Spinal Unloading Devices for the Treatment of Low Back Pain
DESCRIPTION
Spinal unloading devices are being investigated for the treatment of low back pain. These devices provide a traction-like effect in an effort to shift weight bearing off the lower back and onto the hips. The method used to shift weight bearing varies from device to device. Some devices (e.g., LTX 3000™) utilize gravitational force provided by the body mass of the individual. Other devices (e.g., Orthotrac Pneumatic Vest™, STx™ Saunders Lumbar Traction Device, Saunders Lumbar Hometrac™ Deluxe) utilize applied pneumatic pressure in an effort to shift weight bearing.
POLICY
The use of spinal unloading devices for the treatment of low back pain is considered investigational.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
The lack of randomized controlled studies and the poor quality of published studies provide little evidence of the efficacy of these devices for the treatment of low back pain.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (11:2008) Thoracic-lumbo-sacral orthosis with pneumatics (1.04.02). Retrieved February 6, 2009 from BlueWeb. (4 articles and/or guidelines reviewed)
Dallolio, V. (2005). Lumbar spinal decompression with a pneumatic orthesis (Orthotrac): Preliminary study. Acta neurochirurgica. Supplement, 92, 133-137. Abstract retrieved February 6, 2009 from PubMed database. (Level 4 Evidence)
Ferrara, L., Triano, J. J., Sohn, M. J., Song, E., & Lee, D. D. (2005). A biomechanical assessment of disc pressures in the lumbosacral spine in response to external unloading forces. The Spine Journal, 5 (5), 548-553.
National Guideline Clearinghouse. (2007, June). Low back - lumbar & thoracic (acute & chronic). Retrieved February 6, 2009 from http://www.guidelines.gov.
U. S. Food and Drug Administration. (2008, April). Center for Devices and Radiological Health. Code of Federal Regulations: Title 21: Volume 8: 21CFR888.5850: Part 888 Orthopedic Devices: Section 888.5850. Nonpowered orthopedic traction apparatus and accessories. Retrieved February 9, 2009 from http://frwebgate6.access.gpo.gov/cgi-bin/PDFgate.cgi?WAISdocID=213296488427+1+2+0&WAISaction=retrieve.
ORIGINAL EFFECTIVE DATE: 7/1/2002
MOST RECENT REVIEW DATE: 3/12/2009
ID_BT
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