MEDICAL POLICY
POLICY TITLE
LOW-LEVEL LASER THERAPY (FORMERLY TRANSCUTANEOUS
LASER THERAPY)
POLICY NUMBER
MP- 1.097
Original Issue Date (Created):
7/26/2004
Most Recent Review Date (Revised):
5/31/2016
Effective Date:
10/1/2016
POLICY
RATIONALE
DISCLAIMER
POLICY HISTORY
PRODUCT VARIATIONS
DEFINITIONS
CODING INFORMATION
I. POLICY
DESCRIPTION/BACKGROUND
BENEFIT VARIATIONS
REFERENCES
TOP
Low-level laser therapy may be considered medically necessary for prevention of oral mucositis
in patients undergoing cancer treatment associated with increased risk of oral mucositis,
including chemotherapy and/or radiotherapy, and/or hematopoietic stem cell transplantation (see
Policy Guidelines).
Low-level laser therapy is considered investigational for all other indications including but not
limited to:

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



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




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Carpal tunnel syndrome
Neck pain
Subacromial impingement
Adhesive capsulitis
Temporomandibular joint pain
Low back pain
Osteoarthritis knee pain
Heel pain (i.e., Achilles tendinopathy, plantar fasciitis)
Rheumatoid arthritis
Bell palsy
Fibromyalgia
Wound healing
Lymphedema.
There is insufficient evidence to support a conclusion concerning the health outcomes or benefits
associated with this procedure for these indications.
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MEDICAL POLICY
POLICY TITLE
LOW-LEVEL LASER THERAPY (FORMERLY TRANSCUTANEOUS
LASER THERAPY)
POLICY NUMBER
MP- 1.097
POLICY GUIDELINES
In the meta-analysis of 18 trials comparing low-level laser therapy (LLLT) to chemotherapy or
chemoradiation for prevention of oral mucositis (Oberoi et al 2014), the course of LLLT was
generally from day 0 through treatment. In studies of hematopoietic stem cell transplant (HSCT),
the course of LLLT began between day -7 and day 0 and continued as long as day 14 to 15. In
studies that began LLLT at day -7 to day -5 before HSCT, the course of laser therapy ended at
day -1 to day 0.
Other protocols have used low-level laser energy applied to acupuncture points on the fingers
and hand. This technique may be referred to as "laser acupuncture." Laser acupuncture is not
reviewed in this herein.
Cross-reference:
MP-1.094 Skin Contact Monochromatic Infrared Energy for the Treatment of Cutaneous
Ulcers, Diabetic Neuropathy, and Other Miscellaneous Musculoskeletal
Conditions
II. PRODUCT VARIATIONS
TOP
[N] = No product variation, policy applies as stated
[Y] = Standard product coverage varies from application of this policy, see below
[N] Capital Cares 4 Kids
[N] Indemnity
[N] PPO
[N] SpecialCare
[N] HMO
[N] POS
[N] SeniorBlue
[Y] FEP PPO*
[N] SeniorBlue PPO
* For low level laser refer to FEP Medical Policy Manual MP-2.01.56 Low-Level Laser
Therapy. The FEP Medical Policy manual can be found at: www.fepblue.org
III. DESCRIPTION/BACKGROUND
TOP
Low-level laser therapy (LLLT) refers to the use of red-beam or near-infrared lasers with a
wavelength between 600 and 1000 nm and power between 5 MW and 500 MW. (In contrast,
lasers used in surgery typically use 300 W.) When applied to the skin, LLLT produces no
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MEDICAL POLICY
POLICY TITLE
LOW-LEVEL LASER THERAPY (FORMERLY TRANSCUTANEOUS
LASER THERAPY)
POLICY NUMBER
MP- 1.097
sensation and does 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 on tissue healing is unknown;
hypotheses have included improved cellular repair and stimulation of the immune, lymphatic,
and vascular systems. LLLT is being evaluated to treat a wide variety of conditions, including
soft tissue injuries, myofascial pain, tendinopathies, nerve injuries, and joint pain. LLLT has also
been evaluated for lymphedema.
One of the primary disorders for which LLLT has been used is carpal tunnel syndrome. Carpal
tunnel syndrome is the most common entrapment neuropathy and the most commonly performed
surgery of the hand. The syndrome is related to the bony anatomy of the wrist. The carpal tunnel
is bound dorsally and laterally by the carpal bones and ventrally by the transverse carpal
ligament. Through this contained space run the 9 flexor tendons and the median nerve.
Therefore, any space-occupying lesion can compress the median nerve and produce the typical
symptoms of carpal tunnel syndrome—pain, numbness, and tingling in the distribution of the
median nerve. Symptoms of more severe cases include hypesthesia, clumsiness, loss of dexterity,
and weakness of pinch. In the most severe cases, patients experience marked sensory loss and
significant functional impairment with thenar atrophy. Mild-to-moderate cases of carpal tunnel
syndrome are usually first treated conservatively with splinting and cessation of aggravating
activities. Other conservative therapies include oral steroids, diuretics, nonsteroidal antiinflammatory drugs, and steroid injections into the carpal tunnel itself. Patients who do not
respond to conservative therapy or who present with severe carpal tunnel syndrome with thenar
atrophy may be considered candidates for surgical release of the carpal ligament, using either an
open or endoscopic approach.
Another key disorder for which LLLT is being evaluated is cancer therapy‒induced oral
mucositis in patients treated by radiotherapy and/or chemotherapy and hematopoietic stem cell
transplantation. Oral mucositis describes inflammation of the oral mucosa and typically
manifests as erythema or ulcerations that appear 7 to 10 days after initiation of high-dose cancer
therapy. Oral mucositis can cause significant pain and increased risk of systemic infection,
dependency on total parenteral nutrition, and use of narcotic analgesics. Treatment planning may
also need to be modified due to dose-limiting toxicity. There are a number of interventions for
oral mucositis that may partially control symptoms, but none are considered a criterion standard
treatment. When uncomplicated by infection, oral mucositis is self-limited and usually heals
within 2 to 4 weeks after cessation of cytotoxic chemotherapy.
REGULATORY STATUS
A number of low-level lasers have been cleared for marketing by the U.S. Food and Drug
Administration (FDA) through the 510(k) process for the treatment of pain. Data submitted for
the MicroLight 830® Laser consisted of application of the laser over the carpal tunnel 3 times a
week for 5 weeks. The labeling states that the "MicroLight 830 Laser is indicated for adjunctive
use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome." In
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MEDICAL POLICY
POLICY TITLE
LOW-LEVEL LASER THERAPY (FORMERLY TRANSCUTANEOUS
LASER THERAPY)
POLICY NUMBER
MP- 1.097
2006, GRT LITE™ was cleared for marketing, listing the TUCO Erchonia PL3000, the
Excalibur System, the MicroLight 830 Laser, and the Acculaser Pro as predicate devices.
Indications of the GRT LITE for carpal tunnel syndrome are similar to the predicate devices:
“adjunctive use in providing temporary relief of minor chronic pain.” In 2009, the LightStream™
LLL device was cleared for marketing by FDA through the 510(k) process for adjunctive use in
the temporary relief of pain associated with knee disorders with standard chiropractic practice. A
number of clinical trials of low-level laser therapy are underway in the United States, including
studies of wound healing.
IV. RATIONALE
Top
The most recent literature review was performed through December 18, 2015. The following is a
summary of the key findings to date.
The principal outcomes associated with treatment of musculoskeletal conditions, including
carpal tunnel syndrome, are relief of pain and/or functional status. Relief of pain is a subjective
outcome typically associated with a placebo effect. Therefore, blinded and randomized
controlled trials (RCTs) are required to control for the placebo effect and determine its
magnitude and whether any treatment effect provides a significant advantage over the placebo.
The technology must also be evaluated in general groups of patients: (1) in patients with mild-tomoderate symptoms, low-level laser therapy (LLLT) may be compared with other forms of
conservative therapy such as splinting, rest, nonsteroidal anti-inflammatory drugs (NSAIDs), or
steroid injection; and (2) in patients who have exhausted conservative therapy.
