Cigna / ASH Medical Coverage Policies

Cigna / ASH Medical Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document may differ significantly from the standard benefit plans upon which these Cigna / ASH Medical Coverage Policies are based. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Cigna / ASH Medical Coverage Policy. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Determinations in each specific instance may require consideration of:

1. the terms of the applicable benefit plan document in effect on the date of service
2. any applicable laws/regulations
3. any relevant collateral source materials including Cigna-ASH Medical Coverage Policies and
4. the specific facts of the particular situation

Cigna / ASH Medical Coverage Policies relate exclusively to the administration of health benefit plans. Cigna / ASH Medical Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. Some information in these Coverage Policies may not apply to all benefit plans administered by Cigna. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make benefit determinations. References to standard benefit plan language and benefit determinations do not apply to those clients.

GUIDELINES

Experimental, Investigational, Unproven

Home cervical and/or lumbar traction devices, including gravity-assisted traction devices, are considered experimental, investigational or unproven for any indication.

DESCRIPTION and GENERAL BACKGROUND

For the purpose of this policy, traction is the use of a pulling force to treat muscle and skeletal disorders of the spine. Traction is intended for patients with musculoskeletal or neurological impairments of the spine; the objective is to relieve pain, relax muscle spasms, and decompress spinal structures. Traction is a widely used treatment for neck and low back pain and it is typically provided in combination with other treatment modalities and an exercise program.

Cervical and lumbar traction have been utilized to treat many causes of spine-related pain including radiculopathy secondary to herniated disc, narrowing of the intervertebral foramen, degenerative changes resulting in nerve root impingement, and spondylolisthesis. Beyond these broad clinical indications, the particular characteristics of patient subgroups that are likely to benefit from home traction do not appear to have been identified in clinical studies. Treatment plans are usually short-term (less than eight weeks in duration) with treatments 2–3 times per week. The type of traction used depends on the patient’s age, weight and medical condition.

Home Traction Devices – Cervical and Lumbar (CPG 265)

It can be provided manually by a therapist or by mechanical means in a clinic setting, and also may be self-administered using portable devices. Types of traction include, but are not limited to: mechanical traction, manual traction (performed by clinician), autotraction, gravity-dependent ("anti-gravity") traction, pneumatic traction, continuous traction, and intermittent traction. The suggested mechanisms through which traction might be effective include:

• Biomechanical effects, such as separation of the intervertebral motion segment which may increase intervertebral space, thus decreasing mechanical stress and/or spinal nerve root compression
• altering intradiscal pressure, and perhaps reducing intervertebral disc protrusion.

Neurophysiological effects, such as modulation of nociceptive input in either the ascending or descending pathways, thus silencing ectopic impulse generators. These two mechanisms probably work in concert to produce clinical effects, including pain reduction, increased mobility, reduced muscle spasm, and nerve root irritation. Ideally, normalization of the neurologic deficit and relief of radicular pain occurs. However, the proposed mechanisms have not been supported by sufficient empirical information.

Traction, when applied at home, presents with additional factors that may influence clinical effectiveness and the risk of adverse events. The absence of professional supervision decreases confidence that the appropriate amount of force will be consistently applied and the desired angle of pull will be maintained. Another consideration that has the potential to affect treatment response is patient compliance with home-based traction. While there is emerging evidence about the factors associated with poor compliance with home-based care, there has been little study on effective remediation strategies.

U.S. Food and Drug Administration (FDA)

Home traction devices are classified as Class I devices by the U.S. Food and Drug Administration (FDA). The FDA has described these devices as "A non-powered orthopedic traction apparatus is a device that consists of a rigid frame with nonpowered traction accessories, such as cords, pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system."

Home Cervical Traction:

Home traction units generally provide sustained (static) or intermittent distractive forces. Various cervical traction devices are available for use in a home setting including over-the-door pulley systems, pneumatic (inflatable) neck traction devices, rigid or foam collars, and mechanical traction systems.

Some devices intended primarily for home use are limited in comparison to those usually available in supervised outpatient settings. Traction forces used in the clinic setting commonly reach between 20 and 50 pounds. The traditional over-the-door traction units are generally limited to providing less than 20 pounds of traction. This is the most commonly used device employed in which an individual wears a chin strap harness attached to a counterweight that is suspended over a door using a pulley system. The counterweight pulls the chin harness upwards, extending the neck.

Variations of this device using the counterweight and pulley system include frames which attach to a headboard or freestanding units. More recently developed technologies include devices that do not cause pressure to the temporomandibular joint, and reportedly provide cervical traction in the home using forces comparable to those in the outpatient setting. These newer pneumatic devices are designed to be used in the supine position with the device beneath the head and shoulders and a strap or straps holding the head in place. Patient-controlled pressure valves/pumps or bellows allow the individual to increase the tension, pulling the head away from the body, but it also limits the amount of force transmitted to the user and allows for an immediate release of pressure. They also allow the patient to be positioned in any degree of flexion, neutral or in extension.

