Coverage Policy Manual
Policy #: 1997126
Category: Medicine
Initiated: September 1995
Last Review: July 2024
  Low Level Laser Therapy (LLLT) and High Intensity Laser Therapy

Description:
Oral mucositis describes inflammation of the oral mucosa and typically manifests as erythema or ulcerations that appear 7 to 10 days after initiation of high-dose cancer therapy. Oral mucositis can cause significant pain and increased risk of systemic infection, dependency on total parenteral nutrition, and use of narcotic analgesics.
 
Treatment planning may also need to be modified due to dose-limiting toxicity. There are a number of interventions for oral mucositis that may partially control symptoms, but none is considered a criterion standard treatment. When uncomplicated by infection, oral mucositis is self-limited and usually heals within 2 to 4 weeks after cessation of cytotoxic chemotherapy. Low-level laser therapy (LLLT) has been used in cancer therapy-induced oral mucositis in patients treated with radiotherapy and/or chemotherapy and hematopoietic cell transplantation.
 
Musculoskeletal disorder describes a variety of conditions leading to chronic pain and decreased quality of life. Carpal tunnel syndrome (CTS) 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 CTS 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.
 
Several modalities of treatment are used in the management of musculoskeletal pain including medications, immobilization, and physical therapy. The use of LLLT has been investigated for use in musculoskeletal pain conditions. In the case of CTS, mild-to-moderate cases are usually first treated conservatively with splinting and cessation of aggravating activities. Other conservative therapies include oral steroids, diuretics, nonsteroidal anti-inflammatory drugs, and steroid injections into the carpal tunnel itself. Patients who do not respond to conservative therapy or who present with severe CTS with thenar atrophy may be considered candidates for surgical release of the carpal ligament, using either an open or endoscopic approach. Low-level laser therapy is also used to treat CTS.
 
Chronic wounds are wounds that do not improve after 4 weeks or heal within 8 weeks. These include diabetic foot ulcers, venous-related ulcerations, non-healing surgical wounds, and pressure ulcers. They are often found on the feet, ankles, heels, calves, and on the hips, thighs, and buttocks of those who cannot walk.
 
Lymphedema is described as swelling in at least one leg and/or arm. It is commonly caused by the removal of a lymph node. The resulting blockage of the lymphatic system prevents lymph fluid from draining well, leading to fluid build-up and swelling. Other symptoms can include heaviness or tightness in the affected limb, restricted range of motion, aching or discomfort, recurring infections, and dermal fibrosis. Risk factors for developing lymphedema after cancer from cancer treatment or from other secondary causes can include older age, obesity, and rheumatoid or psoriatic arthritis.
 
Chronic wound management involves ensuring adequate blood flow to the area, preventing the wound from drying, controlling infections, debriding scarred and necrotic tissue, and managing pain. The standard of care for diabetic foot ulcers includes debridement, dressings, offloading of pressure, infection management, and glycemic control. Lymphedema is typically managed with pneumatic compression, exercise, or complete decompression therapy. Use of LLLT has been investigated for the management of both chronic wounds and lymphedema.
 
Low-level laser therapy is the use of red-beam or near-infrared lasers with a wavelength between 600 and 1,000 nm and power from 5–500 milliwatts. (In contrast, lasers used in surgery typically use 300 Watts.) 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.
 
Low-lever laser therapy (LLLT) is being evaluated to treat a wide variety of conditions, including soft tissue injuries, myofascial pain, tendinopathies, nerve injuries, joint pain, and lymphedema.
 
High-intensity laser therapy (HILT) is a Class IV therapeutic non-surgical laser device with a power output of more than 500 mW that is capable of transmitting energy beyond the skin to deep musculoskeletal tissues.  HILT is proposed for use in the office setting for various indications including musculoskeletal disorders and Bell’s palsy.  The devices are intended to provide temporary relief of muscle spasms and minor muscle/joint pain by emitting energy in the infrared spectrum to provide topical heat and tissue temperature elevation which in turn promotes temporary muscle relaxation and increased local blood circulation.
 
The mechanism of action of HILT to treat chronic pain or Bell's palsy is not clearly understood. Proposed mechanisms of action include having anti-inflammatory effects through photobiomodulation mechanisms by altering inflammatory markers, photothermal effects leading to improved muscle relaxation and extensibility of connective tissue, or analgesic effects through neural inhibition or endorphin mechanisms (Starzec-Proserpio, 2022).
 
Regulatory Status
 
Selected Low-Level Laser Therapy Devices Cleared by the U.S. Food and Drug Administration:
 
    • FX-635, manufactured by Erchonia Corporation, cleared 6/01/2019 (K190572) for adjunctive use in whole body musculoskeletal pain therapy
    • Super Pulsed Laser Technology, manufactured by Multi Radiance Medical, cleared 1/13/2018 (K171354) for providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin
    • Lightstream Low-Level Laser, manufactured by SOLICA CORPORATION, cleared 4/03/2009 (K081166) for adjunctive use in the temporary relief of pain associated with knee disorders with standard chiropractic practice
    • GRT LITE, MODEL 8-A, manufactured by GRT SOLUTIONS, INC., cleared 2/03/2006 (K050668) for use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin
    • MICROLIGHT 830 LASER SYSTEM, manufactured by MICROLIGHT CORPORATION OF AMERICA, cleared 2/06/2002 (K010175) for use in pain therapy or related indication
 
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 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 U.S., including studies of wound healing. Since 2009, many more similar LLLT devices have received 510(k) clearance from the FDA.
 
Examples of HILT lasers that have been cleared for marketing by the FDA through the 510(k) process include but are not limited to: Diowave Laser System (formerly Avicenna Laser Technology Inc. K031612; K121363; K091285), ESPT-3X (Lighthouse Technical Innovations, Inc.K083560), K-Laser (K-Laser, USA. K091497), LCT-1000 (LiteCure, LLC. K070400), and OptonPro (Zimmer MedizinSysteme. K141564).
HILT devices have a power output greater than 500mW and are classified as Class IV lasers by FDA (FDA, 2024).

Policy/
Coverage:
Effective September 2024
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Low-level laser therapy for prevention of oral mucositis in patients undergoing cancer treatment associated with increased risk of oral mucositis (including chemotherapy and/or radiotherapy, and/or hematopoietic stem cell transplantation) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Low-level laser therapy for any other indication, including but not limited to, carpal tunnel syndrome, neck pain, subacromial impingement, adhesive capsulitis, temporomandibular joint pain, low back pain, osteoarthritic knee pain, heel pain, post-operative pain, rheumatoid arthritis, bell palsy, fibromyalgia, wound healing, and lymphedema does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, low-level laser therapy for any other indication, including but not limited to, carpal tunnel syndrome, neck pain, subacromial impingement, adhesive capsulitis, temporomandibular joint pain, low back pain, osteoarthritic knee pain, heel pain, post-operative pain, rheumatoid arthritis, bell palsy, fibromyalgia, wound healing, and lymphedema is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Multi-wavelength laser therapy (e.g., MLS laser therapy) for all indications does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, multi-wavelength laser therapy (e.g., MLS laser therapy) for all indications, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
High Intensity (High-power), non-surgical laser therapy (class IV therapeutic laser) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for all indications, including but not limited to the following:
    • Treatment of chronic musculoskeletal pain
    • Treatment of Bell’s Palsy
 
