CIGNA MEDICAL COVERAGE POLICY
CIGNA
The following Coverage Policy applies to all health benefit plans administered by CIGNA Companies including
plans formerly administered by Great-West Healthcare, which is now a part of CIGNA.
Subject
Effective Date
Next Review Date
Coverage Policy Number
Low-Level Laser Therapy
Table of Contents
Coverage Policy
General Background
Coding/Billing Information
References
Policy History
7/15/2011
7/15/2012
0115
Hyperlink to Related Coverage Policies
1
1
5
5
8
Acupuncture
Chiropractic Care
Occupational Therapy
Physical Therapy
Plantar Fasciitis Treatments
INSTRUCTIONS FOR USE
Coverage Policies are intended to provide guidance in interpreting certain standard CIGNA HealthCare benefit plans. Please note, the
terms of a customer's particular benefit plan document [Group Service Agreement (GSA), Evidence of Coverage, Certificate of Coverage,
Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these
Coverage Policies are based. For example, a customer's benefit plan document may contain a specific exclusion related to a topic
addressed in a Coverage Policy. In the event of a conflict, a customer's benefit plan document always supercedes the information in the
Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the
applicable benefit plan document. Coverage determinations in each specific instance 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 Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of
health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain
markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. Proprietary information
of CIGNA. Copyright ©2011 CIGNA
Coverage Policy
CIGNA does not cover low-level laser therapy (LLLT) for any indication because it is considered
experimental, investigational or unproven.
General Background
Low-level laser therapy (LLLT) refers to the use of red-beam or near-infrared lasers with a wave-length between
600 and 1000nm power from 5-500 milliwatts. In contrast, lasers used in surgery typically use 300 watts. These
lasers are nonthermal. While the exact mechanism of its effect is unknown, it is theorized that due to the low
absorption by human skin the laser light can penetrate deeply into the tissues where it may have a
photobiostimulation effect. These types of lasers have been advocated for use in a wide range of medical
conditions encompassing: wound healing; smoking cessation; tuberculosis; temporomandibular joint (TMJ)
disorders; and a variety of musculoskeletal conditions that includes carpal tunnel syndrome, fibromyalgia,
osteoarthritis, and rheumatoid arthritis. LLLT may be administered by several different types of providers,
including physicians, chiropractors, physical therapists, or occupational therapists. It is generally provided in an
office or other outpatient setting with no anesthesia or sedation needed.
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Coverage Policy Number: 0115
LLLT is also referred to as cold laser therapy, low-power laser therapy (LPLT), low-intensity laser and lowenergy laser therapy. When LLLT is administered to the acupuncture pressure points, it may be referred to as
laser acupuncture. LLLT includes an extensive variety of procedures involving several laser types and treatment
methods. There does not appear to be standards regarding the laser dose, number of treatments or the length
of treatment. This results in difficulties with the consistency of the literature. Several randomized controlled trials
involving patients with venous ulcers, rheumatoid arthritis, and other musculoskeletal disorders have failed to
demonstrate any significant benefits of LLLT when compared to standard treatment methods or placebos for
these conditions.
Literature Review—Musculoskeletal Conditions
Blue Cross Blue Shield Technology Assessment Center (TEC) conducted a review of the evidence to determine
if low-level laser therapy is effective treatment for carpal tunnel syndrome and chronic neck pain. For the
indication of carpal tunnel syndrome, four randomized, sham-controlled clinical trials of low-level laser therapy
with 151 patients were included. The studies had serious limitations. Two of the four studies demonstrated
statistically significant differences in pain assessed on a visual analog scale (VAS) scale showing benefit of lowlevel laser therapy. One of the studies that indicated benefit had a small sample size of 19 and enrolled patients
with rheumatoid arthritis. The other study had limited follow-up of two weeks beyond the period of treatment. For
the indication of chronic neck pain, six trials enrolling with a 285 patients were included. There were variable
results. Two studies showed statistically significant findings for the principal outcome of change in VAS pain
score. Two studies showed magnitudes of change in VAS pain score consistent with benefit, but were not
statistically significant—One of these studies had a small sample size and the other may have had a flawed
analysis. Two studies showed similar improvements in pain scores in both laser- and sham-treated control
groups which resulted in no difference between the treatments. The review concluded that for both clinical
indications of carpal tunnel syndrome and chronic neck pain, the existing randomized clinical trials are
insufficient to make conclusions regarding the effect of low-level laser therapy.
