Assessing the Impact of Post-Exercise Photobiomodulation Application on Performance, Recovery, and Behavioral State in Trained Special Operator Population
| Registry | NCT06380179, acronym SOF |
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 29 (Actual) |
| Sponsor | Musculoskeletal Injury Rehabilitation Research for Operational Readiness (Fed); collaborators: Uniformed Services University of the Health Sciences, 1st Special Forces Group (Airborne), United States Army, United States Army Special Operations Command, The Geneva Foundation |
| Conditions | Photobiomodulation Therapy, Photomedicine, Low-Level Laser Therapy, Performance Enhancement, Quadriceps, Special Operations Readiness |
| Interventions | THOR3 training + Photobiomodulation Therapy (PBMT), THOR3 training + sham PBMT (Device) |
| Dates | start 2025-01-23, primary completion 2026-03-02, completion 2026-03-02, first posted 2024-04-23, last updated 2026-06-15 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Photobiomodulation Therapy All trials for Photomedicine All trials of THOR3 training + Photobiomodulation Therapy (PBMT) All trials of THOR3 training + sham PBMT
-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.
Expand all sections · Collapse all
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Photobiomodulation Treatment (PBMT) | Active comparator | Device: THOR3 training + Photobiomodulation Therapy (PBMT) | 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. |
| Sham PBMT | Sham comparator | Device: THOR3 training + sham PBMT | 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. |
- THOR3 training + Photobiomodulation Therapy (PBMT) (Device), also known as Low-level Laser Therapy (LLLT), LightForce® XLi: 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 PBMT (Device), also known as THOR3 training + placebo: 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).
+Outcome measures
Primary outcomes
- Countermovement Jump (CMJ) Initial Baseline: Concentric Impulse [Collected prior to treatment starting at time of enrollment.]: Assesses dynamic strength performance, including concentric impulse via force plates and analysis software.
- Countermovement Jump (CMJ) Initial Baseline: Movement Start to Peak Power. [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.
- Countermovement Jump (CMJ) Initial Baseline: Reactive Strength Index-modified (RSImod) [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+
- Countermovement Jump (CMJ) Initial Baseline: Time to Take-Off [Collected prior to treatment starting at time of enrollment.]: Assesses dynamic strength performance, including Time to Take-Off via force plates and analysis software.
- Countermovement Jump (CMJ) Week 1 Follow-up: Concentric Impulse [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.
- Countermovement Jump (CMJ) Week 1 Follow-up: Movement Start to Peak Power [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.
- Countermovement Jump (CMJ) Week 1 Follow-up: Reactive Strength Index-modified (RSImod) [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+
- Countermovement Jump (CMJ) Week 1 Follow-up: Time to Take-Off [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.
- Countermovement Jump (CMJ) Week 2 Follow-up: Concentric Impulse [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.
- Countermovement Jump (CMJ) Week 2 Follow-up: Movement Start to Peak Power [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.
- Countermovement Jump (CMJ) Week 2 Follow-up: Reactive Strength Index-modified (RSImod) [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+
- Countermovement Jump (CMJ) Week 2 Follow-up: Time to Take-Off [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.
- Countermovement Jump (CMJ) Week 3 Follow-up: Concentric Impulse [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.
- Countermovement Jump (CMJ) Week 3 Follow-up: Movement Start to Peak Power [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.
- Countermovement Jump (CMJ) Week 3 Follow-up: Reactive Strength Index-modified (RSImod) [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+
- Countermovement Jump (CMJ) Week 3 Follow-up: Time to Take-Off [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.
- Isometric Quadriceps Strength Testing Initial Baseline: Peak Torque [Collected prior to treatment starting at time of enrollment.]: Measuring isolated strength (Peak Torque).
- Isometric Hamstrings Strength Testing Initial Baseline: Peak Torque. [Collected prior to treatment starting at time of enrollment.]: Measuring isolated strength (Peak Torque).
- Isokinetic Quadriceps Strength Testing Initial Baseline: Peak Torque [Collected prior to treatment starting at time of enrollment.]: Measuring isolated strength (Peak Torque).
- Isokinetic Hamstrings Strength Testing Initial Baseline: Peak Torque [Collected prior to treatment starting at time of enrollment.]: Measuring isolated strength (Peak Torque).
