Abbott Proclaim 3660 Clinician Manual page 67

Table 39. Change in limb 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 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
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
Arm 1: tonic/burst
Tonic
68.1±21.0 (44)
0.4, 93.0
37.2±24.2 (44)
0.7, 82.6
30.9±25.1 (44)
88.0, 13.3
Arm 1:
tonic/burst burst/tonic
52.2±27.9 (45) 52.3±26.9 (55)
0.4, 54.4, 100.0 0.0, 50.1, 97.7
54.3±24.4 (45) 58.5±26.1 (55)
0.8, 54.1, 99.0 0.0, 63.3, 99.3
-2.1±25.8 (45) -6.2±22.8 (55)
-57.0, -0.4, 83.1 -70.1, -2.4, 54.6
63
Arm 2: burst/tonic
Burst
72.5±21.6 (54)
2.1, 98.3
35.9±27.1 (54)
0.0, 98.9
36.6±29.7 (54)
89.1, 16.1
-5.8±27.7
-16.9, 5.4
Arm 2: Pooled
52.3±27.2
(100)
56.6±25.3
(100)
-4.1±12.1
-9.0, 0.7
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