Light Therapy for Good Health

Overseen By Margaret E Hollander

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: United States Air Force Research Laboratory

Must not be taking: Statins, Diuretics, Antihypertensives, others

Disqualifiers: Cardiovascular disease, Cancer, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 20

150 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you do not take certain medications, such as statins, diuretics, antihypertensive agents, and those associated with sensitivity to heat or light. If you are on these medications, you may need to stop them to participate.

What data supports the effectiveness of the treatment Photobiomodulation Therapy?

Research shows that Photobiomodulation Therapy, also known as Low-Level Light Therapy (LLLT), can promote tissue repair, reduce inflammation, and relieve pain, which is beneficial for wound healing and periodontal treatments. However, while many studies report positive effects, there is still variability in study designs and treatment parameters, making it challenging to establish standardized protocols. ^{1 2 3 4 5}

Is light therapy generally safe for humans?

Light therapy, also known as low-level laser therapy (LLLT), is generally considered safe for humans and has been used for various treatments, including pain management and wound healing. However, there is some concern that it could potentially activate precancerous cells or increase existing cancerous tissue, so caution is advised in such cases. ^{2 4 6 7 8}

How does Photobiomodulation Therapy differ from other treatments for this condition?

Photobiomodulation Therapy is unique because it uses light to stimulate cellular processes, promoting healing and reducing inflammation without the use of drugs. Unlike other treatments, it involves the absorption of red or near-infrared light, which enhances energy production in cells and can be applied directly to the affected area. ^{1 2 4 6 9}

What is the purpose of this trial?

Photobiomodulation therapy (PBMT) involves applying non-ionizing forms of light from sources including lasers, LEDs, and broadband light, in the visible and near infrared spectrum, to the body to enhance performance, stimulate healing, modulate recovery, and improve health. The investigators will conduct a single-blinded randomized-control trial with sham control to investigate the effectiveness of providing PBMT in a military population, translating this cutting-edge research to application in the operational setting.

Research Team

Jason Eckerle

Principal Investigator

United States Air Force Research Laboratory

Eligibility Criteria

This trial is for healthy individuals, likely within a military population based on the description. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and be willing to undergo light therapy treatments.

Inclusion Criteria

Active-duty military personnel, government civilians, and government contractors

Ability to read and understand English language

I am willing and able to follow the study's procedures and attend all follow-up visits.

Exclusion Criteria

I have been diagnosed with an autoimmune disease.

Weight exceeds 300lbs

Height exceeds 7ft 3in

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Washout and Baseline Data Collection

Baseline data is collected during a washout week where participants do not receive any treatment.

1 week

1 visit (in-person)

Treatment Part 1

Participants undergo photobiomodulation treatment sessions or sham treatment sessions, 3 times a week for 3 weeks.

3 weeks

9 visits (in-person)

Washout

Participants continue daily study procedures without receiving sham or active PBMT.

1 week

1 visit (in-person)

Treatment Part 2

Participants resume treatment sessions, crossing over into the other condition (either sham or active PBMT), 3 times a week for 3 weeks.

3 weeks

9 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion.

1 week

Treatment Details

Interventions

• Photobiomodulation Therapy

Trial Overview The study is testing two types of full-body light beds: NovoTHOR XL and ARRC LED, which use non-ionizing light to potentially enhance performance and stimulate healing. It's a single-blinded study with some people getting real treatment and others getting sham (fake) treatment as control.

Participant Groups

Group I: Active Photobiomodulation Full Body Light Bed Therapy Active Control 2 Interventions

Active treatment will be provided via a specialized full body light bed equipped with light-emitting diodes (LEDs) emitting specific wavelengths of light. The participant will be asked to lay in the bed for a 20-minute session. Treatment will be provided 3 times a week for 3 weeks.

Group II: Sham Photobiomodulation Full Body Light Bed Therapy Placebo Group 2 Interventions

Sham-PBMT will be delivered in the same manner as indicated for the Active treatment process, but the devices will not be turned on. The participant will be asked to lay in a specialized full body light bed equipped with light-emitting diodes (LEDs) for a 20-minute session. Sham-PBMT Treatment will be provided 3 times a week for 3 weeks.

Photobiomodulation Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Photobiomodulation Therapy for:

• Pain relief
• Tissue repair
• Inflammation reduction
• Wound healing

Approved in European Union as Photobiomodulation Therapy for:

• Pain relief
• Tissue repair
• Inflammation reduction
• Wound healing

Approved in Canada as Photobiomodulation Therapy for:

• Pain relief
• Tissue repair
• Inflammation reduction
• Wound healing

Who Is Running the Clinical Trial?

United States Air Force Research Laboratory

Lead Sponsor

Trials

3

Recruited

310+

Uniformed Services University of the Health Sciences

Collaborator

Trials

130

Recruited

91,100+

The Geneva Foundation

Collaborator

Trials

39

Recruited

13,700+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Findings from Research

Low-level light therapy (LLLT) has been shown to be a safe and effective treatment for skin rejuvenation, acne vulgaris, and body contouring, supported by a reasonable amount of clinical trial evidence.