- Isometric Quadriceps Strength Testing 3-week Follow-up: Peak Torque [Collected at the 3-week follow-up session prior to coach-led training.]: Measuring isolated strength (Peak Torque).
- Isometric Hamstrings Strength Testing 3-week Follow-up: Peak Torque. [Collected at the 3-week follow-up session prior to coach-led training.]: Measuring isolated strength (Peak Torque).
- Isokinetic Quadriceps Strength Testing 3-week Follow-up: Peak Torque [Collected at the 3-week follow-up session prior to coach-led training.]: Measuring isolated strength (Peak Torque).
- Isokinetic Hamstrings Strength Testing 3-week Follow-up: Peak Torque [Collected at the 3-week follow-up session prior to coach-led training.]: Measuring isolated strength (Peak Torque).
- Defense and Veteran's Pain Rating Scale (DVPRS) Initial Baseline [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.
- Defense and Veteran's Pain Rating Scale (DVPRS) Daily Reports [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.
- Visual Analog Scale (VAS) Initial Baseline [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.
- Visual Analog Scale (VAS) Week 1 Follow-up [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.
- Visual Analog Scale (VAS) Week 2 Follow-up [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.
- Visual Analog Scale (VAS) Week 3 Follow-up [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.
- Borg Modified Rating of Perceived Exertion (RPE) Initial Baseline [Collected prior to treatment starting at time of enrollment]: Quantifying perceived exertion on 0-10 scale. Higher scores indicate worse outcomes.
- Borg Modified Rating of Perceived Exertion (RPE) 3-week Follow-up [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.
- Elloumi Fatigue Scale Initial Baseline [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).
- Elloumi Fatigue Scale 3-week Follow-up [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).
- Quick Physical Activity Rating Scale (QPAR) [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.
- Oura Ring Sleep Data: Sleep Metrics - Sleep Duration [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.
- Oura Ring Sleep Data: Sleep Metrics - Time in Bed [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.
- Oura Ring Sleep Data: Sleep Metrics - Light Sleep Length [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.
- Oura Ring Sleep Data: Sleep Metrics - Rapid Eye Movement (REM) Sleep Length [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.
- Oura Ring Sleep Data: Sleep Metrics - Deep Sleep Length [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.
- Oura Ring Sleep Data: Sleep Metrics - Sleep Latency [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.
- Oura Ring Sleep Data: Sleep Metrics - Sleep Efficiency Percentage [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.
- Oura Ring Sleep Data: Sleep Metrics - Sleep Quality Score [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.
- Oura Ring Sleep Data: Readiness Trends - Body Temperature Changes [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.
- Oura Ring Data: Readiness Trends - Daily Heart Rate [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.
- Oura Ring Sleep Data: Readiness Trends - Heart Rate Variability (HRV) [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.
- Oura Ring Sleep Data: Readiness Trends - Respiration Rate [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.
- Oura Ring Sleep Data: Readiness Trends - Blood Oxygen Saturation [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.
- Oura Ring Sleep Data: Readiness Trends - Sleep Balance [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.
