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MP 2.01.56 Low-Level Laser Therapy

Medical Policy    
Section
Medicine 
Original Policy Date
4/29/03
Last Review Status/Date
Reviewed with literature search/11:2014
Issue
11:2014
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Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.


Description

 

Low-level laser therapy (LLLT) refers to the use of red-beam or near-infrared lasers with a wavelength between 600 and 1000 nm and power from 5 to 500 MW. (In contrast, lasers used in surgery typically use 300 W.) When applied to the skin, these lasers produce no sensation and do not burn the skin. Because of the low absorption by human skin, it is hypothesized that the laser light can penetrate deeply into the tissues where it has a photobiostimulative effect. The exact mechanism of its effect on tissue healing is unknown; hypotheses have included improved cellular repair and stimulation of the immune, lymphatic, and vascular systems. LLLT is being evaluated to treat a wide variety of conditions, including soft tissue injuries, myofascial pain, tendinopathies, nerve injuries, and joint pain. LLLT has also been evaluated for lymphedema.

One of the disorders that LLLT has been evaluated for is the treatment of carpal tunnel syndrome. Carpal tunnel syndrome is the most common entrapment neuropathy and the most commonly performed surgery of the hand. The syndrome is related to the bony anatomy of the wrist. The carpal tunnel is bound dorsally and laterally by the carpal bones and ventrally by the transverse carpal ligament. Through this contained space run the 9 flexor tendons and the median nerve. Therefore any space-occupying lesion can compress the median nerve and produce the typical symptoms of carpal tunnel syndrome—pain, numbness, and tingling in the distribution of the median nerve. Symptoms of more severe cases include hypesthesia, clumsiness, loss of dexterity, and weakness of pinch. In the most severe cases, patients experience marked sensory loss and significant functional impairment with thenar atrophy. Mild to moderate cases of carpal tunnel syndrome are usually first treated conservatively with splinting and cessation of aggravating activities. Other conservative therapies include oral steroids, diuretics, nonsteroidal anti-inflammatory drugs (NSAIDs), and steroid injections into the carpal tunnel itself. Patients who do not respond to conservative therapy or who present with severe carpal tunnel syndrome with thenar atrophy may be considered candidates for surgical release of the carpal ligament, using either an open or endoscopic approach.

LLLT is also being evaluated for cancer therapy-induced oral mucositis in patients treated by radiotherapy and/or chemotherapy and hematopoietic stem-cell transplantation (HSCT). Oral mucositis describes inflammation of the oral mucosa and typically manifests as erythema or ulcerations that appear 7 to 10 days after initiation of high-dose cancer therapy. Oral mucositis can cause significant pain and increase risk of systemic infection, dependency on total parenteral nutrition, and use of narcotic analgesics. Treatment planning may also need to be modified due to dose-limiting toxicity. There are a number of interventions for oral mucositis that may partially control symptoms, but none are considered a gold standard treatment. When uncomplicated by infection, oral mucositis is self-limited and usually heals within 2 to 4 weeks after cessation of cytotoxic chemotherapy.

Regulatory Status

A number of low-level lasers have received clearance for marketing from the U.S. Food and Drug Administration (FDA) for the treatment of pain. Data submitted to the FDA as part of the FDA 510(k) approval process for the MicroLight 830® Laser consisted of application of the laser over the carpal tunnel 3 times a week for 5 weeks. The labeling states that the "MicroLight 830 Laser is indicated for adjunctive used in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome." In 2006, the FDA provided marketing clearance for the GRT LITE™, which listed the Tuco Erchonia PL3000, the Excalibur System, the Microlight 830 Laser, and the Acculaser Pro as predicate devices. Indications of the GRT LITE for carpal tunnel syndrome are similar to the predicate devices: “adjunctive use in providing temporary relief of minor chronic pain.” The LightStream™ Low Level Laser device received 510(k) marketing clearance in 2009 for adjunctive use in the temporary relief of pain associated with knee disorders with standard chiropractic practice. A number of clinical trials of LLLT are underway in the United States, including studies of wound healing.


Policy

 

Low-level laser therapy (LLLT) is considered investigational for all indications including, but not limited to treatment of carpal tunnel syndrome.


Policy Guidelines

 

Other protocols have used low-level laser energy applied to acupuncture points on the fingers and hand. This technique may be referred to as "laser acupuncture." Laser acupuncture is not reviewed in this policy.

There is no specific CPT code for low-level laser therapy. However, providers may elect to use CPT code 97026 (application of a modality; infrared), since the laser emits light in the infrared spectrum. In January 2004, a HCPCS code (S8948) was added that is specific to this therapy.


Benefit Application 

 

BlueCard/National Account Issues

MicroLight Corporation has published a list of providers offering low-level laser therapy; the vast majority of providers are chiropractors. Given that the therapy typically requires up to 15 treatments, contractual or benefit restrictions on chiropractic visits for an individual diagnosis may apply.

State or federal mandates (e.g., FEP) may dictate that all devices approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational, and thus these devices may be assessed only on the basis of their medical necessity.

 


 

Rationale

This policy was originally created in 2003 and has been regularly updated with searches of the MEDLINE database. The most recent literature review was performed from September 2013 through October 21, 2014. The following is a summary of the key findings to date.

The principal outcomes associated with treatment of musculoskeletal conditions, including carpal tunnel syndrome, are relief of pain and/or return to work and/or functional status. Relief of pain is a subjective outcome that is typically associated with a placebo effect. Therefore, blinded and randomized controlled trials (RCTs) are required to control for the placebo effect and determine its magnitude and whether any treatment effect provides a significant advantage over the placebo. The technology must also be evaluated in general groups of patients. In patients with mild to moderate symptoms, low-level laser therapy (LLLT) may be compared with other forms of conservative therapy such as splinting, rest, nonsteroidal anti-inflammatory drugs (NSAIDs), or steroid injection. Second, in a group of patients who have exhausted conservative therapy, LLLT must be compared with surgical intervention. Another relevant outcome measure for treatment is return to work. It is difficult to analyze this outcome because the criteria for returning to work are often variable and job-specific, and it is not known whether this decision is driven by the patient, physician, or employer. Finally, the extraclinical issue of workmen's compensation frequently influences the decision to return to work. Outcomes associated with wound
healing include incidence of complete wound closure and time to various stages of wound closure.

Multiple Etiologies of Pain

For the most part, studies of LLLT for treatment of pain compare laser treatment with a sham treatment only, rather than comparison with treatments known to be effective. With very few exceptions, the studies are from centers outside the United States. A 2009 systematic review included controlled trials of LLLT as primary intervention for any tendinopathy.(1) Twenty-five trials were included, with conflicting findings for each indication studied. Twelve studies showed positive effects, and 13 were inconclusive or showed no effect. Thirteen studies investigated LLLT for epicondylitis, 6 of them showing positive results. The largest of these trials had only 58 subjects. Two of the positive studies were of poor quality. Four studies examined LLLT for tendinopathy in the shoulder, 4 of them were of high quality. The largest of these trials had just 30 subjects. Three of these trials found a positive effect of LLLT. Two of the positive studies had placebo controls, and the third compared LLLT with ultrasound (US) or placebo. Of the 5 trials of LLLT for Achilles tendinitis included in the review, 2 demonstrated a benefit of LLLT. One of the positive and 1 of the negative studies of LLLT for Achilles tendinitis received the highest quality rating. One of the negative studies was the largest study (n=89) included in the review but scored only 5 of 10 possible points for study quality. Three studies included subjects with a variety of indications; all reported inconclusive or no effect of LLLT. The authors reported that dosages used in the positive trials suggested that there is an effective dosage window; however the only parameter reported for all studies was wavelength. Power density and dose were not provided, or there was too little information provided in the studies to calculate the dose.

