Assessing the Impact of Post-Exercise Photobiomodulation Application on Performance, Recovery, and Behavioral State in Trained Special Operator Population
Phase: NA
Conditions: Photobiomodulation Therapy, Photomedicine, Low-Level Laser Therapy, Performance Enhancement, Quadriceps, Special Operations Readiness
Sponsor: Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR)

UNIFORMED SERVICES UNIVERSITY OF THE HEALTH 
SCIENCES
4301 JONES BRIDGE ROAD 
BETHESDA, MARYLAND 
March 20, 2024
MEMORANDUM FOR MAJ BRADLEY H. CORNELL, DPT, 1ST SPECIAL FORCES GROUP
SUBJECT: USU Institutional Review Board (IRB) (FWA 00001628; DoD Assurance P60001) 
Approval of Amendment to Protocol USUHS.2023-126 for Human Subjects Participation
The Amendment ref# 970086 for your Minimal Risk human subjects research protocol 
USUHS.2023-126, entitled "Assessing the Impact of Post-Exercise Photobiomodulation 
Application on Performance, Recovery, and Behavioral State in Trained Special Operator 
Population," was reviewed and approved for execution on March 19, 2024 by Edmund Howe, M.D., 
J.D., Chair IRB under the provision of 32 CFR 219.110(b)(1)(ii). This approval will be reported to 
the USU IRB scheduled to meet on March 28, 2024.
This action approves the following changes to the protocol:
1.
2.
3.
Adding USASOC maintenance of de-identified research data for future use.
Included risks associated with counter-movement jump and strength testing.
Minor edits to protocol and study documents to correct typos and improve clarity and general 
understanding.
Documents Reviewed:
1.
2.
3.
4.
5.
6.
7.
8.
9.
EIRB Modification Form - (Version 1.0)
EIRB Protocol Template - (Version 1.3) 
ICF (English) - (Version 1.3)
Appendix D Baseline Data Collection CRF - (Version 1.1) 
Appendix E Follow-Up Data Collection CRF - (Version 1.1) 
Appendix F Activity Log CRF - (Version 1.1)
Appendix I Protocol Adherence CRF - (Version 1.1) 
Appendix J Study Completion CRF - (Version 1.1) 
Appendix K Data Collection Schedule - (Version 1.1)
10. Appendix L Strength Testing SOP - (Version 1.1)
11. Appendix M Screening Script - (Version 1.1)
12. Appendix N Screening Log - (Version 1.1)
13. Appendix O Master List - (Version 1.1)
14. Appendix P Study Flyer - (Version 1.1)
15. Appendix T PBM Dose Calculation Spreadsheet - (Version 1.1)
As a reminder, it is your responsibility to ensure all applicable protocol-related approvals, including 
any required approvals from external/collaborating sites involved (whether considered engaged or 
not engaged in research), have been obtained prior to initiating study activities.
Authorization to conduct protocol USUHS.2023-126 will automatically expire on January 16, 2027. 
If you plan to continue data collection or analysis beyond this date, then HRPP approval for 
continuation is required. Please submit an EIRB Periodic Administrative Report for approval to the 
HRPP Office 60 days prior to the expiration date.
Learning to Care for Those in Harm’s 
v.6/27/18

SUBJECT: USU Institutional Review Board (IRB) (FWA 00001628; DoD Assurance P60001) 
Approval of Amendment 970086 to Protocol USUHS.2023-126 for Human Subjects Participation
You are required to submit amendments to this protocol, changes to the informed consent document 
(if applicable), adverse event reports, and other information pertinent to human research for this 
project. No changes to this protocol may be implemented prior to IRB approval. If you have 
questions regarding this IRB action or questions of a more general nature concerning human 
participation in research, please contact Yaw Adomako-Ankomah, PhD at 301-295- 0428 or 
yaw.adomako-ankomah.ctr@usuhs.edu.
Digitally signed by 
ADOMAKO- 
ANKOMAH.YAW.1541043
ADOMAKO- 
ANKOMAH.YA
442
W.1541043442 Date: 2024.03.20 09:32:25
-04'00'
Yaw Adomako-Ankomah, PhD, CIP 
IRB Analyst
USU Human Research Protection Program

EIRB Protocol Template (Version 1.3)
1.0
General Information
*Please enter the full title of your study:
Assessing the Impact of Post-Exercise Photobiomodulation Application on Performance, 
Recovery, and Behavioral State in a Trained Special Operator Population
 
 
*Please enter the Protocol Number you would like to use to reference the protocol:
Photomedicine Project 14: PBMT for Performance Enhancement in SOF
* This field allows you to enter an abbreviated version of the Protocol Title to quickly identify 
this protocol.
 
 
Is this a multi-site study (i.e. Each site has their own Principal Investigator)?
No
 
 
Does this protocol involve the use of animals?
Yes
No
 
 
2.0
Add Site(s)
2.1 List sites associated with this study:
Primary 
Dept?
Department Name
R and E - Uniformed Services University of the Health Sciences (USUHS)
 
3.0
Assign project personnel access to the project
3.1 *Please add a Principal Investigator for the study:
 
Cornell, Bradley Heyward, DPT MAJ
Select if applicable
Student
Site Chair
Resident
Fellow
 
3.2 If applicable, please select the Research Staff personnel:
 
A) Additional Investigators
HAGER, NELSON ALLEN 
 Associate Investigator
Hughes, Nicholas Runte 
N

 Associate Investigator
O'Hagan, Riley Nicholas 
 Associate Investigator
Schroeder, Jeremy Daniel, DO LTC 
 Associate Investigator
Sims, Donald Cornell 
 Associate Investigator
B) Research Support Staff
Carper, Moriah C 
 Non-engaged Administrator
GABLER, GEOFFREY MARK 
 Research Coordinator
Karikari, Nana-King Ahwoi 
 Research Coordinator
Lucio, Whitley B 
 Non-engaged Administrator
MCKEE, Samantha Jade 
 Research Coordinator
Metzger, Elizabeth C 
 Non-engaged Administrator
Ory, Rian Lyndzie, MS 
 Non-engaged Administrator
Rossi, Robert M, MPH 
 Research Coordinator
Vega, Rakayla Bregina 
 Research Coordinator
3.3 *Please add a Protocol Contact:
 
Carper, Moriah C 
Cornell, Bradley Heyward, DPT MAJ 
HAGER, NELSON ALLEN 
Hughes, Nicholas Runte 
Lucio, Whitley B 
Metzger, Elizabeth C 
O'Hagan, Riley Nicholas 
Ory, Rian Lyndzie, MS 
Sims, Donald Cornell 
Vega, Rakayla Bregina 
The Protocol Contact(s) will receive all important system notifications along with the Principal 
Investigator. (i.e. The protocol contact(s) are typically either the Protocol Coordinator or the 
Principal Investigator themselves).
3.4 If applicable, please select the Designated Site Approval(s):
 
Add the name of the individual authorized to approve and sign off on this protocol from your Site 
(e.g. the Site Chair).
4.0
 
Project Information

4.1  
What department(s) will be associated with this protocol?
* 
Other
4.2  
Is the IRB of record for this study an IRB/HRPP that does NOT use EIRB? If Yes, complete the 
* 
application according to the IRB/HRPP Determination.
If your Projects or Protocols are under the oversight of another IRB that does use EIRB, stop this 
submission and contact the core site and request an invitation as a performing site.
If your Project or Protocol is now being submitted for the first time to an IRB that does use EIRB, 
continue with this application and answer the questions to be reviewed by the IRB.
Answering yes means the board of record is an IRB that does NOT use EIRB.
  Yes   
  No
4.3  
Is this protocol research, expanded access, or humanitarian use device?
* 
 Yes   
 No
4.4  
 What type of protocol is this?
*
Behavioral Research
Biomedical Research
Clinical trial (FDA regulated)
Educational Research
Expanded Access
Humanitarian Use Device (HUD)
Psychosocial Research
Oral History
Other
4.5  Are you conducting this project in pursuit of a personal degree?
  Yes   
  No
4.7  
Is this human subjects research? (As defined by 32 CFR 219) 
* 
   Human subject means a living 
individual about whom an investigator (whether professional or student) conducting research: 
   (i) Obtains information or biospecimens through intervention or interaction with the individual, and 
uses, studies, or analyzes the information or biospecimens; or 
  (ii) Obtains, uses, studies, analyzes or generates identifiable private information or identifiable 
biospecimens.  
 Yes   
 No
4.8  
 Do you believe this human subjects research is exempt from IRB review?
*
  Yes   
  No
5.0
 

Personnel Details
5.1  Does the Principal Investigator have a Permanent Change of Station (PCS) Date or Estimated 
Institutional Departure Date (EIDD)?
  Yes   
  No
5.2  List any Research Team members without EIRB access that are not previously entered in the protocol:
No records have been added
5.3  Are any Contractors or Subcontractors involved in this study? If yes, please list them and describe their role.
 Yes   
 No
Name:
(Last, First, M.I.)
Carper, Moriah C
Role on Protocol:
MIRROR 
Regualtory Affairs 
Coordinator
Phone Number:
540-267-6654
Email Address:
moriah.carper.
ctr@usuhs.edu
Associated 
Institution:
The Geneva 
Foundation / 
USUHS
Name:
(Last, First, M.I.)
Ory, Rian L
Role on Protocol:
MIRROR 
Regualtory Affairs 
Manager
Phone Number:
909-904-5034
Email Address:
rian.ory.ctr@usuhs.
edu
Associated 
Institution:
The Geneva 
Foundation / 
USUHS
Name:
(Last, First, M.I.)
Lucio, Whitley B
Role on Protocol:
MIRROR Sr. 
Regualtory Affairs 
& Data Manager
Phone Number:
202-375-8831
Email Address:
whitley.lucio.
ctr@usuhs.edu
Associated 
Institution:
The Geneva 
Foundation / 
USUHS
Name:
(Last, First, M.I.)
Metzger, 
Elizabeth C
Role on Protocol:
Photomedicine 
Phone Number:
252-562-2419
Email Address:
emetzger@genevausa.
org
Associated 
Institution:
The Geneva 
Foundation / 
USUHS

