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Completed

NCT Number: NCT06380179

Photomedicine Project 14: PBMT for Performance Enhancement in SOF

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.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Joint Base Lewis-McChord

Joint Base Lewis McChord, Washington, 98433, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Active-Duty Special Forces Personnel (18-series)
  • Able to read and understand English language for consent purposes
  • Able to commit to study intervention and follow-up
  • Able to participate in THOR3 coach-lead training, without restriction

Exclusion criteria

  • Obese (body fat > 25%)
  • Cardiovascular disease
  • Use of select medications (e.g., statins, diuretics, hypertensive agents)
  • Female
  • Tattoo in treatment area (body region)
  • Diagnosis with porphyria (light induced allergy) or photosensitive eczema
  • Current use of medications associated with sensitivity to heat or light (e.g., amiodarone, chlorpromazine, doxycycline, hydrochlorothiazide, nalidixic acid, naproxen, piroxicam, tetracycline, thioridazine, voriconazole)
  • Use of pacemaker/underlying cardiac disease
  • Diagnosed with autoimmune disease(s)
  • Albinism
  • Peripheral Neuropathy

Treatment and study plan

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.

Other names: Low-level Laser Therapy (LLLT), LightForce® XLi

THOR3 training + sham PBMT

Device

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).

Other names: THOR3 training + placebo

Primary outcomes

  1. Countermovement Jump (CMJ) Initial Baseline: Concentric Impulse

    Time frame: Collected prior to treatment starting at time of enrollment.

    Assesses dynamic strength performance, including concentric impulse via force plates and analysis software.

  2. Countermovement Jump (CMJ) Initial Baseline: Movement Start to Peak Power.

    Time frame: Collected prior to treatment starting at time of enrollment.

    Assesses dynamic strength performance, including Movement start to peak power. via force plates and analysis software.

  3. Countermovement Jump (CMJ) Initial Baseline: Reactive Strength Index-modified (RSImod)

    Time frame: Collected prior to treatment starting at time of enrollment.

    Assesses dynamic strength performance, including Reactive Strength Index-modified (RSImod) via force plates and analysis software. Reactive Strength Index-modified (RSImod) reflects the efficiency of force production during a countermovement jump. It is calculated as jump height divided by time to take-off. Higher values indicate better explosive performance and lower neuromuscular fatigue, whereas lower values indicate reduced efficiency or increased fatigue. The index ranges from 0 upward with no theoretical maximum; therefore, interpretation should rely on normative ranges or athlete-specific baselines.

    Reference categories:

    Lower performers (L): ~0.20-0.30

    Moderate performers (M): ~0.30-0.45

    Upper performers (U): ~0.45-0.70+

  4. Countermovement Jump (CMJ) Initial Baseline: Time to Take-Off

    Time frame: Collected prior to treatment starting at time of enrollment.

    Assesses dynamic strength performance, including Time to Take-Off via force plates and analysis software.

  5. Countermovement Jump (CMJ) Week 1 Follow-up: Concentric Impulse

    Time frame: Collected at the end of week 1 prior to coach-led training.

    Assesses dynamic strength performance, including concentric impulse via force plates and analysis software.

  6. Countermovement Jump (CMJ) Week 1 Follow-up: Movement Start to Peak Power

    Time frame: Collected at the end of week 1 prior to coach-led training.

    Assesses dynamic strength performance, including Movement Start to peak Power via force plates and analysis software.

  7. Countermovement Jump (CMJ) Week 1 Follow-up: Reactive Strength Index-modified (RSImod)

    Time frame: Collected at the end of week 1 prior to coach-led training.

    Assesses dynamic strength performance, including Reactive Strength Index-modified (RSImod) via force plates and analysis software. Reactive Strength Index-modified (RSImod) reflects the efficiency of force production during a countermovement jump. It is calculated as jump height divided by time to take-off. Higher values indicate better explosive performance and lower neuromuscular fatigue, whereas lower values indicate reduced efficiency or increased fatigue. The index ranges from 0 upward with no theoretical maximum; therefore, interpretation should rely on normative ranges or athlete-specific baselines.