Several studies have been published regarding LLLT for musculoskeletal conditions. Limitations of the studies
included small study size, short follow-up time periods, and heterogeneity in terms of laser, dose, duration and
frequency of treatments. A double-blind, randomized, placebo-controlled study to investigate clinical effects of
low-level laser therapy (LLLT) in patients with acute neck pain with radiculopathy was conducted by
Konstantinovic et al (2010). Sixty subjects received a course of 15 treatments over 3 weeks with active or an
inactivated laser as a placebo procedure. Statistically significant differences between groups were found for
intensity of arm pain (p=0.003, with high effect size d=0.92) and for neck extension (p=0.003 with high effect
size d=0.94). While there was improvement seen in the LLLT group, there were limitations of the study that
included that it considered only short-term effects, and there was potential for selection bias. A randomized,
double-blind, placebo-controlled study of 40 patients found no significant differences between four treatment
groups with respect to all outcome parameters (p>0.05) and there were no differences between laser and
placebo laser treatments on pain severity and functional capacity in patients with acute and chronic low back
pain caused by lumbar disk herniation (Ay, et al., 2010). In 2008, Oken et al. reported on a randomized,
controlled, single-blind trial of 59 patients that evaluate the efficacy of LLT compare to effects of brace or
ultrasound (US) in lateral epicondylitis. No significant difference was noted between the groups in terms of
visual analog scale (VAS), grip strength and global assessment at baseline and at follow-up assessments
(p>.05). Limitations of the study included the relatively small study size, lack of long-term follow-up and that
activities of daily living were not evaluated. Djavid et al. (2007) conducted a randomized, controlled trial of 61
patients to evaluate LLLT for chronic low back pain. There was no between-group difference for any outcome
measure immediately after the six-week intervention. At 12 weeks, there was no difference in the LLLT plus
exercise compared with exercise group, while there was improvement noted that in the LLLT plus exercise
group when compared to the placebo laser therapy plus exercise group—pain was reduced by 1.8 cm (95% CI
0.1 to 3.3, p=0.03), lumbar range of movement increased by 0.9 cm (95% CI, 0.2 to 1.8, p<0.01) on the Shober
Test and by 15 degrees (95% C15 to 25, p<0.01) of active flexion and disability reduced by 9.4 points (95% CI
2.7 to 16.0, p=0.03) on the Oswestry Disability Index.
There are several systematic and technical reviews published regarding the use of LLLT for musculoskeletal
conditions. Bjordal et al. conducted a systematic review with meta-analysis of LLLT in lateral elbow
tendinopathy, with primary outcome measures of pain relief and/or global improvement and subgroup analyses
of methodological quality, wavelengths and treatment procedures. The review included 13 randomized
controlled trials (730 patients). The weighted mean difference for pain relief was 10.2 mm (95% CI: 3.0 to 17.5).
Trials which targeted acupuncture points reported negative results, as did trials with wavelengths 820, 830 and
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Coverage Policy Number: 0115
1064 nm. In a subgroup of five trials with 904 nm lasers and one trial with 632 nm wavelength where the lateral
elbow tendon insertions were directly irradiated, the weighted mean difference for pain relief was 17.2 mm (95%
CI: 8.5 to 25.9) and 14.0 mm (95% CI: 7.4 to 20.6) respectively. The LLLT doses in this subgroup ranged
between 0.5 and 7.2 Joules. In the secondary outcome measures of pain free grip strength, pain pressure
threshold, sick leave, the follow-up data from 3 to 8 weeks after the end of treatment showed consistently
significant results in favor of the same LLLT subgroup (p < 0.02). Yousefi-Nooraie et al. (2008) conducted a
Cochrane review that included seven studies and examined LLLT for nonspecific low-back pain. The authors
concluded that based on the heterogeneity of the populations, interventions and comparison groups, "that there
are insufficient data to draw firm conclusion on the clinical effect of LLLT for low-back pain." In addition the
authors note that there is a need for further methodologically rigorous randomized, controlled trials to evaluate
the effects of LLLT compared to other treatments, different lengths of treatment, wavelengths and dosage.
A review of evidence was conducted for the development of an American Pain Society /American College of
Physicians clinical practice guideline for diagnosis and treatment of low back pain (Chou and Huffman, 2007).
The review examined nonpharmacologic therapies for acute and chronic low back pain and included only
systematic reviews and randomized trials, with seven trials that included LLLT, Four trials found laser therapy
superior to sham for pain or functional status up to one year after treatment, but another higher-quality trial
found no differences between laser and sham in patients receiving exercise. One lower-quality study reported
found similar results for laser, exercise and the combination of laser plus exercise for pain and back-specific
functional status. It was noted that optimal treatment parameters, wavelength, dosage, dose intensity are
uncertain.
A Cochrane systematic review (Brosseau, et al., 2005) was performed for the purpose of reviewing literature
regarding the use of LLLT as treatment for rheumatoid arthritis (RA). Six studies with 220 patients with
rheumatoid arthritis were included in the review. The main limitation with the studies is the heterogeneity of
clinical application. In addition, the results are subject to publication bias, if negative trials have not been
published. It was concluded in this review that "this meta-analysis found that pooled data gave some evidence
of a clinical effect, but the outcomes were in conflict, and it must therefore be concluded that firm documentation
of the application of LLLT in RA is not possible. Conversely, a possible clinical benefit in certain subgroups
cannot be ruled out from the present meta-analysis and further large scaled studies are recommended with
special attention to the findings in this meta-analysis (e.g., low versus high dose wavelength, nerve versus joint
application, and treatment duration)."
