0569 lumbar traction devices (3) - aetna better health€¦ · that lumbar traction for back pain...

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Page 1 of 14 (https://www.aetna.com/) Lumbar Traction Devices Clinical Policy Bulletins Medical Clinical Policy Bulletins Policy History Last Review 11/14/2018 Effective: 11/09/200 Next Review: 06/13/2019 Review History Definitions Additional Information Number: 0569 Policy *Please see amendment for Pennsylvania Medicaid at the end of this CPB. I. Aetna considers autotraction devices experimental and investigational because there is insufficient evidence to support their clinical value in treating low back pain (LBP) or for other indications. Note: Brand names of autotraction devices include the Anatomotor, the Arthrotonic stabilizer, the Quantum 400 inter-segmental traction table, and the Spinalator Spinalign massage inter-segmental traction table. II. Aetna considers home pneumatic lumbar traction devices (e.g., Orthotrac Pneumatic Vest, Saunders Lumbar HomeTrac, Saunders STx, DDS 500 Lumbar Traction) experimental and investigational because they have not been demonstrated to be an effective treatment for LBP or other indications. III. Aetna considers axial spinal unloading (gravity-dependent traction) devices (e.g., LTX 3000, Triton DTS, and Z-Grav Spinal Decompression Table) experimental and investigational for the treatment of LBP or other indications because their effectiveness has not been established. Proprietary http://www.aetna.com/cpb/medical/data/500_599/0569.html 09/23/2019

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Page 1: 0569 Lumbar Traction Devices (3) - Aetna Better Health€¦ · that lumbar traction for back pain is an outmoded technology that has "fallen out of favor". van der Heijden and colleagues

Page 1 of 14

(https://www.aetna.com/)

Lumbar Traction Devices

Clinical Policy Bulletins Medical Clinical Policy Bulletins

Policy History Last

Review

11/14/2018

Effective: 11/09/200 Next Review: 06/13/2019

Review History

Definitions

Additional Information

Number: 0569

Policy *Please see amendment for Pennsylvania Medicaidat the end of this CPB.

I. Aetna considers autotraction devices experimental and investigational

because there is insufficient evidence to support their clinical value in

treating low back pain (LBP) or for other indications.

Note: Brand names of autotraction devices include the Anatomotor, the

Arthrotonic stabilizer, the Quantum 400 inter-segmental traction table, and

the Spinalator Spinalign massage inter-segmental traction table.

II. Aetna considers home pneumatic lumbar traction devices (e.g., Orthotrac

Pneumatic Vest, Saunders Lumbar HomeTrac, Saunders STx, DDS 500

Lumbar Traction) experimental and investigational because they have not

been demonstrated to be an effective treatment for LBP or other

indications.

III. Aetna considers axial spinal unloading (gravity-dependent traction) devices

(e.g., LTX 3000, Triton DTS, and Z-Grav Spinal Decompression Table)

experimental and investigational for the treatment of LBP or other

indications because their effectiveness has not been established.

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See also CPB 0180 - Vertebral Axial Decompression (../100_199/0180.html),

CPB 0232 - Back Pain - Non Invasive Treatments (../200_299/0232.html) and

CPB 0453 - Cervical Traction Devices (../400_499/0453.html).

Background

Traction is a widely used treatment for low back pain (LBP) and it is often provided

in combination with other treatment modalities. Types of traction include

mechanical traction, manual traction (unspecific or segmental traction),

autotraction, gravity-dependent ("(anti-)gravity") traction, pneumatic traction,

continuous traction, and intermittent traction.

The most commonly used traction techniques are manual traction (i.e., the traction

is exerted by the therapist, using arms and/or legs of the patient), inverted

suspension (i.e., the traction is exerted by gravitational forces, through the body

weight of the patient), bed rest traction (i.e., the traction is exerted by a pulley and

weights) and motorized traction (i.e., the traction is exerted by a motorized pulley).

Lumbar traction uses a harness (with Velcro strapping) that is put around the lower

rib cage and around the iliac crest. Duration and level of force exerted through this

harness can be varied in a continuous or intermittent mode.

The exact mechanism through which traction might be effective is still unclear. It

has been suggested that spinal elongation, through decreasing lordosis and

increasing intervertebral space, inhibits pain (nociceptive) impulses, improves

mobility, decreases mechanical stress, reduces muscle spasm or spinal nerve root

compression (due to osteophytes), releases luxation of a disc or capsule from the

zygapophyseal joint, and releases adhesions around the zygapophyseal joint and

the annulus fibrosus. So far, the proposed mechanisms have not been supported

by sufficient empirical information.

