Photobiomodulation TherapySOFNCT06380179
Photomedicine Project 14: PBMT for Performance Enhancement in SOF
A study testing THOR3 training + Photobiomodulation Therapy (PBMT) in people with Photobiomodulation Therapy and Photomedicine, run by Musculoskeletal Injury Rehabilitation Research for Operational Readiness at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Photobiomodulation Therapy, Photomedicine, Low-Level Laser Therapy
- What is being tested?
- THOR3 training + Photobiomodulation Therapy (PBMT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2025to 2 Mar 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Joint Base Lewis-McChord
Joint Base Lewis McChord, Washington, 98433
About this study
Official title: Assessing the Impact of Post-Exercise Photobiomodulation Application on Performance, Recovery, and Behavioral State in Trained Special Operator Population
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.
Read more
The specific aims of this study are to:
- Analyze and describe the physiologic effects, if any, of PBMT application post-exercise in Special Forces Operators undergoing coach-led training.
- Analyze and describe the behavioral effects, if any, of PBMT application post-exercise in Special Forces Operators undergoing coach-led training.
- 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
- Being tested
- THOR3 training + Photobiomodulation Therapy (PBMT), THOR3 training + sham PBMT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THOR3 training + Photobiomodulation Therapy (PBMT)Device
Also called 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 PBMTDevice
Also called 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: THOR3 training + Photobiomodulation Therapy (PBMT) |
| Sham PBMT | Sham 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. Receives: Device: THOR3 training + sham PBMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Countermovement Jump (CMJ) Initial Baseline: Concentric Impulse
Assesses dynamic strength performance, including concentric impulse via force plates and analysis software.
Measured: Collected prior to treatment starting at time of enrollment.
Countermovement Jump (CMJ) Initial Baseline: Movement Start to Peak Power.
Assesses dynamic strength performance, including Movement start to peak power. via force plates and analysis software.
Measured: Collected prior to treatment starting at time of enrollment.
Countermovement Jump (CMJ) Initial Baseline: Reactive Strength Index-modified (RSImod)
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+
Measured: Collected prior to treatment starting at time of enrollment.
Countermovement Jump (CMJ) Initial Baseline: Time to Take-Off
Assesses dynamic strength performance, including Time to Take-Off via force plates and analysis software.
Measured: Collected prior to treatment starting at time of enrollment.
Countermovement Jump (CMJ) Week 1 Follow-up: Concentric Impulse
Assesses dynamic strength performance, including concentric impulse via force plates and analysis software.
Measured: Collected at the end of week 1 prior to coach-led training.
Countermovement Jump (CMJ) Week 1 Follow-up: Movement Start to Peak Power
Assesses dynamic strength performance, including Movement Start to peak Power via force plates and analysis software.
Measured: Collected at the end of week 1 prior to coach-led training.
Countermovement Jump (CMJ) Week 1 Follow-up: Reactive Strength Index-modified (RSImod)
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+
Measured: Collected at the end of week 1 prior to coach-led training.
Countermovement Jump (CMJ) Week 1 Follow-up: Time to Take-Off
Assesses dynamic strength performance, including Time to Take-Off via force plates and analysis software.
Measured: Collected at the end of week 1 prior to coach-led training.
Countermovement Jump (CMJ) Week 2 Follow-up: Concentric Impulse
Assesses dynamic strength performance, including concentric impulse via force plates and analysis software.
Measured: Collected at the end of week 2 prior to coach-led training.
Countermovement Jump (CMJ) Week 2 Follow-up: Movement Start to Peak Power
Assesses dynamic strength performance, including peak force production via force plates and analysis software.
Measured: Collected at the end of week 2 prior to coach-led training.
Countermovement Jump (CMJ) Week 2 Follow-up: Reactive Strength Index-modified (RSImod)
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+
Measured: Collected at the end of week 2 prior to coach-led training.
