For decades, cervical traction has been applied widely for pain relief of neck muscle spasm or nerve root compression. It is a technique in which a force is applied to a part of the body to reduce paravertebral muscle spasms by stretching soft tissues, and in certain circumstances separating facet joint surfaces or bony structures. Additional pounds for cervical traction is usually utilized in the hospitals or clinics for temporary use and in certain situations and under observation with occasional imaging, making sure of not to destabilize the spine. Studies have shown that traction must be constant so that the muscles may tire and the strain falls on the joints. It generally takes 2 minutes of sustained traction before the intervertebral spaces begin to widen. Forces between 20 and 50 pounds are commonly used to achieve intervertebral separation.

Cervical traction is administered by various techniques ranging from supine mechanical motorized cervical traction to seated cervical traction using an over-the-door pulley support with attached weights. Duration of cervical traction can range from a few minutes to 30 minutes, once- or twice-weekly to several times per day. Anecdotal evidence suggests efficacy and safety, but there is no documentation of efficacy of cervical traction beyond short-term pain reduction. In general, over-the-door traction at home is limited to providing less than 20 pounds of traction.

Pneumatic cervical traction devices (e.g., Saunders Cervical Hometrac, ComforTrac Cervical Traction, Pronex Pneumatic Traction Unit) were developed to deliver cervical traction in the home comparable to forces applied by physical therapists in the outpatient setting. The patient is instructed in home traction to relieve symptoms, an exercise routine to relieve spasm and discomfort, and to report any weaknesses, eye symptoms, and bladder or bowel incontinence immediately.

There are some who argue that pneumatic cervical traction should be offered as first line therapy in preference to over-the-door cervical traction, asserting that pneumatic cervical traction is superior to over-the-door cervical traction. There are, however, no studies in the peer-reviewed published medical literature comparing over-the-door cervical traction with pneumatic traction devices. Although pneumatic devices are able to provide more force than over-the-door traction devices, there are no peer-reviewed published clinical studies proving that clinical outcomes are improved by applying greater traction force. In addition, the potential adverse effects of the application of large amounts of cervical traction with pneumatic devices in the home setting have not been sufficiently evaluated in well-designed published clinical studies. There is also no published peer-reviewed evidence proving that pneumatic traction devices result in less irritation, improved compliance, or improved outcomes compared to over-the-door traction. For these reasons, the use of pneumatic cervical traction devices are reserved for persons with neck pain who have failed over-the-door cervical traction.

No matter how clinically effective a therapy is found to be, the treatment process, especially when it is dependent upon home use, is highly dependent upon patient compliance. So, these patients must undergo adequate follow-up to assure proper usage.

Cleland and colleagues (2005) described the outcomes of a consecutive series of patients presenting to physical therapy with cervical radiculopathy and managed with the use of manual physical therapy, cervical traction, and strengthening exercises. A total of 11 consecutive patients (mean age of 51.7 years) who presented with cervical radiculopathy on the initial examination were treated with a standardized approach, including manual physical therapy, cervical traction, and strengthening exercises of the deep neck flexors and scapulothoracic muscles. At the initial evaluation all patients completed self-report measures of pain and function, including a numeric pain rating scale, the Neck Disability Index, and the Patient-Specific Functional Scale. All patients again completed the outcome measures, in addition to the global rating of change (GROC), at the time of discharge from therapy and at a 6-month follow-up session. Ten of the 11 patients (91 %) demonstrated a clinically meaningful improvement in pain and function following a mean of 7.1 physical therapy visits and at the 6-month follow-up. Ninety-one percent (10 of 11) of patients with cervical radiculopathy in this case series improved, as defined by the patients classifying their level of improvement as at least "quite a bit better" on the GROC. However, because a cause-and-effect relationship can not be inferred from a case series, follow-up randomized clinical trials (RCTs) should be performed to further investigate the effectiveness of manual physical therapy, cervical traction, and strengthening exercises in a homogeneous group of patients with cervical radiculopathy.

Borenstein (2007) noted that chronic neck pain is a common patient complaint. Despite its frequency as a clinical problem, there are few evidence-based studies that document effectiveness of therapies for neck pain. The treatment of this symptom is based primarily on clinical experience. Preventing the development of chronic neck pain can be achieved by modification of the work environment with chairs that encourage proper musculoskeletal movement. The use of neck supports for sleep and active neck exercises together can improve neck pain. Passive therapies, including massage, acupuncture, mechanical traction, and electrotherapy, have limited benefit when measured by clinical trial results. Non-steroidal anti-inflammatory drugs, muscle relaxants, and pure analgesics are the mainstays of therapy. Furthermore, the American College of Occupational and Environmental Medicine's guideline on neck and upper back complaints (2004) did not recommend the use of traction.