    Reference categories:

    Lower performers (L): ~0.20-0.30

    Moderate performers (M): ~0.30-0.45

    Upper performers (U): ~0.45-0.70+

  8. Countermovement Jump (CMJ) Week 1 Follow-up: Time to Take-Off

    Time frame: Collected at the end of week 1 prior to coach-led training.

    Assesses dynamic strength performance, including Time to Take-Off via force plates and analysis software.

  9. Countermovement Jump (CMJ) Week 2 Follow-up: Concentric Impulse

    Time frame: Collected at the end of week 2 prior to coach-led training.

    Assesses dynamic strength performance, including concentric impulse via force plates and analysis software.

  10. Countermovement Jump (CMJ) Week 2 Follow-up: Movement Start to Peak Power

    Time frame: Collected at the end of week 2 prior to coach-led training.

    Assesses dynamic strength performance, including peak force production via force plates and analysis software.

  11. Countermovement Jump (CMJ) Week 2 Follow-up: Reactive Strength Index-modified (RSImod)

    Time frame: Collected at the end of week 2 prior to coach-led training.

    Assesses dynamic strength performance, including Reactive Strength Index-modified (RSImod) via force plates and analysis software. Reactive Strength Index-modified (RSImod) reflects the efficiency of force production during a countermovement jump. It is calculated as jump height divided by time to take-off. Higher values indicate better explosive performance and lower neuromuscular fatigue, whereas lower values indicate reduced efficiency or increased fatigue. The index ranges from 0 upward with no theoretical maximum; therefore, interpretation should rely on normative ranges or athlete-specific baselines.

    Reference categories:

    Lower performers (L): ~0.20-0.30

    Moderate performers (M): ~0.30-0.45

    Upper performers (U): ~0.45-0.70+

  12. Countermovement Jump (CMJ) Week 2 Follow-up: Time to Take-Off

    Time frame: Collected at the end of week 2 prior to coach-led training.

    Assesses dynamic strength performance, including Time to Take-Off via force plates and analysis software.

  13. Countermovement Jump (CMJ) Week 3 Follow-up: Concentric Impulse

    Time frame: Collected at the end of week 3 prior to coach-led training.

    Assesses dynamic strength performance, including concentric impulse via force plates and analysis software.

  14. Countermovement Jump (CMJ) Week 3 Follow-up: Movement Start to Peak Power

    Time frame: Collected at the end of week 3 prior to coach-led training.

    Assesses dynamic strength performance, including peak force production via force plates and analysis software.

  15. Countermovement Jump (CMJ) Week 3 Follow-up: Reactive Strength Index-modified (RSImod)

    Time frame: Collected at the end of week 3 prior to coach-led training.

    Assesses dynamic strength performance, including Reactive Strength Index-modified (RSImod) via force plates and analysis software. Reactive Strength Index-modified (RSImod) reflects the efficiency of force production during a countermovement jump. It is calculated as jump height divided by time to take-off. Higher values indicate better explosive performance and lower neuromuscular fatigue, whereas lower values indicate reduced efficiency or increased fatigue. The index ranges from 0 upward with no theoretical maximum; therefore, interpretation should rely on normative ranges or athlete-specific baselines.

    Reference categories:

    Lower performers (L): ~0.20-0.30

    Moderate performers (M): ~0.30-0.45

    Upper performers (U): ~0.45-0.70+

  16. Countermovement Jump (CMJ) Week 3 Follow-up: Time to Take-Off

    Time frame: Collected at the end of week 3 prior to coach-led training.

    Assesses dynamic strength performance, including Time to Take-Off via force plates and analysis software.

  17. Isometric Quadriceps Strength Testing Initial Baseline: Peak Torque

    Time frame: Collected prior to treatment starting at time of enrollment.

    Measuring isolated strength (Peak Torque).

  18. Isometric Hamstrings Strength Testing Initial Baseline: Peak Torque.

    Time frame: Collected prior to treatment starting at time of enrollment.

    Measuring isolated strength (Peak Torque).

  19. Isokinetic Quadriceps Strength Testing Initial Baseline: Peak Torque

    Time frame: Collected prior to treatment starting at time of enrollment.

