Medical Policies - Therapy


Non-Surgical Spinal Decompression Traction Devices

Number:THE803.021

Effective Date:06-15-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

The use of any non-surgical spinal decompression traction device for the treatment of neck or back pain in any setting (e.g., home, office, rehabilitation clinic) is considered experimental, investigational and/or unproven.

Description:

Non-surgical spinal decompression (also referred to as vertebral axial decompression) traction devices are used as traction therapy to treat chronic low back pain. This is done by creating 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. Specific devices available are described below in the Regulatory Status section.

In general, during treatment, the therapy is performed using a specially designed mechanical table that separates in the middle. A patient is prone and 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, a gradual decrease of the tension, 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 cycles of tension and 10 to 15 daily treatments lasting from 30 to 45 minutes. If the cyclic device is use, the nature of the treatment allows the patient to withstand stronger distraction forces compared with static lumbar traction techniques.

Regulatory Status

The American Medical Association (AMA) and U.S. Food and Drug Administration (FDA) consider these devices to be a form of traction. These devices have been cleared for marketing by the FDA through the 510(k) process. The tables are classified by the FDA as powered traction equipment. FDA product code: ITH.

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,

Anatomotor Roller Massage Table,

Antalgic-Trak®,

Art Rajala Spinal Decompression Table,

Axiom Worldwide,

Back Bubble Spinal Decompression,

Back Stretch Chair, Pneumex,

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,

Morgan Lumbar Harness,

PneuBack Chair,

PneuBack Chair Unweighted,

Inversion Therapy Tables,

LDM,

Lordex® Traction Unit,

Lordex® Power Traction Unit,

Nubax® Trio,

PneuBack Exercise,

PneuMap,

PneumoVibro Trac Table,

PneuWeight Treadmill,

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: 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.

Rationale:

This policy was created in 1999 and has been updated periodically using the MedLine database, with the most recent literature update performed through October 11, 2017.

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 these traction devices do not have to return for surgical intervention.

Assessment of efficacy for therapeutic interventions involves a determination of whether the intervention improves health outcomes. The optimal study design for a therapeutic intervention is a randomized controlled trial (RCT) that includes clinically relevant measures of health outcomes. Intermediate outcome measures, also known as surrogate outcome measures, may also be adequate if there is an established link between the intermediate outcome and true health outcomes. Nonrandomized comparative studies and uncontrolled studies can sometimes provide useful information on health outcomes, but are prone to biases such as non-comparability of treatment groups, the placebo effect, and variable natural history of the condition. It is recognized that RCTs are extremely important to assess treatments of painful conditions and low back pain in particular, due to the expected placebo effect, the subjective nature of pain assessment in general, and the variable natural history of low back pain that often responds to conservative care.

The literature searches for this policy have identified a limited number of studies that evaluated patient outcomes associated with vertebral axial decompression. In addition, because 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.

Randomized Controlled Trials (RCTs)

In 2009, Schimmel et al. published results from a randomized sham-controlled trial of intervertebral axial decompression. (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 randomized to a graded activity program with an Accu-SPINA device (20 traction sessions during 6 weeks, reaching >50% of body weight) or to a graded activity program with a nontherapeutic 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 scale [VAS] scores for back and leg pain, Oswestry Disability Index [ODI], 36-Item Short-Form Health Survey), but no significant differences between treatment groups. For example, VAS 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 RCT did not support improvements in health outcomes with vertebral axial decompression (VAD).

In 2016, Isner-Horobeti et al. reported on a preliminary double-blind RCT comparing high-force traction (50% body weight; n=8) with low-force traction (10% body weight; n=9) for individuals with acute low back pain and radiculopathy due to lumbar disc herniation. (2) Patients were enrolled from a French emergency department. Inclusion criteria were lumbar sciatica of less than 6 weeks in duration, secondary to disc herniation based on clinical exam, confirmed by lumbar tomo-densitometry. Patients with clinical neurologic deficits, sciatic due to something other than disc herniation, or abnormalities on tomo-densitometry were excluded. For the trial’s primary outcome (reduction in radicular pain measured by a 100-mm VAS), both groups demonstrated significant improvements from baseline to day 28 (see Table 1 below). However, there was no significant group by time interaction in terms of pain reduction. Similar findings were seen for lumbo-pelvic-hip mobility (measured by the finger-toe test), nerve root compression (measured by the straight leg raise test).

Table 1: Summary Results from Isner-Horobeti et al. (2016) (2)

Outcome Measures for Change From Baseline to Day 28

High-Force Traction Group (n=8)

Low-Force Traction Group (n=9)

Evaluation/Testing

Value (95% CI)

p

Value (95% CI)

p

Radicular pain

(VAS, mm)

-28.8

(-41.8 to -3.7)

<0.001

-34.8

(-52.6 to 017)

<0.001

Lumbar spine mobility

(FTT, mm)

-14.4

(-25.6 to -3.1)

<0.10

-17.6

(-28.3 to -7.0)

<0.001

Straight leg raise test

(elevation angle)

33.1°

(13.3° to 53.0°)

<0.01

36.0°

(17.3° to 54.7°)

<0.001

Table Key:

n: number;

CI: confidence interval;

p: p-value;

FTT: finger-toe test;

mm: millimeter;

VAS: visual analog scale.