Jang and Lee conducted a meta-analysis of 22 randomized sham-controlled trials of LLLT for the treatment of joint pain including temporomandibular joints, glenohumeral joints, knee joints, and cervical and lumbar spinal regions.(2) Only trials that had a Physiotherapy Evidence Database (PEDro) quality rating of 5 or more were included; the average PEDro score of the included trials was 7.96. There were a total of 668 subjects who received laser therapy and 565 subjects who were treated with sham laser. Although half of the trials had negative results, the mean weighted improvement in visual analog scales (VAS) for pain was 13.96 mm (of 100 mm). When only trials that were within the range of recommended energy doses for each joint region were included, the mean improvement in VAS for pain increased to 19.88 or 21.05 mm, depending on the specific recommendations. Typically, a 20% to 30% improvement in pain is considered clinically significant. This meta-analysis did not assess the percentage of subjects in each condition who had a clinically significant improvement in pain.

In 2010, Fulop et al published a meta-analysis of 22 studies of LLLT for treatment of pain of a variety of etiologies.(3) Inclusion criteria did not specify the timing of measuring outcomes. Some included studies measured outcomes only at the end of treatment and, for others, the timing of measurement was not reported in the analysis. Given these questions, this analysis was not reviewed further. Key studies of LLLT for specific joints are summarized next.

Carpal Tunnel Syndrome

Sham Controlled Trials

The largest body of evidence for LLLT describes its use in treatment of carpal tunnel syndrome. As part of the U.S. Food and Drug Administration (FDA) approval process, the manufacturer of the MicroLight device conducted a double-blind, placebo-controlled study of 135 patients with moderate to severe symptoms of carpal tunnel syndrome who had failed conservative therapy for at least 1 month. However, the results of this study have not been published in the peer-reviewed literature, and only a short summary is available in the FDA Summary of Safety and Effectiveness,(4) which does not permit scientific conclusions.

In November 2010, the BlueCross BlueShield Association Technology Evaluation Center (TEC) published a technology assessment of LLLT for carpal tunnel syndrome and chronic neck pain.(5) For inclusion in the assessment, studies had to: be published in a peer-reviewed journal; be randomized, sham-controlled trials, and, if adjunctive therapies were used, they were applied to both groups; measure outcomes at least 2 weeks beyond the end of the treatment period; and, for neck pain studies, be studies of patients with chronic pain. Four of the studies of carpal tunnel syndrome discussed next(6-9) met the inclusion criteria for the TEC Assessment. TEC concluded that the studies have serious limitations including small sample size and limited follow-up, and no one study is so methodologically sound as to provide definitive results.

Tascioglu et al reported a randomized double-blind sham-controlled trial of LLLT in 2011.(10) Sixty patients with carpal tunnel syndrome were assigned to 1 of 2 active laser dosages (1.2 J or 0.6 J per painful point) or placebo treatment 5 times per week for 3 weeks. VAS scores, grip strength, and functional status scores improved significantly in all groups. The only nerve conduction measure to improve was sensorial nerve velocity in the active laser groups. There was no significant difference between groups for any of the outcome measures. In this study, LLLT was no more effective than placebo.

A 2007 double-blinded randomized sham-controlled trial with 81 patients (141 hands) found slight pre- to posttreatment improvements in sensory (0.2 median sensory nerve [MSN]) and distal (0.3 MSN) latencies for the laser group, while sensory nerve velocity improved (by 2.7 and 2.1 MSN, respectively) in both groups (a wrist splint was used at night in both groups).(8) Other measures of nerve conduction were not affected by treatment. There were no differences between the groups in VAS scores for pain or in symptom severity scores. Irvine et al reported the results of a small double-blinded study of 15 patients with carpal tunnel syndrome who were randomized to receive either LLLT or sham laser therapy.(9) There was a significant improvement in both groups, but there was no significant difference between the groups.

Another small, double-blinded RCT (19 patients with rheumatoid arthritis [RA] and carpal tunnel syndrome) found slight improvement in subjective scales of pain and function (eg, 27-point improvement vs 13-point improvement on VAS vs sham laser therapy), but no differences between groups in objective functional measures (eg, grip strength, 0.3 vs 0.3, respectively), or in measures of nerve conduction (eg, motor nerve conduction velocity, 55 vs 55, respectively).(7) Chang et al report on an RCT with short followup comparing LLLT with sham treatment in 36 patients.(6) After 2 weeks of treatment and 2 weeks after the end of treatment, VAS scores for pain were lower in the treatment group than in the sham group (p<0.05). After 2 weeks of treatment, differences in grip strength, symptoms, and functional assessment were not significant but were significant at the 2-week follow-up (p<0.05). There were no significant between-group differences on nerve conduction studies at either time point. Another RCT with sham control, a study with 80 patients, was reported by Shooshtari et al.(11) Outcomes were measured at the end of 15 treatment sessions (5 times a week for 3 weeks). In this study, the treatment group showed significant improvement in clinical symptoms, hand grip, and nerve conduction studies.

Active Control Trials

Bakhtiary and Rashidy-Pour reported on the outcomes of 50 consecutive patients with carpal tunnel syndrome who were randomized to receive either US therapy or LLLT.(12) Improvement was significantly better in those randomized to US. Dincer et al compared splinting with US, splinting with LLLT, and splinting alone in an RCT.(13) Sixty women were randomized; 10 did not complete the study. One hundred hands (50 women), 30 in the splint with US group, 36 in the splint with LLLT group, and 34 with splint only, were followed for 3 months after treatment and included in the analysis. Outcome measures were the Boston Questionnaire Symptom Severity Scale (BQ-SSS) score, the Boston Questionnaire Functional Status Scale score, VAS score, second digit-wrist median nerve sensory velocity (SV), and median nerve motor distal latency. Splinting with US or LLLT was more effective than splinting alone on all measures 3 months after treatment. LLLT was significantly more effective than US on measures of pain on VAS, BQ-SSS (p=0.03), and SV. Patient satisfaction was higher in the US and LLLT groups than the splint-only group (p=0.05).

Section Summary

The literature on LLLT for carpal tunnel syndrome consists of a number of RCTs. However, results of these trials are inconsistent, with many studies showing no benefit with LLLT.

