A Clinical Trial on
Non-Surgical Spinal Decompression Using Vertebral Axial Distraction
Delivered by a Computerized Traction Device
Bruce Gundersen, DC, FACO;
Michael Henrie, MS II, Josh Christensen, DC. The Academy of
Chiropractic Orthopedists Quarterly Journal of ACO - June
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
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
REVIEW OF THE
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
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
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 patients.
The three outcomes assessment
tools were scored and totaled for each patient on intake and after
three weeks of the study.
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
The neck patients all responded
well but not with as high an average as the low back
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
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
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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