Mechanized Axial Spinal Distraction Therapy Devices
Mechanized axial spinal distraction therapy devices are proposed for use in the treatment of a number of conditions including, but not limited to, herniated discs, degenerative disc disease, sciatica, posterior facet syndrome, lumbosacral strain, radiculopathy, and a condition called internal disc disruption (IDD). The basic mechanism of action involves a controlled decompression of vertebral bodies along the spinal axis for the purpose of reducing pressure along the spinal column. Generally, multiple outpatient treatments are administered over a period of time with the intent that the series will result in a considerable reduction in pain for a significant period of time.
Mechanized, computer controlled tables are typically used to apply the decompression. The devices may also utilize other features such as harnesses, belts, and/or biofeedback. Examples of mechanized axial spinal distraction therapy devices available commercially include: VAX-D®, Decompression Reduction Stabilization (DRS®) System, Accu-SPINA® System, DRX-3000®, DRX9000®, SpineMED Decompression Table®, Antalgic-Trak®, Lordex® Traction Unit, and Triton® DTS.
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.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes 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. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits, or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
There is insufficient published evidence demonstrating that the use of a mechanized axial spinal distraction therapy device renders a health benefit equal to, 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. 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.
BlueCross BlueShield Association. Medical Policy Reference Manual. (6:2016). Vertebral axial decompression (8.03.09). Retrieved April 12, 2017 from BlueWeb. (5 articles and/or guidelines reviewed)
Centers for Medicare & Medicaid Services.(1997) National Coverage Determination (NCD) for Vertebral Axial Decompression (VAX-D) (160.16). Retrieved May 26, 2015 from: http://www.cms.gov.
Choi, J., Hwangbo, G., Park, J., and Lee, S. (2014) The effects of manual therapy using joint mobilization and flexion-distraction techniques on chronic low back pain and disc heights. Journal of Physical Therapy Sciences. 26:1259-1262. (Level 4 evidence)
U.S. Food and Drug Administration. (2006, February). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K053223. Retrieved July 1, 2016 from http://www.accessdata.fda.gov.
U.S. Food and Drug Administration. (1996, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K951622. Retrieved July 1, 2016 from http://www.accessdata.fda.gov.
U.S. Food and Drug Administration. (2009, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K091540. Retrieved July 1, 2016 from http://www.accessdata.fda.gov.
ORIGINAL EFFECTIVE DATE: 2/1/2001
MOST RECENT REVIEW DATE: 6/8/2017
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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