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Hypothesis: This study is designed to evaluate the results of using
the Orthotrac Pneumatic Vest versus an EZ Form brace in patients with radiating
leg pain from disc bulge/protrusion/herniation. Specifically, our hypothesis
is that patients given the Orthotrac Pneumatic Vest (OPV) will have greater
pain relief and increased self-reported functionality and fewer progressions
to surgery that those using the EZ Form brace.
Methods: A randomized clinical trial was initiated to contrast the effects
of OPV (n=75) versus EZ Form (EZ) (n=75) brace on patients with 4 weeks failed
conservative care, MRI confirmed disc bulge or protrusion and radiating leg
pain. Inclusion required ability to stand upright and consistent relief with
recumbency. Follow-up evaluations were set at 6, 12, 26 and 52 week intervals.
Measures included VAS, Oswestry, SF-36 and ROM.
Results: Initial results of patients who have reached the 12 week interval
are available. Figure 1 shows the improvement in pain (LBP & leg pain now; LBP
& leg pain in past week) observed with each device. OPV resulted in a 6 times
greater reduction in back pain, 8 times for leg pain (p<0 .0003). Activities of daily living (Oswestry) improved 28 points versus 7.3 (p<0.019). The SF-36 mental health score increased by 24 for OPV but decreased 13 EZ (p<0.06). Flexion 20 degrees in the mean and 5.2 EZ.
Figure 1. Change in VAS
Comparison of the pre- to post-treatment change in VAS scores in the two treatment
groups.
Column 1: LBP New
Column 2: LBP Wk
Column 3: Leg Pain Now
Column 4: Leg Pain Wk
Legend: Blue = OPV, Gray = EZ
Discussion: Axial spine loading from body mass reduces the effective
canal size in less than 5 minutes. Disc patients have radiating pain secondary
to root compression or chemically induced inflammation of the nerve roots. In
cadaver studies, the Orthotrac Vest (OPV) reduces functional disc load by approximately
25% by using pneumatic lifters between a stabilizing ring on the pelvis and
a second one around the rib cage. Results from this study demonstrate significant
benefit in relieving both back and leg pain, improving functionality and decreasing
emotional stress.
Conclusions: A therapeutic method that can reduce axial loading while
weight bearing has the potential of providing significant symptomatic relief
while retaining functionality. Early results strongly favor use of the OPV for
patients who have failed 4 weeks of conservative therapy and are carefully selected
for showing relief from spine unloading.
Peer-reviewed and accepted for podium presentation at North American Spine
Society 2003
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