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

Trial Summary

What is the purpose of this trial?

Special Operations Forces (SOF) train continually to maintain peak performance. Thus, they are nearly always in a state of recovery, and in need of noninvasive therapies to address the taxing workload. Photobiomodulation therapy (PBMT) is a noninvasive treatment where a low-level laser is applied to the body to enhance healing, recovery, and performance. Army Tactical Human Optimization Rapid Rehabilitation and Reconditioning (THOR3) provides a consistent avenue for implementation of PBMT as a modality. Studies in athletes have shown performance and recovery benefits with pre-and post-workout focal application of PBMT. While there is less evidence on the potential cognitive/behavioral effects of a systematic application of PBMT, self-reported fatigue has also been found to be significantly lower in groups with focal PBMT application as compared to placebo. Further, PBMT research in healthy military tactical athletes is limited. PBMT may be a promising tool for enhancing physical performance by accelerating musculoskeletal and psychological recovery in the SOF population. The investigators aim to study the physiologic and behavioral effects of PBMT application post-exercise on performance in SOF Operators. The Intent: The investigators propose to conduct a single-blinded randomized-control trial with sham control to investigate the effectiveness of providing PBMT post physical training in a SOF population. The specific aims of this study are to: 1. Analyze and describe the physiologic effects, if any, of PBMT application post-exercise in Special Forces Operators undergoing coach-led training. 2. Analyze and describe the behavioral effects, if any, of PBMT application post-exercise in Special Forces Operators undergoing coach-led training. 3. Evaluate the overall clinical utility of focal PBMT subsequent to physical training in a US Army SOF, tactical athlete population.

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.

How is photobiomodulation therapy different from other treatments for performance enhancement?

Photobiomodulation therapy (PBMT) is unique because it uses non-thermal light from lasers or LEDs to stimulate healing and improve exercise performance, unlike other treatments that may rely on drugs or physical training. This therapy is novel in its approach by using light to enhance cellular function and energy production, which can lead to improved athletic performance. ^{1 2 3 4 5}

Research Team

Bradley H Cornell, DPT

Principal Investigator

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

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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]

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]

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]

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]

References

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

Clinical evidence of photobiomodulation therapy (PBMT) on implant stability and success: a systematic review and meta-analysis. [2020]

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

Photobiomodulation and Cancer: What Is the Truth? [2019]

3. New Zealand 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. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Photobiomodulation Therapy for Dementia: A Systematic Review of Pre-Clinical and Clinical Studies. [2021]

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

Photobiomodulation: Evolution and Adaptation. [2022]