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Spinal decompression therapy as an alternative modality for
management of low back pain and radicular pain caused by
lumbar disc herniation or protrusion
Ahmed R. El-Zayat
a
, Wael Gomah
a
, Ahmed H. Aldesouky
b
Departments of
a
Rheumatology, Physical
Medicine and Rehabilitation,
b
Radiology,
Faculty of Medicine, Al Azhar University, Cairo,
Egypt
Correspondence to Dr. Ahmed Ramzy
El-Zayat, MD Rheumatology, Physical Medicine
and Rehabilitation, Misr Algadyda, Triumph.
Tel: 00201005300142;
e-mail: arz12003@hotmail.com
Received 5 July 2018
Accepted 16 October 2018
Egyptian Rheumatology & Rehabilitation
2019, 46:183–188
Background
Recent studies have suggested that motorized nonsurgical spinal decompression
AQ5 can reduce chronic low back pain (LBP) due to lumbar disc herniation or
protrusion.
Aim
The purpose of this study was to evaluate the efficacy of motorized nonsurgical
spinal decompression by the DRX9000 device in the reduction of LBP and radicular
pain caused by lumbar disc herniation or protrusion and whether it correlated with
MRI changes in disc height or not.
Patients and methods
This study was carried out on 73 patients with chronic LBP attributed to disc
protrusion selected from outpatients of rheumatology and rehabilitation clinics at
Abdul Latif Jameel Hospital for Medical Rehabilitation, Jeddah, Saudi Arabia; these
patients were divided into two groups. The first group comprised 39 patients who
underwent a 6-week treatment protocol of motorized nonsurgical spinal
decompression via the DRX9000, and the other group comprising 34 patients
underwent a 6-week physiotherapy with deep heat modalities and ordinary traction;
pain assessment using a visual analog scale with MRI was carried out before and
after treatment. Paired t-test or linear regression was used, as appropriate, with P
less than 0.05 considered to be statistically significant.
Results
The main outcomes were a significant improvement in LBP in both groups using
visual analog scale, but radicular pain and disc height using MRI were significantly
improved in group 1 compared with group 2.
Conclusions
The study concluded that nonsurgical spinal decompression was associated with a
reduction in back pain and radicular pain and with an increase in disc height and can
be used as an alternative modality for discogenic LBP.
Keywords:
decompression system, DRX9000, lumbar disc prolapse, LBP
Egypt Rheumatol Rehabil 46:183–188
©2019 Egyptian Society for Rheumatology and Rehabilitation
1110-161X
Introduction
More than 80% of the population will suffer from low
back pain (LBP) at some point in their lives [1]. LBP is
the main factor causing limiting activity in patients less
than 45 years old, the second most frequent cause for
doctor’s visits, and the third most common reason for
surgical procedures [2]. LBP is of significant
socioeconomic relevance, as it affects patients’quality
of life, may lead to a loss of productivity temporarily
and enormous medical and indirect costs, or even
permanent disability [3].
The two most common diseases causing chronic LBP
are discogenic LBP, which is caused by disc
degeneration, responsible for 39% of cases, and disc
herniation, accounting for just less than 30% of cases of
LBP. The clinical pathology of both discogenic LBP
and disc herniation is related to the anatomical
structure of the intervertebral disc [4].
The traditional management of LBP was nonsurgical
treatment with analgesia supplemented by
physiotherapy. There are many modalities of
physiotherapy such as massage, spinal manipulation,
exercises, acupuncture, back school, and cognitive
behavioral therapy [4]. They also report some of the
problems associated with simple traction, such as
fatigue, triggering of muscle spasm, the patient’s
inability to tolerate the force or position, and the
exacerbation of pain [5].
Thus, the other treatment modality is motorized
decompression, a technique designed to decrease
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Original article 183
©2019 Egyptian Rheumatology & Rehabilitation | Published by Wolters Kluwer - Medknow DOI: 10.4103/err.err_34_18
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pressure on the discs, vertically expand the
intervertebral space, and restore disc height [6].