Oral Mucositis
In 2014, the Multinational Association of Supportive Care in Cancer (MASCC) and the
International Society of Oral Oncology (ISOO) issued guidelines that reiterated findings from
their 2012 systematic review recommending LLLT for the prevention of oral mucositis in
patients receiving hematopoietic stem cell transplantation (HSCT) conditioned with high-dose
chemotherapy and for patients undergoing head and neck radiotherapy, without concomitant
chemotherapy.1 The 2012 systematic review included 24 trials on a variety of prophylactic
treatments. The recommendation on which LLLT for prevention of oral mucositis in patients
receiving HSCT was based on what the authors considered to be 1 well-designed, placebocontrolled, randomized trial (described in more detail next),2 together with observational studies.
The trial was double-blind and sham-controlled with 70 patients.2 Patients were randomized to
650 nm laser, 780 nm laser, or placebo. Patients in the 650-nm laser group were more likely to
have received a total body irradiation (TBI) ‒containing regimen compared with the other 2
groups; otherwise, the groups were comparable. LLLT began on the first day of conditioning and
continued for 3 days posttransplant. Of the 70 patients, 47 (67%) had complete or nearly
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MEDICAL POLICY
POLICY TITLE
LOW-LEVEL LASER THERAPY (FORMERLY TRANSCUTANEOUS
LASER THERAPY)
POLICY NUMBER
MP- 1.097
complete mucositis measurements over time; the average number of visits per patient was similar
among the 3 groups. The difference between groups in mean oral mucositis scores was greatest
at day 11 (placebo, 24.3; 650 nm, 16.7; 780 nm, 20.6), but this difference between the 650-nm
group and placebo group was not statistically significant (p=0.06). Patient-specific oral mucositis
scores differed significantly between the 2 groups only when adjusted for TBI exposure. Of the
70 patients in the study, 17 (24%) were assessed for oral pain. With group sizes of 5 and 6, the
650-nm group had significantly lower patient-specific average pain scores (15.6) than the
placebo group (47.2). No adverse events from LLLT were noted. This study was flawed because
it did not achieve statistical significance for the primary outcome measure and had a very small
percentage of patients with pain assessments.
The MASCC/ISOO recommendation for LLLT for the prevention of oral mucositis in patients
undergoing radiotherapy, without concomitant chemotherapy, for head and neck cancer was
based on “weaker evidence” from 3 studies that showed positive results but had major flaws.
Evidence was considered encouraging but insufficient to recommend LLLT in other populations.
The authors emphasized that due to the range of laser devices and variations in individual
protocols, results of each study applied exclusively to the cancer population studied and the
specific wavelength and settings used.
Additional systematic reviews have been published since the 2012 MASCC/ISOO systematic
review.3-5 In 2014, Oberoi et al reported on a systematic review and meta-analysis of 18 RCTs on
LLLT versus no treatment or placebo for oral mucositis.4 Eight RCTs assessed patients
undergoing HSCT, 8 evaluated head and neck cancer patients receiving radiotherapy or
chemoradiation, and the rest studied patients with other conditions receiving chemotherapy. The
investigators used the Cochrane risk of bias tool to evaluate the RCTs. Most studies were
considered at low risk of bias on most domains. For example, 68% were at low risk of bias for
blinding of patients and personnel, and 89% were at low risk of bias on incomplete outcome
data. The primary outcome measure for the review was the incidence of severe mucositis. Ten
studies (total N=689 patients) were included in a pooled analysis of this outcome. The overall
incidence of severe mucositis (grades 3-4) decreased with prophylactic LLLT, with a risk ratio
(RR) of 0.37 (95% confidence interval [CI], 0.20 to 0.67; p = 0.001). Moreover, the absolute risk
reduction in the incidence of severe mucositis (-0.35) significantly favored LLLT (95% CI, -0.48 to 0.21; p<0.001). Among secondary outcomes, LLLT also significantly reduced the overall mean
grade of mucositis (standardized mean difference [SMD], -1.49; 95% CI, -2.02 to -0.95), duration of
severe mucositis (weighted mean difference [WMD], -5.32; 95% CI, -9.45 to -1.19), and incidence
of severe pain as measured on a visual analog scale (VAS; RR=0.26; 95% CI, 0.18 to 0.37). In a
subgroup analysis of the primary outcome (incidence of severe mucositis), the investigators did
not find a statistically significant interaction between the type of condition treated and the
efficacy of LLLT.
A 2015 qualitative systematic review by Doeuk et al addressed literature on LLLT for patients
undergoing maxillofacial surgery.5 The authors identified 45 studies that included more than 10
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MEDICAL POLICY
POLICY TITLE
LOW-LEVEL LASER THERAPY (FORMERLY TRANSCUTANEOUS
LASER THERAPY)
POLICY NUMBER
MP- 1.097
patients. Three RCTs on treatment of oral mucositis in patients with head and neck cancer were
identified and found significantly better outcomes (e.g., pain, symptoms, quality of life) in
patients receiving active LLLT versus sham treatment. Overall, the authors concluded that LLLT
“seems to be effective” for treating oral mucositis after head and neck cancer therapy, but that
LLLT cannot be considered a valid treatment option for patients undergoing other types of
maxillofacial surgery. The systematic review did not address prophylactic LLLT.
Two of the larger RCTs evaluating LLLT for prevention of oral mucositis were published by
Gautam et al in 2012.6,7 One of these studies reported LLLT for the prevention of
chemoradiotherapy-induced oral mucositis in 121 oral cancer patients.7 The second publication
reported LLLT for the prevention of chemoradiotherapy-induced oral mucositis in 221 head and
neck cancer patients.6 There is an apparent overlap in patients in these 2 reports, with the head
and neck cancer study including the 121 patients with a primary tumor site in the oral cavity.
Patients in these studies received LLLT before radiotherapy at 66 Gy delivered daily in 33
fractions, 5 days per week and concurrent with cisplatin. LLLT was delivered at a wavelength of
632.8 nm, power density of 24 mW/cm2, and a dosage of 3 to 3.5 J. In the report on oral cancer,
LLLT before radiotherapy led to significant reductions in the incidence of severe oral mucositis
(29% vs 89%) and its associated pain (18% vs 71%, with a VAS score >7), opioid analgesic use
(7% vs 21%), and total parenteral nutrition (30% vs 39%), all respectively, during the last weeks
of chemoradiotherapy. LLLT also reduced the duration of severe oral mucositis (4.07 days vs
13.96 days), severe pain (5.31 days vs 9.89 days), and total parenteral nutrition (14.05 days vs
17.93 days), all respectively. In the 221 patients treated for head and neck cancer, LLLT was
reported to lead to significant reductions in the incidence and duration of severe oral mucositis
(8.19 days vs 12.86 days) and its associated pain (VAS score of approximately 4 vs 7), total
parenteral nutrition (45.0% vs 65.5%), and opioid analgesic use (9% vs 26% for step III), all
respectively. In 2013, Gautam et al assessed patient-reported outcomes from the same study of
221 head and neck cancer patients using the Oral Mucositis Weekly Questionnaire-Head and
Neck (OMWQ-HN) and the Functional Assessment of Cancer Treatment- Head and Neck
(FACT-HN) questionnaire.8 Patients received LLLT as described earlier in this paragraph.
Patients in the LLLT group reported significantly better outcomes than the placebo group with
lower scores on both the OMWQ-HN (p<0.001) and FACT-HN (p<0.05).
In 2015 and 2016, 3 relatively small (i.e., each <50 patients), double-blind, sham-controlled
RCTs on prevention of oral mucositis in patients undergoing cancer treatment were published.
