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Cold Laser and High-Power LaserTherapies
5/26/2021
Policy History
Last Review
05/21/2021
Effective: 11/09/1999
Next
Review: 03/24/2022
Review History
Definitions
Additional Information
Clinical Policy Bulletin
Notes
Number: 0363
Policy *Please see amendment for Pennsylvania Medicaid at the end of this CPB.
Aetna considers low-level laser therapy medically necessary
for prevention of oral mucositis in persons undergoing cancer
treatment associated with increased risk of oral mucositis,
including chemotherapy and/or radiotherapy, and/or
hematopoietic stem cell transplantation.
Aetna considers cold laser therapy (also known as low-level
laser therapy or class III laser), high-power laser therapy (class
IV therapeutic laser), low-level laser therapy using dynamic
photonic and dynamic thermokinetic energies experimental
and investigational for the following indications (not an all-
inclusive list) because there is inadequate evidence of the
effectiveness of cold laser therapy and high-power laser
therapy for these indications:
◾ Achilles tendinopathy
◾ Alzheimer's disease
◾ Bone regeneration/bone healing
◾ Breast implant capsular contracture
◾ Burning mouth syndrome
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◾ Cardio-protection following myocardial infarction
◾ Carpal tunnel syndrome
◾ Colorectal cancer
◾ Dementia
◾ Dental pain
◾ Dentin hypersensitivity
◾ Depression
◾ Elbow disorders
◾ Fibromyalgia
◾ Hair loss (including alopecia areata and androgenic
alopecia)
◾ Head and neck cancer
◾ Heart failure
◾ Herpes labialis
◾ Hypothyroidism induced by autoimmune thyroiditis
◾ Inferior alveolar nerve and lingual nerve injuries
◾ Keratosis pilaris
◾ Knee osteoarthritis
◾ Lymphedema
◾ Melasma
◾ Musculoskeletal dysfunction
◾ Myofascial pain syndrome
◾ Neurological dysfunctions
◾ Neuropathic orofacial pain (e.g., burning mouth
syndrome, occipital neuralgia, and trigeminal neuralgia)
◾ Obesity
◾ Oral lichen planus
◾ Oral ulcers in chronic graft-versus-host disease
◾ Pain relief (e.g. acute and chronic low back pain/neck
pain, orthodontic pain, neuropathic pain, shoulder pain)
◾ Parkinson's disease
◾ Patella-femoral pain syndrome
◾ Pemphigus vulgaris
◾ Peri-implant mucositis
◾ Peri-odontitis
◾ Physical therapy (including rehabilitation following
carpal tunnel release)
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◾ Recurrent aphthous stomatitis/ulcers
◾ Rheumatoid arthritis
◾ Shoulder impingement syndrome
◾ Skin burn
◾ Stroke
◾ Temporomandibular joint disorders
◾ Tendon repair
◾ Tinnitus
◾ Traumatic brain injury
◾ Wound healing (including diabetic ulcers, following
hammertoe surgery, gingival healing, and pressure
ulcers).
See also CPB 0604 - Infrared Therapy
(../600_699/0604.html).
Background
Low Level Laser Therapy
Low level laser therapy (LLLT), also known as "cold" laser
therapy, refers to a wide variety of procedures involving
several laser types and treatment methods. LLLT uses red
beam or near infrared nonthermal lasers with a wavelength
between 600 and 1000 nanometers and from five to 500
milliwatts. In contrast, lasers used for surgery typically use 300
watts. When applied, the lasers penetrate the surface of the
skin without a heating (burning) effect, produce no sensation
and do not damage the skin. It is believed that due to the low
skin absorption and no side effects, the laser light can
penetrate deeply into tissues and can reach the site of
damage or injury.
Low-energy lasers (also known as cold lasers or class III
lasers) have been promoted as an effective way to produce
analgesia and accelerate healing of a variety of clinical
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conditions. By definition, low energy laser therapy uses
irradiation intensities that induce minimal temperature
elevation (not more than 0.1 to 0.5°C), if any. For practical
purposes, this restricts treatment energies to a few J/cm2 and
laser powers to 500 mW or less.
Despite these constraints, a wide variety of types of lasers,
treatment schedules, and techniques have been used.
Consequently, apparently conflicting results from studies of
low-intensity lasers may not be in conflict, and may represent
fundamental, but poorly understood, differences in treatment
approaches.
LLLT may be administered by a physician, physical therapist,
occupational therapist or Doctor of Chiropractic (DC) in a
physician’s office or other outpatient setting and requires no
sedation or anesthesia. It is theorized that LLLT may cause a
biostimulatory healing effect for the treatment of a range of
conditions, including arthritis, chronic pain commonly
associated with carpal tunnel syndrome, tissue injuries (eg,
tendinopathy, tendonitis) and severe wounds.
Examples of LLLT devices include Acculaser Pro4,Axiom
BioLaser LLLT Series-3, Bioptron 2, Luminex LL Laser
System, MicroLight 830, RianCorp LTU-904, Thor DDII 830
CL3 Laser System, Thor DDII IR Lamp System and
TerraQuant. The TerraQuant device uses a combination of a
"super pulsed" laser, pulsed infrared, red light and static
magnetic field, which is purported to accelerate pain relief.
Although the results from large, uncontrolled, open trials of
low-energy lasers in inducing wound healing have shown
benefit, controlled trials have shown little or no benefit. The
analgesic effects of low-energy lasers have been most
intensely studied in rheumatoid arthritis. Recent well-
designed, controlled studies have found no benefit from low-
energy lasers in relieving pain in rheumatoid arthritis or other
musculoskeletal conditions. Furthermore, although positive
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effects were found in some earlier studies, it was not clear that
the pain relief achieved was large enough to have either
clinical significance or to replace conventional therapies.
Published systematic reviews of the evidence have concluded
that there is a lack of adequate evidence of effectiveness of
cold laser therapy for treatment of chronic wounds (e.g.,
Schneider and Hailey, 1999; Cullum and Petherick, 2007;
Flemming and Cullum, 1999; Samson et al, 2004; Simon et al,
2004; Wang, 2004; Nelson and Jones, 2006), arthritis
(Brosseau et al, 2007; Brosseau et al, 2005; Marks and de
Palma, 1999; Puett and Griffin, 1994; Wang, 2004),
tuberculosis (Vlassov et al, 2006; Ziganshina and Garner,
2005), tinnitus (Waddell, 2004), pain (Gross et al, 1998; van
der Heijden et al, 2002; Binder, 2002; Speed, 2006; Green et
al, 2003), smoking cessation (White et al, 2006), epicondylitis
(Chapell et al, 2002), Achilles tendinitis (McLauchlan et al,
2001), plantar heel pain (Crawford and Thomson, 2003;
Landorf and Menz, 2007), back pain (Yousefi-Nooraie et al,
2008), and other musculoskeletal disorders (de Bie et al, 1998;
Abdulwadud, 2001; Ohio BWC, 2004; Wang, 2004).
Systematic evidence reviews have also concluded that low-
energy laser therapy (e.g., Microlight 830, Microlight
Corporation of America, Missouri City, TX) is ineffective in
treating carpal tunnel syndrome (Gerritsen et al, 2002;
O'Connor et al, 2003; Ohio BWC, 2004; Wang, 2004; CTAF,
2006).
A recent study (Hirschl et al, 2004) evaluated the effectiveness
of low-level laser therapy in patients with primary Raynaud's
phenomenon (n = 48). Laser and sham therapy each were
applied 5 days a week for 3 weeks. The authors found that low-
level laser therapy reduced the frequency and severity of
Raynaud attacks. The findings of this study were interesting
but need to be validated by further investigation with more
patients and follow-up.
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Kreisler et al (2004) assessed the effect of low-level laser
application on post-operative pain after endodontic surgery in
a double-blind, randomized clinical study. A total of 52 healthy
adults undergoing endodontic surgery were included into the
study. After suturing, 26 patients had the operation site
treated with an 809 nm-GaAlAs-laser at a power output of 50
mW and an irradiation time of 150 seconds. Laser treatment
was simulated in another 26 patients. Patients were instructed
to evaluate their post-operative pain on 7 days following
surgery by means of a visual analogue scale. The results
revealed that the pain level in the laser-treated group was
lower than in the placebo group throughout the 7 day follow-up
period. The differences, however, were significant only on the
first post-operative day. The authors stated that low-level laser
therapy can be beneficial for the reduction of post-operative
pain. However, its clinical effectiveness and applicability with
regard to endodontic surgery need further investigation,
especially in terms of the optimal energy dosage and the
number of laser treatments needed after surgery.
In a randomized controlled study, Bingol et al (2005) examined
the effect of low-power gallium-arsenide laser treatment on the
patients with shoulder pain. A total of 40 patients with
shoulder pain and complied with the selection criteria were
included in the study. They were randomly assigned into 2
groups: (i) laser treatment (n = 20), and (ii) control (n = 20).
In group (i), patients were given laser treatment and an
exercise protocol for 10 sessions during a period of 2 weeks.
In group (ii), placebo laser and the same exercise protocol
was given for the same period. Patients were evaluated
according to the parameters of pain, palpation sensitivity,
algometric sensitivity, and shoulder joint range of motion
before and after treatment. Analysis of measurement results
within each group showed a significant post-treatment
improvement for some active and passive movements in both
groups, and also for algometric sensitivity in group (i) (p < 0.05
to 0.01). Post-treatment palpation sensitivity values showed
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improvement in 17 patients (85 %) for group (i) and 6 patients
(30 %) for group (ii). Comparison between 2 groups showed
superior results (p < 0.01 and p < 0.001) in group (i) for the
parameters of passive extension and palpation sensitivity but
no significant difference for other parameters. These
researchers concluded that this study have shown better
results in palpation sensitivity and passive extension, but no
significant improvement in pain, active range of motion, and
algometric sensitivity in laser treatment group compared to the
control group in the patients with shoulder pain.
Markovic and Todorovic (2007) compared the effectiveness of
dexamethasone and low-power laser (LPL) after surgical
removal of impacted lower third molars under local anesthesia
(2 % lidocaine / epinephrine). A total of 120 healthy patients
were divided into 4 groups of 30 each: (i) group 1 received
LPL irradiation immediately after operation (energy output
4 J/cm2 with constant power density of 50 mW, wavelength
637 nm); (ii) group 2 also received intra-muscular (i.m.)
injection of 4 mg dexamethasone (Dexason) into the
internal pterygoid muscle; (iii) group 3 received LPL
irradiation supplemented by systemic dexamethasone, 4
mg i.m. in the deltoid region, followed by 4 mg of
dexamethasone intra-orally 6 hours post-operatively; and
(iv) control group received only the usual post-operative
recommendations (i.e., cold packs, soft diet, etc.). Low-
power laser irradiation with local use of dexamethasone (group
2) resulted in a statistically significant reduction of post
operative edema in comparison to the other groups. No
adverse effects of the procedure or medication were
observed. The authors concluded that LPL irradiation after
lower third molar surgery can be recommended to minimize
swelling. The effect is enhanced by simultaneous local intra-
muscular use of dexamethasone. The drawbacks of this study
were 2-fold: (i) the effects of LPL, if any, was confounded by
the simultaneous use of dexamethasone, and (ii) while the
combination of LPL and dexamethasone achieved a
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statistical significant reduction in edema, its clinical benefit
is unclear.
Stergioulas (2007) compared the effectiveness of a protocol of
combination of laser with plyometric exercises and a protocol
of placebo laser with the same program, in the treatment of
tennis elbow. A total of 50 patients were randomized into 2
groups: (i) group A (n = 25) was treated with a 904 nm Ga-As
laser, frequency 50 Hz, intensity 40 mW and energy density
2.4 J/cm(2), plus plyometric exercises, and (ii) group B (n =
25) that received placebo laser plus the same plyometric
exercises. During 8 weeks of therapy, patients of the 2 groups
received 12 sessions of laser or placebo, 2 sessions per week
(weeks 1 to 4) and 1 session per week (weeks 5 to 8). Pain at
rest, at palpation on the lateral epicondyle, during resisted
wrist extension, middle finger test, and strength testing was
evaluated using visual analog scale (VAS). Also, the grip
strength, the range of motion (ROM) and weight test were
evaluated. Parameters were determined before treatment, at
the end of the 8th week course of treatment (week 8), and 8th
(week 8) after the end of treatment. Relative to group B, group
A had (i) a significant decrease of pain at rest at the end of 8
weeks of the treatment (p < 0.005) and at the end of
following up period (p < 0.05), (ii) a significant decrease in
pain at palpation and pain on isometric testing at 8 weeks
of treatment (p < 0.05), and at 8 weeks follow-up (p <
0.001), (iii) a significant decrease in pain during middle
finger test at the end of 8 weeks of treatment (p < 0.01),
and at the end of the follow-up period (p < 0.05), (iv) a
significant decrease of pain during grip strength testing at 8
weeks of treatment (p < 0.05), and at 8 weeks follow-up (p <
0.001), (v) a significant increase in the wrist ROM at 8 weeks
follow-up (p < 0.01), (vi) an increase in grip strength at 8
weeks of treatment (p < 0.05) and at 8 weeks follow-up (p <
0.01), and (vii) a significant increase in weight-test at 8
weeks of treatment (p < 0.05) and at 8 weeks follow-up (p <
0.005). The authors concluded that these findings suggested
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that the combination of laser with plyometric exercises was
more effective treatment than placebo laser with the same
plyometric exercises at the end of the treatment as well as at
the follow-up. Moreover, they stated that future studies are
needed to establish the relative and absolute effectiveness of
the above protocol.
Kaviani and colleagues (2006) examined the effects of low-
level laser therapy (LLLT) in the treatment of post-mastectomy
lymphedema. A total of 11 women with unilateral post-
mastectomy lymphedema were enrolled in a double-blind
controlled trial. Patients were randomly assigned to laser and
sham groups and received laser or placebo irradiation (Ga-As
laser device with a wavelength of 890 nm and fluence of 1.5
J/cm2) over the arm and axillary areas. Changes in patients'
limb circumference, pain score, ROM, heaviness of the
affected limb, and desire to continue the treatment were
measured before the treatment and at follow-up sessions
(weeks 3, 9, 12, 18, and 22) and were compared to pre-
treatment values. Results showed that of the 11 enrolled
patients, 8 completed the treatment sessions. Reduction in
limb circumference was detected in both groups, although it
was more pronounced in the laser group up to the end of 22nd
week. Desire to continue treatment at each session and
baseline score in the laser group was greater than in the sham
group in all sessions. Pain reduction in the laser group was
more than in the sham group except for the weeks 3 and 9.
No substantial differences were seen in other 2 parameters
between the 2 treatment groups. The authors concluded that
despite the encouraging results, further studies of the effects
of LLLT in management of post-mastectomy lymphedema
should be undertaken to determine the optimal physiological
and physical parameters to obtain the most effective clinical
response.
In a systematic review of common conservative therapies for
arm lymphoedema secondary to breast cancer treatment,
Moseley et al (2007) stated that secondary arm lymphoedema
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is a chronic and distressing condition which affects a
significant number of women who undergo breast cancer
treatment. A number of health professional and patient
instigated conservative therapies have been developed to help
with this condition, but their comparative benefits are not
clearly known. This systematic review undertook a broad
investigation of commonly instigated conservative therapies for
secondary arm lymphoedema including; complex physical
therapy, manual lymphatic drainage, pneumatic pumps, oral
pharmaceuticals, LLLT, compression bandaging and
garments, limb exercises and limb elevation. It was found that
the more intensive and health professional based therapies,
such as complex physical therapy, manual lymphatic drainage,
pneumatic pump and laser therapy generally yielded the
greater volume reductions, whilst self-instigated therapies
such as compression garment wear, exercises and limb
elevation yielded smaller reductions. All conservative
therapies produced improvements in subjective arm symptoms
and quality of life issues, where these were measured.
Despite the identified benefits, there is still the need for large
scale, high level clinical trials in this area.
Information on lymphedema from the BC Cancer Agency
(2007) notes that laser therapy "may or may not work but need
[s] further study."
Carrasco et al (2009) noted that limited studies have
demonstrated that LLLT may have a therapeutic effect on the
treatment of myofascial pain syndrome (MPS). In this study,
60 patients with MPS and having 1 active trigger point in the
anterior masseter and anterior temporal muscles were
selected and assigned randomly to 6 groups (n = 10 in each
group): Groups I to Ill were treated with GaAIAS (780 nm)
laser, applied in continuous mode and in a meticulous way,
twice-weekly, for 4 weeks. Energy was set to 25 J/cm2, 60
J/cm2 and 105 J/cm2, respectively. Groups IV to VI were
treated with placebo applications, simulating the same
parameters as the treated groups. Pain scores were assessed
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just before, then immediately after the 4th application,
immediately after the 8th application, at 15 days and 1 month
following treatment. A significant pain reduction was observed
over time (p < 0.001). The analgesic effect of the LLLT was
similar to the placebo groups. The authors stated that using
the parameters described in this experiment, LLLT was
effective in reducing pain experienced by patients with MPS.
Thus, it was not possible to establish a treatment protocol.
Yelden and colleagues (2009) examined the effectiveness
LLLT in addition to exercise program on shoulder function in
subacromial impingement syndrome (SAIS). A total of 67
patients with SAIS were randomly assigned to either a group
that received laser (n = 34) or a group that received placebo
laser (n = 26). Pain, functional assessment, disability and
muscle strength of shoulder were assessed before and after a
3-week rehabilitation program. Besides laser or placebo laser,
superficial cold and progressive exercise program were
administered to both groups, 5 days a week, for 3 weeks. A
progressive exercise program that was done twice-daily under
supervision in clinic and at home was given to the patients.
After the treatment, all outcome measurements had shown
significant improvement except muscle strength in both the
groups. When the parameters of the improvement were
compared, there were no significant differences between the 2
groups after treatment. The authors concluded that there is no
fundamental difference between LLLT and placebo LLLT when
they are supplementing an exercise program for rehabilitation
of patients with shoulder impingement syndrome.