Scientific Program 
Manager
Name:
(Last, First, M.I.)
Hughes, Nicholas
Role on Protocol:
Associate 
Investigator, 
Research Physical 
Therapist
Phone Number:
206-351-7583
Email Address:
nhughes@genevausa.
org
Associated 
Institution:
The Geneva 
Foundation / 
THOR3, 1st SFG
Name:
(Last, First, M.I.)
Sims, Donald
Role on Protocol:
Associate 
Investigator
Phone Number:
510-593-0402
Email Address:
donald.c.sims3.
ctr@army.mil
Associated 
Institution:
THOR3, 1st SFG
Name:
(Last, First, M.I.)
Gabler, Geoffrey
Role on Protocol:
Research Physical 
Therapist
Phone Number:
253-968-2083
Email Address:
ggabler@genevausa.
org
Associated 
Institution:
The Geneva 
Foundation / JBLM
Name:
(Last, First, M.I.)
Rossi, Robert
Role on Protocol:
Research 
Coordinator
Phone Number:
253-968-2083
Email Address:
rrossi@genevausa.org
Associated 
Institution:
The Geneva 
Foundation / JBLM
Name:
(Last, First, M.I.)
McKee, Samantha
Role on Protocol:
Research Assistant
Phone Number:
253-968-2083
Email Address:
smckee@genevausa.
org
Associated 
Institution:
The Geneva 
Foundation / JBLM
Name:
(Last, First, M.I.)
Karikari, Nana-
king
Role on Protocol:
Research Assistant
Phone Number:
253-968-2083
Email Address:
nkarikari@genevausa.
org
Associated 
Institution:
The Geneva 
Foundation / JBLM

Name:
(Last, First, M.I.)
Hager, Nelson
Role on Protocol:
Photomedicine Sr. 
Medical Advisor
Phone Number:
425-218-1833
Email Address:
nelson.hager.
ctr@usuhs.edu
Associated 
Institution:
The Geneva 
Foundation / 
USUHS
5.4  
Will you have a Research Monitor for this study?
Yes 
No 
N/A 
6.0
 
Data/Specimens
6.1  Does the study involve the use of existing data or specimens only (no interaction with human 
subjects)?
  Yes   
  No
7.0
 
Funding and Disclosures
7.1  Source of Funding:
Funding Source
Funding Type
Amount
:
Other
USUHS Award Number 
HU00011920056
:
Research 
Development 
Testing and 
Evaluation (RDT&E) 
funds
Photomedicine
250000
Total amount of funding:
250000
7.2  Do you or any other Investigator(s) have a disclosure of a personal interest or financial nature 
significant with sponsor(s), product(s), instrument(s) and/or company(ies) involved in this study?
  Yes   
  No
All personnel engaged in research must complete and attach a Conflict of Interest (COI) form.
 

8.0
Study Locations
8.1  Is this a collaborative or multi-site study? (e.g., are there any other institutions involved?)
 Yes   
 No
8.2  Study Facilities and Locations:
Institution Site Name
Site Role
FWA or DoD 
Assurance 
Number
Assurance 
Expiration 
Date
Is there an 
agreement?
IRB Reviewing 
for Site
Army
THOR3, 
1st 
SFG, 
USASOC
Lead site
:
IIA
:
USUHS 
IRB 
#1
P&R
USUHS
Coordinating 
center
FWA00001628
05/04
/2026
:
USUHS 
IRB 
#1
Other:
Other 
Institution Site
Site Role
FWA or DoD 
Assurance 
Number
FWA or DoD 
Expiration Date
Is there an 
agreement?
IRB Reviewing 
for Site
No records have been added
8.3  Are there international sites?
Attach international approval documents, if applicable, when prompted. Note: Ensure local 
research context has been considered
  Yes   
  No
8.4  Is this an OCONUS (Outside Continental United States) study?
  Yes   
  No
Select  the area of responsibility:
Have you obtained permission from that area of responsibility? (This is a requirement prior to 
study approval)
  Yes   
  No
9.0
 
Study Details
9.1  Key Words:
Provide up to 5 key words that identify the broad topic(s) of your study
Photobiomodulation, Photomedicine, Performance Enhancement, Quadriceps, Special Operations 

Readiness
9.2  Background and Significance:
Include a literature review that describes in detail the rationale for conducting the study. Include 
descriptions of any preliminary studies and findings that led to the development of the 
protocol.  The background section should clearly support the choice of study variables and 
explain the basis for the research questions and/or study hypotheses.  This section establishes 
the relevance of the study and explains the applicability of its findings
Military demands require for Special Operations Forces (SOF) populations to be physically fit, 
ready for deployment at any time. To meet this requirement, Special Operators (“Operators") 
train regularly to reach peak performance. This training can be taxing on one’s body, as it is 
nearly always recovering. To provide elite performance and recovery coaching, the United States 
Special Operations Command (SOCOM) initiated Tactical Human Optimization Rapid 
Rehabilitation and Reconditioning (THOR3), in 2009: a program for Special Forces to provide 
wholistic wellness and health to Operators through mental, physical, nutrition, spiritual, and 
cognitive programming. Ultimately, the goal of THOR3 is to optimize physical and mental health 
performance, consequently increasing operational longevity and warfighter readiness. THOR3 
focuses on providing evidence-based interventions, tracks data of Operators’ performance, and is 
on the cutting-edge of performance enhancement in the DoD with elite trainers and providers. 
Thus, this program is at the tip-of-the-spear for initiatives to increase strength, conditioning, and 
recovery (Wyatt, 2017).
A pioneering performance and recovery enhancement tool is Photobiomodulation therapy 
(PBMT). PBMT is a noninvasive treatment where a device that emits low level lasers is applied to 
a body area to enhance recovery and improve performance (Dompe, 2020). Studies in athletes 
have shown performance (improved maximum voluntary contraction, sprint time, CMJ height, 
fatigue index, time on pitch, VO2max, volume and time to anaerobic and aerobic threshold 
appearance) and recovery (decreased inflammatory and oxidative stress markers, delayed onset 
muscle soreness) benefit with both pre-and post-workout application of PBMT (Ailioaie, 2021). 
When applied to the lower body pre-exercise, PBMT has been found to prevent increase of
/decrease creatine kinase (CK) activity, a biomarker of muscle damage. This reduction, as 
compared to placebo, has been observed after cycling tests (Junior, 2009; Junior, 2011), 
eccentric exercise (Baroni, 2010; Vanin, 2016; De Paiva, 2016; Antonialli, 2014; de Oliveria, 
2017), and running tests (Tomazoni, 2019). A case-control study with identical twins 
participating in a workout regimen also showed that PBMT application post-exercise reduced 
creatine kinase (CK) (Ferraresi, 2016). Transferring this observation to other activities, PBMT has 
also shown to decrease/prevent increase of CK in sports performance such as volleyball, 
(Ferraresi, 2015) and futsal (De Marchi, 2019). Compared to other modalities, namely, cold-
water immersion (Junior, 2011), or cryotherapy (De Paiva, 2016), PBMT was significantly more 
effective in positively altering CK activity. Similarly, pre-application of PBMT has also shown to 
reduce lactate after sprint/running tests (Pinto, 2016; Tomazoni, 2019), eccentric exercise 
(Baroni, 2010; de Oliveria, 2017) futsal matches (De Marchi, 2019), and cycling tests, in which it 
also more effectively reduced lactate as compared to other modalities (Junior, 2011). Alike 
results have been noted for Interleukin-6 (IL-6) (Vanin, 2016; de Oliveria, 2017; Tomazoni, 
2019), and carbonylated proteins indicative of an oxidative stress environment (De Marchi, 
2019; Tomazoni, 2019; Ferraresi, 2016). Taken together, these results suggest that PBMT is 
protective against muscle damage. 
Performance metrics have also shown improvement with PBMT. Maximum voluntary contraction 
(MVC) has been found to increase/decrease to a lesser extent after an eccentric exercise routine 
when PBMT was applied pre-workout, as compared to placebo (Baroni, 2010; Antonialli, 2014, 
Vanin, 2016). Maximum involuntary contraction (MVIC) also increased with application of PBMT 
prior to an eccentric exercise program (de Oliveria, 2017; De Paiva, 2016). PBMT application can 
also increase the number of maximum repetitions (de Brito, 2014), torque (De Carvalho, 2020; 
Baroni, 2015; Dornelles, 2019), and CMJ performance (Dornelles, 2019). Succinctly, Rossato et 
al. (2020) found that application of PBMT decreases fatigue while maintaining or increasing 
performance, thus enabling athletes to output the same total work with the availability to 
complete additional sets. Pre-application of PBMT prior to a futsal match also significantly 
increased the time players were able to stay on the pitch (De Marchi, 2019). Thus, PBMT is 
effective at increasing performance metrics across a variety of outcomes. 
Self-reported behavioral effects related to physical performance also show positive effects from 
PBMT. PBMT application has been found to reduce self-reported delayed-onset muscle soreness 
(DOMS) and self-reported fatigue. A randomized, double-blinded, placebo-controlled clinical trial 
found that PBMT decreased DOMS as compared to placebo and cryotherapy alone, or the 

