This policy addresses patient-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. Spinal unloading has been suggested as a conservative treatment for pain related to spinal disc disease and/or joint dysfunction. Two spinal unloading devices currently available on the market include the Orthotrac Pneumatic Vest™ (manufactured by Kinesis Medical, Minneapolis, MN) and the LTX 3000™ (manufactured by Spinal Designs International, Minneapolis, MN).

Investigational/Not Medically Necessary:

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

Currently, there are no randomized placebo-controlled trials published in the peer-reviewed medical literature addressing the use of 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 such data it is not possible to properly evaluate the potential benefits of such devices for the treatment of spine-related pain.

Spinal unloading devices have also been proposed for the treatment of scoliosis. There is currently only one small case series study addressing this method. The available evidence demonstrates that any benefits are not durable once treatment is discontinued. 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 spinal unloading devices for any indication is insufficient to allow any conclusions to be made regarding their efficacy.

Description of Back Pain
According to the National Institute of Neurological Disorders and Stroke, low back pain is the most common cause of job-related disability and the leading contributor to missed work, costing Americans at least $50 billion each year. Low back pain is the number three condition Americans see a doctor for, second only to colds and influenza. It is also the second most common neurological ailment in the United States; only headache is more common.

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. While the human spine is naturally curved on the front to back plane, there should be relatively little or no side to side curvature present in a normal spine. According to the American Physical Therapy Society, 5 to 10 out of every 100 young people, from ages 9 to 14, will develop scoliosis.

There are three general causes of scoliosis: congenital, neuromuscular and idiopathic. Congenital scoliosis is usually related to a problem with the formation of vertebrae or fused ribs during prenatal development and is present at birth. Neuropathic scoliosis is usually due to poor muscle control, muscular weakness or paralysis due to diseases like cerebral palsy, muscular dystrophy, spina bifida and polio. Idiopathic scoliosis is of unknown cause and appears in a previously straight spine.  The idiopathic form in adolescents is the most common and may have a genetic predisposition. Most cases occur in girls and the condition generally will worsen during growth spurts. There are also infantile and juvenile forms that are less common and affect a similar number of boys and girls.

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. The treatment is determined by the cause of the scoliosis, the size and location of the curve, and the stage of bone growth (how near the growth centers are to closure). Most cases of adolescent idiopathic scoliosis require no treatment (less than 20 degrees) but should be followed at regular intervals (often every 6 months).

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 patient 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. Bracing is not effective in congenital or neuromuscular scoliosis and is less effective in infantile and juvenile idiopathic scoliosis.

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 Spinal Unloading Devices
One type of proposed treatment for low back pain is the use of spinal unloading devices, also known as 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. Spinal unloading has been suggested as a conservative treatment for pain related to spinal disc disease and/or joint dysfunction. Two spinal unloading devices currently available on the market include the Orthotrac Pneumatic Vest™ (manufactured by Kinesis Medical, Minneapolis, MN) and the LTX 3000™ (manufactured by Spinal Designs International, Minneapolis, MN).

Proposed Benefits of Devices for Scoliosis
Spinal unloading devices have also been suggested as a treatment for scoliosis. The theory being that unloading of the spine and distraction of the vertebra somehow aids in straightening of the spine. To date there is very limited evidence to support this position. The use of spinal unloading devices is proposed to alleviate lower back pain in patients with chronic low back pain.

Possible Risks of Devices
While there is inadequate medical literature available on the safety of spinal unloading devices, one study demonstrated significant pressure increase on thoracic ribs, with associated temporary loss of cutaneous blood flow. Also reported was a temporary increase in heart rate, blood pressure, and respiratory rate similar to those reported with other back traction devices. The ramifications of these findings have not been evaluated. There are few risks involved with spinal unloading devices. There is some potential for the development of minor skin rashes or other short-lived conditions that resolve with cessation of treatment.

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 policy 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/Not Medically Necessary:

When the code describes a procedure indicated in the Policy section as investigational/not medically necessary

HCPCS

ICD-9 Diagnosis

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 3000 Lumbar Rehabilitation System. Arch Phys Med Rehabil. 1998; 79(5):505-513.
4. 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.

1. American Physical Therapy Association. Scoliosis.  http://www.apta.org/AM/Template.cfm?Section=Search&template =/CM/HTMLDisplay.cfm&ContentID=20446.  Accessed February 7, 2007.
2. 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 February 7, 2007.
3. National Library of Medicine.  Medical Encyclopedia: Back Pain - Low.  http://www.nlm.nih.gov/medlineplus/ency/article/003108.htm.  Accessed February 7, 2007.
4. National Library of Medicine.  Medical Encyclopedia: Scoliosis.  http://www.nlm.nih.gov/medlineplus/ency/article/001241.htm.  Accessed February 7, 2007.

LTX 3000™
Orthotrac Pneumatic Vest ™
Saunders Lumbar Hometrac®
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.

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically.

No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

©CPT Only - American Medical Association