Gautam et al reported on 46 patients with head and neck cancer scheduled for radiotherapy and
found significant reductions in the incidence and duration of severe oral mucositis (p=0.002) and
severe pain (p=0.023) after LLLT versus sham.9 Oton-Leite reported on 30 head and neck cancer
patients undergoing chemoradiation and found that oral mucositis grades were significantly
lower in the LLLT group than in the control group at the week 1, 3, and 5 evaluations.10 For
example, at the last clinical evaluation (week 5), the rates of grade 3 oral mucositis were 25% in
the LLLT group and 54% in the control group. The third RCT, by Ferreira et al, included 36
patients with hematologic cancer undergoing HSCT.11 The overall incidence of oral mucositis
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MEDICAL POLICY
POLICY TITLE
LOW-LEVEL LASER THERAPY (FORMERLY TRANSCUTANEOUS
LASER THERAPY)
POLICY NUMBER
MP- 1.097
did not differ significantly between groups (p=0.146). However, the rate of severe oral mucositis
(grade 3 or 4) was significantly lower in the laser group (18%) than in the control group (61%;
p=0.015).
Section Summary: Oral Mucositis
The literature on LLLT for the prevention of oral mucositis includes several systematic reviews,
including a 2012 review by MASCC/ISOO with a resulting recommendation for LLLT for the
prevention of oral mucositis in adult patients receiving HSCT conditioned with high-dose
chemotherapy. Review of the key study evaluated by the MASCC/ISOO investigators for this
recommendation revealed limitations that include a lack of statistical significance for the primary
outcome measure. The MASCC/ISOO recommendation for LLLT for preventing oral mucositis
in patients undergoing radiotherapy for head and neck cancer was based on lower level evidence.
A 2014 systematic review of LLLTs for prevention of oral mucositis included 18 RCTs,
generally considered at low risk of bias, and found statistically significantly better outcomes with
LLLT than with control conditions on primary and secondary outcomes. In addition, 3 doubleblind, RCTs published in 2015 found significantly better outcomes in patients undergoing LLLT
compared with sham treatment prior to or during cancer treatment.
Neck Pain
The 2010 TEC Assessment, which included 6 trials of LLLT for chronic neck pain, found
inconsistent results.12 In the largest study by Chow et al, 90 patients were randomized to active
LLLT or sham treatment.13 At 5 weeks after the 7-week treatment period, patients in the active
treatment group reported a 2.7-point improvement in VAS pain score versus a 0.3-point
worsening for the sham group. A calculated mean improvement of 43.8% was reported by the
active LLLT group while the sham-treated group improved by 2.1%. The Assessment noted that
baseline VAS pain scores were significantly higher in the active treatment group, possibly
biasing results in favor of LLLT. Overall, the authors concluded that the trials were characterized
by small sample sizes, limited statistical power, and limited long-term follow-up, and thus the
evidence was insufficient.
In a 2013 systematic review and meta-regression, Gross et al evaluated 17 trials on LLLT for
neck pain.14 Ten trials demonstrated high risk of bias. Two trials (n=109 subjects) were
considered to be of moderate quality and found LLLT produced better outcomes than placebo for
chronic neck pain treatment. Other evidence showed improved outcomes with LLLT compared
with placebo for acute neck pain, acute radiculopathy, and cervical osteoarthritis, but was
considered to be low quality. There was conflicting evidence on chronic myofascial neck pain.
Section Summary: Neck Pain
The literature on LLLT for treatment of neck pain is conflicting. While some evidence shows
positive benefits with LLLT over placebo, larger studies are needed. Additionally, laser types,
dosages, and treatment schedules vary in the available evidence and require further study.
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POLICY TITLE
LOW-LEVEL LASER THERAPY (FORMERLY TRANSCUTANEOUS
LASER THERAPY)
POLICY NUMBER
MP- 1.097
Osteoarthritis Knee Pain
Several RCTs and systematic review of RCTs on LLLT for treatment of knee osteoarthritis have
been published. In 2015, Huang et al published a systematic review of RCTs comparing at least 8
treatment sessions of LLLT and sham laser treatment in knee osteoarthritis patients.15 To be
eligible for inclusion in the review, trials had to report pain and/or functional outcomes and a
PEDro quality score. A total of 9 trials (total N=518 patients) met eligibility criteria. In these
studies, interventions included between 8 and 20 laser or sham sessions over 2 to 6 weeks. All 9
trials were considered high quality, as assessed using the PEDro scale (score of 7; maximum
score, 11 points). Primary outcomes of interest were posttreatment pain measured by VAS scores
and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores (Pain and
Function). Meta-analyses did not find that LLLT led to significantly better pain scores than the
sham control, either immediately after treatment or at the 3-month follow-up. For example, a
meta-analysis of 5 studies that reported 12-week pain scores did not find a statistically significant
between-group difference (SMD = -0.06; 95% CI, -0.30 to 0.18). Moreover, there were no
statistically significant differences between active and sham laser interventions on WOMAC
Stiffness scores or WOMAC Function scores. The secondary outcome (range of motion [ROM]
after therapy) also did not significantly favor LLLT over a sham intervention.
Previously, in 2007, Bjordal et al published a systematic review of placebo-controlled RCTs to
determine the short-term efficacy of physical interventions for pain associated with knee
osteoarthritis.16 They included a total of 36 RCTs. The largest proportion of trials evaluated
transcutaneous electrical nerve stimulation (n=11), followed by 8 trials on LLLT and 7 on pulsed
electromagnetic fields. Also included were trials on electroacupuncture, manual acupuncture,
static magnets, and ultrasound. The authors did not report findings of pooled analyses on LLLT
for knee osteoarthritis. In a qualitative analysis, they stated that all the physical interventions but
2 (manual acupuncture, ultrasound) showed better results with active treatment over placebo.
Section Summary: Osteoarthritis Knee Pain
The literature on LLLT for osteoarthritis includes RCTs and 2 systematic reviews of RCTs. The
more recent systematic review, which pooled study findings, did not find that LLLT significantly
improved pain and functional outcomes compared with a sham intervention.
Low Back Pain
A number of RCTs and several systematic reviews of RCTs have been published. In 2015,
Huang et al published a systematic review of RCTs on LLLT for treatment of nonspecific
chronic low back pain.17 The review included trials comparing LLLT and placebo that reported
pain and/or functional outcomes and reported a PEDro quality score. Seven trials (total N=394
patients; 202 assigned to LLLT, 192 assigned to placebo) were included. Six of the 7 trials were
considered high quality (i.e., a PEDro score 7; maximum score, 11 points). Primary outcomes
of interest were posttreatment pain measured by VAS score and disability measured by the
Oswestry Disability Index (ODI) score. ROM and change in pain scores were secondary
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POLICY TITLE
LOW-LEVEL LASER THERAPY (FORMERLY TRANSCUTANEOUS
LASER THERAPY)
POLICY NUMBER
MP- 1.097
outcomes. In pooled analyses of study data, the authors found a statistically significant benefit of
LLLT on pain outcomes, but not disability or ROM. For the primary outcome (posttreatment
pain scores) in a meta-analysis of all 7 trials, mean VAS scores were significantly lower in the
LLLT group than in the placebo group (WMD = -13.57; 95% CI, -17.42 to -9.72). In a metaanalysis of 4 studies reporting the other primary outcome (ODI score), there was no statistically
significant differences between the LLLT and the placebo groups (WMD = -2.89; 95% CI, -7.88
to 2.29).
A 2008 Cochrane systematic review by Yousefi-Nooraie et al also evaluated LLLT for treatment
of nonspecific low back pain.18 The review included 7 RCTs comparing LLLT, alone or in
combination with another intervention, to a control condition. The authors concluded that, due to
heterogeneity among trials, the evidence was insufficient to draw firm conclusions on the
efficacy of LLLT for low back pain. The authors identified 7 RCTs, but did not pool study
findings due to differences among the populations, interventions, and comparison groups.
A large RCT on LLLT for treatment of acute low back pain was published in 2010 by
Konstantinovic et al.19 The study was double-blind and placebo-controlled, and included 546
patients. Patients were randomly assigned to 1 of 3 treatment groups (each including 182
patients). 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 a week for 15 weeks. Statistically significant differences after
treatment were found for all outcomes (p<0.001), but were larger in group A than in B (p<0.005)
or C (p<0.001). Results in group C were better than in group B (p<0.001). The authors
concluded that improvement is better in acute low back pain with LLLT as additional therapy.