Little is known about the adverse effects of traction. Only a few case reports are

available, which suggest that there is some danger for nerve impingement in heavy

traction, i.e., lumbar traction forces exceeding 50 % of the total body weight. Other

risks described for lumbar traction are respiratory constraints due to the traction

harness or increased blood pressure during inverted positional traction. Lumbar

traction forces below 25 % of the total body weight do not seem to increase

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intervertebral distances, and can therefore be regarded as a placebo (sham or low

dose) traction. Placebo traction can only be expected to produce relaxation of

spinal muscles and modification of the spinal curve.

van der Heijden et al (1995) published a systematic review of 21 papers reporting

on 24 randomized controlled trials of traction. The authors concluded that the

information of these studies did not allow for clear conclusions about the

effectiveness of traction due to methodological flaws in study designs. Most studies

were considered to be of poor methodological quality. As this previous review was

based on literature published up to and including 1992 and several new

randomized controlled trials have been published since, the lead author of the 1995

study is preparing an update for the Cochrane Collaboration.

Traction (manual or mechanical pull on extremities or spine to relieve spasm and

pain), when provided by physicians or physical therapists, is typically used in

conjunction with therapeutic procedures, not as an isolated treatment. Standard

treatment is to provide supervised mechanical traction up to 4 sessions per week.

The American Pain Society/American College of Physicians' clinical practice

guideline on non-pharmacological therapies for acute and chronic LBP (Chou and

Huffman, 2007) evaluated the benefits and harms of acupuncture, back schools,

psychological therapies, exercise therapy, functional restoration, inter-disciplinary

therapy, massage, physical therapies (interferential therapy, low-level laser therapy,

lumbar supports, shortwave diathermy, superficial heat, traction, transcutaneous

electrical nerve stimulation, and ultrasonography), spinal manipulation, and yoga for

acute or chronic LBP (with or without leg pain). The authors concluded that

therapies with good evidence of moderate efficacy for chronic or subacute LBP are

cognitive-behavioral therapy, exercise, spinal manipulation, and inter-disciplinary

rehabilitation. For acute LBP, the only therapy with good evidence of efficacy is

superficial heat.

Autotraction

Autotraction is defined as the use of one’s own weight to create the traction force

(i.e., the patient determines the traction force). By utilizing positional and gravity

assisted traction principles, autotraction can provide multi-plane traction. Brand

names of autotraction devices include the Spinalator, Spinalign Massage,

Intersegmental Traction Table and the Anatomotor. These are tables with custom-

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contoured rollers that deliver consistent pressure and move underneath the patient

while they are lying on top of the table. A 3-motor operating system allows for roller

elevation, roller travel, as well as roller rotation (clockwise or counter-clockwise).

There are only 2 published randomized clinical studies comparing autotraction to

other forms of traction; the results of these studies are conflicting. Telso and Merlo

(1993) from Italy reported on a randomized clinical trial comparing conventional

passive traction to autotraction. The investigators measured subjective response

concerning overall improvement, pain intensity using visual analog scale, qualitative

pain severity using the McGill Pain Questionnaire, and pain-related disability using

the Oswestry Low Back Pain Disability Score. The favorable response to

autotraction was 75 % (30 of the 40 patients) versus the 22 % (6 of 27 patients) to

conventional passive traction (p < 0.001).

A study by Ljunggren et al (1984), however, found no differences in effectiveness

between autotraction and manual traction. A total of 49 patients with lumbago-

sciatica and prolapsed lumbar intervertebral discs, comparable concerning

anamnestical and clinical data were randomized for autotraction and manual

traction given by the same therapist for a period of 1 week while strict bed rest was

prescribed. A blind overall assessment performed immediately after the traction

period, after 2 weeks follow-up training and 3 months after hospitalization showed

that the 2 traction modalities are equally efficient. The author concluded that, as

treatment for hospitalized patients with lumbar intervertebral disc prolapses, the

relatively simple manual traction variety should be preferred, if any.