- Oura Ring Sleep Data: Readiness Trends - Readiness Score [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
- Body Measurements: Body Composition (% Body Fat) [Measured prior to treatment starting at time of enrollment.]: Biometrics
- Body Measurements: Height (Inches) [Measured prior to treatment starting at time of enrollment.]: Biometrics
- Body Measurements: Weight (Lbs) [Measured prior to treatment starting at time of enrollment.]: Biometrics
- Body Measurements: C1 - Proximal Thigh Circumference (cm) [Measured prior to treatment starting at time of enrollment.]: Biometrics - used to calculate PBMT dosage
- Body Measurements: C2 - Distal Thigh Circumference (cm) [Measured prior to treatment starting at time of enrollment.]: Biometrics - used to calculate PBMT dosage
- Body Measurements: L1 - Length of Thigh (cm) [Measured prior to treatment starting at time of enrollment.]: Biometrics - used to calculate PBMT dosage
+Eligibility
Sex: Male, ages: 18 Years to 45 Years, accepts healthy volunteers
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
+Posted results
Participant flow
| Milestone | Sham PBMT | Photobiomodulation Treatment (PBMT) |
|---|
| Started | 12 | 13 |
| Completed | 12 | 13 |
| Not completed | 0 | 0 |
Outcome results
- Countermovement Jump (CMJ) Initial Baseline: Concentric Impulse (Primary), Mean, Newton-seconds: Photobiomodulation Treatment (PBMT) 231.06 +/- 24.81; Sham PBMT 232.33 +/- 20.12
- Countermovement Jump (CMJ) Initial Baseline: Movement Start to Peak Power. (Primary), Mean, Seconds: Photobiomodulation Treatment (PBMT) .75 +/- .07; Sham PBMT .75 +/- .08
- Countermovement Jump (CMJ) Initial Baseline: Reactive Strength Index-modified (RSImod) (Primary), Mean, Meters per second: Photobiomodulation Treatment (PBMT) .40 +/- .04; Sham PBMT .43 +/- .08
- Countermovement Jump (CMJ) Initial Baseline: Time to Take-Off (Primary), Mean, Miliseconds: Photobiomodulation Treatment (PBMT) 811.21 +/- 65.79; Sham PBMT 813.82 +/- 79.01
- Countermovement Jump (CMJ) Week 1 Follow-up: Concentric Impulse (Primary), Mean, Newton-seconds: Photobiomodulation Treatment (PBMT) 238.6 +/- 21.99; Sham PBMT 231.06 +/- 13.47
- Countermovement Jump (CMJ) Week 1 Follow-up: Movement Start to Peak Power (Primary), Mean, Seconds: Photobiomodulation Treatment (PBMT) .74 +/- .11; Sham PBMT .71 +/- .08
- Countermovement Jump (CMJ) Week 1 Follow-up: Reactive Strength Index-modified (RSImod) (Primary), Mean, Meters per second: Photobiomodulation Treatment (PBMT) .41 +/- .05; Sham PBMT .45 +/- .07
- Countermovement Jump (CMJ) Week 1 Follow-up: Time to Take-Off (Primary), Mean, Milliseconds: Photobiomodulation Treatment (PBMT) 804.37 +/- 106.72; Sham PBMT 769.15 +/- 79.14
- Countermovement Jump (CMJ) Week 2 Follow-up: Concentric Impulse (Primary), Mean, Newton-seconds: Photobiomodulation Treatment (PBMT) 311.02 +/- 277.05; Sham PBMT 232.41 +/- 15.07
- Countermovement Jump (CMJ) Week 2 Follow-up: Movement Start to Peak Power (Primary), Mean, Seconds: Photobiomodulation Treatment (PBMT) .73 +/- .08; Sham PBMT .73 +/- .07
- Countermovement Jump (CMJ) Week 2 Follow-up: Reactive Strength Index-modified (RSImod) (Primary), Mean, Meters per second: Photobiomodulation Treatment (PBMT) .41 +/- .05; Sham PBMT .45 +/- .08
- Countermovement Jump (CMJ) Week 2 Follow-up: Time to Take-Off (Primary), Mean, Milliseconds: Photobiomodulation Treatment (PBMT) 798 +/- 78.67; Sham PBMT 795.37 +/- 72.04
- Countermovement Jump (CMJ) Week 3 Follow-up: Concentric Impulse (Primary), Mean, Ns: Photobiomodulation Treatment (PBMT) 239.12 +/- 20.52; Sham PBMT 235.30 +/- 12.93
- Countermovement Jump (CMJ) Week 3 Follow-up: Movement Start to Peak Power (Primary), Mean, Seconds: Photobiomodulation Treatment (PBMT) .73 +/- .09; Sham PBMT .73 +/- .08
- Countermovement Jump (CMJ) Week 3 Follow-up: Reactive Strength Index-modified (RSImod) (Primary), Mean, Meters per second: Photobiomodulation Treatment (PBMT) .42 +/- .04; Sham PBMT .47 +/- .07
- Countermovement Jump (CMJ) Week 3 Follow-up: Time to Take-Off (Primary), Mean, Milliseconds: Photobiomodulation Treatment (PBMT) 795.11 +/- 89.13; Sham PBMT 772 +/- 82.31
- Isometric Quadriceps Strength Testing Initial Baseline: Peak Torque (Primary), Mean, Newton-meters: Photobiomodulation Treatment (PBMT) 191.05 +/- 42.93; Sham PBMT 183.32 +/- 17.52
- Isometric Hamstrings Strength Testing Initial Baseline: Peak Torque. (Primary), Mean, Newton-meters: Photobiomodulation Treatment (PBMT) 134.55 +/- 23.01; Sham PBMT 122.95 +/- 126.39
- Isokinetic Quadriceps Strength Testing Initial Baseline: Peak Torque (Primary), Mean, Newton-meters: Photobiomodulation Treatment (PBMT) 185.86 +/- 35.22; Sham PBMT 185.95 +/- 23.45
- Isokinetic Hamstrings Strength Testing Initial Baseline: Peak Torque (Primary), Mean, Newton-meters: Photobiomodulation Treatment (PBMT) 118.91 +/- 19.55; Sham PBMT 117.05 +/- 8.36
- 36 more outcome measures not shown.