For members with contracts without primary coverage criteria, high Intensity (High-power), non-surgical laser therapy (class IV therapeutic laser) is considered investigational for all indications, including but not limited to the following:
    • Treatment of chronic musculoskeletal pain
    • Treatment of Bell’s Palsy
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective April 2024 – August 2024
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Low-level laser therapy for prevention of oral mucositis in patients undergoing cancer treatment associated with increased risk of oral mucositis (including chemotherapy and/or radiotherapy, and/or hematopoietic stem cell transplantation) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Low-level laser therapy for any other indication, including but not limited to, carpal tunnel syndrome, neck pain, subacromial impingement, adhesive capsulitis, temporomandibular joint pain, low back pain, osteoarthritic knee pain, heel pain, post-operative pain, rheumatoid arthritis, bell palsy, fibromyalgia, wound healing, and lymphedema does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, low-level laser therapy for any other indication, including but not limited to, carpal tunnel syndrome, neck pain, subacromial impingement, adhesive capsulitis, temporomandibular joint pain, low back pain, osteoarthritic knee pain, heel pain, post-operative pain, rheumatoid arthritis, bell palsy, fibromyalgia, wound healing, and lymphedema is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Multi-wavelength laser therapy (e.g., MLS ® laser therapy) for all indications does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, multi-wavelength laser therapy (e.g., MLS ® laser therapy) for all indications, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
High Intensity (High-power), non-surgical laser therapy (class IV therapeutic laser) for all indications does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, high Intensity (High-power), non-surgical laser therapy (class IV therapeutic laser) for all indications is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective September 2023 through March 2024
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Low-level laser therapy for prevention of oral mucositis in patients undergoing cancer treatment associated with increased risk of oral mucositis (including chemotherapy and/or radiotherapy, and/or hematopoietic stem cell transplantation) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Low-level laser therapy for any other indication, including but not limited to, carpal tunnel syndrome, neck pain, subacromial impingement, adhesive capsulitis, temporomandibular joint pain, low back pain, osteoarthritic knee pain, heel pain, rheumatoid arthritis, bell palsy, fibromyalgia, wound healing and lymphedema does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, low-level laser therapy for any other indication, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Multi-wavelength laser therapy (eg. MLS ® laser therapy) for all indications does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, multi-wavelength laser therapy (eg. MLS ® laser therapy) for all indications, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
High Intensity (High-power), non-surgical laser therapy (class IV therapeutic laser) for all indications does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, high Intensity (High-power), non-surgical laser therapy (class IV therapeutic laser) for all indications is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective September 2019 through August 2023
  
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Low-level laser therapy for prevention of oral mucositis in patients undergoing cancer treatment associated with increased risk of oral mucositis (including chemotherapy and/or radiotherapy, and/or hematopoietic stem cell transplantation) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Low-level laser therapy for any other indication, including but not limited to, carpal tunnel syndrome, neck pain, subacromial impingement, adhesive capsulitis, temporomandibular joint pain, low back pain, osteoarthritic knee pain, heel pain, rheumatoid arthritis, bell palsy, fibromyalgia, wound healing and lymphedema does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, low-level laser therapy for any other indication, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Multi-wavelength laser therapy (eg. MLS ® laser therapy) for all indications does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, multi-wavelength laser therapy (eg. MLS ® laser therapy) for all indications, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective Prior to September 2019
  
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Low-level laser therapy for prevention of oral mucositis in patients undergoing cancer treatment associated with increased risk of oral mucositis (including chemotherapy and/or radiotherapy, and/or hematopoietic stem cell transplantation) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Low-level laser therapy for prevention of any other indications, including but not limited to, carpal tunnel syndrome, neck pain, subacromial impingement, adhesive capsulitis, temporomandibular joint pain, low back pain, osteoarthritic knee pain, heel pain, rheumatoid arthritis, bell palsy, fibromyalgia, wound healing and lyphedema does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
Effective Prior to January 2017:
For members with benefit contracts or Plans with Primary Coverage Criteria, Low Level Light (Laser) Therapy is not covered because it fails to meet the Primary Coverage Criteria (“The Criteria”) of the applicable benefit certificate or health plan (The Criteria require, among other things, that there be scientific evidence of effectiveness, as defined in The Criteria. The Criteria exclude coverage of treatments, such as low level light (laser) therapy because of lack of scientific evidence of effectiveness.
 
For members with member benefit contracts or Plans with explicit exclusion language for experimental or investigational services, Low Level Light (Laser) Therapy is not covered because it is considered experimental or investigational treatment, as defined in the applicable benefit contract or health plan, which excludes coverage of experimental or investigational treatment or services.

Rationale:
“Due to the detail of the rationale, the complete document is not online. If you would like a hardcopy print, please email: codespecificinquiry@arkbluecross.com”
 
Infrared light therapy involves the treatment of damaged tissues with light from a low intensity infrared laser or light-emitting diode. Since this is a noninvasive treatment, the applied light must travel through the skin and any other overlying  tissues to reach the site of damage. The infrared light must then be absorbed to cause a biostimulatory, healing effect. Although the mechanism or mechanisms by which infrared light therapy might reduce pain and promote healing have not been established, this modality has been investigated as a treatment for a wide range of neuropathies, arthritis, and musculoskeletal disorders, including: diabetic neuropathy, osteoarthritis, rheumatoid arthritis, ankle sprains, plantar fasciitis, chondromalacia patellae, myofascial pain, musculoskeletal pain, fibromyalgia, tendonitis, epicondylitis, and temporomandibular joint disorder. Potential benefits of infrared light therapy include its safety profile and its noninvasive, nonpharmacological nature.
 
Definitive patient selection criteria have not been established for infrared light therapy for musculoskeletal pain or neuropathy.
 
Infrared light therapy treatment protocols vary in many respects. One significant aspect of variation is the light source, which is usually a single-beam infrared laser. The light source could also be a cluster of laser sources or an array of infrared light-emitting diodes. When performed with an array of light-emitting diodes, this procedure has been referred to as monochromatic near-infrared photoenergy (MIRE) therapy. These light sources usually emit light at a single wavelength. The reviewed studies involved infrared light of 820, 830, 860,890, 904, and 1060 nm, some as continuous beams and some as pulsed beams.   Variations in protocols in studies include preparation of the treatment site, placement of the laser - static or sweeping exposure, duration of exposure, total number of treatment and the treatment schedule.  
 
Although a number of placebo-controlled, double-blinded randomized trials of infrared light report that this therapy can reduce pain for certain types of arthritis and other musculoskeletal disorders, other equally well-designed studies report that it is ineffective. Further studies of infrared light therapy for treatment of pain are needed to determine if these conflicting results have arisen due to differences in the infrared therapy applied or differences in the populations of patients who underwent treatment. Efforts to determine effective treatment parameters may be assisted by studies of the fundamental biological effects of low-intensity infrared light. Karu et al. (2004) have reported that infrared light promotes cellular attachment in vitro and have postulated that this effect occurs due to metabolic changes initiated by mitochondrial light absorption. Other potential benefits have been documented by Reddy (2003), who examined the effects of infrared laser light in an animal model and found that this treatment promotes collagen synthesis and wound healing. A thorough evaluation of the wavelengths and intensities of infrared light that stimulate biological activities in experimental systems may guide investigators to discovering the optimal parameters for clinical treatment.
 
