Pending Policies - DME


Pneumatic Traction and Spinal Unloading Devices

Number:DME101.041

Effective Date:03-15-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

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

Examples of pneumatic traction and spinal unloading 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, OR

Any other devices:

o Defined as “thoracic-lumbo-sacral orthosis (with pneumatics)”, and/or

o Defined as “pneumatic orthosis”, and/or

o That operate in a similar manner, and/or

o That are identified through the U.S. Food and Drug Administration (FDA) 510K system as substantially equivalent to any of the devices listed here.

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 unloading 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.

Regulatory Status

These devices are considered a Class I device by the U.S. Food and Drug Administration (FDA). This classification requires notification of the FDA prior to marketing, but does not require submission of clinical data regarding efficacy.

Rationale:

A Medline literature search through January 2018 focused on pneumatic traction devices, pneumatic orthoses, and spinal unloading devices. Following is a summary of the key literature to date:

In 2005, Dallolio (2) 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 (RCT) comparing the Orthotrac Pneumatic Vest with an EZ form brace. (3) The target enrollment was 150 patients who had been recently diagnosed with radiating leg pain from disc bulge, protrusion or herniation; 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 visual analogue scale [VAS] for pain) than observed in the group treated with the EZ brace. The study was completed October 2006 but final study results were not published.

In 2010, Hahne et al. (4) determined the effectiveness and adverse effects of conservative treatments for individuals who have lumbar disc herniation with associated radiculopathy (LDHR).Investigators searched 10 computer databases for trials published between 1971 and 2008.Trials focusing on people with referred leg symptoms and radiological confirmation of a lumbar disc herniation were included if at least 1 group received a conservative and non-injection treatment.A total of 18 trials involving 1,671 participants were included.Seven (39%) trials were considered of high quality.Meta-analysis on 2 high-quality trials revealed that advice is less effective than microdiscectomy surgery at short-term follow-up, but equally effective at long-term follow-up. Individual high-quality trials provided moderate evidence that stabilization exercises are more effective than no treatment, that manipulation is more effective than sham manipulation for people with acute symptoms and an intact anulus, and that no difference exists among traction, laser, and ultrasound.One trial showed some additional benefit from adding mechanical traction to medication and electrotherapy methods.Adverse events were associated with traction (anxiety, fainting, lower limb weakness, andpain) and ibuprofen (gastrointestinal events).The authors concluded that advice is less effective than microdiscectomy in the short-term but equally effective in the long-term forindividuals who have LDHR.Moderate evidence favors stabilization exercises over no treatment, manipulation over sham manipulation, and the addition of mechanical traction to medication and electrotherapy.There was no difference among traction, laser, and ultrasound.Adverse events were associated with traction and ibuprofen.They stated that additional high-quality trials would allow firmer conclusions regarding adverse effects and effectiveness.

In 2014, Fritz et al. (5) conducted an RCT comparing exercise only, exercise with mechanical traction, or exercise with over-the-door traction for patients with cervical radiculopathy. The authors stated that existing studies failed to target patients most likely to benefit from cervical traction. Observational studies suggest that the subgroup of patients most likely to respond were those with neck pain who exhibit signs of cervical radiculopathy. The purpose of their study was to evaluate the ability of cervical traction to improve clinical outcomes when added to a standard exercise program in specific groups of patients. Eighty-eight patients were enrolled in this intention-to-treat analysis, and were randomized to exercise alone, exercise plus mechanical traction, or exercise plus over-the-door traction. In their conclusion, the authors stated that adding mechanical traction to a standard exercise program, particularly with an in-clinic, motorized device, for patients with cervical radiculopathy led to greater improvements in disability and neck and arm pain. They stated that further research is needed to identify the most effective nonsurgical treatments for patients with cervical radiculopathy, and whether clinical decision-making can be enhanced by consideration of more narrow subgrouping strategies. They further noted that the study had a higher-than-anticipated loss to follow-up and was likely underpowered for examining the validity of the subgrouping rule.

DynaMed Plus

In 2016, DynaMed Plus published the following recommendation (6): There is insufficient evidence to support or refute either continuous or intermittent traction for neck disorders with radicular symptoms.