combination of cryotherapy and PBMT (De Paiva, 2016). Other similar studies found a significant 
difference in decreased DOMS as compared to placebo (Antonialli, 2014; de Oliveria, 
2017; Ferraresi, 2016). During sprint tests, in a randomized, crossover, double-blind, placebo-
controlled clinical trial conducted with rugby players, PBMT decreased self-perceived fatigue post 
sprint test (Pinto, 2016). PBMT is effective in reducing perception of fatigue and soreness, even 
when compared to an equivalent placebo. 
Outside of self-reported fatigue or DOMS, there is less information on the potential behavioral 
effects of PBMT focal application (e.g., quadriceps). Studies, however, have shown that 
transcranial application of PBMT has a role in recovery of brain injury and disorders (e.g., 
traumatic brain injury, Parkinson’s disease, and Alzheimer’s), psychological disorders (e.g., 
anxiety and depression), and cognitive enhancement in both healthy and cognitive declining 
populations (Hamblin, 2016).  
Taken as a whole, PBMT is a promising avenue for increasing overall performance by enhancing 
recovery processes, self-reported DOMS and fatigue, and potentially positively affecting 
behavioral health in the Special Operator population. We will conduct a single-blinded 
randomized-control trial with sham control to investigate the effectiveness of providing PBMT 
post physical training in a SOF population, thus translating this cutting-edge research to 
application in the THOR3 setting. 
9.3  
Objectives/Specific Aims/Research Questions:
Describe the purpose and objective(s) of the study, specific aims, and/or research questions
/hypotheses
Aim 1: Describe physiologic effects of PBM application post-exercise in SOF operators undergoing 
THOR3 coach led training 
Aim 2: Describe behavioral effects of PBM application post-exercise in SOF operators undergoing 
a THOR3 coach led training
9.4  Study Design:
Describe study design in one to two sentences (e.g., prospective, use of existing records/data
/specimens, observational, cross-sectional, interventional, randomized, placebo-controlled, 
cohort, etc.). Specify the phase – Phase I, II, III, or IV – for FDA-regulated investigational drug 
research
Randomized, single-blind, sham control trial
9.5  Target Population:
Describe the population to whom the study findings will be generalized
Active-Duty Service Members, combat/tactical Athletes such as police officers and firefighters, 
collegiate athlete populations
9.6  Benefit to the DoD:
State how this study will impact or be of benefit to the Department of Defense
Military demands require for SOF populations to be physically fit, ready for deployment at any 
time. SOF are responsible for executing specific missions and objectives that may be outside of 
the capacity of conventional forces, thus filling a necessary void in the nation’s defense. 
Increasing performance and/or recovery of these Special Operators will contribute to their 
individual warfighter readiness and collectively positively influencing operational longevity.
10.0
 

1.  
2.  
3.  
Study Procedures, Data Management, and Privacy
10.1  Study Procedures:
Describe step-by-step how the study will be conducted from beginning to end
Study activities will occur at Joint Base Lewis-McChord (JBLM) within the 1  Special Forces 
st
Group (SFG). Study activities, including recruitment, will occur in the THOR3 Clinic area or other 
applicable 1  SFG areas.  
st
Recruitment, Pre-Screening (before consent), Study Introduction & Informed Consent:
Potential participants will be identified via three methods: 
Participants may self-refer to participate in the study if they become aware of the study 
by study flyer (Appendix P) or word of mouth. Interested potential participants will be 
able to contact a member of the study team via phone or email. 
Mass briefs at THOR3 coach-lead trainings. 
Briefings will occur at regular intervals, about every 3 weeks, for each training 
class at the 3 Operator focused training sessions. In the course of a month, there 
will be about 4 briefings. 
Briefings will take no more than five (5) minutes. The briefs will be scheduled to 
occur prior to the coach led session. Consenting procedures will not occur during 
these informational briefs.
Leadership would only include the OIC of THOR3, not Group Leadership. Every 
effort will be made to ensure there is not undue coercion. 
"Thank you for taking a few minutes to listen to this brief. We are conducting a 
research study to assess utilizing light therapy to increase recovery post training. 
There is the possibility that it can decrease inflammation, soreness, and fatigue 
and thus increase performance. We will ask you to complete a baseline visit, 
where we collect some self-reported demographic and health information, and 
measure your height, weight, and body fat. We will also ask you to complete a 
strength test and a counter movement jump. We will assign you an Oura Ring to 
wear for the duration of the study. This visit will take about 45 minutes. Then for 3 
weeks, we will ask to provide light therapy 3 times a week after THOR3 coach led 
training. You will be randomly assigned to an active treatment or sham treatment 
group. Each group will wear headphones and blackout glasses. These sessions 
should take 20 minutes. Each week we will ask you to complete a 
countermovement jump, and fill out some questionnaires. These visits will take 
about 15 minutes. We will also ask you to fill out a daily pain questionnaire, and 
complete an activity log, which will take about 5 minutes. At the end of the three 
weeks, we will test your strength and counter movement jump again and ask you 
to fill out final questionnaires. This will take about 25 minutes. You will be 
compensated at each weekly visit, for a total of 150 USD. If you are interested in 
participating or in learning more about the study, please see a member of the 
research study team."
Study advertisements (Appendix P) will be posted in THOR3 and 1  SFG areas that 
st
operators frequent. 
If a potential participant expresses interest in learning more about the research study, a member 
of the research staff will briefly introduce the study, express the voluntary nature of 
participation, assess interest in participating, and screen the potential participant for eligibility. 
Eligibility will be determined in person (individually, with a study team member) using the 
Inclusion/Exclusion Case Report Form (CRF) (Appendix A). Additionally, the potential participant 
may be provided with a study flyer. 
Pre-screening conversations may also take place over the phone, should a participant contact the 
study team, using the Screening Script (Appendix M). Potential participants who meet initial 
eligibility per the Screening Script and express interest in participating will be asked to come to 
the THOR3 area to confirm final eligibility with an authorized study team member.
If the potential participant meets eligibility criteria and expresses interest in participating, an 
authorized study team member will assess whether the individual is comfortable with a group 
consent or an individual consent discussion. In accordance with the individual’s preference, the 
authorized study team member will initiate the formal consent discussion and, if applicable, 
obtain informed consent (as outlined in Protocol Section 13.4). 

If a potential participant would like additional time to review the consent form, study procedures, 
risks and benefits, etc. they will be provided with a consent form to take home and, if applicable, 
they may return at a later date to have any and all remaining questions answered and to finish 
the consent process. 
The research team will keep a password-protected electronic Screening Log (Appendix N), 
containing initials, date of birth (DOB) and eligibility/ineligibility status, in a secure folder on a 
secure drive, accessible only by authorized users. This log is needed to avoid any duplicative 
screening of individuals. This log, therefore, will include initials and dates of birth (DOBs) for 
those that screened formally and informally. Screening IDs will be different from study IDs that 
are assigned post-consent.
Participants that consent to participate will be added to a Master List (Appendix O) that will 
match the participants unique study ID with their name and other direct identifiers. The Master 
List will be stored in a password-protected electronic document on a common access card (CAC)-
enabled server; only on-site study team members will have access to this file. This coded study 
ID will be used on all research data collection forms in place of the participant’s name, 
Department of Defense (DoD) ID, or other protected identifier. 
Contact Information Data Collection (post-consent):
Immediately following consent, the participant will complete an Intake CRF (Appendix B). The 
Intake CRF will collect participant contact information (full name, preferred phone number, email 
address, etc.).
With the exception of the Consent Form, the Intake CRF is the only paper research form that will 
contain participant identifying information. The Intake CRF will be kept with the signed consent 
forms (in a locked cabinet inside of a locked room) and stored separately from all other paper 
research forms. 
Demographics, & Baseline Data Collection:
Prior to receiving study treatment, participants will complete a Demographics CRF (Appendix C) 
which collects relevant demographics including: personal demography, military and employment 
demography, and study-specific demography.
Additionally, participants will complete a Baseline Data Collection CRF (Appendix D) that collects: 
relevant medical history, military & work status, validated self-report measures, and study-
specific measures. The following study-specific measures will be collected by a study team 
member:
Fitzpatrick Skin Phototype
Height, weight, and body fat composition (measured by bioelectrical impedance with 
InBody 770)
Measurements of the participant’s quadriceps to calculate the appropriate PBMT dose. 
(See Appendix S for PBM dosing information).
Assessments of both legs: 
CMJ, assessing jump height, time to take-off, RSImod, Eccentric Deceleration 
Impulse, Countermovement Depth, Concentric Impulse, Movement Start to Peak 
Power, and any asymmetries, and 
Isometric and isokinetic dynamometer testing, assessing isolated strength in the 
lower body (i.e., unilateral Peak Torque and Rate of Force Development of 
quadriceps and hamstrings). 
Processes for these tests can be found in the Appendices L and W. CMJ data will be 
output from the Force Decks software and recorded directly by the study team to 
the Appendix D and E CRF tables at each test iteration.
Each participant will be assigned an Oura Ring at baseline. Participants will be instructed to wear 
the Oura Ring for the duration of the study. The Oura Ring will continuously measure sleep 
quality, heart rate, blood oxygen saturation percentage (SpO2) levels, and activity. Oura Ring 
data will be securely stored in OuraTeams with access only for research team members.
Randomization:
Participants will be randomized to a study arm using a computer-generated randomization model 
prepared by the study biostatistician, to assign participants 1:1 across both study arms (THOR3 
training + sham PBMT, or THOR3 training + PBMT).
Study Treatments (THOR3 training + sham PBMT, THOR3 training + PBMT): 