Hayes, Inc., has issued a technology assessment on Low Level Laser Light Therapy with the following conclusion: A rating of Investigational or experimental is assigned to LLLT for treatment of pain and disability due to knee osteoarthritis and hand osteoarthritis. The hand rating is based on limited evidence of no benefit. A rating of investigational or experimental is assigned LLLT for treatment of 1) osteoarthritis in joints other than the knee or hand; 2) pain and disability due to rheumatoid arthritis in the hand and foot; and 3) pain and disability due to rheumatoid arthritis in joints other than the hand or foot.  A rating of investigational or experimental is assigned LLLT for treatment of chondromalacia patellae based on very weak evidence of only slight benefit. A rating of investigational or experimental is assigned to LLLT for based on limited evidence of no benefit. A rating of investigational or experimental is also assigned to patient-administered LLLT due to the lack of evidence pertaining to the efficacy and safety of LLLT used outside of healthcare settings.
 
2005 Update
A literature search was performed for the period of 2003 through October 2005. No published studies were identified that would prompt reconsideration of the policy statement, which remains unchanged. Irvine and colleagues reported on the results of a small double-blinded study of 15 patients with carpal tunnel syndrome who were randomized to receive either low-level laser therapy or sham laser therapy. There was a significant improvement in both groups, but there was no significant difference between the groups. Bakhtiary and Rashidy-Pour reported on the outcomes of 50 consecutive patients with carpal tunnel syndrome who were randomized to receive either ultrasound therapy or low-level laser therapy. Improvement was significantly better in those randomized to ultrasound.
 
2006-2007 Update
A search of the MEDLINE database was performed for the period of August 2005 through December 2006. A single publication was found for this period, which was a review of the studies discussed above.  No additional published studies were identified. Therefore, the policy statement is unchanged.
 
2008 Update
A search of the MEDLINE database for the period of January 2007 through February 2008 identified 2 studies, both from Turkish University Medical Centers. One double-blinded randomized sham-controlled trial with 81 patients (141 hands) found slight pre- to post-treatment improvements in sensory (0.2 msn) and distal (0.3 msn) latencies for the laser group, while sensory nerve velocity improved (by 2.7 and 2.1 m/sn) in both groups (a wrist splint was used at night in both groups).  Other measures of nerve conduction were not affected by treatment. There were no differences between the groups in visual analogue scales (VAS) for pain or in symptom severity scores. A second small, double-blinded randomized controlled trial (19 patients with rheumatoid arthritis and carpal tunnel syndrome) found slight improvement in subjective scales of pain and function (e.g., 27-point improvement vs. 13-point improvement on VAS) compared with sham laser therapy, but no differences between groups in objective functional measures (e.g., grip strength, 0.3 vs. 0.3) or in measures of nerve conduction (e.g., motor nerve conduction velocity, 55 vs. 55). Existing literature has not shown laser therapy to be as effective as established treatments for the treatment of carpal tunnel syndrome. Therefore, low-level laser therapy is considered investigational.
 
2010 Update
A review of the published literature through December 2009 identified studies and systematic reviews for Low-Level Laser Therapy for the treatment of various indications including, carpal tunnel syndrome, elbow, knee, shoulder and low back pain, Achilles tendinopathy, rheumatoid arthritis, temporal mandibular joint pain, fibromyalgia and wound healing.  
 
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 US. A 2009 systematic review included controlled trials of LLLT as primary intervention for any tendinopathy (Tumilty, 2009).  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, six 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, four of them 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 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 one 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. Studies of LLLT for specific joints with at least 20 subjects are summarized below.
 
Carpal Tunnel Syndrome
The largest body of evidence for LLLT describes its use in treatment of carpal tunnel syndrome. As part of the 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 a month. However, the results of this study have not been published in the peer-reviewed literature, and only a short summary is available in the FDA Summary of Safety and Effectiveness , which does not permit scientific conclusions. Naeser and colleagues published the results of a controlled study of 11 patients with mild to moderate carpal tunnel syndrome who received real and sham treatment of low-level laser acupuncture and TENS therapy (Naeser, 2002). This study is also too small to permit scientific conclusions. Irvine and colleagues reported on the results of a small double-blinded study of 15 patients with carpal tunnel syndrome who were randomized to receive either low-level laser therapy or sham laser therapy (Irvine, 2004).  There was a significant improvement in both groups, but there was no significant difference between the groups. A 2007 double-blinded randomized sham-controlled trial with 81 patients (141 hands) found slight pre- to post-treatment improvements in sensory (0.2 msn) and distal (0.3 msn) latencies for the laser group, while sensory nerve velocity improved (by 2.7 and 2.1 m/sn) in both groups (a wrist splint was used at night in both groups) (Evcik, 2007). Other measures of nerve conduction were not affected by treatment. There were no differences between the groups in visual analogue scales (VAS) for pain or in symptom severity scores. A second small, double-blinded randomized controlled trial (19 patients with rheumatoid arthritis and carpal tunnel syndrome) found slight improvement in subjective scales of pain and function (e.g., 27-point improvement vs. 13-point improvement on VAS) compared with sham laser therapy, but no differences between groups in objective functional measures (e.g., grip strength, 0.3 vs. 0.3) or in measures of nerve conduction (e.g., motor nerve conduction velocity, 55 vs. 55). (6) Chang and colleagues report on a randomized controlled trial (RCT) with short follow-up comparing LLLT with sham treatment in just 36 patients (Chang, 2008).  After 2 weeks of treatment and 2 weeks after the end of treatment, visual analog scores (VAS) 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 nonsignificant, but were significant (P<0.05) at 2-week follow-up. 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 (Shooshtari, 2008) Outcomes were measured at the end of 15 treatment sessions (5x/week for 3 weeks). In this study, the treatment group showed significant improvement in clinical symptoms, hand grip, and nerve conduction studies.
 
Bakhtiary and Rashidy-Pour reported on the outcomes of 50 consecutive patients with carpal tunnel syndrome who were randomized to receive either ultrasound therapy or low-level laser therapy (Bakhtiary, 2004). Improvement was significantly better in those randomized to ultrasound. In a study from Turkey, Dincer et al. compared splinting with ultrasound (US), splinting with LLLT, and splinting alone in a RCT (Dincer, 2009).  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 Score (BQ-SSS), the Boston Questionnaire Functional Status Scale (BQ-FSS, visual analogue scale for pain (VAS), second digit-wrist median nerve sensory velocity (SV), and median nerve motor distal latency (MDL). 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 LLT groups than the splint only group (P=0.05).
 
Elbow Pain
Authors of a systematic review published in 2008 grouped trials by application technique and wave lengths and reported that 7 out 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 2-6 points on the lateral elbow (Bjordal, 2008). Positive results in these trials were consistent on outcomes of pain and function, and significance persisted for at least 3-8 weeks after the end of treatment. The authors noted that the conclusions of their review differed from conclusion of other, prior reviews of this topic.
 
