Thoracic-Lumbo-Sacral Orthosis with Pneumatics
Durable Medical Equipment
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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, Minn.). 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. 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.
A thoracic-lumbo-sacral orthosis incorporating pneumatic inflation is considered investigational.
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State or federal mandates (e.g., FEP) may dictate that all FDA-approved devices may not be considered investigational. However, this policy considers specific applications of an FDA-approved device as investigational. Alternatively, FDA-approved devices may be assessed on the basis of their medical necessity.
A MEDLINE literature search focusing on pneumatic lumbar orthoses did not identify published articles. 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)
A review of the peer-reviewed literature on MEDLINE from the period of 2002 through June 2005 found 1 additional published article on pneumatic lumbar orthoses. 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 for 3 times a day for 5 weeks. (2) A total of 72% of patients reported symptom improvement. However, the lack of a control group limits scientific interpretation. The policy statement is unchanged.
A search of the MEDLINE database for the period of June 2005 through January 2007 did not identify any literature that would support a change in the policy statement.
Orthofix, Inc., has sponsored a randomized controlled trial comparing the Orthotrac Pneumatic Vest with an EZ form brace. (3) The target enrollment is 150 patients who have been recently diagnosed with radiating leg pain from disc bulge, protrusion, or herniation; the completion date with a 52-week follow-up is listed as September 2006. A preliminary report of patients (number unreported) completing the 12-week follow-up was presented in 2003. (4) 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 VAS scale) than observed in the group treated with the EZ brace. No recent updates or peer-reviewed publications were identified. Therefore, evidence remains insufficient and the policy statement remains unchanged.
The policy was updated with a literature search using MEDLINE through September 2008. This review identified no new relevant publications. Thus, the policy statement is unchanged.
A MEDLINE search from September 2008 through September 2009 found no new literature related to the device, and the policy statement is unchanged.
- Van Tulder MW, Jellema P, van Poppel MN et al. Lumbar supports for prevention and treatment of low back pain. Cochrane Database Syst Rev 2000; (3):CD001823
- Dallolio V. Lumbar spinal decompression with a pneumatic orthosis (Orthotrac): preliminary study. Acta Neurochir Suppl 2005; 92:133-7.
- Triano JJ. A randomized, controlled trial of treatment for disc herniation with radiating leg pain. Available at http://www.clinicaltrials.gov/ct/show/NCT00220935
- Triano JJ, Rogers C, Diederich J. Discopathy with leg pain: a randomized controlled trial of Orthotrac vs EZ brace. Spine J 2003; 3(5):105-6.
|HCPCS||E0830||Ambulatory traction device, all types, each|
|Type of Service||Durable Medical Equipment|
|Place of Service||Outpatient|
Back Brace, Pneumatic Orthosis
Orthotrac Pneumatic Vest
|02/15/02||Add to Durable Medicine section||New policy|
|07/17/03||Replace policy||Policy reviewed with literature search; policy unchanged|
|11/9/04||Replace policy||Policy reviewed with literature search; policy unchanged|
|08/17/05||Replace policy||Policy updated with literature search; reference 2 added. No change in policy statement|
|11/13/08||Replace policy||Policy updated with literature search; no change in policy statement|
|11/12/09||Replace policy||Policy updated with literature search; no change in policy statement|