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Orthopaedic Surgery Spine
Management of Low-back Pain with a Non-surgical
Decompression System (DRX9000™) – Case Report
a report by
Joseph V Pergolizzi Jr,
1
Frank Florio,
2
William R Martin
3
and Charlotte Richmond
4
1. Adjunct Assistant Professor, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore; 2. Director of Clinical Research, Axiom
Worldwide, Tampa; 3. Medical Director, Upper Valley Interventional Radiology, McAllen; 4. Director of Clinical Research, NEMA Research, Inc., Miami Beach
Chronic low-back pain (LBP) is a widespread and debilitating syndrome. A said the pain had progressively worsened over the past two months.
Approximately 25% of adults in the US report having experienced LBP in the Patient A also reported radiating pain into the buttocks and legs, as well as a
past three months.
1
LBP is the second most common reason for a visit to a burning sensation down both legs into the feet and the right inguinal region.
physician, the fifth most common cause of admission to a hospital, the third Patient A was 68 inches tall and weighed 192 pounds. His medical history
most common indication for surgery,
2
among the top 10 reasons for visits to revealed cervical spine surgery, diabetes, hypertension and lumbar surgery 13
internists and the most common and most expensive reason for work years previously. Activities that exacerbated patient A’s condition included
disability.
3
While there are three broad treatment options for treating LBP – walking and standing for more than 15 minutes. The pain disrupted his sleep
surgical, non-surgical and pharmacological – there is little consensus on and he had difficulty moving from a sitting to a standing position. Magnetic
which approach is appropriate or preferable for various scenarios. Current resonance imaging (MRI) of the lumbar spine performed on 4 October 2007
evidence-based guidelines recommend conservative treatment for at least showed disc protrusions at all lumber levels with degenerative changes
two months, and often for much longer, before a surgical option is throughout; the size of patient A’s herniated disc and height of his disc space
considered.
4,5
Surgery is associated with risks, and the outcome in many at first visit are shown in Table 1. Patient A underwent 22 treatments on the
patients with discogenic back pain is unpredictable. Conservative treatments DRX9000 over a seven-week period. The initial parameters began at a
vary widely and are individualised to the patient. These include exercise, yoga, maximum decompressive force of 80 pounds, with a minimum force of 40
cognitive behavioural therapy, analgaesics, superficial heat therapy, patient pounds; the final treatment parameters were a maximum of 125 pounds and
education/back school, muscle relaxants, systemic corticosteroids, opioids, a minimum of 62 pounds. The decompressive force was raised in increments
spinal manipulation, acupuncture, acupressure and transcutaneous electrical of five pounds at the discretion of the physician. The angle of treatment
nerve stimulation. More recently, a variety of mechanised and motorised force – which allows the physician to make adjustments to treat the affected
spinal decompression systems have been developed to address the pitfalls of lumbar region – ranged from 10 to 20º. Adjunctive treatment included
the aforementioned therapies. The first of these was the Vertebral Axial electric stimulation, as well as instruction on therapeutic exercise and
Decompression (VAX-D) system (Vat-Tech, Inc.). Several other devices have nutritional support upon discharge. At initial treatment, patient A reported
since been developed, including the DRX9000™ (Axiom Worldwide, Tampa, pain at ‘10’ on a scale of 0 to 10; at the end of the treatment protocol he
Florida). The DRX9000 computerised non-surgical spinal decompression reported pain at ‘1’. Post-treatment, patient A stated that he no longer felt
system was designed to provide maximum patient benefits with the use of a the burning sensation in the buttocks or legs and noticed a decrease in the
non-invasive approach that may help minimise healthcare resources and offer frequency of burning in the right inguinal region. At final evaluation,
a potentially optimal therapeutic approach to the treatment of LBP. the examiner also noted an improvement in patient A’s muscular strength
and sensation to pinprick. MRI of the lumbar spine performed on 28 January
The DRX9000 aims to relieve pain by enlarging intra-discal spaces, reducing 2008 – four months after the initial visit – revealed decreased herniation size
herniation and decreasing intra-discal pressure during treatment. A and increased disc height at multiple lumbar levels (see Table 1 for patient A’s
retrospective chart audit of 94 patients provided preliminary data that chronic pre- and post-treatment MRI measurements, and Figure 1 for pre- and
LBP may improve with DRX9000 spinal decompression.
6
A prospective trial post-treatment MRIs of patient A’s lumbar spine).
with 18 patients found that pain improved significantly after DRX9000
treatment, with patients requiring fewer analgaesics and experiencing Discussion
better function.
7
Information continues to emerge on non-invasive Spinal decompression systems such as the DRX9000 have become more
spinal decompression. Christian C Apfel and colleagues at the University of prominent in clinical practice for the treatment of LBP. These systems were
California at San Francisco conducted a retrospective review of lumbar developed to provide a non-invasive intervention for the treatment of LBP of
computed tomography (CT) scans of 16 patients with chronic discogenic origin, with the goal of expanding the intervertebral space and
musculoskeletal, mechanical or discogenic LBP who underwent a six-week reducing disc protrusion. As described by Richmond et al. in 2007, “the
course of non-invasive spinal decompression treatment using the DRX9000. DRX9000 True Non-surgical Spinal Decompression System™ applies spinal
Dr Apfel’s investigation showed a significant reduction in chronic LBP after distraction forces by using a sensitive computerised feedback mechanism to
non-invasive spinal decompression correlated with an increase in disc height.
8
provide relief of LBP and symptoms associated with herniated discs, bulging
The case report presented here explores the use of the DRX9000 non-surgical or protruding inter-vertebral discs, degenerative disc disease, posterior facet
spinal decompression protocol for the management of chronic LBP. syndrome and sciatica. The DRX9000 uses a split-table design to reduce
friction between the patient and the device. The patient lays supine; a chest
Presentation of Case and shoulder support system controls the upper body and a knee rest is used
A 69 year-old man, patient A, presented at an outpatient facility in October to eliminate pelvic rotation. The apparatus has built-in air bladders,
2007. He complained of having experienced LBP during the past year. Patient disc-angle-pull adjusters and harnesses and can increase the decompression
© TOUCH BRIEFINGS 2008 59
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