Investigation of the Effectiveness of Shockwave Therapy, Photobiomodulation, and Physical Therapy in the Management of Non-insertional Achilles Tendinopathy
Phase: NA
Conditions: Achilles Tendinopathy
Sponsor: Musculoskeletal Injury Rehabilitation Research for Operational Readiness

DEFENSE HEALTH AGENCY
MADIGAN ARMY MEDICAL CENTER
9040 JACKSON AVENUE
TACOMA, WASHINGTON  98431-1100
1
MCHJ-MOE-C
                        
10 February 2023
MEMORANDUM FOR LTC Jeremy Schroeder, Principal Investigator at Madigan Army Medical 
Center
 
SUBJECT: Madigan Army Medical Center Institutional Review Board Expedited Review and 
Approval of Research Protocol Modification for “Investigation of the Effectiveness of 
Shockwave Therapy, Photobiomodulation, and Physical Therapy in the Management of Non-
insertional Achilles Tendinopathy” Protocol #223011
1.  The subject protocol has been reviewed for compliance with applicable human subject 
protection regulations by the Madigan Institutional Review Board (IRB). 
2.  The following documents were reviewed by the IRB Chair:
Submission Components
Form Name
Version
Outcome
EIRB Modification Form
Version 1.0
Acknowledged
EIRB Protocol Template
Version 1.4
Approved
Study Document
Title
Version #
Version Date
Outcome
Metzger_Elizabeth_CITI_OUSD_GCP 
FDA_Report_2026 01 26
Version 1.0
null
Acknowledged
COI - Cin
Version 1.0
null
Acknowledged
COI - McKee
Version 1.0
null
Acknowledged
COI - Stormer
Version 1.0
null
Acknowledged
COI - Hager
Version 1.0
null
Acknowledged
223011 Study Poster ERC 10Feb23
Version 1.0
null
Approved
MAMC Roles & Responsibilities
Version 1.4
null
Acknowledged
Appendix H Follow-Up Data Collection CRF
Version 1.1
null
Approved
Appendix D Baseline Data Collection CRF
Version 1.3
null
Approved
Appendix C Demographics CRF
Version 1.1
null
Approved
Appendix A Inclusion Exclusion CRF
Version 1.2
null
Approved
223011 Study Flyer Rev ERC 10Feb23
Version 1.3
null
Approved
3.  This protocol modification includes a revised protocol, Appendices A, C, D and H, study flyer 
and Roles and Responsibilities document, a new study recruitment poster, a request to add 
Nelson Hager, MD, Jonathan Stormer as Sub-Investigators, Samantha McKee and Honey Cin 
as Study Coordinators, adding Robert Rossi, Geoffery Gabler and Nana-King Karikari as Study 
Coordinators who now have EIRB access and to remove Sub-Investigator CPT Chalee Yimyam. 

SUBJECT: Madigan Army Medical Center Institutional Review Board Expedited Review and 
Approval of Research Protocol Modification for “Investigation of the Effectiveness of Shockwave 
Therapy, Photobiomodulation, and Physical Therapy in the Management of Non-insertional 
Achilles Tendinopathy” Protocol #223011
2
Changes include updating the protocol to the new template adding the use of a study poster for 
recruitment and administrative and editorial corrections.
4.  One (1) revised study recruitment flyer and one (1) study recruitment poster (stamped 
Approved 10 February 2023) have been issued. It is your responsibility to log into EIRB and 
print these versions of your flyer and poster for your use. Please note that only the IRB stamped 
version of this flyer and poster may be used in accordance with the IRB approved protocol and 
the advertising plan approved by the Public Affairs Officer, Madigan Army Medical Center.
5.  The IRB Chair approved the protocol modification in accordance with 32 CFR 
219.110(b)(1)(ii) effective 10 February 2023.
6. As a result of this protocol modification your study may require a revised Data Sharing 
Agreement (DSA) in accordance with DoDM 6025.18 and DoDI 8580.02. You must send the 
following documents to the Defense Health Agency (DHA) Privacy & Civil Liberties Office 
(PCLO) at dha.ncr.j-6.mbx.dsa-mail@health.mil to determine if a revised DSA is required.
                a. IRB Approval Letter (this letter)
                b. EIRB Protocol v1.4
7.  If at any time you have questions about your responsibilities as Principal Investigator, please 
contact the Madigan IRB office at 253-968-3524 for additional information. 
Signature applied by Walter James Sowden  on 
02/08/2023 11:39:59 PM CST
 
WALTER J. SOWDEN, PhD
LTC, MS
Chair, Institutional Review Board
Madigan Army Medical Center

EIRB Protocol Template (Version 1.4)
1.0
General Information
*Please enter the full title of your study:
Investigation of the Effectiveness of Shockwave Therapy, Photobiomodulation, and Physical 
Therapy in the Management of Non-insertional Achilles Tendinopathy
 
 
*Please enter the Protocol Number you would like to use to reference the protocol:
Photomedicine Project 10: SWT, PBMT, PT for Achilles Tendinopathy
* 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)?
Yes
 
 
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
P and R - Madigan Army Medical Center (MAMC)
 
