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VAX-D
Intermediate Care
The
determination of whether or not a patient is a candidate
for VAX-D treatment is based upon a combination of
patient history, physical findings and in some cases
imaging studies. Current plain films are required to
rule out contraindications such as fractures and/or
space occupying lesions. Each potential patient must go
through a consultation, a focused medical history and
work history as well as a physical and psychological
examination.
Patients with discogenic low back pain syndrome require
one session each day. A normal treatment session is
approximately 35-40 minutes duration plus the time it
takes for patient set-up and discharge.
The patient receives sessions,
administered on a daily basis, not less than 5 times per
week over a 4-week period. The total number of sessions
is determined by the severity of the patient’s condition
and by their response to treatment.
An outcome study by Naguszewski
and Gose (Department of Bioengineering, University of
Illinois at Chicago) involving 778 patients with data
collected from twenty-two medical centers reported that
the average number of treatment sessions was nineteen
30.
Only patients with diagnosis of herniated disc,
degenerative disc disease or facet syndrome, which were
confirmed by diagnostic imaging were included in the
study.
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reported the treatment was successful in 71% of
the 778 cases, when success was defined as a
reduction in pain to 0 or 1, on a 0-5 scale. They
also reported that improvements in mobility and
activities of daily living (ADL’s) correlated
strongly with pain reduction.
The average decrease in
pain, plus or minus the standard error of the
estimate, was 2.88 +/-0.05 units on a scale of
0-5, and a paired two-sample t-test shows that
this pain decrease was at least 2.68 units with
p<0.00005.
 The
average increase in mobility was 1.17 +/- 0.03 on
a 0-3 scale, and this value was at least 1.04
units with p<0.00005. Similarly, the average
increase in the activity score was 0.96+/-0.04
units on a 0-3 scale, and this average improvement
was at least 0.83 with p<0.00005. |
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| On a rating
scale of 0 to 3, increases in spine mobility of
one grade or more was seen in 77% of the patients
with mobility limitations. Functional increases of
1 or more grades in the activity score was
recorded in 78% of the patients who, before
treatment were either unable to walk or capable of
only limited walking. The coefficient of linear
correlation between mobility and pain scores was
0.72. Between pain and activity the correlation
was 0.60, and between activity and mobility it was
0.59. On a scale of 0 to 3, the
average
satisfaction with treatment was 2.4, which lies
between 'very satisfied' and 'completely
satisfied'.
Post Surgical Cases
In the above study, 31
patients had previous lumbar disc surgery. MRI
scans showed scar tissue their mobility scores and
61% of their activity scores improved by one unit
or more with therapy. In 65% of the group the pain
scores were reduced to 0 or 1.
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Sherry,
Kitchener and Smart conducted a prospective
randomized controlled study of VAX-D and TENS (as
the control) for the treatment of chronic LBP. The
study was designed by Quintiles and the Human
Research Ethics Committee, University of
Wollongong, NSW, Australia. They reported that
VAX-D demonstrated a success rate of 68.4% and a
success rate of 0% with TENS in forty-four
patients (p<0.001)32.
The Australian National Musculoskeletal Initiative
instructed the investigators on the use of
instruments for the outcome measures. Data
analysis was conducted by Quintiles, the
world's largest health care consultancy
organization that conducts clinical trials for
companies producing or using health care products,
including the world's leading drug companies.
The results of this RCT demonstrate that VAX-D can
achieve a statistically significant improvement in
pain and functional outcome, and that VAX-D is an
effective treatment for the management of patients
suffering from disc related chronic low back pain.
These findings are consistent with earlier studies
by Gose E, Naguszewski W, Naguszewski R.
Patients with advanced pathology at multiple
levels may require more sessions. Gose and
Naguszewski reported a success rate of 72% for 195
cases with multiple herniations. The cases went
from 4.13 to 1.18, a reduction of 71% in pain.
They also reported that VAX-D treatment was 53%
successful in 34 cases with extruded herniated
discs 30. |
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Patients are instructed not to begin treatment
unless they are able to commit to the daily
treatment schedule. If travel or scheduling for
treatment over four weeks presents a problem for a
patient, that patient may elect to schedule two
sessions per day. The treatments are scheduled as
far apart as possible. Patients with ‘Internal
Disc Derangement’ (IDD) may require more sessions
than the average, and usually require a specific
ancillary pharmaceutical regimen.
