By Thomas A. Gionis, MD, JD, MBA, MHA, FICS, FRCS,
and Eric Groteke, DC, CCIC
Orthopedic Technology Review, Vol. 5-6, Nov-Dec
The outcome of a clinical study evaluating the effect
of nonsurgical intervention on symptoms of spine patients with herniated
and degenerative disc disease is presented.
This clinical outcomes study was performed to evaluate
the effect of spinal decompression on symptoms and physical findings of patients
with herniated and degenerative disc disease. Results showed that 86% of
the 219 patients who completed the therapy reported immediate resolution
of symptoms, while 84% remained pain-free 90 days post-treatment. Physical
examination findings showed improvement in 92% of the 219 patients, and remained
intact in 89% of these patients 90 days after treatment. This study shows
that disc disease-the most common cause of back pain, which costs the American
health care system more than $50 billion annually-can be cost-effectively
treated using spinal decompression. The cost for successful non-surgical
therapy is less than a tenth of that for surgery. These results show that
biotechnological advances of spinal decompression reveal promising results
for the future of effective management of patients with disc herniation and
degenerative disc diseases. Long-term outcome studies are needed to determine
if non-surgical treatment prevents later surgery, or merely delays
INTRODUCTION: ADVANCES IN BIOTECHNOLOGY
With the recent advances in biotechnology, spinal
decompression has evolved into a cost-effective nonsurgical treatment for
herniated and degenerative spinal disc disease, one of the major causes of
back pain. This nonsurgical treatment for herniated and degenerative spinal
disc disease works on the affected spinal segment by significantly reducing
intradiscal pressures.1 Chronic low back pain disability is the most expensive
benign condition that is medically treated in industrial countries. It is
also the number one cause of disability in persons under age 45. After 45,
it is the third leading cause of disability.2 Disc disease costs the health
care system more than $50 billion a year.
The intervertebral disc is made up of sheets of
fibers that form a fibrocartilaginous structure, which encapsulates the inner
mucopolysaccharide gel nucleus. The outer wall and gel act hydrodynamically.
The intrinsic pressure of the fluid within the semirigid enclosed outer wall
allows hydrodynamic activity, making the intervertebral disc a mechanical
structure.3 As a person utilizes various normal ranges of motion, spinal
discs deform as a result of pressure changes within the disc.4 The disc deforms,
causing nuclear migration and elongation of annular fibers. Osteophytes develop
along the junction of vertebral bodies and discs, causing a disease known
as spondylosis. This disc narrows from the alteration of the nucleus pulposus,
which changes from a gelatinous consistency to a more fibrous nature as the
aging process continues. The disc space thins with sclerosis of the cartilaginous
end plates and new bone formation around the periphery of the contiguous
vertebral surfaces. The altered mechanics place stress on the posterior
diarthrodial joints, causing them to lose their normal nuclear fulcrum for
movement. With the loss of disc space, the plane of articulation of the facet
surface is no longer congruous. This stress results in degenerative arthritis
of the articular surfaces.5
This is especially important in occupational repetitive
injuries, which make up a majority of work-related injuries. When disc
degeneration occurs, the layers of the annulus can separate in places and
form circumferential tears. Several of these circumferential tears may unite
and result in a radial tear where the material may herniate to produce disc
herniation or prolapse. Even though a disc herniation may not occur, the
annulus produces weakening, circumferential bulging, and loss of intervertebral
disc height. As a result, discograms at this stage usually reveal reduced
The early changes that have been identified in the
nucleus pulposus and annulus fibrosis are probably biomechanical and relate
to aging. Any additional trauma on these changes can speed up the process
of degeneration. When there is a discogenic injury, physical displacement
occurs, as well as tissue edema and muscle spasm, which increase the intradiscal
pressures and restrict fluid migration.6 Additionally, compression injuries
causing an endplate fracture can predispose the disc to degeneration in the
The alteration of normal kinetics is the most prevalent
cause of lower back pain and disc disruption and thus it is vital to maintain
homeostasis in and around the spinal disc; Yong-Hing and Kirkaldy-Willis7
have correlated this degeneration to clinical symptoms. The three clinical
stages of spinal degeneration include:
1. Stage of Dysfunction. There is little pathology
and symptoms are subtle or absent. The diagnosis of Lumbalgia and rotatory
strain are commonly used.
2. Stage of Instability. Abnormal movement of the
motion segment of instability exists and the patient complains of moderate
symptoms with objective findings. Conservative care is used and sometimes
surgery is indicated.
3. Stage of Stabilization. The third phase where
there are severe degenerative changes of the disc and facets reduce motion
with likely stenosis.