    Measuring isolated strength (Peak Torque).

  20. Isokinetic Hamstrings Strength Testing Initial Baseline: Peak Torque

    Time frame: Collected prior to treatment starting at time of enrollment.

    Measuring isolated strength (Peak Torque).

  21. Isometric Quadriceps Strength Testing 3-week Follow-up: Peak Torque

    Time frame: Collected at the 3-week follow-up session prior to coach-led training.

    Measuring isolated strength (Peak Torque).

  22. Isometric Hamstrings Strength Testing 3-week Follow-up: Peak Torque.

    Time frame: Collected at the 3-week follow-up session prior to coach-led training.

    Measuring isolated strength (Peak Torque).

  23. Isokinetic Quadriceps Strength Testing 3-week Follow-up: Peak Torque

    Time frame: Collected at the 3-week follow-up session prior to coach-led training.

    Measuring isolated strength (Peak Torque).

  24. Isokinetic Hamstrings Strength Testing 3-week Follow-up: Peak Torque

    Time frame: Collected at the 3-week follow-up session prior to coach-led training.

    Measuring isolated strength (Peak Torque).

  25. Defense and Veteran's Pain Rating Scale (DVPRS) Initial Baseline

    Time frame: Self-reported at baseline

    Captures subjective pain rating on a 0 - 10 scale (minimum - maximum; 0 = no pain, 10 = severe pain). Higher scores equal worse outcomes.

  26. Defense and Veteran's Pain Rating Scale (DVPRS) Daily Reports

    Time frame: Self-reported, daily after baseline through study completion after 3 weeks.

    Captures subjective pain rating on a 0 - 10 scale (minimum - maximum; 0 = no pain, 10 = severe pain). Higher scores equals worse outcomes. Calculation for this timepoint was dervied from averaging all daily pain scores into an aggregate value.

  27. Visual Analog Scale (VAS) Initial Baseline

    Time frame: Collected prior to treatment starting at time of enrollment.

    Measures delayed onset muscle soreness. Respondents mark on a 10 centimeter line their current level of muscle soreness. The left end of the line represents "I feel no soreness in my muscles" and the right end represents "My muscles feel so sore, I don't want to move them." Scores range from 0-100, with higher scores equaling worse outcomes.

  28. Visual Analog Scale (VAS) Week 1 Follow-up

    Time frame: Collected at the end of week 1 after coach-led training and laser treatment.

    Measures delayed onset muscle soreness. Respondents mark on a 10 centimeter line their current level of muscle soreness. The left end of the line represents "I feel no soreness in my muscles" and the right end represents "My muscles feel so sore, I don't want to move them." Scores range from 0-100, with higher scores equaling worse outcomes.

  29. Visual Analog Scale (VAS) Week 2 Follow-up

    Time frame: Collected at the end of week 2 after coach-led training and laser treatment.

    Measures delayed onset muscle soreness. Respondents mark on a 10 centimeter line their current level of muscle soreness. The left end of the line represents "I feel no soreness in my muscles" and the right end represents "My muscles feel so sore, I don't want to move them." Scores range from 0-100, with higher scores equaling worse outcomes.

  30. Visual Analog Scale (VAS) Week 3 Follow-up

    Time frame: Collected at the end of week 3 after coach-led training and laser treatment.

    Measures delayed onset muscle soreness. Respondents mark on a 10 centimeter line their current level of muscle soreness. The left end of the line represents "I feel no soreness in my muscles" and the right end represents "My muscles feel so sore, I don't want to move them." Scores range from 0-100, with higher scores equaling worse outcomes.

  31. Borg Modified Rating of Perceived Exertion (RPE) Initial Baseline

    Time frame: Collected prior to treatment starting at time of enrollment

    Quantifying perceived exertion on 0-10 scale. Higher scores indicate worse outcomes.

  32. Borg Modified Rating of Perceived Exertion (RPE) 3-week Follow-up

    Time frame: Collected at the 3-week follow-up session after coach-led training and laser treatment.

    Quantifying perceived exertion on 0-10 scale. Higher scores indicate worse outcomes.

