Research results for the Orthotrac Pneumatic
Vest
Preliminary research indicates that for appropriate
patients, significant functional improvement can be
expected with use of this device.
The following research results are currently available:
- In a single group, prospective, pilot study1
of over 200 patients, presented at the May 2003 World
Federation of Chiropractic Meeting, over 70.4% (p<0.01)
of patients realized significant functional improvement
(measured using the SF36), and decreased pain (28.1%,
p<0.01), measured with the Visual Analog Scale
(VAS), within 8 weeks of using the Orthotrac device.
- Results from an intradiscal pressure study2
at the Cleveland Clinic were presented at the May
2003 Spine Arthroplasty Society Meeting. Study results
showed a 23% (p<0.01) decrease in intradiscal pressure
at the L4-L5 segment when the Orthotrac vest was fully
inflated.
- Preliminary data from a prospective, randomized,
controlled, blinded study3 at the Texas
Back Institute demonstrates significant effects from
the Orthotrac when patients are selected according
to the four criteria described on page 1 of this article.
In this study, the Orthotrac group had 6 times greater
reduction in back pain, and an 8 times greater reduction
in leg pain (VAS, p < 0.0003). Activities of daily
living (using the Oswestry scale) improved 28 points
versus 7.3 (p < 0.019).
The SF-36 mental health score increased by 24 points
for the Orthotrac vest group, but decreased 13 points
for the control group (p <0.06). Also, flexion
improved 20 degrees in the mean for the Orthotrac
group and 5.2 degrees for the control group.
All results in this study were measured at 12 weeks
from baseline.
The effectiveness of this device is still being researched.
At the time of this article, there are no peer-reviewed
published clinical studies of the effectiveness of the
Orthotrac pneumatic vest in relieving lower back pain
and/or leg pain. However, the above studies indicate
that the device is showing potential to relieve symptoms
for patients who meet specific criteria.
By: Andrew
J. Cole, MD
May 28, 2003
1. Research funded by Kinesis Medical,
Inc., since acquired by Orthofix, Inc.
2. Research funded by Orthofix, Inc.
3. Research funded by Orthofix, Inc.
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