Spinal decompression has been shown to decompress
the disc space, and in the clinical picture of low back pain is distinguishable
from conventional spinal traction.8,9 According to the literature, traditional
traction has proven to be less effective and biomechanically inadequate to
produce optimal therapeutic results.8-11 In fact, one study by Mangion et
al concluded that any benefit derived from continuous traction devices was
due to enforced immobilization rather than actual traction.10 In another
study, Weber compared patients treated with traction to a control group that
had simulated traction and demonstrated no significant differences.11 Research
confirms that traditional traction does not produce spinal decompression.
Instead, decompression, that is, unloading due to distraction and positioning
of the intervertebral discs and facet joints of the lumbar spine, has been
proven an effective treatment for herniated and degenerative disc disease,
by producing and sustaining negative intradiscal pressure in the disc space.
In agreement with Nachemon's findings and Yong-Hing and Kirkaldy-Willis,1
spinal decompression treatment for low back pain intervenes in the natural
history of spinal degeneration.7,12 Matthews13 used epidurography to study
patients thought to have lumbar disc protrusion. With applied forces of 120
pounds x 20 minutes, he was able to demonstrate that the contrast material
was drawn into the disc spaces by osmotic changes. Goldfish14 speculates
that the degenerated disc may benefit by lowering intradiscal pressure, affecting
the nutritional state of the nucleus pulposus. Ramos and Martin8 showed by
precisely directed distraction forces, intradiscal pressure could dramatically
drop into a negative range. A study by Onel et al15 reported the positive
effects of distraction on the disc with contour changes by computed tomography
imaging. High intradiscal pressures associated with both herniated and
degenerated discs interfere with the restoration of homeostasis and repair
of injured tissue.
Biotechnological advances have fostered the design
of Food and Drug Administration-approved ergonomic devices that decompress
the intervertebral discs. The biomechanics of these decompression/reduction
machines work by decompression at the specific disc level that is diagnosed
from finding on a comprehensive physical examination and the appropriate
diagnostic imaging studies. The angle of decompression to the affected level
causes a negative pressure intradiscally that creates an osmotic pressure
gradient for nutrients, water, and blood to flow into the degenerated and/or
herniated disc thereby allowing the phases of healing to take
This clinical outcomes study, which was performed
to evaluate the effect of spinal decompression on symptoms of patients with
herniated and degenerative disc disease, showed that 86% of the 219 patients
who completed therapy reported immediate resolution of symptoms, and 84%
of those remained pain-free 90 days post-treatment. Physical examination
findings revealed improvement in 92% of the 219 patients who completed the
The study group included 229 people, randomly chosen
from 500 patients who had symptoms associated with herniated and degenerative
disc disease that had been ongoing for at least 4 weeks. Inclusion criteria
included pain due to herniated and bulging lumbar discs that is more than
4 weeks old, or persistent pain from degenerated discs not responding to
4 weeks of conservative therapy. All patients had to be available for 4 weeks
of treatment protocol, be at least 18 years of age, and have an MRI within
6 months. Those patients who had previous back surgery were excluded. Of
note, 73 of the patients had experienced one to three epidural injections
prior to this episode of back pain and 22 of those patients had epidurals
for their current condition. Measurements were taken before the treatments
began and again at week two, four, six, and 90 days post treatment. At each
testing point a questionnaire and physical examination were performed without
prior documentation present in order to avoid bias. Testing included the
Oswetry questionnaire, which was utilized to quantify information related
to measurement of symptoms and functional status. Ten categories of questions
about everyday activities were asked prior to the first session and again
after treatment and 30 days following the last treatment.
Testing also consisted of a modified physical
examination, including evaluation of reflexes (normal, sluggish, or absent),
gait evaluation, the presence of kyphosis, and a straight leg raising test
(radiating pain into the lower back and leg was categorized when raising
the leg over 30 degrees or less is considered positive, but if pain remained
isolated in the lower back, it was considered negative). Lumbar range of
motion was measured with an ergonometer. Limitations ranging from normal
to over 15 degrees in flexion and over 10 degrees in rotation and extension
were positive findings. The investigator used pinprick and soft touch to
determine the presence of gross sensory deficit in the lower
Of the 229 patients selected, only 10 patients did
not complete the treatment protocol. Reasons for noncompletion included
transportation issues, family emergencies, scheduling conflicts, lack of
motivation, and transient discomfort. The patient protocol provided for 20
treatments of spinal decompression over a 6-week course of therapy. Each
session consisted of a 45-minute treatment on the equipment followed by 15
minutes of ice and interferential frequency therapy to consolidate the lumbar
paravertebral muscles. The patient regimen included 2 weeks of daily spinal
decompression treatment (5 days per week), followed by three sessions per
week for 2 weeks, concluding with two sessions per week for the remaining
2 weeks of therapy.