In a prospective, randomized double-blind study, Teggi et al
(2009) examined the effectiveness of LLLT for tinnitus. A total
of 60 outpatients with tinnitus presenting sensorineural hearing
loss in the affected ear were included in the study. They were
randomly divided into 2 groups: (i) active laser therapy 20
mins a day for 3 months with a 650-nm, 5-mW soft laser
(group L), and (ii) control group with dummy device, which
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duplicated all aspects of active laser therapy except for the
activation of the laser beam. One subject in both groups
dropped out due to an increase in tinnitus loudness. Two
more patients in each group ceased to comply with the
protocol due to familiar problems. Main outcome measure was
the Tinnitus Handicap Inventory (THI); no statistical difference
was detected between the 2 groups in the THI total score (p =
0.97), and its functional (p = 0.89), emotional (p = 0.89) and
catastrophic (p = 0.89) subscales. Moreover, a VAS for self-
perceived loudness of the tinnitus showed no difference
between the groups (p = 0.69). Regarding psychoacoustic
parameters, the minimum masking level showed no difference
(p = 0.42), while loudness expressed in sensation level
exhibited lower values in the treatment group (p = 0.0127).
Subjects in the treatment group also reported a decreased
rate of hyper-acusis (p = 0.02). No changes were detected in
the audiometric threshold in both groups. The authors
concluded that soft laser therapy demonstrated no efficacy as
a therapeutic measure for tinnitus.
A systematic evidence review by Chow et al (2009) concluded
that lowLLLT reduced pain immediately after treatment in
acute neck pain, and up to 22 weeks after completion of
treatment, in patients with chronic neck pain. The authors
included randomized controlled trials (RCTs) or quasi-RCTs of
LLLT, for participants aged 16 or over with acute or chronic
neck pain, were eligible for inclusion. Sixteen RCTs (n = 820
participants) met inclusion criteria, with sample sizes ranging
from 20 to 90 participants. The authors reported significant
effects of LLLT on acute and chronic neck pain. An evaluation
of the systematic evidence review by Chow et al by the Centre
for Reviews and Dissemination (2009) found that, although
suitable methods were employed to reduce the risks of
reviewer error and bias for the processes of study selection
and data extraction, the authors did not report on whether
such methods were used to assess study quality, which was
assessed using the Jadad scale. The CRD also found that
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this did not assess methods of allocation concealment, so the
risk on investigator bias affecting trial results could not be
ruled out. Furthermore, no information was provided on the
actual levels of withdrawals and drop-outs. The CRD also
found that all trials included in this systematic review had
relatively small sample sizes and information was not provided
on whether treatment groups (in individual trials) were
comparable at baseline for likely confounders. The CRD
noted that the authors of the systematic review acknowledged
the considerable clinical heterogeneity in laser treatment
parameters, but this also seemed apparent with regard to the
sites treated, diagnoses, frequencies of treatment, and uses of
cointerventions; it is therefore questionable whether meta-
analysis was the most appropriate method of synthesis. The
CRD concluded: "Although many aspects of this review were
well-conducted, the considerable clinical heterogeneity seen,
coupled with uncertainty regarding possible bias in the small
trials included, mean the authors' conclusions should be
interpreted with a degree of caution."
In a a randomized, double-blind, placebo-controlled study, Ay
and colleagues (2010) compared the effectiveness of LLLT on
pain and functional capacity in patients with acute and chronic
low back pain caused by lumbar disk herniation (LDH). A total
of 40 patients with acute (26 females/14 males) and 40
patients with chronic (20 females/20 males) low back pain
caused by LDH were included in the study. Patients were
randomly allocated into 4 groups: (i) group 1 (acute LDH, n =
20) received hot-pack + laser therapy; (ii) group 2 (chronic
LDH, n = 20) received hot-pack + laser therapy; (iii) group 3
(acute LDH, n = 20) received hot-pack + placebo laser
therapy, and (iv) group 4 (chronic LDH, n = 20) received hot-
pack + placebo laser therapy, for 15 sessions during 3
weeks. Assessment parameters included pain, patients'
global assessment, physician's global assessment, and
functional capacity. Pain was evaluated by VAS. Patients'
and physician's global assessment were also measured with
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VAS. Modified Schober test and flexion and lateral flexion
measures were used in the evaluation of ROM of lumbar
spine. Roland Disability Questionnaire (RDQ) and Modified
Oswestry Disability Questionnaire (MODQ) were used in the
functional evaluation. Measurements were done before and
after 3 weeks of treatment. After the treatment, there were
statistically significant improvements in pain severity, patients'
and physician's global assessment, ROM, RDQ scores, and
MODQ scores in all groups (p < 0.05). However, no significant
differences were detected between 4 treatment groups with
respect to all outcome parameters (p > 0.05). 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 LDH.
In a randomized double-blind controlled trial, Meireles and
associates (2010) assessed the effectiveness of LLLT on pain
reduction and improvement in function in the hands of patients
with rheumatoid arthritis. A total of 82 patients with
rheumatoid arthritis were included in this study. The
experimental group was submitted to the application of laser
therapy, whereas the control group received a placebo laser.
Aluminum gallium arsenide laser was used, at a wavelength of
785 nm, dose of 3 J/cm(2) and mean power of 70 mW. The
groups were homogenous at the beginning of the study with
regard to the main variables (p > 0.05). There were no
statistically significant differences between groups in most of
the measurements taken at the end of the intervention
including the primary variables; the following variables were
the exceptions: favoring the experimental group --
inflammation of the inter-phalangeal joint of the right thumb (p
= 0.012) and perimetry of the inter-phalangeal joint of the left
thumb (p = 0.013); and favoring the control group -- flexion of
the proximal inter-phalangeal joint of the right fifth finger (p =
0.021), perimetry of the third proximal inter-phalangeal joint of
the right hand (p = 0.044), grip strength in the left hand (p =
0.010), and the work domain of the Disabilities of the Arm,
Shoulder and Hand (DASH) questionnaire (p = 0.010). The
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authors concluded that low-level aluminum gallium arsenide
laser therapy is not effective at the wavelength, dosage, and
power studied for the treatment of hands among patients with
rheumatoid arthritis.
The Blue Cross and Blue Shield Association Technology
Evaluation Center (2010) concluded that LLLT for either carpal
tunnel syndrome or for chronic neck pain does not meet the
Blue Cross and Blue Shield Association Technology
Evaluation Center (TEC) criteria. Furthermore, the Work Loss
Data Institute's clinical practice guideline on "Carpal tunnel
syndrome" (2011) does not recommend LLLT as a therapeutic
option.
Kadhim-Saleh et al (2013) e xamined the effectiveness of LLLT
in reducing acute and chronic neck pain as measured by the
VAS. A systematic search of 9 electronic databases was
conducted to identify original articles. For study selection, 2
reviewers independently assessed titles, abstracts, and full
text for eligibility. Methodological quality was assessed using
the Detsky scale. Data were analyzed using random-effects
model in the presence of heterogeneity and fixed-effect model
in its absence. Heterogeneity was assessed using Cochran's
Q statistic and quantifying I (2). Risk ratios (RR) with 95 %
confidence intervals (CI) were reported. Eight RCTs involving
443 patients met the strict inclusion criteria. Inter-rater
reliability for study selection was 92.8 % (95 % CI: 80.9 to 100
%) and for methodological quality assessment was 83.9 % (95
% CI: 19.4 to 96.8 %). Five trials included patients with
cervical myofascial pain syndrome (CMPS), and 3 trials
included different patient populations. A meta-analysis of 5
CMPS trials revealed a mean improvement of VAS score of
10.54 with LLLT (95 % CI: 0.37 to 20.71; heterogeneity I(2) =
65 %, p = 0.02). The authors concluded that this systematic
review provided inconclusive evidence because of significant
between-study heterogeneity and potential risk of bias. They
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stated that the benefit seen in the use of LLLT, although
statistically significant, does not constitute the threshold of
minimally important clinical difference.
van Middelkoop et al (2011) determined the effectiveness of
physical and rehabilitation interventions (i.e. exercise therapy,
back school, transcutaneous electrical nerve stimulation
(TENS), LLLT, education, massage, behavioral treatment,
traction, multi-disciplinary treatment, lumbar supports, and
heat/cold therapy) for chronic low back pain (LBP). The
primary search was conducted in MEDLINE, EMBASE,
CINAHL, CENTRAL, and PEDro up to 22 December 2008.
Existing Cochrane reviews for the individual interventions were
screened for studies fulfilling the inclusion criteria. The search
strategy outlined by the Cochrane Back Review Groups
(CBRG) was followed. The following were included for
selection criteria: (i) RCTs, (ii) adult (greater than or equal to
18 years) population with chronic (greater than or equal to
12 weeks) non-specific LBP, and (iii) evaluation of at least
one of the main clinically relevant outcome measures (pain,
functional status, perceived recovery, or return to work).
Two reviewers independently selected studies and extracted
data on study characteristics, risk of bias, and outcomes at
short, intermediate, and long-term follow-up. The GRADE
approach was used to determine the quality of evidence. In
total, 83 RCTs met the inclusion criteria: exercise therapy (n =
37), back school (n = 5), TENS (n = 6), LLLT (n = 3),
behavioral treatment (n = 21), patient education (n = 1),
traction (n = 1), and multi-disciplinary treatment (n = 6).
Compared to usual care, exercise therapy improved post-
treatment pain intensity and disability, and long-term function.
Behavioral treatment was found to be effective in reducing
pain intensity at short-term follow-up compared to no
treatment/waiting list controls. Finally, multi-disciplinary
treatment was found to reduce pain intensity and disability at
short-term follow-up compared to no treatment/waiting list
controls. Overall, the level of evidence was low. Evidence
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from RCTs demonstrated that there is low quality evidence for
the effectiveness of exercise therapy compared to usual care,
there is low evidence for the effectiveness of behavioral
therapy compared to no treatment and there is moderate
evidence for the effectiveness of a multi-disciplinary treatment
compared to no treatment and other active treatments at
reducing pain at short-term in the treatment of chronic LBP.
Based on the heterogeneity of the populations, interventions,
and comparison groups, the authors concluded that there are
insufficient data to draw firm conclusion on the clinical effect of
back schools, LLLT, patient education, massage, traction,
superficial heat/cold, and lumbar supports for chronic LBP.
Lake and Wofford (2011) examined the effectiveness of
therapeutic modalities for the treatment of patients with
patella-femoral pain syndrome (PFPS). Medline was searched
using the following databases: PubMed, CINAHL, Web of
Science Citation Index, Science Direct, ProQuest Nursing &
Allied Health, and Your Journals@OVID. Selected studies
were RCTs that used a therapeutic modality to treat patients
with PFPS. The review included articles with all outcome
measures relevant for the PFPS patient: knee extension and
flexion strength (isokinetic and isometric), patella-femoral pain
assessment during activities of daily life, functional tests (e.g.,
squats), Kujala patella-femoral score, and electromyographic
recording from knee flexors and extensors and quadriceps
femoris cross-sectional areas. Authors conducted
independent quality appraisals of studies using the PEDro
Scale and a system designed for analysis of studies on
interventions for patella-femoral pain. A total of 12 studies met
criteria: 1 on the effects of cold and ultrasound together, ice
alone, iontophoresis, and phonophoresis; 3, neuromuscular
electrical stimulation; 4, electromyographic biofeedback; 3,
electrical stimulation for control of pain; and 1, laser. Most
studies were of low to moderate quality. Some reported that
therapeutic modalities, when combined with other treatments,
may be of some benefit for pain management or other
symptoms. There was no consistent evidence of any
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beneficial effect when a therapeutic modality was used alone.
Studies did not consistently provide added benefit to
conventional physical therapy in the treatment of PFPS. The
authors concluded that none of the therapeutic modalities
reviewed has sound scientific justification for the treatment of
PFPS when used alone.
The American College of Occupational and Environmental
Medicine’s clinical guideline on “Elbow disorders” (ACOEM,
2012) listed low-level laser therapy as one of the
interventions/procedures that were considered, but are not
currently recommended.
In a meta-analysis, Sgolastra et al (2013) evaluated the
effectiveness of lasers in reducing dentin hypersensitivity (DH)
as compared with placebo or no treatment. Seven electronic
databases and a manual search resulted in 2,538 unique
publications. After selection, 13 studies were included in the
meta-analysis. A CONSORT-based quality assessment
revealed that 3 and 10 studies were at low- and high-risk of
bias, respectively. A random-effects model with the generic
inverse variance standardized mean difference (SMD) was
used because of expected heterogeneity. Meta-analyses of
the baseline-end of follow-up changes in pain revealed no
differences for Er,Cr:YSSG versus placebo (SMD = 2.49; 95 %
CI: -0.25 to 5.22; p = 0.07) but did reveal differences in favor of
lasers for Er:YAG versus placebo (SMD, 2.65; 95 % CI: 1.25 to
4.05; p = 0.0002), Nd:YAG versus placebo (SMD, 3.59; 95 %
CI: 0.49 to 6.69; p = 0.02), and GaAlAs versus placebo (SMD,
3.40; 95 % CI: 1.93 to 4.87; p < 0.00001). High and significant
heterogeneity was found for all comparisons. The authors
concluded that Er:YAG, Nd:YAG, and GaAlAs lasers appear to
be effective in reducing DH. However, given the high
heterogeneity of the included studies, future RCTs are needed
to confirm these results.
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In a Cochrane review, Peters et al (2013) reviewed the
effectiveness of rehabilitation following carpal tunnel syndrome
(CTS) surgery compared with no treatment, placebo, or
another intervention. On April 3, 2012, these investigators
searched the Cochrane Neuromuscular Disease Group
Specialized Register (April 3, 2012), CENTRAL (2012, Issue
3), MEDLINE (January 1966 to March 2012), EMBASE
(January 1980 to March 2012), CINAHL Plus (January 1937 to
March 2012), AMED (January 1985 to April 2012), LILACS
(January 1982 to March 2012), PsycINFO (January 1806 to
March 2012), PEDRO (January 29, 2013) and clinical trials
registers (January 29, 2013). Randomized or quasi-
randomized clinical trials that compared any post-operative
rehabilitation intervention with no intervention, placebo or
another post-operative rehabilitation intervention in individuals
who had undergone CTS surgery were selected for analysis.
Two reviewers independently selected trials for inclusion,
extracted data and assessed the risk of bias according to
standard Cochrane methodology. These researchers included
20 trials with a total of 1,445 participants. They studied
different rehabilitation treatments including immobilization
using a wrist orthosis, dressings, exercise, controlled cold
therapy, ice therapy, multi-modal hand rehabilitation, laser
therapy, electrical modalities, scar desensitization, and arnica.
Three trials compared a rehabilitation treatment to a placebo
comparison; 3 trials compared rehabilitation to a no treatment
control; 3 trials compared rehabilitation to standard care; and
14 trials compared various rehabilitation treatments to one
another. Overall, the included studies were very low in quality.
Eleven trials explicitly reported random sequence generation
and, of these, 3 adequately concealed the allocation
sequence. Four trials achieved blinding of both participants
and outcome assessors. Five studies were at high-risk of bias
from incompleteness of outcome data at one or more time
intervals. Eight trials had a high-risk of selective reporting
bias. The trials were heterogeneous in terms of the treatments
provided, the duration of interventions, the nature and timing of
outcomes measured and setting. Therefore, these
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researchers were not able to pool results across trials. Four
trials reported the authors’ primary outcome, change in self-
reported functional ability at 3 months or longer. Of these, 3
trials provided sufficient outcome data for inclusion in this
review. One small high quality trial studied a desensitization
program compared to standard treatment and revealed no
statistically significant functional benefit based on the Boston
Carpal Tunnel Questionnaire (BCTQ) (MD -0.03; 95 % CI:
-0.39 to 0.33). One moderate quality trial assessed
participants 6 months post-surgery using the Disabilities of the
Arm, Shoulder and Hand (DASH) questionnaire and found no
significant difference between a no formal therapy group and a
2-week course of multi-modal therapy commenced at 5 to 7
days post-surgery (MD 1.00; 95 % CI: -4.44 to 6.44). One very
low quality quasi-randomized trial found no statistically
significant difference in function on the BCTQ at 3 months
post-surgery with early immobilization (plaster wrist orthosis
worn until suture removal) compared with a splint and late
mobilization (MD 0.39; 95 % CI: -0.45 to 1.23). The
differences between the treatments for the secondary outcome
measures (change in self-reported functional ability measured
at less than 3 months; change in CTS symptoms; change in
CTS-related impairment measures; presence of iatrogenic
symptoms from surgery; return to work or occupation; and
change in neurophysiological parameters) were generally
small and not statistically significant. Few studies reported
adverse events. The authors concluded that there is limited
and, in general, low-quality evidence for the benefit of the
reviewed interventions. People who have had CTS surgery
should be informed about the limited evidence of the
effectiveness of post-operative rehabilitation interventions.
Until the results of more high-quality trials that evaluate the
safety and effectiveness of various rehabilitation treatments
have been reported, the decision to provide rehabilitation
following CTS surgery should be based on the clinician's
expertise, the patient's preferences and the context of the
rehabilitation environment. It is important for researchers to
identify patients who respond to a certain treatment and those
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who do not, and to undertake high-quality studies that evaluate
the severity of iatrogenic symptoms from the surgery, measure
function and return-to-work rates, and control for confounding
variables.
He and co-workers (2013) examined the effectiveness of LLLT
in the management of orthodontic pain. This systematic
review and meta-analysis was carried out in accordance with
Cochrane Handbook and the Preferred Reporting Items for
Systematic Reviews and Meta-Analyses (PRISMA) statement.
An extensive literature search for RCTs, quasi-RCTs, and
controlled clinical trials (CCTs) was performed through
CENTRAL, PubMed, Embase, Medline, CNKI, and CBM up to
October 2011. Risk of bias assessment was performed via
referring to the Cochrane tool for risk of bias assessment.
Meta-analysis was implemented using Review Manager 5.1.
