WHISPER: A PROSPECTIVE MULTICENTER TRIAL EVALUATING THE USE OF SUBPERCEPTION SCS AT ≤1.2 KHZ
ESRA Academy. Mekel-Bobrov N. Sep 8, 2016; 138438; 0288 Topic: NEUROPATHIC PAIN
Disclosure(s): Dr. Nitzan Mekel-Bobrov is a full time employee of Boston Scientific.
Dr. NItzan Mekel-Bobrov
Dr. NItzan Mekel-Bobrov

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Abstract
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Background and Aims:

Spinal Cord Stimulation (SCS) has historically relied on the concept that paresthesia must be generated at or near the site of pain to achieve pain relief. However, recent studies suggest that effective pain relief can be obtained using stimulation without paresthesia. These studies have focused on high-rate (~10kHz) and burst stimulation programs. However, potential exists for significant charging burden and decreased time before IPG replacement due to frequent recharging.  We therefore undertook a randomized controlled study to investigate the potential of subperception SCS at ≤1.2kHz to elicit pain relief in subjects with chronic pain of trunk and/or limbs.

Methods:

This multi-center, randomized, controlled, crossover, open-label study (WHISPER Study, Boston Scientific Corporation) is on-going. The primary endpoint evaluates the proportion of subjects with ≥50% reduction in overall pain intensity with the use of subperception settings as compared with traditional SCS settings with no increase in baseline average daily medication intake used to treat pain. Other assessments include percent pain relief, low back pain intensity, and quality of life. A total of 146 subjects at up to 25 sites will be included in this study.

Results:

The accompanying report provides details of the study design, demographics, and other preliminary data from this on-going study.

Conclusions:

This study will report the outcomes in subjects with chronic pain of the trunk and/or limbs when using a SCS system at subperception amplitude with commercially available parameters. This is particularly relevant in those who prefer no paresthesia with use of their SCS system.

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