Participants will be blinded to the study arm they are assigned to and will be unblinded at the 
conclusion of the final study visit. 
Participants will be asked to refrain from using perfumes or plant extracts (e.g., St John’s Wort) 
in the treatment areas, as this use can increase photosensitivity. 
THOR3 Coach-Lead Training
All participants will be enrolled in the THOR3 coach-lead training program as a standard daily 
exercise regimen, focusing on muscle strength, endurance, and stamina. This program will 
proceed without interference from the study. Activity during the THOR3 program will be 
documented (e.g., exercises, reps, etc.) on Appendix G THOR3 Training Program Log CRF. A 
study team member will export the training schedule from Bridge Athletic and will insert the 
information into Appendix G and ask the participant to confirm what training they completed.
Photobiomodulation Treatment (PBMT) 
PBMT will be delivered at 40W. A member of the study team will use the quadriceps 
measurements of the treatment area to calculate the PBMT treatment time (approximately 5-20 
minutes). PBMT treatment will be provided up to 3 times a week, for 3 weeks. Participants will be 
asked to engage in 3 sessions per week; however, due to operational demands, we understand 
that they may not be able to attend all sessions and will then aim to minimally have them attend 
2 sessions per week.
PBMT will be provided by a trained study team member. Training for the PBMT will be conducted 
by a LightForce representative. PBMT will be delivered using the LightForce® XLi 40W device 
with the Smart Hand Piece technology, created by LiteCure, LLC/DJO (New Castle, DE) which has 
a built-in accelerometer in the hand piece that controls the speed of light delivery to the 
treatment area. The LightForce® XLi therapy laser is an FDA cleared device for the treatment of 
pain. The trained team members will use the Smart Hand Piece technology, which achieves 
effective treatments and improves dosing accuracy by assessing the operator’s speed and 
providing real-time visual (red – amber – green light) and sensory feedback. The Smart Hand 
Piece is calibrated to shut-off when moving too slowly, and warn the operator when moving too 
fast by vibrating. (See LightForce Brochure). The therapy is delivered through a flexible optical 
fiber threaded through the hand piece, which contains a rolling glass massage ball. PBMT will be 
delivered at specified J/cm2 and applied to the quadriceps area. 
In order to facilitate participant blinding to their randomized study group, all participants 
(regardless of their assigned study group) will be asked to wear blackout glasses and 
headphones during their treatment.
Sham PBMT Arm: 
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). 
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. 
Follow-Up Data Collection:
Follow-up data will be recorded on Appendix E Follow-up Data Collection CRF.
Regardless of study arm assignment, all participants will be asked to log their daily activity and 
pain (Appendix F Activity Log CRF) and wear the Oura Ring for 3 weeks. 
Weekly Follow-Up:
Participants will follow-up with a study team member once a week to:
turn in the activity log and Oura Ring data,
be assessed for any adverse events (AEs),
complete CMJ measurements just prior to THOR3 training session, and
complete a DOMS questionnaire. 
3-Week Follow-Up:
Participants will follow-up with a study team member for a final study visit to:
turn in the final activity log and Oura Ring,
be assessed for any adverse events (AEs),

complete CMJ and lower body strength assessments, 
complete a follow-up questionnaire, and 
be unblinded to their study treatment.
Participants will not be held responsible for lost or damaged Oura Rings.
Study participation will end after the completion of the 3-week follow-up visit.
Data may be captured in-person or remotely (e.g., entered directly into REDCap using a 
personalized coded link with no log-in required, verbally over the phone with a study team 
member, etc.), as applicable. Reminder phone calls, texts, and/or emails will be sent to 
participants at their preferred contact method indicated on the Intake CRF (Appendix B).
Missed Appointments and Study Removal:
If a participant misses a scheduled appointment, they will be contacted to reschedule in order to 
maintain the treatment plan of their assigned study treatment group. In the event that a 
participant misses an appointment, study staff will make one attempt to reschedule each day on 
three separate days (for three total attempts to reschedule). If the participant cannot be reached 
or does not respond/reschedule, they will be removed from the study due to non-compliance.
Additional Information - MIRROR/USU:
This research study is being conducted as part of Musculoskeletal Injury Rehabilitation Research 
for Operational Readiness (MIRROR), which is based out of the Department of Physical Medicine 
& Rehabilitation (PM&R) at the Uniformed Services University (USU).
MIRROR is focused on advancing musculoskeletal injury (MSI) rehabilitative care within the 
military healthcare system in order to reduce the burden MSIs have on military readiness and to 
ultimately enhance the operational capabilities of the armed forces. MSIs affect approximately 
800,000 service members annually and result in 25 million days of limited duty. These conditions 
are the primary reasons for medical discharge/downgrade and result in 34% of medical 
evacuations from theatre. MIRROR was developed as a means to study risk factors of common 
MSIs, generate prevention strategies, optimize treatments, and establish return-to-duty criteria 
that is based on scientific evidence rather than case-specific clinical judgment alone.
MIRROR involves interdisciplinary and inter-service partnerships, the DoD, and several major 
academic medical centers. To ensure military mission focus and scientific relevance, MIRROR is 
guided by a steering committee composed of members from the Joint Program Committees 
(JPCs) at the U.S. Army Medical Research and Development Command (USAMRDC), military 
operational leaders, and experts in musculoskeletal medicine from the military and civilian 
communities. MIRROR aims to be the world’s leader in military relevant musculoskeletal injury 
care research.
Currently, 40+ research projects are being deployed at more than 20 military and civilian 
treatment facilities nationwide.
MIRROR/USU is serving as a Coordinating Center for this study and will also be providing remote 
regulatory support. Staff from MIRROR/USU will not interact with human subjects and will not 
have access to the Master List during the conduct of this study. Deidentified research data will be 
shared with MIRROR/USU and maintained indefinitely for possible use in future research.
10.2  Data Collection:
Describe all the data variables, information to be collected, the source of the data, and how the 
data will be operationally measured.
Please see Appendix K Data Collection Schedule. 
The local study team will obtain the information necessary to complete the study CRFs directly 
from the participant.
Outcome Measures & Functional Assessments:
Defense and Veteran’s Pain Rating Scale (DVPRS) basic - captures pain
Visual Analogue Scale (VAS) - measures delayed onset muscle soreness 
Borg Perceived Exertion and Elloumi scale for behavioral health 
Quick Physical Activity Rating (QPAR) scale

Activity log to record activity and a training log that records the THOR3 training workout 
for all associated participants. 
Percent body fat, height, and weight 
CMJ measurements to assess performance (deceleration/concentric impulse, peak force 
production, rate of force production, any asymmetries) via jump plates 
Isokinetic dynamometer to measure isolated strength. 
Oura Ring will continuously measure sleep, heart rate, Sp02, and activity.
Appendix A Inclusion Exclusion CRF:
Verifies that the potential participant meets eligibility criteria for study participation.
Inclusions/exclusion criteria
Documentation of informed consent
Final eligibility status
Randomization documentation
Appendix B Intake CRF:
Obtains sufficient contact information in order to locate and track the participant during study 
participation.
Appendix C Demographics CRF:
Characterizes the participant’s demographics and relevant medical and work history. This
information may have a significant effect on functional outcomes.
Personal demography
Military & employment demography
Study-specific demography
Appendix D Baseline Data Collection CRF:
Collects relevant baseline research data.
Self-reported medical history
Current military & work status
DVPRS
QPAR
VAS
Borg Perceived Exertion Scale
Elloumi fatigue scale
Fitzpatrick Phototyping Scale
Body measurements
CMJ
Isometric/Isokinetic Strength 
Appendix E Follow-Up Data Collection CRF:
Collects relevant follow-up research data.
VAS
Borg Perceived Exertion Scale (3-week follow-up only)
Elloumi fatigue scale (only at 3-week follow-up)
CMJ
Isometric/Isokinetic Strength (3-week follow-up only) 
Adverse Event (AE) assessment
Appendix F Activity Log
Daily activity
Daily DVPRS
Appendix G THOR3 Training Program Log CRF:
Documents THOR3 training completed (reps, sets, load) for each study visit.
Appendix H Protocol Adherence CRF:
Documents protocol adherence for each study visit.

AE assessment
PD assessment
Appendix J Study Completion CRF:
Documents participant study completion status.
Study completion status
AE assessment
PD assessment
10.3  At any point in the study, will you request, use, or access health information in any form, including 
verbal, hard copy and electronic?
  Yes   
  No
10.14  Managing Data (Data Management and/or Sharing Plan) and/or Human Biological Specimens for 
this Study:
Include in this section the plan for acquiring data (both electronic and hard copy), access during 
the study, data/specimen storage and length of time stored, shipment/transmission, and the 
plan for storage and final disposition at the conclusion of the study. Describe any data 
agreements in place for accessing data within and/or outside of your institution (e.g., Data 
Sharing Agreement, Data Use Agreement, Business Agreements, etc.)
Data Capture Methods: 
The local study team will collect data directly from the study participant (including in person, 
mail, email, or over the phone) and record it on study CRFs.  The completed CRFs will serve as 
source documents for this study.
Participants may enter their coded data directly into REDCap using a personalized survey link (no 
log-in required). In these cases, the completed REDCap forms will be printed and added to the 
participant’s research record to serve as a source document.
Electronic Data Entry:
The study team will enter non-personally identifiable data from the paper CRFs into REDCap. 
Please see Appendix U for additional information on REDCap.
Data Storage & Access:
The ICF and Intake CRF will be stored separately from the coded paper research forms. All paper 
research forms and source documents will be stored in a locked cabinet inside of a locked room 
within the THOR3 area. 
The coded electronic research data for this study will be stored in REDCap, housed on a 
Department of Defense (DoD) server and maintained by USU IT. No PII will be entered into 
REDCap. The local study team will maintain the electronic master list separately from the coded 
electronic research data in a secure, password protected document on a computer and network 
that requires CAC access and will only be accessible by local research staff.
Access to the electronic coded research data will be governed strictly on an individual-by-
individual basis within REDCap. Individual data access as well as privileges will be clearly 
delegated, audited, and monitored by MIRROR/USU. Staff from MIRROR/USU will not have 
access to the paper research records or any identifiable research data.
All research data and forms (both paper and electronic) will only be accessible by authorized 
study staff, authorized staff from MIRROR/USU (coded data entered into REDCap only, as 
described above), the IRB of record, the USASOC HRPP, and applicable governmental agencies 
as part of their duties and in accordance with federal law. 
There will be appropriate data sharing agreements in place.
At study closure, study documents will be securely transported to USU Department of PM&R and 
Military Emergency Medicine (MEM) for record retention. ICFs will be maintained for a period of 6 