Spinal decompression systems such as the DRX9000
have been launched into clinical practice in the last few
years for the treatment of LBP. These systems provide
a noninvasive intervention for the treatment of LBP of
discogenic origin.
DRX9000 True Nonsurgical Spinal Decompression
System was FDA (the US Food and Drug
Administration) approved; it applies spinal
distraction forces by using a sensitive computerized
feedback mechanism to provide relief of LBP
and symptoms associated with herniated discs,
bulging or protruding intervertebral discs,
degenerative disc disease, posterior facet syndrome,
and sciatica [7].
Richmond et al. [7] stated that the DRX9000 aims to
relieve pain by enlarging intradiscal spaces, reducing
herniation, and decreasing intradiscal pressure during
treatment.
Aim
The goal of this study was to evaluate the efficacy of
motorized nonsurgical spinal decompression by the
DRX9000 device in the reduction of LBP and
radicular pain caused by lumbar disc herniation or
protrusion and whether it correlated with MRI
changes in disc height or not.
Patients and methods
This study was carried out on 73 patients; their ages
ranged from 21 to 45 years; they had chronic LBP with
radicular pain caused by disc protrusion or herniation,
as diagnosed by MRI of the lumbosacral spine, and the
duration of the disease was more than 12 weeks [8].
They were selected from outpatients attending the
rehabilitation clinic in Abdul Latif Jameel Hospital
for Medical Rehabilitation, Jeddah, Saudi Arabia,
during the period spanning from January 2016 to
September 2017; consent was taken from every
patient for the treatment and to be included in this
study.
Patients with other causes of LBP, the presence of
osteoporosis, vertebral fracture, displacement,
weakness in the lower limbs, impaired sensation in
both lower limbs or spondylolisthesis and pregnant
women were excluded from the study.
The patients were divided into two groups.
(1) First group: this group comprised a total of 39
patients, 23 (58.97%) male patients and 16
(41.03%) female patients; their ages varied
between 21 and 43 years with a mean age
of 32.06±7.09 years, and the duration of
disease varied from 16 to 56 weeks, with a
mean duration of 34.26±13.45 weeks. Their
weights varied between 64 and 97 kg. This
group underwent decompression using the
DRX9000.
(2) Second group: this group comprised a total of 34
patients, 19 (55.88%) male patients and 15 (44.22%)
female patients; their ages varied between 23 and 45
years with a mean age of 33.21±7.23 years, and the
duration of disease varied from 18 to 53 weeks, with
a mean duration of 32.43±12.22 weeks. Their
weight varied between 61 and 93 kg. This group
underwent physiotherapy including deep heating
modalities and ordinary traction.
All patients were subjected to full history taking;
clinical examination including site of tenderness,
straight leg raise (SLR) test, motor and sensory
assessment, and range of motion of the lumbar spine
were carried out before and after completion of
sessions. Visual analog scale (VAS) from 0 to 10
was used before and after completion of the
treatment course for assessment of LBP during a
flexion-extension range of motion and for
assessment of radicular pain in the lower limbs.
Radiological assessment included radiographic
lumbosacral spine anterioposterior and lateral view
and MRI lumbosacral spine to support a diagnosis
of chronic discogenic LBP due to bulging,
protruding or herniated intervertebral discs that may
have been brought on by degenerative disc disease.
MRI was also repeated after completion of the
treatment course to assess whether there were
changes in disc height or not.
MRI was performed before the start of treatment and
after the end of treatment using a 3.0 T magnetic
resonance unit (MAGNETOM Verio, A Tim
System; Siemens, Erlangen, Germany). The
patients were positioned in the supine position and
scans were performed: (a) sagittal T1 images from T12
to the sacrum (repetition time: 670 ms; echo time:
12 ms, slice thickness: 4 mm), (b) sagittal T2 images
from T12 to sacrum (repetition time: 3000–3600 ms;
echo time: 87–114 ms, slice thickness: 4 mm), and (c)
axial T2 images from L1 to S1 (repetition time:
3000–3600 ms; echo time: 87–114 ms, slice
thickness: 4 mm).