Adverse events
Time frame: All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 1 weeks, 2 weeks, and 3 weeks), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Photobiomodulation Treatment (PBMT) | 0/13 (0.0%) | 0/13 (0.0%) | 2/13 (15.4%) |
| Sham PBMT | 0/12 (0.0%) | 0/12 (0.0%) | 2/12 (16.7%) |
Other adverse events by term
| Term | Organ system | Photobiomodulation Treatment (PBMT) | Sham PBMT |
|---|
| Upper Respiratory Infection (URI) | Respiratory, thoracic and mediastinal disorders | 1/13 | 0/12 |
| Skin irritation/heating | Skin and subcutaneous tissue disorders | 1/13 | 0/12 |
| Hamstring Strain | Musculoskeletal and connective tissue disorders | 0/13 | 1/12 |
| Neck Muscle Strain | Musculoskeletal and connective tissue disorders | 0/13 | 1/12 |
+Locations (1)
| Facility | City | Country | Status |
|---|
| Joint Base Lewis-McChord | Joint Base Lewis McChord, Washington | United States | |
+Publications
- Ailioaie LM, Litscher G. Photobiomodulation and Sports: Results of a Narrative Review. Life (Basel). 2021 Dec 3;11(12):1339. doi: 10.3390/life11121339. PMID 34947870
- Antonialli FC, De Marchi T, Tomazoni SS, Vanin AA, dos Santos Grandinetti V, de Paiva PR, Pinto HD, Miranda EF, de Tarso Camillo de Carvalho P, Leal-Junior EC. Phototherapy in skeletal muscle performance and recovery after exercise: effect of combination of super-pulsed laser and light-emitting diodes. Lasers Med Sci. 2014 Nov;29(6):1967-76. doi: 10.1007/s10103-014-1611-7. Epub 2014 Jun 19. PMID 24942380
- Aver Vanin A, De Marchi T, Tomazoni SS, Tairova O, Leao Casalechi H, de Tarso Camillo de Carvalho P, Bjordal JM, Leal-Junior EC. Pre-Exercise Infrared Low-Level Laser Therapy (810 nm) in Skeletal Muscle Performance and Postexercise Recovery in Humans, What Is the Optimal Dose? A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Photomed Laser Surg. 2016 Oct;34(10):473-482. doi: 10.1089/pho.2015.3992. Epub 2016 Aug 29. PMID 27575834
- Baroni BM, Leal Junior EC, De Marchi T, Lopes AL, Salvador M, Vaz MA. Low level laser therapy before eccentric exercise reduces muscle damage markers in humans. Eur J Appl Physiol. 2010 Nov;110(4):789-96. doi: 10.1007/s00421-010-1562-z. Epub 2010 Jul 3. PMID 20602109
- Baroni BM, Rodrigues R, Freire BB, Franke Rde A, Geremia JM, Vaz MA. Effect of low-level laser therapy on muscle adaptation to knee extensor eccentric training. Eur J Appl Physiol. 2015 Mar;115(3):639-47. doi: 10.1007/s00421-014-3055-y. Epub 2014 Nov 23. PMID 25417170
- Vieira WH, Ferraresi C, Perez SE, Baldissera V, Parizotto NA. Effects of low-level laser therapy (808 nm) on isokinetic muscle performance of young women submitted to endurance training: a randomized controlled clinical trial. Lasers Med Sci. 2012 Mar;27(2):497-504. doi: 10.1007/s10103-011-0984-0. Epub 2011 Aug 26. PMID 21870127
- de Carvalho G, Gobbi A, Gobbi RB, Alfredo DMN, do Carmo Furquim TH, Barbosa RI, Papoti M, de Jesus Guirro RR. Photobiomodulation by light emitting diode applied sequentially does not alter performance in cycling athletes. Lasers Med Sci. 2020 Oct;35(8):1769-1779. doi: 10.1007/s10103-020-02973-9. Epub 2020 Feb 20. PMID 32078062