Another 2 randomized clinical studies compared protocols that included

autotraction with conservative management by a primary care physician; the results

of these studies are conflicting. Moreover, since these latter 2 studies did not

compare autotraction to other forms of manipulation, no conclusions about the

comparative efficacy of autotraction can be drawn from them. Blomberg et al

(1993, 1994) reported on the results of a controlled, multi-center clinical trial

comparing outpatients with acute or subacute LBP who were randomly allocated to

either standardized but optimized conventional activating treatment by primary

health care teams (n = 53) or specific manual treatment such as manipulation,

specific mobilization, muscle stretching, autotraction and cortisone injections (n =

48). The treatment effect was evaluated by standardized telephone interviews 3, 7,

14, 21 and 90 days after the start of treatment. The authors reported that, in the

early phase of treatment as well as at the 90 days' follow-up, the group receiving

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manual treatment had significantly less pain, less disability, faster rate of recovery

and lower drug consumption than patients receiving conventional treatment,

indicating that this type of treatment is superior to conventional treatment.

Seferlis (1998) also compared a program that included autotraction to conventional

management, but unlike Blomberg, found no differences in effectiveness. A total of

180 patients sick-listed less than 2 weeks for LBP with or without sciatica, 95 men

and 85 women aged 19 to 64 years, were randomized to 3 groups: (i) an intensive

training program (I), (ii) a manual therapy program that included autotraction

(R1), or (iii) standard treatment by a general practitioner (R2). The intensive

training program (I) (n = 60) consisted of small groups, muscle training and general

condition training, strength and co-ordination, abdominal, gluteal, paraspinal,

shoulder and lower extremity muscles, 3 times per week, for 8 weeks. The manual

therapy program (R1) (n = 60) consisted of autotraction, manipulation of lumbar

facet joint and sacroiliac joint, mobilization, muscle energy technique, stretching,

and coordination training, with number of sessions decided by the physiotherapist.

The general practitioner program (R2) (n = 60) included standard treatment, rest,

sick leave, drug prescription, postural advice, and back school or physiotherapy for

patients failing to recover. No significant differences were found between the 3

groups in pain intensity, functional status after 1, 3 and 12 months. No significant

differences were found between the 3 groups in number of days off of work due to

back pain; median (range) number of days off work due to back pain after 1 year

was: (I) 23 (5-365), (R1) 28 (4-365), (R2) 30 (4-365). Subjective satisfaction with

treatment was significantly better with intensive training (I) and manual therapy (R1)

than with standard treatment (R2); mean (SD) satisfaction on a 5 point scale after

1, 3, and 12 months was: (I) 4.3 (0.8), 4.4 (0.6), 4.1 (1.1); (R1) 4.4 (0.8), 4.5 (0.6),

4.3 (0.9); (R2) 3.4 (1.2), 3.5 (1.1), 3.6 (1.2). However, mean number of treatment

sessions was least for standard treatment; mean number of treatment sessions for

each of the groups was: (I) 18, (R1) 10, (R2) 4.

A Cochrane review on traction for LBP with or without sciatica (Clarke et al, 2007)

found that while there was moderate evidence that autotraction was more effective

than mechanical traction for global improvement in patients with sciatica, these

studies had methodological limitations and inconsistent results.

Because the clinical evidence is limited and conflicting, no conclusions can be

drawn about the efficacy of autotraction, or about its effectiveness in comparison to

other forms of traction.

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Home Traction

The Norwegian Centre for Health Technology Assessment (2001) completed an

assessment, "Treatment of Lumbar Disc Herniation", that concluded that traction of

patients with lumbar disc herniation has "no effect." The Swedish Council on

Technology Assessment reviewed the literature on treatments of back pain and

concluded that there is in fact, "moderate evidence against" the use of traction in

back pain (Nachemson et al, 2000). Birkmeyer and Weinstein (1999) concluded

that lumbar traction for back pain is an outmoded technology that has "fallen out of

favor".

van der Heijden and colleagues (1995) reviewed the literature on traction for back

pain, and concluded that "the available RCTs do not allow clear conclusions to be

drawn about the effectiveness of cervical or lumbar traction." A Prodigy Clinical

Practice Recommendation (SCHIN, 2001) states, based on the literature, that "[t]

raction does not appear to be effective for low back pain or radiculopathy."

According to the AHCPR Clinical Practice Guideline on Acute Low Back Pain in

Adults (Bigos et a., 1994), the evidence does not demonstrate traction to be

effective in treatment of patients with acute LBP.

