Medical Policy: 08.01.18 

Original Effective Date: July 2007 

Reviewed: June 2021 

Revised: June 2021 

 

Notice:

This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

Vertebral axial decompression (also referred to as mechanized spinal distraction therapy) is as traction therapy to reduce intradiscal pressure and relieve chronic low back pain associated with herniated lumbar discs or degenerative lumbar disc disease.

 

During treatment with vertebral axial decompression the patient wears a pelvic harness and lies prone on a specially equipped table.  The table is slowly extended and a distraction force is applied via the pelvic harness until the desired tension is reached, followed by a gradual decrease of the tension. The cyclic nature of the treatment allows the patient to withstand stronger distraction forces compared to static lumbar traction techniques. An individual session typically includes 15 cycles of tension, and 10 to 15 daily treatments may be administered.

 

Vertebral Axial Decompression for Chronic Lumbar Pain

Clinical Context and Therapy Purpose

The purpose of vertebral axial decompression is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as standard conservative therapy, in patients with chronic lumbar pain due to disc-related causes.

 

Population

The relevant population of interest is individuals with chronic lumbar pain due to disc-related causes.

 

Interventions

The therapy being considered is vertebral axial decompression.

 

Vertebral axial decompression applies traction to the vertebral column to reduce intradiscal pressure, and in doing so, potentially relieves low back pain associated with herniated lumbar discs or degenerative lumbar disc disease.

 

Comparators

The following practice is currently being used to treat chronic lumbar pain due to disc-related causes: standard conservative therapy.

 

Conservative management includes nonsteroidal anti-inflammatory medications, back braces, and physical therapy; other nonsurgical treatments could include muscle relaxants, narcotic pain medications, or epidural steroid injections.

 

Outcomes

The general outcomes of interest are symptoms, functional outcomes, quality of life, and treatment-related morbidity.

 

Follow-up for patients receiving vertebral axial decompression would ideally be 6 months or longer.

 

Agency for Healthcare Research and Quality (AHRQ)

According to the AHRQ publication on Non-Invasive Techniques for Low Back Pain:

  • For low back pain with or without radicular symptoms, a systematic review included 13 trials that found no clear differences with inconsistent effects of traction versus placebo, sham, or no treatment in pain, function, or other outcomes, though two trials reported favorable effects on pain in patients with radicular back pain (SOE: insufficient for pain and function).
  • For low back pain with or without radicular symptoms, a systematic review included five trials that found no clear differences between traction versus physiotherapy versus physiotherapy alone.
  • For low back pain with or without radicular symptoms, a systematic review included 15 trials of traction versus other interventions that found no clear between traction versus other active interventions in pain or function (SOE: low for pain and function).
  • A systematic review included five trials that found no clear differences between different types of traction.
  • Eleven trials of traction in a systematic review reported no adverse events or no difference in risk of adverse events versus placebo or other interventions. Three subsequent trials reported findings consistent with the systematic review.

 

Overall, there is insufficient evidence to support the isolated use of mechanical traction as a treatment for chronic LBP.

 

Summary of Evidence

For individuals with chronic lumbar pain who receive vertebral axial decompression, the evidence includes randomized controlled trials (RCTs). Relevant outcomes are symptoms, functional outcomes, quality of life (QOL), and treatment-related morbidity. Evidence for the efficacy of vertebral axial decompression on health outcomes is limited. Because a placebo effect may be expected with any treatment that has pain relief as the principal outcome, RCT s with sham controls and validated outcome measures are required. The only sham-controlled randomized trial published to date (2009) did not show a benefit of vertebral axial decompression compared with the control group. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

 

Practice Guidelines and Position Statements

American College of Physicians and American Pain Society

According to the American College of Physician’s clinical practice guideline (2017) on noninvasive treatments for acute, subacute, and chronic low back pain, evidence was insufficient to determine the effectiveness of traction tables/devices.

 

Regulatory Status

According to labeled indications from the U.S. Food and Drug Administration (FDA), vertebral axial decompression may be used as a treatment modality for patients with incapacitating low back pain and for decompression of the intervertebral discs and facet joints.