years following study closure and then securely shredded. Paper research forms will be 
maintained for a period of 5 years following study closure and then securely shredded. The 
master list connecting unique study ID to participant identifiers will be destroyed at study 
closure. The electronic coded research data will be maintained indefinitely as described below in 
Protocol Section 10.15.
Is this a data repository?
  Yes   
  No
10.15  Managing Data (Data Management and/or Sharing Plan) and/or Human Biological Specimens for 
Future Research:
If the study involves collecting, storing, or banking human specimens, data, or documents 
(either by the Investigator or through an established repository) for FUTURE research, address. 
How the specimens/data will be used, where and how data/specimens will be stored (including 
shipping procedures, storage plan, etc.), whether and how consent will be obtained, procedures 
that will fulfill subjects’ request as stated in the consent, whether subjects may withdraw their 
data/specimens from storage, whether and how subjects may be recontacted for future research 
and given the option to decline, whether there will be genetic testing on the specimens, who will 
have access to the data/specimens, and the linkage, the length of time that data/specimens will 
be stored and conditions under which data/specimens will be destroyed.
Consent for Future Use of Data:
The ICF for this research study states that de-identified research data will be shared with MIRROR
/USU and the United States Army Special Operations Command (USASOC) and will be 
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."
Long Term Data Storage & Access:
The de-identified electronic dataset will be maintained by MIRROR/USU and the study team 
indefinitely or as long as it is practicable to maintain.
De-identified electronic research data will be securely transmitted from local study teams to the 
MIRROR /USU via REDCap or the DoD secure access file exchange (SAFE) application (or other 
permissible safe data sharing system). REDCap utilizes Secure Sockets Layer (SSL) in addition to 
other safeguards on its web server to maintain secure communication with end-users (see 
Appendix U). DoD SAFE uses a TLS (Transport Layer Security) protocol when files are uploaded 
and downloaded.
Once received, the electronic de-identified research data will be stored within an encrypted, 
access controlled, password protected electronic data capture and management system housed 
on a DoD-compliant server.
Access to the de-identified research data will be governed strictly on an individual-by-individual 
basis within the secure electronic data capture and management system. Individual data access 
as well as privileges will be clearly delegated, audited, and monitored by MIRROR/USU. Any 
future research using retained data will require a research protocol to be approved by an 
Institutional Review Board or other authorized official responsible for protecting human subjects 
of research.
We will also ask participants for permission to store their identifiable contact information for the 
purposes of being contacted to participate in future research studies. Participants will be 
provided the option to opt-in or opt-out of the storage of their contact information. All 
participants that opt in to the storage of contact information for the purposes of being contacted 
to participate in future research studies will have their name and contact information retained at 
study closure. The local study team will securely maintain the contact information indefinitely, or 
as long as it is practical to maintain. The PI will be responsible for ensuring secure storage and 
destruction, as applicable.

Any future research using retained data will require a research protocol to be approved by an 
Institutional Review Board or other authorized official responsible for protecting human subjects 
of research.
Data Withdrawal from Storage:
Participants may request to have their data withdrawn at any time before their personal 
identifiers have been removed. Once their data has been de-identified (when the study master 
list is destroyed at study closure), it will be impossible for the researchers to locate their specific 
study data.
Is this a data repository?
 Yes   
 No
If Yes, provide the name of the Repository
USU OCIO REDCap
Who will have access to the Repository?
MIRROR/USU, study team members, and investigators, as appropriate
What data type will be stored in the Repository?
Protected Health Information
Limited Data Set
De-identified Data
11.0
 
Statistical/Data Analysis Plan
11.1  Statistical Considerations:
List the statistical methods to be used to address the primary and secondary objectives, specific 
aims, and/or research hypotheses.  Explain how missing data and outliers will be handled in the 
analysis.  The analysis plan should be consistent with the study objectives.  Include any sub-
group analyses (e.g., gender or age group).  Specify statistical methods and variables for each 
analysis.  Describe how confounding variables will be controlled in the data analysis
Descriptive statistics will report location and scale in terms of mean and standard deviation for 
normally distributed variables, median and interquartile intervals for ordinal metric variables, and 
in terms of proportion and size for categorical variables. Descriptive statistics will be reported for 
baseline demographic and clinical characteristics at an overall level and by initial treatment 
group. 
Outliers will be removed if determined to be erroneous based on relevant clinical expertise. 
Confounding will be principally controlled by randomization. In regards to the treatment of 
missing data, Oura Ring data will be analyzed despite presence of missing data at any point; 
with regards to non-continuous outcomes, data will be analyzed only if baseline and the 3-week 
follow-up are both present. In the event of missing data for a mid-point follow up (i.e., not 
baseline or the 3-week follow up), said patient will still be included in all models. 
Statistical analyses will use generalized additive models predicting the change in outcome 
measures at 3 weeks relative to baseline for all measures except Oura Ring data. Oura Ring data 
will be aggregated by averaging readings across each 24-hour period and will be modeled using 
multi-level models incorporating random effects. Sensitivity analyses will be performed on 
longitudinal data for each outcome metric and will include multi-level models incorporating 
random effects as well as control variables to account for any differences explained by a 
selection of patient characteristics (such as body weight, etc.).
11.2  Sample Size:
Within one performance site, and assuming roughly 20% attrition and accounting for screen 

failures, we are requesting to enroll up to 116 (58 per arm) participants in order to evaluate a 
final sample of 85 (42-43 per arm).
11.3  Total number of subjects requested (including records and specimens):
116
11.4  If you are recruiting by study arm, please identify the arms of the study and how many subjects will 
be enrolled in each arm
Across one performance site, up to 116 patients will be randomized 1:1 to the two treatment 
arms (PBMT and Sham PBMT).
11.5  Please provide a justification for your sample size
Due to the accepted feasibility/pilot nature of this study, we understand that the proposed study 
may not be appropriately powered. Assuming a moderate effect size of .15 and a significance 
level of 5%; in the event we are able to enroll 116 participants (85 post-attrition) we will achieve 
80% power. If we are able to enroll 135 participants (108 post-attrition), we will achieve 90% 
power. Power was calculated using the linear multiple regression module within G*Power 
(Erdfelder, Faul, & Buchner, 1996).
11.6  Data Analysis Plan: Complete description: Background, Objectives, Design, Step by Step how the 
project is going to be done, Data analysis plan:
Descriptive statistics will report location and scale in terms of mean and standard deviation for 
normally distributed variables, median and interquartile intervals for ordinal metric variables, and 
in terms of proportion and size for categorical variables. Descriptive statistics will be reported for 
baseline demographic and clinical characteristics at an overall level and by initial treatment 
group. 
Statistical analyses will use generalized additive models predicting the change in outcome 
measures at 3 weeks relative to baseline for all measures except Oura Ring data. Oura Ring data 
will be aggregated by averaging readings across each 24-hour period and will be modeled using 
multi-level models incorporating random effects. Sensitivity analyses will be performed on 
longitudinal data for each outcome metric and will include multi-level models incorporating 
random effects as well as control variables to account for patient characteristics. Exact selection 
of control variables will be guided by observed differences within final collected data as well as 
relevant clinical expertise. 
Hypothesis tests will be two-tailed and statistical significance will be considered at the putative 
threshold (alpha=0.05). Any secondary P-values will be subject to a false discovery rate 
adjustment in keeping with best statistical practices. Multilevel models will incorporate random 
effects to account for repeated measures, using distribution families and link functions 
appropriate for the outcomes of interest, determined using quantile-quantile (QQ) plots analyzed 
for best model fit. All statistical analyses will be performed using the R Programming language.
12.0
 
Participant Information
12.1  Subject Population:
Active-duty, male, SFG (18-series) personnel, between the ages of 18-45 (inclusive) years old
12.2  Age Range:
Check all the boxes that apply. if the age range of potential subjects (specimens, records) does 
not match the range(s) selected, please specify in the text box.

0-17
18-24
25-34
35-44
45-54
55-64
65-74
75+
18-45 (inclusive)
12.3  Gender:
Male
Female
Other
12.4  Special categories, check all that apply
Minors /Children
Students
Employees - Civilian
Employees - Contractor
Resident/trainee
Cadets /Midshipmen
Active Duty Military Personnel
Wounded Warriors
Economically Disadvantaged Persons
Educationally Disadvantaged Persons
Physically Challenged (Physical challenges include visual and/or auditory impairment)
Persons with Impaired Decisional Capacity
Prisoners
Pregnant Women, Fetuses, and Neonates
Non-English Speakers
International Research involving Foreign Nationals - Headquarters Review is necessary
You must also consider the requirements of DoDI 3216.02, Enclosure 3, paragraph 7.e.
12.5  Inclusion Criteria:
Order 
Number
Criteria
1 
Active-Duty Special Forces Personnel (18-series)
 
2 
Between the ages of 18-45 years old (inclusive) 
 
3 
Male 
 
4 
Able to read and understand English language for consent purposes 
 
5 
Able to commit to study intervention and follow-up
 
6 
Able to participate in THOR3 coach-lead training, without restriction
 

1.  
2.  
12.6  Exclusion Criteria:
Order 
Number
Criteria
1 
Obese (body fat 
 25%) 
>
 
2 
Cardiovascular disease
 
3 
Use of select medications:
statins (e.g., Atorvastatin/Lipitor, Fluvastatin, Lovastatin, Pitastatin, 
Pravastatin, Rosuvastatin/Crestor, Simvastatin/Zocor), 
diuretics (e.g., Microzide, Lasix, Aldactone, Midamor), or
antihypertensive agents
 
4 
Female 
 
5 
Tattoo in treatment area
 
6 
Diagnosis with porphyria (light induced allergy) or photosensitive eczema
 
7 
Current use of medications associated with sensitivity to heat or light (e.g., 
amiodarone, chlorpromazine, doxycycline, hydrochlorothiazide, nalidixic acid, 
naproxen, piroxicam, tetracycline, thioridazine, voriconazole), 
 
8 
Use of pacemaker/underlying cardiac disease
 
9 
Diagnosis of autoimmune diseases 
 
10 
Albinism
 
11 
Peripheral neuropathy
 
13.0
 
Recruitment and Consent
13.1  Please describe the recruitment process, including how subjects will be identified and selected for 
the study.
Study activities will occur at Joint Base Lewis-McChord (JBLM) within the 1  Special Forces 
st
Group (SFG). Study activities, including recruitment, will occur in the THOR3 area or other 
applicable 1  SFG areas.  
st
Recruitment, Pre-Screening (before consent), Study Introduction & Informed Consent:
Potential participants will be identified via three methods: 
Participants may self-refer to participate in the study if they become aware of the study 
by study flyer (Appendix P) or word of mouth. Interested potential participants will be 
able to contact a member of the study team via phone or email. 
Mass briefs at THOR3 coach-lead trainings. 
Briefings will occur at regular intervals, about every 3 weeks, for each training 
class at the 3 Operator focused training sessions. In the course of a month, there 
will be about 4 briefings. 
Briefings will take no more than five (5) minutes. The briefs will be scheduled to 
occur prior to the coach lead session. Consenting procedures will not occur during 
these informational briefs.