In a Cochrane review on mechanical traction for neck pain with or without radiculopathy, Graham et al (2008) concluded that the current literature does not support or refute the efficacy or effectiveness of continuous or intermittent traction for pain reduction, improved function or global perceived effect when compared to placebo traction, tablet or heat or other conservative treatments in patients with chronic neck disorders. The authors stated that large, well-conducted RCTs are needed to first determine the efficacy of traction, then the effectiveness, for individuals with neck disorders with radicular symptoms.

The American Association of Neurological Surgeons’ clinical guideline on "The diagnosis and management of traumatic atlanto-occipital dislocation injuries" (Theodore et al, 2013) stated that "Traction is not recommended in the management of patients with AOD, and is associated with a 10 % risk of neurological deterioration".

Thoomes et al (2013) evaluated the effectiveness of conservative treatments for patients with cervical radiculopathy, a term used to describe neck pain associated with pain radiating into the arm. Little is known about the effectiveness of conservative treatment for patients with cervical radiculopathy. These researchers electronically searched the Cochrane Controlled Trials Register, MEDLINE, EMBASE, and CINAHL for RCTs. Conservative therapies consisted of physiotherapy, collar, traction etc. Two authors independently assessed the risk of bias using the criteria recommended by the Cochrane Back Review Group and extracted the data. If studies were clinically homogenous, a meta-analysis was performed. The overall quality of the body of evidence was evaluated using the GRADE method. A total of 15 articles were included that corresponded to 11 studies; 2 studies scored low risk of bias. There is low-level evidence that a collar is no more effective than physiotherapy at short-term follow-up and very low-level evidence that a collar is no more effective than traction. There is low-level evidence that traction is no more effective than placebo traction and very low level-evidence that intermittent traction is no more effective than continuous traction. The authors concluded that on the basis of low-level to very low-level evidence, no one intervention seems to be superior or consistently more effective than other interventions. Furthermore, regardless of the intervention assignment, patients seem to improve over time, indicating a favorable natural course; use of a collar and physiotherapy show promising results at short-term follow-up.

Bryans et al (2014) developed evidence-based treatment recommendations for the treatment of non-specific (mechanical) neck pain in adults. Systematic literature searches of controlled clinical trials published through December 2011 relevant to chiropractic practice were conducted using the databases Medline, Embase, Emcare, Index to Chiropractic Literature, and the Cochrane Library. The number, quality, and consistency of findings were considered to assign an overall strength of evidence (strong, moderate, weak, or conflicting) and to formulate treatment recommendations. A total of 41 RCTs meeting the inclusion criteria and scoring a low risk of bias were used to develop 11 treatment recommendations. Strong recommendations were made for the treatment of chronic neck pain with manipulation, manual therapy, and exercise in combination with other modalities. Strong recommendations were also made for the treatment of chronic neck pain with stretching, strengthening, and endurance exercises alone. Moderate recommendations were made for the treatment of acute neck pain with manipulation and mobilization in combination with other modalities. Moderate recommendations were made for the treatment of chronic neck pain with mobilization as well as massage in combination with other therapies. A weak recommendation was made for the treatment of acute neck pain with exercise alone and the treatment of chronic neck pain with manipulation alone. Thoracic manipulation and trigger point therapy could not be recommended for the treatment of acute neck pain. Transcutaneous nerve stimulation, thoracic manipulation, laser, and traction could not be recommended for the treatment of chronic neck pain.

An UpToDate review on "Treatment of cervical radiculopathy" (Robinson and Kathari, 2016) states that "Cervical traction is the application of a distracting force to the neck, which can in theory separate the cervical segments, expand the intervertebral joint spaces, and relieve compression of the nerve roots. However, controlled studies of cervical traction delivered in the course of a physical therapy program for a variety of causes of neck and arm pain have not demonstrated benefit over sham traction or placebo …. Traction should not be used unless neuroimaging has been performed, and should be discontinued if symptoms worsen with the application of distracting force. Traction is not recommended in the presence of spinal cord compression or large disc protrusion …. We generally do not prescribe cervical traction as initial therapy for patients with cervical radiculopathy. Nevertheless, cervical traction is a reasonably safe alternative for patients with persistent or refractory pain who do not want epidural glucocorticoid injections or surgery".