Practice Guidelines and Position Statements

North American Spine Society (NASS)

The 2011 NASS Clinical Practice Guideline (7) on the diagnosis and treatment of degenerative lumbar spinal stenosis states: “There is insufficient evidence to make a recommendation for or against traction, electrical stimulation or TENS for the treatment of patients with lumbar spinal stenosis. (Grade of Recommendation: Insufficient Evidence) An extensive review of all articles cited found no direct comparison of ancillary treatments (traction, electrical stimulation or TENS) to an untreated control group. In 2012, NASS published a clinical practice guideline for the treatment of lumbar disc herniation with radiculopathy stating that there is insufficient evidence to make a recommendation for or against the use of traction with a grade of recommendation: I (Insufficient Evidence). A RCT with long-term follow up and validated outcome measures would assist in providing evidence to assess the efficacy of traction in the treatment of lumbar disc herniation with radiculopathy. (8)

American Physical Therapy Association (ATPA)

The 2012 clinical practice guidelines linked to the international classification of functioning, disability and health from the orthopedic section of the physical therapy association (9) states that there is conflicting evidence for the efficacy of intermittent lumbar traction for patients with low back pain. There is preliminary evidence that a sub­group of patients with signs of nerve root compression along with peripheralization of symptoms or a positive crossed straight leg raise may benefit from intermittent lumbar traction in the prone position. There is moderate evidence that clinicians should not utilize intermittent or static lumbar traction for reducing symptoms in patients with acute or subacute, nonradicular low back pain or patients with chronic low back pain. (Recommendation based on conflicting evidence.)

In 2017, the APTA revised the clinical practice guidelines for neck pain. The revision includes the following recommendations (10):

“For patients with chronic neck pain with mobility deficits: Clinicians should provide a multimodal approach of the following:

Thoracic manipulation and cervical manipulation or mobilization,

Mixed exercise for cervical/scapulothoracic regions: neuromus­cular exercise (e.g., coordination, proprioception, and postural training), stretching, strengthening, endurance training, aerobic conditioning, and cognitive affective elements,

Dry needling, laser, or intermittent mechanical/manual traction.”

“For patients with chronic neck pain with radiating pain: Clinicians should provide mechanical intermittent cervical traction, combined with other interventions such as stretching and strengthening exercise plus cervical and thoracic mobilization/ manipulation.”

American College of Physicians (ACP)

In 2017, the ACP developed a guideline for noninvasive treatments for acute, subacute, and chronic low backpain to present the evidence and provide clinical recommendations on noninvasive treatment of low back pain. This guideline states the following (11):

“Evidence was insufficient to determine the effectiveness of transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation, inferential therapy, short-wave diathermy, traction, superficial cold, motor control exercise (MCE), Pilates, tai chi, yoga, psychological therapies, multidisciplinary rehabilitation, ultrasound, and taping.”

Summary of Evidence

The lack of published studies does not permit scientific conclusions about pneumatic traction and spinal unloading devices alone or in comparison to other types of back orthoses. The literature regarding pneumatic traction and spinal unloading devices is, in general, of poor quality. Without appropriate scientific evidence, the potential benefits of these devices cannot be evaluated therefore, pneumatic traction and spinal unloading devices are considered experimental, investigational, and/or unproven in any setting (e.g., home, office, rehabilitation clinic).

Contract:

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 are any exclusions 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.

Coding:

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.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

None

HCPCS Codes

E0830, E0849, E0856

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Posture Pump® Elliptical Back Rocker. Posture Pump. Huntington Beach, California. Available at <https://posturepump.com> (accessed - 2018 January 5).

2. Dallolio V. Lumbar spinal decompression with a pneumatic orthosis (Orthotrac): preliminary study. Acta Neurochir Suppl. 2005; 92:133-7. PMID 15830985

3. Triano JJ. A Randomized, Controlled Trial of Treatment for Disc Herniation With Radiating Leg Pain - NCT00220935 (2006). Available at <https://clinicaltrials.gov> (accessed - 2018 January 5).

4. Hahne AJ, Ford JJ, McMeeken JM. Conservative management of lumbar disc herniation with associated radiculopathy: A systematic review. Spine. May 15 2010; 35(11):E488-E504. PMID 20421859

5. Fritz JM, Thackeray A, Brennan GP, et al. 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 Orthopaedic & Sports Physical Therapy. Feb 2014; 44(2):45-57. PMID 24405257

6. DynaMed Plus. [Internet]. Ipswich (MA): EBSCO Information Services. 1995 - Record No. 116531, Cervical radicular pain and radiculopathy; updated 2016 Sep 19. Available at <http://www.dynamed.com> (accessed – 2018 January 5)

7. North American Spine Society (NASS). Evidence-Based Clinical Guidelines for Multidisciplinary Spine Care. Diagnosis and treatment of degenerative lumbar spinal stenosis (Revised 2011). Available at <https://www.spine.org> (accessed - 2018 January 5).

