Photomedicine Project 14: PBMT for Performance Enhancement in SOF

Summary

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.

Conditions

• Photobiomodulation Therapy
• Photomedicine
• Low-Level Laser Therapy
• Performance Enhancement
• Quadriceps
• Special Operations Readiness

Interventions

DEVICE

THOR3 training + Photobiomodulation Therapy (PBMT)

PBMT will be delivered at 32-40W (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. PBMT will be delivered by a trained study team member using the LightForce® XLi 40W device with the Smart Hand Piece technology, which has a built-in accelerometer in the hand piece that controls the speed of light delivery to the treatment area. The trained team members will use the Smart Hand Piece technology, which assesses the operator's speed and provides real-time visual and sensory feedback calibrated to shut-off when moving too slowly and warns the operator when moving too quickly by vibrating. Treatment is delivered through a flexible optical fiber threaded through the hand piece, which contains a rolling glass massage ball.

DEVICE

THOR3 training + sham PBMT

Sham PBMT will be provided by a trained study team member. Sham PBMT will be delivered in the same manner as indicated for the PBMT process above, but the device will stay in standby mode (i.e., the treatment mode will not be turned on). As infrared light is invisible to the naked eye, the only visible difference between treatment and standby modes is the presence of a few tiny amber lights (these lights are on during treatment mode).

Sponsors & Collaborators

• Uniformed Services University (USU) of the Health Sciences

  collaborator UNKNOWN

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

  collaborator UNKNOWN

• United States Army Special Operations Command

  collaborator UNKNOWN

• The Geneva Foundation

  collaborator OTHER

• Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR)

  lead UNKNOWN

Principal Investigators

• Bradley H Cornell, DPT · 1st Special Forces Group Tactical Human Optimization, Rapid Rehabilitation and Reconditioning (THOR3)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-01-23

Primary Completion

2025-12-31

Completion

2025-12-31

FDA Device

Yes

Countries

• United States

Study Locations