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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