MEDICAL NEWS

What is the evidence for Motorized Lumbar Traction Devices?

Recently, there has been an aggressive marketing campaign for a device (DRX9000) that purports using "space age technology" to provide "surgical decompression without surgery." The DRX9000 is one of a number of spinal "distraction or decompression" devices currently in use in the medical community.

The Food and Drug Administration (FDA) subjects these devices to their class II controls. As with other devices in this category such as power wheelchairs, infusion pumps and surgical drapes, class II controls may include special labeling or post market surveillance requirements.

The DX9000 is distributed by Axiom Technologies Worldwide. Advertisements from Axiom and clinics that purchase and promote this device make claims such as : "The DRX9000 is clinically proven to have an 86% success rate with patients suffering from lower back pain." This marketing blitz has led to numerous inquiries from patients to their spine physicians. The cost of this intervention ranges into several thousands of dollars and is not covered by most insurance carriers. Spine physicians serve a major role in advising often desperate low back pain patients on the cost/benefit ratio of new interventions.

The DRX9000 is marketed as spinal decompression therapy, as opposed to spinal traction therapy, because it provides alternating cycles of distraction and relaxation instead of a constant traction force. The theory behind this system is that, through the cyclic process of distraction and relaxation, there is pressure relief of spinal structures that may be pain generators (eg. inter vertebral disc). Devices in this decompression therapy category include VAX-D, DRX2000, DRX3000, DRX5000, DRX9000, Tru Trac 401, Lordex Power Traction Equipment and SpineRx LDM. Our contention, like the one formulated by the FDA, is that these decompression devices are akin to distraction or motorized traction devices.

A 2006 Cochrane review of 24 randomized controlled trials on various forms of lumbar traction concluded that there was strong evidence that traction as a single treatment is no more effective that placebo, sham, no treatments or other treatments for patients with low back pain who may or may not have sciatica. However, lumbar traction continues to be utilized by physical therapists, and chiropractic and medical physicians based on empiric, anecdotal evidence. As with most treatments for spinal disorders, there may be a subset of individuals who benefit from lumbar traction. Fritz and George described a clinical prediction rule to determine if lumbar traction is appropriate for some cases of lumbar radiculopathy.

These devices' efficacy in the management of low back or radicular pain remains unsupported in the peer reviewed literature. This lack of proven clinical efficacy should be seriously considered before referring or seconding a recommendation that a patient pay out-of-pocket for these therapies.

Risks

Motorized controlled traction devices are not completely risk free. The VAXD web site (www.vaxd.net) states that not one single patient has sustained an injury since the first VAZX-D treatment in 1987. However, Deen et al reported on sudden progression of a lumbar disc protrusion during VAX-D treatment. During a patient's fifth treatment, his radicular pain abruptly increased to 10/10 on the visual analog scale (VAS) and VAX-D therapy was discontinued. Repeat magnetic resonance imaging revealed an extrusion with a caudally migrated fragment. The patient underwent microdiscectomy and the VAS score reduced to 0/10 at six weeks.

Conclusion

Myriad decompression-type powered traction devices are on the market, including the DRX9000 and VAX-D. These devices' efficacy in the management of low back or radicular pain remains unsupported in the peer reviewed literature. There may be a role for traction in some cases of low back pain; however, there is no current data to support these devices as being more effective than manual traction. This lack of proven clinical efficacy should be seriously considered before referring or a seconding a recommendation that a patient pay out-of-pocket for these therapies.