Durability of these outcomes was not measured.
Section Summary: Low Back Pain
The literature on LLLT for low back pain consists of a number of RCTs and several systematic
reviews of RCTs. The systematic reviews did not consistently find that LLLT improved
outcomes for patients with nonspecific low back pain.
Carpal Tunnel Syndrome
In November 2010, a TEC Assessment evaluated LLLT for carpal tunnel syndrome and chronic
neck pain.12 For inclusion in the Assessment, studies had to: be published in a peer-reviewed
journal; be a randomized, sham-controlled trial, and, if adjunctive therapies were used, they had
to have been applied to both groups; measure outcomes at least 2 weeks beyond the end of the
treatment period; and, for neck pain studies, evaluate patients with chronic pain. Four RCTs met
the inclusion criteria.20-23 The authors concluded that the studies had serious limitations,
including small sample size and limited follow-up, and no study was so methodologically sound
as to provide definitive results.
Several additional RCTs have been published. In 2012, Tascioglu et al reported a randomized,
double-blind, sham-controlled trial of LLLT.24 Sixty patients with carpal tunnel syndrome were
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POLICY TITLE
LOW-LEVEL LASER THERAPY (FORMERLY TRANSCUTANEOUS
LASER THERAPY)
POLICY NUMBER
MP- 1.097
assigned to 1 of 2 active laser dosages (1.2 J or 0.6 J per painful point) or sham placebo
treatment 5 times per week for 3 weeks. In this study, there were no significant differences
between groups for any of the outcome measures (VAS scores, grip strength, functional status
scores).
In 2015, Barbosa et al evaluated the efficacy of orthoses and patient education with or without
the addition of LLLT in patients with mild and moderate carpal tunnel syndrome.25 Laser
treatment was provided twice a week for 6 weeks. Forty-eight patients were randomized and 30
(63%) completed the study protocol. Compared with baseline, outcomes (e.g., scores on the
Boston Carpal Tunnel Questionnaire and its domains) did not differ significantly between groups
after treatment.
Section Summary: Carpal Tunnel Syndrome
The literature on LLLT for carpal tunnel syndrome consists of a number of RCTs. However, a
2010 TEC Assessment concluded that the evidence from sham-controlled RCTs was insufficient
and more recent RCTs have not found that LLLT significantly improves outcomes.
Subacromial Impingement
Several RCTs evaluating LLLT for treatment of subacromial impingement have been published.
Two sham-controlled studies, by Yeldan et al (2009)26 and by Dogan et al (2010),27 did not find
statistically significantly better pain or functional outcomes with active treatment that with sham.
A third RCT, published by Abrisham et al (2011) compared exercise plus pulsed LLLT or sham
laser 5 times per week for 2 weeks in 80 patients with subacromial syndrome (rotator cuff and
biceps tendinitis).28 At the end of the treatment period, although both groups improved in VAS
scores for pain and shoulder ROM, the improvement was significantly better for the active LLLT
group than for the sham laser group for VAS score (4.4 vs 2.9), and all measures of ROM (active
and passive flexion, abduction, external rotation). The durability of this effect was not assessed.
Other RCTs did not show statistically significant benefits of LLLT versus conservative
treatment. In a 2009 study designed to assess the effectiveness of LLLT in patients with
subacromial impingement syndrome, 44 patients were randomized to receive a 12-week home
exercise program with or without LLLT.29 Outcome measures of night pain, Shoulder Pain and
Disability Index (SPADI), and University of California-Los Angeles (UCLA) end-result scores
were assessed at the second and twelfth weeks of intervention. No distinct advantage was
demonstrated by LLLT over exercise alone. Both groups showed significant reductions in night
pain and SPADI scores at 2- and 12-week assessments, but the differences between groups were
not statistically significant.
In 2011, Calis et al randomized 52 patients with subacromial impingement syndrome to LLLT,
ultrasound, or exercise.30 Patients were treated 5 days a week for 3 weeks with hotpack plus
ultrasound plus exercise, hotpack plus laser plus exercise, or hotpack plus exercise. All 3 groups
showed improvement from baseline to posttreatment in pain at rest, ROM, and function, but
there were no significant differences between groups.
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LOW-LEVEL LASER THERAPY (FORMERLY TRANSCUTANEOUS
LASER THERAPY)
POLICY NUMBER
MP- 1.097
Section Summary: Subacromial Impingement
The literature on LLLT for subacromial syndrome consists of several RCTs. Most trials did not
show a significant benefit of LLLT compared with sham treatment or with an alternative
intervention (e.g., exercise).
Adhesive Capsulitis (Frozen Shoulder)
A 2014 Cochrane review evaluated LLLT and other electrotherapy modalities for adhesive
capsulitis, also known as frozen shoulder.31 The review found limited evidence to draw
conclusions on the effectiveness of electrotherapy modalities for frozen shoulder. Only 1 RCT of
40 patients compared LLLT with placebo. This trial administered LLLT for 6 days. On day 6,
patients receiving LLLT showed some improvement on a global assessment of treatment success
compared with patients receiving placebo. However, this study was considered to be of low
quality and the small size and short follow-up limited interpretation of results. Another RCT on
LLLT discussed in the Cochrane review by Page et al was considered to be of moderate quality.
In that RCT by Stergioulas, 63 patients with frozen shoulder were randomized to an 8-week
program of LLLT (n=31) or to placebo (n=32).32 Both groups also participated in exercise
therapy. Compared with the sham group, the active laser group had a significant decrease in
overall, night, and activity pain scores after 4 and 8 weeks of treatment, and at the end of 8 more
weeks of follow-up. At the same time intervals, significant decreases in SPADI scores and Croft
Shoulder Disability Questionnaire scores were observed, while significant decreases in Disability
of Arm, Shoulder, and Hand Questionnaire scores were observed at 8 weeks of treatment and at
16 weeks postrandomization; significant decreases in Health Assessment Questionnaire scores
were observed at 4 weeks and 8 weeks of treatment.
Section Summary: Adhesive Capsulitis
A Cochrane review found limited evidence on LLLT for treating adhesive capsulitis.
Heel Pain
Achilles Tendinopathy
Stergioulas et al randomized 52 recreational athletes with chronic Achilles tendinopathy
symptoms to an 8-week (12-session) program of eccentric exercises with LLLT or with sham
LLLT.33 By intention-to-treat (ITT) analysis, results for the primary outcome of pain during
physical activity on a VAS were significantly lower in the exercise group with LLLT group at 4
weeks (p<0.001), 8 weeks (p<0.001), and 12 weeks (p=0.007) after randomization.
Tumilty et al reported a randomized, double-blinded, sham-controlled trial of LLLT as an
adjunct to 3 months of exercise training in 40 patients with Achilles tendinopathy.34 Active or
sham LLLT was administered 3 times a week for 4 weeks, and exercises were performed twice a
day for 12 weeks. The primary outcome was the Victorian Institute of Sport
Assessment‒Achilles Questionnaire (VISA-A) at 12 weeks. Following treatment, the only
significant difference between the groups on an ITT basis was at 4 weeks on VISA-A scores and
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the difference favored the sham-control group. The VISA-A and pain numeric rating scale scores
did not differ significantly between the active and the sham groups at 12-week or 1-year followups.
Plantar Fasciitis
A 2015, double-blind RCT by Macias et al assessed 69 patients with unilateral chronic plantar
fasciitis and chronic heel pain of 3 months or longer that was unresponsive to conservative
treatments (e.g., rest, stretching, physical therapy).35 Patients were randomized to twice weekly
treatment for 3 weeks of LLLT or sham treatment. The primary efficacy outcome, reduction of
heel pain pre- to posttreatment, differed significantly between groups (p<0.001). Mean VAS
scores decreased from 69.1 to 39.5 in the LLLT group and from 67.6 to 62.3 in the sham group.
