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Abbott Proclaim 3667
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40
Table 19. Pain treatment history
Randomization
Pain History
Subjects with
Baseline Visit
(N=141)
Arm 1:
Tonic/Burst
(N=45)
Arm 2:
Burst/Tonic
(N=55)
p
-value
Other
55/141
(39.0%)
19/45
(42.2%)
23/55
(41.8%)
0.968
c
At least on non-invasive
intervention
141/141
(100.0%)
45/45
(100.0%)
55/55
(100.0%)
Invasive Nonsurgical Interventions
Steroid injections (epidural,
facet [zygapophysial]
injections, etc.)
130/141
(92.2%)
43/45
(95.6%)
51/55
(92.7%)
0.688
f
Therapeutic intradiscal
injections
7/141 (5.0%) 4/45 (8.9%) 1/55 (1.8%) 0.171
f
Intrathecal therapy
2/141 (1.4%) 0/45 (0.0%) 1/55 (1.8%) 1.000
f
Therapeutic medial branch
block
33/141
(23.4%)
8/45 (17.8%)
12/55
(21.8%)
0.615
c
Botulinum toxin
3/141 (2.1%) 0/45 (0.0%) 3/55 (5.5%) 0.250
f
Radiofrequency denervation
33/141
(23.4%)
10/45
(22.2%)
9/55 (16.4%) 0.458
c
Intradiscal electrothermal
therapy (IDET)
0/141 (0.0%) 0/45 (0.0%) 0/55 (0.0%)
Percutaneous intradiscal
radiofrequency
thermocoagulation
0/141 (0.0%) 0/45 (0.0%) 0/55 (0.0%)
Local anesthetic injections
(tender or trigger-point
injections)
28/141
(19.9%)
7/45 (15.6%)
10/55
(18.2%)
0.728
c
Other
30/141
(21.3%)
9/45 (20.0%)
13/55
(23.6%)
0.662
c
At least one nonsurgical
intervention
138/141
(97.9%)
45/45
(100.0%)
54/55
(98.2%)
1.000
f
Surgical Interventions
Laminectomy
54/141
(38.3%)
16/45
(35.6%)
23/55
(41.8%)
0.523
c
Facetectomy
3/141 (2.1%) 1/45 (2.2%) 2/55 (3.6%) 1.000
f
Foraminotomy
1/141 (0.7%) 1/45 (2.2%) 0/55 (0.0%) 0.450
f
Laminoplasty
0/141 (0.0%) 0/45 (0.0%) 0/55 (0.0%)
Fusion and vertebral disc
replacement
56/141
(39.7%)
18/45
(40.0%)
22/55
(40.0%)
1.000
c

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