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FREQUENTLY
ASKED QUESTIONS ABOUT VAX-D
Has VAX-D
Treatment proven to be Effective?
Yes. VAX-D is classified as a class II medical device and approved by the F.D.A. The first
piece of research conducted on VAX-D was conducted in 1987 by the medical physicians, Dr.
S.J. Peerless, Dr. I. Meissner, Dr. H.J.M. Barnett and Dr. C.R. Stiller, at the University
Hospital in London, Ontario.
The purpose of this study was to compare the efficacy of the VAX-D Treatment on patients
with acute recent disabling low back pain through a sham control where on treatment group
would receive concurrent best available medical therapy and the other group VAX-D. Each
group would consist of 48 patients.
The finding from this research indicated a 66% effective rate among those patients
receiving VAX-D.
The second study conducted in 1994 to validate VAX-D Treatment was administered by the
Neurosurgeons, Dr. Gustavo Ramos and Dr. William Martin through the Departments of
Neurosurgery and Radiology, Rio Grande Regional hospital. McAllen, Texas, and the Division
of Neurosurgery, Health Sciences Center, University of Texas, San Antonio, Texas.
This study was conducted to measure intradiscal pressures among 55 workers' compensation
patients with a subligamental herniation of the L4-5 disc, and who were candidates for
percutaneous discectomy.
These studies included fluoroscopic videos of these patients during VAX-D Treatment
substantiating the fact VAX-D does achieve decompression of intervertebral lumbar spaces
during treatment. The sole measure of successful treatment for these patients was their
ability to return to work mid a 70% Effectiveness Rate was achieved.
A third study in 1996 was, conducted by Earl E. Gose, Ph.D., a Professor
of Bioengineering at the University of Illinois at Chicago. In this study twenty-two
medical centers were asked to complete evaluation forms on 622 Patients who had a
diagnosis of herniated disc, degenerative disc or Facet syndrome confirmed by an x-ray or
MRI scan and who underwent VAX-D Treatment.
Treatment being defined as reduction in pain, showed a success rate of 75% among these
patients.
In comparing this research volume and proven efficacy rates to those of back surgery one
will soon see the VAX-D patient volume to be greater and the Effectiveness Rate to be
better.
Why is VAX-D Treatment different, or better than, spinal traction?
VAX-D Treatment evolved from research examining various procedures for the treatment of
low back pain and differs significantly in a variety of ways from spinal traction. This is
exactly the reason VAX-D received United States and International patents where traction
cannot. There are many factors incorporated in the design and treatment protocol allowing
VAX-D to attain negative intradiscal pressure without pain or risk of injury to the
patient.
Traction and inversion tables can help but don't get to the root of the
problem. Most back pain suffers have a process that develops over time. Trauma
to the muscles, vertebrae or discs occurs either by small microtraumas or actual
injuries producing joint stiffness. The joint stiffness leads to disc
dehydration which is termed degenerative disc disease causing the disc to crack
and then tears develop producing bulges or herniations. VAX-D produces a vacuum
effect within the disc drawing fluids back into to the disc, rehydrating and
drawing any bulges or herniations back into place. The fluids drawn back into
the disc contain oxygen and nutrients that create the healing environment that
corrects the problem.
Inversion tables or traction do not produce a vacuum effect because the muscle
that surround a joint are very strong and when an attempt to stretch the joint
is sensed the muscles contract. Studies on traction show that the
disc pressure actually goes up rather than down. The reason VAX-D is so
effective is that the pull curve is gradual and logarithmic which
"fools" the muscles and allows separation to occur.
A major consideration is, of course, the fact VAX-D has been proven an effective treatment
in several separate and distinct clinical settings. It is important to note clinical
trials at teaching hospitals were largely earned out on a patient population who were
referred to neurosurgical department because they had failed to respond to other
non-interventional treatments. Equally important is the fact VAX-D Treatment is the only
non-surgical treatment method shown clinically, by objective measurements, to decompress
lumbar intervertebral structures. This, coupled with modern imaging technology recording
modifications in the extent of herniated discs with VAX-D Treatment, places this procedure
of treatment above all others on a scientific basis. No other non-interventional means of
treating low back pain, mechanical or otherwise, has the research backing to match these
claims.
Can VAX-D Treatment separate each vertebra of the lumbar spine
individually, or is the entire lumbar spine distracted?
VAX-D utilizes a patented hand grip method of restraining the upper body while the
patented pelvic belt is attached to the moveable tensionometer housing. VAX-D medical
treatment provides for progressive distraction between the pelvic girdle and the fixed
shoulder girdle under controlled parameters determined by the logic control system. The
degree of intervertebral distraction and subsequent decompression level achieved is
maximum at the lower levels and decreases gradually toward the upper levels of The lumbar
column.
Intradiscal pressure measurements on patients undergoing VAX-D Treatment have shown fire
extent of decompression measured in mm Hg. follows an inverse relationship to the tension
applied to the pelvic belt during treatment. The relationship follows a Polynomial
equation with the threshold level at which the intradiscal pressure changes from a
positive pressure to a negative level, exerting decompression, determined by the amount of
tension applied and the intervertebral level or the spine involved. This relationship and
the precise control provided by the VAX-D Medical Tables enables a physician to focus
decompression to the level of the anatomical defect.
Radiological research studies were carried out in which fluoroscopic videos of patients
with a myelogram were recorded while patients were undergoing VAX-D Treatment. Distraction
of intervertebral lumbar spaces was observed on VAX-D Treatment and the filling defect of
a myelogram, from a herniated disc was decreased. Records were obtained showing a
myelogram displacement from a herniated disc at L4-5, change from a convex image of
protrusion, to a concave image at the vertebral interspace.
Is the Patient put at any risk of injury during treatment on the VAX-D Table?
Absolutely not! The patented hand grips allow the patient the opportunity at any time to
release their grip and completely relax tension. Since 1987, when the first treatment
table was utilized through present day when over 100 VAX-D Treatment Tables are utilized
daily, not one single injury has been sustained by a patient.
Does VAX-D
Treatment result in permanent recovery?
The typical case does not require additional treatment after successful completion.
However, as with any treatment of more severe cases certain job descriptions/activities
may necessitate the need for future re-evaluation.
Each session averages 30 minutes in duration. Research has
established that optimum clinical results are achieved with sessions consisting of 15
decompression relaxation cycles administered once or twice daily. Most patients with low
back pain syndrome achieve relief of pain while undergoing therapy and require, on
average, one session each day for 20 sessions to attain remission of debilitating
symptoms. The number of sessions depends on the severity of the underlying condition. For
example, herniated discs generally respond within 15 to 25 sessions while patients with
degenerated discs often achieve significant relief with 10 to 20 sessions. On the other
hand, patients with posterior facet syndromes usually achieve complete remission with
fewer than 10 sessions.
Experience has shown that the majority of patients that
recover on VAX-D Therapy generally remain in remission and do not require additional
treatment. However, some individuals whose lifestyle or work environment tends to expose
them to higher risk factors have found that a maintenance program offers a measure of
protection against disabling exacerbations of their low back pain syndrome. Patients in
this category tend to develop their own rhythm of maintenance visits that keeps them free
of problems.
The use of VAX-D treatment on patients who have had spinal
surgery in most cases is not contraindicated. It has has been tried as a follow-up therapy
for patients that continue to complain of post-surgical low back pain.
The use of VAX-D Therapy on patients with a history of
previous laminectomy may be undertaken when the extent of surgical excision has not
compromised the vertebral articulations and ligamental structures.
Many patients have found that VAX-D treatment has reduced
or eliminated their back and leg pain even after the failed back surgery.
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