Countermovement Jump (CMJ) Week 2 Follow-up: Time to Take-Off
Assesses dynamic strength performance, including Time to Take-Off via force plates and analysis software.
Measured: Collected at the end of week 2 prior to coach-led training.
Countermovement Jump (CMJ) Week 3 Follow-up: Concentric Impulse
Assesses dynamic strength performance, including concentric impulse via force plates and analysis software.
Measured: Collected at the end of week 3 prior to coach-led training.
Countermovement Jump (CMJ) Week 3 Follow-up: Movement Start to Peak Power
Assesses dynamic strength performance, including peak force production via force plates and analysis software.
Measured: Collected at the end of week 3 prior to coach-led training.
Countermovement Jump (CMJ) Week 3 Follow-up: Reactive Strength Index-modified (RSImod)
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+
Measured: Collected at the end of week 3 prior to coach-led training.
Countermovement Jump (CMJ) Week 3 Follow-up: Time to Take-Off
Assesses dynamic strength performance, including Time to Take-Off via force plates and analysis software.
Measured: Collected at the end of week 3 prior to coach-led training.
Isometric Quadriceps Strength Testing Initial Baseline: Peak Torque
Measuring isolated strength (Peak Torque).
Measured: Collected prior to treatment starting at time of enrollment.
Isometric Hamstrings Strength Testing Initial Baseline: Peak Torque.
Measuring isolated strength (Peak Torque).
Measured: Collected prior to treatment starting at time of enrollment.
Isokinetic Quadriceps Strength Testing Initial Baseline: Peak Torque
Measuring isolated strength (Peak Torque).
Measured: Collected prior to treatment starting at time of enrollment.
Isokinetic Hamstrings Strength Testing Initial Baseline: Peak Torque
Measuring isolated strength (Peak Torque).
Measured: Collected prior to treatment starting at time of enrollment.
Isometric Quadriceps Strength Testing 3-week Follow-up: Peak Torque
Measuring isolated strength (Peak Torque).
Measured: Collected at the 3-week follow-up session prior to coach-led training.
Isometric Hamstrings Strength Testing 3-week Follow-up: Peak Torque.
Measuring isolated strength (Peak Torque).
Measured: Collected at the 3-week follow-up session prior to coach-led training.
Isokinetic Quadriceps Strength Testing 3-week Follow-up: Peak Torque
Measuring isolated strength (Peak Torque).
Measured: Collected at the 3-week follow-up session prior to coach-led training.
Isokinetic Hamstrings Strength Testing 3-week Follow-up: Peak Torque
Measuring isolated strength (Peak Torque).
Measured: Collected at the 3-week follow-up session prior to coach-led training.
Defense and Veteran's Pain Rating Scale (DVPRS) Initial Baseline
Captures subjective pain rating on a 0 - 10 scale (minimum - maximum; 0 = no pain, 10 = severe pain). Higher scores equal worse outcomes.
Measured: Self-reported at baseline
Defense and Veteran's Pain Rating Scale (DVPRS) Daily Reports
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.
Measured: Self-reported, daily after baseline through study completion after 3 weeks.
Visual Analog Scale (VAS) Initial Baseline
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.
Measured: Collected prior to treatment starting at time of enrollment.
Visual Analog Scale (VAS) Week 1 Follow-up
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.
Measured: Collected at the end of week 1 after coach-led training and laser treatment.
Visual Analog Scale (VAS) Week 2 Follow-up
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.
Measured: Collected at the end of week 2 after coach-led training and laser treatment.
Visual Analog Scale (VAS) Week 3 Follow-up
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.
Measured: Collected at the end of week 3 after coach-led training and laser treatment.
Borg Modified Rating of Perceived Exertion (RPE) Initial Baseline
Quantifying perceived exertion on 0-10 scale. Higher scores indicate worse outcomes.
Measured: Collected prior to treatment starting at time of enrollment
Borg Modified Rating of Perceived Exertion (RPE) 3-week Follow-up
Quantifying perceived exertion on 0-10 scale. Higher scores indicate worse outcomes.