Cervical Traction Device for Pediatric Atlantoaxial Rotatory Subluxation

Masoudi and colleagues (2017) introduced a novel traction device for management of pediatric atlanto-axial rotatory subluxation (AARS) in source-limiting areas. Atlanto-axial (C1 to C2) joint is accountable for up to 2/3 of total axial cranio-cervical rotation. Its major role in pivotal rotation of cervical spine makes it more vulnerable to a certain type of injury known as AARS. Management of AARS is based on the Fielding classification that includes closed reduction and immobilization and cervical fusion in unstable cases. There are several cervical traction devices including the Gardner-Wells tongs and halter traction device. All the available devices require insertion of pins into the calvarial periosteum which is a painful, invasive and intolerable procedure especially for the pediatric patients. These researchers designed a simple hand-made cervical traction device that is composed of 2 soft padded straps (40 × 4 cm) and 2 connecting strings that can be applied easily under the chin and occipital areas of the patients. These researchers successfully treated a 9-year old girl with AARS with the device. The advantage of the device was its available, inexpensive and non-invasive; and the patient might tolerate it more easily compared to the previously designed instruments. The authors concluded that this hand-made simple cervical traction device in source-limiting centers and hospitals was a good example of doing more with less. It was effective and the tolerance of the patient was acceptable. Moreover, they stated that further studies with larger series are needed for providing appropriate evidence.

Thoracic Pillow (Spinal Traction Device)

In a non-controlled clinical trial, Shahar and Sayers (2019) examined the efficacy of a simple home spinal traction device on sagittal cranio-cervical posture and related symptoms. Subjects (n = 13, 18 to 36 years of age) were drawn from a mildly symptomatic population, all presented with cranio-cervical mal-alignment and considerable forward head protraction (FHP). Subjects used a simple home spinal traction device (Thoracic Pillow) for 12 weeks, 10 mins/day. Sagittal cervical radiographs and the SF36 health survey were obtained pre-/post-intervention and guideline compliance was recorded. Radiographic evaluation included typical measurements of sagittal cranio-cervical alignment and FHP (e.g., atlas plane line, vertical axis line, sagittal cranial angle, absolute rotation angle). Standard paired samples t tests, Chi-squared, and effect size analyses were used to assess pre- and post-intervention changes. Each of the key radiographic variables recorded significant moderate to very large positive changes as a result of the intervention. Similarly, Chi-squared analyses indicated that sagittal cervical spine configuration tended to become more lordotic (p = 0.007), with 4 participants shifting from a kyphotic to a lordotic presentation; SF36 health survey data showed mostly significant positive changes throughout all tested domains, and moderate positive changes were recorded across all radiographic cranio-cervical measured parameters (e.g., decreased FHP, increased cervical lordosis, and cranial extension). Subjects indicated high level of protocol compliance. The authors concluded that the findings of this study showed that the un-supervised daily use of a simple home spinal traction device proved effective in bringing positive plastic changes to the sagittal cranio-cervical alignment and reduction in symptoms in the tested population during a short intervention period. Leve lo evidence = III. This was a small study (n = 13) with a short treatment period (12 weeks); these preliminary findings need to be validated by well-designed studies.

Appendix

Documentation Requirements: It is expected that the patient’s medical records will reflect the need for the care provided. The patient’s medical records include the physician’s office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request. An order for the cervical traction device must be signed and dated by the treating physician, kept on file by the supplier, and be available upon request.

Cervical traction equipment not requiring a stand or frame describes cervical traction devices that provide traction on the cervical anatomy without the use of a door or external frame or stand. Traction may be applied by means of mandibular or occipital pressure.

Overdoor cervical traction equipment describes cervical traction devices that provide traction on the cervical anatomy through a system of pulleys and rope and are attached to a door. Traction may be applied in either the upright or supine position.

Pneumatic cervical traction devices describe cervical traction devices that provide traction on the cervical anatomy by means of pneumatic displacement to anatomical areas other than the mandible (e.g., the occipital region of the skull). These devices must be capable of generating traction forces greater than 20 pounds. In addition, these devices allow traction to be applied with alternative vectors of force (e.g., 15 degrees of lateral neck flexion).

Scope of Policy

This Clinical Policy Bulletin addresses cervical traction devices.

Medical Necessity

Aetna considers the following cervical traction devices medically necessary:

Aetna considers a cervical collar with an inflatable air bladder not medically necessary; CMS has determined that such devices (e.g., Pneu-trac Traction Collar and TracCollar), which can be used with ambulation, are not reasonable and necessary (NHIC, 2011).

Experimental and Investigational

The following interventions are considered experimental and investigational because the effectiveness of these approaches has not been established: