61
Table 35. Summary of decrease in overall VAS score from baseline by three categories
Decrease in Overall VAS From Baseline
Burst
Tonic
All Subjects
<30%
40/100 (40.0%)
49/100 (49.0%)
≥30%, <50%
21/100 (21.0%)
19/100 (19.0%)
≥50%
39/100 (39.0%)
32/100 (32.0%)
The following two tables summarize trunk VAS scores for the randomization subject population
and only from baseline to 12 weeks. The complete data show that trunk VAS scores for burst
stimulation were lower than those during tonic stimulation by 5.7. Average changes for trunk VAS
scores for baseline to week 12 are also lower for burst stimulation by 8.9.
Table 36. Summary of trunk VAS scores
Randomization
Arm 1:
tonic/burst
Arm 2:
burst/tonic
Pooled
Burst
Mean ± SD (N)
39.7±25.3 (45) 41.8±25.8 (55)
40.9±25.5
(100)
Minimum, Median, Maximum
0.6, 38.0, 85.4
0.0, 40.6, 99.0
—
Tonic
Mean ± SD (N)
44.2±21.9 (45) 48.8±25.6 (55)
46.7±24.0
(100)
Minimum, Median, Maximum
0.6, 48.9, 84.0
0.0, 51.1, 86.7
—
Burst-Tonic
Mean ± SD (N)
-4.5±22.0 (45)
-7.0±23.1 (55)
—
Minimum, Median, Maximum
-49.6, -3.7, 57.9 -75.7, -2.3, 36.4
—
Burst-Tonic Average ± Pooled SD
Across Arms
-5.7±11.3
95% CI
-10.3, -1.2