Mechanized Axial Spinal Distraction Therapy Devices
DESCRIPTION
Mechanized axial spinal distraction therapy devices (e.g., VAX-D®, Decompression Reduction Stabilization [DRS]® System, DRX9000™, Accu-Spina System™ IDD Therapy) are generally marketed as a method for treating back pain. The basic mechanism of action involves a controlled distraction of vertebral bodies along the spinal axis for the purpose of reducing pressure along the spinal column (i.e., vertebral axial decompression). Generally, multiple treatments are administered over a period of time with the intent that the series of mechanized distractions will result in a significant reduction in pain for a significant period of time. Mechanized, computer controlled tables are typically used to apply the distractive tension; the devices may also utilize other features such as harnesses, belts, and/or biofeedback. Mechanized axial spinal distraction therapy devices are used in the treatment of a number of conditions including, but not limited too, herniated discs, degenerative disc disease, sciatica, posterior facet syndrome, lumbosacral strain, radiculopathy, and a condition called internal disc disruption (IDD).
Note: This medical policy was previously entitled Vertebral Axial Decompression.
POLICY
Mechanized axial spinal distraction therapy devices for the treatment of all indications, including but not limited to the treatment of back pain, are considered investigational.
ADDITIONAL INFORMATION
There is insufficient published evidence demonstrating that the use of a mechanized axial spinal distraction therapy device renders a health benefit equal too, or greater than, other established alternatives (e.g., simple mechanical traction, flexion/distraction, inversion therapy). Many of the studies available are uncontrolled, or contain significant methodological flaws that undermine the validity of stated positive results. Also, at present a number of study results posted on the Internet in support of some devices (e.g., the Accu-Spina System IDD Therapy device) have not yet been published in a professional, peer-reviewed journal. Well-conducted randomized, controlled trials are required in order to draw adequate conclusions as to the level of health benefit to be obtained by using these devices.
Mechanized axial spinal distraction therapy devices do not meet the following technology evaluation criteria:
The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes.
The technology must improve the net health outcome.
The technology must be as beneficial as any established alternatives.
The improvement must be attainable outside the investigational settings.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2005). Vertebral axial decompression (8.03.09). Retrieved August 25, 2005 from BlueWeb.
Complete Guide to Medicare Coverage Issues [Computer software]. (2005, April). Vertebral axial decompression (VAX-D) (NCD 160.16, p. 2-71). St. Anthony Publishing.
Deen, H. G. Jr., Rizzo, T.D., & Fenton, D. S. (2003). Sudden progression of lumbar disk protrusion during vertebral axial decompression traction therapy. Mayo Clinic Proceedings, 78 (12), 1554-1556. Abstract retrieved August 26, 2005 from PubMed database.
Gose, E. E., Nagusezewski, W. K., & Nagusezewski, R. K. (1998). Vertebral axial decompression therapy for pain associated with herniated or degenerated discs or facet syndrome: An outcome study. Neurological Research, 20 (3), 186-190.
Medical Services Advisory Committee. (2001, April). Vertebral axial decompression therapy for chronic low back pain. Canberra: Medical Services Advisory Committee (MSAC) (Application No. 1012). Retrieved November 26, 2003 from The Cochrane Library health technology assessment database.
Ramos, G., & Martin, W. (1994). Effects of vertebral axial decompression on intradiscal pressure. Journal of Neurosurgery, 81 (3), 350-353. Retrieved April 19, 2002 from PubMed database.
Sherry, E., Kitchener, P., & Smart, R. (2001). A prospective randomized controlled study of VAX-D and TENS for the treatment of chronic low back pain. Neurological Research, 23 (7), 780-784. Abstract retrieved April 19, 2002 from PubMed database.
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EFFECTIVE DATE |
3/28/2007 |
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