Literature Review—Wound Healing
There are several systematic technical reviews published regarding the use of low level laser for wound healing.
The Agency for Healthcare Research and Quality (AHRQ) published an evidence report technology assessment
(Samson, 2004) and found that regarding LLLT, it was noted that 11 studies met selection criteria, of which nine
were rated poor in quality; one was rated good, and one was rated fair. It was concluded by the reviewers that
the "available data suggest that the addition of laser therapy does not improve wound healing, as the vast
majority of comparisons in these studies do not report any group differences in the relevant outcomes." A
Cochrane systematic review (Flemming, et al., 2004) was performed for the purpose of assessing the
effectiveness of LLLT in the treatment of venous leg ulcers. The reviewers concluded that "there is insufficient
evidence in this review to give a clear direction for practice. There is no evidence of a benefit of lasers on leg
ulcer healing." It was noted that the trials were small and of poor quality. The Alberta Heritage Foundation for
Medical Research (AHFMR) (Simon, 2004) published a technology assessment regarding LLLT in treatment of
chronic wounds, specifically leg ulcers and pressure sores. It was noted in this review that "systematic reviews
of the literature indicate that the efficacy of LLLT in this application is not established, although it poses little or
no safety risk to patients. There is no good scientific evidence to support its use and mounting evidence to
indicate it does not benefit wound healing."
Literature Review—Oral Mucositis
Clarkson et al. (2010) reported on a Cochrane to assess the effectiveness of interventions for treating oral
mucositis or its associated pain in patients with cancer receiving chemotherapy or radiotherapy or both. The
review found that there is limited evidence from two small trials that low level laser treatment reduces the
severity of the mucositis. The authors concluded that there is weak and unreliable evidence that low level laser
treatment reduces the severity of the mucositis with a need for further, well designed, placebo or no treatment
controlled trials assessing the effectiveness of interventions for mucositis.
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Coverage Policy Number: 0115
Kuhn et al. (2009) conducted a placebo-controlled randomized trial using LLT or placebo (sham treatment). The
study involved 21 children with cancer who developed oral mucositis as a complication of chemotherapy. Nine
patients were randomized in the laser group and 12 in the placebo group. Both groups of patients had daily oral
mucositis grading assessments before treatment and thereafter until there was healing of the lesions. At day
seven after the oral mucositis diagnosis, there were one of nine patients that remained with lesions in the laser
group and in the placebo group there was nine of the 12 patients (p=0.029). The mean of oral mucositis duration
was 5.8 ± 2 days in the laser group and in placebo group it was 8.9. ± 2.4 days (p=0.004). In 2008, Arora et al.
reported on a prospective, controlled study that evaluated the efficacy of LLLT for the prevention and treatment
of radiotherapy-induced oral mucositis in oral cancer patients. The study included 24 patients who were
assigned to either group treated with laser daily before radiotherapy (n=11) or Group 2, the control group
(n=13). Pain increased gradually and was the greatest at the end of seven weeks with the difference between
the laser and control groups noted to statistically significant (p=.033). The authors noted that additional studies
using different laser energies and application schedules are needed to define optimal treatment variables along
with cellular and molecular studies to define mechanisms of laser effect.
Literature Review—Various Medical Conditions
Systematic and Technical Reviews:
There are several Cochrane reviews that are not specifically focused on LLLT, but rather examine a range of
interventions, including LLLT, for various medical conditions. These reviews include White et al. (2011) who
conducted a review of effectiveness of various interventions for smoking cessation including laser treatment. It
was found that the evidence on acupressure and laser stimulation was insufficient and could not be combined
and the evidence suggest that electrostimulation is not superior to sham electrostimulation. McNeely et al.
(2006), who conducted a systematic review that assessed the evidence concerning the effectiveness of physical
therapy interventions, including LLLT in the management of TMD. Of the six studies in the review, there was
one that compared LLLT to sham laser. No significant difference was found in pain reduction between these two
groups. No evidence was found to support the use of any of the electrophysical modalities to reduce pain. The
authors concluded that there is a clear need for well-designed, randomized controlled clinical trials to examine
physical therapy interventions for TMD. McLauchlan et al. (2003) conducted a Cochrane review to assess the
interventions for treating acute and chronic Achilles tendinitis. The review included nine trials, with one study
comparing low-energy laser with sham laser in 98 patients. It was noted that no data could be extracted from six
charts showing stiffness, mean pain, reddening, swelling, mean soreness and crepitation presented in the trial
report.
U.S. Food and Drug Administration (FDA)
Since 2002, the U.S. Food and Drug Administration (FDA) granted 510(k) approval to several companies to
market lasers that provide LLLT. The LLLT lasers are classified as class II devices under the physical medicine
devices section as "Lamp, Non-heating, for Adjunctive Use in Pain Therapy."