Low Back Pain
A 2008 update of the Cochrane Database System Review of low level laser therapy 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 low-back pain” (Yousefi-Nooraie, 2008).  Chou and colleagues assessed benefits and harms of nonpharmacological 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 (Chou, 2007). In a study by Djavid et al., 61 patients were randomized to LLLT alone , LLLT with exercise, or sham laser treatment with exercise (Djavid, 2007).  Outcomes of pain on VAS, lumbar range of motion (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 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% confidence interval [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 Shrober Test and by 15 degrees (95% CI 5-25, 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 advise that larger trials are needed to detect differences between groups for some outcomes.
 
Achilles Tendinopathy
Stergioulas and colleagues randomized 52 recreational athletes with chronic Achilles tendinopathy symptoms to an 8-week (12 sessions) program eccentric exercises (EE) with LLLT or with sham LLLT (Stergioulus, 2008).  By intention-to-treat analysis, results for the primary outcome of pain during physical activity on visual analog scale (VAS) were significantly lower in the EE with LLLT group at 4 weeks, 8 weeks, and 12 weeks after randomization. Results of EE with LLLT at 4 weeks were similar to results for the EE plus sham LLLT group after 12 weeks.
 
Shoulder Pain
In a study designed to assess the effectiveness of LLLT in patients with subcacromial impingement syndrome, 44 patients were randomized in equal numbers to receive a 12-week home exercise program with or without LLLT (Bal, 2009).  Outcome measures of night pain, shoulder pain and disability index (SPADI), and University of California-Lost Angeles end-result scores were assessed at the 2nd and 12th weeks 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 (Yeldan, 2009). Both groups improved significantly, and there were no significant between-group differences on measures of pain, function, disability, and muscle strength. Sixty-three patients with frozen shoulder were included in a RCT comparing an 8-week program of LLLT or placebo (Stergioulas, 2008). Compared to the sham group, the active laser group had a significant decrease in overall, night, and activity pain scores after 4 weeks and 8 weeks of treatment, and at the end of 8 more weeks of follow-up. At the same time intervals, a significant decrease in shoulder pain, disability index (SPADI) scores, and Croft shoulder disability questionnaire scores was observed, while a significant decrease in disability of arm, shoulder, and hand questionnaire (DASH) scores was observed at 8 weeks of treatment and 16 weeks’ postrandomization; and a significant decrease in health assessment questionnaire scores was observed at 4 weeks and 8 weeks of treatment.
 
Knee Pain
In 2007, Bjordal et al. published a systematic review of placebo-controlled RCTs to determine the shortterm efficacy of physical interventions for osteoarthritic knee pain (Bjordal, 2007). They concluded that transcutaneous electrical stimulation (TENS) (including interferential currents), and LLLT offered clinically relevant pain relieving effects on VAS compared to 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.
 
Rheumatoid Arthritis (RA)
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 visual analogue scale compared to placebo, reduced morning stiffness duration by 27.5 minutes, and increased tip-to-palm flexibility by 1.3 cm (Brosseau, 2005).  Other outcomes, such as functional assessment, range of motion and local swelling, did not differ between groups. For RA, relative to a control group using the opposite hand (one 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.”
 
Temporal Mandular Joint (TMJ) Pain
Outcomes of trials of LLLT for TMJ pain are inconsistent. In a study from Brazil, 40 patients with TMJ were treated with LLLT or placebo (da Cunha, 2008).  After 4 weeks of weekly treatment, patients were evaluated on pain on visual analog scale (VAS) and the Craniomandibular Index (CMI). 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 (Emshoff, 2008).  After 8 weeks of 2-3 treatments/week, both groups showed improvements in pain during function. Between-group differences were not significant. Fikácková and colleagues treated 61 patients TMJ or myofascial pain with LLLT at one of 2 densities (10 J/cm2 or 15 J/cm2) and 19 patients with sham LLLT (0.1 J/cm2) (Fikácková, 2007). Outcomes were measured by self administered questionnaire. The authors report significantly better outcomes in patients treated with 10 j/cm2 or 15 J/cm2 than in patients given sham treatment. There were no differences in outcomes between patients with TMJ and myofascial pain.
 
Fibromyalgia
Matsutani and colleagues randomized 20 patients with fibromyalgia to receive laser treatment and stretching exercises or stretching alone (Matsutani, 2007).  Outcome measures were visual analog scale of pain (VAS) and dolorimetry at tender points, quality of life 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 non-healing wounds prepared for the Agency for Healthcare Research and Quality was based on 11 studies of LLLT (Samson, 2004). 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”. No newer studies were identified in the literature search. Clinical trials are underway.
 
In summary, the available literature has not shown laser therapy to be as effective as established treatments for the treatment of various musculoskeletal conditions, including carpal tunnel syndrome, or for wound healing. Outcomes of studies comparing LLLT with sham laser therapy for treatment of pain are inconsistent and generally involve small numbers of participants. There is some evidence of a dose dependent effect in the treatment of tendinopathies. Randomized controlled trials involving larger numbers of patients comparing low-lever laser therapy with established treatments and reporting complete dosage information are required. Evidence for LLLT for many conditions including chronic wounds and nerve damage is extremely limited and FDA clearance has not been given for use of LLLT   for these indications.
 
2012 Update
A search of the MEDLINE database was conducted through August 2012.  There was no new information identified that would prompt a change in the coverage statement. Key studies of LLLT for specific joints are summarized below.
 
Carpal Tunnel Syndrome
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. 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 studies of carpal tunnel syndrome assessing LLLT for the treatment of carpal tunnel syndrome (Irvine, 2004; Evcik, 2007; Ekim, 2007; Chang, 2008) 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 (Tascioglu, 2010). 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.
 
Neck Pain
The 2010 TEC Assessment included 6 trials of LLLT for chronic neck pain and found inconsistent results. In the largest study by Chow et al., 90 patients were randomized to active LLLT or sham treatment (Chow, 2006). 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 (Chow, 2004). 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.
An RCT of LLLT for acute neck pain with radiculopathy by Konstantinovic and colleagues published in 2010 did not report outcomes at least 2 weeks beyond the end of the treatment period (Konstantinovic, 2010).
 
Subacromial Impingement
In a 2010 report, Dogan et al. randomized 52 patients with subacromial impingment syndrome to active or sham LLLT 5 times per week for 14 sessions (Dogan, 2010). All patients were also given an exercise program. Both groups showed improvements in pain, some measures of range of motion, and on the Shoulder Pain and Disability Index. There were no significant differences between the 2 groups.
 
Calis et al. randomized 52 patients with subacromial impingment syndrome to LLLT, US, or exercise in 2011 (Calis, 2011). 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 post-treatment in pain at rest, range of motion, 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 (Abrisham, 2011). At the conclusion of the treatment period, both groups showed improvement in VAS for pain and shoulder range of motion. 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 range of motion (active and passive flexion, abduction, and external rotation). The durability of this effect was not assessed.
 
Temporomandibular Pain
Venezian et al. randomized 48 patients with myofascial pain to one of 2 doses of laser (25 J/cm2 or 60 J/cm2) or placebo twice a week for 4 weeks (Venezian, 2010). Surface electromyography (EMG) at the conclusion of testing showed no difference between the 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 and colleagues compared superpulsed LLLT with NSAIDs for pain caused by temporomandibular joint disorders secondary to disc displacement without reduction or osteoarthritis (Marini, 2010). 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.
 