The difference in Foot Function Index scores did not differ significantly between groups.
An RCT on LLLT for plantar fasciitis was reported by Kiritsi et al in 2010.36 The trial was
double-blind and sham-controlled trial and included 30 patients. Twenty-five (83%) patients
completed the study, with treatment 3 times a week over 6 weeks. At baseline, plantar fascia
thickness, measured by ultrasound was significantly greater in symptomatic compared with
asymptomatic feet (5.3 mm vs 3.0 mm). Plantar fascia thickness decreased in both the LLLT and
the sham groups during the study. Although plantar fascia thickness after 6 weeks of treatment
did not differ significantly between the 2 groups (3.6 mm in LLLT, 4.4 mm in sham), there was a
significant difference between groups in the change in thickness (1.7 mm LLLT vs 0.9 mm
sham). VAS scores after night rest or daily activities improved significantly more in the LLLT
group (59% improvement) than in the sham group (26% improvement). At baseline, pain after
daily activities was rated as 67 out of 100 by both groups. At the end of treatment, VAS scores
after daily activities were rated as 28 out of 100 for LLLT and 50 out of 100 for sham.
Section Summary: Heel Pain
Several sham-controlled RCTs have evaluated LLLT for heel pain (Achilles tendinopathy,
plantar fasciitis). Findings are inconsistent. There were no RCTs comparing LLLT to an
alternative treatment for heel pain. Moreover, studies offer limited long-term follow-up data.
Temporomandibular Joint Pain
Several meta-analyses of RCTs on LLLT for temporomandibular joint (TMJ) pain have been
published. A 2015 meta-analysis by Chen et al assessed pain and functional outcomes after
LLLT for TMJ pain.37 Fourteen placebo-controlled RCTs were identified. Ten trials provided
data on pain, measured by a VAS. A pooled analysis of these studies found no significant
differences between active treatment and placebo for VAS scores at final follow-up (WMD = 19.39; 95% CI, -40.80 to 2.03; p=0.08). However, meta-analyses did find significantly better
functional outcomes (i.e., maximum active mouth opening, maximum passive mouth opening).
For example, the mean difference in maximum active mouth opening for active treatment versus
placebo was 4.18 (95% CI, 0.73 to 7.63).
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In 2014, Chang et al published a meta-analysis of 7 RCTs on LLLT for TMJ pain.38 RCTs
included in the review compared LLLT with no treatment or placebo. Six studies with a total of
223 patients were eligible inclusion in the meta-analysis. The number of treatment sessions
ranged from 4 to 20. The pooled effect size of pain relief using the VAS was a mean decrease of
0.6 (95% CI, -0.47 to -0.73).
A third meta-analysis of RCTs on LLLT for treating TMJ disorders was published in 2011.39 The
investigators identified 6 randomized, placebo-controlled trials that met the inclusion criteria. A
pooled analysis of data from the 6 trials did not find a statistically significant difference in the
primary outcome of interest, change in pain from baseline to end point. The pooled difference in
pain, measured on a VAS, was a mean difference of 7.77 millimeters (95% CI, -2.49 to 18.02
mm; p=0.14). All studies had small sample sizes (range, 14-52 participants), and the confidence
interval in the pooled analysis was wide.
Outcomes of individual trials of LLLT for TMJ pain are inconsistent. In a study from Brazil, 40
patients with TMJ were treated with LLLT or placebo.40 After 4 weeks of weekly treatment,
patients were evaluated for pain on a VAS and the Craniomandibular Index. Both groups
improved on both measures (p<0.05), and there were no significant differences between groups.
Emshoff et al evaluated LLLT in the management of TMJ in a double-blinded RCT of 52
patients randomized equally to LLLT or sham treatment.41 After 8 weeks of 2 to 3
treatments/week, both groups showed improvements in pain during function. Between-group
differences were not significant.
Fikackova et al treated 61 patients with TMJ or myofascial pain with LLLT at 1 of 2 densities
(10 or 15 J/cm2) and 19 patients with sham LLLT (0.1 J/cm2).42 Outcomes were measured by
self-administered questionnaire. The authors reported significantly better outcomes in patients
treated with 10 or 15 J/cm2 than in patients given sham treatment. Outcomes were similar
between patients with TMJ and myofascial pain.
Carrasco et al randomly assigned 60 patients with myofascial pain and 1 active trigger point in
the anterior masseter and anterior temporal muscles to 6 groups.43 Three groups received laser
treatment twice a week for 4 weeks at different energy levels for each group (25, 60, or 105
J/cm2). The other 3 groups received placebo treatment simulating the same parameters as the
treated groups. Pain scores were assessed just before, immediately after the fourth and eighth
applications, and at 15 days and 1 month after treatment. An analgesic effect was seen starting
from the third evaluation in both the treated and placebo groups, and placebo was as effective as
laser (p<0.05). Differences in pain VAS scores between groups treated at different energy levels
were not significant.
Venezian et al randomized 48 patients with myofascial pain to 1 of 2 doses of laser (25 or 60
J/cm2) or placebo twice a week for 4 weeks.44 Surface electromyography at the conclusion of
testing showed no difference between groups. Pain with palpation was measured by VAS scores
before, at the conclusion of, and 30 days after laser therapy. VAS scores declined in all groups
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and were more consistently decreased (more regions of the palpated muscles) after active laser
therapy. However, there were no significant differences in VAS scores between the active and
sham-controlled groups.
Marini et al compared superpulsed LLLT with NSAIDs for TMJ pain secondary to disc
displacement without reduction or osteoarthritis.45 Ninety-nine patients were randomized to 1 of
3 groups: 39 received LLLT in 10 sessions over 2 weeks, 30 received sham LLLT on the same
schedule, and 30 patients received ibuprofen 800 mg twice a day. Pain intensity was measured at
baseline and after 2, 5, 10, and 15 days of treatment. Mandibular function (active and passive
mouth openings, right and left lateral motions) was evaluated at baseline, 15 days, and 1 month
of treatment. Durability of pain relief beyond the end of treatment was not reported. Mandibular
function was significantly better at 1 month after treatment in the active laser-treated group.
Section Summary: Temporomandibular Joint Pain
There are a number of medium to large, randomized, sham-controlled trials of LLLT for TMJ
syndrome. Findings of these trials, as well as of systematic reviews of RCTs, are mixed, and
most trials do not show a benefit of LLLT.
Rheumatoid Arthritis
A 2005 Cochrane Review included 5 placebo-controlled RCTs and found that, relative to a
separate control group, LLLT reduced pain by 1.10 points on VAS compared with placebo,
reduced morning stiffness duration by 27.5 minutes, and increased tip-to-palm flexibility by 1.3
cm.46 Other outcomes, such as functional assessment, ROM, and local swelling, did not differ
between groups. For rheumatoid arthritis, 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 2010 randomized, double-blind, placebo-controlled trial comparing outcomes of pain
reduction and improvement in hand function in 82 patients with rheumatoid arthritis treated with
LLLT or placebo laser was reported by Meireles et al.47 There were no statistically significant
differences between groups for most outcome measurements, including the primary variables,
though a few measures significantly favored either the active or placebo treatment. The authors
concluded that LLLT at the dosage used in the study was not effective for the treatment of hands
among patients with rheumatoid arthritis.
Section Summary: Rheumatoid Arthritis
A Cochrane review and a more recent RCT did not find consistent evidence supporting the
efficacy of LLLT for treating rheumatoid arthritis.
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Fibromyalgia
Several small RCTs evaluating LLLT for treating fibromyalgia have been published. In 2014,
Ruaro et al reported on 20 patients randomized to receive LLLT or sham treatment 3 times a
week for 4 weeks (12 total treatments).48 Outcomes included scores in the Fibromyalgia Impact
Questionnaire (FIQ), which measures physical function, ability to work, pain, fatigue, and
depression; the McGill Pain Questionnaire (MPQ); and a pain VAS. All 3 outcomes were
significantly better in the active than in sham after treatment. Mean overall FIQ scores were 18.6
in the LLLT group and 5.2 in the sham group (p=0.003). Mean change scores also differed
significantly between groups for MPQ score (p=0.008) and VAS score (p=0.002).
