Spinal Decompression
By Thomas A. Gionis, MD, JD, MBA, MHA, FICS, FRCS, and Eric
Groteke, DC, CCIC
Orthopedic Technology Review, Vol. 5-6, Nov-Dec 2003.
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 it.
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 interdiscal pressure.
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 future.
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:
- Stage of Dysfunction. There is little pathology and symptoms
are subtle or absent. The diagnosis of Lumbalgia and rotatory
strain are commonly used.
- 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.
- 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 place.
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 therapy.
METHODS
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 extremities.
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 (5).
RESULTS
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 motion.
SUMMARY
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 it.
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 Wilkes-Barre.
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