  33. Elloumi Fatigue Scale Initial Baseline

    Time frame: Collected prior to treatment starting at time of enrollment.

    Behavioral health rating of fatigue. The short questionnaire of fatigue uses eight questions that highlight perception of training difficulty, sleep, leg discomfort, infection/colds, concentration, work efficacy, anxiety and overall stress. Each question is rated by the respondent on a 7-point scale: 1 point (not at all) to 7 points (very much). The summed total score of the 8 questions allows for a total score of fatigue (TSF). Total score of fatigue ranges from 8 points (not at all fatigued) to 56 points (very much fatigued).

  34. Elloumi Fatigue Scale 3-week Follow-up

    Time frame: Collected at the 3-week follow-up session after coach-led training and laser treatment.

    Behavioral health rating of fatigue. The short questionnaire of fatigue uses eight questions that highlight perception of training difficulty, sleep, leg discomfort, infection/colds, concentration, work efficacy, anxiety and overall stress. Each question is rated by the respondent on a 7-point scale: 1 point (not at all) to 7 points (very much). The summed total score of the 8 questions allows for a total score of fatigue (TSF). Total score of fatigue ranges from 8 points (not at all fatigued) to 56 points (very much fatigued).

  35. Quick Physical Activity Rating Scale (QPAR)

    Time frame: Collected prior to treatment starting at time of enrollment.

    Higher scores indicate better outcome. Scaled rating of various types of physical activity participation. Respondent reporting quantifies the overall amount of physical activity that the respondent regularly engages in. Activities are weighted in intensity that ranges from 1 (light) to 3 (heavy). Activity weekly frequency reported as never (0 days), seldom (1-2 days), sometime (3-4 days), and often (5-7 days). Activity duration collected as less than one hour per day, 1-2 hours per day, and more than two hours per day. Intensity (1-3), frequency (0-3) and duration (1-3) scores are multiplied and provide a physical activity score that may range from 0 - 153 points, 0 being very low physical activity and 153 representing very high physical activity.

  36. Oura Ring Sleep Data: Sleep Metrics - Sleep Duration

    Time frame: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.

    Oura Ring will continuously measure aspects of sleep, including duration of sleep. Calculation for this measure was dervied from averaging all daily sleep scores into an aggregate value.

  37. Oura Ring Sleep Data: Sleep Metrics - Time in Bed

    Time frame: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.

    Oura Ring will continuously measure aspects of sleep, including time spent in bed. Calculation for this measure was dervied from averaging all daily scores into an aggregate value.

  38. Oura Ring Sleep Data: Sleep Metrics - Light Sleep Length

    Time frame: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.

    Oura Ring will continuously measure aspects of sleep, including duration of light sleep stage. Calculation for this measure was dervied from averaging all daily scores into an aggregate value.

  39. Oura Ring Sleep Data: Sleep Metrics - Rapid Eye Movement (REM) Sleep Length

    Time frame: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.

    Oura Ring will continuously measure aspects of sleep, including duration of REM sleep stage. Calculation for this measure was dervied from averaging all daily scores into an aggregate value.

  40. Oura Ring Sleep Data: Sleep Metrics - Deep Sleep Length

    Time frame: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.

    Oura Ring will continuously measure aspects of sleep, including duration of deep sleep stage (seconds). Calculation for this measure was dervied from averaging all daily scores into an aggregate value.

  41. Oura Ring Sleep Data: Sleep Metrics - Sleep Latency

    Time frame: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.

    Oura Ring will continuously measure aspects of sleep, including sleep latency (time taken to fall asleep in seconds). Calculation for this measure was dervied from averaging all daily scores into an aggregate value.

  42. Oura Ring Sleep Data: Sleep Metrics - Sleep Efficiency Percentage

    Time frame: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.

    Oura Ring will continuously measure aspects of sleep, including sleep efficiency percentage (time spent in bed asleep). Higher percentages are better. 0-100. Calculation for this measure was dervied from averaging all daily scores into an aggregate value.

  43. Oura Ring Sleep Data: Sleep Metrics - Sleep Quality Score

    Time frame: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.