Several devices that provide LLLT have been approved under the 501(k) approval process for various
indications. These devices include but are not limited to:
•
MicroLight 830 - (MicroLight Corporation of America, Missouri City, TX)
•
Thor Laser System (Thor International Ltd, Amersham, UK)
•
Luminex LL Laser System® (Medical Laser Systems, Inc, Branford CT)
®
•
Vectra Genisys Laser System (Chattanooga Group, Hixson, TN)
In the data submitted to the FDA as part of the FDA 510(k) approval process in 2002, the manufacturer of the
MicroLight device conducted a double-blind, placebo-controlled study of 135 patients with moderate to severe
symptoms of carpal tunnel syndrome who had failed conservative therapy for at least a month. However, the
results of this study have not been published in the peer-reviewed literature, and only a short summary is
available in the FDA Summary of Safety and Effectiveness, which does not permit scientific conclusions.
Professional Societies/Organizations
The evidence-based guidelines published by the American Pain Society /American College of Physicians found
that there is insufficient evidence to recommend LLLT for treatment of low back pain (Chou, et al., 2007).
The American Academy of Orthopaedic Surgeons (AAOS) published clinical practice guidelines on the
treatment of carpal tunnel syndrome (AAOS, 2008). In the guidelines, laser treatment was included in
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Coverage Policy Number: 0115
treatments that carry no recommendation for or against their use and notes that there is insufficient evidence to
recommend the use of the treatment. It was noted that the modality requires further investigation in
appropriately designed studies to determine the efficacy in treatment of carpal tunnel syndrome.
Summary
Low-level laser therapy (LLLT) has been proposed for a wide variety of uses, including wound healing,
tuberculosis, and musculoskeletal conditions such as osteoarthritis, rheumatoid arthritis, fibromyalgia and carpal
tunnel syndrome. There is insufficient evidence in the published, peer-reviewed scientific literature to
demonstrate that LLLT is effective for these conditions or other medical conditions. Large, well-designed clinical
trials are needed to demonstrate the effectiveness of LLLT for the proposed conditions.
Coding/Billing Information
Note: This list of codes may not be all-inclusive.
Experimental/Investigational/Unproven/Not Covered:
HCPCS
Codes
Description
S8948
Application of a modality (requiring constant provider attendance) to one or more
areas, low-level laser, each 15 minutes
ICD-9-CM
Diagnosis
Codes
Description
722.10
723.4
739.3
784.0
844.2
Displacement of lumbar intervertebral disc without myelopathy
Brachial neuritis or radiculitis NOS
Nonallopathic lesions, not elsewhere classified, Lumbar region
Symptoms involving head and neck, Headache
Sprains and strains of knee and leg, Cruciate ligament of knee
All other codes
*Current Procedural Terminology (CPT ®) ©2010 American Medical Association: Chicago, IL.
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17. Crossley K, Bennell K, Green S, McConnell J. A systematic review of physical interventions for
patellofemoral pain syndrome. Clin J Sport Med. 2001 Apr;11(2):103-10.
18. Cullum N, Nelson EA, Flemming K, Sheldon T. Systematic reviews of wound care management: (5)
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19. Djavid GE, Mehrdad R, Ghasemi M, Hasan-Zadeh H, Sotoodeh-Manesh A, Pouryaghoub G. In chronic
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21. Emshoff R, Bosch R, Pumpel E, Schoning H, Strobl H. Low-level laser therapy for treatment of
temporomandibular joint pain: a double-blind and placebo-controlled trial. Oral Surg Oral Med Oral
Pathol Oral Radiol Endod. 2008 Apr;105(4):452-6.
22. Fikackova H, Dostalova T, Navratil L, Klaschka J. Effectiveness of low-level laser therapy in
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Aug;25(4):297-303.
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Library, Issue 3,2004 .
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chemotherapy or radiotherapy. Curr Opin Oncol. 2005 May;17(3):236-40.
25. Gerritsen AA, de Krom MC, Struijs MA, Scholten RJ, de Vet HC, Bouter LM. Conservative treatment
options for carpal tunnel syndrome: a systematic review of randomised controlled trials. J Neurol. 2002
Mar;249(3):272-80.
26. Gur A, Karakoc M, Nas K, Cevik R, Sarac J, Demir E. Efficacy of low power laser therapy in
fibromyalgia: a single-blind, placebo-controlled trial. Lasers Med Sci. 2002;17(1):57-61.
27. Gur A, Sarac AJ, Cevik R, Altindag 0, Sarac S. Efficacy of 904 nm gallium arsenide low level laser
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Rev. 2006 Apr 19;(2):CD003490.
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ult.asp
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16;(2):CD005107.
