This document addresses self-operated spinal unloading devices, which are designed to support the upper body's weight and transfer that weight to the hips via a mechanical or pneumatic mechanism. Self-operated spinal unloading has been suggested as a conservative treatment for pain related to spinal disc disease or joint dysfunction. Several self-operated spinal unloading devices are currently available on the market, such as the LTX 3000™ (manufactured by Spinal Designs International, Minneapolis, MN) and the Lumbar Hometrac^® (manufactured by Saunders Medical Inc, Ozark, AL).

Investigational and Not Medically Necessary: 

Self-operated spinal unloading devices, including, but not limited to, gravity-dependent and pneumatic devices, are considered investigational and not medically necessary for all indications, including, but not limited to the treatment of low back pain and scoliosis.

Currently, there are no randomized controlled trials published in the peer-reviewed medical literature addressing the use of self-operated spinal unloading devices for the treatment of any spine-related pain condition. Such studies are especially important when addressing pain treatment modalities in order to isolate the effects of treatment from any potential placebo effect that may affect health outcomes. Without adequate and appropriate data it is not possible to properly evaluate the potential benefits of such devices for the treatment of spine-related pain.

Self-operated spinal unloading devices have been proposed for the treatment of scoliosis. There is currently only one small case series study addressing this method (Hales, 2002). The available evidence demonstrates that any benefits are not durable, and the data indicate that once the device is removed spinal curvature returns to pre-intervention levels. 

These devices are considered Class I devices by the U.S. Food and Drug Administration. This classification does not require submission of clinical data regarding efficacy, only notification to the FDA prior to marketing. The level of evidence supporting the use of self-operated spinal unloading devices for any indication is insufficient to allow any conclusions to be made regarding their efficacy.

Description of Back Pain
Pain felt in the lower back may come from the spine, muscles, nerves, or other structures in that region of the back. It may also radiate from other areas like the mid- or upper back, a hernia in the groin, or a problem in the testicles or ovaries. However, most back problems are due to injury from stress or strain that can cause temporary or permanent damage to various structures of the lower back.  Examples of such structures include intervertebral discs and various ligaments and tendons of the spine. Damage to peripheral nerves or even the spinal cord itself may also occur. Most low back injuries will heal on their own, but if symptoms persist for longer than a few weeks, medical intervention may be warranted.

Treatment for low back pain may be as simple as a non-prescription analgesic medication, such as aspirin, or other non-steroidal anti-inflammatory drugs and short-term bed rest. For more severe cases, various prescription medications may be provided by a physician, including opioids for the most serious cases. Physical exercise may also be one of the most effective ways to speed recovery from back injuries; however, a doctor should be consulted prior to undertaking any exercise regimen in the presence of a back injury. In the most severe or chronic cases, there are invasive treatment methods available, including injections of steroids and surgical procedures, to address anatomic anomalies or injuries.

Description of Scoliosis
Scoliosis is a condition where the back is abnormally curved.  Most cases of scoliosis are mild and do not need any treatment except for regular exams. A few cases do need treatment so that other problems will not develop in later years, such as breathing problems due to chest constriction.  If spinal curves progress above 25 to 30 degrees in a child who is still growing, spinal bracing is usually recommended to help slow the progression of the curve. There are many different kinds of braces available and each has a different appearance and method of application. The selection of a brace and the manner in which it is used is determined by many factors including the specific characteristics of the curvature and individual and physician preference. A back brace does not reverse the curve; rather the spine is straightened by the brace from asymmetric pressure, and can be adjusted with body growth.

A curvature of 50 degrees or greater usually requires surgery due to the high risk of progressing even after bone growth stops. Surgical correction involves correcting the curve (although not entirely) and fusing the bones in the curve together. The bones are held in place with one or two metal rods held down with hooks and screws until the bones heal together. Sometimes surgery is performed through an incision in the back and sometimes through an incision on the abdomen or beneath the ribs. A brace may be required after surgery to stabilize the spine.

Functional Description of Self-Operated Spinal Unloading Devices
One type of proposed treatment for low back pain is the use of self-operated spinal unloading devices, also known as self-operated thoracic-lumbo-sacral orthoses. These devices are designed to support the upper body's weight and transfer that weight to the hips via a mechanical or pneumatic mechanism. This weight transfer is theorized to stabilize and decompress the spine, relieving stress from the lower back resulting from bearing the upper body's weight. Self-operated spinal unloading has been suggested as a conservative treatment for pain related to spinal disc disease or joint dysfunction. Several spinal unloading devices are currently available on the market, including the LTX 3000™ (manufactured by Spinal Designs International, Minneapolis, MN) and the Lumbar Hometrac^® (manufactured by Saunders Medical Inc, Ozark, AL).

Scoliosis: a condition where the back is abnormally curved laterally

Spinal Unloading Devices: devices designed to alleviate stress on the lower back by transferring the weight of the upper body to the hips

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. 

When services are Investigational and Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary

Peer Reviewed Publications:

1. Hales J, Larson P, Iaizzo PA. Treatment of adult lumbar scoliosis with axial spinal unloading using the LTX3000^™ Lumbar Rehabilitation System. Spine. 2002; 27(3):E71-E79.
2. Janke AW, Kerkow TA, Griffiths HG, et al. The biomechanics of gravity-dependent traction of the lumbar spine. Spine. 1997; 22(3):253-260.
3. Podein RJ, Iaizzo PA. Applied forces and associated physiologic responses induced by axial spinal unloading with the LTX 3000Ô Lumbar Rehabilitation System. Arch Phys Med Rehabil. 1998; 79(5):505-513.

Government Agency, Medical Society, and Other Authoritative Publications: 

1. Clarke JA, van Tulder MW, Blomberg SEI, de Vet HCW, van der Heijden GJMG, Bronfort G, Bouter LM. Traction for low-back pain with or without sciatica. Cochrane Database of Systematic Reviews 2007, Issue 2. Art. No.: CD003010.
2. U.S. Preventive Services Task Force. Primary Care Interventions to Prevent Low Back Pain: Brief Evidence Update. February 2004. Agency for Healthcare Research and Quality, Rockville, MD. Available at: http://www.ahrq.gov/clinic/3rduspstf/lowback/lowbackup.htm. Accessed on December 10, 2010.

1. National Institute of Neurological Disorders and Stroke. Low Back Pain Fact Sheet. http://www.ninds.nih.gov/health_and_medical/pubs/back_pain.htm. Accessed on December 10, 2010.
2. National Library of Medicine.  Medical Encyclopedia: Scoliosis. http://www.nlm.nih.gov/medlineplus/ency/article/001241.htm.  Accessed on December 10, 2010.

LTX 3000^™
Patient-operated
Saunders Lumbar Hometrac^®
Saunders STx^®
Scoliosis - Congenital, Neuromuscular, Idiopathic
Spinal Distraction Devices
Thoracic-Lumbo-Sacral Orthoses

The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.