Mechanized Axial Spinal Distraction Therapy Devices
Mechanized axial spinal distraction therapy, also known as vertebral axial decompression, is a therapy used for lower back pain due to 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 therapy uses a computer-driven table to control the disc decompression. For the treatment, the individual lies on the table and is subjected to a series of cycles as the table is slowly extended and a distraction force is applied via a pelvic harness. When the desired tension is reached, it is gradually released. This repetitive cycle builds up the individual’s tolerance to stronger distraction forces. 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.
Several devices have been cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process. Devices include the 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.
Evidence for the efficacy of vertebral axial decompression using mechanized axial spinal distraction devices on health outcomes is limited. Randomized controlled trials with sham controls and validated outcome measures are required.
BlueCross BlueShield Association. Evidence Positioning System (5:2020). Vertebral axial decompression (8.03.09). Retrieved February 5, 2021 from https://www.evidencepositioningsystem.com/. (6 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., & 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: 4/8/2021
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