In 2007, Matsutani et al randomized 20 patients with fibromyalgia to receive laser treatment and
stretching exercises or stretching alone.49 Outcome measures were VAS scores and dolorimetry
at tender points, QOL on the FIQ, and the 36-Item Short-Form Health Survey (SF-36) scores. At
the end of treatment, both groups demonstrated pain reduction, higher pain threshold at tender
points (all p<0.01), lower mean FIQ scores, and higher SF-36 mean scores (all p<0.05). No
significant differences were found between groups.
Section Summary: Fibromyalgia
Few RCTs evaluating LLLT for treatment of fibromyalgia are available and existing trials are
small (i.e., <25 patients each). One RCT with 20 patients found significantly better outcomes
with LLLT than with sham, and another RCT with 20 patients did not find statistically
significant between-group differences for similar outcomes. Additional RCTs with sufficient
numbers of patients are needed.
Bell Palsy
In 2014, Alayat et al reported on a randomized, double-blind, placebo-controlled trial of laser
therapy for the treatment of 48 patients with Bell palsy.50 Facial exercises and massage were
given to all patients. Patients were randomized to 1 of 3 groups: high-intensity laser therapy,
LLLT, or exercise only. Laser treatment was given 3 times a week to 8 points of the affected side
for 6 weeks. At 3 and 6 weeks posttreatment, outcomes were assessed using the Facial Disability
Scale and the House-Brackmann Scale. Significant improvements in recovery were seen in both
laser therapy groups over exercise alone, with the most improvement seen with high-intensity
laser.
Section Summary: Bell Palsy
The limited evidence on laser therapy for Bell palsy is insufficient to draw conclusions. Because
Bell palsy often improves within weeks and may completely resolve within months, it is difficult
to determine any improvements from laser therapy over the natural resolution of the illness.
Therefore, sham-controlled studies are needed in addition to comparisons with corticosteroids,
antivirals, or other Bell palsy treatments.
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Lymphedema
Several systematic reviews of RCTs and observational studies have been published. In 2015,
Smoot et al published a systematic review of studies on the effect of LLLT on symptoms in
women with breast cancer‒related lymphedema.51 The authors identified 9 studies, 7 RCTs and 2
single-group studies. Three studies had a sham control group, 1 used a waitlist control, and 3
compared LLLT to an alternative intervention (e.g., intermittent compression). Only 3 studies
had blinded outcome assessment and, in 3 studies, participants were blinded. A pooled analysis
of 4 studies found significantly greater reduction in upper-extremity volume with LLLT than
with the control condition (effect size [ES], -0.62; 05% CI, -0.97 to -0.28). Only 2 studies were
suitable for a pooled analysis of the effect of LLLT on pain. This analysis did not find a
significant difference in pain between LLLT and control (ES = -1.21; 95% CI, -4.51 to 2.10).
Omar et al published a qualitative systematic review of LLLT for the management of breast
cancer‒related lymphedema in 2012.52 They included 8 studies (total N=230 patients) in the
review. Five studies were graded as Sackett evidence level II (small randomized trial with high
false-positive or false-negative errors), 2 were graded as level III (nonrandomized comparative
study), and 1 study was graded as level V evidence (case series). The authors noted major
methodologic flaws and little uniformity in trial designs.
One of the larger double-blind RCTs was published in 2011 by Omar et al; the study reported on
50 patients with postmastectomy lymphedema.53 The average length of time that patients had
swelling was 14 months (range, 12-36 months). Patients were treated with active or sham laser 3
times a week for 12 weeks over the axillary and arm areas. In addition, all participants were
instructed to perform daily arm exercises and to wear a pressure garment. Limb circumference,
shoulder mobility, and grip strength were measured before treatment and at 4, 8, and 12 weeks.
Limb circumference declined over time in both groups, with significantly greater reduction in the
active laser group at 8 (20.0 cm vs 16.4 cm), 12 (29 cm vs 21.8 cm), and 16 (31 weeks vs 2
weeks 3) weeks. Shoulder flexion and abduction were significantly better in the active laser
group at 8 and 12 weeks. Grip strength was significantly better in the active laser group after 12
weeks (26.2 kg vs 22.4 kg). The durability of these effects was not assessed.
Section Summary: Lymphedema
Two systematic reviews of RCTs and observational studies found methodologic flaws in the
available studies and did not consistently find better outcomes in patients receiving LLLT versus
a control condition for treatment of lymphedema.
Chronic Wounds
A 2004 evidence report on vacuum-assisted and low-level laser wound therapies for treatment of
chronic nonhealing wounds, prepared for the Agency for Healthcare Research and Quality, was
based on 11 studies of LLLT.54 It stated: “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
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unlikely to have concealed existing effects. Future studies may determine whether different
dosing parameters or other laser types may lead to different results.”
In 2014, a Cochrane review of RCTs on light therapy, including phototherapy, ultraviolet, and
laser, for pressure ulcers was published.55 The few trials available for analysis were of small size
and very low quality. The reviewers found the available evidence overall was insufficient to
draw conclusion on the effects light therapy on pressure ulcers.
Section Summary: Chronic Wounds
Two systematic reviews of the literature did not find sufficient evidence from controlled studies
demonstrating that LLLT is effective for wound healing.
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this review are listed in Table 1
Summary of Evidence
The evidence for low-level laser therapy (LLLT) in individuals who have increased risk of oral
mucositis due to some cancer treatments (e.g., chemotherapy, radiotherapy) and/or hematopoietic
stem cell transplantation includes randomized controlled trials (RCTs)and systematic reviews of
RCTs. Relevant outcomes are symptoms, morbid events, quality of life, and treatment-related
morbidity. Studies included patients undergoing various cancer chemotherapy regimens or
hematopoietic stem cell transplantation. A recent systematic review of RCTs on LLLT for
prevention of oral mucositis included 18 RCTs, generally considered at low risk of bias, and
found statistically significantly better outcomes with LLLT than control conditions on primary
and secondary outcomes. In addition, 3 double-blind, RCTs published in 2015 found
significantly better outcomes in patients undergoing LLLT than undergoing sham treatment prior
to or during cancer treatment. The evidence is sufficient to determine qualitatively that the
technology results in a meaningful improvement in the net health outcome.
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The evidence for LLLT in individuals who have orthopedic pain (i.e., neck pain, osteoarthritis
knee pain, low back pain, carpal tunnel syndrome) includes RCTs and, for some indications,
systematic reviews of RCTs. Relevant outcomes are symptoms, functional outcomes, quality of
life, and treatment-related morbidity. Findings of the RCTs were mixed and had methodologic
limitations. The evidence is insufficient to determine the effects of the technology on health
outcome.
The evidence for LLLT in individuals who have shoulder conditions, heel pain, or
temporomandibular joint pain includes RCTs and, for some indications, systematic reviews of
RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatmentrelated morbidity. Findings of the RCTs were mixed and had methodologic limitations. The
evidence is insufficient to determine the effects of the technology on health outcome.
The evidence for LLLT in individuals who have bone, ligament, and joint conditions (e.g.,
rheumatoid arthritis, fibromyalgia) includes RCTs and, for some indications, systematic reviews
of RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatmentrelated morbidity. Findings of the RCTs were mixed and had methodologic limitations. The
evidence is insufficient to determine the effects of the technology on health outcome.
The evidence for LLLT in individuals who have Bell palsy includes an RCT. Relevant outcomes
are change in disease status, functional outcomes, quality of life, and treatment-related
morbidity. Bell palsy may completely resolve within months and, thus, it is difficult to determine
improvements from laser therapy over the natural resolution of the illness. The available RCT
did not include a sham treatment; LLLT was superior to exercise only in this study. Shamcontrolled studies are needed as well as additional studies comparing LLLT with alternative Bell
palsy treatments. The evidence is insufficient to determine the effects of the technology on health
outcome.