Low Back Pain
In 2010, Ay and colleagues randomized 80 patients with acute and chronic low back pain attributed to lumbar disc herniation (LDH) into 4 groups of 20 (Ay, 2010). 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, range of motion, Roland Disability Questionnaire, and Modified Oswestry Disability Questionnaire (p<0.05). There were no significant differences between treatment groups on any outcomes (p<0.05). Durability of the treatment effect was not reported.
 
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 (Konstantinovi, 2010). All patients received nimesulide 200 mg; patients in group A received active LLLT, patients in group B received only nimesulide, and patients in group C received placebo LLLT. Treatments were given 5 times per week for 15 weeks. Statistically significant differences after treatment were found on all outcomes (p<0.001) but were larger in group A than in B (p<0.005) and C (p<0.0005). Results in group C were better than in group B (p<0.0005). The authors conclude that improvement is better in acute low back pain with LLLT as additional therapy. Durability of these outcomes was not measured.
 
Rheumatoid Arthritis (RA)
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. (Meireles, 2010). 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.
 
Plantar Fasciitis
Kiritsi and colleagues reported a randomized double-blind sham-controlled trial of LLLT in 30 subjects with plantar fasciitis in 2010 (Kiritsi, 2010). 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 two 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 67/100 by both groups. At the end of treatment, VAS after daily activities was rated as 28/100 for LLLT and 50/100 for sham.
 
Lymphedema
In 2011, Omar et al. reported a randomized double-blind sham controlled trial of LLLT in 50 patients with post-mastectomy lymphedema (Omar, 2011). The average length of time that patients had swelling was 14 months (range 12-36 month). 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.
 
Summary
The available literature on low-level laser therapy as a treatment for lymphedema, wound healing, or pain of various etiologies and in a variety of anatomical sites presents inconsistent results and methodologic weaknesses, including lack of follow-up evaluation, that prevent drawing firm conclusions regarding efficacy.
 
2014 Update
A literature search conducted through October 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Kidney Transplantation
Two retrospective studies of kidney transplant recipients found statistically significant correlations between ATP production and WBC. In a study of 39 patients at a single center in Japan, Nishikawa et al
(2014) reported correlation coefficients (R2) of 0.573 (p=0.03) and 0.510 (p=0.02) for associations between WBC and neutrophil counts, respectively. (Nishikawa, 2014).  In this study, ATP levels in 5 patients who developed viral infections in the early post-transplantation period (<50 days) were within normal limits. Methodological limitations prevented any conclusion about the association of ATP levels with infections in 8 patients in the late post-transplantation period (>120 days). In a study of 306 patients at a single U.S. center, Sageshima et al (2014) reported a correlation coefficients (R2) of 0.264 (p<0.001) for the association between ATP production and WBC (Sageshima, 2014). In this study, mean (SE) ATP production in patients with biopsy-proven rejection (389 [56] ng/ml) and borderline/clinical rejection (254 [41] mg/mL) were not statistically higher compared with ATP production in patients without rejection (not reported).
 
Kidney Transplantation
Subsequent studies in kidney transplant recipients have demonstrated no association between ATP production and risk of acute rejection or viral infections using manufacturer-recommended cutoffs for ImmuKnow®  (Libri, 2013; Myslik, 2014) have suggested an alternative approach to determining optimal cutoff values (Quaglia, 2014; Wang, 2014). In a prospective cohort study of 55 patients followed for 3 years, Libri et al (2014) observed that ATP production was often lower in patients with acute rejection compared with patients without acute rejection, and was often greater in patients with infection compared with patients without infection. Using labelled cutoffs for ImmuKnow®, AUC was 0.44 (95% CI: 0.18 to 0.71) for acute rejection and 0.37 (95% CI: 0.22 to 0.53) for viral or major respiratory tract infections. In a prospective study of 67 patients undergoing kidney transplant, patients with low preoperative ATP production had statistically fewer rejection episodes than those with high preoperative ATP production (p<0.001) (Myslik, 2014). The cutoff used for this analysis was 300 ng/mL. To optimize ImmuKnow® performance, Quaglia et al (2014) and Wang et al (2014) both proposed assessing change in ATP production over time, rather than single values. In a retrospective study of 118 patients, Quaglia et al reported AUC of 0.632 (95% CI: 0.483 to 0.781) for infection risk using a cutoff of –30 ng/mL for the decrease in ATP production from month 1 to month 3 (Quaglia, 2014). In a prospective study of 140 patients, Wang et al reported AUC of 0.929 for risk of acute rejection using a cutoff of 172.55 ng/mL for the increase in ATP production from “right before” the rejection episode to the occurrence of rejection (Wang, 2014).
 
HIV
Natsuda et al (2014) assessed ATP production in 28 patients co-infected with HIV and HCV (Natsuda, 2014). These patients were all receiving anti-retroviral therapy with undetectable viral load in most, and were classified Child-Pugh class A. Results were compared with those of 24 HCV-infected liver transplant recipients and 11 healthy volunteers. Median ATP levels in the HIV/HCV co-infected group (259 ng/ML [range: 30-613]) were statistically higher compared with the HCV mono-infected group (33 ng/mL [range: 6-320]; Mann-Whitney U test, p<0.001) and significantly lower compared with healthy volunteers (446 ng/mL [range: 309-565]; Mann-Whitney U test, p=0.001). In HIV/HCV co-infected patients, ATP production was significantly correlated with CD4+ cell count (Spearman rank correlation, p=0.03) but not with CD4/CD8 ratio (Spearman rank correlation, p=0.76). The clinical significance of these findings, for either HCV mono-infected liver transplant recipients or HIV/HCV co-infected patients, is unclear.
 
Lupus Nephritis
Liu et al (2014) compared ATP production in 22 patients with lupus nephritis and severe infection requiring hospitalization, 74 patients with lupus nephritis and no infection, and 28 healthy controls (Liu, 2014). Mean ATP production was significantly lower in patients with lupus nephritis and severe infection compared with non-infected patients and healthy controls (p<0.01 for both comparisons). Mean ATP production in non-infected LN patients did not differ statistically from that in healthy controls. Using a cutoff of 300 ng/mL, sensitivity and specificity for severe infection were both 77%. Strength of the correlation between ATP production and severe infection (r=–0.040, p<0.001) was less than that between C-reactive protein and severe infection (r=0.962, p<0.001).
 
2016 Update
A literature search conducted through September 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Carpal Tunnel Syndrome
In 2015, Barbosa and colleagues evaluated the efficacy of orthoses and patient education with or without the addition of LLLT in patients with mild and moderate carpal tunnel syndrome (Barbosa, 2015). Laser treatment was provided twice a week for 6 weeks. Forty-eight patients were randomized and 30 (63%) completed the study protocol. Compared with baseline, outcomes (eg, scores on the Boston Carpal Tunnel Questionnaire and its domains) did not differ significantly between groups after treatment. The study is limited by the high dropout rate.
 
