Summary Of Odi Scores; Summary Of Sf Mpq-2 Scores - Abbott Proclaim 3660 Clinician Manual

The following table shows a summary of ODI scores. Subjects experienced a reduction in ODI
scores from baseline during both stimulation modes. However, neither burst nor tonic stimulation
produced clinically meaningful changes on the ODI. One reason for this observation may be the
relatively low baseline scores observed in this population. The baseline score for the ODI was
49.1, which is less than what is typical for chronic pain patients. Typical scores are in the 61- to
80-point range (Kumar, 2007). Thus, in light of the low baseline ODI scores, a significant
improvement would not necessarily be expected.
Table 45. Summary of ODI scores
Randomization
Baseline
Mean ± SD (N)
Minimum, Median, Maximum
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 Short Form McGill Pain Questionnaire (SF MPQ-2) assesses pain quality and the intensity or
severity of those qualities. The following table shows a summary of the mean SF MPQ-2 score.
Both burst and tonic stimulation show improvement from baseline scores.
Table 46. Summary of SF MPQ-2 scores
Randomization
Baseline
Mean ± SD (N)
Minimum, Median, Maximum
Arm 1:
tonic/burst burst/tonic
48.9±11.3 (45) 49.2±10.6 (50)
24.0, 50.0, 80.0 17.8, 50.0, 72.0
33.4±16.9 (45) 37.5±15.6 (50)
0.0, 32.0, 80.0 4.0, 41.0, 70.0
34.4±15.3 (45) 36.5±14.3 (50)
0.0, 34.0, 74.0 0.0, 37.9, 72.0
-1.0±12.5 (45) 1.0±11.8 (50)
28.0, -2.0, 40.0 24.0, 2.0, 44.0
Arm 1:
tonic/burst burst/tonic
4.5±1.8 (44) 4.6±1.2 (51)
0.5, 4.4, 7.7 1.5, 4.5, 7.4
67
Arm 2: Pooled
49.1±10.9 (95)
35.6±16.3 (95)
35.5±14.8 (95)
0.0±6.1
-2.5, 2.5
Arm 2: Pooled
4.5±1.5 (95)
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