Measured: Collected at the 3-week follow-up session after coach-led training and laser treatment.
Elloumi Fatigue Scale Initial Baseline
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).
Measured: Collected prior to treatment starting at time of enrollment.
Elloumi Fatigue Scale 3-week Follow-up
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).
Measured: Collected at the 3-week follow-up session after coach-led training and laser treatment.
Quick Physical Activity Rating Scale (QPAR)
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.
Measured: Collected prior to treatment starting at time of enrollment.
Oura Ring Sleep Data: Sleep Metrics - Sleep Duration
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.
Measured: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Oura Ring Sleep Data: Sleep Metrics - Time in Bed
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.
Measured: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Oura Ring Sleep Data: Sleep Metrics - Light Sleep Length
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.
Measured: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Oura Ring Sleep Data: Sleep Metrics - Rapid Eye Movement (REM) Sleep Length
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.
Measured: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Oura Ring Sleep Data: Sleep Metrics - Deep Sleep Length
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.
Measured: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Oura Ring Sleep Data: Sleep Metrics - Sleep Latency
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.
Measured: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Oura Ring Sleep Data: Sleep Metrics - Sleep Efficiency Percentage
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.
Measured: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Oura Ring Sleep Data: Sleep Metrics - Sleep Quality Score
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.
Measured: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Oura Ring Sleep Data: Readiness Trends - Body Temperature Changes
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.
Measured: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Oura Ring Data: Readiness Trends - Daily Heart Rate
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.
Measured: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Oura Ring Sleep Data: Readiness Trends - Heart Rate Variability (HRV)
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.
Measured: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Oura Ring Sleep Data: Readiness Trends - Respiration Rate
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.
Measured: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Oura Ring Sleep Data: Readiness Trends - Blood Oxygen Saturation
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.
Measured: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Oura Ring Sleep Data: Readiness Trends - Sleep Balance
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.
Measured: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Oura Ring Sleep Data: Readiness Trends - Readiness Score
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.
Measured: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Secondary outcomes (6)
Body Measurements: Body Composition (% Body Fat)
Biometrics
Measured: Measured prior to treatment starting at time of enrollment.
Body Measurements: Height (Inches)
Biometrics
Measured: Measured prior to treatment starting at time of enrollment.
Body Measurements: Weight (Lbs)
Biometrics
Measured: Measured prior to treatment starting at time of enrollment.
Body Measurements: C1 - Proximal Thigh Circumference (cm)
Biometrics - used to calculate PBMT dosage
Measured: Measured prior to treatment starting at time of enrollment.
Body Measurements: C2 - Distal Thigh Circumference (cm)
Biometrics - used to calculate PBMT dosage
Measured: Measured prior to treatment starting at time of enrollment.
Body Measurements: L1 - Length of Thigh (cm)
Biometrics - used to calculate PBMT dosage
Measured: Measured prior to treatment starting at time of enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start23 Jan 2025
- Primary completion2 Mar 2026
- Study completion2 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Photobiomodulation TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Approach: Special Operators attending THOR3 coach led training will be invited to participate. After consenting and screening for inclusion/exclusion, participants will be randomized into two groups: 1) sham PBMT and 2) PBMT (applied to quadriceps up to 3 times per week, post coach-led training, taking approximately 5-20 minutes each time). Baseline measurements will include body fat percentage, height, weight and military/demographic information. Metrics for counter movement jump and self-reported delayed muscle onset soreness will be taken at baseline and weekly for three weeks. Isokinetic dynamometer measurements for the lower extremities, and self-reported exertion and fatigue will be taken at baseline and at the 3-week follow-up (post three-week intervention). Oura rings will be assigned at baseline and will continuously measure sleep, heart rate, Sp02, and activity. Activity and pain will also be self-reported throughout the duration of the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Musculoskeletal Injury Rehabilitation Research for Operational Readiness
- Sponsor type
- US federal agency
- 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
- Responsible party
- Sponsor
- Investigators
- Tanner Santarelli, DPT, Principal investigator, 1st Special Forces Group Tactical Human Optimization, Rapid Rehabilitation and Reconditioning (THOR3)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380179
- Sponsor's protocol ID
- USUHS.2023-126
- Acronym
- SOF
- Status last verified
- May 2026
- First submitted
- 13 Mar 2024
- Last updated
- 15 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The Initial Consent Form (ICF) for this research study states that de-identified research data will be shared with MIRROR and USU and maintained indefinitely for possible use in future research. By consenting to participate in this research study, participants agree to allow us to maintain their de-identified research data indefinitely for possible use in future research. Participants will not be given the option to opt out of us retaining their de-identified research data indefinitely for possible future use. The ICF states, "If you do not want your deidentified data collected as part of this research study to be kept for use in future research studies, you should not sign this consent form."