3.0
Assign project personnel access to the project
3.1 *Please add a Principal Investigator for the study:
 
Schroeder, Jeremy Daniel, DO LTC
Select if applicable
Student
Site Chair
Resident
Fellow
 
3.2 If applicable, please select the Research Staff personnel:
 
A) Additional Investigators
Galvin, Joseph William, D.O. LTC 
 Associate Investigator
Grogan, Scott Patrick, DO, MBA LTC 
N

 Associate Investigator
HAGER, NELSON ALLEN 
 Associate Investigator
Konitzer, Lisa Nicole 
 Associate Investigator
Persinger, John Edward 
 Associate Investigator
Stormer, Jonathan David 
 Associate Investigator
B) Research Support Staff
Cin, Honey Lal Sui 
 Research Coordinator
GABLER, GEOFFREY MARK 
 Research Coordinator
Karikari, Nana-King Ahwoi 
 Research Coordinator
Lucio, Whitley B 
 Research Coordinator
MCKEE, Samantha Jade 
 Research Coordinator
Metzger, Elizabeth C 
 Research Coordinator
Ory, Rian Lyndzie, MS 
 Research Coordinator
Rossi, Robert M, MPH 
 Research Coordinator
3.3 *Please add a Protocol Contact:
 
Cin, Honey Lal Sui 
GABLER, GEOFFREY MARK 
HAGER, NELSON ALLEN 
Karikari, Nana-King Ahwoi 
Lucio, Whitley B 
MCKEE, Samantha Jade 
Metzger, Elizabeth C 
Ory, Rian Lyndzie, MS 
Rossi, Robert M, MPH 
Schroeder, Jeremy Daniel, DO LTC 
Stormer, Jonathan David 
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?
* 
Family Medicine
Orthopedics
Podiatry
Physical Therapy
Physical Medicine & Rehab
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.)
Hager, Nelson
Role on Protocol:
Associate 
Investigator
Phone Number:
425-218-1833
Email Address:
nelson.hager.
ctr@usuhs.edu
Associated 
Institution:
The Geneva 
Foundation / 
MAMC
Name:
(Last, First, M.I.)
Persinger, John
Role on Protocol:
Associate 
Investigator
Phone Number:
253-350-5075
Email Address:
jpersinger@genevausa.
org
Associated 
Institution:
The Geneva 
Foundation / 
MAMC
Name:
(Last, First, M.I.)
Gabler, Geoffrey
Role on Protocol:
Research Physical 
Therapist and 
Phone Number:
360-269-3443
Email Address:
ggabler@genevausa.
org
Associated 
Institution:
The Geneva 
Foundation / 
MAMC

Clinical Laser 
Safety Officer 
(CLSO)
Name:
(Last, First, M.I.)
Rossi, Robert
Role on Protocol:
Research 
Coordinator
Phone Number:
551-404-1923
Email Address:
rrossi@genevausa.org
Associated 
Institution:
The Geneva 
Foundation / 
MAMC
Name:
(Last, First, M.I.)
Cin, Honey
Role on Protocol:
Research 
Coordinator
Phone Number:
425-761-5507
Email Address:
hcin@genevausa.org
Associated 
Institution:
The Geneva 
Foundation / 
MAMC
Name:
(Last, First, M.I.)
McKee, Samantha
Role on Protocol:
Research 
Assistant II
Phone Number:
229-412-4567
Email Address:
smckee@genevausa.
org
Associated 
Institution:
The Geneva 
Foundation / 
MAMC
Name:
(Last, First, M.I.)
Karikari, Nana-
king
Role on Protocol:
Research 
Assistant
Phone Number:
253-228-7347
Email Address:
nkarikari@genevausa.
org
Associated 
Institution:
The Geneva 
Foundation / 
MAMC
Name:
(Last, First, M.I.)
Ory, Rian L.
Role on Protocol:
MIRROR 
Regulatory 
Affairs Manager
Phone Number:
909-904-5034
Email Address:
rian.ory.ctr@usuhs.edu
Associated 
Institution:
The Geneva 
Foundation / 
USUHS / MAMC
Name:
(Last, First, M.I.)
Lucio, Whitley B.
Role on Protocol:
Phone Number:
202-375-8831
Email Address:
whitley.lucio.
Associated 
Institution:
The Geneva 