As a result, 4 RCTs, 2 quasi-RCTs, and 2 CCTs were
selected from 152 relevant studies, including 641 patients from
6 countries. The meta-analysis demonstrated that 24 % risk of
incidence of pain was reduced by LLLT (RR = 0.76, 95 % CI:
0.63 to 0.92, p = 0.006). In addition, compared to the control
group, LLLT brought forward "the most painful day" (MD =
-0.42, 95 % CI: -0.74 to -0.10, p = 0.009). Furthermore, the
LLLT group also implied a trend of earlier end of pain
compared with the control group (MD = -1.37, 95 % CI: -3.37 to
0.64, p = 0.18) and the pseudo-laser group (MD = -1.04, 95 %
CI: -4.22 to 2.15, p = 0.52). However, the authors concluded
that because of the methodological shortcomings and risk of
bias of included trials, LLLT was proved with limited evidence
in delaying pain onset and reducing pain intensity. Moreover,
they stated that in the future, larger and better-designed RCTs
are needed to provide clearer recommendations.
Thornton et al (2013) stated that shoulder pain is a common
musculo-skeletal condition that affects up to 25 % of the
general population. Shoulder pain can be caused by any
number of underlying conditions including subacromial
impingement syndrome, rotator-cuff tendinitis, and biceps
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tendinitis. Regardless of the specific pathology, pain is
generally the number 1 symptom associated with shoulder
injuries and can severely affect daily activities and quality of
life of patients with these conditions. Two of the primary goals
in the treatment of these conditions are reducing pain and
increasing shoulder ROM. Conservative treatment has
traditionally included a therapeutic exercise program targeted
at increasing ROM, strengthening the muscles around the
joint, proprioceptive training, or some combination of those
activities. In addition, these exercise programs have been
supplemented with other interventions including non-steroidal
anti-inflammatory drugs, corticosteroid injections, manual
therapy, activity modification, and a wide array of therapeutic
modalities (e.g., cryotherapy, EMS, ultrasound). Recently,
LLLT has been used as an additional modality in the
conservative management of patients with shoulder pain.
However, the authors noted that true effectiveness of LLLT in
decreasing pain and increasing function in patients with
shoulder pain is unclear.
Amid et al (2014) reviewed the data published in the field of
the effects of LLLT on proliferation and differentiation of the
cells contributing in bone regeneration. These researchers
performed an electronic search in PubMed from 2001 to April
2014. English language published papers on LLLT were found
using the selected keyword. The full texts of potentially
suitable articles were obtained for final assessment according
to the exclusion and inclusion criteria. A total of 240 articles
were found from 2001 to April 2014. Following the initial
screening of titles and abstracts as well as the final screening
of full texts, 22 articles completely fulfilled the inclusion criteria
of this study. Wavelength used in LLLT irradiation varied
between 600 to 1,000 nm with an energy density of 0.04 to
60J/cm(2). Although almost all studies agreed on getting
positive effects from LLLT, some had opposing results. The
authors concluded that low level laser with low-energy density
range appears to exert a bio-stimulatory effect on bone tissue,
enhance osteoblastic proliferation as well as differentiation on
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cell lines used in in-vitro studies. They stated that despite the
fact that many researches have been recently done on the
effects of LLLT on different cell lines, without knowing the
precise mechanism and effects, they were not able to offer a
clinical treatment protocol.
Doeuk et al (2015) noted that LLLT is currently being used for
various disorders, but with no convincing scientific evidence.
Most recently these investigators have noticed an increase in
published RCTs that have focused on its applications in wound
healing, scarring, disorders of the temporomandibular joint
(TMJ), oral mucositis, and dental pain. These researchers
evaluated the scientific evidence about its effectiveness in
maxillofacial surgery. They reviewed PubMed from January
2003 to January 2013 using the key phrase "low level laser
treatment". The inclusion criterion was intervention studies in
humans of more than 10 patients. The authors excluded
animal studies and papers in languages other than English,
French, and German. These researchers found 45 papers
that they screened independently. The resulting full texts were
scrutinized by 2 authors who awarded a maximum of 5 points
using the Jadad scale for assessing the quality of RCT, and
extracted the data according to sample size, variables of LLLT,
the authors' conclusions, and the significance of the result.
The authors concluded that LLLT seems to be effective for the
treatment of oral mucositis after treatment for head and neck
cancer. However, it cannot yet be considered a valid
treatment for disorders of the TMJ; and it seems to improve
gingival healing, and myofascial and dental pain.
Huang et al (2015) examined the effectiveness of LLLT of
knee osteoarthritis (KOA) by a systematic literature search
with meta-analyses on selected studies. MEDLINE, EMBASE,
ISI Web of Science and Cochrane Library were systematically
searched from January 2000 to November 2014. Included
studies were RCTs written in English that compared LLLT (at
least 8treatment sessions) with sham laser in KOA patients.
The efficacy effective size was estimated by the SMD.
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Standard fixed or random-effects meta-analysis was used,
and inconsistency was evaluated by the I-squared index (I(2)).
Of 612 studies, 9 RCTs (7 double-blind, 2 single-blind, totaling
518 patients) met the criteria for inclusion. Based on 7
studies, the SMD in VAS pain score right after therapy (RAT)
(within 2 weeks after the therapy) was not significantly different
between LLLT and control (SMD = -0.28 [95 % CI: -0.66 to
0.10], I(2) = 66 %). No significant difference was identified in
studies conforming to the World Association of Laser Therapy
(WALT) recommendations (4 studies) or on the basis of OA
severity. There was no significant difference in the delayed
response (12 weeks after end of therapy) between LLLT and
control in VAS pain (5 studies). Similarly, there was no
evidence of LLLT effectiveness based on Western Ontario and
McMaster Universities Arthritis Index (WOMAC) pain, stiffness
or function outcomes (5 and 3 studies had outcome data right
after and 12 weeks after therapy respectively). The authors
concluded that the findings of this study indicated that the best
available current evidence does not support the effectiveness
of LLLT as a therapy for patients with KOA.
Aphthous Stomatitis / Ulcers
Pavlic et al (2015) stated that recurrent aphthous stomatitis
(RAS) is defined as multi-factor immunologic inflammatory
lesions in the oral cavity, characterized by painful, recurrent
single/multiple, shallow, round or ovoid ulcerations of mucosal
tissues. To-date, a considerable number of RAS treatment
protocols have been suggested, but since the etiology of RAS
is idiopathic, these therapeutic options have symptomatic
rather than curative or preventive effect. Recently, it has been
suggested that laser therapy could be successfully used as an
efficient treatment approach in therapy of RAS. These
investigators estimated the effects of laser therapy in treatment
of RAS analyzing results of clinical studies published in peer-
reviewed journals. The studies published until December 31,
2013 were obtained from the Medline/PubMed, Science Direct
and Cochrane Library of the Cochrane Collaboration
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(CENTRAL) online databases, using following search terms
and key words: "laser" and "recurrent aphthous stomatitis",
"laser" and "aphthous", and "laser" and "aphthae". A total of 4
original research articles met the all required
inclusion/exclusion criteria, and were used for this review. The
main outcome measures assessed were: a reduction of pain
associated with RAS and a reduction in episode duration
(faster RAS healing). The assessed literature demonstrated
the benefits of laser therapy mainly due to immediate
analgesia and ability to speed up a RAS healing process. The
authors concluded that although the assessed literature
suggested beneficial outcomes of laser therapy in treatment of
RAS, these results should be interpreted with caution. They
stated that the issues related to the study designs and different
sets of laser irradiation parameters of a limited number of
available studies with the same treatment outcomes prevented
them from making definite conclusions.
Vale et al (2015) noted that recurrent aphthous ulcers (RAUs)
are the most common lesion found in the oral cavity. There is
no definitive cure for RAUs and current treatments are aimed
at minimizing symptoms. Since LLLT modulates inflammatory
responses, and promotes pain reduction and cellular bio-
stimulation, LLLT can be suggested as an alternative
treatment for RAUs. The literature concerning the potential of
LLLT in the treatment of RAUs was evaluated. A systematic
literature review identified 22 publications, of which only 2
studies were adopted. The eligibility criteria consisted of
RCTs. Both RCTs achieved significant results concerning
LLLT and pain-level reductions and reduced healing times.
Despite the variance in irradiation conditions applied in both
studies, very similar wavelengths were adopted. There is
accordingly strong evidence that wavelength plays an
important role in RAU treatment. Taking into account the
different parameters applied by selected RCTs, it is not
possible to suggest that a specific protocol should be used.
However, in light of the significant results found in both
studies, LLLT can be suggested as an alternative for RAU
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treatment. The authors concluded that additional RCTs should
be performed in order to reach a clinical protocol and better
understand the application of LLLT in RAU treatment.
In a systematic review, Ahmed and colleagues (2020)
compared LLLT with topical medications for the treatment of
aphthous ulcers. These investigators carried out a search of
articles in 6 databases. Treatment and comparative groups
comprised of patients subjected to laser therapy and topical
medications, respectively. Two different treatment outcomes
were considered; pain and size of the lesion. Risk of bias was
examined using the Revised Cochrane risk-of-bias tool for
randomized trials. From 109 articles, 5 RCTs fulfilled the
selection criteria. The overall sample comprised of 98 men
and 232 women, with a mean age of 32.4 years. The laser
therapies in each included study had different active media
and varying wavelengths. Topical medication used in the
comparative group were triamcinolone acetonide, amlexanox,
granofurin, and solcoseryl. Findings showed that patients who
reported lower pain and decreased aphthous ulcer lesions
were more in the laser therapy group than in the topical
medication group. The authors concluded that LLLT was
better in treating aphthous ulcer lesions in comparison to
topical medications; and all laser wavelengths in the included
reports were found to be effective. However, the results
should be interpreted with caution, because none of the
included studies demonstrated a low-risk of bias in all the
assessed domains.
The authors stated that the risk of bias assessment judgment
inferred that most of the studies did not describe how the
randomization process was performed. Furthermore, 4 out of
5 studies did not have a blinded investigator to evaluate the
outcome. Cochrane guidelines state that each step in the
methodology should be clearly explained to achieve a low-risk
score in the 5 domains of assessment; thus, further evidence
using robust methodologies is needed to validate the
effectiveness of laser therapy over other treatment
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approaches. In addition, RCTs should consider reporting the
potential side-effects that are experienced by the patients
while undergoing laser therapies and/or treatment by
medication. Finally, it is highly recommended that a general
clinical protocol be derived for the use of laser therapy in
treating aphthous ulcer lesions.
Bone Regeneration / Bone Healing
Atasoy and colleagues (2017) evaluated the effectiveness of
low-level 940 nm laser therapy with energy intensities of 5, 10
and 20 J/cm2 on bone healing in an animal model. A total of
48 female adult Wistar rats underwent surgery to create bone
defects in the right tibias. Low-level laser therapy was applied
immediately after surgery and on post-operative days 2, 4, 6,
8, 10 and 12 in 3 study groups with energy intensities of 5
J/cm2, 10 J/cm2 and 20 J/cm2 using a 940 nm Gallium-
Aluminum-Arsenide (Ga-Al-As) laser, while 1 control group
underwent only the tibia defect surgery. All animals were
sacrificed 4 or 8 weeks post-surgery. Fibroblasts, osteoblasts,
osteocytes, osteoclasts and newly formed vessels were
evaluated by a histological examination. No significant change
was observed in the number of osteocytes, osteoblasts,
osteoclasts and newly formed vessels at either time period
across all laser groups. Although LLLT with the 10 J/cm2
energy density increased fibroblast activity at the 4th week in
comparison with the 5 and 20 J/cm2 groups, no significant
change was observed between the laser groups and the
control group. The authors concluded that these findings
showed that low-level 940 nm laser with different energy
intensities may not have marked effects on the bone healing
process in both phases of bone formation.
In a systematic review, Skondra and colleagues (2018)
evaluated the evidence on the effects of LLLT on bone healing
following rapid maxillary expansion (RME). Electronic search
was performed in Medline, Scopus, and Embase databases
using appropriate Medical Subject Heading terms, with no time
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restriction. ClinicalTrials.gov ( www.clinicaltrials.gov ) was also
searched using the terms "low level laser therapy" and
"maxillary expansion". Original research articles on human
clinical trials that involved both RME and LLLT were included.
Animal studies were also assessed on an exploratory basis.
The search strategy resulted in 12 publications (4 RCTs, 8
animal studies). In human studies, bone density was
assessed radiographically (either 2-Dl or 3-D imaging).
Regardless of the discrepancies in the intervention protocols,
the total of the trials revealed that LLLT had stimulatory effects
on bone regeneration following RME. The studies in animal
models measured the formation and maturation of new bone
qualitatively or quantitatively. The authors concluded that
despite the limited evidence, LLLT appeared to be a promising
intervention for stimulating immediate bone regeneration and
healing following mid-palatal suture expansion. Moreover,
these researchers stated that long-term, RCTs are needed to
formulate safe results and establish a reliable clinical protocol,
rendering the method clinically applicable.
Carpal Tunnel Syndrome
Li and colleagues (2016) evaluated the effectiveness of LLLT
in the treatment of mild-to-moderate CTS using a Cochrane
systematic review. The authors concluded that the findings of
this study revealed that LLLT improved hand grip, VAS, and
SNAP after 3 months of follow-up for mild-to-moderate CTS.
However, they stated that more high-quality studies using the
same laser intervention protocol are needed to confirm the
effects of LLLT in the treatment of CTS.
Bekhet and associates (2017) performed a meta-analysis to
investigate the efficacy of LLLT in the management of mild-to-
moderate CTS. These investigators searched PubMed, Web
of Knowledge, Scopus, Cochrane Central, and Virtual Health
Library for RCTs that compared the effects of LLLT with or
without splinting versus placebo on functional and
electromyographic (EMG) outcomes in CTS. All outcomes
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were pooled as mean differences (MD) under the inverse
variance or random effects model, using the statistical add-in
(MetaXL, version 5.0). A total of 8 RCTs (473 patients/631
wrists) were eligible for the final analysis. The overall effect
estimates did not favor LLLT therapy group over placebo in all
primary outcomes: VAS (MD -1.11, 95 % CI: -2.58 to 0.35),
symptom severity scale score (MD -1.41, 95 % CI: -5.12 to
2.29), and functional status scale score (MD -1.33, 95 % CI:
-3.27 to 0.61). However, LLLT was superior to placebo in
terms of grip strength (MD 2.19, 95 % CI: 1.63 to 2.76) and
inferior to placebo in terms of sensory nerve action potential
(MD -2.74, 95 % CI: -3.66 to -1.82]). The authors concluded
that laser therapy was superior to placebo in terms of
improving the grip strength; however, no significant difference
was found between both groups in terms of functional status
improvement, pain reduction, or motor electro-diagnostic
evaluations. They stated that further high-quality trials with
longer follow-up periods are needed to establish the efficacy of
LLLT for CTS treatment.
Temporomandibular Joint Disorders
Shukla and Muthusekhar (2016) evaluated the effectiveness of
LLLT in patients with temporomandibular disorders (TMDs).
Medline search was done from 1997 to 2011 using search
terms appropriate to establishing a relation between LLLT and
TMD. Only RCTs were included in this study. Outcome
variables related to pain, muscle tenderness, mandibular
movements, and EMG activity were considered. Of the 242
articles examined, 13 were finally included in the critical
analysis conducted as a part of the present systematic review;
7 articles showed significant improvement in the study group,
whereas 5 showed no significant improvement between the
study and control groups. The primary outcome of most of the
studies was pain. Other variables considered were muscle
tenderness, mandibular movements; EMG activity was
considered. The authors concluded that LLLT appeared to be
effective in reduction of pain in TMDs. The hypothesis that
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LLLT acts through a dose-specific anti-inflammatory effect in
the irradiated joint capsule is a possible explanation of the
positive results. However, due to the limitations of this review,
findings must be interpreted with caution. Moreover, they
stated that there is a need for more well-conducted RCTs
examining LLLT as interventions for TMDs. These studies
need to be clear in the reporting of allocation, blinding,
sequence generation, withdrawals, intention-to-treat analysis,
and any other potential source of bias in the study. In addition,
there should be use of well-validated standardized outcomes
so that the RCTs could be compared with other similar trials.
The sample size of the RCTs should also be calculated
beforehand so that the study has adequate statistical power.
Magri and colleagues (2017) noted that women with TMD
frequently report pain areas in body regions. This process is
associated with central sensitization phenomena, present in
chronic pain; LLLT has been reported as a therapeutic option
for the painful TMD treatment. These investigators analyzed
the effect of LLLT on pain intensity (VAS), pain sensitivity in
orofacial and corporal points (pressure pain threshold, PPT),
and on Short Form-McGill Pain Questionnaire (SF-MPQ)
indexes of women with myofascial pain (subtype of muscle
TMD). A total of 91 women (18 to 60 years) were included in
the study, among which 61 were diagnosed with myofascial
pain (Research Diagnostic Criteria for Temporomandibular
Disorder-Ia and Ib) and were divided into laser (n = 31) and
placebo group (n = 30), and 30 were controls; LLLT was
applied at pre-established points, twice-weekly, 8 sessions
(780 nm; masseter and anterior temporal = 5 J/cm2, 20 mW,
10 s; TMJ area = 7.5 J/cm2, 30 mW, 10 s). Pain intensity, pain
sensitivity, and the SF-MPQ indexes were measured at the
baseline, during laser sessions, and 30 days after treatment.
For intra-group comparisons, the Friedman test was
performed, and for inter-group, the Mann-Whitney test.
Increased pain sensitivity was found in women with
myofascial pain when compared to controls (p < 0.05). There
was a reduction in pain intensity for both groups after LLLT.
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However, LLLT did not change the PPT for any group (p >
0.05). Active laser and placebo reduced the indexes of
sensory, total pain, and VAS, maintaining the results after 30
days; there was a reduction in the affective pain rating index
for both groups, with no maintenance after 30 days for
placebo, and the present pain intensity decreased in the laser
group and did not change in the placebo after LLLT. The
authors concluded that LLLT active or placebo were effective
in reducing the overall subjective perception of myofascial pain
(VAS and SF-MPQ indexes); however, they had no
effectiveness in reducing the pain sensitivity in orofacial and
corporal points (PPT increase).
Neuropathic Orofacial Pain (e.g., Burning Mouth Syndrome, Occipital Neuralgia, and Trigeminal Neuralgia)
Arbabi-Kalati and colleagues (2015) evaluated the
effectiveness of LLLT in improving the symptoms of burning
mouth syndrome (BMS). A total of20 patients with BMS were
enrolled in this study; they were divided in 2 groups randomly.