- De Marchi T, Leal-Junior ECP, Lando KC, Cimadon F, Vanin AA, da Rosa DP, Salvador M. Photobiomodulation therapy before futsal matches improves the staying time of athletes in the court and accelerates post-exercise recovery. Lasers Med Sci. 2019 Feb;34(1):139-148. doi: 10.1007/s10103-018-2643-1. Epub 2018 Sep 27. PMID 30264178
- de Oliveira AR, Vanin AA, Tomazoni SS, Miranda EF, Albuquerque-Pontes GM, De Marchi T, Dos Santos Grandinetti V, de Paiva PRV, Imperatori TBG, de Carvalho PTC, Bjordal JM, Leal-Junior ECP. Pre-Exercise Infrared Photobiomodulation Therapy (810 nm) in Skeletal Muscle Performance and Postexercise Recovery in Humans: What Is the Optimal Power Output? Photomed Laser Surg. 2017 Nov;35(11):595-603. doi: 10.1089/pho.2017.4343. PMID 29099680
- de Paiva PR, Tomazoni SS, Johnson DS, Vanin AA, Albuquerque-Pontes GM, Machado CD, Casalechi HL, de Carvalho PT, Leal-Junior EC. Photobiomodulation therapy (PBMT) and/or cryotherapy in skeletal muscle restitution, what is better? A randomized, double-blinded, placebo-controlled clinical trial. Lasers Med Sci. 2016 Dec;31(9):1925-1933. doi: 10.1007/s10103-016-2071-z. Epub 2016 Sep 13. PMID 27624781
- Dompe C, Moncrieff L, Matys J, Grzech-Lesniak K, Kocherova I, Bryja A, Bruska M, Dominiak M, Mozdziak P, Skiba THI, Shibli JA, Angelova Volponi A, Kempisty B, Dyszkiewicz-Konwinska M. Photobiomodulation-Underlying Mechanism and Clinical Applications. J Clin Med. 2020 Jun 3;9(6):1724. doi: 10.3390/jcm9061724. PMID 32503238
- Dornelles MP, Fritsch CG, Sonda FC, Johnson DS, Leal-Junior ECP, Vaz MA, Baroni BM. Photobiomodulation therapy as a tool to prevent hamstring strain injuries by reducing soccer-induced fatigue on hamstring muscles. Lasers Med Sci. 2019 Aug;34(6):1177-1184. doi: 10.1007/s10103-018-02709-w. Epub 2019 Jan 3. PMID 30607719
- Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146. PMID 17695343
- Ferraresi C, Dos Santos RV, Marques G, Zangrande M, Leonaldo R, Hamblin MR, Bagnato VS, Parizotto NA. Light-emitting diode therapy (LEDT) before matches prevents increase in creatine kinase with a light dose response in volleyball players. Lasers Med Sci. 2015 May;30(4):1281-7. doi: 10.1007/s10103-015-1728-3. Epub 2015 Feb 27. PMID 25722067
- Ferraresi C, Bertucci D, Schiavinato J, Reiff R, Araujo A, Panepucci R, Matheucci E Jr, Cunha AF, Arakelian VM, Hamblin MR, Parizotto N, Bagnato V. Effects of Light-Emitting Diode Therapy on Muscle Hypertrophy, Gene Expression, Performance, Damage, and Delayed-Onset Muscle Soreness: Case-control Study with a Pair of Identical Twins. Am J Phys Med Rehabil. 2016 Oct;95(10):746-57. doi: 10.1097/PHM.0000000000000490. PMID 27088469
- Hamblin MR. Shining light on the head: Photobiomodulation for brain disorders. BBA Clin. 2016 Oct 1;6:113-124. doi: 10.1016/j.bbacli.2016.09.002. eCollection 2016 Dec. PMID 27752476