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Intervertebral disc height
Intervertebral disc height of the lumbar spine was
measured on midsagittal MRI from the middle of the
superior border of the disc to the middle of the inferior
border of the disc withthe inclusion of both end plates.In
our study, we detect the difference of disc height between
two MRIs to avoid personal variation in disc height.
Paired t-test or linear regression was used, as
appropriate, with Pless than 0.05 considered to be
statistically significant.
Treatment protocol
(1) First group: a total of 39 patients received
treatment with the DRX9000 (Axiom
Worldwide, Tampa, Florida, USA) according to
the intervention’s operating guidelines [9].
(2) Second group: a total of 34 patients received
physiotherapy including ultrasound,
transcutaneous electrical nerve stimulation
(TENS), and vertebral traction.
The protocol of the DRX9000 includes 20 sessions of
spinal decompression over a 6-week period with 30-
min active treatment sessions. Each patient was
administered treatment five times per week for the
first 2 weeks and three times per week for a further 2
weeks, and it was then tapered down to two sessions per
week for the last 2 weeks. At the start of the session, the
patient is fitted into the supine position. To start active
treatment, the machine pulls the patient gently on the
lower harness while the upper harness remains
stationary, thus distracting the patient’s spine. A
safety button can be pushed at any time by the
patient to release all tension immediately.
The initial decompression force was adjusted to patient
tolerance, starting at 4.54 kg (10 lbs) less than half their
body weight. If a patient described the decompression
pull as ‘strong or painful,‘this distraction force was
decreased by 10–25%. In subsequent treatment
sessions, the distraction force was increased as
tolerated to final levels of 4.54–9.07 kg (10–20 lbs)
more than half their body weight. After the end of each
therapy session, a cold pack with electrical muscle
stimulation was applied to help paravertebral muscles
consolidate after treatment.
Results
First group
Before patients underwent the treatment sessions, the
mean of LBP by VAS was 7.66±1.62, and, after
sessions, it was 2.23±1.67 with Pvalue less than
0.005 considered as significant difference. With
regard to the lower extremity radicular pain assessed
by VAS, before taking sessions, the mean was 7.43
±2.50, and, after sessions, it was 1.33±1.79 with P
value less than 0.005 considered as significant
difference. There was one (2.56%) patient who
presented with severe LBP after five sessions, and
the patient stopped undergoing the sessions. There
were six (15.38%) patients who had muscular pain
during the sessions, but they continued the sessions;
pain persisted in four of them (10.25%) until the end
of the sessions.
MRI
There were improvements of disc height in 27
(72.97%) patients, ranging from 1.1 up to 5.3 mm,
with a mean of 2.31±1.24 mm.
LBP was improved in 29 (74.36%) patients while
radicular pain improved in 33 (84.61%) patients; disc
height improved in 27 (72.97%) patients.
Second group
Before patients underwent the treatment sessions, the
mean of LBP by VAS was 7.55±1.78, and, after
sessions, it was 4.14±1.52, with Pvalue less than
0.005 considered as significant difference. With
regard to lower extremity radicular pain by VAS,
before patients underwent the treatment sessions,
the mean was 7.32±2.32, and, after sessions, it was
6.82±1.95 with no significant difference, Pvalue
greater than 0.005.
MRI
There were improvements of disc height in four
(11.76%) patients, ranging from 0.1 up to 0.3 mm,
with a mean of 0.043±0.091 mm.
LBP was improved in 25 (73.53%) patients while
radicular pain improved in seven (20.59%) patients;
disc height improved in four (11.76%) patients.
When we compared both groups, we found that there
were nonsignificant differences in the improvement of
LBP and a highly significant difference in the
improvement of radicular pain and disc height
between both groups (Figs 1–4 and Tables 1–4).
Discussion
Discogenic pain is a major problem in the lumbar area,
and it may be caused by progressive annular breakdown
and tearing, which cause pain by stimulating pain fibers
Spinal decompression therapy El-Zayat et al. 185
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in the outer one-third of the annulus and by
compression over the nerves’roots.