In the laser group, in each patient, 10 areas on the oral
mucosa were selected and underwent LLL irradiation at a
wavelength of 630 nm, and a power of 30 mW for 10 seconds
twice-weekly for 4 weeks. I n the placebo group, silent/off laser
therapy was carried out during the same period in the same
areas. Burning sensation and quality of life were evaluated.
Burning sensation severity and quality of life in the 2 groups
after intervention were different significant (p = 0.004, p = 0.01,
respectively). Patients in laser group had better results. The
authors concluded that LLLT might decrease the intensity of
BMS. However, the present study had some limitations,
including the small sample size and long duration of the
application of LLL, which decreases the cooperation of
patients. These researchers stated that further research is
needed to validate our findings.
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Al-Maweri and colleagues (2017) stated that BMS is a chronic
pain condition with indefinite cure, predominantly affecting
post-menopausal women. These researchers reviewed the
effectiveness of LLLT in the treatment of BMS. PubMed,
Embase and Scopus were searched from date of inception till
and including October 2016 using various combinations of the
following keywords: burning mouth syndrome, BMS,
stomatodynia, laser therapy, laser treatment and
phototherapy. The inclusion criteria were: prospective,
retrospective and case series studies. Letter to editors,
reviews, experimental studies, studies that were not published
in English, theses, monographs, and abstracts presented in
scientific events were excluded. Due to heterogeneity of data
no statistical analyses were performed. A total of 10 clinical
studies fulfilled the eligibility criteria, 5 of which were
randomized clinical trials. In these studies, the laser
wavelengths, power output and duration of irradiation ranged
between 630 to 980 nm, 20 to 300 mW, 10 seconds to
15minutes, respectively. Most of studies reported laser to be
an effective therapy strategy for management of BMS. The
authors concluded that the majority of the studies showed that
laser therapy seemed to be effective in reducing pain in BMS
patients. However, they stated that due to the varied
methodologies and substantial variations in laser parameters
among these studies, more clinical trials are needed to
determine the effectiveness of laser for treating BMS.
In a systematic review, de Pedro and colleagues (2020)
examined the efficacy of LLLT for the management of
neuropathic orofacial pain. This systematic review was
conducted according to PRISMA guidelines. A comprehensive
search of the literature was conducted in the PubMed/Medline,
Scopus, and Cochrane Library databases up to March 8,
2018, using terms such as low-level laser therapy, neuropathic
pain, orofacial pain, neuralgia, neuropathy, and all the entities
described in section 13 of the International Classification of
Headache Disorders, 3rd edition. The primary outcome was
measurement of pain intensity. A total of 997 studies were
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obtained with the initial search; 13 (8 RCTs, 2 prospective
studies, and 3 case series) met the inclusion criteria and were
analyzed for data extraction; 3 provided data for the treatment
of trigeminal neuralgia (TN), 1 for occipital neuralgia, and 10
for BMS. All studies showed a reduction in pain intensity
(most of them significant). The different studies analyzed
LLLT alone and compared to placebo, to another treatment, or
to different LLLT application protocols. The authors concluded
that LLLT appeared to be effective as a therapeutic option for
different neuropathic orofacial pain entities such as TN,
occipital neuralgia, and BMS as a single or combined
treatment. Moreover, these researchers stated that more
quality studies assessing all outcome measures of chronic
pain are needed in the medium- and long-terms. Furthermore,
due to the lack of standardization of the application technique,
more well-designed studies are needed to confirm the results
of this systematic review.
Cardio-Protection Following Myocardial Infarction / Heart Failure
Carlos and colleagues (2016) systematically reviewed the role
of LLLT in cardiac remodeling after myocardial infarction (MI).
Literatures were systematically searched in several electronic
databases. These researchers included only studies with a
well-standardized coronary occlusion model in-vivo LLLT
application. After screening, a total of 14 studies were eligible
for review. The study heterogeneity was described in terms of
rationality, gender, irradiation parameters, treatment numbers
and moment of LLLT application; 3 studies showed a null role
of LLLT on infarct size, and only 1 study found positive LLLT
effects on the cardiac performance. The cardio-protective role
of LLLT was mediated by anti-inflammatory, pro-angiogenic
and anti-oxidant actions. The authors concluded that the
reduction in infarct size was a major finding. The stated that
LLLT cardio-protection may be mediated by several molecular
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and cellular mechanisms; although these results are exciting,
there are many limitations that must be resolved before LLLT
clinical trials.
Manchini and associates (2017) noted that LLLT has been
targeted as a promising approach that can mitigate post-
infarction cardiac remodeling. There is some interesting
evidence showing that the beneficial role of the LLLT could
persist long-term even after the end of the application, but it
remains to be systematically evaluated. These researchers
tested the hypothesis that LLLT beneficial effects in the early
post-infarction cardiac remodeling could remain in overt heart
failure (HF) even with the disruption of irradiations. Female
Wistar rats were subjected to the coronary occlusion to induce
MI or sham operation. A single LLLT application was carried
out after 60 seconds and 3 days post-coronary occlusion,
respectively. Echocardiography was performed 3 days and at
the end of the experiment (5 weeks) to evaluate cardiac
function. After the last echocardiographic examination, LV
hemodynamic evaluation was performed at baseline and on
sudden afterload increases. Compared with the sham group,
infarcted rats showed increased systolic and diastolic internal
diameter as well as a depressed shortening fraction of LV.
The only benefit of the LLLT was a higher shortening fraction
after 3 days of infarction. However, treated-LLLT rats showed
a lower shortening fraction in the 5th week of study when
compared with sham and non-irradiated rats. A worsening of
cardiac function was confirmed in the hemodynamic analysis
as evidenced by the higher left ventricular end-diastolic
pressure and lower +dP/dt and -dP/dt with 5 weeks of study.
Cardiac functional reserve was also impaired by infarction as
evidenced by an attenuated response of stroke work index and
cardiac output to a sudden afterload stress, without LLLT
repercussions. No significant differences were found in the
myocardial expression of Akt1/VEGF pathway. The authors
concluded that these findings showed that LLLT improved LV
systolic function in the early post-infarction cardiac remodeling;
however, this beneficial effect may be dependent on the
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maintenance of phototherapy. They stated that long-term
studies with LLLT application are needed to establish whether
these effects ultimately translate into improved cardiac
remodeling.
Hair Loss
Zarei and colleagues (2016) noted that despite the current
treatment options for different types of alopecia, there is a
need for more effective management options. Recently, LLLT
was evaluated for stimulating hair growth. These investigators
reviewed the current evidence on the LLLT effects with an
evidence-based approach, focusing more on RCTs by critically
evaluating them. In order to examine if in individuals
presenting with hair loss (male pattern hair loss (MPHL),
female pattern hair loss (FPHL), alopecia areata (AA), and
chemotherapy-induced alopecia (CIA)) LLLT is effective for
hair re-growth, several databases including PubMed, Google
Scholar, Medline, Embase, and Cochrane Database were
searched using the following keywords: alopecia, hair loss,
Hair growth, low level laser therapy, low level light therapy, low
energy laser irradiation, and photobiomodulation (PBM). From
the searches, 21 relevant studies were summarized in this
review including 2 in-vitro, 7 animal, and 12 clinical studies.
Among clinical studies, only 5 were RCTs, which evaluated
LLLT effect on male and female pattern hair loss. The RCTs
were critically appraised using the created checklist according
to the Critical Appraisal for Therapy Articles Worksheet
created by the Center of Evidence-Based Medicine, Oxford.
The results demonstrated that all the performed RCTs have
moderate to high quality of evidence. However, only 1 out of 5
studies performed intention-to-treat analysis, and only another
study reported the method of randomization and subsequent
concealment of allocation clearly; all other studies did not
include this very important information in their reports. None of
these studies reported the treatment effect of factors such as
number needed to treat. Based on this review on all the
available evidence about effect of LLLT in alopecia, these
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researchers found that the FDA-cleared LLLT devices are both
safe and effective in patients with MPHL and FPHL who did
not respond or were not tolerant to standard treatments. The
authors concluded that future RCTs of LLLT are strongly
encouraged to be conducted and reported according to the
Consolidated Standards of Reporting Trials (CONSORT)
statement to facilitate analysis and comparison.
In a Cochrane review, van Zuuren and associates (2016)
evaluated the safety and effectiveness of the available options
for the treatment of female pattern hair loss in women. These
investigators updated their searches of the following
databases to July 2015: the Cochrane Skin Group Specialized
Register, CENTRAL in the Cochrane Library (2015, Issue 6),
Medline(from 1946), Embase (from 1974), PsycINFO (from
1872), AMED (from 1985), LILACS (from 1982), PubMed (from
1947), and Web of Science (from 1945). They also searched
5 trial registries and checked the reference lists of included
and excluded studies. They included RCTs that assessed the
effectiveness of interventions for FPHL in women; 2 review
authors independently assessed trial quality, extracted data
and carried out analyses. The authors concluded that
although there was a predominance of included studies at
unclear to high risk of bias, there was evidence to support the
safety and effectiveness of topical minoxidil in the treatment of
FPHL (mainly moderate-to-low quality evidence).
Furthermore, there was no difference in effect between the
minoxidil 2 % and 5 % with the quality of evidence rated
moderate-to-low for most outcomes. Finasteride was no more
effective than placebo (low quality evidence). They stated that
there were inconsistent results in the studies that evaluated
laser devices (moderate-to-low quality evidence), but there
was an improvement in total hair count measured from
baseline. These investigators stated that further RCTs of other
widely-used treatments, such as spironolactone, finasteride
(different dosages), dutasteride, cyproterone acetate, and laser-
based therapy are needed.
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Gupta and Foley (2017) consolidated evidence and
established which data are still required for the widespread
acceptance of LLLT for hair loss therapy. A thorough search
of the PubMed database was conducted to obtain studies
investigating LLLT for andro-genetic alopecia (AGA) in men
and women. A total of 9 trials were identified for comb and
helmet/cap devices, 5 of which were RCTs. Data comparison
across LLLT trials and with traditional hair loss therapy
(minoxidil, finasteride) was not straight forward because there
was a lack of visual evidence, sample sizes were low, and
there were large variations in study duration and effectiveness
measurements. The authors concluded that there are a
number of unanswered questions about the optimum
treatment regimen, including maintenance treatment and the
long-term consequences of LLLT use. They stated that
moving forward, protocols should be standardized across
trials; and it is recommended that future trials include visual
evidence and trial duration be expanded to 12 months.
Afifi and co-workers (2017) reviewed the existing research
studies to examine if LLLT is an effective therapy for AGA
based on objective measurements and patient satisfaction.
These researchers performed a systematic literature review to
identify articles on Medline, Google Scholar, and Embase that
were published between January 1960 and November 2015.
All search hits were screened by 2 reviewers and examined for
relevant abstracts and titles. Articles were divided based on
study design and assessed for risk of bias. A total of 11
studies were evaluated, which investigated a total of 680
patients, consisting of 444 males and 236 females; 9 out of 11
studies assessing hair count/hair density found statistically
significant improvements in both males and females following
LLLT treatment. Additionally, hair thickness and tensile
strength significantly improved in 2 out of 4 studies. Patient
satisfaction was investigated in 5 studies, and was overall
positive, though not as profound as the objective outcomes.
The authors concluded that the majority of studies covered in
this review found an overall improvement in hair re-growth,
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thickness, and patient satisfaction following LLLT therapy.
They stated that although caution is needed when interpreting
these findings, LLLT therapy appeared to be a promising
monotherapy for AGA and may serve as an effective
alternative for individuals unwilling to use medical therapy or
undergo surgical options.
Darwin and colleagues (2018) examined the clinical trials to
determine whether the body of evidence supports the use of
low-level laser therapy (LLLT) to treat androgenic alopecia
(AGA). A literature search was conducted through PubMed,
Embase, and Clinicaltrials.gov for clinical trials using LLLT to
treat AGA. Thirteen clinical trials were assessed. Review
articles were not included. Ten of 11 trials demonstrated
significant improvement of androgenic alopecia in comparison
to baseline or controls when treated with LLLT. In the
remaining study, improvement in hair counts and hair diameter
was recorded, but did not reach statistical significance. Two
trials did not include statistical analysis, but showed marked
improvement by hair count or by photographic evidence. Two
trials showed efficacy for LLLT in combination with topical
minoxidil. One trial showed efficacy when accompanying
finasteride treatment. LLLT appears to be a safe, alternative
treatment for patients with androgenic alopecia. Clinical trials
have indicated efficacy for androgenic alopecia in both men
and women. It may be used independently or as an adjuvant
of minoxidil or finasteride. More research needs to be
undertaken to determine the optimal power and wavelength to
use in LLLT as well as LLLT's mechanism of action.
Delaney and Zhang (2018) stated that alopecia is a common
disorder affecting over 50 % of the world's population. Within
this condition, androgenic alopecia (AA) is the most common
type, affecting 50 % of men over 40 years of age and 75 % of
women over 65. Anecdotal paradoxical hypertrichosis noted
during laser epilation has generated interest in the possibility
of using laser to stimulate hair growth. These investigators
evaluated the application of LLLT for the treatment of AA in
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adults. They carried out a systematic review on studies
identified on Medline, Embase, Cochrane database, and
clinicaltrials.org. Double-blinded RCTs were selected and
analyzed quantitatively (meta-analysis) and qualitatively
(quality of evidence, risk of bias). The authors concluded that
LLLT appeared to be a promising non-invasive treatment for
AA in adults that is safe for self-administration in the home-
setting. These researchers stated that although shown to
effectively stimulate hair growth when compared to sham
devices, these results must be interpreted with caution. They
stated that further studies with larger samples, longer follow-
up, and independent funding sources are needed to determine
the clinical effectiveness of this novel therapy.
Liu and colleagues (2019) examined the effectiveness of LLLT
in the treatment of adult AA (AAA). A systematic search of
studies on LLLT for AAA was conducted mainly in PubMed,
Embase, and Cochrane Systematic Reviews. The SMD in the
changes of hair density treated by LLLT versus sham devices
was analyzed. The meta-analysis included 8 studies
comprising a total of 11 double-blinded RCTs. The
quantitative analysis showed a significant increase in hair
density for those treated by LLLT versus sham group (SMD
1.316, 95 % CI: 0.993 to 1.639) . The subgroup analysis
demonstrated that LLLT increased hair growth in both
genders, in both comb- and helmet-type devices, and in short-
and long-term treatment course. The subgroup analysis also
showed a more significant increase of hair growth for the LLLT
versus sham in the low-frequency treatment group (SMD
1.555, 95 % CI: 1.132 to 1.978) than in the high-frequency
group (SMD 0.949, 95 % CI: 0.644 to 1.253). The review was
limited by the heterogeneity of included trials; LLLT
significantly increased hair density in AAA. The authors
concluded that the findings of this meta-analysis suggested
that low treatment frequency by LLLT had a better hair growth
effect than high treatment frequency. They stated that LLLT
represents a potentially effective treatment for AAA in both
male and female.
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Marchitto and colleagues (2019) noted that alopecia areata
(AA) is a common form of patchy, non-scarring hair loss.
Although intralesional steroid injections are currently the
mainstay therapy for AA, other non-steroid-based therapies,
including platelet-rich plasma (PRP), ultra-violet radiation
(UVR), and laser-based modalities, are emerging as
management options. These researchers systematically
reviewed non-steroid-based therapies for the treatment of AA.
They carried out a systematic review of the literature searching
PubMed/Medline databases identifying studies examining
PRP, UVR, and laser-based modalities for the treatment of
AA. Literature search yielded 644 articles entailing PRP, UVR,
and laser treatment modalities for AA. Of the 644 articles, 46
met inclusion criteria. Although numerous reports
demonstrated strong potential for PRP, UVR, and laser
modalities in treating AA, high-quality evidence supporting
their efficacy is still lacking. The authors concluded that there
is an abundance of evidence for non-steroid-based therapies
in the treatment of AA. Moreover, these researchers stated
that RCTs comparing these therapeutic options head-to-head
should be conducted to better understand the true
effectiveness of these therapies.
Head and Neck Cancer
Zecha and colleagues (2016) noted that recent advances in
PBM technology, together with a better understanding of
mechanisms involved, may expand the applications for PBM in
the management of other complications associated with head
and neck cancer (HNC) treatment. This article (part 1)
described PBM mechanisms of action, dosimetry, and safety
aspects and, in doing so, provided a basis for a companion
paper (part 2), which described the potential breadth of
potential applications of PBM in the management of side-
effects of (chemo)radiation therapy in patients being treated
for HNC and proposed PBM parameters. These investigators
reviewed PBM mechanisms of action and dosimetric
considerations. Virtually, all conditions modulated by PBM
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(e.g., ulceration, inflammation, lymphedema, pain, fibrosis,
neurological and muscular injury) are thought to be involved in
the pathogenesis of (chemo)radiation therapy-induced
complications in patients treated for HNC. The impact of PBM
on tumor behavior and tumor response to treatment has been
insufficiently studied. In-vitro studies assessing the effect of
PBM on tumor cells report conflicting results, perhaps
attributable to inconsistencies of PBM power and dose.
However, the biological bases for the broad clinical activities
ascribed to PBM have also been noted to be similar to those
activities and pathways associated with negative tumor
behaviors and impeded response to treatment. While there
are no anecdotal descriptions of poor tumor outcomes in
patients treated with PBM, confirming its neutrality with respect
to cancer responsiveness is a critical priority. The authors
concluded that based on its therapeutic effects, PBM may
have utility in a broad range of oral, oropharyngeal, facial, and
neck complications of HNC treatment. They stated that
although evidence suggested that PBM using LLLT is safe in
HNC patients, more research is imperative and vigilance
remains warranted to detect any potential adverse effects of
PBM on cancer treatment outcomes and survival.
Furthermore, National Comprehensive Cancer Network’s
clinical practice guideline on “Head and neck cancers
“ (Version 1.2017) does not mention LLLT as a management
option.
