Medical Policy

This document addresses the use of mechanized spinal distraction therapy. There are many devices currently available that are used for this therapy, including, but not limited to the Vertebral Axial Decompression (VAX-D^®) Therapeutic Table, the Decompression Reduction Stabilization DRS^® System and the Accu-Spina System^™ IDD Therapy.

Investigational and 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^™ IDD Therapy, is considered investigational and not medically necessary for the treatment of low back pain or any other condition.

Mechanized spinal distraction therapy has been proposed as a treatment for back pain. While large case series of the use of vertebral axial decompression in individuals with low back pain have reported improvements in pain, mobility and activity in the majority of study participants, these studies were uncontrolled. For pain therapies, controlled studies are particularly relevant in order to eliminate the possibility of a significant placebo effect.

A small double-blind randomized clinical trial (RCT) involving 17 participants with acute lumbar sciatica secondary to disc herniation was reported by Isner-Horobeti and colleagues (2016). Participants were assigned to either high-force mechanical traction at 50% body weight (LT50, n=8) or to low force mechanical traction at 10% body weight (LT10, n=9). Treatment was applied to both groups for 10 sessions over a 2-week period. Study evaluations were undertaken at baseline and at 7, 14, and 28 days. Outcome measures included radicular pain as measured on a 10-point visual analogue scale (VAS), lumbo-pelvic-hip complex motion (finger-to-toe test), lumbar-spine mobility (Schöber-Macrae test), nerve root compression (straight-leg-raising test), disability (EIFEL score), drug consumption, and overall evaluation. The authors reported that significant (p<0.05) improvements were observed in the LT50 and LT10 groups, respectively, between day 0 and day 14 (end of treatment) for VAS (-44% and -36%, respectively), EIFEL score (-43% and -28%, respectively) and overall patient evaluation (+3.1 and +2.0 points, respectively). Additionally, between baseline and day 14, the LT50 group had additional improvements in the finger-to-toe test (-42%), the straight-leg-raising test (+58), and drug consumption (-50%). The treatment effect was found to be independent of medication levels. From day 14 through day 28, only the LT10 group improved (p<0.05) in VAS (-52%) and EIFEL scores (-46%). The authors reported that mechanical lumbar traction “reduced radicular pain and functional impairment and improved well-being regardless of the traction force group to which they were assigned.” While the results are promising, there are many methodological issues with this study, including small population, lack of a standard of care comparison group, and short duration of follow-up.

There is insufficient evidence in the peer-reviewed medical literature to support the use of any method of mechanized spinal distraction therapy for the treatment of back pain or other spine conditions. The few studies showing a semblance of efficacy have not demonstrated that mechanized spinal distraction therapy is as beneficial as any established alternative or leads to improved net health outcomes.

Low back pain is a common problem. It is estimated low back pain affects 75%-85% of Americans during their life (American Association of Neurological Surgeons). 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, TENS, percutaneous electrical nerve stimulation, acupuncture, and other techniques. Selected cases may require surgical intervention to reduce pressure on nerves or the spinal cord.

Mechanized spinal distraction devices utilize computer controlled mechanical tables to apply distractive tension, or stretching, along the spinal axis. 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. There are several mechanized spinal distraction devices which have United States Food and Drug Administration (FDA) clearance to market through the FDA’s 510k process. These devices are proposed as nonoperative treatment options for the relief of 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 spine and relieve pressure on structures that cause back pain.

During the therapy, the individual wears a pelvic harness and is positioned on a table which restricts torso movement in some fashion. Each end of the table is then slowly moved in opposing directions to apply a distraction force to the individual’s back. This is then followed by a gradual decrease of tension. The individual is subjected to several cycles of this distraction and release, which enables the individual to withstand stronger distraction forces compared to static spinal 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.

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 and may cause 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.

Spondylolisthesis: A condition in which a vertebra in the spine slips out of the proper position onto the vertebra below it, potentially causing nerve compression. There are three main types of spondylolisthesis: congenital, isthmic (resulting from stress fractures of spondylolysis) and degenerative, which is the most common cause. Traumatic, post-surgical, and pathological (osteoporosis, tumor) causes also occur, though less commonly.

Spondylolysis: A specific defect in the connection between vertebrae which results from weakness in the section of the facet joints called the pars interarticularis. It can lead to small stress fractures and is most common in people younger than 26 and often related to sports and hyperextension of the spine. Exact cause of the weakness is unknown.

The following codes for treatments and procedures applicable to this document 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 and Not Medically Necessary:
For the following procedure codes, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Peer Reviewed Publications:

1. Beattie PF, Nelson RM, Michener LA, et al. Outcomes after a prone lumbar traction protocol for patients with activity-limiting low back pain: a prospective case series study. Arch Phys Med Rehabil. 2008; 89(2):269-274.
2. Gose EE, Naguszewski WK, Naguszewski RK. Vertebral axial decompression therapy for pain associated with herniated or degenerated discs or facet syndrome: an outcome study. Neurol Res. 1998; 20(3):186-190.
3. Isner-Horobeti ME, Dufour SP, Schaeffer M, et al. High-force versus low-force lumbar traction in acute lumbar sciatica due to disc herniation: a preliminary randomized trial. J Manipulative Physiol Ther. 2016; 39(9):645-654.
4. Naguszewski WK, Naguszewski RK, Gose EE. Dermatomal somatosensory evoked potential demonstration of nerve root decompression after VAX-D therapy. Neurol Res. 2001; 23(7):706-714.
5. Ramos G, Martin W. Effects of vertebral axial decompression on intradiscal pressure. J Neurosurg. 1994; 81(3):350-353.
6. 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.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Agency for Healthcare Research and Quality. Decompression therapy for the treatment of lumbosacral pain. Technology Assessment Report. 2007 April. Available at: https://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id47TA.pdf. Accessed on July 26, 2024.
2. Centers for Medicare and Medicaid Services. National Coverage Determination: Vertebral Axial Decompression (VAX-D). NCD #160.16. Effective April 15, 1997. Available at: https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=124&ncdver=1&bc=0. Accessed on July 26, 2024.

1. American Association of Neurological Surgeons. Low back pain. Available at: https://www.aans.org/en/Patients/Neurosurgical-Conditions-and-Treatments/Low-Back-Pain. Accessed on July 26, 2024.
2. National Institute of Neurological Disorders and Stroke. Pain Information Page. Last Modified July 22, 2024. Available at: https://www.ninds.nih.gov/health-information/disorders/back-pain?search-term=back%20pain. Accessed on July 26, 2024.

Accu-Spina System IDD Therapy
DRX9000^™
Lordex^â Spine System
SpineMED^â
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.