Cervical Traction Devices for Home Use
DESCRIPTION
Cervical traction is noninvasive traction, used to stretch the soft tissues of the neck and to separate the spinal joint structures in order to relieve neck pain.
A variety of cervical traction devices are available for use in the home:
Ambulatory cervical traction: Ambulatory cervical traction (e.g., Cervico 2000™) is an adjustable wearable frame device. The frame supports the neck and rests on the individual’s shoulders delivering traction while allowing the individual to be mobile.
Freestanding cervical traction units are units that can be freestanding or a unit attached to the headboard (e.g., C-Flex I™). The individual can wear a chin strap harness or head halter that is attached to a counterweight and a pulley system. The weight pulls the chin strap harness or head halter upwards that relieves tension on the neck.
Inflatable cervical traction collars: Inflatable cervical traction collars (e.g., DR-HO’s Neck Comforter; TruLife Pneu-Trac® Cervical Traction Collar) allow individuals to move around or to be stationary while using the collar. These devices are made of semi-rigid polyethylene to shape to the contours of the neck and shoulders while providing support to the neck. The air pressure is applied by the individual using a hand-held inflation bulb and releases the traction by using the pressure release valve.
Over-the-door cervical traction: The most commonly used traction device is the ‘over the door’ design (e.g., Neckpro™ Overdoor Traction). An individual wears a chin strap harness or head halter that is attached to a counterweight, which is suspended over the door using a pulley system. The weight pulls the chin strap harness or head halter upwards, relieving tension on the neck.
Pneumatic cervical traction: Pneumatic cervical traction devices (e.g., ComforTrac™ Cervical Traction; Posture Pump® Cervical Disc Hydrator®; Pronex® Pneumatic Cervical Traction Unit; Saunders Cervical HomeTrac®) cradle the individual’s head and neck between two foam cushions while the individual is lying in a supine position. The pressure level is controlled by the individual using a hand-held inflator bulb or pump and releases the traction by using the pressure release valve.
POLICY
An over-the-door cervical traction device for home use is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Cervical traction devices for home use, including but not limited to, the following: ambulatory cervical traction, freestanding cervical traction units, inflatable cervical traction collars, pneumatic cervical traction devices is considered investigational.
MEDICAL APPROPRIATENESS
An over-the-door cervical traction device for home use is considered medically appropriate if ALL of the following criteria are met:
The individual has a musculoskeletal or neurologic impairment requiring traction equipment
The appropriate use of the over-the-door cervical traction device for home use has been demonstrated to the individual
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Traction devices are classified as Class I devices by the U.S. Food and Drug Administration (FDA). 510(k) clearance is not required, although registration with FDA is required. The FDA has described orthopedic devices as follows: “A non-powered orthopedic traction apparatus is a device that consists of a rigid frame with non-powered traction accessories, such as cords, pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system.”
According to Centers for Medicare & Medicaid Services (CMS), the 2009 Local Coverage for Determination (LCD) for CIGNA Government Services, it states that “Cervical traction applied via attachment to a headboard or a free-standing frame has no proven clinical advantage compared to cervical traction applied via an over-the-door mechanism.”
The lack of randomized controlled studies and the poor quality of published articles provide little evidence of the efficacy for the use of ambulatory cervical traction, inflatable cervical traction collars, or pneumatic cervical traction devices. In addition, there is a lack of documentation in published articles for specific duration and frequency of these devices that would aid in net health outcomes.
SOURCES
Borman, P., Keskin, D., Ekici, B., & Bodur, H. (2008). The efficacy of intermittent cervical traction in patients with chronic neck pain. Clinical Rheumatology, 27 (10 ), 1249-1253.
Complete Guide to Medicare Coverage Issues [Computer software]. (2010, April). Durable medical equipment (NCD 280.1, 2-205, 2-210. Ingenix.
Graham, N., Gross, A. R., Goldsmith, C., & the Cervical Overview Group. (2006). Mechanical traction for mechanical neck disorders: A systemic review. Journal of Rehabilitation Medicine, 38 (3), 145-152.
Polston, D. W. (2007). Cervical radiculopathy. Neurologic Clinics, 25 (2), 373-385.
Raney, N. H., Petersen, E. J., Smith, T. A., Cowan, J. E., Rendeiro, D. G., Deyle, G. D., et al. (2009). Development of a clinical prediction rule to identify patients with neck pain likely to benefit from cervical traction and exercise. European Spine Journal, 18 (3), 382-391.
U. S. Department of Health & Human Services. Centers for Medicare & Medicaid Services. LCDs for CIGNA Government Services. (2009, September). LCD for cervical traction devices (L15905). Retrieved December 30, 2010 from http://www.cms.gov/mcd/viewlcd.asp?lcd_id=15905&lcd_version=32&show=all.
U. S. Food and Drug Administration. (2010, April). Center for Devices and Radiological Health. Code of Federal Regulations. Title 21, Volume 8. Section 888.5850. Nonpowered orthopedic traction apparatus and accessories. Retrieved January 25, 2011 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRsearch.cfm?FR=888.5850.
U. S. Food and Drug Administration. (2011). Center for Devices and Radiological Health. Establishment registration & device listing. 80101100. Retrieved December 30, 2010 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=33550&lpcd=HST.
U. S. Food and Drug Administration. (2011). Center for Devices and Radiological Health. Establishment registration & device listing. 1721293. Retrieved December 30, 2010 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=174094&lpcd=HST.
Washington State of Labor and Industries. (2002, August). Technology Assessment. Pronex and HomeTrac cervical traction. Retrieved December 30, 2010 from http://www.lni.wa.gov/ClaimsIns/Files/OMD/PronexAndSaundersTA.pdf.
Young, I. A., Michener, L. A., Cleland, J. A., Aguilera, A. J., & A. R. Snyder. (2009). Manual therapy, exercise, and traction for patients with cervical radiculopathy: A randomized clinical trial. Physical Therapy, 89 (7), 632-642. (Level 2 Evidence - Industry sponsored)
ORIGINAL EFFECTIVE DATE: 6/11/2011
MOST RECENT REVIEW DATE: 6/11/2011
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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