8. North American Spine Society (NASS). Evidence-Based Clinical Guidelines for Multidisciplinary Spine Care. Diagnosis and treatment of lumbar disc herniation with radiculopathy (2012). Available at <https://www.spine.org> (accessed - 2018 January 5).

9. Delitto A, George SZ, Orthopaedic Section of the American Physical Therapy Association, et al. Low back pain. J Orthop Sports Phys Ther. Apr 2012; 42(4):A1-A57. PMID 22466247

10. Blanpied PR, Gross AR, Elliot JM, et al. Neck Pain: Revision 2017. J Orthop Sports Phys Ther. Jul 2017; 47(7):A1-A83. PMID 28666405

11. Qaseem A, Wilt TJ, McLean RM, et al. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Apr 4 2017; 166(7):514-530. PMID 28192789

12. Waylonis GW, Tootle D, Dengart C, et al. Home cervical traction: evaluation of alternate equipment. Arch Phys Med Rehabil. Aug 1982; 63(8):388-91. PMID 7115034

13. Pal B, Mangion P, Hossain MA, et al. A controlled trial of continuous lumbar traction in the treatment of back pain and sciatica. Br J Rheumatol. May 1986; 25(2):181-3. PMID 3011174

14. Wheeler AH. Diagnosis and management of low back pain and sciatica. Am Fam Physician. Oct 1995; 52(5):1333-41, 1347-8. PMID 7572557

15. Janke AW, Kerkow TA, Griffiths HJ, et al. The biomechanics of gravity-dependent traction of the lumbar spine. Spine. Feb 1 1997; 22(3):253-60. PMID 9051886

16. Podein RJ, and PA Iaizzo. Applied forces and associated physiologic responses induced by axial spinal unloading with the LTX 3000 Lumbar Rehabilitation System. Arch Phys Med Rehabil. May 1998; 79(5):505-13. PMID 9596389

17. Swezey RL, Swezey AM, Warner K. Efficacy of home cervical traction therapy. Am J Phys Med Rehabil. Jan-Feb 1999; 78(1):30-2. PMID 9923426

18. Van Tulder MW, Jellema P, van Poppel MN, et al. Lumbar supports for prevention and treatment of low back pain. Cochrane Database Syst Rev. 2000; (3):CD001823. PMID 10908512

19. Van Tulder MW, Jellema P, van Poppel MN, et al. WITHDRAWN: Lumbar supports for prevention and treatment of low back pain. Cochrane Database Syst Rev. Jul 18 2007; (2):CD001823. PMID 17636685

20. Falkenberg J, Podein RJ, Pardo X, et al. Surface EMG activity of the back musculature during axial spinal unloading using LTX 3000 Lumbar Rehabilitation System. Electromyogr Clin Neurophysiol. Oct-Nov 2001: 41(7):419-27. PMID 11721297

21. Hales J, Larson P, Iaizzo PA. Treatment of adult lumbar scoliosis with axial spinal unloading using the LTX 3000 Lumbar Rehabilitation System. Spine. Feb 1 2002; 27(3):E71-9. PMID 11805711

22. Smith D, McMurray N, Disler P. Early intervention for acute back pain: can we finally develop an evidence-based approach? Clin Rehabil. Feb 2002; 16(1):1-11. PMID 11837522

23. Harte AA, Baxter GD, Gracey JH. The efficacy of traction for back pain: a systematic review of randomized controlled trials. Arch Phys Med Rehabil. Oct 2003; 84(10):1542-53. PMID 14586924

24. Modern spinal traction devices utilizing controlled spinal distraction. The Burton Report®. Available at <www.burtonreport.com> (accessed - 2015 August 6).

25. Ctrac Device and Use. MeDevice. Available at <www. medevnet.com> (accessed - 2015 August 6).

26. Cervical Traction Devices. Chicago, Illinois: Blue Cross Blue Shield Association – Technology Evaluation Center-Medical Policy Clearinghouse News (December 17, 2004).

27. Thoracic-Lumbo-Sacral Orthosis with Pneumatics (Archived). Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (November 2014) Durable Medical Equipment 1.03.03.

Policy History:

Date Reason
3/15/2018 Document updated with literature review. Coverage unchanged.
7/1/2016 Reviewed. No changes.
9/15/2015 Document updated with literature review. Coverage unchanged. Rationale and references revised. Title changed from Pneumatic Traction and Spinal Uploading Devices
9/15/2014 Reviewed. No changes.
11/1/2013 Literature reviewed. No change.
6/1/2008 Policy reviewed without literature review; new review date only. This policy is no longer scheduled for routine literature review and update.
8/15/2007 Revised/updated entire document

Archived Document(s):

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