 cm±1.5 cm at baseline to 2.4 cm±2.3 cm or 65.1%) than traditional SCS (7.6 cm±1.4 cm at baseline to 3.9 cm±2.8 cm or 46.0%, p=0.002). More subjects were responders to HF10 therapy than traditional SCS (Back pain: 76.5% versus 49.3%, p<0.001; Leg pain: 72.9% versus 49.3%, p<0.001).

Conclusions:

This study demonstrates the long-term superiority of HF10 therapy over traditional SCS in treating both back and leg pain.

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