Neuropathic Pain
de Andrade and colleagues (2016) reviewed the literature on
the use of LLLT in neuropathic pain with the goal of
establishing a "therapeutic window" for the effective use of this
treatment. These researchers analyzed 14 articles, 10 in
experimental animals and 4 in humans. The results were
presented in 3 tables, the first being for comparison of the
studies' application parameters, the second showing the
average and median parameters experimental studies and
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third showing the clinical studies embodiment. The
experimental studies revealed better results for LLLT and
infrared laser powers above 70 mW. Clinical studies were
inconclusive as to the application parameters, due to the
discrepancy; however all demonstrated the effectiveness of
LLLT. According to the data presented, the authors concluded
that LLLT had positive effects on the control of analgesia for
neuropathic pain, but further studies with high scientific rigor
are needed in order to define treatment protocols that optimize
the action LLLT in neuropathic pain.
Oral Mucositis
Bayer and colleagues (2017) stated that oral mucositis (OM)
induces severe pain and limits fundamental life behaviors such
as eating, drinking, and talking for patients receiving
chemotherapy or radiotherapy. In addition, through
opportunistic microorganisms, OM frequently leads to systemic
infection, which then leads to prolonged hospitalization.
Severe lesions often adversely affect curative effects in
cancer cases. Thus, the control of OM is important for oral
health quality of life and prognosis. Low-level laser therapy
and ozone may be useful to accelerate wound healing. In this
study, 24 Sprague-Dawley rats were divided into 3 groups: (i)
control, (ii) ozone, and (iii) laser groups. All groups received
5-fluorouracil intra-peritoneally and trauma to the mouth pouch
with a needle. After the formation of OM in the mouth, the
control group had no treatment; the ozone group was
administered ozone, and the laser group, LLLT. Then, all
groups were sacrificed and basic fibroblast growth factor
(bFGF), transforming growth factor (TGF-β), and platelet-
derived growth factor (PDGF) were evaluated in all groups;
LLLT was found to be statistically significantly more effective
than ozone on FGF and PDGF. However, in respect of
TGF-β, no statistically significant difference was observed
between the groups. The authors concluded that within the
limitations of this study, LLLT was more effective than ozone;
however, further studies on this subject are needed.
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de Lima et al (2020) reported on a systematic review and
meta-analysis to determine the effectiveness of low-level laser
therapy in preventing oral mucositis in patients undergoing
chemoradiotherapy for head and neck cancer. The following
databases were searched through September 2018, with last
search performed on May 2019, for clinical trials: MEDLINE via
PubMed, Cochrane Central, Scopus, Lilacs, ISI Web of
Science and SIGLE via Open Grey. From 14,525 records, 4
studies were included in the review and 3 studies were
included in meta-analysis. Data from 500 patients (mean age
of 53.595 and 54.14 for intervention and control groups,
respectively) were analyzed. Meta-analysis showed that laser
therapy prevents oral mucositis incidence in 28% and 23% of
cases during the third and fourth follow-up week, respectively,
in comparison to a placebo-treated control group. There was
no statistically significant difference the prevention of pain;
dysphagia and quality of life were not analyzed due to missing
data. The authors concluded that laser therapy was effective in
preventing oral mucositis from the 15th to the 45th days of
chemoradiotherapy. However, new primary studies with low
risk of bias are needed so a higher scientific evidence can be
obtained.
Peralta-Mamani and colleagues (2019) noted that dosimetry
for LLLT depends on several parameters, such as target tissue
type, lesion type and laser equipment used. These
researchers determined the most used LLLT dosimetry for the
treatment and prevention of OM resulting from radiation
therapy (RT) in head and neck cancer patients (HNCP). This
research was conducted according to the PRISMA guidelines
using the PICO framework. After extensively searching
PubMed, Web of Science, Embase, Scopus, BVS and
Cochrane Library databases, these investigators found 130
records and selected 7 studies, involving 363 HNCP with an
average age of 60.6 years who received RT. Briefly, sites
affected by tumors were the following: oral cavity (n = 170),
oropharynx (n = 91), throat (n = 42), larynx (n = 32),
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nasopharynx (n = 11), hypopharynx (n = 9), and in 8 cases,
sites were not reported. These studies used several
classifications for OM (RTOG/EORTC, WHO, NCI-CTC) and
pain (numeric rating scale [NRS], VAS and modified VAS).
These various researchers performed the LLLT punctual
application of different forms using several protocols making
analysis difficult. However, LLLT was effective regardless of
the parameters used (632.8 nm to 685 nm, 1.8 J/cm2 to 3.0
J/cm2, 10 mW to 60 Mw, 0.8 J to 3.0 J). The meta-analysis
showed a better results with preventive LLLT 660 nm, 3.8
J/cm2, 15 mW; 0.15 J compared to preventive LLLT 660 nm,
1.3 J/cm2, 5 mW; 0.05 J (OMS: p = 0.03; NCI-CTC: p = 0.027).
The authors concluded that there is, as of yet, no evidence of
better laser dosimetry being more effective; RCTs to determine
which doses of LLLT are most appropriate for treating and
preventing OM due to RT are lacking and should be further
investigated.
Pressure Ulcers
Machado and colleagues (2017) evaluated the effects of LLT
in pressure ulcers (PU) in humans through a systematic review
of randomized studies. The search includes the databases
Medline, PEDro, Cochrane CENTRAL, and Lilacs, as well a
manual search until May, 2016. This included randomized
clinical trials of LLT compared with other interventions,
different types of LLT, LLT placebo, or control in the treatment
of PU. The outcomes evaluated were the ulcer area, healing
rate, and overall healing rate. The risk of bias was evaluated
using the tool of the Cochrane Collaboration, and the results
were analyzed descriptively. From the 386 articles identified,
only 4 studies were included, with 2 LLT used with single
wavelength (1: 904 nm versus control and 2: 940 nm versus
808 nm versus 658 nm versus placebo) and 2 LLT used to
probe cluster. One study compared to different single
wavelengths showed a significant 71 % reduction of the PU
and an improved healing rate in which 47 % of PU healed
completely after 1 month of therapy with the use of LLT with a
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wavelength of 658 nm compared with other lengths. The other
analyzed wavelengths were not significant in the assessed
outcomes. Significant results were observed in the use of LLT
with a 658 nm wavelength, and no evidence was found for use
of wavelengths above that for the treatment of PU. The
authors also found no evidence in the laser used to probe the
cluster.
Furthermore, an UpToDate review on “Overview of treatment
of chronic wounds” (Evans and Kim, 2017) does not mention
LLLT as a therapeutic option.
Traumatic Brain Injury
Thunshelle and Hamblin (2016) LLLT or PBM is a possible
treatment for brain injury, including traumatic brain injury
(TBI). These investigators reviewed the fundamental
mechanisms at the cellular and molecular level and the effects
on the brain were discussed. There are several contributing
processes that have been proposed to lead to the beneficial
effects of PBM in treating TBI such as stimulation of
neurogenesis, a decrease in inflammation, and
neuroprotection. Both animal and clinical trials for ischemic
stroke were outlined. A number of articles have shown how
transcranial LLLT (tLLLT) is effective at increasing memory,
learning, and the overall neurological performance in rodent
models with TBI. The authors’ laboratory has conducted 3
different studies on the effects of tLLLT on mice with TBI. The
1st studied pulsed against continuous laser irradiation, finding
that 10 Hz pulsed was the best. The 2nd compared 4 different
wavelengths, discovering only 660 and 810 nm to have any
effectiveness, whereas 732 and 980 nm did not. The 3rd
looked at varying regimens of daily laser treatments (1, 3, and
14 days) and found that 14 laser applications was excessive.
The authors also reviewed several studies of the effects of
tLLLT on neuroprogenitor cells, brain-derived neurotrophic
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factor and synaptogenesis, immediate early response
knockout mice, and tLLLT in combination therapy with
metabolic inhibitors.
Furthermore, an UpToDate review on “Management of acute
severe traumatic brain injury” (Hemphill and Phan, 2017) does
not mention LLLT as a therapeutic option.
Breast Cancer-Related Lymphedema
In a systematic review, Baxter and associates (2017)
evaluated the effectiveness of LLLT (also known as
photobiomodulation (PBM)) in the management of breast
cancer related lymphedema (BCRL). Clinical trials were
searched in PubMed, AMED, Web of Science, and China
National Knowledge Infrastructure up to November 2016; 2
reviewers independently assessed the methodological quality
and adequacy of LLLT in these clinical trials. Primary outcome
measures were limb circumference/volume, and secondary
outcomes included pain intensity and ROM. Because data
were clinically heterogeneous, best evidence synthesis was
performed. A total of 11 clinical trials were identified, of which
7 RCTs were chosen for analysis. Overall, the methodological
quality of included RCTs was high, whereas the reporting of
treatment parameters was poor. Results indicated that there
was strong evidence (3 high quality trials) showing LLLT was
more effective than sham treatment for limb
circumference/volume reduction at a short-term follow-up.
There was moderate evidence (1 high quality trial) indicating
that LLLT was more effective than sham laser for short-term
pain relief, and limited evidence (1 low quality trial) that LLLT
was more effective than no treatment for decreasing limb
swelling at short-term follow-up. The authors concluded that
based upon the current systematic review, LLLT may be
considered an effective treatment approach for women with
BCRL. However, they stated that due to the limited numbers
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of published trials available, there is a clear need for well-
designed high-quality trials in this area. The optimal treatment
parameters for clinical application have yet to be elucidated.
Obesity
Silva and colleagues (2018) noted that obesity represents a
continuously growing global epidemic and is associated with
the development of type 2 diabetes mellitus (T2DM). The
etiology of T2DM is related to the resistance of insulin-
sensitive tissues to its action leading to impaired blood glucose
regulation. Photobiomodulation therapy might be a non-
pharmacological, non-invasive strategy to improve insulin
resistance. It has been reported that PBM therapy in
combination with physical exercise reduces insulin resistance.
These researchers examined the effects of PBM therapy on
insulin resistance in obese mice. Male Swiss albino mice
received low-fat control diet (n = 16, LFC) or high-fat diet (n =
18, HFD) for 12 weeks. From 9th to 12th week, the mice
received PBM therapy (laser) or sham (light-off) treatment and
were allocated into 4 groups: LFC sham (n = 8), LFC PBM (n =
8), HFD sham (n = 9), and HFD PBM (n = 9). The PBM
therapy was applied in 5 locations: to the left and right
quadriceps muscle, upper limbs and center of the abdomen,
during 40 s at each point, once-daily, 5 days a week, for 4
weeks (780 nm, 250 mW/cm2, 10 J/cm2, 0.4 J per site; 2 J
total dose per day). Insulin signaling pathway was evaluated
in the epididymal adipose tissue. PBM therapy improved
glucose tolerance and phosphorylation of Akt (Ser473) and
reversed the HFD-induced reduction of GLUT4 content and
phosphorylation of AS160 (Ser588). Also, PBM therapy
reversed the increased area of epididymal and mesenteric
adipocytes. The authors concluded that these findings
showed that chronic PBM therapy improved parameters
related to obesity and insulin resistance in HFD-induced
obesity in mice.
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Oral Lichen Planus
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Al-Maweri and co-workers (2017) stated that oral lichen planus
(OLP) is a chronic inflammatory disease of unknown etiology
and indefinite cure. In a systematic review, thee investigators
assessed the efficacy LLLT in the treatment of symptomatic
OLP. Electronic databases (PubMed, Scopus, and Web of
Science) were searched from date of inception till and
including December 2016, using various combinations of the
following keywords: oral lichen planus, laser therapy, low-level
laser therapy, and phototherapy. Owing to heterogeneity of
data, no statistical analyses were conducted. Initially, 227
publications were identified. After selection, only 6 studies
were included in this systematic review. In these studies, the
laser wavelengths, power output, and duration of irradiation
ranged between 630 to 980 nm, 20 to 300 mW, and 10 s to 15
min, respectively. All of the included studies found laser to be
effective in management of OLP, without any reported adverse
effects. The authors concluded that the results of the included
studies confirmed that LLLT was effective in management of
symptomatic OLP and could be used as an alternative to
corticosteroids. However, they stated that due to variety of
methods and substantial variations in laser parameters among
these studies, more RCTs with large sample sizes are needed.
In a systematic review, Akram and colleagues (2018)
evaluated the efficacy of LLLT, in comparison with
corticosteroid therapy, in the treatment of OLP. This
systematic review aimed to address the following focused
question: "Does LLLT yield better clinical outcomes than
corticosteroid therapy in the treatment of OLP"? Indexed
databases were searched up to and including April 2017.
Clinical trials in humans diagnosed clinically and/or
histologically with OLP allocated to test (LLLT) versus control
(steroid therapy) groups were included. A total of 5 clinical
studies were included. The risk of bias was considered high in
4 studies and moderate in 1 study. Laser wavelengths, power,
spot size, and duration of laser exposure ranged between 630
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and 970 nm, 10 to 3,000 mW, 0.2 to 1.0 cm2 , and 6 to 480
seconds, respectively. The follow-up period ranged from 4 to
48 weeks. All included studies reporting clinical scores
showed that LLLT was effective in the treatment of OLP in
adult patients at follow-up; 3 studies showed significantly
higher improvements with topical use of corticosteroids
compared to LLLT, while 1 study showed significant
improvement with LLLT; 1 study showed comparable
outcomes between LLLT and corticosteroid application. The
authors concluded that it remained debatable whether LLLT is
more effective as compared to corticosteroids in the treatment
of OLP, given that the scientific evidence was weak.
Moreover, they stated that these findings were preliminary
and further RCTs are recommended.
Pemphigus Vulgaris
Yousef and associates (2017) stated that pemphigus vulgaris
is a chronic blistering skin disease. Management of
recalcitrant pemphigus ulcers is a great problem; LLLT is
known to supply direct bio-stimulative light energy to body
cells. In a pilot study, these investigators evaluated the
efficacy of low power laser in the healing of pemphigus
lesions. A total of 10 patients with pemphigus vulgaris were
enrolled in the trial. The LED-LLLT system used was the Thor
LED clusters (109, 69 or 19 diode) with 660-nm wavelength in
continuous wave (CW) and 30 mW energy. Both sides of the
patients' lesion were photographed prior to the study and in
each laser therapy session. The pattern of changes in
qualitative wound score (QWS) patterns differed significantly
over time between the 2 therapies (treatment × time
interactions, p < 0.0001). When compared to the routine
therapy, the laser therapy showed more decrease in mean
QWS in all sessions in comparison with baseline. The authors
concluded that application of LLLT simultaneously with
conventional therapy could result in sensational healing of
ulcers especially in patients who did not respond to
conventional treatment or suffering from recalcitrant lesions.
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Moreover, they stated that since this was a pilot study with a
small sample size (n = 10), it is suggested that further
research be performed. In order to determine the real efficacy
of LLLT (the optimal set of laser irradiation parameters and
well-defined duration and frequency of intervals), further
carefully designed long-term clinical trials with a larger sample
size (possibly international) are needed as well as prolonged
follow-up period.
Diabetic Foot Ulcers
Beckmann et al (2014) stated that diabetic foot ulcers (DFUs)
are one of the most common complications of diabetes
mellitus are defined as non-healing or long-lasting chronic skin
ulcers in diabetic patients. Multi-disciplinary care for the
diabetic foot is common, but treatment results are often
unsatisfactory. Low level laser therapy on wound areas as
well as on acupuncture points, as a non-invasive, pain-free
method with minor side effects, has been considered as a
possible treatment option for the diabetic foot syndrome. A
systematic literature review identified 1,764 articles on this
topic. These researchers adopted 22 eligible references; 8 of
them were cell studies, 6 were animal studies, and 8 were
clinical trials. Cell studies and animal studies gave evidence
of cellular migration, viability, and proliferation of fibroblast
cells, quicker re-epithelization and reformed connective tissue,
enhancement of microcirculation, and anti-inflammatory effects
by inhibition of prostaglandins, interleukin, and cytokine as well
as direct anti-bacterial effects by induction of reactive oxygen
species (ROS). The transferal of these data into clinical
medicine is under debate. The majority of clinical studies
showed a potential benefit of LLLT in wound healing of
diabetic ulcers. But there are a lot of aspects in these studies
limiting final evidence about the actual output of this kind of
treatment method. The authors concluded that all studies
gave enough evidence to continue research on laser therapy
for diabetic ulcers, but clinical trials using human models do
not provide sufficient evidence to establish the usefulness of
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LLLT as an effective tool in wound care regimes at present.
They stated that further well-designed studies are needed to
determine the true value of LLLT in routine wound care.
In a systematic review and meta-analysis, Li and colleagues
(2018) examined if LLLT is effective at healing DFU and
provided evidence-based recommendations and clinical
guidelines for the future clinical treatment of DFUs. Medline,
Embase, Scopus, Cochrane Library, and Web of Science
databases were searched for studies published up to June 30,
2017, without language or data restrictions; RCTs that
examined the use of LLLT for DFU treatment were included.
Standard methods of meta-analysis were performed to
evaluate outcomes of LLLT on the healing of DFU. A total of 7
RCTs involving 194 participants were eligible for this
systematic review and meta-analysis. The results of meta-
analysis showed that LLLT has emerged as a potential non-
invasive treatment for DFUs, as LLLT was found to effectively
reduce the ulcer area [weighted MD (WMD) 34.18, 95 % CI:
19.38 to 48.99, p < 0.00001], improve the complete healing
rate [odds ratio (OR) 6.72, 95 % CI: 1.99 to 22.64, p = 0.002].
Qualitative analysis of the included RCTs found that LLLT
also played a role in the treatment of DFUs through promoting
rapid granulation formation and shortening ulcer closure time,
as well as alleviating foot ulcer pain. None of the treatment-
related adverse event (AE) was reported. The authors
concluded that LLLT was recognized as a potential method in
the comprehensive treatment of DFUs. These researchers
stated that further well designed and high-quality studies are
needed to confirm the role of LLLT in the management of
DFUs.