Neck Pain

In a 2013 systematic review and meta-regression, Gross et al evaluated 17 trials on LLLT for neck pain.(14) Ten of these trials were found to demonstrate high risk of bias. Two trials consisting of 109 subjects were considered to be of moderate quality and found LLLT produced better outcomes than placebo for chronic neck pain treatment. Other evidence showed improved outcomes with LLLT compared with placebo for acute neck pain, acute radiculopathy and cervical osteoarthritis but was considered to be low quality. There was conflicting evidence on chronic myofascial neck pain.

The 2010 TEC Assessment included 6 trials of LLLT for chronic neck pain and found inconsistent results.(5) In the largest study by Chow et al, 90 patients were randomized to active LLLT or sham treatment.(15) At 5 weeks after the 7-week treatment period, patients in the active treatment group reported a 2.7 point improvement in VAS pain versus a 0.3 point worsening for the sham group. A calculated mean improvement of 43.8% was reported by the active LLLT group while the sham-treated group improved by 2.1%. TEC noted that baseline VAS pain scores were significantly higher in the active treatment group possibly biasing results in favor of LLLT. In a 2004 RCT, possibly a pilot study for the larger trial reported by Chow, 20 patients were randomized to LLLT or sham laser.(16) The VAS pain scores improved 2.1 points in the laser-treated group and 0.7 in the sham-treated group, which was not significant; however the percent change was statistically significant, and the change in the neck pain questionnaire scores, McGill Pain Questionnaire, and a global measure of self-reported improvement were significantly greater in the laser-treated group.

Gur et al randomized 30 patients to active or sham laser treatment and reported significant improvement in the active—but not in the sham-treated groups—on numerous measures; however, analysis of the presented results was problematic.(17) In a study by Ceccherelli et al, 27 women were randomized to active (n=13) or sham (n=14) laser treatment and, at 3 months after treatment, the VAS pain score was significantly more improved in the active treatment group.(18) An imbalance in patient characteristics may have impacted results. In a study by Altan et al, 48 patients with myofascial pain syndrome were randomized to active or sham treatment, and all were instructed to perform daily isometric and stretching exercises.(19) At 12 weeks, both groups had improved pain VAS, and there were no significant between-group differences. Ilbuldu et al randomized 40 women with myofascial pain syndrome to active or sham laser.(20) All patients were instructed to do stretching exercises. There were no significant differences between groups for any outcomes measure. (A third group received dry needling; those results were not included in the TEC Assessment.) The TEC Assessment did comment on a systematic review and metaanalysis of randomized placebo or active-treatment controlled trials by Chow et al21 and noted “some studies evaluated acute neck pain, some had insufficient follow-up beyond the period of treatment, one had no sham control.…” Overall, TEC concluded that “the studies are characterized by small sample sizes, limited statistical power, and limited long-term follow-up.”

An RCT of LLLT for acute neck pain with radiculopathy by Konstantinovic et al published in 2010 did not report outcomes at least 2 weeks beyond the end of the treatment period.(22)

Section Summary

The literature on LLLT for treatment of neck pain is conflicting. While some evidence shows positive benefits with LLLT over placebo, larger studies are needed. Additionally, laser types, dosages, and treatment schedules vary in the available evidence and require further study.

Myofascial Neck/Shoulder Pain

Rayegani et al evaluated LLLT in a randomized trial of 49 patients with myofascial pain of the upper trapezius muscle.(23) Following baseline assessments, the patients were randomized to active or sham laser or to US (5 times a week for 2 weeks). All of the patients received stretching exercises, transcutaneous electrical nerve stimulation (TENS), and hot packs. The patients, assessors, and statisticians were blinded to treatment condition. Compared with sham controls, the LLLT group showed significantly greater improvements in VAS during activity, VAS at rest, VAS at night, the Neck Disability Index (NDI), and pain-provoking threshold. Laser was also found to be more effective than US for the NDI and pain provoking threshold, but not in the VAS for pain.

Subacromial Impingement

In a 2009 study designed to assess the effectiveness of LLLT in patients with subacromial impingement syndrome, 44 patients were randomized in equal numbers to receive a 12-week home exercise program with or without LLLT.(24) Outcome measures of night pain, Shoulder Pain and Disability Index (SPADI), and University of California-Los Angeles (UCLA) end-result scores were assessed at the second and twelfth week of intervention. Both groups showed significant reductions in night pain and SPADI at 2- and 12-week assessments. UCLA scores improved significantly in both groups at 12 weeks. No distinct advantage was demonstrated by LLLT over exercise alone.

Another RCT compared outcomes of a 3-week program of exercise with either LLLT or sham therapy for treatment of subacromial impingement.(25) Both groups improved significantly, and there were no significant between-group differences on measures of pain, function, disability, and muscle strength.

In a 2010 report, Dogan et al randomized 52 patients with subacromial impingement syndrome to active or sham LLLT 5 times per week for 14 sessions.(26) All patients were also given an exercise program. Both groups showed improvements in pain, some measures of range of motion (ROM), and on the SPADI. There were no significant differences between the 2 groups.

In 2011, Calis et al randomized 52 patients with subacromial impingement syndrome to LLLT, US, or exercise.(27) Patients were treated 5 days a week for 3 weeks with hotpack + ultrasound + exercise, hotpack + laser + exercise, or hotpack + exercise. All 3 groups showed improvement from baseline to posttreatment in pain at rest, ROM, and function. There were no significant differences between the groups.

In a 2011 publication, Abrisham et al randomized 80 patients with subacromial syndrome (rotator cuff and biceps tendinitis) to exercise plus pulsed LLLT or sham laser 5 times per week for 2 weeks.(28) At the conclusion of the treatment period, both groups showed improvement in VAS for pain and shoulder ROM. The improvement was significantly better for the active LLLT group than the sham laser group for VAS (4.4 vs 2.9), and all measures of ROM (active and passive flexion, abduction, external rotation). The durability of this effect was not assessed.

Section Summary

The literature on LLLT for subacromial syndrome consists of a number of medium-sized RCTs. Most of these trials do not show a benefit of LLLT compared with sham controls.

Frozen Shoulder/Adhesive Capsulitis

A 2014 Cochrane review evaluated LLLT and other electrotherapy modalities for frozen shoulder.(29) The review found limited evidence to draw conclusions on the effectiveness of electrotherapy modalities for frozen shoulder. Only 1 RCT of 40 patients compared LLLT with placebo. This trial administered LLLT for 6 days. On the sixth day, LLLT was considered to have some improvement in a global assessment of treatment success when compared with placebo. However, this study was considered to be of low quality and the small size and short follow-up limited interpretation of results. One other RCT on LLLT discussed in the Cochrane review by Stergioulas(30) was considered to be of moderate quality. In this study, 63 patients with frozen shoulder were included in an RCT comparing an 8-week program of LLLT (n=31) or
placebo (n=32).(30) Both groups also participated in exercise therapy. Compared with the sham group, the active laser group had a significant decrease in overall, night, and activity pain scores after 4 weeks and 8 weeks of treatment, and at the end of 8 more weeks of follow-up. At the same time intervals, a significant decrease in SPADI scores, and Croft shoulder disability questionnaire scores was observed, while a significant decrease in Disability of Arm, Shoulder, and Hand Questionnaire scores was observed at 8 weeks of treatment and at 16 weeks postrandomization; and a significant decrease in health assessment questionnaire scores was observed at 4 weeks and 8 weeks of treatment.