Spinal decompression systems using the DRX9000
have become a noninvasive intervention for the
treatment of LBP caused by disc protrusion or
herniation by expanding the intervertebral space and
reducing the disc protrusion.
Our study showed that there was an improvement in
back pain and lower extremities’radicular pain with
the decompression system; the improvement was
more significant in lower extremities’pain than
back pain.
There was a significant improvement in the disc
heights of the majority of patients by the
decompression system. Comparing with the control
group, we found highly significant improvement in
patients treated with the decompression system with
regard to radicular pain and disc height compared with
other physiotherapy modalities.
Our study was in agreement with Richmond et al. [7]
who stated that Nonsurgical Spinal Decompression
Figure 1
DRX9000.
Figure 2
MRI performed before decompression therapy showing protruded disc L4-L5. MRI performed after completion of decompression therapy course
using DRX9000 showing nearly completely improved protruded disc.
Figure 3
MRI performed before decompression therapy showing protruded
disc L5-S1. MRI performed after completion of the decompression
therapy course using DRX9000 showing improved protruded disc
with an increase in its hydration.
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System by using the DRX9000 resulted in relief of
LBP and symptoms associated with herniated discs,
bulging or protruding intervertebral discs,
degenerative disc disease, posterior facet syndrome
and sciatica by using a sensitive computerized
feedback mechanism.
In another study, Apfel et al. [10] found that spinal
decompression by DRX9000 for treating chronic
discogenic LBP caused relief of pain and
restoration of disc height, and there was a
correlation between pain reduction and degree of
restoration of disc height, which agreed with our
study; however, the difference between this study
and our study was that they assessed disc height by
using CT scan but we used MRI.
Thomas et al. [11] agreed with our study, as they stated
that nonsurgical spinal decompression (DRX9000) had
effective treatment of discogenic back pain by
decompressive force, as pain was reduced in 86% of
patients who were candidates for surgery, and
mechanical function was restored in 92%, but 2% of
patients presented with pain after 90 days and 3% of
patients suffered a relapse.
Leslie et al. [9] also stated that, when patients are
treated with DRX9000 completing the full 6-week
course of spinal decompression, patients’pain
reduced and patient activity function became better,
as measured by the Oswestry Disability Index.
The decompression system is a good modality for
treating discogenic LBP, as it reduces pain, improves
function and decreases surgical intervention.
Figure 4
Percentage of improvement in both groups.
Table 1 Comparison between the two groups
Group 1 Group 2
LBP before treatment 7.66±1.62 7.55±1.78
LBP after treatment 2.23±1.67 4.14±1.52
LBP % of improvement 74.36 73.53
Radicular pain before treatment 7.43±2.50 7.32±2.32
Radicular pain after treatment 1.33±1.79 7.32±2.32
Radicular pain % of improvement 84.61 20.59
Improvement in disc height 2.31±1.24 0.043±0.091
% improvement in disc height 72.97 11.76
LBP, low back pain.
Table 2 Percentage of improvement between the two groups
Group 1
(%)
Group 2
(%)
P
value
LBP % of improvement 74.36 73.53 >0.05
Radicular pain % of
improvement
84.61 20.59 <0.01
% improvement in disc height 72.97 11.76 <0.01
LBP, low back pain.
Table 3 Group 1 before and after treatment
Before After Pvalue
LBP 7.66±1.62 2.23±1.67 <0.05
Radicular pain 7.43±2.50 1.33±1.79 <0.05
LBP, low back pain.
Table 4 Group 2 before and after treatment
Before After Pvalue
LBP 7.55±1.78 4.14±1.52 <0.05
Radicular pain 7.32±2.32 7.32±2.32 >0.05
LBP, low back pain.
Spinal decompression therapy El-Zayat et al. 187
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Conclusion
Overall, this study suggests that treatment with the
DRX9000 nonsurgical spinal decompression system,
reduced patient’s chronic LBP and radicular lower
extremities’pain, with patients requiring fewer
analgesics, compared with other modalities.
Moreover, improvement in disc height measured by
MRI has been found.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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