Dos Santos and colleagues (2020) noted that DFUs are
considered one of the most aggressive and expensive
complications of diabetes; and LLLT has been highlighted as a
potential modality of treatment to accelerate the healing of
ulcers. In a systematic review and meta-analysis, these
researchers examined the efficacy of LLLT in the treatment of
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DFU and identified the LLLT application parameters
recommended for the treatment of DFU over the past 10
years. They carried out a systematic search in PubMed, BVS,
PEDro, Scopus, Web of Science, and CINAHL up to March 31,
2019. Following the PRISMA guidelines, RCTs that examined
the effect of LLLT on the treatment of DFU were included. A
total of 13 RCTs with a total of 361 subjects were included in
this review; 3 RCTs reported a reduction in the percentage
size of the ulcers and were included in the meta-analysis. The
meta-analysis of the percentage size difference showed a
significant reduction in ulcer size in the LLLT group compared
with controls (22.96 [95 % CI: 18.22 to 27.69; z = 9.51, p <
0.0001]). Treatment with 632.8 to 685 nm, 50 mW/cm2, 3 to 6
J/cm2, and irradiation for 30 to 80 seconds, 3 times weekly for
a month was of benefit to patients with DFU. The authors
concluded that LLLT was safe and effective for the treatment
of DFU. Moreover, these researchers stated that well-
designed, high-quality studies are needed to allow its ideal
parameterization for clinical practice.
Herpes Labialis
de Paula Eduardo et al (2014) noted that recurrent herpes
labialis (RHL) is a worldwide life-long oral health problem that
remains unsolved. It affects approximately 1/3 of the world
population and causes frequent pain and discomfort episodes,
as well as social restriction due to its compromise of esthetic
features. In addition, the available anti-viral drugs have not
been successful in completely eliminating the virus and its
recurrence. Currently, different kinds of laser treatment and
different protocols have been proposed for the management of
recurrent herpes labialis. These investigators reviewed the
literature regarding the effects of laser irradiation on recurrent
herpes labialis and identified the indications and most
successful clinical protocols. The literature was searched with
the aim of identifying the effects on healing time, pain relief,
duration of viral shedding, viral inactivation, and interval of
recurrence. According to the literature, none of the laser
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treatment modalities is able to completely eliminate the virus
and its recurrence. However, laser phototherapy appears to
strongly decrease pain and the interval of recurrences without
causing any side effects. Photodynamic therapy can be
helpful in reducing viral titer in the vesicle phase, and high-
power lasers may be useful to drain vesicles. The main
advantages of the laser treatment appear to be the absence of
side effects and drug interactions, which are especially helpful
for older and immune-compromised patients. The authors
concluded that although these results indicated a potential
beneficial use for lasers in the management of recurrent
herpes labialis, they are based on limited published clinical
trials and case reports. They stated that the literature still
lacks double-blind, controlled clinical trials verifying these
effects and such trials should be the focus of future research.
Al-Maweri and associates (2018) stated that RHL is a highly
prevalent viral infection that affects the orofacial region.
Current therapeutic options have limited efficacy in reducing
healing time and recurrence rate of the disease. Recently,
LLLT has been proposed as a potential treatment alternative
for the management of RHL with no side effects. These
investigators examined the effectiveness of laser therapy in
the management and prevention of RHL. A comprehensive
search of Medline/PubMed, Scopus, and Web of Science was
carried out to identify published clinical trials comparing laser
intervention to active and/or non-active controls for the
treatment of RHL. Due to marked heterogeneity of available
data, studies were assessed qualitatively, and no statistical
analysis was performed. Of the retrieved 227 articles, 6
clinical trials met the eligibility criteria. The wavelengths, the
power output, and energy density ranged between 632.5 to
870 nm, 5 to 80 W, and 2.04 to 48 J/cm2, respectively. All
included studies found laser to be effective in the management
and prevention of RHL, without any side effects. The authors
concluded that the findings of this review suggested that laser
is potentially a safe and effective treatment alternative for the
management of RHL. However, these researchers stated that
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due to high variability in study designs and inconsistency in
laser parameters among the included studies, more well-
designed RCTs with standardized laser parameters are
needed.
Low Back Pain and Neck Pain
In a clinical practice guideline on “Management of neck pain
and associated disorders” from the Ontario Protocol for Traffic
Injury Management (OPTIMa) Collaboration, Cote et al (2016)
concluded that “For neck pain and associated disorders (NAD)
grade III of less than or equal to 3 months duration, clinicians
may consider supervised strengthening exercises in addition
to structured patient education. In view of evidence of no
effectiveness, clinicians should not offer structured patient
education alone, cervical collar, low-level laser therapy, or
traction”.
In a clinical practice guideline for “Physical therapy
assessment and treatment in patients with nonspecific neck
pain” (Bier et al, 2018) stated that “The physical therapist is
advised not to use dry needling, low-level laser,
electrotherapy, ultrasound, traction, and/or a cervical collar”.
The Agency for Healthcare Research and Quality (AHRQ)’s
systematic review on “Noninvasive nonpharmacological
treatment for chronic pain” (Skelly et al, 2018) stated that for
chronic neck pain, low-level laser therapy was associated with
a moderate improvement in short-term function (2 trials,
pooled difference -14.98 , 95 % CI: -23.88 to -6.07, I2 = 39 %,
0 to 100 scale) and pain (3 trials [n = 26, 45, and 30 for laser
treatment; and the quality of the study was fair, good, and fair,
respectively], pooled difference -1.81 on a 0-10 scale, 95 %
CI: -3.35 to -0.27, I2 = 75 %) compared with sham (Strength of
evidence (SOE): Moderate for function and pain). However,
there is no evidence to support its effectiveness for
improvement of intermediate-term and long-term function and
pain. For LBP, SOE on the use of cold laser therapy for the
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treatment of LBP was low (short-term improvement in function
and pain). No clear improvement in function was observed at
intermediate-term for low-level laser therapy (SOE: Low); and
there is no evidence to support its effectiveness for
improvement of long-term function and pain.
Breast Implant Capsular Contracture
Azimi and colleagues (2018) stated that breast reconstruction
with implants can be complicated by symptomatic capsular
contracture, especially after radiotherapy. A phase-I, non-
randomized clinical trial reported improvement in capsular
contracture and avoidance of revision surgery with LLLT. In a
phase-II, double-blind, RCT, these investigators examined the
efficacy of LLLT for treating capsular contracture in women
with breast reconstruction following mastectomy for breast
cancer. Participants had completed their definitive implant-
based reconstruction a minimum of 6 months previously and
were randomized to weekly treatments over 6 weeks with
either an active or inactive LLL hand-piece (Riancorp LTU-
904). Pain, tightness, arm movement, and appearance were
assessed by patient questionnaires. Breast symmetry, shape,
naturalness, softness, and grade of contracture were
assessed by clinician reports. Participants were assessed at 1
and 6 months after completion of the treatments. A total of 42
patients (intervention arm, n = 20; placebo, n = 22) were
assessed in the trial; 32 had post-mastectomy radiotherapy.
There was no significant difference in the change in any
patient-reported outcomes or clinician-reported outcomes of
breast symmetry, shape, or naturalness for the 2 groups.
There was a significantly greater improvement in clinician-
reported breast softness (p < 0.05) and degree of contracture
(p < 0.05) in the placebo group at both 1- and 6-month follow-
up. The authors concluded that LLLT was not an effective
therapy for breast implant capsular contracture in
reconstruction patients. Level of evidence = I.
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Hypothyroidism Induced by Autoimmune Thyroiditis
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In a RCT, Hofling and colleagues (2018) examined the efficacy
of LLLT for hypothyroidism induced by chronic autoimmune
thyroiditis (CAT). These researchers evaluated the safety and
actions of LLLT 6 years after completion of the RCT. A total of
43 participants were invited to participate in this study 6 years
after completion of the RCT; 25 were subjected to LLLT (group
L), and 18 were subjected to placebo (group P). Primary
outcome measure was frequency of thyroid nodules, which
were subjected to fine-needle aspiration biopsy. Secondary
outcome measures included dose of levothyroxine needed to
treat hypothyroidism, thyroid peroxidase antibodies (anti-TPO),
and anti-thyroglobulin antibodies (anti-Tg). In group L, a
nodule was observed in 3 patients, who all had a Bethesda II
classification. In group P, a nodule was also observed in 3
patients, with 2 classified as Bethesda II and 1 as Bethesda III.
The levothyroxine dose needed by group L was significantly
lower than that required by group P (p = 0.002). The anti-TPO
and anti-Tg levels did not differ between the 2 groups. The
authors concluded that the findings of this study suggested
that LLLT was safe for the treatment of patients with CAT-
induced hypothyroidism under the specified conditions, and
thus, subsequent applications may be considered for the
purpose of maintaining or improving the obtained results.
These researchers stated that future research will be
important to corroborate these findings.
The authors stated that this study had several drawbacks. The
vascularization was evaluated by means of a subjective
method, with classification of the vascularization into 4
different patterns. Although the evaluation of thyroid
vascularization pattern TVP was performed by a single
experienced examiner, there may be intra-observer variations
in interpretation in the case of borderline patterns. However, 2
separate analyses by 2 independent investigators could also
be employed to improve this evaluation. The use of different
anti-TPO and anti-Tg measurement kits during the RCT and
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the present study made comparative analysis impossible at
those moments. The safety analysis was based on a small
sample of patients. Thus, further research is needed to
confirm these results.
Inferior Alveolar Nerve and Lingual Nerve Injuries
Miloro and Criddle (2018) noted that iatrogenic damage to the
inferior alveolar nerve (IAN) and lingual nerve (LN) may occur
during routine oral and maxilla-facial surgeries. In a
prospective, double-blind RCT, these investigators examined if
the proportion of nerve-injured patients with post-operative
neurosensory improvement over a 3-month period differed
significantly between a LLLT group and a control group. The
study sample consisted of 35 patients with iatrogenic nerve
injury due to 3rd molar odontectomy, dental implant
placement, or local anesthetic injection. The investigators
used a randomized, double-blind laser delivery system to
administer either placebo or LLLT to patients who met the
inclusion criteria. The outcome variable of neurosensory
improvement was defined as a minimum 1-unit increase from
baseline in VAS rating and was based on standard objective
clinical neurosensory testing. Study variables included the
affected nerve (IAN or LN) and time from injury to treatment (3
to 12 months or greater than 12 months). Uni-variate
statistical analysis (χ2 test) was performed to determine
significance between the 2 groups. Neurosensory
improvement was observed in 46.7 % of the LLLT patients,
who showed at least a 1-unit improvement at 3 months,
compared with 38.5 % improvement for controls (p = 0.66),
regardless of the specific nerve involved (IAN or LN). In
addition, no observed difference was noted between the study
groups based on time from injury to treatment. The authors
concluded that this study failed to provide sufficient evidence
to conclude that a difference in neurosensory improvement
exists between the LLLT and placebo groups with IAN or LN
injuries. However, this study was unique in the prospective
double-blind study design and comprehensive neurosensory
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testing protocols. These researchers stated that there is a
continued need for further clinical studies on LLLT in oral and
maxillofacial surgery nerve injuries.
Peri-Implant Mucositis
In a systematic review, Albaker and colleagues (2018)
examined the effect of photodynamic therapy (PDT) or laser
therapy (LT) in the management of peri-implant mucositis
(p-iM). The electronic databases were searched until October
2017. Outcome measures were bleeding on probing (BOP),
plaque index (PI), or probing depth (PD). The addressed
PICO (population-intervention-comparator-outcome) question
was: "Is PDT and LT effective in the management of p-iM?" A
total of 5 studies included in the qualitative analysis, 2 of which
had a low-risk of bias; 3 studies used PDT while 2 studies
used LT. All studies reported a significant improvement in
clinical peri-implant inflammatory parameters in p-iM. For
PDT, 1 study demonstrated a significant reduction for PDT
group as compared to manual debridement (MD), while 1
study indicated comparable outcomes when tested with
probiotics at follow-up. One study used PDT alone and
indicated significant improvements in peri-implant parameters
at follow-up. However, in the studies using LT, one study
demonstrated a significant improvement in peri-implant
parameters as compared to scaling and root planing alone,
while other study indicated comparable outcomes when
compared with manual debridement / chlorhexidine group at
follow-up. The authors concluded that this systematic review
demonstrated inconclusive findings to show the effect of PDT
or LT in the management of p-iM due to methodological
heterogeneity such as non-standard control groups, laser
parameters and short follow-up period. These researchers
stated that the findings of this review should be considered
preliminary and further, more robust, well-designed studies
with long-term follow-up and standardized comparators with
laser parameters are needed.
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Peri-Odontitis
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In a systematic review, Mokeem (2018) examined the efficacy
of LLLT as an adjunct to scaling and root planing (SRP) versus
SRP alone in the treatment of aggressive periodontitis (AgP).
The addressed PICO (Population, Interventions, Comparisons
and Outcomes) question was: Is LLLT as an adjunct to SRP
effective in the treatment of AgP? Electronic databases,
including Medline via PubMed, Cochrane Central Register of
Controlled Trials and Cochrane Oral Health Group Trials, and
Embase, were searched until March 2018. A total of 4 clinical
studies were included; 3 studies showed significant
improvement in periodontal outcomes among LLLT group
compared to SRP alone, whereas only 1 study showed
comparable periodontal outcomes between the adjunctive
LLLT and SRP groups at follow-up. The overall MD for clinical
attachment level gain (WMD = -1.69, 95 % CI: -3.46 to 0.07, p
< 0.061) was non-significant. However, significant difference
for probing depth reduction (WMD = -0.95, 95 % CI: -1.66 to
0.23, p = 0.009) was noticed between groups at follow-up.
Whether LLLT as an adjunct to SRP is more effective than
SRP alone in the treatment of AgP remains debatable. The
authors concluded that further RCTs with long follow-up
periods and standard laser parameters are needed to reach a
strong conclusion.
Skin Burn
Brassolatti and colleagues (2018) noted that burn is defined as
a traumatic injury of thermal origin, which affects the organic
tissue; and LLLT has gained great prominence as a treatment
in this type of injury; however, the application parameters are
still controversial in the literature. These investigators
reviewed the literature studies that use LLLT as a treatment in
burns conducted in an experimental model, discussed the
main parameters used, and high-lighted the benefits found in
order to choose an appropriate therapeutic window to be
applied in this type of injury. The selection of the studies
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related to the theme was performed in the main databases
(PubMed, Cochrane Library, LILACS, Web of Science, and
Scopus in the period from 2001 to 2017). Subsequently, the
articles were then chosen that fell within the inclusion criteria
previously established. A total of 22 studies were evaluated,
and the main parameters were presented. The analyzed
studies presented both LLLT use in continuous and pulsed
mode. Differences between the parameters used (power,
fluence, and total energy) were observed. In addition, the
protocols were distinct as to the type of injury and the number
of treatment sessions. Among the results obtained by the
authors were the improvements in the local micro-circulation
and cellular proliferation; however, a study reported no effects
with LLLT as a treatment. The authors concluded that LLLT
was effective in accelerating the healing process; however,
there is immense difficulty in establishing the most adequate
protocol, due to the great discrepancy found in the applied
dosimetry values.
Tendon Repair
Lucke and colleagues (2019) noted that the cellular therapy
using adipose-derived mesenchymal stem cells (ASCs) aims
to improve tendon healing, considering that repaired tendons
often result in a less resistant tissue. These researchers
examined the effects of the ASCs combined with a LLLT for
the healing processes. Rats calcaneal tendons were divided
into 5 groups: normal (NT), transected (T), transected and
ASCs (SC) or LLLT (L), or with ASCs and LLLT (SCL). All
treated groups presented higher expression of Dcn and
greater organization of collagen fibers. In comparison with T,
LLLT also up-regulated Gdf5 gene expression, ASCs up-
regulated the expression of Tnmd, and the association of LLLT
and ASCs down-regulated the expression of Scx. No
differences were observed for the expression of Il1b, Timp2,
Tgfb1, Lox, Mmp2, Mmp8 and Mmp9, neither in the
quantification of hydroxyproline, TNF-α, PCNA and in the
protein level of Tnmd. A higher amount of IL-10 was detected
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in SC, L and SCL compared to T, and higher amount of
collagen I and III was observed in SC compared to SCL. The
authors concluded that transplanted ASCs migrated to the
transected region, and all treatments altered the re-modelling
genes expression. The LLLT was the most effective in the
collagen reorganization, followed by its combination with
ASCs. These researchers stated that further investigations
are needed to elucidate the molecular mechanisms involved in
the LLLT and ASCs combination during initial phases of
tendon repair.
Brain Photobiomodulation Therapy / Transcranial LLLT
Hennessy and colleagues (2017) noted that transcranial PBM
also known as tLLLT relies on the use of red/near-infrared
(NIR) light to stimulate, preserve and regenerate cells and
tissues. The mechanism of action entails photon absorption in
the mitochondria (cytochrome c oxidase), and ion channels in
cells leading to activation of signaling pathways, up-regulation
of transcription factors, and increased expression of protective
genes. These researchers have studied PBM for treating TBI
in mice using a NIR laser spot delivered to the head. Mice had
improved memory and learning, increased neuro-progenitor
cells in the dentate gyrus and sub-ventricular zone, increased
brain-derived neurotrophic factor (BDNF) and more
synaptogenesis in the cortex. These highly beneficial effects
on the brain suggested that the applications of tLLLT are much
broader than at first conceived. Other groups have studied
Alzheimer's disease (AD), depression, Parkinson's disease
(PD), stroke (animal models and clinical trials), as well as
cognitive enhancement in healthy subjects. The authors
concluded that due to the extremely positive results obtained
in studies in animal models, and the small clinical trials that
have been conducted thus far, broader clinical testing of PBM
and its applications for neurological conditions is certainly
needed, as much as it is necessary if PBM is to ever become a
widely accessible treatment
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Salehpour and co-workers (2018) stated that brain PBM
therapy enhances the metabolic capacity of neurons and
stimulates anti-inflammatory, anti-apoptotic, and antioxidant
responses, as well as neurogenesis and synaptogenesis. Its
therapeutic role in disorders such as dementia and PD, as well
as to treat brain trauma, depression, and stroke has gained
increasing interest. In the transcranial PBM approach,
delivering a sufficient dose to achieve optimal stimulation is
challenging due to exponential attenuation of light penetration
in tissue. Alternative approaches such as intracranial and
intranasal light delivery methods have been suggested to
overcome this limitation.
