This policy addresses the use of mechanized spinal distraction devices for the treatment of disabling low back pain associated with lumbar disk herniation, degenerative disc disease, posterior facet syndrome, sciatica, or radiculopathy.  There are many devices currently available that are used for this therapy, including, but not limited to: Vertebral axial decompression (VAX-D®), the Decompression Reduction Stabilization DRS® System and the Accu-Spina System™ IDD Therapy.

Investigational/Not Medically Necessary:

Use of mechanized spinal distraction therapy, including, but not limited to, the VAX-D® Therapeutic Table, the Decompression Reduction Stabilization DRS® System, and Accu-Spina System^TM IDD Therapy, is considered investigational/not medically necessary in all cases for the treatment of low back pain.

Rationale

At this time, there is insufficient, convincing evidence in the peer-reviewed medical literature, in terms of clinical effectiveness and safety to support the use of any method of mechanized spinal distraction therapy for the treatment of low back pain. Specifically, the few studies showing a semblance of efficacy have not demonstrated that mechanized spinal distraction therapy is superior to, or even comparable with, existing treatments.

While a large case series of the use of vertebral axial decompression in patients with low back pain has reported improvements in pain, mobility and activity in the majority of patients, these studies were uncontrolled.    For pain therapies, controlled studies are particularly relevant in order to eliminate the possibility of a significant placebo effect. Sherry and colleagues conducted a randomized trial comparing VAX-D® with transcutaneous electrical nerve stimulation (TENS). While a 68% success rate was associated with VAX-D® compared to a 0% success rate associated with TENS therapy, without a true placebo control, the results are difficult to interpret scientifically.  

Background/Overview

 Mechanized spinal distraction devices utilize computer controlled mechanical tables to apply distractive tension, or stretching, along the spinal axis. These devices provide gradual and controlled stretch designed to overcome muscle resistance, thereby allowing effective distraction of the intervertebral discs and/or the intervertebral joint spaces. Axial spinal distraction therapy is based on the theory that reducing intradiscal pressure will relieve back pain.

Low back pain is a common problem affecting approximately 90% of adults in the United States at some point in their lives. Etiologies are related primarily to various musculoskeletal problems, mostly muscle strain and degenerative disease of the vertebral joints. Standard therapy includes use of analgesic medications, a balanced rest program, exercises, physical therapy, and ergonomic counseling. Alternative therapies include various forms of manipulation, massage, injections, traction, transcutaneous electrical nerve stimulation (TENS), percutaneous electrical nerve stimulation, acupuncture, and other techniques. Selected cases may require surgical intervention to reduce pressure on nerves or the spinal cord.

The devices, including, among others, the VAX-D Therapeutic Table, the Decompression Reduction Stabilization (DRS) System, and the Accu-Spina System™ IDD Therapy, are cleared  through the United States Food and Drug Administration’s 510k process.  They are designed to provide gradual, controlled distraction along the spinal axis, based on the theory that reducing pressure in the intervertebral discs and/or intervertebral joint spaces will relieve back pain. These devices are proposed as nonoperative treatment options for the relief of low back pain associated with disc protrusion, disc herniation, degenerative disc disease, facet syndrome, or radiculopathy.  The devices are designed to apply static, intermittent, and cycling distraction tension forces to the lumbar spine and relieve pressure on structures that cause low back pain.

During the therapy, the patient wears a pelvic harness and is positioned on a table which restricts torso movement in some fashion.  Each end of the table is then is slowly moved in opposing directions to apply a distraction force to the patient’s back. This is then followed by a gradual decrease of tension. The patient is subjected to several cycles of this distraction and release, which the individual to withstand stronger distraction forces compared to static lumbar traction. Each session averages 30 minutes in duration and includes 15 decompression relaxation cycles.  The number of sessions varies depending on the severity of underlying conditions but typically involves one session each day for 20 days.  

Definitions

Common injuries or disorders of the spine

Degenerative Disc Disease: a condition where intervertebral discs degenerate as a natural part of the aging process. The discs of some people degenerate much more quickly and profoundly than others

Herniated Disc: sometimes referred to as a 'slipped', 'ruptured', or 'torn' disc.  This occurs when the outer portion of the disc (annulus) weakens and allows the inner core (nucleus pulposus) to bulge out or extrude, sometimes compressing nearby nerve roots

Spinal Stenosis: a condition caused by the narrowing of the space in the spinal vertebrae that surrounds and protects the spinal cord. This condition may result in pressure on the spinal cord and/or nerve roots. The result is back pain as well as pain in the legs and or arms. This disorder is more common after the age of 50, although it can occur in younger people

Spondylolysis: the medical term for a stress fracture of the vertebrae; this is the most common cause of low back pain in adolescent athletes and usually affects either the fourth or the fifth lumbar vertebra in the lower back

Spondylolisthesi s:this is a condition in which a stress fracture weakens the vertebrae so much that it is unable to maintain its proper position and subsequently slips out of place

Coding

The following codes for treatments and procedures applicable to this policy are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational/Not Medically Necessary:
For the following procedure codes, or when the code describes a procedure indicated in the Policy section as investigational/not medically necessary.

CPT

HCPCS

ICD-9 Diagnosis

References

Peer Reviewed Publications:

1. Gose EE, Nagusezewski WK, Nagusezewski RK.  Vertebral axial decompression therapy for pain associated with herniated or degenerated discs or facet syndrome: an outcome study.  Neurol Res. 1998; 20(3):186-90.
2. Naguszewski WK, Naguszewski RK, Gose EE. Dermatomal somatosensory evoked potential demonstration of nerve root decompression after VAX-D therapy. Neurol Res. 2001; 23:706-714.
3. Ramos G, Martin W.  Effects of vertebral axial decompression on intradiscal pressure.  J Neurosurg. 1994; 81(3):350-353.
4. Shealy CN, Borgmeyer V. Decompression, reduction, and stabilization of the lumbar spine: a cost-effective treatment for lumbosacral pain. Am J Pain Manage. 1997; 7(2):63-65.
5. Sherry E, Kitchener P, Smart R.  A prospective randomized controlled study of VAX-D and TENS for the treatment of chronic low back pain.  Neurol Res. 2001; 23(7):780-784.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Centers for Medicare and Medicaid Services. National Coverage Determination for Vertebral Axial Decompression (VAX-D). NCD #160.16. Effective April 15, 1997. Available at: http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd. Accessed on February 13, 2007.
2. Hayes Inc. Hayes Medical Technology Directory. Mechanized Spinal Distraction Therapy for Low Back Pain.  Lansdale, PA. Hayes, Inc. January 13, 2003. Search updated December 5, 2006.
   

Web Sites for Additional Information

1. National Institute of Neurological Disorders and Stroke. Back Pain Information Page Available at: http://www.ninds.nih.gov/disorders/backpain/backpain.htm  Accessed February 13, 2007.

Index

Accu-Spina System^TM IDD Therapy
Decompression Reduction Stabilization DRS System
DRX2000™
DRX3000™
DRX5000™
DRX9000™
Lordex® Spine System
SpineRx® Lumbar Decompression Machine
SpineRx® LDM
VAX-D®
Vertebral Axial Decompression

The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Policy History

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically.

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