Despite its commercial success, the quality of evidence for LLLT is limited by methodological flaws and small sample sizes, highlighting the need for more rigorous, independent clinical trials to validate its therapeutic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation: The Clinical Applications of Low-Level Light Therapy. Glass, GE.[2022]

Low level laser therapy (LLLT) effectively promotes tissue repair and reduces inflammation, making it a valuable tool for enhancing wound healing.

LLLT works by regulating cell behavior through light, influencing cell proliferation and the release of bioactive substances, which contributes to its therapeutic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Advancement in the research of effect of low level laser therapy on wound healing]. Mao, HS., Yao, M., Fang, Y.[2015]

Low-level laser therapy (LLLT) shows promise as a non-invasive treatment for inflammatory diseases, particularly for skin and joint conditions, due to its anti-inflammatory effects and ability to stimulate tissue repair with minimal side effects.

Despite its potential, the variability in laser application methods and a lack of standardized studies on laser type and dosage create challenges in fully understanding and implementing LLLT effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser Light Therapy in Inflammatory, Musculoskeletal, and Autoimmune Disease. Wickenheisser, VA., Zywot, EM., Rabjohns, EM., et al.[2020]

Low-level light therapy (LLLT) shows promising benefits in periodontal and dental implant treatments, demonstrating biostimulatory, anti-inflammatory, and analgesic effects that can enhance healing and reduce inflammation.

Despite the positive findings, there is significant variability in study designs and light irradiation parameters, making it difficult to establish standardized evidence-based protocols for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation in Periodontology and Implant Dentistry: Part 1. Gholami, L., Asefi, S., Hooshyarfard, A., et al.[2020]

Low-level laser therapy (LLLT) has a positive effect on bone regeneration, particularly when there is an optimal relationship between the dose and output power used, as shown in a review of 19 studies.

LLLT stimulates cellular metabolism and increases protein synthesis, which contributes to enhanced bone regeneration, especially when using a high dose with low power or a low dose with high power.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Low-Level Laser Therapy on Bone Regeneration During Osseointegration and Bone Graft. Zein, R., Selting, W., Benedicenti, S.[2018]

Low-level laser therapy (LLLT) effectively reduces pain and promotes healing by using coherent light in the 600 to 1000 nm wavelength range, which triggers biochemical changes in cells and has been supported by numerous clinical and experimental studies.

LLLT has shown significant analgesic and anti-inflammatory effects, making it a promising complementary treatment option for managing symptoms in patients with osteoarthritis and chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Literature on Low-level Laser Therapy Benefits for Nonpharmacological Pain Control in Chronic Pain and Osteoarthritis. Dima, R., Tieppo Francio, V., Towery, C., et al.[2019]

Low level laser therapy (LLLT) can increase the proliferation of cancer cells, as shown in a study using osteosarcoma and lung carcinoma cell lines, indicating potential risks when used in dental treatments.

The study found that the proliferation rates of cancer cells increased with both the power output of the laser and the number of applications, suggesting that LLLT could inadvertently activate precancerous cells or exacerbate existing cancerous tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low level laser therapy induces increased viability and proliferation in isolated cancer cells. Kara, C., Selamet, H., Gökmenoğlu, C., et al.[2022]

Low level laser therapy (LLLT) has been widely used and accepted in Eastern Europe and Asia for various medical conditions, indicating its perceived efficacy among clinicians and patients.

Despite its popularity and reported clinical benefits, LLLT has not yet undergone thorough evaluation through randomized clinical trials in North America and Australasia, highlighting a need for more rigorous research to assess its true value.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

It is time to test low level laser therapy in Great Britain. Moshkovska, T., Mayberry, J.[2018]

Low level light/laser therapy (LLLT) shows promise for treating oral and dental disorders, with 130 out of 153 reviewed studies reporting positive effects such as pain relief and faster healing.

LLLT is considered a safe and novel approach for oral applications, suggesting it could address unmet clinical needs in dental care, although its use in this area has been limited compared to other medical fields.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developments in low level light therapy (LLLT) for dentistry. Carroll, JD., Milward, MR., Cooper, PR., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Photobiomodulation: The Clinical Applications of Low-Level Light Therapy. [2022]

2. China pubmed.ncbi.nlm.nih.gov

[Advancement in the research of effect of low level laser therapy on wound healing]. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Laser Light Therapy in Inflammatory, Musculoskeletal, and Autoimmune Disease. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Photobiomodulation in Periodontology and Implant Dentistry: Part 1. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of Low-Level Laser Therapy on Bone Regeneration During Osseointegration and Bone Graft. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Review of Literature on Low-level Laser Therapy Benefits for Nonpharmacological Pain Control in Chronic Pain and Osteoarthritis. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Low level laser therapy induces increased viability and proliferation in isolated cancer cells. [2022]

8. England pubmed.ncbi.nlm.nih.gov

It is time to test low level laser therapy in Great Britain. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Developments in low level light therapy (LLLT) for dentistry. [2022]