Medicine Section - Vertebral Axial Decompression

IMPORTANT REMINDER

Regence Medical Policies are developed to provide guidance for members and providers regarding coverage in accordance with contract terms. Benefit determinations are based in all cases on the applicable contract language. To the extent there may be any conflict between the Medical Policy and contract language, the contract language takes precedence.

PLEASE NOTE: Contracts exclude from coverage, among other things, services or procedures that are considered investigational or cosmetic. Providers may bill members for services or procedures that are considered investigational or cosmetic. Providers are encouraged to inform members before rendering such services that the members are likely to be financially responsible for the cost of these services.

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.

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. This is followed by a gradual decrease of the tension, and the cycle is repeated. The cyclic nature of the treatment allows the patient to withstand stronger distraction forces compared to static lumbar traction techniques. The level of tension is individually calibrated and recorded. An individual session typically includes 15 cycles of tension, lasting approximately 30 minutes; 10 to 15 daily treatments may be administered.

Several devices used for vertebral axial decompression have received 510(k) marketing clearance from the US Food and Drug Administration (FDA). According to the FDA-labeled indications, 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.

POLICY/CRITERIA

Vertebral axial decompression is considered investigational.

SCIENTIFIC BACKGROUND ^[1]

A placebo effect may be expected with any treatment whose principal outcome is pain relief. Therefore, randomized trials are required to evaluate the magnitude of the expected placebo effect and to determine if there is an independent effect of active treatment.

Randomized Clinical Trials

Sham-controlled randomized trial

Results from a randomized sham-controlled trial of intervertebral axial decompression were published in 2009. ^[2] 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 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.

Other randomized trials

Two small randomized studies (n=27 and 64) reported little to no difference between patients treated with or without mechanical traction. ^[3,4]

Sherry and colleagues conducted a randomized trial comparing vertebral axial decompression (using theVAX-D device) with transcutaneous electrical nerve stimulation (TENS). ^[5] While a 68% success rate was associated with VAX-D compared to a 0% success rate associated with TENS therapy, without a true placebo control, the results are difficult to interpret scientifically.

Non-randomized Studies

A number of non-randomized studies have been published ^[6-10]; however, data from these studies is unreliable due to limitations associated with observational studies of chronic pain, most importantly, lack of control for placebo or treatment effect. Other flaws in the case series include failure to use a validated outcome measures, and failure to report methods of patient identification or collection of data, duration of treatment benefit, and follow-up time.

Summary

Evidence for the efficacy of 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 compared to the control group. Therefore, current evidence is insufficient to permit conclusions regarding the effect of vertebral axial decompression on net health outcomes.

REFERENCES

1. BlueCross BlueShield Association Medical Policy Reference Manual "Vertebral Axial Decompression." Policy No. 8.03.09
2. Schimmel, JJ, de Kleuver, M, Horsting, PP, Spruit, M, Jacobs, WC, van Limbeek, J. 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 Dec;18(12):1843-50.  PMID: 19484433
3. 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
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 (Phila Pa 1976). 2007 Dec 15;32(26):E793-800.  PMID: 18091473
5. 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 Oct;23(7):780-4.  PMID: 11680522
6. Ramos, G, Martin, W. Effects of vertebral axial decompression on intradiscal pressure. J Neurosurg. 1994 Sep;81(3):350-3.  PMID: 8057141
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. 1998 Apr;20(3):186-90.  PMID: 9583577
8. Ramos, G. Efficacy of vertebral axial decompression on chronic low back pain: study of dosage regimen. Neurol Res. 2004 Apr;26(3):320-4.  PMID: 15142327
9. Macario, A, Richmond, C, Auster, M, Pergolizzi, JV. Treatment of 94 outpatients with chronic discogenic low back pain with the DRX9000: a retrospective chart review. Pain Pract. 2008 Jan-Feb;8(1):11-7.  PMID: 18211590
10. Beattie, PF, Nelson, RM, Michener, LA, Cammarata, J, Donley, J. 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 Feb;89(2):269-74.  PMID: 18226650

CROSS REFERENCES

None

Medicine Section Table of Contents