Oral Mucositis
Eight RCTs included patients undergoing HSCT, 8 were on head and neck cancer patients receiving radiotherapy or chemoradiation and the rest of the studies were on patients with other conditions receiving chemotherapy. The investigators used the Cochrane risk of bias tool to evaluate the RCTs. Most studies were considered at low risk of bias on most domains. For example, 68% were at low risk of bias for blinding of patients and personnel and 89% were at low risk of bias on incomplete outcome data. The primary outcome measure for the review was the incidence of severe mucositis. Ten studies (total N=689 patients) were included in a pooled analysis of this outcome. The overall incidence of severe mucositis (grades 3-4) decreased with prophylactic LLLT with a risk ratio (RR) of 0.37 (95% confidence interval [CI], 0.20 to 0.67; p = 0.001). Moreover, absolute risk reduction in the incidence of severe mucositis significantly favored LLLT (-0.35; 95% CI, -0.48 to -0.21; p<0.001). Among secondary outcomes, LLLT also significantly reduced the overall mean grade of mucositis (standardized mean difference [SMD], -1.49; 95% CI, -2.02 to -0.95), duration of severe mucositis (weighted mean difference, -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 a subgroup analysis of the primary outcome, incidence of severe mucositis, the investigators did not find a statistically significant interaction between the type of condition being treated and the efficacy of LLT.
 
A 2015 qualitative systematic review by Doeuk and colleagues addressed literature on LLLT for patients undergoing maxillofacial surgery (Doeuk, 2015). The authors identified a total of 45 studies that included more than 10 patients. Three RCTs on treatment of oral mucositis in patients with head and neck cancer were identified and these found significantly better outcomes (eg, pain, symptoms, quality of life) in patients receiving active LLLT versus sham treatment. Overall, the authors conduced that LLT “seems to be effective” for treating oral mucositis after head and neck cancer therapy, but that LLLT cannot be considered a valid treatment option for patients undergoing other types of maxillofacial surgery. The systematic review did not address prophylactic LLLT.
 
In 2015, 3 relatively small (ie, <50 patients), double-blind, sham-controlled RCTs on prevention of oral mucositis in patients undergoing cancer treatment were published. Gautam and colleagues reported on 46 patients with head and neck cancer scheduled for radiotherapy and found significant reductions in the incidence and duration of severe oral mucositis (p=0.0016) and severe pain (p=0.023) after LLLT versus sham (Gautam, 2015). Oton-Leiter reported on 30 head and neck cancer patients undergoing chemoradiation and found that the oral mucositis grade was significantly lower in the LLLT group than the control group at the week 1, 3, and 5 evaluations (Oton-Leite, 2015). For example, at the last clinical evaluation (week 5), the rate of grade 3 oral mucositis was 25% in the LLLT group and 54% in the control group. The third RCT, by Ferreira and colleagues, included 36 patients with hematologic cancer undergoing HSCT (Ferreira, 2016). The overall incidence of oral mucositis did not differ significantly between the groups (p=0.146). However, the rate of severe oral mucositis (grade 3 or 4) was significantly lower in the laser group (18%) than the control group (61%; p=0.015).
 
The MASCC/ISOO recommendation for LLLT for preventing oral mucositis in patients undergoing radiotherapy for head and neck cancer was based on lower level evidence. A 2014 systematic review of RCTs on LLLT for prevention of oral mucositis included 18 RCTs, generally considered at low risk of bias, and found statistically significantly better outcomes with LLLT than control conditions on primary and secondary outcomes. In addition, 3 double-blind, RCTs published in 2015 found significantly better outcomes in patients undergoing LLLT compared with sham treatment prior to or during cancer treatment.
 
Temporomandibular Joint Pain
Several systematic reviews and meta-analyses of RCTs on LLLT for temporomandibular joint (TMJ) pain have been published. A 2015 systematic review by Chen and colleagues published a meta-analysis of pain and functional outcomes after LLLT for TMJ pain (Chen, 2015). Fourteen placebo-controlled RCTs were identified. Ten trials provided data on pain, measured by a visual analog scale (VAS). A pooled analysis of these studies found no significant difference between active treatment and placebo on the VAS at final follow-up (weighted mean difference [WMD], -19.39; 95% CI, -40.80 to 2.03; p=0.08). However, meta-analyses did find significantly better functional outcomes (ie, maximum active mouth opening, maximum passive mouth opening). For example, the mean difference in maximum active mouth opening, active treatment versus placebo, at final follow-up was a mean difference (MD) of 4.18 (95% CI, 0.73 to 7.63).
 
There are a number of medium to large, randomized, sham-controlled trials of LLLT for temporomandibular syndrome. Findings of these trials, as well as of systematic reviews of RCTs, are mixed and most trials do not show a benefit of LLLT.
 
Low Back Pain
A number of RCTs and several systematic reviews of RCTs have been published. In 2015, Huang and colleagues published a systematic review of RCTs on LLLT for treatment of nonspecific chronic low back pain (Huang, 2015a). The review included trials comparing LLLT and placebo that reported pain and/or functional outcomes and reported a PEDro quality score. Seven trials with a total of 394 patients were included (202 assigned to LLLT and 192 assigned to placebo). Six of the 7 trials were considered high quality (ie, a PEDro score of at least 7 out of 11 possible points). Primary outcomes of interest were posttreatment pain measured by VAS and disability measured by the Oswestry Disability Index (ODI). Range of motion and change in pain scores were secondary outcomes. In pooled analyses of study data, the authors found a statistically significant benefit of LLLT on pain outcomes, but not disability or range of motion. For the primary outcome posttreatment pain scores, in a meta-analysis of all 7 trials, mean VAS was significantly lower in the LLLT compared with the placebo group (WMD = -13.57; 95% CI, -17.42 to -9.72). In a meta-analysis of 4 studies reporting the other primary outcome, ODI, there was not a statistically significant difference between LLLT and placebo groups (WMD = -2.89; 95% CI, -7.88 to 2.29).
 
The literature on LLLT for low back pain consists of a number of RCTs and several systematic reviews of RCTs. Systematic reviews of RCTs did not consistently find that LLLT improved outcomes for patients with nonspecific low back pain.
 
Osteoarthritis Knee Pain
Several RCTs and systematic review of RCTs on LLLT for treatment of knee osteoarthritis have been published. In 2015, Huang and colleagues published a systematic review of RCTs comparing at least 8 treatment sessions of LLLT and sham laser treatment in knee osteoarthritis patients (Huang, 2015b). To be eligible for inclusion in the review, trials needed to report pain and/or functional outcomes and a PEDro quality score. A total of 9 trials (total N=518 patients) met eligibility criteria. In these studies, the interventions included between 8 and 20 laser or sham sessions over 2 to 6 weeks. All 9 trials were considered high quality according to the PEDro scale (score of at least 7 out of 11 possible points). Primary outcomes of interest were post treatment pain measured by VAS and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores (pain and function). Meta-analyses did not find that LLLT led to significantly better pain scores than the sham control, either immediately after treatment or at the 3-month follow-up. For example, a meta-analysis of 5 studies that reported 12-week pain scores did not find a statistically significant between-group difference (standardized mean difference [SMD], -0.06; 95% CI, -0.30 to 0.18). Moreover, there were not statistically significant differences between active and sham laser interventions on WOMAC stiffness cores or WOMAC function scores. The secondary outcome, range of motion after therapy, also did not significantly favor LLLT over a sham intervention.
 