Fibromyalgia
de Carvalho Pde et al (2012) noted that LLLT has been widely
used as adjuvant strategy for treatment of musculo-skeletal
disorders. The light-tissue interaction (photo-biostimulation)
promotes analgesic and anti-inflammatory effects and
improves tissue healing, which could justify the
recommendation of this therapy for patients with fibromyalgia,
leading to an improvement in pain and possibly minimizing
social impact related to this disease. These researchers
proposed to evaluate the effect of LLLT on tender points in
patients with fibromyalgia, correlating this outcome with quality
of life and sleep. A total of 120 patients with fibromyalgia will
be treated at the Integrated Health Center and the Sleep
Laboratory of the Post Graduate Program in Rehabilitation
Sciences of the Nove de Julho University located in the city of
Sao Paulo, Brazil. After fulfilling the eligibility criteria, a clinical
evaluation and assessments of pain and sleep quality will be
carried out and self-administered quality of life questionnaires
will be applied. The 120 volunteers will be randomly allocated
to an intervention group (LLLT, n = 60) or control group
(CLLLT, n = 60). Patients from both groups will be treated 3
times per week for 4 weeks, totaling 12 sessions. However,
only the LLLT group will receive an energy dose of 6 J per
tender point. A standardized 50-min exercise program will be
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performed after the laser application. The patients will be
evaluated regarding the primary outcome (pain) using the
following instruments: VAS, McGill Pain Questionnaire and
pressure algometry. The secondary outcome (quality of life
and sleep) will be assessed with the following instruments:
Medical Outcomes Study 36-item Short-Form Health Survey,
Fibromyalgia Impact Questionnaire, Berlin Questionnaire,
Epworth Sleepiness Scale and polysomnography. ANOVA
test with repeated measurements for the time factor will be
performed to test between-groups differences (followed by the
Tukey-Kramer post hoc test), and a paired t-test will be
performed to test within-group differences. The level of
significance for the statistical analysis will be set at 5 % (p ≤
0.05).
Winkelmann et al (2012) stated that the scheduled update to
the German S3 guidelines on fibromyalgia syndrome by the
Association of the Scientific Medical Societies was planned
starting in March 2011. The development of the guidelines
was coordinated by the German Interdisciplinary Association
for Pain Therapy, 9 scientific medical societies, as well as 2
patient self-help organizations. Eight working groups with a
total of 50 members were evenly balanced in terms of gender,
medical field, potential conflicts of interest and hierarchical
position in the medical and scientific fields. Literature
searches were performed using the Medline, PsycInfo, Scopus
and Cochrane Library databases (until December 2010). The
grading of the strength of the evidence followed the scheme of
the Oxford Center for Evidence-Based Medicine. The
formulation and grading of recommendations was
accomplished using a multi-step, formal consensus process.
The guidelines were reviewed by the boards of the
participating scientific medical societies. The authors
concluded that low-to-moderate intensity aerobic exercise and
strength training are strongly recommended; chiropractic, laser
therapy, magnetic field therapy, massage, and transcranial
current stimulation are not recommended.
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In a systematic review and meta-analysis, Yeh and colleagues
(2019) examined the efficacy of LLLT on patients with
fibromyalgia. These researchers carried out a systematic
review and meta-analysis of RCTs evaluating the effect of
LLLT on patients with fibromyalgia. PubMed, Embase, and
the Cochrane Library were searched for articles published
before August 2018; RCTs meeting the selection criteria were
included. The methodological quality of the RCTs was
evaluated according to the Cochrane risk-for-bias method.
Review Manager version 5.3 was used to perform the meta-
analysis. The primary outcomes were the total scores on the
Fibromyalgia Impact Questionnaire (FIQ), pain severity, and
number of tender points. The secondary outcomes were
changes in fatigue, stiffness, anxiety, and depression; SMD,
95 % CI, and p values were calculated for outcome analysis.
These investigators identified 9 RCTs that included 325
fibromyalgia patients undergoing LLLT or placebo laser
treatment with or without an exercise program. The meta-
analysis showed that patients receiving LLLT demonstrated
significantly greater improvement in their FIQ scores (SMD:
1.16; 95 % CI: 0.64 to 1.69), pain severity (SMD: 1.18; 95 %
CI: 0.82 to 1.54), number of tender points (SMD: 1.01; 95 %
CI: 0.49 to 1.52), fatigue (SMD: 1.4; 95 % CI: 0.96 to 1.84),
stiffness (SMD: 0.92; 95 % CI: 0.36 to 1.48), depression (SMD:
1.46; 95 % CI: 0.93 to 2.00), and anxiety (SMD: 1.46; 95 % CI:
0.45 to 2.47) than those receiving placebo laser. Furthermore,
when compared with the standardized exercise program
alone, LLLT plus the standardized exercise program provided
no extra advantage in the relief of symptoms. On the other
hand, the results of the only RCT using combined LLLT/LED
phototherapy showed significant improvement in most
outcomes except for depression when compared to placebo.
When compared with pure exercise therapy, combined
LLLT/LED phototherapy plus exercise therapy had additional
benefits in reducing the severity of pain, number of tender
points, and fatigue. The authors concluded that the findings of
this systematic review and meta-analysis indicated that LLLT
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is an emerging, non-invasive, well-tolerated treatment for
fibromyalgia to relieve discomfort, particularly in patients who
do not exercise regularly.
The authors stated that this study had several drawbacks;
mostly because of the low-to-middle methodological quality of
the selected studies. First, most studies did not report the
allocation process clearly and only blinded the patients; neither
phototherapy programmer nor outcome assessor were
blinded. Considering that nearly all outcomes were subjective
parameters, the above shortcomings may introduce allocation
bias, performance bias, and detection bias. Second, one
study used per-protocol analysis because of a 20 % loss to
follow-up without reporting the reasons for, or the distribution
of, the loss to follow-up; this may have introduced attrition bias.
Third, although LLLT was used in all trials, the differences in
laser types, energy sources, and exposure times used in the
studies may have resulted in some heterogeneity. Fourth,
although patients with fibromyalgia did not take associated
medications in most RCTs, patients in 1 trial maintained their
usual pharmacological therapies, another trial included some
patients continuing their regular medications, and the other 3
RCTs did not mention whether subjects were under concurrent
medication; thus, these investigators could not clarify the
separate roles of medication or phototherapy in fibromyalgia.
Finally, long-term follow-up up to 6 months was only
conducted in 1 RCT.
Tinnitus
In a systematic review and meta-analysis, Chen and
associates (2020) examined the effectiveness of LLLT on adult
patients with complaints of tinnitus. These investigators
searched PubMed, Embase, Scopus, Web of Science, and the
Cochrane Library from inception through September 17, 2020;
RCTs that involved adult patients with complaints of tinnitus,
compared LLLT to a placebo and provided sufficient
information for meta-analysis were considered eligible.
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Outcome measures included THI score; improvement rates of
the VAS, verbal rating scale (VRS) and NRS scores. A total of
11 studies involving 670 patients were included. No significant
difference in the overall effect according to the THI score (MD,
-2.85; 95 % CI: -8.99 to 3.28; p = 0.362; I2 = 0 %) and the
rating scale score improvement rate (RR, 1.35; 95 % CI, 0.81
to 2.27; p = 0.250; I2 = 67 %) was demonstrated between
patients receiving LLLT and those receiving a placebo. None
of the subgroup analyses showed significant differences,
regardless of underlying sensori-neural hearing loss (SNHL),
the number of irradiation sessions or the wavelength used.
The authors concluded that the findings of this meta-analysis
suggested that the value of LLLT in controlling the severity of
tinnitus remains unclear, in part due to the relatively small
number of patients and underlying heterogeneity. These
researchers stated that more large-scale studies of LLLT for
tinnitus related to inner ear disease are needed to further
elucidate the therapeutic effects.
In a systematic review, Ferreira and colleagues (2021)
examined the effects of LLLT on the severity of tinnitus when
compared to no therapy or other modalities of therapies.
These investigators carried out a search in each of the
following databases: Embase, LILACS, PubMed, Science
Direct, Scopus, Web of Science, Google Scholar, and
ProQuest. The inclusion criteria consisted of studies in adults
over 16 years of age, randomized clinical trials in which
subjects presented chronic (greater than or equal to 6 months)
and subjective tinnitus (unilateral or bilateral) as well as with or
without bilateral SNHL, and studies that used only LLLT for
treatment of tinnitus compared to no-therapy group or other
modalities of therapy. No language or time restrictions were
stipulated. The references were managed by Endnote Web
and Rayyan QCRI. After the screening process, a total of 7
studies remained that attained the eligibility criteria.
Regarding the risk of bias, only 1 study was categorized as
low-risk of bias; the remaining 6 studies were classified as
moderate-risk of bias. The 7 included studies mainly
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examined the LLLT effects on tinnitus by VAS, THI, pitch and
loudness matching, minimum masking level, and pure-tone
audiometry. All 7 selected studies found different degrees of
significant results regarding tinnitus severity; however, there
was no consensus among the results. The authors concluded
that although LLLT showed positive effects in the tinnitus
severity in some studies, it is not possible yet to make any
recommendation over its uses for the treatment of tinnitus
severity.
Achilles Tendinopathy
In a systematic review and meta-analysis, Martimbianco and
colleagues (2020) examined the benefits and harms of LLLT
for the treatment of Achilles tendinopathy. Search strategies
were conducted (from inception to February 2020) in
Cochrane Central Register of Controlled Trials (CENTRAL),
Medline, Embase, Cumulative Index to Nursing and Allied
Health Literature (CINAHL), Literatura Latino Americana em
Ciências da Saúde e do Caribe (LILACS), Physiotherapy
Evidence Database (PEDro), SPORTDiscus,
ClinicalTrials.gov, World Health Organization (WHO)-ICTRP
and OpenGrey databases, to retrieve all RCTs that compared
laser therapy with inactive/active interventions. This study was
reported following the PRISMA statement. The risk of bias
was evaluated using the Cochrane Risk of bias table. Meta-
analyses were carried out on dependence of homogeneity,
otherwise results were reported narratively. The certainty of
evidence was assessed using the Grading of
Recommendations Assessment, Development and Evaluation
(GRADE) approach. A total of 4 trials (119 subjects) were
analyzed. Laser therapy associated to eccentric exercises
when compared to eccentric exercises and sham had very low
to low certainty of evidence in pain and function assessment.
Despite 1 trial favored laser therapy at 2 months (MD -2.55, 95
% CI: -3.87 to -1.23), the CIs did not include important
differences between groups at 3 and 13 months. The function
assessment showed an improvement favoring the placebo
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group at 1 month (MD 9.19, 95 % CI: -16.16 to -2.23) and non-
significant difference between groups at 3 and 13 months.
Adverse events (AEs) were poorly reported but restricted to
minor events related to the exercises. The authors concluded
that the certainty of evidence was low to very low, and the
results were insufficient to support the routine use laser
therapy for Achilles tendinopathy.
Burning Mouth Syndrome
Matos and colleagues (2021) noted that primary burning
mouth syndrome (BMS) is a chronic clinical condition of
idiopathic mainly characterized by pain and a burning
sensation in the oral cavity. The application of laser at low
intensity therapy is a therapeutic option. In a systematic
review, these investigators examined the effectiveness of laser
therapy in treating symptoms of BMS. The study was
conducted according to the PRISMA and Cochrane
guidelines. A total of 7 databases were used as primary
sources of research. Only randomized controlled trials (RCTs)
were included. The effectiveness of the therapy was
estimated comparing the values of the visual and numerical
scales of pain before and after laser treatment, via qualitative
analysis. The search yielded 348 records and only 8 met the
eligibility criteria and were included. All studies examined pain
and / or a burning sensation considering a time interval of 2 to
10 weeks. The total sample consisted of 314 patients
submitted to treatment: 123 from the control group, who
participated with laser off or with the tip blocked, and 191 from
the intervention group, treated with LLLT. The female gender
stood out and the average age of the subjects was 60.89
years. The main symptoms reported were pain and a burning
sensation in the oral mucosa and tongue. The parameters
adopted by these researchers for laser treatment were diverse
and the variables were not fully described in the published
studies; VAS and numerical scales were used to evaluate
symptoms; and only 3 studies showed statistical significance.
The authors concluded that it is suggested that laser therapy
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may be an effective alternative in the treatment of BMS.
Moreover, these researchers stated that new randomized
clinical trials should consider well-established protocols to
better understand the effectiveness of laser therapy without
confounding the effects.
Keratosis Pilaris
Kechichian and colleagues (2020) noted that keratosis pilaris
(KP) is a common hereditary keratinization disorder. Keratosis
pilaris rubra and KP atrophicans faciei are less frequent
variants of the disease. Topical treatments often yield
ineffective and temporary results. These researchers
examined available studies that used light and laser devices
for the treatment of KP and its variants. On January 15, 2017,
an online search of the Medline, Embase, and Cochrane
databases was carried out using the following combination of
keywords: "keratosis pilaris" and "treatment". A total of 17
studies related to light and laser treatments were retained for
analysis. The total number of treated patients was 175; of
which, 22 patients had KP atrophicans faciei, 17 patients had
KP rubra, and 136 patients had KP. The authors concluded
that light and laser devices have been emerging as promising
therapeutic options for a disfiguring disease that still lacks,
until today, an effective long-term treatment.
Furthermore, an UpToDate review on “Keratosis
pilaris” (Landis, 2021) states that “Third-line therapies include
systemic retinoids, laser therapy, or other ablative procedures.
Combination treatments with lasers (e.g., pulsed-dye laser,
long-pulsed 755-nm alexandrite laser, 810-nm long-pulsed
diode laser, long-pulsed 1064-nm Nd:YAG laser) and
microdermabrasion have been tried in a few patients with
temporary reduction of perifollicular erythema and skin
roughness”. Moreover, laser is not listed in the “Summary and
Recommendations” section of the review.
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Melasma
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Masub and colleagues (2020) stated that melasma is a
common acquired disorder of hyper-pigmentation, classically
manifesting as symmetric brown patches on the face.
Although the exact pathogenesis is still unclear, vascular
abnormalities have been implicated in melasma. In a
systematic review, these researchers examined the laboratory
and clinical evidence regarding the safety and effectiveness of
anti-vascular agents for the treatment of melasma. They
carried out a systematic search of PubMed, Embase, and
Cochrane on May 13, 2020, using the PRISMA guidelines.
Original research articles examining the role of vascularity
and/or evaluating the use of anti-vascular therapeutics in
melasma were included. Clinical recommendations were
based on the American College of Physicians (ACP)
guidelines. A total of 34 original research articles were
identified: 4 laboratory studies, 15 diagnostic studies, and 15
therapeutic studies. The authors concluded that there is
promising evidence supporting the use of tranexamic acid and
laser/light therapies to treat the vascular component of
melasma, and more rigorous clinical trials are needed to
validate their efficacy. Clinicians may consider treatment with
1 or more anti-vascular therapeutics in patients with melasma.
Moreover, these researchers stated that further research is
needed to characterize the role of cutaneous vascularization in
melasma and may provide insights for novel therapies.
Oral Ulcers in Chronic Graft-Versus-Host Disease
In a retrospective study, Finfter and colleagues (2020)
examined the pain-relieving effect of photobiomodulation (low-
level laser) therapy (PBMt) in patients with oral ulcers of
chronic graft-versus-host disease (cGVHD) refractory to 1st-
line therapy with topical corticosteroids. This study included all
patients who underwent PBMt for pain relief of refractory oral
cGVHD lesions. PBMt was applied using an intra-oral
approach to all sites with mucosal lesions, using a 940-nm
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InGaAsP diode laser device, with the following parameters:
pulsed modulation (duty cycle of 50 %), power 0.7 W,
illuminated spot size 7.1 cm2, irradiance 98.6 mW/cm2, and
irradiation time 90 s per point. Pain was self-assessed using a
0 to 10 scale immediately before and after PBMt. Data from
11 patients with a total of 56 PBMt sessions were analyzed. In
48 (85.7 %) sessions, the patients reported less pain
immediately after treatment, with a reduction of greater than or
equal to 50 % of the initial pain level in 43 (76.8 %) sessions.
Mean pre- and post-treatment pain levels were 5.20 ± 2.7 and
1.38 ± 2.1, respectively (p < 0.001), i.e., a post-treatment
reduction of 73.4 % of the initial pain level. The benefits of the
treatment remained for a mean of 6.50 ± 5.4 days (range of 2
to 14 days). No adverse effects were reported. The authors
concluded that PBMt appeared to be a promising treatment
modality for refractory oral cGVHD lesions as a rapid pain
reliever with relatively long-lasting effects. Moreover, these
researchers stated that prospective, larger-scale, randomized
placebo-controlled trials are needed to validate these
preliminary findings.
The authors stated that the drawbacks of this study included
the absence of a placebo control group and the small number
of patients (n = 11); however, in this study, each patient was
compared with him/herself immediately before PBMt, and pain
relief was reported by all patients after the vast majority of
sessions. Despite the small number of patients, the total
number of treatment sessions was sufficient. Thus, these
findings supported previous studies, and together, they
highlighted the potential of PBMt in the treatment of oral
cGVHD lesions.
High Powered Lasers
High power laser therapy devices, also referred to as high
does laser therapy (HDLT), (class IV therapeutic lasers) are
purported to stimulate accelerated healing energy from
superficial to deep levels (six to nine inches) over a larger
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surface treatment area. Its proposed use includes conditions
such as arthritis, carpal tunnel syndrome, epicondylitis,
sprains/strains, trigger points and various other
musculoskeletal disorders. These devices are not to be
confused with class IV surgical lasers. Examples of high power
laser therapy devices that have received US Food and Drug
Administration (FDA) approval are the AVI HP-7.5, AVI HPLL-
12 and Diowave Laser System.
High-power lasers (class IV therapeutic lasers; not to be
confused with class IV surgical lasers) have power output of
up to 7,500 mW; and supposedly offer more power,
deeper penetration (can penetrate up to 10 cm2 instead of 0.5
to 2.0 cm2 for class III lasers) and a larger surface treatment
area (cover up to 77 cm2 instead of 0.3 to 5.0 cm2 for class III
lasers). Despite little scientific support, high-power
lasers have been employed for various indications including
musculoskeletal disorders (e.g., carpal tunnel syndrome and
lateral epicondylitis), pain relief, and wound healing.
