RecruitingNot ApplicableNCT06380179

Photomedicine Project 14: PBMT for Performance Enhancement in SOF

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


Sponsor

Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR)

Enrollment

116 participants

Start Date

Jan 23, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria4

  • 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 Criteria11

  • 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

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Interventions

DEVICETHOR3 training + Photobiomodulation Therapy (PBMT)

PBMT will be delivered at 32-40W (depending on participant skin pigmentation). PBMT will be applied to the quadriceps area. A study team member will use the quadriceps measurements of the treatment area to calculate the PBMT treatment time (approximately 5-20 minutes) and specified J/cm2. PBMT treatment will be provided 3 times per week, for 3 weeks. PBMT will be delivered by a trained study team member using the LightForce® XLi 40W device with the Smart Hand Piece technology, which has a built-in accelerometer in the hand piece that controls the speed of light delivery to the treatment area. The trained team members will use the Smart Hand Piece technology, which assesses the operator's speed and provides real-time visual and sensory feedback calibrated to shut-off when moving too slowly and warns the operator when moving too quickly by vibrating. Treatment is delivered through a flexible optical fiber threaded through the hand piece, which contains a rolling glass massage ball.

DEVICETHOR3 training + sham PBMT

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


Locations(1)

Joint Base Lewis-McChord

Joint Base Lewis McChord, Washington, United States

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