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.
PubMed 34947870Antonialli 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.
PubMed 24942380Aver 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.
PubMed 27575834Baroni 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.
PubMed 20602109Baroni 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.
PubMed 25417170Vieira 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.
PubMed 21870127de 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.
PubMed 32078062De 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.
PubMed 30264178de 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.
PubMed 29099680de 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.
PubMed 27624781Dompe 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.
PubMed 32503238Dornelles 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.
PubMed 30607719Faul 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.
PubMed 17695343Ferraresi 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.
PubMed 25722067Ferraresi 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.
PubMed 27088469
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Post-Exercise Photobiomodulation Application on Performance, Recovery, and Behavioral State in Trained Special Operator Population
- ClinicalTrials.gov ID
- NCT06380179
- Acronym / sponsor ID
- SOF / USUHS.2023-126
- Conditions
- Photobiomodulation Therapy, Photomedicine, Low-Level Laser Therapy, Performance Enhancement, Quadriceps, Special Operations Readiness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Musculoskeletal Injury Rehabilitation Research for Operational ReadinessUS federal agency
- 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
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 23 Apr 2024 (actual)
- Results
- Posted 15 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Analyze and describe the physiologic effects, if any, of PBMT application post-exercise in Special Forces Operators undergoing coach-led training.
- Analyze and describe the behavioral effects, if any, of PBMT application post-exercise in Special Forces Operators undergoing coach-led training.
- Evaluate the overall clinical utility of focal PBMT subsequent to physical training in a US Army SOF, tactical athlete population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Approach: Special Operators attending THOR3 coach led training will be invited to participate. After consenting and screening for inclusion/exclusion, participants will be randomized into two groups: 1) sham PBMT and 2) PBMT (applied to quadriceps up to 3 times per week, post coach-led training, taking approximately 5-20 minutes each time). Baseline measurements will include body fat percentage, height, weight and military/demographic information. Metrics for counter movement jump and self-reported delayed muscle onset soreness will be taken at baseline and weekly for three weeks. Isokinetic dynamometer measurements for the lower extremities, and self-reported exertion and fatigue will be taken at baseline and at the 3-week follow-up (post three-week intervention). Oura rings will be assigned at baseline and will continuously measure sleep, heart rate, Sp02, and activity. Activity and pain will also be self-reported throughout the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| 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 PBMTThe 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 may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- Obese (body fat > 25%)
- Cardiovascular disease
- Use of select medications (e.g., statins, diuretics, hypertensive agents)
- Female
- Tattoo in treatment area (body region)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THOR3 training + Photobiomodulation Therapy (PBMT)Also: Low-level Laser Therapy (LLLT), LightForce® XLiPBMT 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. | Device | Photobiomodulation Treatment (PBMT) |
| THOR3 training + sham PBMTAlso: THOR3 training + placeboSham 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). | Device | Sham PBMT |
Primary outcome
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.
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.
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+
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.
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.
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.
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+
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.
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.
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.
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+
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.
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.
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.
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+
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.