- Leal Junior EC, de Godoi V, Mancalossi JL, Rossi RP, De Marchi T, Parente M, Grosselli D, Generosi RA, Basso M, Frigo L, Tomazoni SS, Bjordal JM, Lopes-Martins RA. Comparison between cold water immersion therapy (CWIT) and light emitting diode therapy (LEDT) in short-term skeletal muscle recovery after high-intensity exercise in athletes--preliminary results. Lasers Med Sci. 2011 Jul;26(4):493-501. doi: 10.1007/s10103-010-0866-x. Epub 2010 Nov 19. PMID 21088862
- Leal Junior EC, Lopes-Martins RA, Baroni BM, De Marchi T, Rossi RP, Grosselli D, Generosi RA, de Godoi V, Basso M, Mancalossi JL, Bjordal JM. Comparison between single-diode low-level laser therapy (LLLT) and LED multi-diode (cluster) therapy (LEDT) applications before high-intensity exercise. Photomed Laser Surg. 2009 Aug;27(4):617-23. doi: 10.1089/pho.2008.2350. PMID 19302015
- Pinto HD, Vanin AA, Miranda EF, Tomazoni SS, Johnson DS, Albuquerque-Pontes GM, Aleixo IO Junior, Grandinetti VD, Casalechi HL, de Carvalho PT, Leal-Junior EC. Photobiomodulation Therapy Improves Performance and Accelerates Recovery of High-Level Rugby Players in Field Test: A Randomized, Crossover, Double-Blind, Placebo-Controlled Clinical Study. J Strength Cond Res. 2016 Dec;30(12):3329-3338. doi: 10.1519/JSC.0000000000001439. PMID 27050245
- Rossato M, Dellagrana RA, Sakugawa RL, Baroni BM, Diefenthaeler F. Dose-Response Effect of Photobiomodulation Therapy on Muscle Performance and Fatigue During a Multiple-Set Knee Extension Exercise: A Randomized, Crossover, Double-Blind Placebo-Controlled Trial. Photobiomodul Photomed Laser Surg. 2020 Dec;38(12):758-765. doi: 10.1089/photob.2020.4820. Epub 2020 Nov 24. PMID 33232629
- Tomazoni SS, Machado CDSM, De Marchi T, Casalechi HL, Bjordal JM, de Carvalho PTC, Leal-Junior ECP. Infrared Low-Level Laser Therapy (Photobiomodulation Therapy) before Intense Progressive Running Test of High-Level Soccer Players: Effects on Functional, Muscle Damage, Inflammatory, and Oxidative Stress Markers-A Randomized Controlled Trial. Oxid Med Cell Longev. 2019 Nov 16;2019:6239058. doi: 10.1155/2019/6239058. eCollection 2019. PMID 31827687
- Vanin AA, Miranda EF, Machado CS, de Paiva PR, Albuquerque-Pontes GM, Casalechi HL, de Tarso Camillo de Carvalho P, Leal-Junior EC. What is the best moment to apply phototherapy when associated to a strength training program? A randomized, double-blinded, placebo-controlled trial : Phototherapy in association to strength training. Lasers Med Sci. 2016 Nov;31(8):1555-1564. doi: 10.1007/s10103-016-2015-7. Epub 2016 Jul 1. PMID 27371449
- Wyatt Daniel Army Staff SGT. Program boosts special forces members' physical, mental capabilities. U.S. Department of Defense. December 6, 2017. Accessed July 13, 2022. https://www.defense.gov/News/News-Stories/Article/Article/1389545/program-boosts-specialforces- members-physical-mental-capabilities/
+Study documents
+Investigators
- Tanner Santarelli, DPT, Principal investigator, 1st Special Forces Group Tactical Human Optimization, Rapid Rehabilitation and Reconditioning (THOR3)