 

Numerous proprietary spinal decompression devices have been granted 510(K) clearance under the FDA’s pre-market approval process and are marketed under various trade names.

 

Examples of vertebral decompression therapy devices include, but may not be limited to:

  • Acua-Spina System utilizing Intervertebral Differential Dynamics (IDD Therapy)
  • Decompression Reduction Stabilization (DRS) System
  • DRX-3000, DRX-5000
  • DRX9000
  • Lordex Power Traction Unit
  • SpineMED Decompression Table
  • V DRX 9000
  • VAX-D Table
  • Mettler Traction Device [MTD 4000]
  • Dynapro™ DX2, Spinerx LDM
  • Tru Trac 401
  • Integrity Spinal Care System Alpha-SPINA System
  • Spinerx LDM

 

Prior Approval:

Not applicable

 

Policy:

Vertebral axial decompression (also referred to as mechanized spinal distraction therapy) for the treatment of chronic low back pain and all other indications is considered investigational, because the evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

  • S9090 vertebral axial decompression; per session

 

Selected References:

  • Gose EE, Naguszewski WK, Naguszewski RK. Vertebral axial decompression therapy for pain associated with herniated or degenerated discs or facet syndrome: An outcome study. Neurolog Res;1998 Apr;20 (3):186-90.
  • Ramos G. Efficacy of vertebral axial decompression on chronic low back pain: study of dosage regimen.Neurol Res. 2004 Apr;26(3):320-4.
  • Martin CW. Vertebral axial decompression for low back pain. Australian Evidence-Based Practice Group, Feb 2005.
  • Jurecki-Tiller M, Bruening W, Tregear S, et al. Decompression therapy for the treatment of lumbosacral pain. Prepared by the ECRI Institute Evidence-Based Practice Center for the Agency for Healthcare Research and Quality (AHRQ) (Contract No. 290-02-0019). Rockville, MD: AHRQ; April 26, 2007.
  • Manchikanti L, Abdi S, Atluri S, et al. An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations. Pain Physician. 2013 Apr;16(2 Suppl):S49-283
  • Park WM, Kim K, Kim YH. Biomechanical analysis of two-step traction therapy in the lumbar spine. Man Ther. 2014 May 22.
  • Isgro, M, Buraschi, R, Barbieri, C, Baruzzi, E, Imperio, G, Noro, F, Villafane, JH, and Negrini, S. Conservative management of degenerative disorders of the spine. J Neurosurg Sci. 2014;58(2 Suppl 1):73-76. PubMed 25371952
  • 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. Nov – Dec 2016;39(9):645-654. PMID 27838140
  • Amir Qaseem, MD, PhD, MHA; Timothy J. Wilt, MD, MPH; Robert M. McLean, MD; Mary Ann Forciea, MD; for the Clinical Guidelines Committee of the American College of Physicians * Clinical Guidelines |4 April 2017 Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline from the American College of Physicians 
  • Chou, R, Qaseem, A, Snow, V, et al. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Annals of internal medicine. 2007 Oct 2;147(7):478-91. PMID: 17909209
  • Jurecki-Tiller M, Bruening W, Tregear S, et al. Decompression therapy for the treatment of lumbosacral pain. Prepared by the ECRI Institute Evidence-Based Practice Center for the Agency for Healthcare Research and Quality (AHRQ) (Contract No. 290-02-0019). Rockville, MD: AHRQ

 

Policy History:

  • June 2021 - Annual Review, Policy Revised
  • June 2020 - Annual Review, Policy Revised
  • June 2019 - Annual Review, Policy Renewed
  • June 2018 - Annual Review, Policy Renewed
  • June 2017 - Annual Review, Policy Renewed
  • July 2016 - Annual Review, Policy Renewed
  • August 2015 - Annual Review, Policy Revised
  • September 2014 - Annual Review, Policy Renewed
  • October 2013 - Annual Review, Policy Renewed
  • December 2012 - Annual Review, Policy Renewed
  • December 2011 - Annual Review, Policy Renewed
  • December 2010 - Annual Review, Policy Renewed

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.