Policy History
Pre-Merger
Organizations
CIGNA HealthCare
Last Review
Date
Policy
Number
Title
7/15/2008
0115
Low-Level Laser Therapy
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Coverage Policy Number: 0115
Low Level Laser Treatment of Neuromuscular Pain Disorders and Other Miscellaneous C... Page 1 of 7
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Medicine Section - Low Level Laser Treatment of Neuromuscular Pain Disorders
and Other Miscellaneous Conditions
Topic: Low Level Laser Treatment of Neuromuscular
Pain Disorders and Other Miscellaneous Conditions
Section: Medicine
Effective Date:
08/01/2009
Date of Origin: 01/2003
Policy No: 105
IMPORTANT REMINDER
Regence Medical Policies are developed to provide guidance for members and providers
regarding coverage in accordance with contract terms. Benefit determinations are based in
all cases on the applicable contract language. To the extent there may be any conflict
between the Medical Policy and contract language, the contract language takes
precedence.
PLEASE NOTE: Contracts exclude from coverage, among other things, services or
procedures that are considered investigational or cosmetic. Providers may bill members
for services or procedures that are considered investigational or cosmetic. Providers are
encouraged to inform members before rendering such services that the members are
likely to be financially responsible for the cost of these services.
DESCRIPTION
Low level laser therapy (LLLT), also called photobiomodulation, refers to the use of redbeam or near-infrared lasers with a wavelength between 600 and 1000 nm and Watts
from 5 to 500 milliwatts. This is in contrast to surgical lasers that typically use 300 Watts.
Low-level laser energy that is applied to acupuncture points on the body may be referred
to as "laser acupuncture."
When applied to the skin, low level lasers produce no sensation and do not burn the skin.
Because of the low absorption by human skin, it is hypothesized that the laser light can
penetrate deeply into the tissues where it has a photobiostimulative effect. The exact
mechanism of its effect is unknown; hypotheses have included improved cellular repair
and stimulation of the immune, lymphatic, and vascular systems.
LLLT has been proposed as a treatment of carpal tunnel syndrome, painful
musculoskeletal disorders such as temporomandibular joint disfunction and low back pain,
soft tissue injuries, tendinopathies, and osteoarthritis. LLLT has been used outside the US
to treat oral mucositis associated with radiation and chemotherapy, stimulate healing of
chronic wounds, treat nerve injuries, and as an adjunct to antituberculosis drug treatment.
A number of low level lasers have received US Food and Drug Administration (FDA) 510
(k) approval, including:
•
MicroLight ML8300
•
GRT
•
LightStream ."" Low Level Laser
TouchOner" (OTC)
•
POLICY/CRITERIA
Low level laser treatment and laser acupuncture are considered investigational for all
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indications, including but not limited to the following:
1.
Acute or chronic headache
2.
Acute pain (e.g., postoperative pain, strains and sparins, labor pain)
3.
Arthritis
4.
Back, neck or shoulder pain
5.
Carpal tunnel syndrome
6.
Chemotherapy-induced mucositis
7.
Fibromyalgia
8.
Lateral or medial epicondylitis
9.
Orthodontic pain
10.
Other pain disorders
11.
Temporomandibular joint (TM3) pain
12.
Tendonitis
13.
Tinnitus
14.
Wound healing
SCIENTIFIC BACKGROUND 01
The principal outcomes associated with treatment of carpel tunnel syndrome and
musculoskeletal conditions are relief of pain, return to work, and improved functional
level. Relief of pain is a subjective outcome that is typically associated with a placebo
effect. Therefore, data from adequately powered, blinded, randomized controlled trials
(RCT) are required to control for the placebo effect, determine its magnitude, and
determine whether any treatment effect provides a significant advantage over the
placebo.
The technology must also be evaluated in general groups of patients against existing
treatments. In patients with mild to moderate symptoms, LLLT or laser acupuncture may
be compared to other forms of conservative therapy such as splinting, rest, non-steroidal
anti-inflammatory medications, or steroid injection. In patients who have exhausted
conservative therapy, LLLT or laser acupuncture must be compared to surgical treatment,
if any.
Low level laser treatment
-
Carpal Tunnel Syndrome (CTS).
The largest body of evidence for LLLT describes its use in the treatment of CTS. This
evidence was evaluated in a 2010 BlueCross BlueShield Association Technology Evaluation
Center (TEC) Assessment, which concluded that the existing randomized clinical trials
were insufficient to determine the effect of low-level laser therapy on CTS. [21
For inclusion in the assessment, studies had to meet the following criteria:
•
Published in a peer-reviewed journal
•
Randomized
•
Sham-controlled
•
If adjunctive therapies were used, they had to be applied to both groups of
patients
•
Outcomes had to be measured at least 2 weeks beyond the end of the treatment
period
Only four studies met the above inclusion criteria, and findings from these studies were
inconsistent. No one study was so methodologically sound that its results were considered
definitive. Overall, the available studies were small and most did not follow patients for
sufficient periods of time beyond the treatment period to determine the durability of any
treatment effects.
Chemotherapy-induced Mucositis
Treatment of malignant diseases with cytotoxic chemotherapy or radiotherapy is
associated with severe ulceration of the oral mucosa. A 2010 Cochrane review concluded
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there was weak and unreliable evidence that LLLT reduced the severity of mucositis.