3.  
Leadership would only include the OIC of THOR3, not Group Leadership. Every 
effort will be made to unsure there is not undue coercion. 
"Thank you for taking a few minutes to listen to this brief. We are conducting a 
research study to assess utilizing light therapy to increase recovery post training. 
There is the possibility that it can decrease inflammation, soreness, and fatigue 
and thus increase performance. We will ask you to complete a baseline visit, 
where we collect some self-reported demographic and health information, and 
measure your height, weight, and body fat. We will also ask you to complete a 
strength test and a counter movement jump. We will assign you an Oura Ring to 
wear for the duration of the study. This visit will take about 45 minutes. Then for 3 
weeks, we will ask to provide light therapy 3 times a week after THOR3 coach led 
training. You will be randomly assigned to an active treatment or sham treatment 
group. Each group will wear headphones and blackout glasses. These sessions 
should take 20 minutes. Each week we will ask you to complete a 
countermovement jump, and fill out some questionnaires. These visits will take 
about 15 minutes. We will also ask you to fill out a daily pain questionnaire, and 
complete an activity log, which will take about 5 minutes. At the end of the three 
weeks, we will test your strength and counter movement jump again and ask you 
to fill out final questionnaires. This will take about 25 minutes. You will be 
compensated at each weekly visit, for a total of 150 USD."
Study advertisements (Appendix P) will be posted in THOR3 and 1  SFG areas that 
st
operators frequent. 
If a potential participant expresses interest in learning more about the research study, a member 
of the research staff will briefly introduce the study, express the voluntary nature of 
participation, assess interest in participating, and screen the potential participant for eligibility. 
Eligibility will be determined in person (individually, with a study team member) using the 
Inclusion/Exclusion Case Report Form (CRF) (Appendix A). Additionally, the potential participant 
may be provided with a study flyer. 
Pre-screening conversations may also take place over the phone, should a participant contact the 
study team, using the Screening Script (Appendix M). Potential participants who meet initial 
eligibility per the Screening Script and express interest in participating will be asked to come to 
the THOR3 area to confirm final eligibility with an authorized study team member.
If the potential participant meets eligibility criteria and expresses interest in participating, an 
authorized study team member will assess whether the individual is comfortable with a group 
consent or an individual consent discussion. In accordance with the individual’s preference, the 
authorized study team member will initiate the formal consent discussion and, if applicable, 
obtain informed consent (as outlined in Protocol Section 13.4). 
If a potential participant would like additional time to review the consent form, study procedures, 
risks and benefits, etc. they will be provided with a consent form to take home and, if applicable, 
they may return at a later date to have any and all remaining questions answered and to finish 
the consent process. 
The research team will keep a password-protected electronic Screening Log (Appendix N), 
containing initials, date of birth (DOB) and eligibility/ineligibility status, in a secure folder on a 
secure drive, accessible only by authorized users. This log is needed to avoid any duplicative 
screening of individuals. This log, therefore, will include initials and dates of birth (DOBs) for 
those that screened formally and informally. Screening IDs will be different from study IDs that 
are assigned post-consent.
13.2  Compensation for Participation:
Participants may receive up to $150 for participation in this research. 
Participants will be compensated at the following intervals:
$50 USD gift card for completing the activity log and turning it in at the 1-week follow-up
$50 USD gift card for completing the activity log and turning it in at the 2-week follow-up
$50 USD gift card for completing the activity log and turning it in at the 3-week follow-up
Eligible participants will be compensated through the Greenphire platform. Participants will be 
registered in the Greenphire platform upon confirmation of final eligibility. Once registered, the 
participant will be classified as a (1) non-active duty, or (2) active-duty employee category, and 
a Greenphire debit card will be assigned to them. Participants will be given an envelope 
containing their debit card and all information needed to access their funds, and they will be 

instructed to retain that card for the duration of their study participation. At the various 
compensation intervals indicated above, an assigned user will verify the study visit was 
completed and will issue a stipend through the Greenphire system, which will electronically 
release funds to the assigned debit card.
If needed, a Greenphire debit card can be mailed to a participant. In this case, a participant will 
be registered into the appropriate employee category, the debit card will be assigned (but not 
activated) and will be mailed to the participant. Stipends will be issued only after the participant 
confirms receipt of the card.
DHA-AI 3200.01 indicates active-duty service members may receive additional compensation for 
the completion of a daily health diary when completed off-duty. In accordance with DHA-AI 
3200.01 the following definitions of on-duty and off-duty will apply to active duty-service 
member study participants:
An individual is on-duty when they are expected or required to perform the duties of their 
assigned job or position.
An individual is off-duty if the individual is not scheduled to perform any work that may 
arise during the period.
13.3  Please describe the pre-screening process. If no pre-screening, enter Not Applicable in the text editor
If a potential participant expresses interest in learning more about the research study, a member 
of the research staff will briefly introduce the study, express the voluntary nature of 
participation, assess interest in participating, and screen the potential participant for initial 
eligibility using the Inclusion/Exclusion CRF (Appendix A). Pre-screening conversations may take 
place over the phone using the Screening Script (Appendix M).
13.4  Consent Process:   Revised Common Rule, Section 219.116:  General requirements for informed 
consent, whether written or oral, are set forth in this paragraph and apply to consent obtained in 
accordance with the requirements set forth in paragraphs (b) through (d) of this section. Broad 
consent may be obtained in lieu of informed consent obtained in accordance with paragraphs (b) and 
(c) of this section only with respect to the storage, maintenance, and secondary research uses of 
identifiable private information and identifiable biospecimens.
Are you requesting a waiver or alteration of informed consent?
  Yes   
  No
Please explain the consent process:
Consent (individual and group) will be obtained in accordance with principles of Belmont Report 
and Common Rule guidelines.
The potential participant(s) will be given a copy of the ICF to read before the informed consent 
discussion with an authorized study team member. Sufficient time will be given to the potential 
participant to understand the study purpose, study procedures, time commitments, potential 
risks and benefits, and the types of information that will be collected and used by the research 
team if they agree to participate in the study.
Questions can be raised by the potential participant(s) at any time. The potential participant(s) 
will be reminded that their participation is completely voluntary and that they may withdraw 
from the study at any time without penalty. Their decision to participate, or not, will not affect 
their access to health care that they are otherwise entitled to and it will not affect their military 
position.
Formal consent, as represented by the act of signing a dated, IRB-approved ICF for the study will 
occur after: confirming eligibility using the Inclusion/Exclusion CRF, a thorough review of what is 
involved in the study (including all available study treatments as well as blinding and 
randomization processes), and all questions have been answered. Informed consent will be 
obtained in person and may include consenting as a group, based on the participants’ 
comfortability and scheduling. Each individual will be asked for their preference for a group or 
individual consent discussion, and the individual’s preference will be utilized. A copy of the signed 
consent form will be given to the participant and the original will be securely stored. No Legally 
Authorized Representatives will be utilized.

Every effort will be made to eliminate the perception of authority. When applicable, the study 
investigators will be in civilian clothes instead of uniform and will not utilize or display their 
military rank when introducing themselves. Some potential participants may be patients of the 
study PI or AI. In these cases, the consent conversation will be initiated by non-provider study 
staff to prevent any misconception of coercion or undue influence.
In the event that there are significant new findings that may affect participants’ willingness to 
continue in the study, an information sheet will be provided to all current and past participants, 
and the ICF will be amended for future participants.
Following completion of informed consent, a unique study ID will be generated. This coded study 
ID will be used on all research data collection forms in place of the participant’s name, 
Department of Defense (DoD) ID, or other protected identifier. No PII will be entered into 
REDCap.
13.5  DoDI 3216.02 requires an ombudsman to be present during recruitment briefings when research 
involves greater than minimal risk and recruitment of Service members occurs in a group setting. If 
applicable, you may nominate an individual to serve as the ombudsman.
N/A 
Propose ombudsman 
13.6  Withdrawal from Study Participation:
Explain the process for withdrawal and specify whether or not the subjects will be given the 
opportunity to withdraw their data their data/specimens in the event they wish to withdraw from 
the study
Participant Withdrawal:
Participants may contact a member of the study team in writing to formally withdraw from the 
study.
Participants may withdraw from the study at any time without penalty. Participants will be 
informed that withdrawal will not affect their access to health care that they are otherwise 
entitled to and it will not affect their military position.
If a participant withdraws from the study, we may retain and analyze all coded/de-identified data 
collected up to the time of withdrawal if the data is necessary to maintain the integrity of the 
study. However, no further data will be collected after the date of withdrawal.
Withdrawal Without Participant Consent:
A participant may be withdrawn from the study without their consent if remaining in the study 
might be dangerous or harmful to them, the military mission requires it, they lose their right to 
receive medical care at a military hospital, the study is canceled, they fail to adhere to the 
protocol and/or therapy plan, or if they display inappropriate behavior towards study personnel.
Participants will be asked to return all study materials at the time of study withdrawal. 
Participants will be contacted up to three times for each contact method (e.g., call, text, email, 
or in-person interactions) to retrieve the study materials. Once all attempts are exhausted, no 
further contacts will be made.  
14.0
 
