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A Clinical Trial on Non-Surgical Spinal
Decompression Using Vertebral Axial Distraction Delivered by a Computerized
Bruce Gundersen, DC, FACO; Michael
Henrie, MS II, Josh Christensen, DC. The Academy of Chiropractic
Orthopedists Quarterly Journal of ACO - June 2004
Hypothesis: Axial traction of the spine
produces remission of symptoms in specific conditions that have not responded
to traditional manipulative protocols when computerized decompression traction,
electrical stimulation and biofeedback exercise stabilization are applied under
a controlled regimen.
The study is a pilot project and was not
considered by an IRB for the initial phase. Continued investigation is
suggested. The equipment for the study was provided by Calhoon Health Products.
No fees for treatment were charged to any patients and no subjects were paid to
participate in the study.
REVIEW OF THE LITERATURE
There are many studies on traction in the
current literature. We have sited 20 indicating a broad interest in this
concept and a continued search for alternatives to surgical decompression of
the spine. The articles with a brief synopsis are listed at the end with the
reference. The primary clinical point of the literature review is that
compression of the neuronal elements of the spine seems to be a leading cause
or generator of the pain in chronic situations. Decompression has proven
effective and various forms of decompression are elaborated. In conclusion from
analyzing these articles, vertebral axial distraction can be accomplished
several ways and reports of reduction of intradiscal pressure, reduction of
disc herniations, and associated symptoms are cited.
A trial was designed to measure the
improvement on low back and leg pain and neck and arm pain patients. Patients
who had reported symptoms in those areas were notified of the project and
invited to participate. Other providers of physical medicine were notified as
well and encouraged to have patients with similar unresponsive conditions
inquire. All patients admitted to the study had a lengthy history of pain with
multiple episodes of chiropractic manipulation and physical therapy with
A combination of questionnaires were used
to compute an intake score for each patient. The score was computed using the
formula, the sum of the total score from each questionnaire. Categories of
severity were created as follows: 0-150; 151-175; 176-200; and > 200.
Protocols were determined based on total
intake score and ranged from 3 to 6 treatment sessions per week. Traction
protocols were determined based on patient history and symptoms, chronicity and
extent of radicular signs. Treatment frequency was determined by total points:
under 150 - 3 days per week, 151 to 175 - 4 days per week, 176 to 200 - 5 days
per week and over 200 - 6 days per week.
The Axial Disc Compression Traction
Therapy unit, manufactured by Chattanooga, was utilized in this study.
Directions contained in the D.T.S. Information manual, copyright 2002 by Jay
Kennedy were followed.
In this study, there were nine men and 5
woman ranging in age between 26-64. The range in chronicity for LB/Leg pain was
6 months to 29 years and neck to arm pain 1 year to 7 years. Exclusion criteria
included, those with spinal fusions from hardware implant, those with non-disc
related central spinal stenosis, those over age 70 or under age 18.
Intake measurements include modified
Oswestry Low Back Pain Disability Questionnaire (Fairbanks, 1980) and the Neck
Disability Index (Vernon and Mior, 1988) Activities Discomfort Scale (Turner,
1983) and a quadruple visual analogue pain scale (Yeomans, 2000). Each item was
scored and the total recorded and compared to the exit scores. For this
project, no objective tests were obtained on intake or exit, only standardized
outcomes assessment tools.
Patients who qualified to enter into the
study were measured and fitted to the traction unit. Both prone and supine
protocols were considered for lumbar decompression. The prone position is
usually recommended but can be modified per patient ability to tolerate the
position. Cervical decompression is done in the supine position. Precise
positioning for each patient is critical for outcomes to be optimized A 100%
compliance was expected from each subject accepted into the study in order to
optimize the statistical analysis.
The specific treatment protocol was
determined by the doctor after assessing the intake examination and evaluation.
The computer controls the variations in the traction allowing for spinal
decompression and attempting to reduce the muscle reaction and subsequent
compression that can occur with some types of traditional or conventional
traction devices. The preprogrammed patterns for ramping up and down the amount
of axial distraction allows for optimal levels of spinal decompression and disc
hydration when possible.
Proper patient positioning and specific
technique insure expected results.
Of the 14 patients that were admitted
into the study on May 17, 2004, the group was divided into the neck and arm
pain group with 4 patients and the low back and leg pain group with 10
The three outcomes assessment tools were
scored and totaled for each patient on intake and after three weeks of the
Using a single tool, the Revised Oswestry
form for low back, it is noted that improvement parallels, in all but one case,
the combination of the three tools.
The neck patients all responded well
but not with as high an average as the low back patients.
Following the three-week initial
phase of the study, the patient sample in this study continued to receive
decompression at variable rates based on improvement. The outcome measurements
are repeated at one month intervals to determine if the disability levels and
perceived improvement parallel each other.
It is interesting to note that the
measured results parallel the perceived or reported improvement in all but one
case. That case would not be included in a long term study due to
non-compliance but was included here because that is a regular obstacle in
daily clinical practice.
Decompression of the spine is possible
using axial distraction as a modality. Study limitations include remission of
symptoms may also be linked to electrochemical effects and biomechanical
stabilization. All but two of the patients in the study improved at least 30%
or more in the first three weeks. Two did not. One drove 2 hours to and 2 hours
from treatment sessions and was not expected to achieve much improvement
notwithstanding. He did report considerable relief immediately after each
session and understood that the driving more than negated any improvements. The
other patient who did not measure any improvement did not comply with the
protocol as outlined and would have been dismissed from the study due to poor
Continued follow- up with this patient
sample is recommended in Part II of this study at 1, 3, 6 and 12 month results
with and without additional treatment. Studies on surgical decompression
procedures of the spine are often designed to include a 2-3 year follow-up as
well as reporting any associated morbidity during the study time for up to 5
years. Additional patients should be likewise admitted and studied and the 5
year plan should be instituted. Patients will also be instructed in regular use
and frequency of the stabilization exercises.
This study utilized an outcomes based
research design. Given the significant improvements reported in this study, it
is hopeful that a randomized, controlled trial where sham traction (placebo)
can be compared to decompression therapy. Also, separate subject groups can
also be randomized to electrical stimulation, pelvic stabilization groups, and
a combined therapies group.
Utilizing the outcome measures, this form
of decompression reduces symptoms and improves activities of daily living.
Long-term benefits were not studied but will be reported in another study. The
future study will include regular follow-up measurements to determine if the
remission continues with or without recurrence. Also, the future study will
investigate whether or not periodic supportive treatment sessions are needed to
maintain symptom satisfaction.
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