Isometric Quadriceps Strength Testing Initial Baseline: Peak Torque
Time frame: Collected prior to treatment starting at time of enrollment.
Measuring isolated strength (Peak Torque).
Isometric Hamstrings Strength Testing Initial Baseline: Peak Torque.
Time frame: Collected prior to treatment starting at time of enrollment.
Measuring isolated strength (Peak Torque).
Isokinetic Quadriceps Strength Testing Initial Baseline: Peak Torque
Time frame: Collected prior to treatment starting at time of enrollment.
Measuring isolated strength (Peak Torque).
Isokinetic Hamstrings Strength Testing Initial Baseline: Peak Torque
Time frame: Collected prior to treatment starting at time of enrollment.
Measuring isolated strength (Peak Torque).
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
6 secondary outcomes
Body Measurements: Body Composition (% Body Fat)
Time frame: Measured prior to treatment starting at time of enrollment.
Body Measurements: Height (Inches)
Time frame: Measured prior to treatment starting at time of enrollment.
Body Measurements: Weight (Lbs)
Time frame: Measured prior to treatment starting at time of enrollment.
Body Measurements: C1 - Proximal Thigh Circumference (cm)
Time frame: Measured prior to treatment starting at time of enrollment.
Body Measurements: C2 - Distal Thigh Circumference (cm)
Time frame: Measured prior to treatment starting at time of enrollment.
Body Measurements: L1 - Length of Thigh (cm)
Time frame: Measured prior to treatment starting at time of enrollment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34947870Ailioaie LM, Litscher G. Photobiomodulation and Sports: Results of a Narrative Review. Life (Basel). 2021 Dec 3;11(12):1339. doi: 10.3390/life11121339.
- Background: PubMed 24942380Antonialli 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.
- Background: PubMed 27575834Aver 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.
- Background: PubMed 20602109Baroni 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.
- Background: PubMed 25417170Baroni 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.
- Background: PubMed 21870127Vieira 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.
- Background: PubMed 32078062de 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.
- Background: PubMed 30264178De 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.
- Background: PubMed 29099680de 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.
- Background: PubMed 27624781de 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.
- Background: PubMed 32503238Dompe 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.
- Background: PubMed 30607719Dornelles 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.
- Homepage for all current Photomedicine projects, including PM#14.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The Initial Consent Form (ICF) for this research study states that de-identified research data will be shared with MIRROR and USU and maintained indefinitely for possible use in future research. By consenting to participate in this research study, participants agree to allow us to maintain their de-identified research data indefinitely for possible use in future research. Participants will not be given the option to opt out of us retaining their de-identified research data indefinitely for possible future use. The ICF states, "If you do not want your deidentified data collected as part of this research study to be kept for use in future research studies, you should not sign this consent form."
Related trials for Photobiomodulation Therapy
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
Shock Wave Therapy Versus High-Intensity Laser Therapy for Coccydynia (Tailbone Pain)
Coccydynia, Coccygodynia
Not yet recruiting
ACUTE EFFECTS OF HIGH-INTENSITY LASER THERAPY ON PAIN, MUSCLE STIFFNESS, AND GRIP STRENGTH IN HEALTHY ADULTS
Exercise-Induced Muscle Fatigue, Fatigue Recovery
Not yet recruitingObservational study
Determinants of Radiation Dermatitis in Head and Neck Cancer Patients Receiving Preventive Photobiomodulation
Head and Neck Neoplasms, Radiodermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanner Santarelli, DPT principal investigator
1st Special Forces Group Tactical Human Optimization, Rapid Rehabilitation and Reconditioning (THOR3)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THOR3 training + Photobiomodulation Therapy (PBMT) in people with Photobiomodulation Therapy and Photomedicine, run by Musculoskeletal Injury Rehabilitation Research for Operational Readiness at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Countermovement Jump (CMJ) Initial Baseline: Concentric Impulse (time frame: Collected prior to treatment starting at time of enrollment.). The study lists 50 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06380179, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.