Several additional systematic evidence reviews have been published more recently

that have reached these same conclusions about the lack of adequate evidence of

lumbar traction for back pain (e.g., Harte et al, 2003; Vroomen et al, 2000;

Philadelphia Panel, 2001; Clarke et al, 2007; McIntosh and Hall, 2007). A

Cochrane review on traction for LBP with or without sciatica (Clarke et al, 2007)

noted that various types of traction are used in the treatment of patients with LBP,

often in conjunction with other treatments. These investigators concluded that that

traction is probably not effective. Neither continuous nor intermittent traction by

itself was more effective in improving pain, disability or work absence than placebo,

sham, or other treatments for patients with a mixed duration of LBP, with or without

sciatica. They also noted that while there was moderate evidence that autotraction

was more effective than mechanical traction for global improvement in patients with

sciatica, these studies had methodological limitations and inconsistent results.

Spinal Unloading Devices

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Spinal unloading devices provide a traction-like effect in an effort to shift weight-

bearing off the lower back and onto the hips. The method used to shift weight-

bearing varies from device to device. Some devices (e.g., LTX 3000) utilize

gravitational force provided by the body mass of the individual. Other devices (e.g.,

Orthotrac Pneumatic Vest, STx -- Saunders Lumbar Traction Device, Saunders

Lumbar Hometrac Deluxe) utilize applied pneumatic pressure in an effort to shift

weight-bearing.

The DDS 500 Lumbar Traction is described as having a unique and patented spinal

air-traction design that provides traction and support as opposed to just support.

The manufacturer states that the DDS 500 acts to provide traction between the

lower part of the rib cage and the upper part of the hip creating weight-bearing

forces away from the lower back and reduces the pressure in the lumbar spine

(spinal decompression). The unique quality that DDS 500 offers is the use of

vertically expandable columns to provide a secure mechanical support and as well

as spinal decompression for the lumbar vertebrae. The manufacturer states that

it converts to a soft LSO and provides greater flexibility.

These devices were cleared by the Food and Drug Administration based on a 510

(k) premarket notification, so that the manufacturer was not required to submit the

evidence of effectiveness that would be required to support a premarket approval

application.

Falkenberg and associates (2001) examined the surface electromyographic (EMG)

changes during axial spinal unloading using the LTX 3000 in normal subjects to

determine the optimal time for effective traction. Hales et al (2002) reported on the

short-term effect of LTX3000 on spinal curvature. Janke et al (1997) and

Podien and Iaizzo (1998) have reported on the biomechanical and physiologic

changes during axial spinal unloading the LTX 3000. However, there is a lack of

evidence regarding the clinical value of LTX 3000 in improving clinical outcomes

(reduction in pain and disability, improvements in function) in patients with LBP.

There are a lack of published peer-reviewed studies that have specifically

evaluated the safety and effectiveness of the Saunders Lumbar HomeTrac or

Saunders STx (The Saunders Group, Chaska, MN) home pneumatic traction

devices for back pain. In addition, there is a lack of well-designed studies

comparing the safety and effectiveness of the Saunders Lumbar HomeTrac or

Saunders STx with lumbar traction provided by a physical therapist. Well-designed

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controlled clinical studies demonstrating reductions in pain and disability and

improvements in function are especially important in evaluating pain interventions

because of the susceptibility of this symptom to placebo effects. One is unable to

determine from uncontrolled observations whether any noted improvements are

due to the application of home lumbar traction, the impact of any other interventions

that the patient was concurrently receiving, or the waxing and waning natural

history of chronic back pain.

The Orthotrac™ Pneumatic Vest (Orthofix, Inc., McKinney, TX) is an inflatable

pneumatic vest that has been promoted for use in relieving back pain from a variety

of causes (e.g., herniated disc, spinal stenosis, facet syndrome, spondylolysthesis,

etc). The Orthotrac was evaluated in a study of 41 patients with radicular pain due

to degenerative discopathy (Dallolio, 2005). The investigator reported that, after 5

weeks, 32 patients (78 %) have showed improvements on a SF-36 inventory, and

all patients referred a decrease or disappearance of radicular pain. The

investigator concluded, however, that “further multicenter and interdisciplinary

studies on a greater number of patients are obviously needed to confirm these

preliminary results.” The primary limitations of this study was the uncontrolled

nature of this study, its short duration, and the subjective endpoints.

Hahne et al (2010) determined the effectiveness and adverse effects of

conservative treatments for people who have lumbar disc herniation with

associated radiculopathy (LDHR). These investigators searched 10 computer

databases for trials published in English 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, and pain) and ibuprofen (gastrointestinal events). The authors

concluded that advice is less effective than microdiscectomy in the short-term but

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equally effective in the long-term for individuals 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.