Temporomandibular Joint Pain

In 2014 Chang et al published a meta-analysis of 7 RCTs on LLLT for temporomandibular joint (TMJ) pain.(31) Included RCTs compared LLLT with no treatment or placebo. Only 6 studies were sufficient to be included in the meta-analysis for a total of 223 patients. The number of treatment sessions ranged from 4 to 20. The pooled effect size of pain relief using the VAS was a mean decrease of 0.6 (95% confidence interval [CI], -0.47 to -0.73). Another meta-analysis of RCTs on LLLT for treating TMJ disorders was published in 2011.32 The investigators identified 6 randomized, placebo-controlled trials that met the inclusion criteria. A pooled analysis of data from the 6 trials did not find a statistically significant difference in the primary outcome of interest, change in pain from baseline to end point. The pooled difference in pain, measured on a VAS, was a mean difference of 7.77 mm (95% CI, -2.49 to 18.02; p=0.14). All studies had small sample sizes (range, 14-52 participants), and the  confidence interval in the pooled analysis was wide.

Outcomes of individual trials of LLLT for TMJ pain are inconsistent. In a study from Brazil, 40 patients with TMJ were treated with LLLT or placebo.(33) After 4 weeks of weekly treatment, patients were evaluated for pain on VAS and the Craniomandibular Index. Both groups improved on both measures (p<0.05), and there were no significant differences between groups. Emshoff et al evaluated LLLT in the management of TMJ in a double-blinded RCT with 52 patients randomized equally to LLLT or sham treatment.(34) After 8 weeks of 2 to 3 treatments/week, both groups showed improvements in pain during function. Betweengroup differences were not significant.

Fikackova et al treated 61 patients with TMJ or myofascial pain with LLLT at 1 of 2 densities (10 or 15 J/cm²) and 19 patients with sham LLLT (0.1 J/cm²).(35) Outcomes were measured by self-administered questionnaire. The authors report significantly better outcomes in patients treated with 10 or 15 J/cm² than in patients given sham treatment. There were no differences in outcomes between patients with TMJ and myofascial pain.

Carrasco et al randomly assigned 60 patients with myofascial pain and 1 active trigger point in the anterior masseter and anterior temporal muscles to 6 groups.(36) Three groups received laser treatment twice a week for 4 weeks using different energy levels for each group (25, 60, or 105 J/cm2 ). The other 3 groups received placebo treatment simulating the same parameters as the treated groups. Pain scores were assessed just before, immediately after the fourth and eighth applications, and at 15 days and 1 month after treatment. An analgesic effect was seen starting from the third evaluation in both the treated and placebo groups, and placebo was as effective as laser (p<0.05). Differences in pain VAS between groups treated at different energy levels were not significant.

Venezian et al randomized 48 patients with myofascial pain to 1 of 2 doses of laser (25 or 60 J/cm2 ) or placebo twice a week for 4 weeks.(37) Surface electromyography at the conclusion of testing showed no difference between groups. Pain with palpation was measured by VAS before, at the conclusion of, and 30 days after laser therapy. VAS scores declined in all groups and were more consistently decreased (more regions of the palpated muscles) after active laser therapy. However, there were no significant differences in VAS between the active and sham-controlled groups.

Marini et al compared superpulsed LLLT with NSAIDs for pain caused by TMJs secondary to disc displacement without reduction or osteoarthritis.(38) Ninety-nine patients were randomized to 1 of 3 groups: 39 received LLLT in 10 sessions over 2 weeks, 30 received sham LLLT on the same schedule, and 30 patients received ibuprofen 800 mg twice/day. Pain intensity was measured at baseline and after 2, 5, 10, and 15 days of treatment. Mandibular function (active and passive mouth openings and right and left lateral motions) was evaluated at baseline, 15 days, and 1 month of treatment. Durability of pain relief beyond the end of treatment is not reported. Mandibular function was significantly better at 1 month after treatment in the active laser-treated group.

Section Summary

There are a number of medium to large, randomized, sham-controlled trials of LLLT for temporomandibular syndrome. Most of these trials, along with a recent meta-analysis, do not show a benefit of LLLT.

Bell Palsy

In 2013, Alayat et al reported on a randomized, double-blind, placebo-controlled trial of laser therapy for the treatment of 48 patients with Bell palsy.(39) Facial exercises and massage were given to all patients. Patients were randomized to 1 of 3 groups: high-intensity laser therapy, LLLT, or exercise only. Laser treatment was given 3 times per week to 8 points of the affected side for 6 weeks. At 3 and 6 weeks after treatment, outcomes were assessed using the Facial Disability Scale and the House-Brackmann Scale.

Significant improvements in recovery were seen in both laser therapy groups over exercise alone with the most improvement seen with high-intensity laser.

Section Summary

The limited evidence on laser therapy for Bell palsy is insufficient to draw conclusions. Because Bell palsy often improves within weeks and may completely resolve within months, it is difficult to determine any improvements from laser therapy over the natural resolution of the illness. Therefore, larger studies are needed in addition with comparisons with corticosteroids, antivirals or other Bell palsy treatments.

Low Back Pain

A 2007 update of the Cochrane Database System Review of LLLT for nonspecific low back pain concluded that “based on the heterogeneity of the populations, interventions, and comparison groups, we conclude that there are insufficient data to draw firm conclusions on the clinical effect of LLLT for lowback pain.”(40) Chou and Huffman assessed benefits and harms of nonpharmacologic therapies including LLLT for acute and chronic low back pain in a 2007 review of evidence and did not find good evidence of efficacy for LLLT for either indication.(41)

In a large double-blind placebo-controlled study published in 2010, Konstantinovic et al randomized 546 patients with acute low back pain to 3 groups of 182 patients.(42) All patients received nimesulide 200 mg; patients in group A received active LLLT, patients in group B received only nimesulide, and patients in group C received placebo LLLT. Treatments were given 5 times per week for 15 weeks. Statistically significant differences after treatment were found on all outcomes (p<0.001) but were larger in group A than in B (p<0.005) and C (p<0.001). Results in group C were better than in group B (p<0.001). The authors conclude that improvement is better in acute low back pain with LLLT as additional therapy. Durability of these outcomes was not measured.

In 2010, Ay et al randomized 80 patients with acute and chronic low back pain attributed to lumbar disc herniation (LDH) into 4 groups of 20.(43) All patients received hot packs and group 1 (acute LDH) received laser therapy; group 2 (chronic LDH) received laser therapy, group 3 (acute LDH) received placebo laser therapy; and group 4 (chronic LDH) received placebo laser therapy for 15 sessions over 3 weeks. Outcome measures were pain on VAS, patients’ global assessment, physicians’ global  assessment, and functional capacity and were measured after 3 weeks of treatment. After treatment, all groups had statistically significant improvements in pain severity, patients’ and physicians’ global assessment, ROM, Roland-Morris Disability Questionnaire, and Modified Oswestry Disability Index (p<0.05). There were no significant differences between treatment groups on any outcomes (p<0.05). Durability of the treatment effect was not reported.