This extends the neck, stretches the affected muscles and increases the intervertebral spaces. Pneumatic devices typically can deliver up to 50 pounds of tension, which manufacturers' state more closely mimics traction given within an outpatient setting. It is suggested that these devices manufactured for home use are sufficiently sophisticated that outpatient treatment protocols can confidently be translated to the home setting.

Home Traction Devices – Cervical and Lumbar (CPG 265)

Home traction devices include both traditional over-the-door devices (applied in a sitting position) and more advanced technologies (applied in a supine position), such as the HomeTrac® (Empi, Shoreview, MN) and Pronex® Pneumatic Traction Unit (Glacier Cross Inc., Kalispell, MT). Standard over-the-door traction devices are traditionally limited to delivering 20 pounds or less of traction.

Devices that are used in the home and allow greater traction force include the HomeTrac and Pronex cervical traction devices. The Pronex is a patient-controlled, pneumatic traction device that is used in a supine position. The device cradles a reclining patient’s head and neck between two soft foam cushions. An air-inflated bellows between the cushions provides up to 20 pounds of continuously adjustable traction. The Pronex II is a newer device capable of delivering greater than 20 pounds of force. The HomeTrac may provide up to 50 pounds of traction force at a 15° angle. Traction forces are directed at the occiput, preventing undue pressure on the TMJ. The device has an adjustable extension foot that allows additional traction angles of 20° and 25°. The patient can immediately release the traction force by using a pressure release valve. Both HomeTrac and Pronex are operated by a patient-controlled, hand-held pump.

Manufacturers and therapists propose that these devices maintain the normal cervical lordosis, resulting in uniform traction posteriorly and anteriorly across the vertebral disc, in comparison to other devices, which occlude the anterior disc space for temporary relief posteriorly. The manufacturers suggest that the use of these devices in a home setting allows treatment comparable to that provided in an outpatient setting and may provide more continuous pain relief. These devices can be used to deliver a traction force that avoids TMJ force and allows patients control of their own comfort level.

There are cervical traction devices that may be used with ambulation. They may also be referred to as a cervical support brace. The device consists of an inflatable collar that is inflated with attached bulb pumps. Cervical traction equipment that does not prevent ambulation during use has not been shown to be effective and is considered not medically necessary as a treatment for musculoskeletal and/or neurological conditions. Scientific evidence supporting the efficacy of this device is lacking.

Examples of these devices include but are not limited to:

• Pneu-trac® Traction Collar (Trulife, Poulsbo, WA)
• TracCollar® (BodySport®, Ft. Worth, Texas)

Home Lumbar Traction:

Lumbar traction is used to treat low back pain, often in conjunction with other treatment modalities. The traction may be applied intermittently, using any of several methods to treat conditions of the spine, in either an outpatient setting or in a home setting. Typically, these modalities are used short term. The duration of the exerted force applied may be intermittent or continuous throughout a treatment session.

Generally, during lumbar traction a harness is attached around the pelvis (to deliver a caudal pull), and the upper body is stabilized with a chest harness or voluntary arm force (for the cephalad pull) (Wieting, et al., 2013). In some cases, 70–150 pounds of pull are required to distract lumbar vertebrae (Wieting, et al., 2013). Some of the most commonly used lumbar traction techniques are not suited for home use. Manual traction (distractive force is exerted by and under the control of the clinician) and motorized traction (distractive force is exerted by a motorized pulley) are not practical for home application.

There are also questions about the ability of lumbar traction some devices designed for home use to achieve the magnitude of distractive force (80-120 lbs or >50% of body weight) necessary to increase intervertebral joint space. Devices may include the use of a table, vest, weights, gravity or pneumatic devices. Several available home lumbar traction devices that are not pulley and weight systems may apply increased traction forces (greater than 20 pounds). This type of device is designed to provide traction (stretching) to the lumbar region (low back).

Examples include Saunders Lumbar Home Traction© (DJO Global Inc., Vista, CA) and Lo-Bak TRAXTM (Allstar Products Group, Hawthorne NY). The Back Bubble® (Back Bubble, Solana Beach, CA) is an inflatable lumbar traction device that is suspended from a door and connects with a buoyancy spring to an inflatable body harness which encircles and suspends the patient in air-cushioned weightlessness. The manufacturer’s website states that the patient’s own body weight will provide a gentle stretch which relaxes the lower back.

There is insufficient evidence in the medical literature regarding the efficacy of inflatable traction devices in the treatment of back pain.

Gravity-Assisted Traction:

Inversion therapy is a form of traction facilitated by gravity as the patient is either hung or laid upside down typically at an angle of greater than 45° below the horizontal axis. This therapy is used in the treatment of back pain and is believed to help in the decompression of the disks and joints. This therapy takes many forms, from gravity boots to inversion tables the patient lies on before inverting the table.

Contraindications to inversion therapy include hernia, glaucoma, retinal detachment, conjunctivitis, high blood pressure, recent stroke, heart or circulatory disorders, spinal injury, cerebral sclerosis, swollen joints, osteoporosis, unhealed fractures, surgically implanted supports, use of anticoagulants, ear infection, and obesity.

Home Traction Devices – Cervical and Lumbar (CPG 265)