Abbott Proclaim 3667 - Page 66

62
Table 37. Change in trunk 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)
70.4±17.2 (45) 77.0±11.6 (55)
Minimum, Maximum
19.3, 98.3 42.6, 97.1
VAS at Week 12
Mean ± SD (N)
44.2±21.9 (45) 41.8± 25.8 (55)
Minimum, Maximum
0.6, 84.0 0.0, 99.0
Burst-Tonic
Mean ± SD (N)
26.3±23.4 (45) 35.2±27.0 (55)
Minimum, Maximum
87.0, 36.4 83.7, 7.3
Burst-Tonic
-8.9±25.4
95% CI
-19.2, 1.2
The following two tables summarize limb VAS scores for the randomization subject population and
only from baseline to 12 weeks. The complete data show that limb VAS scores for burst
stimulation were lower than those during tonic stimulation by 4.7. Average changes for limb VAS
scores for baseline to week 12 are also lower for burst stimulation by 5.8.
Table 38. Summary of limb VAS scores
Randomization
Arm 1:
tonic/burst
Arm 2:
burst/tonic
Pooled
Burst
Mean ± SD (N)
37.2± 27.8 (44) 35.9± 27.1 (54) 36.5±27.3 (98)
Minimum, Median, Maximum
0.7, 38.2, 100.0 0.0, 30.0, 98.9 —
Tonic
Mean ± SD (N)
37.2± 24.2 (44) 45.2± 27.3 (54) 41.6±26.1 (98)
Minimum, Median, Maximum
0.7, 36.2, 82.6 0.0, 43.6, 99.0 —
Burst-Tonic
Mean ± SD (N)
-0.0± 22.2 (44) -9.3± 22.9 (54) —
Minimum, Median, Maximum
-44.0, -0.1, 82.0 -69.3, -5.2, 40.1 —
Burst-Tonic Average ± Pooled SD
Across Arms
-4.7±11.3
95% CI
-9.2, -0.1
NOTE: This analysis includes only subjects who reported limb pain at baseline.