In a 2007 study by Djavid et al, 61 patients were randomized to LLLT alone (n=20), LLLT with exercise (n=21), or sham laser treatment with exercise (n=20).(44) Outcomes of pain on VAS, lumbar ROM, and disability were measured by blinded assessors after 6 weeks of treatment, after another 6 weeks and 12 weeks without treatment. By intention-to-treat (ITT) analysis, there were no between-group differences for any outcome measure immediately after the 6-week intervention. After 6 weeks without intervention, there was no difference between the LLLT alone group and the placebo laser therapy plus exercise group; however, in the LLLT plus exercise group, pain had reduced by 1.8 cm (95% CI, 0.1 to 3.3; p=0.03), lumbar ROM increased by 0.9 cm (95% CI, 0.2 to 1.8; p≤0.01) on the Schober test and by 15° (95% CI, 5 to 25; p<0.01) of active flexion, and disability reduced by 9.4 points (p=0.03) on the Oswestry Disability Index more than in the placebo laser therapy plus exercise group. The authors advised that larger trials are needed to detect differences between groups for some outcomes.

Section Summary

The literature on LLLT for low back pain consists of several medium- to large-sized randomized shamcontrolled trials. Results of these trials are inconsistent.

Osteoarthritis Knee Pain

In 2007, Bjordal et al published a systematic review of placebo-controlled RCTs to determine the short-term efficacy of physical interventions for osteoarthritis (OA) knee pain.(45) They concluded that TENS (including interferential currents) and LLLT offered clinically relevant pain-relieving effects on VAS scores compared with placebo control. Follow-up data up to 121 weeks were sparse, but positive effects seemed to persist for at least 4 weeks after the course of treatment.

In 2011, Alfredo et al reported a randomized, double-blind, sham-controlled trial of LLLT in 40 patients with knee OA.(46) Laser or sham treatments were delivered 3 times per week for 3 weeks, and both groups received exercise sessions 3 times per week for 8 weeks. The active laser group showed significant improvements from baseline in pain scores, activity, ROM, and functionality, but there were no significant differences between the active and sham laser groups.

Hegedus et al reported a randomized, double-blind, sham-controlled trial of LLLT in 35 patients with knee OA in 2009.(47) Eight patients from the sham group left the experiment, leaving 18 patients in the active LLLT group and 9 in the sham group. Treatments were delivered twice a week over a period of 4 weeks at a dose of 6 J/point (48 J/cm² ). Follow-up was performed immediately, 2 weeks, and 2 months after completing the therapy. In the group treated with LLLT, a significant improvement was found in pain (5.75 to 1.18), pressure sensitivity (2.33 to 0.77), and flexion (105.83° to 122.94°) at 2 months. In the placebo group, baseline to posttreatment changes in joint flexion and pain were not significant. It was not reported if these changes were significantly improved in comparison with the sham group. Circumference of the
joint was not significantly changed for either group. Thermographic measurements at 2 months showed an increase in temperature of 0.5° or greater in patients in the active laser group who experienced pain relief, suggesting an improvement in circulation.

Section Summary

The literature on LLLT for OA includes a systematic review and some small randomized, sham-controlled trials. Results of these studies are inconsistent.

Meniscal Knee Pain

In a 2013 study, Malliaropoulos et al reported on a randomized, double-blind, placebo-controlled study of LLLT in 64 patients with unilateral medial knee pain for more than 6 weeks that was related to meniscal pathology (ie, grade 3 tiny attenuation or intrasubstance tears on magnetic resonance imaging [MRI]).(48) Pain improved significantly with LLLT than placebo (p<0.001). However, 4 patients (12.5 %) did not have improvement with LLLT. Pain returned in 3 patients at 6 months and in 5 patients after 1 year. Repeat MRIs were not performed.

Section Summary

The literature on LLLT for meniscal knee pain is limited to 1 small RCT. This evidence is not sufficient to draw conclusions and further studies are needed.

Medial Tibial Stress Syndrome

In a 2013 systematic review by Winters et al of treatments for medial tibial stress syndrome, LLLT was not found to be effective.(49) Studies in the systematic review were all considered to have methodologic bias.

Section Summary

The literature on LLLT for medial tibial stress syndrome is limited and in these, LLLT has not demonstrated benefit.

Rheumatoid Arthritis

A 2005 Cochrane Review included 5 placebo-controlled RCTs and found that relative to a separate control group, LLLT reduced pain by 1.10 points on VAS compared with placebo, reduced morning stiffness duration by 27.5 minutes, and increased tip-to-palm flexibility by 1.3 cm.(50) Other outcomes, such as functional assessment, ROM, and local swelling, did not differ between groups. For RA, relative to a control group using the opposite hand (1 study), there was no difference observed between the control and treatment hand for morning stiffness duration and no significant improvement in pain relief. The authors noted that “despite some positive findings, this meta-analysis lacked data on how LLLT effectiveness is affected by four important factors: wavelength, treatment duration of LLLT, dosage, and site application over nerves instead of joints.”

A 2010 randomized, double-blind, placebo-controlled trial comparing outcomes of pain reduction and improvement in hand function in 82 patients with RA treated with LLLT or placebo laser was reported by Meireles et al.(51) There were no statistically significant differences between groups in most of the outcome measurements including the primary variables, though a few measures significantly favoring either the active or placebo treatment were found. The authors concluded that LLLT at the dosage used in the study was not effective for the treatment of hands among patients with RA.

Elbow Pain

Authors of a systematic review published in 2008 grouped trials by application technique and wave lengths and reported that 7 of the 13 included trials had a narrowly defined regimen where lasers of 904 nm wavelength with low output (5-50 MW) were used to irradiate the tendon insertion at 2 to 6 points on the lateral elbow.(52) Positive results in these trials were consistent on outcomes of pain and function, and significance persisted for at least 3 to 8 weeks after the end of treatment. The authors noted that the conclusions of their review differed from conclusions of prior reviews of this topic.

Achilles Tendinopathy

Stergioulas et al randomized 52 recreational athletes with chronic Achilles tendinopathy symptoms to an 8-week (12 sessions) program of eccentric exercises (EE) with LLLT or with sham LLLT.(53) By ITT analysis, results for the primary outcome of pain during physical activity on VAS were significantly lower in the EE with LLLT group at 4 weeks (p<0.001), 8 weeks (p<0.001), and 12 weeks (p=0.007) after randomization. Results of EE with LLLT at 4 weeks were similar to results for the EE plus sham LLLT
group after 12 weeks.

Tumilty et al reported a randomized, double-blinded, sham-controlled trial of LLLT as an adjunct to 3 months of EE in 40 patients with Achilles tendinopathy.(54) Active or sham LLLT was administered 3 times per week for 4 weeks, and exercises were performed twice a day for 12 weeks. The primary outcome was the Victorian Institute of Sport Assessment‒Achilles questionnaire (VISA-A) at 12 weeks. There was a trend for the active laser group to score lower on the VISA-A at baseline (p=0.051). Following treatment, the only significant difference between the groups on an ITT basis was at 4 weeks on the VISA-A and favored the sham-control group. The VISA-A and numeric rating scale for pain were not significantly different between the active and sham groups at 12-week or 1-year follow-up.

