A Clinical Trial on Non-Surgical Spinal Decompression
Using Vertebral Axial Distraction Delivered by a Computerized Traction
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 limited
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
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
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 patients.
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 treatment compliance.
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
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