Risks and Benefits
14.1  
Risks of Harm:
Identify all research-related risks of harm to which the subject will be exposed for each research 
procedure or intervention as a result of participation in this study.  Consider the risks of breach 

of confidentiality, psychological, legal, social, and economic risks as well as physical risks.  Do 
not describe risks from standard care procedures; only describe risks from procedures done for 
research purposes
The risks associated with PBMT are minimal. PBMT is used by a variety of healthcare 
practitioners for painful clinical conditions. Mild discomfort may be experienced during the 
treatment, the treatment should not feel “hot”, but participants should notify the study team 
member if they feel any uncomfortable warming. Individuals with neuropathies or difficulty 
distinguishing changes in skin temperature are at higher risk. Potential research-related risks 
include damage to eye structures, headaches post-procedure, uncomfortable skin heating or 
erythema/redness, which are both very rare. 
The risks associated with the counter-movement jump and strength testing are minimal risks 
that may be experienced in everyday life, including loss of balance, fall, discomfort, or injury. 
Additionally, any time information is collected for a study, there is a small risk of breach of 
confidentiality.
14.2  
Measures to Minimize Risks of Harm (Precautions, safeguards):
For each research procedure or intervention, describe all measures to minimize and/or eliminate 
risk of harms to subjects and study personnel
All available measures to minimize risks will be taken in accordance with standard clinic protocols.
Protective eyewear will be worn by all participants and study team members during PBMT and 
sham PBMT treatment sessions to avoid potential eye damage. Along with the Laser Safety 
Officer (LSO), the PI will ensure that the treatment space meets all regulatory requirements for 
utilization of a treatment laser, including appropriate signage and use of laser blocking screens to 
absorb any potential scatter/refraction of light outside of the treatment area.
In the rare occurrence that participants experience uncomfortable warmth over the treatment 
area during PBMT, the treatment will be modified or stopped.
All available measures will be taken by research staff to protect participant confidentiality. See 
Protocol Section 14.3 for additional information on confidentiality protections. 
All participants will be evaluated for AEs at each follow-up visit. All AEs, regardless of severity, 
will be reported to the PI and the IRB according to the guidelines stated in Protocol Section 16.0.
14.3  
Confidentiality Protections (for research records, data and/or specimens):
Describe in detail the plan to maintain confidentiality of the research data, specimens, and 
records throughout the study and at its conclusion (e.g., destruction, long term storage, or 
banking). Explain the plan for securing the data (e.g., use of passwords, encryption, secure 
servers, firewalls, and other appropriate methods). If data will be shared electronically with 
other team members/collaborators outside the institution, describe the method of transmission 
and safeguards to maintain confidentiality. Explain whether this study may collect information 
that State or Federal law requires to be reported to other officials or ethically requires action, e.
g., child or spouse abuse
Upon consenting for the study, participants will be assigned a unique study ID. With the 
exception of the ICF, Intake Form, and electronic Master List, all research data (both paper and 
electronic) will be identified using this unique study ID only.
Paper research forms and source documents will be stored in a locked cabinet inside of a locked 
room, accessible only by local research staff designated and authorized by the PI. The paper 
Intake CRF and ICFs will be stored separately from the coded paper research forms.

The electronic Master List will be stored separately from the coded electronic research data in a 
secure, password-protected electronic document on a computer and network that requires CAC 
access.
The coded electronic research data for this study will be stored in REDCap, an encrypted, access 
controlled, password protected electronic data capture and management system housed on a 
DoD server and maintained by USU IT. No PII will be entered into REDCap. 
MIRROR, which is based out of the Department of PM&R at USU, is serving as the data 
coordinating center for this research study. As such, authorized staff from MIRROR/USU will have 
access to the coded research data that is entered into REDCap. Authorized staff from MIRROR
/USU will not have access to the electronic Master List.
All research data and forms (both paper and electronic) will only be accessible by authorized 
study staff, the IRB of record, the local research office, and applicable governmental agencies as 
part of their duties and in accordance with federal law. These duties include making sure that 
research participants are protected.
Any research data shared with an approved agency for review will be linked only to the 
participant’s unique study ID. If the research data is used in scholarly presentations or journal 
articles, the investigators will protect the anonymity of individual participants and report only 
aggregate data (e.g., group means) where appropriate. Participants will not be individually 
identified in any publication or presentation of research results.
14.4  
Potential Benefits:
Describe any real and potential benefits of the research to the subject and any potential benefits 
to a specific community or society
If the individuals in the research are considered experimental subjects (per 10 USC 980), and 
they cannot provide their own consent, the protocol must describe the intent to directly benefit 
all subjects
We cannot guarantee that participants will benefit from participation in this research study. The 
aim of this study is to improve performance and recovery. All participants will still receive 
standard THOR3 coach-lead training. 
14.5  
Privacy for Subjects:
Describe the measures to protect subject’s privacy during recruitment, the consent process, and 
all research activities, etc.
Consent conversations and follow-up research activities will take place in a private setting (e.g., 
over a private phone line, in a closed clinic room, investigator’s office, etc.) to minimize the 
potential opportunity to be overheard or inadvertently witnessed. Each individual will be asked 
for their preference for a group or individual consent discussion, and the individual’s preference 
will be utilized. Information being collected will be limited to only the minimum amount of data 
necessary to accomplish the proposed research.
No uniformed service members or supervisors will be present during consent discussions.
14.6  
Incidental or Unexpected Findings:
Describe the plan to address incidental findings and unexpected findings about individuals from 
screening to the end of the subject’s participation in the research. In cases where the subject 
could possibly benefit medically or otherwise from the information, state whether or not the 

1.  
2.  
3.  
4.  
5.  
results of screening, research participation, research tests, etc., will be shared with subjects or 
their primary care provider. State whether the researcher is obligated or mandated to report 
results to appropriate military or civilian authorities and explain the potential impact on the 
subject
Because information regarding participant health may be required to be reported to appropriate 
medical or command authorities, participants will not have the option to opt out of receiving the 
results of incidental findings from this research.
The PI will review all incidental findings and determine whether or not the incidental finding 
should be reported to the participant. The PI will utilize guidance provided by the Office of 
Human Research Protections (OHRP) Attachment F - Recommendations on Reporting Incidental 
Finding. Specifically, the PI will consider whether the findings are validated and actionable, and if 
they have potential implications for a participants physical and mental wellbeing. The PI will 
assume responsibility for notifying participants of incidental findings, explaining the findings, 
implications, and recommendations for next-steps to follow-up with their clinical care team. The 
CSC/CSU surgeon will also be notified.
In cases involving military personnel, information regarding their health may be required to be 
reported to appropriate medical or command authorities to ensure the proper execution of the 
military mission, including evaluation of fitness for duty.
15.0
 
Study Monitoring
15.1  Your study requires either Data and Safety Monitoring Plan (DSMP) or a Data and Safety Monitoring 
Board (DSMB).
DSMP 
DSMB 
Both 
Not Applicable 
A DSMP should describe the plan to monitor the data to verify that the data are collected and 
analyzed as specified in the protocol. Include who will conduct the monitoring, what will be 
monitored, and the frequency of monitoring. It should also include the plan to ensure the safety 
of subjects
Participant Safety Monitoring Plan:
To ensure the safety of participants the PI will:
Monitor the conduct of the protocol per the approved study plan and ensure protection of 
human participants. This may involve periodic review of research files of enrolled 
participants.
Review and keep abreast of AEs and protocol deviations (PDs) that occur during the 
research.
The PI will review and sign AE/PD logs and continuing review (CR) progress reports.
If there is concern about the welfare of enrolled participants, the PI will stop the research 
study in progress, remove individual participants from a study, and take whatever steps 
necessary to protect the safety and well-being of research participants until the IRB can 
assess the situation.
Ensure that all study team members keep current required human subjects research 
trainings which require renewal every 3 years.
If an AE or PD occurs, it will be evaluated by the PI and appropriate actions will be taken as 
outlined in Protocol Section 16.0. In the case of an emergency, first responders will be called. In 
order to address the challenge of early identification of an increased risk of a known AE, all AE 
data will be tracked and evaluated.
Participants can elect to withdraw from the study at any time. Participants may also be taken out 
of the study at any point if it is determined to no longer be safe for them to continue with the 
study. If a participant elects to drop out of the study or is withdrawn for safety reasons, they will 
be encouraged to seek care with their healthcare provider, if applicable, and the CSC/CSU 
surgeon will be notified.

Data Monitoring Plan:
Data will be collected and stored in both paper CRF and electronic format as described previously 
in Protocol Section 10.14 Data Management. In addition to data quality and data validation 
checks done continually by REDCap for electronic format data, authorized MIRROR staff will 
perform routine checks of the coded electronic data entered into REDCap to ensure that data has 
been properly input and that data entry is consistent with expected values. The local PI will 
ensure that paper research forms and the electronic Master List are completed and securely 
stored in accordance with stated protocol procedures.
Please see Protocol Section. 14.3 Confidentiality Protections and 14.5 Privacy for Subjects for 
additional information regarding how we will protect participant privacy and confidentiality 
throughout this study.
16.0
 
Reportable Events
16.1  Reportable Events: Consult with the research office at your institution to ensure requirements are 
met. Describe plans for reporting unexpected adverse events and unanticipated problems. Address 
how unexpected adverse events will be identified, who will report, how often adverse events and 
unanticipated problems will be reviewed to determine if any changes to the protocol or consent form 
are needed and the scale that will be used to grade the severity of the adverse event. 
Consult with the research office at your institution to ensure requirements are met
 
• Describe plans for reporting expected adverse events. Identify what the expected adverse 
events will be for this study, describe the likelihood (frequency, severity, reversibility, short-
term management and any long-term implications of each expected event)
 
• Describe plans for reporting unexpected adverse events and unanticipated problems. Address 
how unexpected adverse events will be identified, who will report, how often adverse events and 
unanticipated problems will be reviewed to determine if any changes to the research protocol or 
consent form are needed and the scale that will be used to grade the severity of the adverse 
event
AEs & Unanticipated Problems:
All AEs will be recorded by the study team using an AE Log. The PI will promptly review and 
assess events to determine severity and relatedness to research activities.
All Serious Adverse Events (SAEs) that are at least possibly related to study participation and all 
Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSOs) will be reported to the 
IRB and USASOC HPD via telephone or email within 24 hours of discovery, and a complete 
written report will be submitted via EIRB within 5 business days. The written report will be 
provided to the USASOC HPD at the time of submission.
All expected AEs and all SAEs that are not possibly related to study participation will be reported 
to the IRB and USASOC HPD at the time of CR or study closure (as applicable). 
Protocol Deviations:
All PDs will be recorded by the study team using a PD log. The PI will promptly review and assess 
events to determine severity.
All major PDs will be promptly reported to the IRB and USASOC HPD via telephone or email 
within 24 hours of discovery, and a complete written report will be submitted via EIRB within 5 
working days. The written report will be provided to the USASOC HPD at the time of submission.
All minor/administrative PDs will be reported to the IRB and USASOC HPD at the time of CR or 
study closure (as applicable).
17.0
 
