Medical Policy

 

Subject: Self-Operated Spinal Unloading Devices
Document #: DME.00025 Publish Date:    03/29/2018
Status: Reviewed Last Review Date:    02/27/2018

Description/Scope

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 and the Lumbar Hometrac®.

Position Statement

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.

Rationale

Currently, there is only one 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 other effects, for example, potential placebo effects or the effects of time that may affect health outcomes.  Without data it is not possible to properly evaluate the 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).  This limited evidence demonstrates that benefits are not durable, and the data indicate that once the device is removed spinal curvature returns to pre-intervention levels. 

In 2017, Urquhart and colleagues published the results of a small randomized controlled trial (RCT) comparing the use of TLSOs to no orthosis in 36 subjects with acute AO Type A3 thoracolumbar burst fractures who were followed for up to 10 years.  A total of 16 subjects were assigned to the TLSO group and 20 to the no TLSO group.  The primary outcome, measurements on the Roland Morris Disability Questionnaire (RMDQ) score at the last 5- to 10-year follow-up visit, was 3.6 ± 0.9 (mean ± SE) for the TLSO group and 4.8 ± 1.5 for the control group (p=0.486).  Additionally, no differences were reported between the two groups with regard to time-weighted average treatment effects for RMDQ, the mental and physical component summary, or for average pain. The authors concluded that, “Compared with patients treated with a TLSO, patients treated using early mobilization without orthosis maintain similar pain relief and improvement in function for 5-10 years.”

These devices are considered Class I devices by the U.S. Food and Drug Administration (FDA).  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.

Background/Overview

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 heal without intervention, but if symptoms persist for longer than a few weeks, treatment may be warranted.

Treatments for low back pain include non-prescription analgesic medications, such as aspirin or other non-steroidal anti-inflammatory drugs, or short-term bed rest.  For some individuals, other prescription medications may be needed, including opioids for severe pain.  Physical exercise may also be effective to speed recovery from back injuries.  In the most severe or chronic cases, invasive treatment methods, including injections of steroids and surgical procedures, may be indicated.

Description of Scoliosis

Scoliosis is a condition where the back is abnormally curved.  Most cases of scoliosis are mild and do not need treatment.  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 can 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 are determined by many factors including the specific characteristics of the curvature and individual and physician preference.

More severe curvatures of the spine may require surgery to address the risk of progressing even after bone growth stops.  Surgical correction involves improving the curvature and fusing the bones and a brace may be required after surgery to stabilize the spine.

Functional Description of Self-Operated Spinal Unloading Devices

Self-operated spinal unloading devices, also known as self-operated thoracic-lumbo-sacral orthoses have been proposed for the treatment of back pain.  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 devices have 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 (Spinal Designs International, Minneapolis, MN) and the Lumbar Hometrac (Saunders Medical Inc, Ozark, AL).

Definitions

Scoliosis: A condition where the back is abnormally curved.

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

Coding

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.

HCPCS

 

L1499

Spinal orthosis, not otherwise specified [when specified as a spinal unloading device]

 

 

ICD-10 Diagnosis

 

 

All diagnoses

References

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 (Phila Pa 1976). 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 (Phila Pa 1976). 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. Urquhart JC, Alrehaili OA, Fisher CG, et al. Treatment of thoracolumbar burst fractures: extended follow-up of a randomized clinical trial comparing orthosis versus no orthosis. J Neurosurg Spine. 2017; 27(1):42-47.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. AOSpine Thoracolumbar Classification system. Available at: https://aospine.aofoundation.org/Structure/education/online-education/classifications/Documents/aos_100x150pCard_ThoracoCS.pdf.  Accessed on December 15, 2017.
  2. Clarke JA, van Tulder MW, Blomberg SE, et al. Traction for low-back pain with or without sciatica. Cochrane Database Syst Rev. 2007;(2):CD003010.
  3. Qaseem A, Wilt TJ, McLean RM, Forciea MA.; Clinical Guidelines Committee of the American College of Physicians. Noninvasive treatments for acute, subacute, and chronic low back pain: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2017; 166(7):514-530.
Websites for Additional Information
  1.  National Library of Medicine.  Medical Encyclopedia: Scoliosis. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/001241.htm. Accessed on October 31, 2017.
Index

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. 

Document History

Status

Date

Action

Reviewed

02/27/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. The document header wording updated from “Current Effective Date” to “Publish Date.” Updated Rationale and References sections.

Reviewed

02/02/2017

MPTAC review. 

Reviewed

02/04/2016

MPTAC review. Removed ICD-9 codes from Coding section.

Reviewed

02/05/2015

MPTAC review. Updated Background and Reference sections.

Reviewed

02/13/2014

MPTAC review. Updated References section.

Reviewed

02/14/2013

MPTAC review.

Reviewed

02/16/2012

MPTAC review.

Reviewed

02/17/2011

MPTAC review. Updated title to replace “Patient” with “Self”.

Reviewed

05/13/2010

MPTAC review. Updated References section.

Reviewed

05/21/2009

MPTAC review. Updated Rationale, Background and References sections.

Reviewed

05/15/2008

MPTAC review. Updated References and Index sections.

 

02/21/2008

The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary." This change was approved at the November 29, 2007 MPTAC meeting.

Reviewed

05/17/2007

MPTAC review.

 

11/29/2006

Added Saunders Lumbar Hometrac to index section.

Reviewed

06/08/2006

MPTAC review. References updated.

Revised

07/14/2005

MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.

Pre-Merger Organizations

Last Review Date

Document Number

Title

Anthem, Inc.

 

04/27/2004

DME.00025

Patient-Operated Spinal Unloading Devices

WellPoint Health Networks, Inc.

09/23/2004

9.07.03

Spinal Unloading Devices for Treatment of Low Back Pain