Abbott Proclaim 3660 Clinician Manual page 66

Table 37. Change in trunk VAS score from baseline to week 12
Randomization
Stimulation
VAS at Baseline
Mean ± SD (N)
Minimum, Maximum
VAS at Week 12
Mean ± SD (N)
Minimum, Maximum
Burst-Tonic
Mean ± SD (N)
Minimum, Maximum
Burst-Tonic
95% CI
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
Burst
Mean ± SD (N)
Minimum, Median, Maximum
Tonic
Mean ± SD (N)
Minimum, Median, Maximum
Burst-Tonic
Mean ± SD (N)
Minimum, Median, Maximum
Burst-Tonic Average ± Pooled SD
Across Arms
95% CI
NOTE: This analysis includes only subjects who reported limb pain at baseline.
Arm 1: tonic/burst
Tonic
70.4±17.2 (45)
19.3, 98.3
44.2±21.9 (45)
0.6, 84.0
26.3±23.4 (45)
87.0, 36.4
Arm 1:
tonic/burst burst/tonic
37.2± 27.8 (44) 35.9± 27.1 (54)
0.7, 38.2, 100.0 0.0, 30.0, 98.9
37.2± 24.2 (44) 45.2± 27.3 (54)
0.7, 36.2, 82.6 0.0, 43.6, 99.0
-0.0± 22.2 (44) -9.3± 22.9 (54)
-44.0, -0.1, 82.0 -69.3, -5.2, 40.1
62
Arm 2: burst/tonic
Burst
77.0±11.6 (55)
42.6, 97.1
41.8± 25.8 (55)
0.0, 99.0
35.2±27.0 (55)
83.7, 7.3
-8.9±25.4
-19.2, 1.2
Arm 2: Pooled
36.5±27.3 (98)
41.6±26.1 (98)
-4.7±11.3
-9.2, -0.1
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