Abbott Proclaim 3660 Clinician Manual page 72

Implantable pulse generator
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Table 46. Summary of SF MPQ-2 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
The PCS measures negative thoughts and feelings associated with pain. The following table shows
the overall PCS scores. Both burst and tonic stimulation reduced the PCS score; however, neither
produced clinically meaningful changes on the PCS. Again, the reason for this observation may be
the relatively low baseline scores observed in the study population. The average baseline PCS
score of 20.4 was well below what is considered to reflect a clinically relevant level of pain
catastrophizing, which is a score that is more than 30 (Sullivan, 2009).
Table 47. Summary of PCS scores
Randomization
Baseline
Mean ± SD (N)
Minimum, Median, Maximum
Burst
Mean ± SD (N)
Minimum, Median, Maximum
Tonic
Mean ± SD (N)
Minimum, Median, Maximum
Arm 1:
tonic/burst
burst/tonic
2.0±2.0 (44)
2.2±1.4 (51)
0.0, 1.3, 8.0
0.0, 2.2, 5.3
2.2±1.8 (44)
2.4±1.7 (51)
0.0, 1.7, 8.5
0.0, 2.4, 8.0
-0.2±1.6 (44)
-0.2±1.2 (51)
4.3, -0.1, 5.3
-3.0, -0.2, 2.0
Arm 1:
tonic/burst
burst/tonic
21.0±11.9 (45)
20.0±11.8 (51)
1.0, 20.0, 47.0
0.0, 20.0, 44.0
10.3±11.1 (45)
14.6±10.9 (51)
0.0, 8.0, 50.0
0.0, 15.0, 52.0
12.5±11.2 (45)
11.5±11.6 (51)
0.0, 12.0, 43.0
0.0, 9.0, 45.0
68
Arm 2:
Pooled
2.1±1.7 (95)
2.3±1.8 (95)
-0.2±0.7
-0.5, 0.1
Arm 2:
Pooled
20.4±11.8 (96)
2.1±1.7 (96)
12.0±11.4 (96)

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