The evidence for LLLT in individuals who have lymphedema includes RCTs, observational
studies, and systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality
of life, and treatment-related morbidity. Systematic reviews of RCTs and observational studies
found methodologic flaws in the available studies and have not consistently found better
outcomes in patients receiving LLLT than in patients receiving a control condition treatment.
The evidence is insufficient to determine the effects of the technology on health outcome.
The evidence for LLLT in individuals who have chronic wounds includes RCTs and systematic
reviews. Relevant outcomes are symptoms, change in disease status, and treatment-related
morbidity. The few existing RCTs tend to have small sample sizes and risk of bias. The evidence
is insufficient to determine the effects of the technology on health outcome.
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Practice Guidelines and Position Statements
Multinational Association of Supportive Care in Cancer et al
In 2014, the Multinational Association of Supportive Care in Cancer (MASCC) and the
International Society of Oral Oncology (ISOO) published a guideline on the management of
mucositis secondary to cancer therapy.1
For the prevention of oral mucositis, the MASCC/ISOO recommended the following treatments,
based on strong evidence: LLLT (650 nm, power of 40 mW) in patients receiving hematopoietic
stem cell transplantation (HSCT) conditioned with high-dose chemotherapy with or without total
body irradiation; oral cryotherapy in patients receiving bolus 5-fluorouracil chemotherapy;
recombinant human keratinocyte growth factor-1 in patients receiving high-dose chemotherapy
and total body irradiation, followed by autologous stem cell transplantation for a hematological
malignancy; benzydamine mouthwash in patients with head and neck cancer receiving moderatedose radiotherapy without concomitant chemotherapy.
Additionally, the following treatments were recommended for the prevention of oral mucositis
based on weaker evidence: LLLT (632.8 nm) in patients undergoing radiotherapy, without
concomitant chemotherapy, for head and neck cancer; oral care protocols for patients undergoing
any cancer treatment; oral cryotherapy in patients receiving high-dose melphalan as conditioning
for HSCT; oral zinc supplements in oral cancer patients receiving radiotherapy or
chemoradiation.
National Comprehensive Cancer Network
The National Comprehensive Cancer Network’s 2015 guideline on head and neck cancers does
not address prevention or treatment or oral mucositis.56
American Physical Therapy Association
In 2010, the American Physical Therapy Association (APTA) published a guideline on the
diagnosis and treatment of Achilles tendinitis.57 APTA gave a level B recommendation (based on
moderate evidence) to consider the use of LLLT to decrease pain and stiffness in patients with
Achilles tendinopathy. APTA stated in its review of the evidence, that “given the limited number
of studies employing LLLT in this population, additional study is warranted.”
National Institute for Health and Clinical Excellence
The U.K.’s National Institute for Health and Clinical Excellence’s 2009 guideline on early
management of persistent nonspecific low back pain did not recommend laser treatment, citing
limited evidence.58
American Pain Society
The 2007 American Pain Society guideline states that there is insufficient evidence to
recommend LLLT for treatment of low back pain (with the American College of Physicians),59
and LLLT is not mentioned in the 2009 guideline.60
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American Academy of Orthopaedic Surgeons
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 support their
use.61
U.S. Preventive Services Task Force Recommendations
Not applicable.
Medicare National Coverage
There is no national coverage determination (NCD).
V. DEFINITIONS
TOP
CARPAL TUNNEL SYNDROME is a condition of pain or numbness that affects some part of the
median nerve distribution of the hand (the palmar side of the thumb, the index finger, the radial
half of the ring finger, and the radial half of the palm) and may radiate into the arm.
EPICONDYLITIS is the inflammation of the epicondyle of the humerus and surrounding tissues.
FIBROMYALGIA is chronic and frequently difficult to manage pain in muscles and soft tissues
surrounding joints.
RHEUMATOID ARTHRITIS is a chronic systemic disease marked by inflammation of multiple
synovial joints.
TENDINITIS is an inflammation of a tendon.
TMJ SYNDROME is severe pain in and about the temporomandibular joint, made worse by
chewing.
VI. BENEFIT VARIATIONS
TOP
The existence of this medical policy does not mean that this service is a covered benefit under
the member's contract. Benefit determinations should be based in all cases on the applicable
contract language. Medical policies do not constitute a description of benefits. A member’s
individual or group customer benefits govern which services are covered, which are excluded,
and which are subject to benefit limits and which require preauthorization. Members and
providers should consult the member’s benefit information or contact Capital for benefit
information.
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VII. DISCLAIMER
TOP
Capital’s medical policies are developed to assist in administering a member’s benefits, do not constitute medical
advice and are subject to change. Treating providers are solely responsible for medical advice and treatment of
members. Members should discuss any medical policy related to their coverage or condition with their provider
and consult their benefit information to determine if the service is covered. If there is a discrepancy between this
medical policy and a member’s benefit information, the benefit information will govern. Capital considers the
information contained in this medical policy to be proprietary and it may only be disseminated as permitted by law.
VIII. CODING INFORMATION
TOP
Note: This list of codes may not be all-inclusive, and codes are subject to change at any
time. The identification of a code in this section does not denote coverage as
coverage is determined by the terms of member benefit information. In addition, not
all covered services are eligible for separate reimbursement.
Covered when medically necessary, low-level laser therapy for prevention of oral
mucositis in patients undergoing cancer treatment:
CPT Codes ®
97026
Current Procedural Terminology (CPT) copyrighted by American Medical Association. All Rights Reserved.
HCPCS
Code
S8948
Description
Application of a modality (requiring constant provider attendance) to one or more areas;
low-level laser; each 15 minutes
ICD-10 CM
Diagnosis
Codes
Description
K12.31
K12.33
K12.39
Oral mucositis (ulcerative) due to antineoplastic therapy
Oral mucositis (ulcerative) due to radiation
Other oral mucositis (ulcerative)
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IX. REFERENCE
TOP
Low-Level Laser
1. Lalla RV, Bowen J, Barasch A, et al. MASCC/ISOO clinical practice guidelines for the
management of mucositis secondary to cancer therapy. Cancer. May 15 2014;120(10):14531461. PMID 24615748
2. Schubert MM, Eduardo FP, Guthrie KA, et al. A phase III randomized double-blind placebocontrolled clinical trial to determine the efficacy of low level laser therapy for the prevention
of oral mucositis in patients undergoing hematopoietic cell transplantation. Support Care
Cancer. Oct 2007;15(10):1145-1154. PMID 17393191
3. Figueiredo AL, Lins L, Cattony AC, et al. Laser therapy in the control of oral mucositis: A
meta-analysis. Rev Assoc Med Bras. Oct 9 2013. PMID 24119379
4. Oberoi S, Zamperlini-Netto G, Beyene J, et al. Effect of prophylactic low level laser therapy
on oral mucositis: a systematic review and meta-analysis. PLoS One. 2014;9(9):e107418.