[33
ChronicNekPa
The 2010 TEC Assessment also determined that the evidence was insufficient to allow
conclusions regarding the effect of LLLT on chronic neck pain. [2] The 6 trials that met the
assessment inclusion criteria reported variable results, and no single study was
methodologically sound. It was not possible to explain the differences in results due to
the numerous differences in patient selection, treatment regimens, and trial cointerventions.
Low Back Pain
•
An update of the Cochrane Database systematic review of LLLT for nonspecific low
back pain was conducted in 2008. [4] The authors stated that "based on the
heterogeneity of the populations, interventions, and comparison groups, we
conclude that there are insufficient data to draw firm conclusions on the clinical
effect of LLLT groups for low-back pain."
•
A systematic review by Chou and colleagues assessed benefits and harms of
nonpharmacological therapies including LLLT for acute and chronic low back pain.
[5I The reviewers did not find good evidence of efficacy for LLLT for either
indication.
•
Since publication of the Cochrane Review, two additional randomized trials,
reporting conflicting results were published.
o In a large double-blind placebo-controlled study, Konstantinovic et al.
randomized 546 patients with acute low back pain to 3 groups of 182
patients. [6] All patients received nimesulide 200 mg; patients in group A
received active LLLT, patients in group B received only nimesulide, and
patients in group C received placebo LLLT. Treatments were given 5 times
per week for 15 weeks. Statistically significant differences after treatment
were found on all outcomes (p<0.001) but were larger in group A than in B
(p<0.005) and C (p<0.0005). Results in group C were better than in group
B (p<0.0005). The authors conclude that improvement is better in acute
low back pain with LLLT as additional therapy. However, duration of these
outcomes was not measured.
o Ay and colleagues randomized 80 patients with acute and chronic low back
pain attributed to lumbar disc herniation (LDH) into 4 groups of 20. [7] All
patients received hot-packs and group 1 (acute LDH) received laser
therapy; group 2 (chronic LDH) received laser therapy, group 3 (acute LDH)
received placebo laser therapy; and group 4 (chronic LDH) received placebo
laser therapy for 15 sessions over 3 weeks. After treatment all groups had
statistically significant improvements in pain severity, patients' and
physician's global assessment, range of motion, Roland Disability
Questionnaire, and Modified Oswestry Disability Questionnaire (p<0.05).
There were no significant differences between treatment groups on any
outcomes (p<0.05). Durability of treatment effect was not reported.
Rheumatoid Arthritis (RA)
•
A 2005 Cochrane Review included 5 placebo-controlled randomized trials and found
that relative to a separate control group, LLLT reduced pain and morning stiffness,
and increased tip-to-palm flexibility. [81 Other outcomes did not differ between
groups, including functional assessment, range of motion, and local swelling. For
RA, relative to a control group using the opposite hand (1 study), there was no
difference observed between the control and treatment hand for morning stiffness
duration and no significant improvement in pain relief. The authors noted that
"despite some positive findings, this meta-analysis lacked data on how LLLT
effectiveness. is affected by four important factors: wavelength, treatment duration
of LLLT, dosage and site application over nerves instead of joints."
•
A randomized double-blind placebo-controlled trial comparing outcomes of pain
reduction and improvement in hand function in 82 patients with RA treated with
low-level laser or placebo laser was reported by Meireles et al. [91 There were no
statistically significant differences between groups in most of the outcome
measurements, including the primary variables, though a few measures
significantly favoring either the active or placebo treatment were found. The
authors concluded that low-level laser at the dosage used in the study was not
effective for the treatment of hands among patients with rheumatoid arthritis.
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Shoulder Pain
Three randomized trials report conflicting results:
•
In a study designed to assess the effectiveness of LLLT in patients with
subacromial impingement syndrome, 44 patients were randomized in equal
numbers to receive a 12-week home exercise program with or without LLLT.
(103
NodistncavgewmostrdbyLTvexcisalon.
•
Another randomized controlled trial compared outcomes of a 3-week program of
exercise with either LLLT or sham therapy for treatment of subacromial
impingement. (Ill Both groups improved significantly, and there were no
significant between-group differences on measures of pain, function, disability, and
muscle strength.
•
Seventy-four patients with frozen shoulder were included in a randomized,
controlled, double-blind trial comparing an 8-week program of LLLT (n=31) or
placebo (n=32). (123 Compared to the sham group, the active laser group had a
significant decrease in overall, night, and activity pain scores after 4 weeks and 8
weeks of treatment, and at the end of 8 more weeks of follow-up. At the same
time intervals, a significant decrease in shoulder pain, disability index (SPADI)
scores, and Croft shoulder disability questionnaire scores was observed, while a
significant decrease in disability of arm, shoulder, and hand questionnaire (DASH)
scores was observed at 8 weeks of treatment and at 16 weeks' postrandomization; and a significant decrease in health assessment questionnaire
scores was observed at 4 weeks and 8 weeks of treatment. Results from this study
are not reliable because 11 patients included in the original randomization were
excluded from analysis after leaving the study to seek other treatments. It is not
known how this loss might have biased the final outcomes of the study.
