BlueCross and BlueShield of Montana Medical Policy/Codes
Pneumatic Traction and Spinal Uploading Devices
Chapter: Durable Medical Equipment
Current Effective Date: August 27, 2013
Original Effective Date: August 27, 2013
Publish Date: May 27, 2013
Description

Traction is the application of a mild stretch to muscles, ligaments, and tissue to provide relief of pain resulting from a variety of conditions, such as muscle spasm, nerve root compression, osteoarthritis, degenerative joint disease, and others.  Traction is frequently used to treat the spine, most often either the cervical or the lumbar spine.  When used on the spine, traction promotes separation of the intervertebral joint spaces to reduce impingement of structures in the area.  The goal of traction is usually short term pain relief, returning the patient to normal range of motion, and return to work. 

Although traction can be accomplished in a variety of ways, home traction is commonly achieved using a system of pulleys, weights, and counterweights connected to a stand (either freestanding or attached to the bed) or “over-the-door” equipment.  Some pneumatic devices are worn like a garment or brace.  These are inflated by the patient and are designed to lift the patient’s body weight off the spine and relieve intervertebral compression.  Other pneumatic devices, such as Ctrac for carpal tunnel, are designed to relieve pressure on nerves or other structures by stretching ligaments in the area.  Some of these devices allow the patient to be ambulatory during treatment (such as the Orthotrac Pneumatic Vest), while others require the patient to remain stationary.  The LTX-3000 system is a gravity-dependent spinal uploading device that promotes controlled spinal distraction by suspending the patient in a seated position, with the body weight supported from the rib cage by means of a brace-type device fastened around the lower chest.  All of these devices are designed to be used on an intermittent basis, usually two or three times per day.  

These devices are considered a Class I device by the FDA. This classification requires notification of the FDA prior to marketing, but does not require submission of clinical data regarding efficacy.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there is any exclusion or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coverage

Pneumatic traction and spinal uploading devices are considered experimental, investigational, and unproven in any setting (e.g., home, office, rehabilitation clinic).

Examples of pneumatic traction and spinal uploading devices include, but are not limited to:

  • LTX 3000™ Lumbar Rehabilitation System,
  • Orthotrac Pneumatic Vest™,
  • Saunders Lumbar STx™,
  • Saunders Lumbar Hometrac™ Deluxe,
  • Pronex™ cervical traction,
  • Saunders Cervical HomeTrac™,
  • Ctrac™ MeDevice,
  • Any other devices:
    • defined as “thoracic-lumbo-sacral orthosis (with pneumatics)”,and/or
    • defined as “pneumatic orthosis”, and/or
    • that operate in a similar manner, and/or
    • that are identified through the U.S. Food and Drug Administration (FDA) 510K system as substantially equivalent to any of the devices listed here.

Rationale

A Medline literature search that focused on pneumatic traction devices, pneumatic orthoses, and spinal uploading devices did not identify randomized, placebo-controlled studies published in the peer-reviewed literature that support the efficacy, safety, and benefit of these devices.  As with any therapy for pain, placebo-controlled trials are particularly important to document the extent of the expected placebo effect and to determine the independent contribution of the therapy itself.  Without appropriate scientific evidence, the potential benefits of these devices cannot be evaluated.

While the lack of published studies does not permit scientific conclusions about a pneumatic lumbar orthosis alone or in comparison to other types of back orthoses, it should be noted that the literature regarding back braces and supports is, in general, of poor quality.  A meta-analysis of lumbar support devices reported that there was limited evidence that lumbar supports are more effective than no treatment of low back pain, and that it was unclear if lumbar supports are more effective than other interventions for treatment of low back pain.

In 2005, Dallolio reported on a case series of 41 patients with radicular back pain who were treated with an Orthotrac pneumatic lumbar vest, worn for 60 minutes for three times a day for five weeks.  A total of 72% of patients reported symptom improvement.  However, the lack of a control group limits scientific interpretation. 

Orthofix, Inc. has sponsored a randomized controlled trial comparing the Orthotrac Pneumatic Vest with an EZ form brace.  The target enrollment was 150 patients who had been recently diagnosed with radiating leg pain from disc bulge, protrusion or herniation; the completion date with a 52-week follow-up was listed as September 2006.  A preliminary report of patients (number unreported) completing the 12-week follow-up was presented in 2003.  The patients, who were carefully selected to show relief from spine unloading, showed subjective improvements in lower back and leg pain that were 6- to 8-fold greater (5 to 7 points on a VAS scale) than observed in the group treated with the EZ brace.  No recent updates or peer-reviewed publications were identified.  Therefore, evidence remains insufficient and the policy statement remains unchanged.