MIRROR Sr. 
Regulatory 
Affairs & Data 
Manager
ctr@usuhs.edu
Foundation / 
USUHS
Name:
(Last, First, M.I.)
Metzger, Elizabeth
Role on Protocol:
MIRROR 
Scientific 
Program Manager
Phone Number:
252-562-2419
Email Address:
emetzger@genevausa.
org
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
Award Number 
HU00011920056
:
Research 
Development 
Testing and 
Evaluation (RDT&E) 
funds
Photomedicine
880567
Total amount of funding:
880567
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
MAMC
Lead site
FWA00003277
09/13
/2024
:
IAIR
:
RHC 
- P 
IRB
Army
FBCH
Performance 
site
FWA00017754
06/10
/2024
:
IAIR
:
RHC 
- P 
IRB
P&R
USUHS
Coordinating 
center
FWA00001628
09/14
/2024
:
IAIR
:
RHC 
- P 
IRB
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
Achilles Tendinopathy, Photobiomodulation, Shockwave, ESWT, Photomedicine, Military
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
Non-insertional Achilles Tendinopathy (AT) is a common overuse injury in adults who are both 
athletes and nonactive.
Tendinopathy occurs when there is either a failed healing response or 
1 
the failure of normal turnover or remodeling response, and results in pain and limited movement.
 AT contributes to between 6.2% and 9.5% of running injuries.  It’s been estimated in some 
2
3
studies that burden of AT may reach 52% lifetime prevalence in runners.  In the military, lower-
4
extremity injuries due to overuse, (e.g., AT) are the most common category of injuries, with the 
highest rates of these injuries occurring in the Army.  
5
The most common treatment of choice for AT is exercise loading programs, however eccentric 
strengthening (ECC) may only improve symptoms in approximately 60% of patients.  Laser-
1
induced photobiomodulation (PBM) has been shown to increase cell proliferation and metabolism, 
which may aid in the repair and remodeling process.
Studies have found that PBM was 
2,6 
effective in the treatment of AT, but it was more effective when paired with exercise sessions.
 
2,6
Extracorporeal shockwave therapy (ESWT or SWT) is a process in which energy is delivered to 
the muscles or tendons for pain relief.
A recent network meta-analysis showed that ESWT is 
7 
effective in treating AT when combined with ECC.  Moreover, a recent narrative review presented 
1
ESWT as an effective treatment for specific tendinopathies, including AT.
Notably PBMT was not 
8 
able to be compared in the analysis due to no published studies meeting criteria for inclusion. 
There is also limited information available on the best energy settings to be used in treating AT 
and the impacts on short term recovery;  therefore more research needs to be done into the 
1
impact of ESWT on treating AT. 
Photobiomodulation therapy (PBMT) and ESWT are effective tendinopathy treatments, and a 
study on the treatment of other tendons in the body - lateral epicondylitis (tennis elbow) - 
showed improvement in both the PBMT and the ESWT arms, with ESWT showing a significant 
difference in increasing handgrip strength.  Studies such as this are promising that ESWT and 
9
PBMT will be effective in treating other tendon injuries such as AT, however, these treatment 
methods have not been evaluated in comparison or combination with each other. Promising 
results from these studies combined with the previous unclarity in the best treatment for AT 
justifies the need for more research. 
This combination of treatment (SWT + PBMT) may provide improved healing over siloed 
modalities. ESWT works by creating microtears that in turn stimulate the body’s inflammatory 
response and healing cascade.  PBMT could then increase this cascade further by increasing the 
7
cellular function, particularly when the body is in an inflamed state, such as the state after ESWT.
Thus, this treatment combination should be explored.
2,6 
The sub-section of AT amongst Active-Duty (AD) personnel has had very limited research and 
given the high prevalence, should be addressed. Therefore, our study will compare four different 
treatment arms utilizing traditional physical therapy (PT), PT plus shockwave therapy (SWT), PT 
plus PBMT, and PT plus SWT and PBMT. Both self-reported questionnaires and measured 
outcomes will be used to assess the most effective treatment for AT.
9.3  
Objectives/Specific Aims/Research Questions:

1.  
Describe the purpose and objective(s) of the study, specific aims, and/or research questions
/hypotheses
The primary aim is to evaluate the effects of standard PT compared to PT with SWT, PT with 
PBMT, and PT with a combination of SWT and PBMT in the management of AT. We hypothesize 
servicemembers in each treatment allocation will see improvement in functional outcomes, pain 
and measures of Achilles tendon structure compared to baseline measures. As SWT and PBMT 
may change structural properties and modulate pain in tendinopathy, we anticipate greater 
measures in activity function for participants assigned to SWT and PBMT over PT as sole 
treatment. 
The secondary outcome will be to evaluate cross-over response. After the initial 3-month 
randomized control trial, participants who are not satisfied with results will be able to select a 
different treatment arm for the remaining 3 months of the study.
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
A Randomized Control Trial with Elective Cross-Over Design
9.5  Target Population:
Describe the population to whom the study findings will be generalized
Active-Duty Service Members (ADSMs) and the active civilian runner population
9.6  Benefit to the DoD:
State how this study will impact or be of benefit to the Department of Defense
AT is a common overuse running injury among ADSMs that can impact their combat readiness 
throughout their military career. Current rehabilitation treatment plans include ECC, but its 
success rate is limited leaving approximately 40% without full relief of pain and symptoms and 
decreased activity levels. The use of SWT, PBMT, or both SWT and PBMT along with physical 
therapy on ADSM with AT, may improve their recovery time. Faster healing translates to quicker 
return to higher level activities, return to duty (RTD), and ultimately mission ready status. 
10.0
 