Temporomandibular Joint (TINJ) Pain
Two randomized trials of LLLT for TMJ pain are reported no significant differences between
sham and active treatment groups. [13,14]
Wound Healing
A 2004 evidence report on vacuum-assisted and low-level laser wound therapies for
treatment of chronic non-healing wounds prepared for the Agency for Healthcare Research
and Quality was based on 11 studies of LLLT. [153 It stated that "The best available trial
[of low level laser wound therapy] did not show a higher probability of complete healing at
6 weeks with the addition of low-level laser compared to sham laser treatment added to
standard care. Study weaknesses were unlikely to have concealed existing effects. Future
studies may determine whether different dosing parameters or other laser types may lead
to different results".
Laser acupuncture
The randomized clinical trial data related to laser acupuncture is limited to four small,
short-term studies, each focused on a different pain condition. The conditions included
chronic tension headache, migraine and tension headaches in children, whiplash injury,
and osteoarthritis of the knee. The available clinical trial data did not permit scientific
conclusions concerning the impact of laser acupuncture on health outcomes for any of
these conditions.
•
Ebneshahidi and colleagues in a single-blind, randomized, placebo-controlled trial
of 50 patients with chronic tension headache reported that laser acupuncture using
a LLLT device may provide benefit over placebo. (161 The study was small and the
acupuncturists administering the true or sham treatments as well as the assessors
were aware of the allocation and thus could have positively influenced the laser
acupuncture group. In addition, the baseline measures were different from the
subsequent measurements performed in follow-up. The results from this small
study need to be validated in a larger, randomized, double-blind clinical trial.
•
A second trial of laser acupuncture on 43 children with both migraine and tension
headaches provided highly individualized treatment and additional therapies which
do not permit conclusions regarding the independent effects of laser treatment.
(17]
•
Two studies reported no significant difference between patients treated with active
vs. sham laser acupuncture for the treatment of whiplash injury (183 and knee
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osteoarthritis [191 .
Clinical Practice Guidelines
•
The American Academy of Orthopaedic Surgeons 2008 clinical practice guideline on
the treatment of carpal tunnel syndrome included laser treatment among
treatments that carry no recommendation for or against their use because there is
insufficient evidence to recommend their use. [20)
•
The 2007 American Pain Society guideline states that there is insufficient evidence
to recommend LLLT for treatment of low back pain and LLLT is not mentioned in
the 2009 guideline. [211
•
The British NHS National Institute for Health and Clinical Excellence (NICE) 2009
Guideline on early management of persistent non-specific low back pain does not
recommend laser treatment citing limited evidence and a systematic review. [223
Summary
The available literature has not shown LLLT to be as effective as established treatments
for a variety of indications, including carpal tunnel syndrome, various musculoskeletal
conditions, chemotherapy-induced mucositis, and wound healing, Outcomes of studies
comparing LLLT with sham laser therapy for treatment of pain and other conditions are
inconsistent and generally involve small numbers of participants. Most studies found no
statistically significant difference in symptom relief or functional status between the active
LLLT group and the control group. This was true whether the control group received sham
LLLT, surgical treatment, or other conservative treatment modalities. The bulk of the
clinical trials included small numbers of patients with short follow-up periods that did not
permit assessment of the durability of any benefit received from treatment. Data from
adequately powered, blinded RCTs that report longer follow up and consistent dosing
parameters are needed to determine efficacy and safety for each indication.
There is no evidence-based clinical practice guideline that recommends LLLT as a
treatment for any condition.
REFERENCES
1.
BlueCross BlueShield Association Medical Policy Reference Manual "Low-Level Laser
Therapy." Policy No. 2.01.56
2.
TEC Assessment 2010. "Low-Level Laser Therapy for Carpal Tunnel Syndrome and
Chronic Neck Pain." BlueCross BlueShield Association Technology Evaluation Center,
Vol. 25, Tab 4.
3.
Clarkson, 3E, Worthington, HV, Furness, S, McCabe, M, Khalid, T, Meyer, S.
Interventions for treating oral mucositis for patients with cancer receiving treatment.
Cochrane Database Syst Rev. 2010;8:CD001973. PMID: 20687070
4.
Yousefi-Nooraie, R, Schonstein, E, Heidari, K, et al. Low level laser therapy for
nonspecific low-back pain. Cochrane Database Syst Rev. 2008(2):CD005107. PMID:
18425909
5.
Chou, R, Huffman, LH. 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 Oct 2;147(7):492-504.
PMID: 17909210
6.
Konstantinovic, LM, Kanjuh, ZM, Milovanovic, AN, et al. Acute low back pain with
radiculopathy: a double-blind, randomized, placebo-controlled study. Photomed
Laser Surg. 2010 Aug;28(4):553-60. PMID: 20001318
7.
Ay, S, Dogan, 5K, Evcik, D. Is low-level laser therapy effective in acute or chronic
low back pain? C/in Rheumatol. 2010 Aug;29(8):905-10. PMID: 20414695
8.
