|MP 8.03.09||Vertebral Axial Decompression|
|Original Policy Date
|Last Review Status/Date
Reviewed with literature search/10:2014
|Return to Medical Policy Index|
Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract. Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage. Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.
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 to 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.
Several devices used for vertebral axial decompression have received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA). According to labeled indications from the 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
There is a specific HCPCS code for this therapy - S9090 Vertebral axial decompression, per session.
BlueCard/National Account Issues
State or federal mandates (e.g., FEP) may dictate that all FDA-approved devices may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
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.
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 6 weeks, reaching >50% 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 scores 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)
Nonrandomized 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.
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
An online search of 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 noncoverage policy (160.16) for vertebral axial decompression in 1997.(10)
- 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):1843-50.
- 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):780-4.
- 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.
- 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.
- Ramos G. Efficacy of vertebral axial decompression on chronic low back pain: study of dosage regimen. Neurol Res 2004; 26(3):320-4.
- 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):186-90.
- Ramos G, Martin W. Effects of vertebral axial decompression on intradiscal pressure. J Neurosurg 1994; 81(3):350-3.
- 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):269-74.
- 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):11-7.
- Centers for Medicare and Medicaid Services. National Coverage Decision for Vertebral Axial Decompression (VAX-D) (160.16). Available online at: 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. Last accessed August 2013.
Application of a modality to one or more areas; traction, mechanical
Investigational for all codes
Vertebral axial decompression, per session
|ICD-10-CM (effective 10/1/15)||Investigational for all diagnoses|
|M51.04-M51.07||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with myelopathy code range|
|M51.14-M51.17||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy code range|
|M51.24-M51.27||Other thoracic, thoracolumbar and lumbosacral intervertebral disc displacement code range|
|M51.34-M51.37||Other thoracic, thoracolumbar and lumbosacral intervertebral disc degeneration code range|
|M54.5||Low back pain|
|ICD-10-PCS (effective 10/1/15)||ICD-10-PCS codes are only used for inpatient services. There is no specific ICD-10-PCS code for this therapy; possible codes are included below.|
|F07L0YZ||Physical rehabilitation, motor treatment, musculoskeletal system – lower back, range of motion and joint mobility, other equipment|
|F07L6CZ; F07L6HZ, F07L6YZ||Physical rehabilitation, motor treatment, musculoskeletal system – lower back, therapeutic exercise; mechanical, mechanical or electromechanical, and other equipment codes|
|F07L7ZZ||Physical rehabilitation, motor treatment, musculoskeletal system – lower back, manual therapy techniques|
Type of Service
Place of Service
Vertebral axial decompression
|05/30/97||Add to Therapy section||New policy|
|07/10/98||Replace policy||Policy updated|
|07/12/02||Replace policy||Policy reviewed; no change in policy statement|
|10/9/03||Replace policy||Policy reviewed with literature search; no change in policy statement|
|03/15/05||Replace policy||Policy reviewed with literature search; no change in policy statement|
|03/7/06||Replace policy||Policy reviewed with literature search; no change in policy statement|
|07/10/08||Replace policy||Policy updated with literature search; references 5-8 added; Policy statement unchanged|
|10/06/09||Replace policy||Policy updated with literature search; no references added; Policy statement unchanged|
|10/08/10||Replace policy||Policy updated with literature search; reference 9 added; policy statement unchanged|
|10/04/11||Replace policy||Policy updated with literature search through August 2011; policy statement unchanged|
|10/11/12||Replacy Policy||Policy updated with literature search through August 2012; references reordered; policy statement unchanged|
|10/10/13||Replace policy||Policy updated with literature search through August 22, 2013; policy statement unchanged|
|10/09/14||Replace policy||Policy updated with literature review through September 15, 2014; policy statement unchanged|