Plaghki and Mouraux (2005) noted that laser heat stimulators
selectively activate Adelta and C-nociceptors in the superficial
layers of the skin. Their high-power output produces steep
heating ramps, which improve synchronization of afferent
volleys and thus allow the recording of time-locked events
(e.g., laser-evoked brain potentials). Study of the electrical
brain activity evoked by Adelta- and C-nociceptor afferent
volleys revealed the existence of an extensive, sequentially
activated, cortical network. These electro-physiological
responses are modulated by stimulus-driven and, even more
extensively, top-down processes. The specificity and validity
of these components for pain research are currently under
intense scrutiny.
In a systematic review on treatment of pressure ulcers, Reddy
and colleagues (2008) concluded that there is little evidence to
support routine nutritional supplementation or adjunctive
therapies including laser therapy compared with standard
care.
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CPT Codes / HCPCS Codes / ICD-10 Codes
Information in the [brackets] below has been added for clarification purposes. Codes requiring a 7th character are represented by "+":
Code Code Description
CPT codes covered if selection criteria are met:
0552T Low-level laser therapy, dynamic photonic and
dynamic thermokinetic energies, provided by a
physician or other qualified health care
professional
CPT codes not covered for indications listed in the CPB:
High-power laser therapy (class IV therapeutic laser) - no specific code:
Other CPT codes related to the CPB:
20560 Needle insertion(s) without injection(s); 1 or 2
muscle(s)
20561 3 or more muscles
HCPCS codes not covered for indications listed in the CPB:
S8948 Application of a modality (requiring constant
provider attendance) to one or more areas; low-
level laser; each 15 minutes
ICD-10 codes covered if selection criteria are met:
C00.0 –
C17.9,
C22.0 –
C96.9
Malignant neoplasm [except Malignant
neoplasm of colon, rectum, rectosigmoid
junction, anus and anal canal]
K12.30 -
K12.39
Oral mucositis (ulcerative)
ICD-10 codes not covered for indications listed in the CPB (not all-inclusive):
B00.9 Herpesviral infection, unspecified
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Code Code Description
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C18.0 -
C21.8
Malignant neoplasm of colon, rectum,
rectosigmoid junction, anus and anal canal
D89.811 Chronic graft-versus-host disease
D89.812 Acute on chronic graft-versus-host disease
E06.3 Autoimmune thyroiditis
E66.01 -
E66.9
Overweight and obesity
E75.00 -
E75.6
Disorders of sphingolipid metabolism and other
lipid storage disorders
F01.50 -
F01.51
Vascular dementia with or without behavioral
disturbance
F02.80 -
F02.81
Dementia in other diseases classified
elsewhere with or without behavioral
disturbance
F03.90 -
F03.91
Unspecified dementia with or without behavioral
disturbance
F32.0 -
F33.9
Major depressive disorder, single episode or
recurrent
G10 -
G37.9
G90.01 -
G94
Degenerative diseases of the central nervous
system
G50.0 Trigeminal neuralgia
G56.00 -
G56.03
Carpal tunnel syndrome [rehabilitation following
carpel tunnel release]
H93.11 -
H93.19
Tinnitus
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Code Code Description
H93.A1 -
H93.A9
Pulsatile tinnitus
I21.01 -
I23.8
Myocardial infarction [cardio-protection
following]
I50.1 -
I50.9
Heart failure
I60.00 -
I68.8
Cerebrovascular disease [stroke]
I89.0 -
I89.9
Other noninfective disorders of lymphatic
vessels and lymph nodes
I97.2 Postmastectomy lymphedema syndrome
K04.4,
K04.5,
K05.20 -
K05.229,
K05.30 -
K05.329
Periodontitis
K08.0 -
K08.0
Other disorders of teeth and supporting
structures [orthodontic pain] [dentin
hypersensitivity]
K12.0 Recurrent oral aphthae
K14.6 Glossodynia [burning mouth syndrome]
L10.0 Pemphigus vulgaris
L43.0 -
L43.9
Lichen planus [oral]
L63.0 -
L63.9
Alopecia areata
L64.0 -
L64.9
Androgenic alopecia
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Code Code Description
L65.0 -
L65.9
Other nonscarring hair loss
L81.1 Chloasma [Melasma]
L85.8 Other specified epidermal thickening [Keratosis
pilaris]
L89 -
L89.95
Pressure ulcer
M00.00 -
M99.9
Diseases of the musculoskeletal system and
connective tissue
N64.4 Mastodynia
Q35.1 -
Q37.9
Cleft lip and cleft palate [bone healing following
rapid maxillary expansion]
S04.30XA
-
S04.32XS
Injury of trigeminal nerve [inferior alveolar nerve
and lingual nerve injuries]
S06.0x0+
-
S06.9x9+
Intracranial injury
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Code Code Description
S39.001A
-
S39.093S,
S46.001A
-
S46.999S,
S56.001A
-
S56.999S,
S66.001A
-
S66.999S,
S76.001A
-
S76.999S,
S86.001A
-
S86.999S,
S96.001S
-
S96.999S
Injury of muscle, fascia and tendon
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Code Code Description
T20.00A
T20.39S,
T21.00A
T21.39S,
T22.00A
T22.399S,
T23.00A
T23.399S,
T24.00A
T24.399S,
T25.00A
T25.399S,
T26.00A
T26.399S,
T31.00A
T31.99S
Burns [skin]
T81.89x+ Other complications of procedures, not
elsewhere classified [Non-healing surgical
wound]
T85.44A -
T85.44S
Capsular contracture of breast implant
Z98.890 Other specified postprocedural states [wound
healing following hammertoe surgery]
Numerous
options
Open wound [Codes not listed due to expanded
specificity]
The above policy is based on the following references:
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Clayton, VIC: Centre for Clinical Effectiveness (CCE);
2001.
2. Afifi L, Maranda EL, Zarei M, et al. Low-level laser
therapy as a treatment for androgenetic alopecia.
Lasers Surg Med. 2017;49(1):27-39.
3. Ahmed MK, Jafer M, Nayeem M, et al. Low-level laser
therapy and topical medications for treating aphthous
ulcers: A systematic review. J Multidiscip Healthc.
2020;13:1595-1605.
4. Akram Z, Abduljabbar T, Vohra F, Javed F. Efficacy of
low-level laser therapy compared to steroid therapy in
the treatment of oral lichen planus: A systematic
review. J Oral Pathol Med. 2018 Jan;47(1):11-17.
5. Albaker AM, ArRejaie AS, Alrabiah M, Abduljabbar T.
Effect of photodynamic and laser therapy in the
treatment of peri-implant mucositis: A systematic
review. Photodiagnosis Photodyn Ther. 2018;21:147-
152.
6. Alberta Heritage Foundation for Medical Research
(AHFMR), Institute of Health Economics. The use of low
level laser therapy in wound care in Alberta, Canada:
Results of a survey of physical therapists involved in
rehabilitation, long term care and home care.
Edmonton, AB: AHFMR; 2001.
7. Al-Maweri SA, Javed F, Kalakonda B, et al. Efficacy of
low level laser therapy in the treatment of burning
mouth syndrome: A systematic review. Photodiagnosis
Photodyn Ther. 2017;17:188-193.
8. Al-Maweri SA, Kalakonda B, AlAizari NA, et al. Efficacy
of low-level laser therapy in management of recurrent
herpes labialis: A systematic review. Lasers Med Sci.
2018;33(7):1423-1430.
9. Al-Maweri SA, Kalakonda B, Al-Soneidar WA, et al.
Efficacy of low-level laser therapy in management of
symptomatic oral lichen planus: A systematic review.
Lasers Med Sci. 2017;32(6):1429-1437.
https://aetnet.aetna.com/mpa/cpb/300_399/0363.html
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10. Altan L, Bingol U, Aykac M, Yurtkuran M. Investigation
of the effect of GaAs laser therapy on cervical
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(1):23-27.
11. American College of Occupational and Environmental
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12. Amid R, Kadkhodazadeh M, Ahsaie MG, Hakakzadeh A.
Effect of low level laser therapy on proliferation and
differentiation of the cells contributing in bone
regeneration. J Lasers Med Sci. 2014;5(4):163-170.
13. Arbabi-Kalati F, Bakhshani NM, Rasti M. Evaluation of
the efficacy of low-level laser in improving the
symptoms of burning mouth syndrome. J Clin Exp
Dent. 2015;7(4):e524-e527.
14. Atasoy KT, Korkmaz YT, Odaci E, Hanci H. The efficacy
of low-level 940 nm laser therapy with different energy
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15. Ay S, Doğan SK, Evcik D. Is low-level laser therapy
effective in acute or chronic low back pain? Clin
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16. Azimi F, Flitcroft K, Mathieu E, et al. Low-level laser
treatment is ineffective for capsular contracture:
Results of the LaTCon randomized controlled trial.
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therapy (Photobiomodulation therapy) for breast
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cancer-related lymphedema: A systematic review. BMC
Cancer. 2017;17(1):833.
20. Bayer S, Kazancioglu HO, Acar AH, et al. Comparison of
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22. Beckmann KH, Meyer-Hamme G, Schroder S. Low level
laser therapy for the treatment of diabetic foot ulcers:
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23. Bekhet AH, Ragab B, Abushouk AI, et al. Efficacy of low-
level laser therapy in carpal tunnel syndrome
management: A systematic review and meta-analysis.
Lasers Med Sci. 2017;32(6):1439-1448.
24. Bier JD, Scholten-Peeters WGM, Staal JB, et al. Clinical
practice guideline for physical therapy assessment and
treatment in patients with nonspecific neck pain. Phys
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28. Brassolatti P, de Andrade ALM, Bossini PS, et al.
Evaluation of the low-level laser therapy application
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29. Brosseau L, Robinson V, Wells G, et al. Low level laser
therapy (Classes I, II and III) for treating rheumatoid
arthritis. Cochrane Database Syst Rev. 2005;
(4):CD002049.
30. Brosseau L, Robinson V, Wells G, et al. Low level laser
therapy (Classes III) for treating osteoarthritis.
Cochrane Database Syst Rev. 2007;(1):CD002046.
31. Bulow PM, Jensen H, Denneskiold-Samsoe B. Low-
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159.
32. California Technology Assessment Forum (CTAF). Low-
energy laser therapy for the treatment of carpal tunnel
syndrome. Technology Assessment. San Francisco, CA:
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33. Carati CJ, Anderson SN, Gannon BJ, Piller NB.
Treatment of postmastectomy lymphedema with low-
level laser therapy: A double blind, placebo-controlled
trial. Cancer. 2003; 98(6):1114-1122.
34. Carlos FP, Gradinetti V, Manchini M, et al. Role of low-
level laser therapy on the cardiac remodeling after
myocardial infarction: A systematic review of
experimental studies. Life Sci. 2016;151:109-14.
35. Carrasco TG, Guerisoli LD, Guerisoli DM, Mazzetto MO.
Evaluation of low intensity laser therapy in myofascial
pain syndrome. Cranio. 2009;27(4):243-247.
36. Centre for Reviews and Dissemination (CRD). Efficacy
of low-level laser therapy in the management of neck
pain: A systematic review and meta-analysis of
randomised placebo or active-treatment controlled
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York, UK: University of York; November 25, 2009.
37. Chapell R, Turkelson CM, Coates V, et al. Diagnosis and
treatment of worker-related musculoskeletal disorders
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of the upper extremity. Evidence Report/Technology
Assessment 62. Rockville, MD: AHRQ; 2002.
38. Chen C-H, Huang C-Y, Chang C-Y, Cheng Y-F. Efficacy of
low-level laser therapy for tinnitus: A systematic review
with meta-analysis and trial sequential analysis. Brain
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39. Cheung WKW, Wu IXY, Sit RWS, et al. Low-level laser
therapy for carpal tunnel syndrome: Systematic review
and network meta-analysis. Physiotherapy.
2020;106:24-35.
40. Chi CC, Wang SH, Delamere FM, et al. Interventions for
prevention of herpes simplex labialis (cold sores on
the lips). Cochrane Database Syst Rev.
2015;8:CD010095.
41. Chow RT, Johnson MI, Lopes-Martins RA, Bjordal JM.
Efficacy of low-level laser therapy in the management
of neck pain: A systematic review and meta-analysis of
randomised placebo or active-treatment controlled
trials. Lancet. 2009;374(9705):1897-1908.
42. Cote P, Wong JJ, Sutton D, et al. Management of neck
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43. Crawford F, Thomson C. Interventions for treating
plantar heel pain. Cochrane Database Syst Rev. 2003;
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44. Cullum N, Petherick E. Pressure ulcers. In: BMJ Clinical
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2007.
45. Darwin E, Heyes A, Hirt PA, et al. Low-level laser
therapy for the treatment of androgenic alopecia: A
review. Lasers Med Sci. 2018;33(2):425-434.
46. de Andrade AL, Bossini PS, Parizotto NA. Use of low
level laser therapy to control neuropathic pain: A
systematic review. J Photochem Photobiol B.
2016;164:36-42.
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47. de Bie RA, de Vet HC, Lenssen AF, et al. Low-level laser
therapy in ankle sprains: A randomized clinical trial.
Arch Phys Med Rehabil. 1998;79(11):1415-1420.
48. de Carvalho Pde T, Leal-Junior EC, Alves AC, et al. Effect
of low-level laser therapy on pain, quality of life and
sleep in patients with fibromyalgia: Study protocol for
a double-blinded randomized controlled trial. Trials.
2012;13:221.
49. de Lima VHS, de Oliveira-Neto OB, da Hora Sales PH, et
al. Effectiveness of low-level laser therapy for oral
mucositis prevention in patients undergoing
chemoradiotherapy for the treatment of head and
neck cancer: A systematic review and meta-analysis.
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50. de Paula Eduardo C, Aranha AC, Simoes A, et al. Laser
treatment of recurrent herpes labialis: A literature
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51. de Pedro M, Lopez-Pintor RM, de la Hoz-Aizpurua JL, et
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52. Delaney SW, Zhang P. Systematic review of low-level
laser therapy for adult androgenic alopecia. J Cosmet
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53. Doeuk C, Hersant B, Bosc R, et al. Current indications
for low level laser treatment in maxillofacial surgery: A
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54. Dos Santos CM, da Rocha RB, Hazime FA, Cardoso VS.
A systematic review and meta-analysis of the effects of
low-level laser therapy in the treatment of diabetic
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[Online ahead of print].
55. Evans K, Kim PS. Overview of treatment of chronic
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56. Ferreira MC, de Matos IL, de Toledo IP, et al. Effects of
low-level laser therapy as a therapeutic strategy for
patients with tinnitus: A systematic review. J Speech
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57. Finfter O, Avni B, Grisariu S, et al. Photobiomodulation
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58. Flemming K, Cullum N. Laser therapy for venous leg
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59. Flemming K, Cullum N. Systematic reviews of wound
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60. Gerritsen AA, de Krom MC, Struijs MA, et al.
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61. Green S, Buchbinder R, Hetrick S. Physiotherapy
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62. Gross AR, Aker PD, Goldsmith CH, et al. Physical
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63. Gross AR, Dziengo S, Boers O, et al. Low level laser
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64. Gupta AK, Foley KA. A critical assessment of the
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65. He WL, Li CJ, Liu ZP, et al. Efficacy of low-level laser
therapy in the management of orthodontic pain: A
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67. Hennessy M, Hamblin MR. Photobiomodulation and
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68. Heussler JK, Hinchey G, Margiotta E, et al. A double
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69. Hirschl M, Katzenschlager R, Ammer K, et al. Double-
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70. Hirschl M, Katzenschlager R, Francesconi C, Kundi M.
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71. Hofling DB, Chavantes MC, Buchpiguel CA, et al. Safety
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72. Huang Z, Chen J, Ma J, et al. Effectiveness of low-level
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73. Johannsen F, Hauschild B, Remvig L, et al. Low energy
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74. Kadhim-Saleh A, Maganti H, Ghert M, et al. Is low-level
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75. Kaviani A, Fateh M, Yousefi Nooraie R, et al. Low-level
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76. Kechichian E, Jabbour S, El Hachem L, et al. Light and
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77. Krasheninnikoff M, Ellitsgaard N, Rogvi-Hansen B, et al.
No effect of low power laser in lateral epicondylitis.
Scand J Rheumatol. 1994;23(5):260-263.
78. Kreisler MB, Haj HA, Noroozi N, Willershausen B.
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79. Lake DA, Wofford NH. Effect of therapeutic modalities
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83. Li S, Wang C, Wang B, et al. Efficacy of low-level light
therapy for treatment of diabetic foot ulcer: A
systematic review and meta-analysis of randomized
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2018;143:215-224.
84. Li X, Zhang L, Gu S, et al. Comparative effectiveness of
extracorporeal shock wave, ultrasound, low-level laser
therapy, noninvasive interactive neurostimulation, and
pulsed radiofrequency treatment for treating plantar
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fasciitis: A systematic review and network meta-
analysis. Medicine (Baltimore). 2018;97(43):e12819.
85. Li ZJ, Wang Y, Zhang HF, et al. Effectiveness of low-level
laser on carpal tunnel syndrome: A meta-analysis of
previously reported randomized trials. Medicine
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86. Liu KH, Liu D, Chen YT, Chin SY. Comparative
effectiveness of low-level laser therapy for adult
androgenic alopecia: A system review and meta-
analysis of randomized controlled trials. Lasers Med
Sci. 2019;34(6):1063-1069.
87. Lucke LD, Bortolazzo FO, Theodoro V, et al. Low-level
laser and adipose-derived stem cells altered
remodelling genes expression and improved collagen
reorganization during tendon repair. Cell Prolif.
2019;52(3):e12580.
88. Machado RS, Viana S, Sbruzzi G. Low-level laser
therapy in the treatment of pressure ulcers:
Systematic review. Lasers Med Sci. 2017;32(4):937-944.
89. Magri LV, Carvalho VA, Rodrigues FC, et al.
Effectiveness of low-level laser therapy on pain
intensity, pressure pain threshold, and SF-MPQ
indexes of women with myofascial pain. Lasers Med
Sci. 2017;32(2):419-428.
90. Manchini MT, Antônio EL, Silva Junior JA, et al. Low-
level laser application in the early myocardial
infarction stage has no beneficial role in heart failure.
Front Physiol. 2017;8:23.
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