Study Procedures, Data Management, and Privacy
10.1  Study Procedures:
Describe step-by-step how the study will be conducted from beginning to end
The study procedures will take place in the Physical Therapy, Sports and Exercise Medicine, and 
Orthopaedic and Podiatry Clinics.
Recruitment, Pre-Screening (before consent), Study Introduction & Informed Consent:
Potential participants will be identified via four methods:
Under the provisions of an approved Partial HIPAA Waiver Application for this study, local 
study team members will review medical records of patients coming in to the Sports 
Medicine, Physical Therapy, Orthopedic, Podiatry, and Physical Medicine & Rehabilitation 
(PM&R) clinics for suspected/confirmed AT in order to identify prospective research 

2.  
3.  
4.  
participants and to seek their authorization to participate/use their protected health 
information for this research study. The study team will receive approval from the 
potential participant's provider prior to approaching for possible study participation. 
Direct referral from local healthcare providers in the local Sports Medicine, Family 
Medicine, Orthopedic and Podiatry, Physical Therapy, Holistic Health and Fitness (H2F), 
and Physical Medicine & Rehabilitation (PM&R) clinics.
Patients may self-refer to participate in the study. Interested potential participants will be 
able to contact a member of the study team via email. Potential participants who contact 
the study team directly will be instructed to seek care with Physical Therapy or their 
primary care manager for a physical exam and diagnosis of AT, or confirmation of a 
previous AT diagnosis. The Physical Therapy Clinic is a direct access clinic that does not 
require a referral. 
Study advertisements will be posted within the following locations, and copies will be 
provided to clinic staff:
Internal Medicine
Aviation Medicine
H2F
McChord Clinic
Winder Clinic
Okubo SCMH
Allen Soldier -Center Medical Home
SRU
Puyallup Community Medical Home
South Sound Community Medical Home
Armed Forces Wellness Center
Intrepid Spirit Center
Madigan Medical Mall
Pharmacy waiting areas, if possible
Physical Therapy
Podiatry 
Sports Medicine 
THOR3 
Physical Medicine and Rehabilitation
Coffee bar
Dining Facility entrance
Intranet screen saver page 
2/75 Ranger Clinic
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 using the Inclusion/Exclusion Case Report Form (CRF) 
(Appendix A).
If the potential participant meets eligibility criteria as determined by the Inclusion/Exclusion CRF 
and expresses interest in participating, an authorized study team member will initiate the formal 
consent discussion and, if applicable, obtain informed consent.
Pre-screening conversations may also take place remotely, should a participant contact the study 
team, using the Screening Script (Appendix O). Potential participants who meet initial eligibility 
per the Screening Script and express interest in participating will be asked to come to clinic to 
complete an Inclusion/Exclusion CRF to confirm final eligibility with an authorized study team 
member prior to providing informed consent as outlined in the respective section below. 
Participants are enrolled once the consent process is completed.
Baseline Data Collection/Week 1 Visit 1 (post-consent):
Post-consent, secondary exclusion of pregnancy will be determined by a hCG test for women, 
which will be conducted by the lab, and completed prior to randomization.
Questionnaires: Prior to receiving their assigned study treatment, participants will provide their 
contact information (Appendix B Intake CRF) and complete demographic (Appendix C 
Demographics CRF) and study specific measures (Appendix D Baseline Data Collection CRF). 
Ultrasound: A study team member will assess ultrasound measures at baseline for both limbs. 
Measures of interest include cross-sectional area, width and degree of thickening within the 
tendon at site of maximal circumference and maximal pain, relative neovascularity, and 
elastography. A trained study team member will conduct the ultrasound. 