Plantar Fasciitis

Kiritsi et al reported a randomized, double-blind, sham-controlled trial of LLLT in 30 subjects with plantar fasciitis in 2010.(55) Twenty-five patients (83%) completed the study, with treatment 3 times per week over 6 weeks. At baseline, plantar fascia thickness measured by US was significantly greater in the symptomatic compared with asymptomatic feet (5.3 mm vs 3.0 mm). Plantar fascia thickness decreased in both LLLT and sham groups over the course of the study. Although plantar fascia thickness after 6 weeks of treatment was not significantly different between the 2 groups (3.6 mm LLLT and 4.4 mm sham), there was a significant difference between the groups in the change in thickness (1.7 mm LLLT vs 0.9 mm sham). VAS after night rest or daily activities was significantly improved in the LLLT group compared with the sham, with a 59% improvement in the active laser group and a 26% improvement for the sham-treated subjects. At baseline, pain after daily activities was rated as 67 of 100 by both groups. At the end of treatment, VAS after daily activities was rated as 28 of 100 for LLLT and 50 of 100 for sham.

Oral Mucositis

The Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) published a systematic review of laser and other light therapy for the management of oral mucositis in 2012.(56) A total of 24 trials were included for the review. Based on their review of the evidence, the MASCC/ISOO made a new recommendation for LLLT for the prevention of oral mucositis in adult patients receiving hematopoietic stem-cell transplantation (HSCT) conditioned with high-dose chemotherapy. This recommendation was based on what was considered to be 1 welldesigned placebo-controlled randomized trial (described in more detail next),(57) together with a series of studies classified at a lower level of evidence. Evidence was insufficient to provide a guideline for laser as a treatment of oral mucositis in HSCT patients.

The MASCC/ISOO made a new “suggestion” for low-level laser for the prevention of oral mucositis in patients undergoing radiotherapy, without concomitant chemotherapy, for head and neck cancer. This guideline was based on 3 studies that showed positive results but were considered to have major flaws.

Evidence was considered encouraging but insufficient to recommend LLLT in other populations. The authors emphasized that due to the variety of laser devices and the variation in individual protocols, results of each study apply exclusively to the cancer population studied and the specific wavelength and settings used.

The pivotal study for the MASCC/ISOO recommendation was a randomized, double-blind, shamcontrolled trial with 70 patients who were undergoing HSCT.(57) Patients were randomized to 650 nm laser, 780 nm laser, or placebo (randomization method not described). Patients in the 650 nm laser group were more likely to have received a total body irradiation (TBI)‒containing regimen compared with the other 2 groups; otherwise, the groups were comparable. LLLT began on the first day of conditioning and continued for 3 days posttransplant. Of the 70 patients, 47 (67%) had complete or nearly complete mucositis measurements over time; the average number of visits per patient was similar for the 3 groups. The difference between groups in mean oral mucositis scores was greatest at day 11 (placebo 24.3, 650 nm 16.7, 780 nm 20.6), and this difference between the 650 nm group and placebo approached statistical significance (p=0.06). Thus, there was no significant difference in mean oral mucositis scores between the 650 nm and placebo group at the other time points. Patient-specific oral mucositis scores were significantly different between the 2 groups only when adjusted for TBI exposure. Of the 70 patients in the study, 17 (24%) were assessed for oral pain. With group sizes of 5 and 6, the 650-nm group had significantly lower patient-specific average pain scores (15.6) compared with placebo (47.2). No adverse events from LLLT were noted. This study, which formed the basis for the  ASCC/ISOO recommendation, suffers from limitations that include not achieving statistical significance for the primary outcome measure and a very small percentage of patients with pain assessments. In 2014, the MASCC/ISOO guidelines reiterated the 2012 systematic review findings recommending LLLT for the prevention of oral mucositis in patients receiving HSCT conditioned with high-dose chemotherapy and in patients undergoing head and neck radiotherapy, without concomitant chemotherapy.(58)

In 2014 Oberoi et al reported on a meta-analysis of 18 RCTs on LLLT versus no treatment or placebo for oral mucositis.(59) A total of 1144 patients were included in the meta-analysis. The overall risk of severe mucositis (grades 3-4) decreased with prophylactic LLLT with a risk ratio (RR) of 0.37 (95% CI, 0.20 to 0.67; p = 0.001). LLLT also reduced the overall mean grade of mucositis (standardized mean difference, -1.49, 95% CI, -2.02 to -0.95), duration of severe mucositis (weighted mean difference, -5.32; 95% CI, -9.45 to -1.19) and incidence of severe pain as measured on a VAS (RR=0.26; 95% CI, 0.18 to 0.37).

In 2013, Figueiredo et al reported on a systematic review and meta-analysis of laser therapy for oral mucositis.(60) In the systematic review of 12 studies and meta-analysis of 7 studies, laser therapy was found to be significantly more effective in preventing grade greater than 3 oral mucositis than patients who did not receive laser treatment (p=0.009). The authors noted that larger studies are needed.

Gautam et al reported 2 double-blinded, randomized, sham-controlled trials in 2012.61,62 One of the studies reported LLLT for the prevention of chemoradiotherapy-induced oral mucositis in 121 oral cancer patients.(61) The second publication reported LLLT for the prevention of chemoradiotherapy-induced oral mucositis in 221 head and neck cancer patients.(62) There is an apparent overlap in patients in these 2 reports, with the head and neck cancer report including the 121 patients with a primary tumor site in the oral cavity. Patients in these studies received LLLT before radiotherapy at 66 Gy delivered daily in 33 fractions, 5 days per week and concurrent with cisplatin. LLLT was delivered at a wavelength of 632.8 nm, power density of 24 mW/cm² and a dosage of 3 to 3.5 J. In the report on oral cancer, LLLT before radiotherapy led to significant reductions in the incidence of severe oral mucositis (29% vs 89%) and its associated pain (18% vs 71% with a VAS >7) opioid analgesic use (7% vs 21%) and total parenteral nutrition (30% vs 39%, all respectively) during the last weeks of chemoradiotherapy. LLLT also reduced the duration of severe oral mucositis (4.07 vs 13.96 days), severe pain (5.31 vs 9.89 days), and total parenteral nutrition (14.05 vs 17.93 days, all respectively). In the 221 patients treated for head and neck cancer, LLLT was reported to lead to significant reductions in the incidence and duration of severe oral mucositis (8.19 vs 12.86 days) and its associated pain (VAS of approximately 4 vs 7), total parenteral nutrition (45.0% vs 65.5%), and opioid analgesic use (9% vs 26% for step III, all respectively). In 2013 Gautam et al(63) reported on patient-reported outcomes from the same study of 220 head and neck cancer patients(62) using the Oral Mucositis Weekly Questionnaire-Head and Neck (OMWQ-HN) and the Functional Assessment of Cancer Treatment- Head and Neck (FACT-HN) questionnaire. Patients in this study received LLLT before radiotherapy at 66 Gy delivered daily in 33 fractions, 5 days per week and concurrent with cisplatin. LLLT was delivered at a wavelength of 632.8 nm, power density of 24 mW/cm² and a dosage of 3.0 J. Patients in the LLLT group reported significantly better outcomes than the placebo group with lower scores on both the OMWQ-HN (p<0.001) and FACT-HN (p<0.05).

