Photomedicine Project 14: PBMT for Performance Enhancement in SOF
NCT ID: NCT06380179
Last Updated: 2025-07-03
Study Results
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Basic Information
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RECRUITING
NA
116 participants
INTERVENTIONAL
2025-01-23
2025-12-31
Brief Summary
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The Intent: The investigators propose to conduct a single-blinded randomized-control trial with sham control to investigate the effectiveness of providing PBMT post physical training in a SOF population.
The specific aims of this study are to:
1. Analyze and describe the physiologic effects, if any, of PBMT application post-exercise in Special Forces Operators undergoing coach-led training.
2. Analyze and describe the behavioral effects, if any, of PBMT application post-exercise in Special Forces Operators undergoing coach-led training.
3. Evaluate the overall clinical utility of focal PBMT subsequent to physical training in a US Army SOF, tactical athlete population.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Photobiomodulation Treatment (PBMT)
PBMT will be delivered at 32-40 watts (W) (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.
THOR3 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.
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 + 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).
Interventions
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THOR3 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.
THOR3 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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
MALE
Yes
Sponsors
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Uniformed Services University (USU) of the Health Sciences
UNKNOWN
1st Special Forces Group (Airborne), United States Army
UNKNOWN
United States Army Special Operations Command
UNKNOWN
The Geneva Foundation
OTHER
Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR)
UNKNOWN
Responsible Party
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Principal Investigators
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Bradley H Cornell, DPT
Role: PRINCIPAL_INVESTIGATOR
1st Special Forces Group Tactical Human Optimization, Rapid Rehabilitation and Reconditioning (THOR3)
Locations
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Joint Base Lewis-McChord
Joint Base Lewis McChord, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Bradley H Cornell
Role: primary
References
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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.
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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.
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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.
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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/
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Homepage for all current Photomedicine projects, including PM#14.
Other Identifiers
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USUHS.2023-126
Identifier Type: -
Identifier Source: org_study_id
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