CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 29 enrolled / 29 target
Drug / intervention
THOR3 training + Photobiomodulation Therapy (PBMT) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06380179
NCT06380179N/ACompletedOn Track (1.7/mo)Completion was 4mo ago

Assessing the Impact of Post-Exercise Photobiomodulation Application on Performance, Recovery, and Behavioral State in Trained Special Operator Population

Musculoskeletal Injury Rehabilitation Research for Operational Readiness·interventional·Posted Apr 23, 2024·Updated Jun 15, 2026

In Brief

A clinical study evaluating THOR3 training + Photobiomodulation Therapy (PBMT) and THOR3 training + sham PBMT for Photobiomodulation Therapy and 5 related conditions. Completed, enrolled 29 participants across 1 site.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
20252026
First PostedApr 23, 2024
Enrollment StartJan 23, 2025
Primary CompletionMar 2, 2026
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 2.2 years ago

Arms & Interventions

Photobiomodulation Treatment (PBMT)active_comparator

PBMT will be delivered at 40 watts (W). 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.

Device: THOR3 training + Photobiomodulation Therapy (PBMT)
Sham PBMTsham_comparator

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.

Device: THOR3 training + sham PBMT

Interventions

THOR3 training + Photobiomodulation Therapy (PBMT)device

PBMT will be delivered at 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.

THOR3 training + sham PBMTdevice

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).