In 2013 Antunes et al also reported on LLLT to prevent oral mucositis in a double-blinded, randomized sham-controlled trial of 94 head and neck squamous-cell carcinoma patients.(64) Patients received LLLT before radiotherapy at 70.2 Gy delivered daily in 39 fractions, 5 days per week and concurrent with cisplatin. In this study, LLLT was delivered at a higher dose of 660 nm, 100 mW and 1 J to 4 J/cm². Three patients (6.4%) in the LLLT group developed grade 3 or 4 oral mucositis, as measured by the World Health Organization oral mucositis scale compared with 19 patients (40.5%) in the placebo group (relative RR=0.158; 95% CI, 0.050 to 0.498). Additionally, 28 patients (59.6%) in the LLLT group did not develop ulcers compared with 10 patients (21.3%) in the placebo group (p<0.001). Incidence of severe pain, narcotic analgesic use and gastrostomy was also lower in the LLLT group. Differences in radiation and LLLT dosages and oral hygiene protocols used may influence outcomes in these studies.

Another randomized sham-controlled trial from 2012 evaluated the effect of LLLT on quality of life (QOL) in 60 patients undergoing radiotherapy in the region of the major salivary glands.(65) QOL was measured by the University of Washington QOL questionnaire at baseline and after 15 and 30 treatment sessions. QOL decreased significantly in both groups over the 30 treatment sessions, but there was a smaller decrease in QOL in the LLT group compared with the placebo group. The domains of appearance, activity, recreation, speech, taste, pain, chewing, and saliva were less affected in the LLLT group compared with the placebo group at either the mid-treatment or final assessment. More patients in the sham control group had an interruption of radiotherapy (25 vs 12), which was primarily due to mucositis.

Section Summary

The literature on LLLT for the prevention of oral mucositis includes a systematic review by MASCC/ISOO with a resulting recommendation for LLLT for the prevention of oral mucositis in adult patients receiving HSCT conditioned with high-dose chemotherapy. Review of the pivotal study for this recommendation reveals serious limitations that include a lack of statistical significance for the primary outcome measure. The systematic review by MASCC/ISOO considered the evidence insufficient to recommend LLLT for the prevention or treatment of oral mucositis in any other situation. Since the publication of this systematic review, 3 randomized sham-controlled trials from South America and Asia have reported some efficacy of LLLT for the prevention of oral mucositis in patients with head and neck cancer undergoing radiotherapy or chemoradiotherapy. Additional study in these patient populations is needed to determine the efficacy of LLLT with greater certainty.

Fibromyalgia

Matsutani et al randomized 20 patients with fibromyalgia to receive laser treatment and stretching exercises or stretching alone.(66) Outcome measures were VAS and dolorimetry at tender points, QOL on the Fibromyalgia Impact Questionnaire (FIQ), and the 36-Item Short-Form Health Survey (SF-36). At the end of treatment, both groups demonstrated pain reduction, higher pain threshold at tender points (all p<0.01), lower mean FIQ scores, and higher SF-36 mean scores (all p<0.05). No significant differences were found between groups.

Wound Healing

A 2004 evidence report on vacuum-assisted and low-level laser wound therapies for treatment of chronic nonhealing wounds prepared for the Agency for Healthcare Research and Quality was based on 11 studies of LLLT.(67) It stated that “The best available trial [of low-level laser wound therapy] did not show a higher probability of complete healing at 6 weeks with the addition of low-level laser compared to sham laser treatment added to standard care. Study weaknesses were unlikely to have concealed existing effects. Future studies may determine whether different dosing parameters or other laser types may lead to different results.”

In 2014 a Cochrane review of RCTs on light therapy, including phototherapy, ultraviolet and laser, for pressure ulcers was published.(68) The few trials available for analysis were of small size and very low quality. The reviewers found the available evidence overall was insufficient to draw conclusion on the effects light therapy on pressure ulcers.

Lymphedema

Omar et al published a qualitative systematic review of LLLT for the management of breast cancer-related lymphedema in 2012.(69) They included 8 studies with a total of 230 patients in the review. Five studies were graded as Sackett evidence level II (small randomized trial with high false-positive or false-negative errors), 2 were graded as level III (nonrandomized comparative study), and 1 study was graded as level V evidence (case series). The authors noted major methodologic flaws and little uniformity in the design of the studies.

One of the studies included in the review was a 2011 publication by Omar et al reporting a randomized, double-blind, sham-controlled trial of LLLT in 50 patients with postmastectomy lymphedema.(70) The average length of time that patients had swelling was 14 months (range, 12-36 months). Patients were treated with active or sham laser 3 times per week for 12 weeks over the axillary and arm areas. In addition, all participants were instructed to perform daily arm exercises and to wear a pressure garment. Limb circumference, shoulder mobility, and grip strength were measured before treatment and at 4, 8, and 12 weeks. Limb circumference declined over time in both groups, with significantly greater reduction in limb circumference in the active laser group at 8 (20.0 vs 16.4 cm), 12 (29 vs 21.8 cm), and 16 weeks (31 vs 23). Shoulder flexion and abduction were significantly better in the active laser group at 8 and 12 weeks. Grip strength was significantly better in the active laser group after 12 weeks of laser therapy (26.2 vs 22.4 kg). The durability of these effects was not assessed.

Section Summary

The evidence on LLLT for postmastectomy lymphedema includes 5 small randomized trials with high potential for false-positive or false-negative errors. Larger sham-controlled studies are needed to determine the efficacy of LLLT for postmastectomy lymphedema with greater certainty.

Ongoing and Unpublished Clinical Trials

An online search of ClinicalTrials.gov on October 24, 2014, identified many ongoing studies using LLLT as an intervention. Studies focused on a variety of conditions including mucositis, TMJ pain, orofascial pain, neck pain, low back pain, osteoarthritis, lymphedema, autoimmune thyroiditis, and alopecia.

Summary of Evidence

Low-level laser therapy (LLLT), also called photobiomodulation, is being evaluated to treat a variety of conditions including soft tissue injuries, myofascial pain, tendinopathies, nerve injuries, joint pain, lymphedema, and oral mucositis.

The available literature on LLLT as a treatment for lymphedema, prevention of oral mucositis, wound healing, or pain of various etiologies and in a variety of anatomic sites presents inconsistent results and methodologic weaknesses, including lack of follow-up evaluation, that prevent drawing firm conclusions regarding efficacy.  Therefore, LLLT remains investigational for all indications.

Practice Guidelines and Position Statements

In 2010, the American Physical Therapy Association (APTA) published a guideline on the diagnosis and treatment of Achilles tendinitis.(71) APTA gave a level B recommendation (based on moderate evidence) to consider the use of LLLT to decrease pain and stiffness in patients with Achilles tendinopathy. APTA states in their review of the evidence, that “given the limited number of studies employing LLLT in this population, additional study is warranted.”