The participant will be prone with his/her feet overlying the edge of the bed with a pillow under 
the anterior ankle for comfort. The team member will scan initially in the longitudinal plane to 
identify the region of pathology near the avascular zone. The full interrogation should start at the 
gastroc-soleus junction and proceed distally to the Achilles insertion. Other pathology such as 
insertional tendinopathic changes, retrocalcaneal bursal changes, aponeurosis pathology, and 
Achilles tendon tears will be annotated if present. An ultrasound system capable of operating 
frequencies above 12 MHz will be used for the evaluation. Following the initial grey scale 
evaluation, color doppler with microvascular flow will be utilized in the area of interest to assess 
the relative level of hyperemia and neovascularity. The color doppler evaluation should be 
conducted in both orthogonal planes (transverse and longitudinal) at the area of maximal 
thickness/width. The relative level of neovascularization will be rated from grade 0: no visible 
vessels, grade 2: 3 to 5 vessels within the region of interest (ROI), grade 3: vessel’s in up to 
30% of the ROI. Following the color doppler evaluation, the elastography evaluation should be 
conducted in two orthogonal planes at the area of maximal thickness/width, IAW manufacture 
guidance on elastography image collections. 
The participant will be identified on the ultrasound system using only the assigned participant ID. 
This information will be included on the Baseline Data Collection CRF (Appendix D).These images 
will also be uploaded to the TeleRay data platform. More information in Managing Data Sections 
10.14-10.15. 
Function: Quantitative function in heel raises to fatigue will be measured at baseline on both 
limbs. Ankle strength will be graded (0 to 5). We will also ask the participants to complete 20 
single-leg hops on both legs and rate their pain using Defense and Veteran Pain Rating Scale 
(DVPRS) basic (i.e., DVPRS basic will be completed for both the right and left leg). Ankle-
dorsiflexion and plantar flexion range of motion (ROM), both active and passive, will be 
measured using a goniometer. This information will be included on the Baseline Data Collection 
CRF (Appendix D).
A study team member will also acquire measurements of the participant’s back of the knee and 
bottom of the leg, including the Achilles Tendon, to calculate the appropriate PBMT dose. (See 
Appendix N for PBM dosing information). These measurements will be included on the Baseline 
Data Collection CRF (Appendix D). The study team member will also indicate the participant’s 
Fitzpatrick Skin Phototype for PBM treatment on Appendix D. 
Randomization:
Participants will be randomly assigned to one of 4 study groups (PT only, PT + SWT, PT + PBMT, 
or PT + PBMT + SWT) using a computer-generated randomization model prepared by the study 
biostatistician.
Study treatments (PT only, PT + SWT, PT + PBMT, PT + SWT + PBMT): 
This study has been split into two parts. Part 1 is the initial randomized control trial, and Part 2 is 
when the participants can select the treatment they want to receive if they are dissatisfied with 
their initial treatment. Participants cannot/will not be blinded to the treatment arm that they 
receive due to the obvious differences in the treatments.
Part 1 
All participants may complete a PT program as standard of care (SoC) treatment addressing 
individual strength, mobility, and flexibility deficits in both proximal (e.g., spine and hip girdle) 
along with distal (thigh, leg and foot/ankle) muscle groups. The provider may also use other 
modalities to address distal issues. The PT treatment received as SoC is not a study-specific 
research procedure; however, physical therapy care provided will be tracked by a chart review 
(Appendix G).
If a participant has not been placed on profile at the time of consent, a profile may be written by 
the study medical provider to ensure limitation of activities, as medically appropriate.
In order to standardize the loading program for study participants, we will provide all participants 
with an at-home exercise program designed by Dr. Karin Silbernagel for progressive Achilles 
tendon loading.
This will be completed alongside the standard of care PT they are receiving. 
10 
Activities including running will be allowed as tolerated following published guidelines by Dr. 
Silbernagel.
 This treatment protocol consists of four phases that last 12 weeks to 6 
11,12,13
months. The first phase includes a circulation exercise and various forms of toe raises. Phase two 
increases the intensity of the various toe raise exercises, and in phases three and four plyometric 
activities are added. Participants are expected to exercise every day for the first 12 weeks and 
then can decrease to 2-3 times per week thereafter, up to 6-months. The at-home exercise 
program instructions are outlined in participant handout Appendix J Silbernagel Guidelines. 

All participants will also follow the University of Delaware Return to Sport protocol for returning 
to running (Appendix K). 
All activities, including home exercises and running, pain, and pain medications taken, will be 
recorded by the participant daily in a log (Appendix E). 
If a study participant has bilateral AT, the leg with the most severe symptoms [determined by 
the Victorian Institute of Sports Assessment – Achilles (VISA-A) in the Data Collection CRF; more 
information regarding the VISA-A in Section 10.2] will be chosen as the primary data point for 
the study. However, both legs will be treated consistently according to the treatment group the 
participant was randomized into. 
Physical Therapy (PT) Only Arm
Participants in the PT only arm will follow the PT program outlined above. Twice a week for 
three weeks, a team member will check-in with the participants to ensure physical therapy 
exercise adherence, and response to treatment. During the second check-in of the week, the 
study team member will also ensure the participant is keeping their activity/medication/pain 
log; the study team member will also deliver the DVPRS with supplemental questions. (See 
Appendix F for Check-in Data Collection CRF). These check-ins may occur virtually or in-
person.  
In Part 1, the 
 arm requires 8 visits. The participants will complete 2 
physical therapy only
check-in visits each week (remote or in person), for three weeks. Follow-up data will be 
collected at 6 weeks (virtual or in-person) and at 3 months (in-person).
PT + Shockwave Therapy (SWT) Arm:
The 
 arm will receive SWT once a week for three weeks 
physical therapy + shockwave therapy
in addition to the PT treatment described above. Twice a week, for three weeks, a team 
member will check-in with the participants to ensure physical therapy exercise adherence, 
and response to treatment. During the second check-in of the week, the study team member 
will also ensure the participant is keeping their activity/medication/pain log; the study team 
member will also deliver the DVPRS with supplemental questions. (See Appendix F for Check-
in Data Collection CRF). The first check-in of the week will occur in-person after the SWT, if, 
however, this is not feasible, it may be conducted virtually; the second check-in of the week 
may occur virtually or in-person.  
In total, participants will receive one SWT treatment each week (in person) and complete two 
check-ins each week (remote or in person), for three weeks. The SWT will take 
approximately 5-20 minutes. 
A medical provider will conduct SWT on study participants, using the OrthoPlus Ultra 100
/radial D-Actor. (See OrthoPulse Radial Edition Application Brochure and OrthoPlus Ultra 100 
Operations Manual). This Extracorporeal Pressure Activation Treatment (EPAT) device will be 
used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with 
a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 
counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over 
symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to 
proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force 
applied by applicator head by patient comfort. The maximum setting for each treatment 
applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be 
applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The 
settings used for each participant will be recorded and followed in a similar approach to 
treatment.  
A CuraMedix representative will provide training to the study team for this machine. 
In Part 1, participants in this group will have 8 visits: 3 combined SWT and check-ins post-
treatment (in person), 3 check-in only visits (remote or in person), 6-week follow-up (virtual 
or in-person), and 3 month follow-up (in person). 
PT + Photobiomodulation Therapy (PBMT) Arm: 
The 
 arm will receive PBMT twice a week, for 
physical therapy + photobiomodulation therapy
three weeks, in addition to the PT treatment described above. 