Previously, in 2007, Bjordal and colleagues published a systematic review of placebo-controlled RCTs to determine the short-term efficacy of physical interventions for pain associated with knee osteoarthritis (Bjordal, 2007). They included a total of 36 RCTs. The largest proportion of trials evaluated TENS (n=11), followed by 8 trials on LLLT and 7 on pulsed electromagnetic fields. Also included were trials on electroacupuncture, manual acupuncture, static magnets, and ultrasound. The authors did not report findings of pooled analyses on LLLT for knee osteoarthritis. In a qualitative analysis, they stated that all the physical interventions but 2 (manual acupuncture, ultrasound) showed better results with active treatment over placebo.
 
The literature on LLLT for OA includes RCTs and 2 systematic reviews of RCTs. The more recent systematic review, which was also the only one to pool study findings, did not find that LLLT significantly improved pain and functional outcomes compared with a sham intervention.
 
Plantar Fasciitis
A 2015 RCT by Macias and colleagues published a double-blind RCT that 69 patients with unilateral chronic plantar fasciitis and chronic heel pain of 3 months or longer that was unresponsive to conservative treatments (eg, rest, stretching, physical therapy) (Macias, 2015). Patients were randomized to twice weekly treatment for 3 weeks of LLLT or sham treatment. The primary efficacy outcome, difference in reduction of heel pain pre- to posttreatment, differed significantly between groups (p<0.001). Mean VAS decreased from 69.1 to 39.5 in the LLLT group and from 67.6 to 62.3 in the sham group. The difference in scores on the Foot Function Index did not differ significantly between groups.
 
There are several sham-controlled RCTs evaluating LLLT for heel pain (Achilles tendinopathy, plantar fasciitis). Findings of these trials are inconsistent. There were no RCTs comparing LLLT to an alternative treatment for heel pain. Moreover, there are limited long-term follow-up data.
 
Fibromyalgia
Several small RCTs evaluating LLLT for treating fibromyalgia have been published. In 2014, Ruaro and colleagues reported on 20 patients randomized to receive LLLT or sham treatment 3 times a week for 4 weeks (total of 12 treatments) (Ruaro, 2014). Outcomes included scores in the Fibromyalgia Impact Questionnaire (FIQ) which measures physical function, ability to work, pain, fatigue and depression, the McGill Pain Questionnaire (MPQ) and a pain VAS. All 3 outcomes were significantly better in the active compared to sham group after treatment. The mean overall FIQ score was 18.6 in the LLLT group and 5.2 in the sham group (p=0.003). Mean change scores also differed significantly between groups for MPQ score (p=0.008) and VAS score (p=0.002).
 
Few RCTs evaluating LLLT for treatment of fibromyalgia are available and existing trials are small (ie, <2s5 patients each). One RCT with 20 patients found significantly better outcomes with LLLT versus sham and another RCT with 20 patients did not find statistically significant between-group differences on similar outcomes. Additional RCTs with sufficient numbers of patients are needed.
 
Lymphedema
Several systematic reviews of RCTs and observational studies have been published. In 2015, Smoot and colleagues published a systematic review of studies on the effect of LLLT on symptoms in women with breast cancer‒related lymphedema (Smoot, 2015). The authors identified 9 studies, 7 RCTs and 2 single-group studies. Three studies had a sham control group, 1 used a waitlist control, and 3 compared LLLT to an alternative intervention (eg, intermittent compression). Only 3 studies had blinded outcome assessment and, in 3 studies, participants were blinded. A pooled analysis of 4 studies found significantly greater reduction in upper-extremity volume with LLLT versus the control condition (effect size [ES], -0.62; 05% CI, -0.97 to - 0.28). Only 2 studies were suitable for a pooled analysis of the effect of LLLT on pain. This analysis did not find a significant difference in pain between LLLT and control (ES = -1.21; 95% CI, -4.51 to 2.10).
 
Two systematic reviews of RCTs and observational studies found methodologic flaws in the available studies and did not consistently find better outcomes in patients receiving LLLT versus a control condition for treatment of lymphedema.
 
Summary of Evidence
The evidence for low-level laser therapy (LLLT) in individuals who have increased risk of oral mucositis due to some cancer treatments (eg, chemotherapy, radiotherapy) and/or hematopoietic stem cell transplantation includes RCTs and systematic reviews of randomized controlled trials (RCTs). Relevant outcomes are symptoms, morbid events, quality of life, and treatment-related morbidity. Studies included patients undergoing various cancer chemotherapy regimens or hematopoietic stem cell transplantation. A recent systematic review of RCTs on LLLT for prevention of oral mucositis included 18 RCTs, generally considered at low risk of bias, and found statistically significantly better outcomes with LLLT than control conditions on primary and secondary outcomes. In addition, 3 double-blind, RCTs published in 2015 found significantly better outcomes in patients undergoing LLLT compared with sham treatment prior to or during cancer treatment. The evidence is sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome.
 
The evidence for LLLT in individuals who have orthopedic pain (ie, neck pain, osteoarthritis knee pain, low back pain, carpal tunnel syndrome) includes RCTs and, for some indications, systematic reviews of RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Findings of the RCTs were mixed and had methodologic limitations. The evidence is insufficient to determine the effects of the technology on health outcome.
 
The evidence for LLLT in individuals who have shoulder conditions, heel pain, or temporomandibular joint pain includes RCTs and, for some indications, systematic reviews of RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Findings of the RCTs were mixed and had methodologic limitations. The evidence is insufficient to determine the effects of the technology on health outcome.
 
The evidence for LLLT in individuals who have bone, ligament, and joint conditions (eg, rheumatoid arthritis, fibromyalgia) includes RCTs and, for some indications, systematic reviews of RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Findings of the RCTs were mixed and had methodologic limitations. The evidence is insufficient to determine the effects of the technology on health outcome.
 
The evidence for LLLT in individuals who have Bell palsy includes an RCT. Relevant outcomes are change in disease status, functional outcomes, quality of life, and treatment-related morbidity. Bell palsy may completely resolve within months and, thus, it is difficult to determine any improvements from laser therapy over the natural resolution of the illness. The available RCT did not include a sham treatment; LLLT was superior to exercise only in this study. Sham-controlled studies are needed as well as additional studies comparing LLLT with alternative Bell palsy treatments. The evidence is insufficient to determine the effects of the technology on health outcome.
 
The evidence for LLLT in individuals who have lymphedema includes RCTs, observational studies, and systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment related morbidity. Systematic reviews of RCTs and observational studies found methodologic flaws in the available studies and did not consistently find better outcomes in patients receiving LLLT than in patients receiving a control condition treatment. The evidence is insufficient to determine the effects of the technology on health outcome.
 
Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology
In 2014, the Mucositis Guidelines leadership Group of the Multinational Association of Supportive Care in Cancer MASCC) and the International Society of Oral Oncology (ISOO) published a guideline on the management of mucositis secondary to cancer therapy
 
For the prevention of oral mucositis, the MASCC/ISOO recommended the following treatments, based on strong evidence: LLLT (650 nm, power of 40 mW) in patients receiving HSCT conditioned with high-dose chemotherapy with or without total body irradiation; oral cryotherapy in patients receiving bolus 5- fluorouracil chemotherapy; recombinant human keratinocyte growth factor-1 in patients receiving high-dose chemotherapy and total body irradiation, followed by autologous stem cell transplantation for a hematological malignancy; benzydamine mouthwash in patients with head and neck cancer receiving moderate dose radiotherapy without concomitant chemotherapy.
 
