BlueCross and BlueShield of Montana Medical Policy/Codes
Non-Surgical Spinal Decompression Traction Devices
Chapter: Medicine: Treatments
Current Effective Date: August 27, 2013
Original Effective Date: May 01, 1999
Publish Date: August 27, 2013
Revised Dates: April 14, 2004; March 9, 2009; March 5, 2013; July 19, 2013
Description

Non-surgical spinal decompression traction devices are used to create negative pressure on the spine so that the vertebrae are elongated and pressure is removed from the nerve roots. The mechanism of action of this technology is based on the fact that herniated and degenerated disks cause pain by applying pressure to the spinal nerves.

This therapy is performed using a specially designed mechanical table that separates in the middle. A patient is strapped to the lower part of the table using a pelvic harness, and either holds on to handgrip at the top of the table or the upper chest is strapped onto the table with a thoracic harness. The table is then mechanically separated in the middle and distractive force is applied to relieve pressure on the compressed spinal nerve which is the cause of the pain. The amount of force applied is calculated for each individual patient and the cycle usually lasts about 60 seconds. Depending on the type of device utilized, static, intermittent or cycled distractive force may be applied. An individual therapy session typically includes 15 to 20 cycles of tension and 10 to 15 daily treatments lasting from 30 to 45 minutes.

The American Medical Association (AMA) and U.S. Food and Drug Administration (FDA) consider these devices to be a form of traction. The tables used for decompression therapy are classified by the FDA as powered traction equipment and approved for marketing through the 510(k) approval process.

The following is a list of non-surgical spinal decompression traction devices that includes, but is not limited to the following:

  • Back specific exercise testing and strengthening devices (e.g., MedX, Isostation B-200, Cybex, Biodes, kin-Com);
  • Spinal unloading devices that include, but are not limited to, those listed in the table below; or
  • Devices identified through the FDA’s 510K clearance criteria  similar to these treatment devices listed in the table below:

Non-Surgical Spinal Decompression Traction Devices

  • ABS Model DRS,
  • ABS Model Ultra,
  • Accu-Spina® System,
  • Antalgic-Trak,
  • Art Rajala Spinal Decompression Table,
  • Axiom Worldwide,
  • Back Bubble Spinal Decompression,
  • Bass Antalgic Trac,
  • Chattanooga Decompression Table,
  • Da Vinci X10™,
  • Decompression Reduction Stabilization (DRS) System,
  • DRX,
  • DRX-2000,
  • DRX-3000,
  • DRX-5000,
  • DRX-9000,
  • DRX 9000C,
  • DRX-9500,
  • DTS (Dynamic Traction System),
  • Elite Electromedical Autotrax FX,
  • Decompression Table ATX FX,
  • Extentrac Elite,
  • Health Star Elite,
  • Inversion Therapy Tables,
  • LDM,
  • Lordex Traction Unit,
  • Lordex Power Traction Unit,
  • Nubax® Trio,
  • Saunders Active Trac,
  • Saunders 3-D Active Trac Spinal Decompression Table,
  • SpineForce,
  • SpineMED Traction,
  • SpineMED Decompression Table,
  • SpineRX – LCD,
  • Spinal Health Decompression Therapy,
  • Spinal Health Decompression Therapy ABS,
  • Spinal Health Elite,
  • Spinerx LDM,
  • Triton DTS,
  • Tritron True – Trac/tx,
  • Tru Tac 401,
  • VAX-D® (Vertebral Axial Decompression),
  • Z-GRAV Table (zero gravity table),
  • 2IDD Therapy®, and
  • 3 D Activetrac.

NOTE: Several devices used for vertebral axial decompression have received 510(k) marketing clearance from the FDA. According to labeled indications from the FDA, the VAX-D® device may be used as a treatment modality for patients with incapacitating low back pain and for decompression of the intervertebral discs and facet joints.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Investigational

Blue Cross and Blue Shield of Montana (BCBSMT) considers the use of any non-surgical spinal decompression traction device for the treatment of back pain in any setting (e.g., home, office, rehabilitation clinic) experimental, investigational and unproven.

Policy Guidelines

CPT Code 97012 should not be used to describe vertebral axial decompression; there is a specific HCPCS S-code, S9090 for vertebral axial decompression.

Rationale

This policy has been updated periodically using the MedLine database, with the most recent literature update performed through May 2013. These literature searches have identified a limited number of studies evaluating patient outcomes with non-surgical spinal decompression traction devices. 

Non-surgical spinal decompression traction devices are an expensive high-tech form of mechanical traction that provides relief in some cases of low back pain but it is widely promoted by manufacturers to correct degenerated and herniated discs without surgery. Non-surgical spinal decompression traction devices may provide relief for properly selected patients. However, there are reasons to believe that manual therapy can in most cases accomplish the same thing more quickly, safely, and less expensively. There have been no long term studies that show that patients that are helped initially by this traction device do not have to return for surgical intervention.