A member of the study team will measure the treatment area according to a standard 
protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, 
approximately 5-20 minutes. PBMT will be delivered at 25W. 
The 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® XPi 
25W device with the Smart Hand Piece technology, provided 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® XPi 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 10 J/cm
and applied in a serpentine 
2 
pattern to the calf from the fold in the back of the knee to the bottom of the leg including 
distal Achilles tendon and calcaneus. The setting for treatment will be adjusted for skin 
pigmentation using the Fitzpatrick Scale and values recorded for each participant.
After each PBMT visit (twice a week, for three weeks), a team member will check-in with the 
participants to ensure physical therapy exercise adherence, and response to treatment. 
During the second check-in of the week, the study team member will also ensure the 
participant is keeping their activity/medication/pain log; the study team member will also 
deliver the DVPRS with supplemental questions. When/if needed, check-ins may occur 
virtually. (See Appendix F for Check-in Data Collection CRF). 
In Part 1, participants will receive PBMT twice each week, for three weeks. The PBMT 
treatment arm requires 8 visits: 6 combined PBMT and check-ins (in person), 6-week follow-
up (virtual or in-person), and 3-month follow-up (in person).
PT + SWT and PBMT Arm
The 
 arm will receive 
physical therapy + shockwave therapy + photobiomodulation therapy
both SWT and PBMT treatments in addition to PT treatment described above. The SWT and 
PBMT will be performed by a trained study team member. Participants will receive PBMT twice 
each week and SWT one time each week, for three weeks. The SWT visit may be combined 
with a PBMT visit in the same week. Up to two times each week after a treatment visit (for 
three weeks), a team member will check-in with the participants to ensure physical therapy 
exercise adherence, and response to treatment. During the second check-in of the week, the 
study team member will also ensure the participant is keeping their activity/medication/pain 
log; the study team member will also deliver the DVPRS with supplemental questions. When
/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection 
CRF). 
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check-
ins (in person), 3 for PBMT & SWT with check-ins (in person), 6-week follow-up (virtual or in-
person), and 3-month follow-up (in person).
Part 2
At the 3-month follow-up, participants who are not satisfied with their current treatment 
response will be given the option to choose any one of the remaining treatment arms. 
Participants will also have the option to decline further treatment. Any biological female of child 
bearing age and capacity that opts to receive treatment with SWT and/or PBMT will be required 
to complete a urine hCG test prior to receiving treatment in Part 2 of the study.
For all groups in Part 2, the number of non-PT study treatment visits the participants will need to 
complete will be dependent on which treatment arm the participant selects; however, regardless 
of what treatment the participant chooses, if any, the participant will be required to complete at 
least one in-person visit at the 6-month follow-up. 
Follow-Up Data Collection:
Regardless of study arm assignment, all participants will be asked to log their activity, pain, and 
medication intake (Appendix E), daily for 12 weeks. This log will be collected/checked weekly for 
the first 3 weeks and then at the 6-week and 3-month follow-up visits.

Check-ins (remote or in person, as applicable/convenient) will be conducted twice a week for the 
first three weeks. Any issues with treatment will be recorded on Appendix F Weekly Check-In 
CRF. In addition, once a week, for the first 3 weeks, the DVPRS with supplemental questions will 
be administered.
A chart review will be completed at 3 months to ensure that all PT visit information is recorded in 
study documentation (Appendix G). A medical record review will be completed to obtain this 
information. A study visit is not required on behalf of the participant.
A self-report battery will be obtained for each Achilles tendon, regardless of treatment, using 
Appendix H Follow-Up Data Collection CRF, which will be administered at 3-weeks, 6-weeks, 3-
months, and 6-months post-intervention start.
Participants will complete the ultrasound imaging, heel raise test, ankle strength and ROM, 
hopping test, and be asked to complete a patient satisfaction and expectation survey at the 3-
month and 6-month timepoints. 
Participants will be evaluated for adverse events at each follow-up time point and any 
complications will be documented.
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.). Reminder phone calls, texts, and/or emails will be sent to participants at their 
preferred contact method indicated on the Intake Form (Appendix B).
Please see the Study Flow Diagram (Appendix L) for a visual representation of the study 
procedures.
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.
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.
Questionnaires:
The Demographics CRF (Appendix C) and the Data Collection CRF (Appendix D) will be 
used to will be used to obtain demographic information, Fitzpatrick Skin Phototype, and 
foot, ankle, and calf measurements for PBMT dosage calculation. The Fitzpatrick Skin 
Prototype is a rating of susceptibility to skin damage from ultraviolet (UV) radiation.
Symptoms severity specific to Achilles will be Victorian Institute of Sports Assessment – 
Achilles (VISA-A) 
The VISA-A is currently the only valid and reliable measure to assess function and 
pain in AT (validity, 
; test-re-test reliability, 
)
P<0.01
r = 0.98
Patient-Reported Outcomes Measurement Information System 
 will be used 
(PROMIS-29)
to capture other aspects of non-disease specific measures of health-related domains 
(physical, mental and social health). 
The University of Wisconsin Running Injury and Recovery Index 
will measure 
(UWRI)
aspects unique to returning to running. 
Defense and Veteran’s Pain Rating Scale 
will capture pain; basic applied after 
(DVPRS)
hop test and supplemental provided at each visit. 
Lower Extremity Functional Scale 
will capture functional status. 
(LEFS) 
To quantify patient choice and motivation for treatment, an unvalidated survey will be 
obtained to determine patient goals of enrollment in study and reason for selecting a 
different intervention, and patient satisfaction with treatment. 

