Clinical UM Guideline

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^®.

Not Medically Necessary:

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

The following codes for treatments and procedures applicable to this guideline 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 Not Medically Necessary:
When the code describes a procedure indicated in the Clinical Indications section as not medically necessary.

Summary

Self-operated spinal unloading devices, including traction-based interventions and orthoses such as thoracic-lumbar-sacral orthoses (TLSOs), have been proposed for the management of spine-related pain and deformities like scoliosis. However, despite being available for many years, their use in clinical practice has not been widely accepted. This is partially based on the fact that current clinical evidence supporting their efficacy is largely unsupportive. A 2017 randomized controlled trial (RCT) by Urquhart involving 36 participants with thoracolumbar burst fractures found no statistically significant difference in long-term outcomes between those treated with a TLSO and those treated without an orthosis, including metrics such as Roland Morris Disability Questionnaire scores, pain levels, and physical/mental health summaries. Similarly, a 2013 Cochrane Review encompassing 16 RCTs concluded that spinal traction provides little to no clinically meaningful benefit in reducing pain or improving function in individuals with low back pain, citing small effect sizes and low-quality evidence. Reflecting this, the North American Spine Society (NASS, 2020) issued a Grade A recommendation against the use of traction for subacute or chronic low back pain, and the United States Department of Veterans Affairs/Department of Defense guidelines (VA/DoD, 2022) state there is insufficient evidence to support or oppose its use. These devices are classified as Class I by the FDA, meaning they are subject to minimal regulatory oversight and do not require clinical efficacy data prior to marketing.

Discussion

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.

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.

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 and the Lumbar Hometrac (Saunders Medical Inc., Ozark, AL).

Self-operated spinal unloading devices have been proposed for the treatment of spine-related pain and scoliosis. However, evidence to support their efficacy is limited.

In 2017, Urquhart and colleagues published the results of a small RCT comparing the use of TLSOs to no orthosis in 36 participants with acute AO Type A3 thoracolumbar burst fractures who were followed for up to 10 years. A total of 16 participants 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.”

A Cochrane Review (2013) assessed the effects of traction compared to placebo, sham traction, reference treatments, and no treatment in people with low back pain. The review included 16 RCTs of both manual and machine delivered traction. The review concluded that:

These findings indicate that traction, either alone or in combination with other treatments, has little or no impact on pain intensity, functional status, global improvement and return to work among people with LBP. There is only limited‐quality evidence from studies with small sample sizes and moderate to high risk of bias. The effects shown by these studies are small and are not clinically relevant.

NASS(2020) issued the following recommendation:

In patients with subacute or chronic low back pain, traction is not recommended to provide clinically significant improvements in pain or function.
Grade of Recommendation: A

The U.S. Department of Veterans Affairs (VA) and the U.S. Department of Defense (DoD) published a joint document addressing the diagnosis and treatment of low back pain (VA, 2022). That document includes the following recommendation:

14. For patients with low back pain, with or without radicular symptoms, there is insufficient evidence to recommend for or against mechanical lumbar traction.

They state, “The available evidence is insufficient to recommend for or against the use of mechanical traction for patients with LBP with or without radicular symptoms.”

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.

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.

Spinal traction: A form of decompression therapy, performed manually or mechanically, that relieves pressure on the spine.

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 Vaccaro AR, Oner C, Kepler CK, et al.; AOSpine Spinal Cord Injury & Trauma Knowledge Forum. AOSpine thoracolumbar spine injury classification system: fracture description, neurological status, and key modifiers. Spine (Phila Pa 1976). 2013; 38(23):2028-37.
2. North American Spine Society. Evidence-based clinical guidelines for multidisciplinary spine care: diagnosis & treatment of low back pain. 2020. Available at: https://www.spine.org/Portals/0/assets/downloads/ResearchClinicalCare/Guidelines/LowBackPain.pdf. Accessed on July 31 2025.
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.
4. United States Department of Veterans Affairs/Department of Defense. VA/DoD clinical practice guidelines. diagnosis and treatment of low back pain (LBP) (2022). Available at https://www.healthquality.va.gov/guidelines/pain/lbp/. Accessed on July 31, 2025.
5. Wegner I, Widyahening IS, van Tulder MW, et al. Traction for low-back pain with or without sciatica. Cochrane Database Syst Rev. 2013; (8):CD003010.

1. National Library of Medicine. Medical Encyclopedia: Back pain. Last updated June 29, 2025. Available at: https://medlineplus.gov/backpain.html. Accessed on July 31 2025.
2. National Library of Medicine. Medical Encyclopedia: Scoliosis. Review Date August 12, 2023. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/001241.htm. Accessed on July 31, 2025.

LTX 3000
Orthotrac Pneumatic Decompression Vest
Patient-operated
Pronex Pneumatic Traction Unit
Saunders Lumbar Hometrac
Saunders STx^®
Scoliosis - Congenital, Neuromuscular, Idiopathic
Spinal Distraction Devices
Thoracic-Lumbo-Sacral Orthoses
Vertetrac Dynamic Ambulatory

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.

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