Additionally, the following treatments were recommended for the prevention of oral mucositis based on weaker evidence: LLLT (632.8nm) in patients undergoing radiotherapy, without concomitant chemotherapy, for head and neck cancer; oral care protocols for patients undergoing any cancer treatment; oral cryotherapy in patients receiving high-dose melphalan as conditioning for HSCT; oral zinc supplements in oral cancer patients receiving radiotherapy or chemoradiation.
 
National Comprehensive Cancer Network
The National Comprehensive Cancer Network 2015 guideline on head and neck cancers does not address prevention or treatment or oral mucositis (NCCN, 2015).
 
2017 Update
 
A literature search was conducted using the MEDLINE database through October 2017. There was no new literature identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Carpel Tunnel Syndrome
In 2016, Li et al published a meta-analysis of RCTs on LLLT for CTS (Li, 2016). Reviewers identified 7 RCTs. Meta-analyses evaluated outcomes for hand grip strength, pain measured by a VAS, symptom severity scores, and functional status scores. Short-term follow-up was defined as less than 6 weeks after treatment and long-term follow-up as at least 12 weeks after treatment. For 6 of the 8 meta-analyses, there were not statistically significant between-group differences in outcomes. They included short-term assessment of hand grip, short-term assessment of pain (VAS), and short- and long-term assessment of symptom severity and functional status scores. Meta-analyses found stronger hand grip (3 studies) and greater improvement in VAS scores (2 studies) at the long-term follow-up in the LLLT group than in the control. Most data for these 2 positive analyses were provided by a single RCT (Fusakul et al [2014]14). Reviewers concluded that additional high-quality trials with similar LLLT protocols would be needed to confirm that the intervention significantly improves health outcomes.
 
Low Back Pain
A number of RCTs and several systematic reviews of RCTs have been published. Most recently, Glazov et al (2016) published a meta-analysis of blinded sham-controlled trials evaluating LLLT for treatment of chronic low back pain (Glazov, 2016). Fifteen RCTs (total n=1039 patients) met reviewers’ eligibility criteria. Reviewers found that 3 of the 15 trials were at higher risk of bias (using a modified Cochrane risk of bias tool), mainly due to lack of blinding. The primary outcomes of interest to reviewers were pain measured by a VAS or a numeric rating scale, and a global assessment measure evaluating overall improvement and/or satisfaction with the intervention. Outcomes were reported immediately posttreatment (<1 week) and at short-term (1-12 weeks) follow-up. Longer term outcomes (ie, at 6 and 12 months) were secondary measures. For the pain outcome, meta-analysis of 10 trials found significantly greater reduction in pain scores in the LLLT group at immediate follow-up (WMD = -0.79 cm; 95% CI, -1.22 to 0.36 cm). In a meta-analysis of 6 trials, there was no significant difference in pain reduction at short-term follow-up. However, in subgroup analyses, there was significantly greater reduction in pain with LLLT in trials that used a higher dose (>3 J/point), but not a lower dose, and in trials that included patients with a short duration of back pain (5-27 months) but not long duration (49 months to 13 years). Decisions on the cutoff to use for laser dose and duration of back pain were made post hoc and considered review findings. Findings were similar for the global assessment outcome. Meta-analyses found significantly higher global assessment scores at immediate follow-up (5 trials) but not at short-term follow-up (3 trials). Only 2 trials reported pain or global assessment at 6 months and 12 months and neither found statistically significant differences between the LLLT and sham groups.
 
National Institute for Health and Care Excellence
The U.K.’s National Institute for Health and Care Excellence issued guidance in 2009 on early management of persistent nonspecific low back pain did not recommend laser treatment, citing limited evidence (NICE, 2009). The 2016 updated guidance does not mention laser therapy (NICE, 2016).
 
American Academy of Orthopaedic Surgeons
The American Academy of Orthopaedic Surgeons’ 2016 guidelines on management of carpal tunnel syndrome rated laser therapy state: “limited evidence supports that laser therapy might be effective compared to placebo” (AAOS, 2016).
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2019. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Wang et al published a systematic review and meta-analysis of 6 RCTs comparing LLLT (alone or combined with other interventions) and controls (placebo or other interventions) (Wang, 2019). A total of 315 adults with plantar heel pain or plantar fasciitis were included in the analysis. Compared with controls, VAS was significantly reduced after treatment (SMD=-0.95; 95% CI -1.20 to -0.70; p<0.001), as well as remaining significantly better at 3 months (SMD= -1.13; 95% CI -1.53 to -0.72; p<0.001). The meta-analysis was limited by the small number of studies included, its small sample size, and insufficient data for longer-term outcomes.
 
Honda et al published a systematic review and meta-analysis of RCTs evaluating pain relief modalities for fibromyalgia. Eleven studies with a total of 498 patients (range, 20-80) were included (Honda, 2018). Compared with control, LLLT was not associated with a reduction of VAS-measured pain (MD -4.0; 95% CI -23.4 to 15.4; p=0.69). LLLT showed a significant reduction in tender points compared with control (MD -2.21; 95% CI -3.51 to -0.92; I2=42%; p=0.0008) and in Fibromyalgia Impact Questionnaire score (MD -4.35; 95% CI -6.69 to -2.01; I2= 62%; p=0.03). The analysis was limited by only English language studies and only studies with a pure control group or placebo group (ie, no other intervention) being included and by the high heterogeneity score for included studies.
 
Li et al published a systematic review and meta-analysis of 7 RCTs (total patients, n=194) evaluating LLLT as a treatment for a diabetic foot ulcer (Li, 2018). Ulcer area was significantly reduced with LLLT compared with control (WMDweighted mean difference 34.18; 95% CI 19.38–48.99; p<0.001), and the complete healing rate significantly improved with LLLT (OR 6.72; 95% CI 1.99–22.64; p=0.002). The analysis was limited by the number of studies included and small sample size, and by each study having different parameters, demographic information, ulcer characteristics, follow-up time, and treatment period.
 
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2020. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Additional systematic reviews have been published since the MASCC/ISOO (2012) systematic review, with similar findings to support the use of LLLT (Figueiredo, 2013; Doeuk, 2015; Peng, 2020).
 
Several RCTs and systematic review of RCTs have evaluated LLLT for treatment of knee OA, coming to inconsistent conclusions (Huang, 2015; Bjordal, 2007). The most inclusive and up-to-date of these was published by Stausholm et al and compared LLLT with placebo for knee OA patients (Stausholm, 2019). To be eligible for inclusion, trials had to report pain, disability, or QOL. A total of 22 trials (N=1063) met eligibility criteria. Interventions included between 5 to 16 sessions of LLLT or sham LLLT. A total of 9 included studies used a non-re
  

CPT/HCPCS:
0552TLow level laser therapy, dynamic photonic and dynamic thermokinetic energies, provided by a physician or other qualified health care professional
97026Application of a modality to 1 or more areas; infrared
97037Application of a modality to 1 or more areas; low level laser therapy (ie, nonthermal and non ablative) for post operative pain reduction
97039Unlisted modality (specify type and time if constant attendance)
S8948Application of a modality (requiring constant provider attendance) to one or more areas; low level laser; each 15 minutes

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