Ultrasound: Ultrasound measures will be assessed at baseline, 3 months and 6 months. 
Measures of interest include cross-sectional area, width and degree of thickening within the 
tendon at site of maximal circumference and maximal pain, relative neovascularity, and 
elastography. 
Function: Quantitative function in heel raises to fatigue, and ankle strength and ROM, will be 
measured at baseline, 3 months and 6 months on both limbs. We will also ask the participants to 
complete 20 hops and rate their pain using the Defense and Veteran’s Pain Rating Scale 
(DVPRS). 
Return to activity: We will be asking participants to record their return to activity, tracking the 
date, exercise and pain level and medication use using the training diary.
A chart review will be conducted at the end of 3 months to capture all PT visits.
Check-ins will be conducted to ensure at home exercise adherence and address any rehabilitation 
issues; weekly the DVPRS with supplemental questions will be delivered (Appendix F). 
Study Visits for all treatment arms:
An overview of the questionnaires and measurements that will be taken at various time points, 
regardless of treatment arm, are described in the Data Collection Schedule (see Appendix T).
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
10.4  Review the definitions below and respond to the following two questions.  If you are not sure of the 
answers, email 
 for assistance.
DHA.PrivacyBoard@mail.mil
   The 
 is 
Military Health System (MHS)
defined as all DoD health plans and DoD health care providers that are organized under the 
management authority of, or in the case of covered individual providers, assigned to or employed by, 
  
the Defense Health Agency (DHA), the Army, the Navy, or the Air Force  
 
MHS workforce members
are employees, volunteers, trainees, and other persons whose conduct, in the performance of work 
  
for the MHS, is under the direct control of the MHS, whether or not they are paid by the MHS.  MHS 
 are persons or entities that provide a service to the MHS and require protected 
business associates
health information (PHI) to provide the service.
Are you an MHS workforce member?
Yes, I am an MHS workforce member 
No, I am not an MHS workforce member 
Are you an MHS business associate?
Yes, I am an MHS business associate 
No, I am not an MHS business associate 
10.5  Have you consulted with an MHS data expert to determine the data elements required for your study?
Consulting with a data expert often saves time later in the compliance process because the data 
expert can advise on the data available in the numerous MHS information systems, the quality of 
that data and the methods for encrypting and collapsing data.  To schedule a consult with an 
MHS data expert, send an email to: (
)
DHA.PrivacyBoard@mail.mil
Yes, then complete the questions below according to the data consult 
No, then complete the questions below according to the best of your knowledge 
10.6  Indicate how you will request data from the MHS.  Select all that apply.
Talking with MHS health care providers or MHS health plans about specific research 

participants
Obtaining MHS hard copy records specific to research participants
Obtaining data from an MHS information system(s)
10.7  If you are obtaining data from an MHS information system(s), indicate whether you plan to receive a 
data extract or whether you plan to access an MHS information system directly to create a data set.
A data extract is when the MHS or a contractor provides the data set directly to the 
researcher.  When receiving a data set through data extract, the researcher may indicate 
whether the data elements should be provided as is, encrypted or collapsed.  In contrast to a 
data extract, access to an information system means that the researcher may directly access an 
MHS information system and create a data set for the research study
Data Extract
Access
10.8  Do you intend to request de-identified data from the MHS in your research study? 
There are different two methods for de-identifying data pursuant to HIPAA:
1) Safe Harbor Method: Removing all of the identifiers listed in Table 1 below, provided that the 
researcher does not have actual knowledge that the remaining data can be used alone or in 
combination with other information to identify the individual who is the subject of the information
2) Statistical Method: An expert, with appropriate knowledge of and experience with generally 
accepted statistical and scientific principles and methods for rendering information not 
individually identifiable, determines that the data is not individually identifiable
  Yes   
  No
10.9  Indicate the MHS information system(s) from which you will seek to obtain data
If you do not know which system(s) contains the data elements you need, refer to the Guide for 
DoD Researchers on Using MHS Data or request guidance from an MHS data expert at: DHA.
.
PrivacyBoard@mail.mil
 