Brosseau, L, Robinson, V, Wells, G. Low level laser therapy (Classes I, II and III) for
treating rheumatoid arthritis. Cochrane Database of Systematic Reviews. 2005
(4):CD002049. PMID: No PMID Entry
9.
Meireles, SM, Jones, A, Jennings, F, Suda, AL, Parizotto, NA, Natour, J. Assessment
of the effectiveness of low-level laser therapy on the hands of patients with
rheumatoid arthritis: a randomized double-blind controlled trial. C/in Rheumatol.
2010 May;29(5):501-9. PMID: 20082104
10.
Bal, A, Eksioglu, E, Gurcay, E, Gulec, B, Karaahmet, 0, Cakci, A. Low-level laser
therapy in subacromial impingement syndrome. Photomed Laser Surg, 2009 Feb;27
(1):31-6. PMID: 19250050
11.
Yeldan, I, Cetin, E, Ozdincler, AR. The effectiveness of low-level laser therapy on
shoulder function in subacromial impingement syndrome. Disabil Rehabil. 2009;31
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Low Level Laser Treatment of Neuromuscular Pain Disorders and Other Miscellaneous C... Page 6 of 7
(11):935-40. PMID: 19031167
12.
Stergioulas, A. Low-power laser treatment in patients with frozen shoulder:
preliminary results. Photomed Laser Surg. 2008 Apr;26(2):99-105. PMID:
18341417
13.
da Cunha, LA, Firoozmand, LM, da Silva, AP, Camargo, SE, Oliveira, W. Efficacy of
low-level laser therapy in the treatment of temporomandibular disorder. Int Dent J.
2008 Aug;58(4):213-7. PMID: 18783114
14, Emshoff, R, Bosch, R, Pumpel, E, Schoning, H, Strobl, H. Low-level laser therapy for
treatment of temporomandibular joint pain: a double-blind and placebo-controlled
trial. Oral Surg Oral Med Oral Pathol Oral Radial Endod. 2008 Apr;105(4):452-6.
PMID: 18329580
15.
Samson, D, Lefevre, F, Aronson, N. Wound-healing technologies: low-level laser and
vacuum-assisted closure. Evid Rep Technol Assess (Summ). 2004 Dec(111):1-6.
PMID: 15663354
16.
Ebneshahidi, NS, Heshmatipour, M, Moghaddami, A, Eghtesadi-Araghi, P. The effects
of laser acupuncture on chronic tension headache--a randomised controlled trial.
Acupunct Med. 2005 Mar;23(1):13-8. PMID: 15844435
17.
Gottschling, 5, Meyer, 5, Gribova, I, et al. Laser acupuncture in children with
headache: a double-blind, randomized, bicenter, placebo-controlled trial. Pain. 2008
Jul 15; 137(2):405-12. PMID: 18022318
18.
Aigner, N, Fialka, C, Radda, C, Vecsei, V. Adjuvant laser acupuncture in the
treatment of whiplash injuries: a prospective, randomized placebo-controlled trial.
Wien Klin Wachenschr. 2006 Mar;118(3-4):95-9. PMID: 16703253
19, Yurtkuran, M, Alp, A, Konur, S, Ozcakir, S, Bingo!, U. Laser acupuncture in knee
osteoarthritis: a double-blind, randomized controlled study. Photomed Laser Surg.
2007 Feb;25(1):14-20. PMID: 17352632
20.
Keith, MW, Masear, V, Chung, KC, et al. American Academy of Orthopaedic Surgeons
clinical practice guideline on the treatment of carpal tunnel syndrome. J Bone Joint
Surg Am. 2010 Jan;92(1):218-9. PMID: 20048116
21.
Chou, R, Qaseem, Al Snow, V, et al. Diagnosis and treatment of low back pain: a
joint clinical practice guideline from the American College of Physicians and the
American Pain Society. Ann Intern Med. 2007 Oct 2;147(7):478-91. PMID:
17909209
22.
Savigny P, Kuntze 5, Watson P et al. Low back pain: early management of persistent
non-specific low back pain. National Collaborating Centre for Primary Care and Royal
College of General Practitioners. [cited 12/10/2009]; Available from:
http://www.nice.orq ,ukinicemedia/pdf/CG88fullquideline.pdf
Cross References
Regence ConsumerTx: Low Level Laser Therapy
Codes "Number
'Description
There is no specific CPT code identifying low level laser therapy. HCPCS code 58948
specifically identifies LLLT. Since the service is used by a variety of practitioners who
may be required to bill using specific codes related to their specialty, the following are
documented:
When LLLT is administered in the office or clinic setting CPT codes 97026, 97039,
97799 for physical medicine modalities, 97810-97814 for acupuncture or 98940-98943
for chiropractic services may be used. These CPT codes are not specific for LLLT and
cannot be distinguished by CPT code alone from other types of modalities, acupuncture
or chiropractic services.
CPT
None
Application of a modality (requiring constant provider
HCPCS
58948
attendance) to one or more areas; low level laser, each 15
minutes
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