Significantly more subjects (70.8%) preferred burst stimulation over tonic stimulation (p < 0.001). Superiority of burst was also achieved (p < 0.017). The SUNBURST study demonstrated that burst stimulation is noninferior to tonic stimulation (p < 0.001).

Descriptive statistics were used analyze additional endpoints and to characterize the safety profile of the device.

Subjects then used the stimulation mode of their choice and were followed for one year. An intention-to-treat analysis was conducted using data at the 12- and 24-week visits. The primary endpoint assessed the noninferiority of the within-subject difference between tonic and burst for the mean daily overall VAS score. The purpose of the multicenter, randomized, unblinded, crossover Success Using Neuromodulation with BURST (SUNBURST) study was to determine the safety and efficacy of a device delivering both traditional tonic stimulation and burst stimulation to patients with chronic pain of the trunk and/or limbs.įollowing a successful tonic trial, 100 subjects were randomized to receive one stimulation mode for the first 12 weeks, and then the other stimulation mode for the next 12 weeks.