Overall, this trial suggested some rapid short-term within-subjects improvements with a high-dose lumbar traction. Although lumbar traction was not compared with a placebo, the comparison with low-level traction may approximate a placebo, similar to the Schimmel et al. RCT, which used traction at 10% body weight traction as a placebo. The lack of significant interaction term suggests that the active intervention is not associated with improved outcomes. However, the trial’s small size may mean that it was underpowered.

Sherry et al. (2001) conducted an RCT comparing VAD (using the VAX-D® device) with transcutaneous electrical nerve stimulation (TENS). (3) While a 68% success rate was associated with VAX-D® compared with a 0% success rate with TENS, without a true placebo control, the results are difficult to interpret scientifically. In 2007, 2 small randomized trials (N=27, N=64) found little to no difference between patients treated with or without mechanical traction. (4, 5)

Nonrandomized Comparative Studies

In 2004, Ramos reported a nonrandomized comparison of patients receiving 10 sessions versus 20 sessions of vertebral axial decompression treatment. (6) 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

Gose et al. (1998) reported on an uncontrolled case series of 778 patients. (7) Although this study reported improvements in pain, mobility, and activity in most 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. (8) Two case series in 2008 reported symptom improvement in patients with chronic low back pain. (9, 10) Due to limitations associated with observational studies of chronic pain, RCTs are needed to demonstrate efficacy of this treatment.

Ongoing and Unpublished Clinical Trials

An online search of www.ClinicalTrials.gov did not identify ongoing clinical trials related to vertebral axial decompression.

Practice Guidelines and Position Statements

No guidelines or statements were identified.

Summary of Evidence

For individuals who have chronic lumbar pain who receive vertebral axial decompression, the evidence includes randomized controlled trials (RCTs). Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Non-randomized and observational studies did not yield any further evidence supporting use of these devices. Evidence for the efficacy of vertebral axial decompression (VAD) on health outcomes is limited. Because a placebo effect may be expected with any treatment that has pain relief as the principal outcome, RCTs with sham controls and validated outcome measures are required. The only sham-controlled randomized trial published to date did not show a benefit of VAD compared with the control group. The evidence is insufficient to determine the effects of the technology on health outcomes.

Contract:

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.

Coding:

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

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.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

97012, 97530

HCPCS Codes

S9090

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position.

A national coverage position for Medicare may have been changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Schimmel JJ, de Kleuver M, Horsting PP, 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. Dec 2009; 18(12):1843-50. PMID 19484433

2. 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):645-54. PMID 27838140

3. Sherry E, Kitchener P, Smart R. A prospective randomized controlled study of VAX-D and TENS for the treatment of chronic low back pain. Neurol Res. Oct 2001; 23(7):780-4. PMID 11680522

4. Fritz JM, Lindsay W, Matheson JW, 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. PMID 18091473

5. Harte AA, Baxter GD, Gracey JH. 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. PMID 18047650

6. Ramos, G. Efficacy of vertebral axial decompression on chronic low back pain: study of dosage regimen. Neurol Res. Apr 2004; 26(3):320-4. PMID 15142327

7. 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. Apr 1998; 20(3):186-90. PMID 9583577

8. Ramos G, Martin W. Effects of vertebral axial decompression on intradiscal pressure. J Neurosurg. Sep 1994; 81(3):350-3. PMID 8057141

9. 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. Feb 2008; 89(2):269-74. PMID 18226650

10. Macario A, Richmond C, Auster M, et al. Treatment of 94 outpatients with chronic discogenic low back pain with the DRX9000: a retrospective chart review. Pain Pract. Jan-Feb 2008; 8(1):11-7. PMID 18211590

11. Vertebral Axial Decompression. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2017 April) Therapy 8.03.09.

Policy History:

DateReason
6/15/2018 Reviewed. No changes.
12/15/2017 Document updated with literature review. Coverage unchanged.
9/15/2016 Reviewed. No changes.
5/1/2015 Document updated with literature review. Coverage statement changed to include “neck” pain: The use of any non-surgical spinal decompression traction device for the treatment of neck or back pain in any setting (e.g., home, office, rehabilitation clinic) is considered experimental, investigational and/or unproven.
8/1/2013 Document updated with literature review. Coverage unchanged. Rationale and References reorganized.
5/1/2011 Document updated with literature review. No change in coverage.
5/15/2008 Policy reviewed without literature review; new review date only. This policy is no longer scheduled for routine literature review and update.
8/15/2007 Revised/updated entire document
2/1/2007 Revised/updated entire document
10/15/2004 Revised/updated entire document
12/1/2003 Revised/updated entire document
1/1/2000 Revised/updated entire document
8/1/1999 New medical document

Archived Document(s):

Back to Top