Cervical Traction Devices for Home Use
Cervical traction devices for home use are noninvasive traction devices intended to stretch the soft tissues of the neck and to separate the spinal joint structures to relieve neck pain.
A variety of cervical traction devices are available for use in the home:
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 (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 device is the most commonly used traction device (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 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.
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 are considered investigational.
Cervical traction devices are considered medically appropriate if ALL of the following criteria are met:
Request must be for an over-the-door cervical traction device for use in the home only
Individual has a documented musculoskeletal or neurologic impairment requiring traction equipment
Individual has been taught the appropriate use of the over-the-door cervical traction device
Any specific products referenced in this policy are just examples and are intended for illustrative purposes 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. These examples are contained in the parenthetical e.g. statement.
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.
Non powered 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 Code of Federal Regulations describes non powered orthopedic devices as: “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.”
Randomized controlled studies continue to be deficient, and the poor quality of published articles also provides 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.
Cahaba Government Services Administrators, LLC. (2017, January). Local Coverage Determination (LCD): Cervical Traction Devices (L33823). Retrieved August 9, 2017 from https://www.cms.gov.
Fritz, J., Thackeray, A., Brennan, G., and Childs, J. (2014). Exercise only, exercise with mechanical traction, or exercise with over-door traction for patients with cervical radiculopathy, with or without consideration of status on a previously described subgrouping rule: a randomized clinical trial. Journal of Orthopedics, Sports & Physical Therapy, 44 (2), 45-47. Abstract retrieved August 9, 2017 from PubMed database.
Kang, J. H., & Park, T. S. (2015). Changes in cervical muscle activity according to the traction force of an air-inflatable neck traction device. Journal of Physical Therapy Science, 27 (9), 2723-2725. (Level 4 evidence)
U. S. Code of Federal Regulations. (1987, current as of August 2017). Title 21, Volume 8. Section 888.5850. Orthopedic Devices, Surgical Devices. Nonpowered orthopedic traction apparatus and accessories. Retrieved August 8, 2017 from https://www.ecfr.gov.
MOST RECENT REVIEW DATE: 8/9/2018
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