The United Kingdom’s National Institute for Health and Clinical Excellence 2009 Guideline on early management of persistent nonspecific low back pain does not recommend laser treatment, citing limited evidence.(72)

The 2007 American Pain Society guideline states that there is insufficient evidence to recommend LLLT for treatment of low back pain,(73) and LLLT is not mentioned in the 2009 guideline.(74)

The American Academy of Orthopaedic Surgeons 2008 clinical practice guideline on the treatment of carpal tunnel syndrome included laser treatment among treatments that carry no recommendation for or against their use because there is insufficient evidence to recommend their use.(75)

U.S. Preventive Services Task Force Recommendations
Not applicable.

Medicare National Coverage
There is no national coverage determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers.

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  57. Schubert MM, Eduardo FP, Guthrie KA, et al. A phase III randomized double-blind placebo-controlled clinical trial to determine the efficacy of low level laser therapy for the prevention of oral mucositis in patients undergoing hematopoietic cell transplantation. Support Care Cancer. Oct 2007;15(10):1145-1154. PMID 17393191
  58. Lalla RV, Bowen J, Barasch A, et al. MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. May 15 2014;120(10):1453-1461. PMID 24615748
  59. Oberoi S, Zamperlini-Netto G, Beyene J, et al. Effect of prophylactic low level laser therapy on oral mucositis: a systematic review and meta-analysis. PLoS One. 2014;9(9):e107418. PMID 25198431
  60. Figueiredo AL, Lins L, Cattony AC, et al. Laser therapy in the control of oral mucositis: A meta-analysis. Rev Assoc Med Bras. Oct 9 2013. PMID 24119379
  61. Gautam AP, Fernandes DJ, Vidyasagar MS, et al. Low Level Helium Neon Laser therapy for chemoradiotherapy induced oral mucositis in oral cancer patients - A randomized controlled trial. Oral Oncol. Sep 2012;48(9):893-897. PMID 22502814
  62. Gautam AP, Fernandes DJ, Vidyasagar MS, et al. Low level laser therapy for concurrent chemoradiotherapy induced oral mucositis in head and neck cancer patients - A triple blinded randomized controlled trial. Radiother Oncol. Sep 2012;104(3):349-354. PMID 22884841
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  66. Matsutani LA, Marques AP, Ferreira EA, et al. Effectiveness of muscle stretching exercises with and without laser therapy at tender points for patients with fibromyalgia. Clin Exp Rheumatol. May-Jun 2007;25(3):410-415. PMID 17631737
  67. Samson D, Lefevre F, Aronson N. Wound-healing technologies: low-level laser and vacuum-assisted closure. Evid Rep Technol Assess (Summ). Dec 2004(111):1-6. PMID 15663354
  68. Chen C, Hou WH, Chan ES, et al. Phototherapy for treating pressure ulcers. Cochrane Database Syst Rev. 2014;7:CD009224. PMID 25019295
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  70. Omar MTA, Ebid AA, El Morsy AM. Treatment of post-mastectomy lymphedema with laser therapy: double blind placebo control randomized study. J Surg Res. Jan 2011;165(1):82-90. PMID 20538293
  71. Carcia CR, Martin RL, Houck J, et al. Achilles pain, stiffness, and muscle power deficits: achilles tendinitis. J Orthop Sports Phys Ther. Sep 2010;40(9):A1-26. PMID 20805627
  72. Savigny P, Kuntze S, Watson P, et al. Low back pain: early management of persistent non-specific low back pain. National Collaborating Centre for Primary Care and Royal College of General Practitioners. 2009; http://www.nice.org.uk/nicemedia/pdf/CG88fullguideline.pdf. Accessed October 24, 2014.
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  75. American Academy of Orthopaedic Surgeons. Clinical practice guideline on the treatment of carpal tunnel syndrome. 2008; http://www.aaos.org/research/guidelines/CTSTreatmentGuideline.pdf. Accessed October 24, 2014.

Codes

Number

Description

CPT  97026  Application of a modality to one or more area; infrared 
ICD-9 Diagnosis  354.0  Carpal tunnel syndrome 
HCPCS  S8948  Application of a modality (requiring constant provider attendance) to one or more areas; low-level laser; each 15 minutes 
ICD-10-CM (effective 10/1/15)    Investigational for all diagnoses
  G56.0-G56.02 Carpal tunnel syndrome
   L98.411-L98.499 Non-pressure chronic ulcer of skin, not elsewhere classified, code range
   M05.00-M05.9 Rheumatoid arthritis with rheumatoid factor code range
   M06.00-M06.9 Other rheumatoid arthritis code range
   M17.0-M17.9 Osteoarthritis of knee code range
   M25.521-M25.529 Pain in elbow code range
   M26.60-M26.69 Temporomandibular joint disorders code range
   M54.5 Low back pain
   M75.40-M75.42 Impingement syndrome of shoulder code range
   M76.60-M76.72 Achilles tendinitis code range
   M79.7 Fibromyalgia
ICD-10-PCS (effective 10/1/15)    ICD-10-PCS codes are only used for inpatient services. There is no specific ICD-10-PCS code for this procedure.

Index

Carpal Tunnel Syndrome, Low Level Laser
Laser Therapy, Carpal Tunnel Syndrome
MicroLight, Low Level Laser, Carpal Tunnel Syndrome


Policy History

 

Date Action Reason
04/29/03 Add policy to Medicine section New policy
04/16/04 Replace policy Policy updated with literature review; no new literature, no change in policy statement
03/15/05 Replace policy Policy updated with literature review; no change in policy statement. Reference numbers 6 and 7 added
12/14/05 Replace policy Policy updated with literature review; no change in policy statement
7/20/06 Replace policy – correction only Corrected CPT code number in the Policy Guidelines section.
02/15/07 Replace policy Policy updated with literature review; reference number 8 added; no change in policy statement
04/09/08 Replace policy  Policy updated with literature review; reference numbers 9-10 added; no change in policy statement
09/21/09 Replace policy with Local policy Policy updated to include all indications as investigational; new references added; Carpal Tunnel Syndrome removed from title
12/10/09 Replace policy (no longer local) Policy updated with literature review and expanded beyond carpal tunnel syndrome to include other musculoskeletal conditions and wound healing. Title shortened to “Low Level Laser Therapy.” Reference numbers 1, 7, 8, 10 to 26 added.
3/10/11 Replace policy Policy updated with literature review, reference numbers 26-40 and 42-44 added, policy statement unchanged
11/10/11 Replace policy Policy updated with literature review through August 2011, references added and reordered, policy statement unchanged
11/08/12 Replace Policy Policy updated with literature review through September 2012, references added and reordered, policy statement unchanged
11/14/13 Replace policy Policy updated with literature review through September 2013, references 14, 37, 46-47,56, 59-60 added, policy statement unchanged
11/13/14 Replace policy Policy updated with literature review through October 21, 2014, references 29, 31, 58-59, and 68 added, policy statement unchanged