Abbott Proclaim 3667 - SUNBURST Study Data and Conclusions

37
SUNBURST™ Study Demographics and Pain Baseline Characteristics
A total of 141 subjects had a baseline visit in this study, 100 of whom were randomized (45 to
receive tonic stimulation then burst stimulation [tonic/burst] and 55 to receive burst stimulation
then tonic stimulation [burst/tonic]). The following tables show subject demographics and primary
diagnosis. Pain duration, origin, and prior treatments are also shown, respectively.
Table 17. Demographics and primary diagnosis
Randomization
Variable
Subjects with
Baseline Visit
(N=141)
Arm 1:
Tonic/Burst
(N=45)
Arm 2:
Burst/Tonic
(N=55)
p -value
Age
Mean ± SD
59.1±13.5
(141)
58.8±13.6
(45)
60.4±13.4
(55)
0.562
t
Minimum, Median,
Maximum
25.0, 60.0,
88.0
27.0, 62.0,
88.0
25.0, 61.0,
84.0
Gender, n/N (%)
Female
85/141
(60.3%)
26/45
(57.8%)
31/55
(56.4%)
0.887
c
Male
56/141
(39.7%)
19/45
(42.2%)
24/55
(43.6%)
Weight (lb)
Mean ± SD
191.7±48.0
(141)
189.0±42.8
(45)
195.31±47.1
(55)
0.509
t
Minimum, Median,
Maximum
85.0, 190.0,
350.0
85.0, 184.0,
340.0
113.0,
193.0, 289.0
Height (in)
Mean ± SD
66.7±4.4
(141)
66.2±4.4
(45)
66.8±4.4
(55)
0.502
t
Minimum, Median,
Maximum
55.0, 66.0,
79.1
57.0, 66.1,
73.0
55.0, 66.0,
76.0
Race, n/N (%)
Black or African American 3/141 (2.1%) 0/45 (0.0%) 1/55 (1.8%)
1.000
f
White
136/141
(96.5%)
45/45
(100.0%)
54/55
(98.2%)
Other 2/141 (1.4%) 0/45 (0.0%) 0/55 (0.0%)
Ethnicity, n/N (%)
Hispanic or Latino 2/141 (1.4%) 0/45 (0.0%) 0/55 (0.0%)
—
Non-Hispanic or Non-Latino
139/141
(98.6%)
45/45
(100.0%)
55/55
(100.0%)