63
Table 39. Change in limb VAS score from baseline to week 12
Randomization
Arm 1: tonic/burst
Arm 2: burst/tonic
Stimulation
Tonic
Burst
VAS at Baseline
Mean ± SD (N)
68.1±21.0 (44)
72.5±21.6 (54)
Minimum, Maximum
0.4, 93.0
2.1, 98.3
VAS at Week 12
Mean ± SD (N)
37.2±24.2 (44)
35.9±27.1 (54)
Minimum, Maximum
0.7, 82.6
0.0, 98.9
Burst-Tonic
Mean ± SD (N)
30.9±25.1 (44)
36.6±29.7 (54)
Minimum, Maximum
88.0, 13.3
89.1, 16.1
Burst-Tonic
-5.8±27.7
95% CI
-16.9, 5.4
The following table summarizes worst VAS scores for the randomization subject population. The
data shows that burst stimulation worst VAS scores were lower than those during tonic stimulation
by 4.1 points.
Table 40. Summary of worst VAS scores
Randomization
Arm 1:
tonic/burst
Arm 2:
burst/tonic
Pooled
Burst
Mean ± SD (N)
52.2±27.9 (45) 52.3±26.9 (55)
52.3±27.2
(100)
Minimum, Median, Maximum
0.4, 54.4, 100.0 0.0, 50.1, 97.7
—
Tonic
Mean ± SD (N)
54.3±24.4 (45) 58.5±26.1 (55)
56.6±25.3
(100)
Minimum, Median, Maximum
0.8, 54.1, 99.0
0.0, 63.3, 99.3
—
Burst-Tonic
Mean ± SD (N)
-2.1±25.8 (45)
-6.2±22.8 (55)
—
Minimum, Median, Maximum
-57.0, -0.4, 83.1 -70.1, -2.4, 54.6
—
Burst-Tonic Average ± Pooled SD
Across Arms
-4.1±12.1
95% CI
-9.0, 0.7