    Oura Ring will continuously measure aspects of sleep, including sleep quality score. Scores range from 0-100 with higher scores being better outcomes. Calculation for this measure was dervied from averaging all daily scores into an aggregate value.

  44. Oura Ring Sleep Data: Readiness Trends - Body Temperature Changes

    Time frame: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.

    Oura Ring will continuously measure changes in body temperature. Oura calculates body-temperature readiness by measuring average skin temperature during sleep, comparing it to long-term baseline, and reporting the difference as a positive or negative deviation. Calculation for this measure was dervied from averaging all daily scores into an aggregate value.

  45. Oura Ring Data: Readiness Trends - Daily Heart Rate

    Time frame: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.

    Oura Ring will continuously measure aspects of physical readiness trends, including changes in heart rate. Calculation for this measure was dervied from averaging all daily scores into an aggregate value.

  46. Oura Ring Sleep Data: Readiness Trends - Heart Rate Variability (HRV)

    Time frame: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.

    Oura Ring will continuously measure aspects of physical readiness trends, including HRV - a measure of the fluctuation in the time intervals between adjacent heartbeats. Calculation for this measure was dervied from averaging all daily scores into an aggregate value.

  47. Oura Ring Sleep Data: Readiness Trends - Respiration Rate

    Time frame: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.

    Oura Ring will continuously measure aspects of physical readiness trends, including respiratory rate. Calculation for this measure was dervied from averaging all daily scores into an aggregate value.

  48. Oura Ring Sleep Data: Readiness Trends - Blood Oxygen Saturation

    Time frame: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.

    Oura Ring will continuously measure aspects of physical readiness trends, including blood oxygen saturation. Calculation for this measure was dervied from averaging all daily scores into an aggregate value.

  49. Oura Ring Sleep Data: Readiness Trends - Sleep Balance

    Time frame: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.

    Oura Ring will continuously measure aspects of physical readiness trends, including sleep balance- a measure of how consistent nightly total sleep duration is compared to baseline, reported on a 0-100 scale where higher means sleep length is closely matched night-to-night. Scores near 100 indicate very stable sleep duration that supports recovery; 60-80 indicates moderate variability that may mildly reduce readiness; scores below ~60 reflect inconsistent sleep duration likely to lower Readiness. Higher scores are better outcomes. Calculation for this measure was dervied from averaging all daily scores into an aggregate value.

  50. Oura Ring Sleep Data: Readiness Trends - Readiness Score

    Time frame: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.

    Oura Ring will continuously measure aspects of physical readiness trends, including readiness score. The score ranges from 0-100, higher scores indicate better outcomes. Calculation for this measure was dervied from averaging all daily scores into an aggregate value.

Secondary outcomes

  1. Body Measurements: Body Composition (% Body Fat)

    Time frame: Measured prior to treatment starting at time of enrollment.

    Biometrics

  2. Body Measurements: Height (Inches)

    Time frame: Measured prior to treatment starting at time of enrollment.

    Biometrics

  3. Body Measurements: Weight (Lbs)

    Time frame: Measured prior to treatment starting at time of enrollment.

    Biometrics

  4. Body Measurements: C1 - Proximal Thigh Circumference (cm)

    Time frame: Measured prior to treatment starting at time of enrollment.

    Biometrics - used to calculate PBMT dosage

  5. Body Measurements: C2 - Distal Thigh Circumference (cm)

    Time frame: Measured prior to treatment starting at time of enrollment.

    Biometrics - used to calculate PBMT dosage

  6. Body Measurements: L1 - Length of Thigh (cm)

    Time frame: Measured prior to treatment starting at time of enrollment.

    Biometrics - used to calculate PBMT dosage

Sponsors and collaborators

Lead sponsor

Musculoskeletal Injury Rehabilitation Research for Operational Readiness

Fed

Collaborators

  • 1st Special Forces Group (Airborne), United States Army
  • The Geneva Foundation
  • Uniformed Services University of the Health Sciences
  • United States Army Special Operations Command

Registry information

Official study title

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

Acronym: SOF

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 23, 2024
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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