PMID 25198431
5. Doeuk C, Hersant B, Bosc R, et al. Current indications for low level laser treatment in
maxillofacial surgery: a review. Br J Oral Maxillofac Surg. Apr 2015;53(4):309-315. PMID
25740083
6. Gautam AP, Fernandes DJ, Vidyasagar MS, et al. Low level laser therapy for concurrent
chemoradiotherapy induced oral mucositis in head and neck cancer patients - A triple
blinded randomized controlled trial. Radiother Oncol. Sep 2012;104(3):349-354. PMID
22884841
7. Gautam AP, Fernandes DJ, Vidyasagar MS, et al. Low Level Helium Neon Laser therapy for
chemoradiotherapy induced oral mucositis in oral cancer patients - A randomized controlled
trial. Oral Oncol. Sep 2012;48(9):893-897. PMID 22502814
8. Gautam AP, Fernandes DJ, Vidyasagar MS, et al. Effect of low-level laser therapy on patient
reported measures of oral mucositis and quality of life in head and neck cancer patients
receiving chemoradiotherapy--a randomized controlled trial. Support Care Cancer. May
2013;21(5):1421-1428. PMID 23224689
9. Gautam AP, Fernandes DJ, Vidyasagar MS, et al. Low level laser therapy against radiation
induced oral mucositis in elderly head and neck cancer patients-a randomized placebo
controlled trial. J Photochem Photobiol B. Mar 2015;144:51-56. PMID 25704314
10. Oton-Leite AF, Silva GB, Morais MO, et al. Effect of low-level laser therapy on
chemoradiotherapy-induced oral mucositis and salivary inflammatory mediators in head and
neck cancer patients. Lasers Surg Med. Apr 2015;47(4):296-305. PMID 25824475
11. Ferreira B, da Motta Silveira FM, de Orange FA. Low-level laser therapy prevents severe
oral mucositis in patients submitted to hematopoietic stem cell transplantation: a randomized
clinical trial. Support Care Cancer. Mar 2016;24(3):1035-1042. PMID 26248655
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POLICY TITLE
LOW-LEVEL LASER THERAPY (FORMERLY TRANSCUTANEOUS
LASER THERAPY)
POLICY NUMBER
MP- 1.097
12. Blue Cross and Blue Shield Technology Evaluation Center (TEC). Low-level laser therapy
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15. Huang Z, Chen J, Ma J, et al. Effectiveness of low-level laser therapy in patients with knee
osteoarthritis: a systematic review and meta-analysis. Osteoarthritis Cartilage. Sep
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16. Bjordal JM, Johnson MI, Lopes-Martins RA, et al. Short-term efficacy of physical
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18. Yousefi-Nooraie R, Schonstein E, Heidari K, et al. Low level laser therapy for nonspecific
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19. Konstantinovic LM, Kanjuh ZM, Milovanovic AN, et al. Acute low back pain with
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20. Chang WD, Wu JH, Jiang JA, et al. Carpal tunnel syndrome treated with a diode laser: a
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POLICY TITLE
LOW-LEVEL LASER THERAPY (FORMERLY TRANSCUTANEOUS
LASER THERAPY)
POLICY NUMBER
MP- 1.097
25. Barbosa RI, Fonseca MC, Rodrigues EK, et al. Efficacy of low-level laser therapy associated
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trial. J Back Musculoskelet Rehabil. Sep 25 2015. PMID 26444330
26. Yeldan I, Cetin E, Ozdincler AR. The effectiveness of low-level laser therapy on shoulder
function in subacromial impingement syndrome. Disabil Rehabil. 2009;31(11):935-940.
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28. Abrisham SM, Kermani-Alghoraishi M, Ghahramani R, et al. Additive effects of low-level
laser therapy with exercise on subacromial syndrome: a randomised, double-blind,
controlled trial. Clin Rheumatol. May 4 2011;30(10):1341-1346. PMID 21538218
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syndrome. Photomed Laser Surg. Feb 2009;27(1):31-36. PMID 19250050
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results. Photomed Laser Surg. Apr 2008;26(2):99-105. PMID 18341417
33. Stergioulas A, Stergioula M, Aarskog R, et al. Effects of low-level laser therapy and eccentric
exercises in the treatment of recreational athletes with chronic achilles tendinopathy. Am J
Sports Med. May 2008;36(5):881-887. PMID 18272794
34. Tumilty S, McDonough S, Hurley DA, et al. Clinical effectiveness of low-level laser therapy
as an adjunct to eccentric exercise for the treatment of Achilles' tendinopathy: a randomized
controlled trial. Arch Phys Med Rehabil. May 2012;93(5):733-739. PMID 22541305
35. Macias DM, Coughlin MJ, Zang K, et al. Low-Level Laser Therapy at 635 nm for Treatment
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Sep-Oct 2015;54(5):768-772. PMID 25769363
36. Kiritsi O, Tsitas K, Malliaropoulos N, et al. Ultrasonographic evaluation of plantar fasciitis
after low-level laser therapy: results of a double-blind, randomized, placebo-controlled trial.
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37. Chen J, Huang Z, Ge M, et al. Efficacy of low-level laser therapy in the treatment of TMDs:
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38. Chang WD, Lee CL, Lin HY, et al. A meta-analysis of clinical effects of low-level laser
therapy on temporomandibular joint pain. J Phys Ther Sci. Aug 2014;26(8):1297-1300.
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POLICY TITLE
LOW-LEVEL LASER THERAPY (FORMERLY TRANSCUTANEOUS
LASER THERAPY)
POLICY NUMBER
MP- 1.097
39. Petrucci A, Sgolastra F, Gatto R, et al. Effectiveness of low-level laser therapy in
temporomandibular disorders: a systematic review and meta-analysis. J Orofac Pain. Fall
2011;25(4):298-307. PMID 22247925
40. da Cunha LA, Firoozmand LM, da Silva AP, et al. Efficacy of low-level laser therapy in the
treatment of temporomandibular disorder. Int Dent J. Aug 2008;58(4):213-217. PMID
18783114
41. Emshoff R, Bosch R, Pumpel E, et al. 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. Apr 2008;105(4):452-456. PMID 18329580
42. Fikackova H, Dostalova T, Navratil L, et al. Effectiveness of low-level laser therapy in
temporomandibular joint disorders: a placebo-controlled study. Photomed Laser Surg. Aug
2007;25(4):297-303. PMID 17803388
43. Carrasco TG, Guerisoli LD, Guerisoli DM, et al. Evaluation of low intensity laser therapy in
myofascial pain syndrome. Cranio. Oct 2009;27(4):243-247. PMID 19891258
44. Venezian GC, da Silva MA, Mazzetto RG, et al. Low level laser effects on pain to palpation
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treating rheumatoid arthritis. Cochrane Database Syst Rev. 2005(4):CD002049. PMID
16235295
47. Meireles SM, Jones A, Jennings F, et al. Assessment of the effectiveness of low-level laser
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POLICY TITLE
LOW-LEVEL LASER THERAPY (FORMERLY TRANSCUTANEOUS
LASER THERAPY)
POLICY NUMBER
MP- 1.097
53. Omar MTA, Ebid AA, El Morsy AM. Treatment of post-mastectomy lymphedema with laser
therapy: double blind placebo control randomized study. J Surg Res. Jan 2011;165(1):82-90.
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carpal tunnel syndrome. 2008;
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2016.
X. POLICY HISTORY
MP-1.097
TOP
CAC 10/28/03
CAC 5/31/05
CAC 2/28/06
CAC 2/27/07
CAC 1/29/08
CAC 1/27/09
CAC 1/26/10 Consensus review.
CAC 4/26/11 Consensus review.
CAC 6/26/12 Consensus review. BCBSA Background/Description adopted for
low-level laser therapy. No change to policy statements, references updated.
7/26/13 Admin coding review complete
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MEDICAL POLICY
POLICY TITLE
LOW-LEVEL LASER THERAPY (FORMERLY TRANSCUTANEOUS
LASER THERAPY)
POLICY NUMBER
MP- 1.097
CAC 9/24/13 Consensus review. No change to policy statements. References
updated.
CAC 9/30/14 Consensus review. No change to policy statements. Rationale
added for low level laser therapy. References updated.
CAC 9/29/15 Consensus review. No change to the policy statements. Reference
and rationale update. Coding Review
CAC 5/31/16 Minor revision. BCBSA adopted for this review. Policy title
revised to “Low Level Laser Therapy”. Statement added that low-level laser
therapy may be considered medically necessary for prevention of oral mucositis
in selected patients. Additional bullet points to the investigational statement and
the statement was changed to investigational for “all other indications”. High
power Class IV therapeutic laser light lasers removed from policy. Background,
rationale, and references updated. FEP variation revised. Coding reviewed.
Top
.
Health care benefit programs issued or administered by Capital BlueCross and/or its subsidiaries, Capital Advantage
Insurance Company®, Capital Advantage Assurance Company® and Keystone Health Plan® Central. Independent
licensees of the BlueCross BlueShield Association. Communications issued by Capital BlueCross in its capacity as
administrator of programs and provider relations for all companies
Page 27