Photobiomodulation Therapy for Performance Enhancement

(SOF Trial)

Overseen By Bradley H Cornell, DPT

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR)

Must not be taking: Statins, Diuretics, Hypertensive agents

Disqualifiers: Obesity, Cardiovascular disease, Autoimmune, others

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

Compensation: Varies

Number of Visits: 11

Duration: 3 weeks

116 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a noninvasive treatment called Photobiomodulation Therapy (PBMT) to determine its effectiveness in helping Special Forces Operators recover and improve performance after workouts. PBMT uses low-level lasers on the body and has shown promising results in athletes for enhancing recovery and reducing fatigue. The trial compares PBMT to a sham treatment to assess any real benefits. It seeks active-duty Special Forces members who can participate in regular training and do not have conditions like cardiovascular disease or specific skin issues. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance recovery and performance.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as statins, diuretics, hypertensive agents, and any medications that make you sensitive to heat or light. If you are on these medications, you may not be eligible to participate.

What prior data suggests that photobiomodulation therapy is safe for performance enhancement?

Research has shown that photobiomodulation therapy (PBMT) is generally safe and easy to tolerate. Studies indicate that PBMT is non-invasive and drug-free, resulting in very few side effects. Some individuals might experience mild, temporary effects like redness at the laser site, but serious issues are rare.

In terms of overall safety, PBMT has been used in many situations and is considered safe for the skin. It has even been studied for managing side effects in cancer treatment, with no evidence of causing or worsening cancer. A growing body of research supports its safety and effectiveness in various areas, including aiding athletes with performance and recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Photobiomodulation Therapy (PBMT) for performance enhancement because it offers a novel approach compared to traditional methods like physical training, nutritional supplements, or pharmacological aids. PBMT utilizes light therapy, delivering photons directly to the quadriceps, which may enhance muscle performance by boosting cellular energy and reducing inflammation. Unlike conventional treatments that often take weeks to show results, PBMT has the potential to enhance performance with just three weekly sessions over three weeks, providing a quicker, non-invasive alternative.

What evidence suggests that photobiomodulation therapy could be effective for performance enhancement in Special Operations Forces?

Research has shown that light therapy, known as photobiomodulation therapy (PBMT), can enhance sports performance and speed up recovery. In this trial, participants will receive either active PBMT or a sham PBMT treatment. Studies have found that using PBMT before and after exercise boosts performance and helps muscles recover more quickly. Athletes using PBMT reported feeling less tired compared to those who received a fake treatment. PBMT aids in healing and reduces muscle damage after workouts. While more research is needed, current evidence suggests that PBMT could be promising for improving physical performance and recovery, especially in challenging activities like those faced by Special Forces. ^{6 7 8 9 10}

Who Is on the Research Team?

Bradley H Cornell, DPT

Principal Investigator

1st Special Forces Group Tactical Human Optimization, Rapid Rehabilitation and Reconditioning (THOR3)

Are You a Good Fit for This Trial?

This trial is for active-duty Special Forces personnel who can read and understand English, commit to the study's requirements, and participate in THOR3 coach-led training without restrictions.

Inclusion Criteria

I am currently an active-duty member of the Special Forces.

I can read and understand English for signing consent.

I can fully participate in THOR3 training without any limitations.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Initial baseline measurements including strength testing, body composition, and sleep metrics

1 week

1 visit (in-person)

Treatment

Participants receive PBMT or sham treatment post-exercise, 3 times per week

3 weeks

9 visits (in-person)

Follow-up

Participants are monitored for performance and recovery outcomes after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Photobiomodulation Therapy (PBMT)

Trial Overview The trial tests if Photobiomodulation Therapy (PBMT) after physical training enhances recovery and performance. It compares two groups: one receiving PBMT plus THOR3 training, the other getting a sham treatment with their training.

How Is the Trial Designed?

Group I: Photobiomodulation Treatment (PBMT) Active Control 1 Intervention

PBMT will be delivered at 32-40 watts (W) (depending on participant skin pigmentation). PBMT will be applied to the quadriceps area. A study team member will use the quadriceps measurements of the treatment area to calculate the PBMT treatment time (approximately 5-20 minutes) and specified J/cm2. PBMT treatment will be provided 3 times per week, for 3 weeks.

Group II: Sham PBMT Placebo Group 1 Intervention

The inclusion of sham PBMT will ensure all participant treatment procedures remain the same, with the exception of emission of photons (active treatment), thus, allowing for contribution of any differences between groups to be credited to the use of PBMT.

Who Is Running the Clinical Trial?

Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR)

Lead Sponsor

Trials

1

Recruited

120+

United States Army Special Operations Command

Collaborator

Trials

1

Recruited

120+

The Geneva Foundation

Collaborator

Trials

39

Recruited

13,700+

1st Special Forces Group (Airborne), United States Army

Collaborator

Trials

1

Recruited

120+

Uniformed Services University (USU) of the Health Sciences

Collaborator

Trials

1

Recruited

120+

Published Research Related to This Trial

Photobiomodulation (PBM) therapy may have potential benefits for cancer patients, as it has been shown to increase survival rates in clinical trials, despite concerns about its use over tumor sites.

While some animal studies suggest PBM therapy could be harmful, many studies indicate it can damage tumors, enhance other cancer treatments, and stimulate the immune system, warranting further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation and Cancer: What Is the Truth? Hamblin, MR., Nelson, ST., Strahan, JR.[2019]

A systematic review of 36 studies on photobiomodulation (PBM) for dementia showed positive results across all studies, including in vitro, animal, and clinical trials involving dementia patients.

PBM demonstrated no adverse effects and was easy to use, indicating its potential as a safe treatment option, warranting further investigation through larger clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation Therapy for Dementia: A Systematic Review of Pre-Clinical and Clinical Studies. Salehpour, F., Khademi, M., Hamblin, MR.[2021]

A systematic review of 8 clinical studies on photobiomodulation therapy (PBMT) for dental implants found no significant differences in implant stability or success rates compared to control groups.

The review highlighted that while some studies had low risk of bias, the overall evidence was insufficient to support the effectiveness of PBMT, indicating a need for more high-quality randomized controlled trials to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evidence of photobiomodulation therapy (PBMT) on implant stability and success: a systematic review and meta-analysis. Chen, Y., Liu, C., Chen, X., et al.[2020]

Photobiomodulation (PBM) uses low-power lasers or LEDs in visible and near-infrared light to treat living tissues, highlighting its potential as a medical intervention.

The article discusses the mechanisms of PBM, including its effects on mitochondria, and reviews current treatment protocols and ongoing research, indicating a growing interest in its therapeutic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation: Evolution and Adaptation. Lipko, NB.[2022]

Photobiomodulation therapy (PBMT) significantly enhances muscle endurance in single-joint exercises and improves time to exhaustion in cycling, based on a meta-analysis of 37 studies involving 586 participants.

However, PBMT does not show effectiveness in improving muscle strength in single-joint exercises or performance metrics in running and swimming, indicating its benefits are specific to certain types of exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deconstructing the Ergogenic Effects of Photobiomodulation: A Systematic Review and Meta-analysis of its Efficacy in Improving Mode-Specific Exercise Performance in Humans. Dutra, YM., Malta, ES., Elias, AS., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8706093/

Photobiomodulation and Sports: Results of a Narrative Review Conclusion: Pre-exercise PBM, mainly with 50 J, significantly increases performance and improves biochemical markers related to skeletal muscle damage and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6546960/

Clinical and scientific recommendations for the use of ... PBMT has a clear dose therapeutic window for exercise performance enhancement and post-exercise recovery.

3. mdpi.com mdpi.com/2076-3417/13/5/3147

Effects of Photobiomodulation in Sports Performance Photobiomodulation therapy has a positive effect on sports performance. Scientific studies on the subject are limited and more research in this line is needed.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1572100025001668

Photobiomodulation therapy (PBMT) in skeletal muscle ... Although PBMT shows great potential for accelerating muscle recovery and improving performance, particularly for acute or exercise-related injury, more work is ...

5. dupuytrens.org dupuytrens.org/wp-content/uploads/2023/05/2016_Pinto.pdf

Photobiomodulation therapy (PBMT) improves performance and ... PBMT effectiveness in performance enhancement and accelerating recovery have been conducted in laboratory-controlled environment. To demonstrate real world ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7666741/

Safety and efficacy of photobiomodulation therapy in ... A significant and growing literature indicates that PBMT is safe and effective, and may even offer a benefit in patient overall survival.

7. fda.gov fda.gov/media/164417/download

Photobiomodulation (PBM) Devices - - Premarket ... This is a draft guidance document for Photobiomodulation (PBM) devices, for premarket notification [510(k)] submissions, and is for comment ...

8. lightforcemedical.com lightforcemedical.com/is_photobiomodulation_therapy_safe/

Is Photobiomodulation Therapy Safe? What the Research ... PBMT is generally safe, non-invasive, and drug-free, with few side effects. Some may experience mild, short-term effects like redness or ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1368837519301058

Tumor safety and side effects of photobiomodulation ... This seems to be the first systematic review evaluating the body of evidence about the safety of PBMT use in the prevention and management of toxicities related ...

10. academic.oup.com academic.oup.com/asj/article/43/5/NP357/7018419

Photobiomodulation: A Systematic Review of the Oncologic ... Current evidence suggests PBM is oncologically safe for skin rejuvenation, with no evidence of new or recurrent malignancy.