Equipment/non-FDA Regulated Devices

17.1  Does the study involve the use of any unique non-medical devices/equipment?
 Yes   
 No
Please describe:
HUMAC® NORM™ Testing & Rehabilitation System will be used to measure isometric and 
isokinetic strength.
InBody770 will be used to measure height, weight, and body fat composition.
Oura Ring will be used to measure measure sleep quality, heart rate, blood oxygen saturation 
percentage (SpO2) levels, and activity.
VALD ForceDecks will be used to measure countermovement jump measurements (jump height, 
time to take-off, RSImod, eccentric deceleration impulse, countermovement depth, concentric 
impulse, movement start to peak power).
18.0
 
FDA-Regulated Products
18.1  Will any drugs, dietary supplements, biologics, or devices be utilized in this study?
Drugs
Dietary Supplements
Biologics
Devices
N/A
18.3  Device Details:
Are device(s) in this research being used in accordance to the approved labeling?
Are device(s) in this research being used in a manner other than its approved labeling?
When adding a device indicate in the details section of the device if the use is either used in 
accordance to the approved labeling or in a manner other than it's approved labeling
View Details
Device Name
LightForce® XLi therapy laser 
Manufacturer/Supplier of 
Device
LiteCure, DJO Global, Envois 
Where will the Devices Be 
Stored
In the research area 
Will Devices be supplied at no 
Cost
No 
Is this a HUD (HDE)
No 
HDE Number
N/A 
Who holds the IDE
N/A  
IDE details
N/A  
18.4  Reporting Requirements for FDA-regulated research under IND and IDE:
Describe the process for complying with FDA regulatory requirements for adverse event 
reporting and adverse device effects reporting to the sponsor

The PI will be responsible for reporting any unanticipated adverse effects and unanticipated 
problems to the manufacturer and FDA for the device.
18.5  Sponsor (organization/institution/company):
N/A
If applicable, provide sponsor contact information:
N/A
19.0
 
Research Registration Requirements
19.1  ClinicalTrials.gov Registration:
Registration is not required 
Registration pending 
Registration complete 
19.2  Defense Technical Information Center Registration (Optional):
Registration is not required 
Registration pending 
Registration complete 
20.0
 
References and Glossary
20.1  References:
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(Basel). 2021 Dec 3;11(12):1339. doi: 10.3390/life11121339. PMID: 34947870; PMCID: 
PMC8706093.
Antonialli FC, De Marchi T, Tomazoni SS, et al. Phototherapy in skeletal muscle performance and 
recovery after exercise: effect of combination of super-pulsed laser and light-emitting diodes. 
Lasers in medical science. 2014;29(6):1967-1976. doi:10.1007/s10103-014-1611-7 
Aver Vanin A, De Marchi T, Silva Tomazoni S, et al. 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. 
Photomedicine and laser surgery. 2016;34(10):473-482. doi:10.1089/pho.2015.3992 
Baroni BM, Leal Junior ECP, De Marchi T, Lopes AL, Salvador M, Vaz MA. Low level laser therapy 
before eccentric exercise reduces muscle damage markers in humans. European journal of 
applied physiology. 2010;110(4):789-796. doi:10.1007/s00421-010-1562-z
Baroni BM, Rodrigues R, Freire BB, Franke R de A, Geremia JM, Vaz MA. Effect of low-level laser 
therapy on muscle adaptation to knee extensor eccentric training. European journal of applied 
physiology. 2015;115(3):639-647. doi:10.1007/s00421-014-3055-y 
de Brito Vieira WH, Ferraresi C, de Andrade 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 in medical science. 2011;27(2):
497-504. doi:10.1007/s10103-011-0984-0 

de Carvalho, G.; Gobbi, A.; Gobbi, R.B.; Alfredo, D.; do Carmo Furquim, T.H.; Barbosa, R.I.; 
Papoti, M.; de Jesus Guirro, R.R. Photobiomodulation by light emitting diode applied sequentially 
does not alter performance in cycling athletes. Lasers Med. Sci. 2020, 35, 1769–1779.
De Marchi T, Leal-Junior ECP, Lando KC, et al. Photobiomodulation therapy before futsal matches 
improves the staying time of athletes in the court and accelerates post-exercise recovery. Lasers 
in medical science. 2019;34(1):139-148. doi:10.1007/s10103-018-2643-1 
de Oliveira AR, Vanin AA, Tomazoni SS, et al. Pre-Exercise Infrared Photobiomodulation Therapy 
(810 nm) in Skeletal Muscle Performance and Postexercise Recovery in Humans: What Is the 
Optimal Power Output? Photomedicine and laser surgery. 2017;35(11):595-603. doi:10.1089
/pho.2017.4343
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-Leśniak K, et al. Photobiomodulation—underlying 
mechanism and clinical applications. Journal of Clinical Medicine. 2020;9(6):1724. doi: 10.3390
/jcm9061724
Dornelles, M.P.; Fritsch, C.G.; Sonda, F.C.; Johnson, D.S.; Leal-Junior, E.; Vaz, M.A.; Baroni, B.
M. Photobiomodulation therapy as a tool to prevent hamstring strain injuries by reducing soccer-
induced fatigue on hamstring muscles. Lasers Med. Sci. 2019, 34, 1177–1184. https://doi.org
/10.1007/s10103-018-02709-w 
Faul, F., Erdfelder, E., Lang, A.-G., & Buchner, A. (2007). G*Power 3: A flexible statistical power 
analysis program for the social, behavioral, and biomedical sciences. Behavior Research Methods, 
39(2), 175–191.
Ferraresi C, Bertucci D, Schiavinato J, et al. 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. American journal of physical medicine & 
rehabilitation. 2016;95(10):746-757. doi:10.1097/PHM.0000000000000490 
Ferraresi, C., dos Santos, R.V., Marques, G. et al. Light-emitting diode therapy (LEDT) before 
matches prevents increase in creatine kinase with a light dose response in volleyball players. 
Lasers Med Sci 30, 1281–1287 (2015). https://doi-org.usu01.idm.oclc.org/10.1007
/s10103-015-1728-3
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2016;6:113-124. doi:10.1016/j.bbacli.2016.09.002
Leal Junior EC, de Godoi V, Mancalossi JL, et al. 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 in medical science. 2011;26
(4):493-501. doi:10.1007/s10103-010-0866-x 
Leal Junior ECP, Lopes-Martins RAB, Baroni BM, et al. Comparison between single-diode low-level 
laser therapy (LLLT) and LED multi-diode (cluster) therapy (LEDT) applications before high-
intensity exercise. Photomedicine and laser surgery. 2009;27(4):617-623. doi:10.1089/pho.
2008.2350
Pinto HD, Vanin AA, Miranda EF, et al. Photobiomodulation Therapy Improves Performance and 
Accelerates Recovery of High-Level Rugby Players in Field Test: A Randomized, Crossover, 
Double-Blind, Placebo-Controlled Clinical Study. Journal of strength and conditioning research. 
2016;30(12):3329-3338. doi:10.1519/JSC.0000000000001439
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, S.S.; Machado, C.; De Marchi, T.; Casalechi, H.L.; Bjordal, J.M.; de Carvalho, P.; Leal-
Junior, E. 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, 6239058. https://doi.org/10.1155/2019/6239058 
Vanin AA, Miranda EF, Machado CSM, et al. 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 in medical science. 2016;
31(8):1555-1564. doi:10.1007/s10103-016-2015-7
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-special-
forces-members-physical-mental-capabilities/
20.2  Abbreviations and Acronyms:
Adverse Event (AE)
Case Report Form (CRF)
Centimeter (cm)
Common Access Card (CAC)
Continuing Review (CR)
Countermovement Jump (CMJ)
Creatine Kinase (CK) 
Date of birth (DOB)
Defense and Veteran’s Pain Rating Scale (DVPRS)
Defense Health Agency Administrative Instruction (DHA-AI)
Delayed Onset Muscle Soreness (DOMS)
Department of Defense (DoD)
Electronic Institutional Review Board (EIRB)
Exempli Gratia (E.g.)
Etcetera (etc.)
Food & Drug Administration (FDA)
Identification (ID)
Id Est (I.e.)
Informed Consent Form (ICF)
Interleukin-6 (IL-6) 
Institutional Review Board (IRB)
Information Technology (IT) 
Joint Base Lewis McChord (JBLM)
Joint Program Committee (JPC)
Joule (J)
Laser Safety Officer (LSO)
Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR)
Musculoskeletal injury (MSI)
Maximum Involuntary Contraction (MVIC)
Maximum Volume of Oxygen Consumption (VO2max)
Maximum Voluntary Contraction (MVC) 
Military Emergency Medicine (MEM)
Office of Human Research Protections (OHRP)
Office of the Chief Information Officer (OCIO)
Oxygen Saturation Percentage (SpO2)
Photobiomodulation Therapy/Treatment (PBMT) 
Photobiomodulation (PBM)
Physical Medicine & Rehabilitation (PM&R)
Point of Contact (POC)
Principal Investigator (PI)
Protocol Deviation (PD)
Quantile-Quantile (QQ)
Research Electronic Data Capture (REDCap)
Secure Access File Exchange (SAFE)
Secure Sockets Layer (SSL)
Serious Adverse Event (SAE)
Special Forces Group (SFG)
Special Operations Command (SOCOM)
Special Operations Forces (SOF) 
Tactical Human Optimization, Rapid Rehabilitation and Reconditioning (THOR3)
TLS (Transport Layer Security)
Ultraviolet (UV)
Unanticipated Problem Involving Risks to Subjects or Others (UPIRTSO)

Uniformed Services University (USU)
Uniformed Services University of the Health Sciences (USUHS)
United States Army Medical Research and Development Command (USAMRDC)
United States Army Special Operations Command (USASOC)
Visual Analogue Scale (VAS)
Watt (W)