After the patients symptoms have resolved, the
patient is
scheduled to return for one session per week for 4
weeks. The patient remains under the physicians
care during this period
and
his/her condition, symptoms, and activities are
monitored. General activity is encouraged during
this period but the patient must refrain from
exercises that increase intradiscal pressures
and/or torsional strain on the lumbar spine.
Some patients with advanced conditions that are
slow to resolve may require more than one session
per week in the exit phase period.
Patients are encouraged to remain at light duty
work during VAX-D treatment (or modified work
activity) providing work activities do not
aggravate their condition. Absence from work has
negative aspects, and return to work has a variety
of benefits for the patient, and prevents
de-conditioning and disabling inactivity, it
reinforces the patient’s self esteem and sense of
well-being, and improves the therapeutic outcome
39. In many
cases, if the patient remains inactive at home,
this may lead to muscle and joint soreness, a loss
of muscle tone and mass, and an increase in pain
and stiffness. |
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Naguszewski Naguszewski and Gose used Dermatomal
Somatosensory Evoked Potentials (DSSEPs) to
demonstrate lumbar nerve root decompression
following VAX-D therapy. Traditionally, the term
"decompression" as applied to the spine has
referred to surgical nerve root decompression.
DSSEPs are the traditionally accepted technology
used to measure relief of neurocompression with
surgery.
In
this study
patients suffering from chronic low back pain and
radiculopathy had multiple nerve root
abnormalities based on
abnormal DSSEPs. Successful treatment by VAX-D
therapy resulted in clinical reduction in pain and
improved DSSEP waveforms demonstrated that nerve
root decompression occurred at multiple levels.
The average pain reduction was 77%
33.
Tilaro and Miskovich also reported on the effects
of VAX-D on sensory nerve dysfunction in patients
with LBP and radiculopathy. The group of patients
in this study received VAX-D therapy and Current
Perception Threshold (CPT) neurometer testing.
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CPT
readings on 22 peripheral nerves were taken before
and after VAX-D therapy. Only patients with
initial abnormal CPT readings, symptoms of
sciatica, positive Straight Leg Raise, and
positive imaging studies were reported on.
 The
results after therapy were as follows: Ninety-one
percent (91%) demonstrated improved neurological
function measured by the CPT Neurometer after
VAX-D therapy. Sixty-four percent (64%) of the
patient showing abnormal dysfunction secondary to
a compressive radiculopathy achieved complete
recovery of neurologic function. Of the remainder
27% showed improvement, 4.5% had no improvement
and 4.5% showed deterioration.
Overall improvement was statistically significant
at p<0.05.The data from these studies demonstrates
that the VAX-D therapeutic table is capable of
improving spinal sensory nerve dysfunction in
abnormal nerves secondary to a compressive
radiculopathy. |
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Boudreau
and Odell have reported excellent four-year
results in a series of patients with chronic
discogenic low back pain treated with VAX-D. This
retrospective survey included 34 patients treated
between January and April 1995; of these, 23
patients responded. All had undergone several
types of treatment before receiving VAX-D. On
average patients underwent 15 treatments. Those
who received more treatments tended to have better
pain relief. Subsequent studies have shown that
patients with single-level discogenic disease
require 20 treatments, but patients with
multilevel discogenic disease may require more.
Progress was measured with Visual Analogue Scale
(VAS) pain scores. A 50% reduction in score was
considered a successful result. At four years,
patients were sent a |
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questionnaire survey by mail (and surveyed by
telephone if the questionnaire was not returned).
"Among 23 patients, 71% showed more than 50%
reduction in pain immediately after treatment, and
86% showed a 50% or better pain reduction at four
years. After four years, 52% of respondents
reported a pain level of zero. "
"91% were able to resume their normal daily
activities, and 87% were either working or were
retired without having back pain as the cause for
retirement."
"The average pain level was 7.41 before VAX-D
treatment and 3.41 immediately afterward and at
four years the level had dropped to 1.57. None of
the respondents underwent surgery for their back
condition after receiving VAX-D treatment." |
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::Continued::
in
Indications/Contraindications
section of Physicians Forum
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