A search of the MEDLINE database through July 2007 did not identify any literature that would support a change in the policy statement.  Therefore, pneumatic traction devices, pneumatic orthotic devices, and spinal uploading devices are not supported by evidence in the peer-reviewed medical literature that:

  • Permits conclusions on the effect of these devices on health outcomes;
  • Demonstrates an improvement in net health outcome through use of these devices;  
  • Demonstrates that use of these devices is as beneficial as established alternatives.

2013 Update

The absence of controlled studies of thoracic-lumbo-sacral orthosis with pneumatics precludes any conclusions regarding effectiveness for the treatment of low back pain; the device is considered experimental, investigational and unproven.

A search of peer reviewed literature through June 2013 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.

Coding

Disclaimer for coding information on Medical Policies           

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.           

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.           

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

ICD-9 Codes

Experimental, investigational, and unproven for all codes.

ICD-10 Codes

Experimental, investigational, and unproven for all codes.

Procedural Codes: E0830, E0849, E0856
References
  1. Waylonis, G.W., Tootle, D., et al. Home cervical traction: evaluation of alternate equipment.  Archives of Physical Medicine and Rehabilitation (1982 August) 63(8):388-91.
  2. Pal, B., Mangion, P., et al. A controlled trial of continuous lumbar traction in the treatment of back pain and sciatica. British Journal of Rheumatology (1986 May) 25(2):181-3.
  3. Wheeler, A.H.  Diagnosis and management of low back pain and sciatica.  American Family Physician (1996 October) 52(5):1333-41, 1347-8.
  4. Janke, A.W., Kerkow, T.A., et al.  The biomechanics of gravity-dependent traction of the lumbar spine. Spine (1997 February 1) 22(3):253-60.
  5. Podein, R.J., and P.A. Iaizzo. Applied forces and associated physiologic responses induced by axial spinal unloading with the LTX 3000 Lumbar Rehabilitation System. Archives of Physical Medicine and Rehabilitation (1998 May) 79(5):505-13.
  6. Swezey, R.L., Warner, K., et al. Efficacy of home cervical traction therapy. American Journal of Physical Medicine and Rehabilitation (1999 January-February) 78(1):30-2.
  7. Van Tulder, M.W., Jellema, P., et al.  Lumbar supports for prevention and treatment of low back pain. Cochrane Database System Review (2000) (3):CD001823.
  8. Falkenberg, J., Podein, R.J., et al.  Surface EMG activity of the back musculature during axial spinal unloading using LTX 3000 Lumbar Rehabilitation System. Electromyography and Clinical Neurophysiology (2001 October-November) 41(7):419-27.
  9. A guide to our home cervical and lumbar traction products. The Saunders Group, Inc. 2001.  <www.thesaundersgroup.com>.
  10. Hales, J., Larson, P., et al.  Treatment of adult lumbar scoliosis with axial spinal unloading using the LTX 3000 Lumbar Rehabilitation System. Spine (2002 February 1) 27(3):E71-9.
  11. Smith, D., McMurray, N., et al. Early intervention for acute back pain: can we finally develop an evidence-based approach? (2002 February) 16(1):1-11.
  12. Harte, A.A., Baxter, G.D., et al. The efficacy of traction for back pain: a systematic review of randomized controlled trials. Archives of Physical Medicine and Rehabilitation (2003 October) 84(10):1542-53.
  13. Triano, J.J., Rogers, C., et al. Discopathy with leg pain: a randomized controlled trial of Orthotrac vs EZ brace. Spine Journal (2003) 3(5):105-6.
  14. Cervical Traction Devices. Chicago, Illinois: Blue Cross Blue Shield Association – Technology Evaluation Center-Medical Policy Clearinghouse News (December 17, 2004).
  15. Modern spinal traction devices utilizing controlled spinal distraction. The Burton Report®. Accessed on February 9, 2005 at <www.burtonreport.com>.
  16. Ctrac Device and Use. MeDevice. Accessed on February 3, 2005 at <www.medevice.com>.
  17. Dallolio, V.  Lumbar spinal decompression with a pneumatic orthosis (Orthotrac): preliminary study. Acta Neurochirurgica Supplement (2005) 92:133-7.
  18. Triano JJ.  A Randomized, Controlled Trial of Treatment for Disc Herniation With Radiating Leg Pain. Study completed July 2006. Clinical Trials gov Identifier NCT00220935.  Accessed July 2007 <www.clinicaltrials.gov>.
  19. Thoracic-Lumbo-Sacral Orthosis with Pneumatics. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2007 April) Durable Medical Equipment 1.04.02.
  20. Thoracic-Lumbo-Sacral Orthosis with Pneumatics, Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (May 2013) Durable Medical Equipment 1.03.03.
History
May 2013 New 2013 BCBSMT medical policy.  Considered eperimental, investigational, and unproven.
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Pneumatic Traction and Spinal Uploading Devices