Randomized Controlled Trials:  Results from a randomized sham-controlled trial of intervertebral axial decompression were published in 2009. (1) Sixty subjects with chronic symptomatic lumbar disc degeneration or bulging disc with no radicular pain and no prior surgical treatment (dynamic stabilization, fusion, or disc replacement) were randomly assigned to a graded activity program with an AccuSPINA device (20 traction sessions during six weeks, reaching >50% body weight) or to a graded activity program with a non-therapeutic level of traction (<10% body weight). In addition to traction, the device provided massage, heat, blue relaxing light, and music during the treatment sessions. Neither patients nor evaluators were informed about the intervention received until after the 14-week follow-up assessment, and intention-to-treat analysis was performed (93% of subjects completed follow-up). Both groups showed improvements in validated outcome measures (visual analog scores for back and leg pain, Oswestry Disability Index, and Short-Form 36), with no differences between the treatment groups. For example, visual analog scores for low back pain decreased from 61 to 32 in the active group and from 53 to 36 in the sham group. Evidence from this recent randomized controlled trial does not support an improvement in health outcomes with vertebral axial decompression.

Sherry and colleagues conducted a randomized trial comparing vertebral axial decompression (using the VAX-D® device) with transcutaneous electrical nerve stimulation (TENS). (2) While a 68% success rate was associated with vertebral axial decompression compared to a 0% success rate associated with TENS therapy, without a true placebo control, the results are difficult to interpret scientifically. In 2007, two small randomized trials (n=27, n=64) found little to no difference between patients treated with or without mechanical traction. (3, 4)

Non-randomized Comparative Studies: In 2004, Ramos reported a nonrandomized comparison of patients receiving 10 sessions versus 20 sessions of vertebral axial decompression treatment. (5) Patients receiving 20 sessions had a response rate of 76% versus a 43% response in those receiving 10 sessions. The study has several limitations and deficiencies; it is not randomized, the follow-up time is not stated, and it does not use a validated outcome measure.

Observational Studies:  In 1998, Gose and colleagues reported on an uncontrolled case series of 778 patients. (6) Although this study reported improvements in pain, mobility, and activity in the majority of patients, the study did not detail methods of patient identification or collection of data and did not indicate the duration of treatment success. Finally, the study was uncontrolled.

In a 1994 study of 5 patients, Ramos and Martin reported that intradiscal pressure decreased during the treatment period. (7) Two case series in 2008 reported symptom improvement in patients with chronic low back pain. (7, 8) Due to limitations associated with observational studies of chronic pain, randomized controlled trials (RCTs) are needed to demonstrate efficacy of this treatment.

Summary

Evidence for the efficacy of non-surgical spinal decompression traction devices, including vertebral axial decompression on health outcomes is limited. Since a placebo effect may be expected with any treatment that has pain relief as the principal outcome, randomized trials with validated outcome measures are required to determine if there is an independent effect of active treatment. The only sham-controlled randomized trial published to date did not show a benefit of vertebral axial decompression services compared to the control group. Therefore, treatment with non-surgical spinal decompression traction devices, including the VAX-D® device, is considered experimental, investigational and unproven.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

Experimental, investigational and unproven for all diagnoses.

ICD-10 Codes

Experimental, investigational and unproven for all diagnoses.

Procedural Codes: 97012, 97530, S9090
References
  1. Schimmel, J.J., de Kleuver, M., et al. No effect of traction in patients with low back pain: a single centre, single blind, randomized controlled trial of Intervertebral Differential Dynamics Therapy. Eur Spine J (2009) 18(12):1843-50.
  2. Sherry, E., Kitchener, P., et al. A prospective randomized controlled study of VAX-D and TENS for the treatment of chronic low back pain. Neurology Research (2001) 23(7):780-4.
  3. Fritz, J.M., Lindsay, W., et al. Is there a subgroup of patients with low back pain likely to benefit from mechanical traction? Results of a randomized clinical trial and subgrouping analysis. Spine (2007) 32(26):E793-800.
  4. Harte, A.A., Baxter, G.D., et al. The effectiveness of motorized lumbar traction in the management of LBP with lumbo sacral nerve root involvement: a feasibility study. BMC Musculoskelet Disord (2007) 8:118.
  5. Ramos, G. Efficacy of vertebral axial decompression on chronic low back pain: study of dosage regimen. Neurological Research, (2004 April) 26(3):320-4.
  6. Gose, E.E., Naguszewski, W.K., et al. Vertebral axial decompression therapy for pain associated with herniated or degenerated discs or facet syndrome: an outcome study. Neurology Research. (1998) 20(3):186-90.
  7. Ramos, G., and W. Martin. Effects of vertebral axial decompression on intradiscal pressure. Journal of Neurosurgery. (1994)  81(3):350-3.
  8. Beattie, P.F., Nelson, R.M., 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):269-74.
  9. Macario, A., Richmond, C., et al. Treatment of 94 outpatients with chronic discogenic low back pain with the DRX9000: a retrospective chart review. Pain Pract (2008) 8(1):11-7.
  10. Vertebral Axial Decompression. Chicago, Illinois:  Blue Cross Blue Shield Association Medical Policy Reference Manual (2012 October) Therapy 8.03.09.
History
March 2013  Changed title from "Spinal decompression therapy with VAX-D or similar devices" to "Spinal Decompression Therapy".
August 2013 Policy formatting and language revised.  Title changed from "Spinal Decompression Therapy" to "Non-Surgical Spinal Decompression Traction Devices".  Policy statement unchanged.  Added codes 97012 and 97530.  Removed CPT 97999.
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Non-Surgical Spinal Decompression Traction Devices