On the first day of treatment, the applied pressure
was measured as one half of the person's body weight minus 10 pounds, followed
on the second day with one half of the person's body weight. The pressure
placed for the remainder of the 18 sessions was equivalent to one half of
the patient's body weight plus an additional 10 pounds. The angle of treatment
was set according to manufacturer's protocol after identifying a specific
lumbar disc correlated with MRI findings. A session would begin with the
patient being fitted with a customized lower and upper harness to fit their
specific body frame. The patient would step onto a platform located at the
base of the equipment, which simultaneously calculated body weight and determined
proper treatment pressure. The patient was then lowered into the supine position,
where the investigator would align the split of table with the top of the
patient's iliac crest. A pneumatic air pump was used to automatically increase
lordosis of the lumbar spine for patient comfort. The patient's chest harness
was attached and tightened to the table. An automatic shoulder support system
tightened and affixed the patient's upper body. A knee pillow was placed
to maintain slight flexion of the knees. With use of the previously calculated
treatment pressures, spinal decompression was then applied. After treatment,
the patient received 15 minutes of interferential frequency (80 to 120 Hz)
therapy and cold packs to consolidate paravertebral muscles.
During the initial 2 weeks of treatment, the patients
were instructed to wear lumbar support belts and limit activities, and were
placed on light duty at work. In addition, they were prescribed a nonsteroidal,
to be taken 1 hour before therapy and at bedtime during the first 2 weeks
of treatment. After the second week of treatment, medication was decreased
and moderate activity was permitted.
Data was collected from 219 patients treated during
this clinical study. Study demographics consisted of 79 female and 140 male
patients. The patients treated ranged from 24 to 74 years of age (see Table
1). The average weight of the females was 146 pounds and the average weight
of the men was 195 pounds. According to the Oswestry Pain Scale, patients
reported their symptoms ranging from no pain (0) to severe pain
According to the self-rated Oswestry Pain Scale,
treatment was successful in 86% of the 219 patients included in this study.
Treatment success was defined by a reduction in pain to 0 or 1 on the pain
scale. The perception of pain was none 0 to occasional 1 without any further
need for medication or treatment in 188 patients. These patients reported
complete resolution of pain, lumbar range of motion was normalized, and there
was recovery of any sensory or motor loss. The remaining 31 patients reported
significant pain and disability, despite some improvement in their overall
pain and disability score.
In this study, only patients diagnosed with herniated
and degenerative discs with at least a 4-week onset were eligible. Each patient's
diagnosis was confirmed by MRI findings. All selected patients reported 3
to 5 on the pain scale with radiating neuritis into the lower extremities.
By the second week of treatment, 77% of patients had a greater than 50%
resolution of low back pain. Subsequent orthopedic examinations demonstrated
that an increase in spinal range of motion directly correlated with an
improvement in straight leg raises and reflex response. Table 2 shows a summary
of the subjective findings obtained during this study by category and total
results post treatment. After 90 days, only five patients (2%) were found
to have relapsed from the initial treatment program.
Ninety-two percent of patients with abnormal physical
findings improved post-treatment. Ninety days later only 3% of these patients
had abnormal findings. Table 3 summarizes the percentage of patients that
showed improvement in physician examination findings testing both motor and
sensory system function after treatment. Gait improved in 96% of the individuals
who started with an abnormal gait, while 96% of those with sluggish reflexes
normalized. Sensory perception improved in 93% of the patients, motor limitation
diminished in 86%, 89% had a normal straight leg raise test who initially
tested abnormal, and 90% showed improvement in their spinal range of
In conclusion, nonsurgical spinal decompression
provides a method for physicians to properly apply and direct the decompressive
force necessary to effectively treat discogenic disease. With the
biotechnological advances of spinal decompression, symptoms were restored
by subjective report in 86% of patients previously thought to be surgical
candidates and mechanical function was restored in 92% using objective data.
Ninety days after treatment only 2% reported pain and 3% relapsed, by physical
examination exhibiting motor limitations and decreased spinal range of motion.
Our results indicate that in treating 219 patients with MRI-documented disc
herniation and degenerative disc diseases, treatment was successful as defined
by: pain reduction; reduction in use of pain medications; normalization of
range of motion, reflex, and gait; and recovery of sensory or motor loss.
Biotechnological advances of spinal decompression indeed reveal promising
results for the future of effective management of patients with disc herniation
and degenerative disc diseases. The cost for successful nonsurgical therapy
is less than a tenth of that for surgery. Long-term outcome studies are needed
to determine if nonsurgical treatment prevents later surgery or merely delays
Thomas A. Gionis, MD, JD, MBA, MHA, FICS, FRCS,
is chairman of the American Board of Healthcare Law and Medicine, Chicago;
a diplomate professor of surgery, American Academy of Neurological and
Orthopaedic Surgeons; and a fellow of the International College of Surgeons
and the Royal College of Surgeons.
Eric Groteke, DC, CCIC, is a chiropractor and is
certified in manipulation under anesthesia. He is also a chiropractic insurance
consultant, a certified independent chiropractic examiner, and a certified
chiropractic insurance consultant. Groteke maintains chiropractic centers
in northeastern Pennsylvania, in Stroudsburg, Scranton, and
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