The North American Spine Society's clinical practice guideline on "Diagnosis and

treatment of degenerative lumbar spinal stenosis" (2011) noted that there is

insufficient evidence to make a recommendation for or against traction, electrical

stimulation or transcutaneous electrical nerve stimulation for the treatment of

patients with lumbar spinal stenosis. Moreover, the Work Loss Data Institute's

clinical practice guideline on "Low back - lumbar & thoracic (acute &

chronic)" (2011) listed DRX® (traction), Powered traction devices/Lordex®/vertebral

axial decompression (VAX-D®), and Traction/IDD therapy (intervertebral disc

decompression) as interventions/procedures that were considered, but are not

recommended.

CPT Codes / HCPCS Codes / ICD-10 Codes

Information in the [brackets] below has been added f or clarification purposes. Codes requiring a 7th character are represented by "+":

Other CPT codes related to the CPB:

97012 Application of a modality to one or more areas; traction, mechanical

97140 Manual therapy techniques (e.g., mobilization/manipulation, manual

lymphatic drainage, manual traction), one or more regions, each 15

minutes

HCPCS codes not covered for indications listed in the CPB:

Z-Grav Spinal Decompression table - no specific code:

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L0631

ICD-10 codes not covered for indications listed in the CPB:

M54.5

The above policy is based on the following references:

1. Tesio L, Merlo A. Autotraction versus passive traction: An open controlled

study in lumbar disc herniation. Arch Phys Med Rehabil. 1993;74(8):871-

876.

2. Blomberg S, Tibblin G. A controlled, multicentre trial of manual therapy

with steroid injections in low-back pain: Functional variables, side effects

and complications during four months follow-up. Clin Rehabil. 1993;7

(1):49-62.

3. Blomberg S, Svardsudd K, Tibblin G. A randomized study of manual

therapy with steroid injections in low-back pain. Telephone interview

follow-up of pain, disability, recovery and drug consumption. Eur Spine J.

1994;3(5):246-254.

4. Ljunggren AE, Weber H, Larsen S. Autotraction versus manual traction in

patients with prolapsed lumbar intervertebral discs. Scand J Rehabil Med.

1984;16(3):117-124.

5. van der Heijden GJ, Beurskens AJ, Koes BW, et al. The efficacy of traction

for back and neck pain: A systematic, blinded review of randomized clinical

trial methods. Phys Ther. 1995;75(2):93-104.

6. Seferlis T, Nemeth G, Carlsson AM, Gillstrom P. Conservative treatment in

patients sick-listed for acute low-back pain: A prospective randomised

study with 12 months' follow-up. Eur Spine J. 1998;7(6):461-470.

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pain: Evidence and clinical practice. Eff Clin Pract. 1999;2(5):218-227.

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spinal unloading in the treatment of adolescent idiopathic scoliosis: A case

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with or without sciatica. Cochrane Database Syst Rev. 2007;(2):CD003010.

31. Chou R, Huffman LH; American Pain Society; American College of

Physicians. Nonpharmacologic therapies for acute and chronic low back

pain: A review of the evidence for an American Pain Society/American

College of Physicians clinical practice guideline. Ann Intern Med. 2007;147

(7):492-504.

32. Hahne AJ, Ford JJ, McMeeken JM. Conservative management of lumbar disc

herniation with associated radiculopathy: A systematic review. Spine.

2010;35(11):E488-E504.

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33. North American Spine Society (NASS). Diagnosis and treatment of

degenerative lumbar spinal stenosis. Burr Ridge, IL: North American Spine

Society (NASS); 2011.

34. Work Loss Data Institute. Low back - lumbar & thoracic (acute & chronic).

Encinitas, CA: Work Loss Data Institute; 2011.

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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan

benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial,

general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care

services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in

private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible

for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to

change.

Copyright © 2001-2019 Aetna Inc.

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AETNA BETTER HEALTH® OF PENNSYLVANIA

Amendment to Aetna Clinical Policy Bulletin Number: 0569 Lumbar

Traction Devices

The following code is covered under the Pennsylvania Medical Assistance Program and will be considered on case by case basis:

L0631 Lumbo-sacral orthosis

www.aetnabetterhealth.com/pennsylvania annual 10/01/2019

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