Abbott Proclaim 3660 Clinician Manual page 44

Table 19. Pain treatment history
Pain History
Other
At least on non-invasive
intervention
Invasive Nonsurgical Interventions
Steroid injections (epidural,
facet [zygapophysial]
injections, etc.)
Therapeutic intradiscal
injections
Intrathecal therapy
Therapeutic medial branch
block
Botulinum toxin
Radiofrequency denervation
Intradiscal electrothermal
therapy (IDET)
Percutaneous intradiscal
radiofrequency
thermocoagulation
Local anesthetic injections
(tender or trigger-point
injections)
Other
At least one nonsurgical
intervention
Surgical Interventions
Laminectomy
Facetectomy
Foraminotomy
Laminoplasty
Fusion and vertebral disc
replacement
Subjects with Arm 1:
Baseline Visit Tonic/Burst
(N=141) (N=45)
55/141 19/45
(39.0%) (42.2%)
141/141 45/45
(100.0%) (100.0%)
130/141 43/45
(92.2%) (95.6%)
7/141 (5.0%) 4/45 (8.9%)
2/141 (1.4%) 0/45 (0.0%)
33/141
8/45 (17.8%)
(23.4%)
3/141 (2.1%) 0/45 (0.0%)
33/141 10/45
(23.4%) (22.2%)
0/141 (0.0%) 0/45 (0.0%)
0/141 (0.0%) 0/45 (0.0%)
28/141
7/45 (15.6%)
(19.9%)
30/141
9/45 (20.0%)
(21.3%)
138/141 45/45
(97.9%) (100.0%)
54/141 16/45
(38.3%) (35.6%)
3/141 (2.1%) 1/45 (2.2%)
1/141 (0.7%) 1/45 (2.2%)
0/141 (0.0%) 0/45 (0.0%)
56/141 18/45
(39.7%) (40.0%)
40
Randomization
p
Arm 2: -value
Burst/Tonic
(N=55)
23/55
0.968
(41.8%)
55/55
(100.0%)
51/55
0.688
(92.7%)
1/55 (1.8%) 0.171
1/55 (1.8%) 1.000
12/55
0.615
(21.8%)
3/55 (5.5%) 0.250
9/55 (16.4%) 0.458
0/55 (0.0%)
0/55 (0.0%)
10/55
0.728
(18.2%)
13/55
0.662
(23.6%)
54/55
1.000
(98.2%)
23/55
0.523
(41.8%)
2/55 (3.6%) 1.000
0/55 (0.0%) 0.450
0/55 (0.0%)
22/55
1.000
(40.0%)
c
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f
f
f
c
f
c
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c
f
c
f
f
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c