MEDICAL POLICY

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Vertebral Axial Decompression

Number 8.03.09*

Effective Date December 17, 2014

Revision Date(s) 12/08/14; 12/09/13; 12/11/12; 11/10/11; 12/14/10; 12/08/09; 10/14/08; 10/09/07; 03/14/06; 05/10/05; 02/10/04; 11/12/02; 09/01/98; 11/11/97

Replaces N/A

*Medicare has a policy.

Policy

Vertebral axial decompression is considered investigational.

Related Policies

7.01.551

Lumbar Spine Decompression Surgery: Discectomy, Foraminotomy, Laminotomy, Laminectomy

8.03.501

Chiropractic Services

Policy Guidelines

Coding

CPT

97012

Application of a modality to one or more areas; traction, mechanical

Description

Vertebral axial decompression is a type of lumbar traction that has been investigated as a technique to reduce intradiscal pressure and relieve low back pain associated with herniated lumbar discs or degenerative lumbar disc disease.

Background

Vertebral axial decompression is a type of lumbar traction in which a pelvic harness is worn by the patient. The specially equipped table on which the patient lies 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 with static lumbar traction techniques. An individual session typically includes 15 cycles of tension, and 10 to 15 daily treatments may be administered. 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.

Regulatory Status

Several devices used for vertebral axial decompression have received 510(K) marketing clearance from FDA. According to labeled indications from 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. FDA product code: ITH.

Scope

Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply. This medical policy does not apply to Medicare Advantage.

Benefit Application

N/A

Rationale

This policy was created in 1997 and has been updated periodically using the MEDLINE® database. the most recent literature review was performed through September 15, 2014.

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 noncomparability 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.

RCTs

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 6 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 [VAS] for back and leg pain, Oswestry Disability Index, and 36-Item Short-Form Health Survey), with no differences between the treatment groups. For example, VAS 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 does not support an improvement in health outcomes with vertebral axial decompression.

Sherry et al. conducted an RCT comparing vertebral axial decompression (using the VAX-D device) with transcutaneous electrical nerve stimulation (TENS). (2) While a 68% success rate was associated with VAX-D compared with a 0% success rate associated with TENS therapy, 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. (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 et al. reported on an uncontrolled case series of 778 patients. (6) 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. (7) Two case series in 2008 reported symptom improvement in patients with chronic low back pain. (8, 9) Due to limitations associated with observational studies of chronic pain, RCTs are needed to demonstrate efficacy of this treatment.

Ongoing and Unpublished Clinical Trials

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

Summary of Evidence

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, randomized trials with validated outcome measures are required. The only sham-controlled randomized trial published to date did not show a benefit of vertebral axial decompression compared with the control group. Therefore, treatment with vertebral axial decompression is considered investigational.

Practice Guidelines and Position Statements

No guidelines or statements were identified.

U.S. Preventive Services Task Force Recommendations

Vertebral axial decompression is not a preventive service.

Medicare National Coverage

Medicare has issued a national non-coverage policy (160.16) for vertebral axial decompression in 1997.. (10)

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. 2009; 18(12):1843-1850. PMID
  2. 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. 2001; 23(7):780-784. PMID
  3. 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
  4. Harte AA, Baxter GD, Gracey JH. The effectiveness of motorised lumbar traction in the management of LBP with lumbo sacral nerve root involvement: a feasibility study. BMC Musculoskelet Disord. 2007; 8:118. PMID 18047650
  5. Ramos G. Efficacy of vertebral axial decompression on chronic low back pain: study of dosage regimen. Neurol Res. 2004;26(3):320-324. PMID
  6. 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. PMID
  7. Ramos G, Martin W. Effects of vertebral axial decompression on intradiscal pressure. J Neurosurg. 1994; 81(3):350-353. PMID
  8. 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. PMID
  9. 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. 2008; 8(1):11-17. PMID
  10. Centers for Medicare and Medicaid Services. National Coverage Decision for Vertebral Axial Decompression (VAX-D) (160.16). http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=160.16&ncd_version=1&basket=ncd%3A160%2E16%3A1%3AVertebral+Axial+Decompression+%28VAX%2DD%29. Accessed July, 2014.

Coding

Codes

Number

Description

CPT

97012

Application of a modality to one or more areas; traction, mechanical

HCPCS

S9090

Vertebral axial decompression, per session

Type of Service

Surgery

 

Place of Service

Outpatient

 

Appendix

N/A

History

Date

Reason

11/11/97

Add to Therapy Section - New Policy

09/01/98

Replace policy - Policy updated

11/12/02

Replace policy - Policy reviewed; no change in policy statement

02/10/04

Replace policy - Policy reviewed; no change in policy statement.

05/10/05

Replace policy - Policy reviewed; no change in policy statement.

03/14/06

Replace policy - Policy reviewed with literature search; no change in policy statement. VAX-D added to title.

10/09/07

Replace policy - Policy updated with literature review; no change in policy statement. Reference update and addition.

10/14/08

Replace policy - Policy updated with literature search; no change to the policy statement. References added.

12/08/09

Replace policy - Policy updated with literature search; no change to the policy statement.

12/14/10

Replace policy - Policy updated with literature search; reference 9 added; policy statement unchanged.

11/10/11

Replace policy – Policy updated with literature search through August 2011; policy statement unchanged.

12/19/12

Replace policy. Policy updated with literature search through August 2012; references reordered; policy statement unchanged.

12/09/13

Replace policy. Policy reviewed. Policy Guidelines reformatted for readability. A literature search through August 22, 2013 did not prompt a revision of the references. Policy statement unchanged. CPT code 97012 removed; it is not specific to this policy.

01/21/14

Update Related Policies. Add 7.01.551.

12/17/14

Annual Review. Policy updated with literature review through September 15, 2014; policy statement unchanged. ICD-10 diagnosis and procedure codes removed; these do not relate to policy adjudication.


Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
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