Description:
Thoracic-lumbo-sacral orthosis (TLSO) with pneumatics consists of a vest with inflatable inserts. Inflation of these expandable inserts and pressure are controlled by the patient. The device is used to unload body weight from the spine onto the iliac crests.

Background
A variety of back supports or braces are designed to offer stabilization and decompression as a conservative treatment for pain related to spinal disc disease and/or joint dysfunction. For example, HCPCS codes L0450 through L0492 describe a variety of thoracic-lumbo-sacral orthoses (TLSO). An orthotic that includes a pneumatic component has become commercially available, the Orthotrac Pneumatic Vest^™ (manufactured by Kinesis Medical, Minneapolis, MN). Orthofix, Inc. acquired Kinesis Medical in 2000.

The pneumatic component is inflated by the patient and is designed to lift the patient's body weight off the spine and relieve intervertebral compression. The orthotic is designed to be worn intermittently throughout the day.

Regulatory Status
According to the manufacturer, the device is considered a Class I device by the U.S. Food and Drug Administration (FDA). This classification does not require submission of clinical data regarding efficacy but only notification of the FDA prior to marketing.

Policy:
A thoracic-lumbo-sacral orthosis incorporating pneumatic inflation is considered INVESTIGATIONAL.

Benefit Application
Blue Card^®/National Account Issues
State or federal mandates (e.g., FEP) may dictate that all FDA-approved devices, drugs or biologics (including those requiring only notification) may not be considered investigational and, thus, these devices may be assessed only on the basis of their medical necessity.

Rationale
As with any therapy for pain, placebo-controlled trials are particularly important to document the extent of the expected placebo effect and to determine the independent contribution of the therapy itself. While the lack of published studies does not permit scientific conclusions about a pneumatic lumbar orthosis alone or in comparison to other types of back orthoses, it should be noted that the literature regarding back braces and supports is, in general, of poor quality. A meta-analysis of lumbar support devices reported that there was limited evidence that lumbar supports are more effective than no treatment of low back pain and that it was unclear if lumbar supports are more effective than other interventions for treatment of low back pain.¹

Orthofix, Inc. has sponsored a randomized controlled trial comparing the Orthotrac Pneumatic Vest with an EZ form brace.² The target enrollment was 150 patients who had been recently diagnosed with radiating leg pain from disc bulge, protrusion or herniation. The study is listed as completed as of October 2006. A preliminary report of patients (number unreported) completing the 12-week follow-up was presented in 2003.³ The patients, who were carefully selected to show relief from spine unloading, showed subjective improvements in lower back and leg pain that were 6- to 8-fold greater (5 to 7 points on a visual analogue scale) than observed in the group treated with the EZ brace. No further reports of this trial were found in literature searches through September 2011.

In 2005, Dallolio reported on a case series of 41 patients with radicular back pain who were treated with an Orthotrac pneumatic lumbar vest, worn for 60 minutes, 3 times a day, for 5 weeks.⁴ A total of 72 percent of patients reported symptom improvement. However, the lack of a control group limits scientific interpretation.

Summary
The absence of controlled studies of thoracic-lumbo-sacral orthosis with pneumatics precludes any conclusions regarding effectiveness for the treatment of low back pain; the device is considered investigational.

References:

1. Van Tulder M, Jellema P, van Poppel M et al. Lumbar supports for prevention and treatment of low back pain. Cochrane Database Syst Rev 2000; (3):CD001823.
2. Triano J. A randomized, controlled trial of treatment for disc herniation with radiating leg pain. 
3. Triano J, Rogers C, Diederich J. Discopathy with leg pain: a randomized controlled trial of Orthotrac vs EZ brace. Spine J 2003; 3(5):105-6.
4. Dallolio V. Lumbar spinal decompression with a pneumatic orthosis (Orthotrac): preliminary study. Acta Neurochir Suppl 2005; 92:133-7.

Coding Section

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.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

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