|
Yes. VAX-D® is classified as a class II medical
device and approved by the FDA. The first piece of research performed
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 in 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.
BACK TO TOP
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. 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 logrythmetic 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.
BACK TO TOP
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 success 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.
BACK TO TOP
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.
BACK TO TOP
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.
BACK TO TOP
What
is the average length of each session per patient?
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.
BACK TO TOP
Follow-up
therapy: How often is it required and how beneficial is it?
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.
BACK TO TOP
Can VAX-D®
treatment be used after spinal surgery?
The use of VAX-D® treatment on patients
who have had spinal surgery in most cases is not contraindicated.
It 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.
|