Below is a list of commonly used MHS systems. If the system from which you seek to obtain 
data is not listed below, list the name of the system in the “Other MHS Systems” category below
PHI Systems:
MHS Information System
Requesting Data
:
AHLTA
:
Yes
:
CHCS
:
Yes
PII-Only Systems:
MHS Information System
Requesting Data
No records have been added
De-Identified Data & Other Systems:
Information System
Requesting Data
Other MHS System (May include PII and/or 
PHI)
List other system here:
Genesis
:
Yes

10.10  Do you intend to merge or otherwise associate the requested data with data from any sources 
outside of the MHS, including other DoD systems that are not part of the MHS?
Yes, will merge data  
No, will not merge data 
10.11  Indicate the data elements about research participants or relatives, employers, or household 
members of the research participants that you will request from MHS hard copies or from MHS 
information systems. 
If you will merge data, also indicate non-MHS data elements about research participants or 
relatives, employers, or household members of the research participants that you will have access 
to in any form or medium.
Direct and 
Indirect 
Identifiable Data 
Elements
DHA Hard 
Copies
DHA Data 
Elements 
to be 
Accessed
DHA Data 
Elements 
Verbal
Extracted 
DHA Digital 
Data
Downloaded 
DHA Digital 
Data
Non-DHA 
Hard 
Copies or 
Digital
1.  Names 
2.  Postal 
address with 
only town, 
city, state, 
and zip code 
3.  Postal 
address with 
all geographic 
subdivisions 
smaller than 
state, 
including 
street 
address, city, 
county, 
precinct, zip 
code and their 
equivalent 
geocodes, 
except for the 
initial three 
digits of a zip 
code if, 
according to 
the current 
publicly 
available data 
from the 
Bureau of 
Census: 1) 
the 
geographic 
unit formed by 
combining all 
zip codes with 
the same 
three initial 
digits contains 
more than 
20,000 
people; and 2) 

the initial 
three digits of 
a zip code 
from all such 
geographic 
units 
containing 
20,000 or 
fewer people 
is changed to 
000
4.  Dates 
including all 
elements 
(except year) 
directly 
related to an 
individual, 
including 
birthdate, 
admission 
date, 
discharge 
date, and date 
of death 
5.  Ages over 
89 and all 
elements of 
dates 
(including 
year) 
indicative of 
such age, 
unless you will 
only request a 
single 
category of 
“age 90 or 
older” 
6. Telephone 
Numbers
7.  Fax 
Numbers 
8.  Email 
Addresses
9.    Social 
Security 
Numbers
10.   Medical 
Record 
Numbers 
(MRN) 

(including 
record ID)
11.   Health 
Plan 
Beneficiary 
Numbers  
(including 
DEERS ID, 
Electronic 
Data 
Interchange 
Personal 
Identifier 
(EDIPI) or 
Number 
(EDIPN))
12.   Account 
Numbers 
13.   Certificate
/License 
Numbers 
14.   Vehicle 
identifiers and 
serial 
numbers, 
including 
license plate 
numbers 
15.   Device 
identifiers and 
serial numbers 
16.   Web 
Universal 
Resource 
Locators 
(URLs) 
17.   Internet 
Protocol (IP) 
address 
numbers 
18.   Biometric 
identifiers, 
including 
finger and 
voice prints 
19.   Full-face 
photographic 
images and 

any 
comparable 
images
20.   Any 
other unique 
identifying 
number, 
characteristic, 
or code 
(including non-
military 
provider IDs)
21.   Free Text 
Fields
If you are obtaining SSNs, provide a justification as to why and explain why a substitute cannot 
be used.
Due to guidelines stated within DoDI 1000.30, Reduction of SSN Use within DoD, the reduction 
or elimination of SSN usage must occur wherever possible. If SSNs are required to complete the 
project, the PI must provide a justification and explanation as to why a substitution cannot be 
used.
For example:
• If alternatives to SSN (e.g., EDIPNs or pseudo person IDs) are sufficient in other instances, 
will those alternatives to SSN usage be sufficient to respond to Congressional inquiries and
/or Senior DoD stakeholders inquiries?
• Are alternatives to SSN used first?
• Are those alternatives to SSN insufficient to combine data from multiple data sources? Is 
the issue that some individuals do not possess alternatives ID numbers and SSN is the only 
way to identify them?
N/A
a. Will you receive or obtain health information?
Note: If you indicate you are not receiving health information, the answer 
must be consistent with the DHA data source. For a non-health 
information data request, if you are a non-MHS employee or non-MHS 
business associate, you may not access an information system that has 
PHI or LDS. For both MHS and Non-MHS employees and MHS business 
associates, you may 
 include data elements in the above table on: 
NOT
1)  lines 10 or 11, 2) line 21 if the free text field comes from a PHI or LDS 
system, and 3) lines 12, 13, or 18 if the account numbers, certificate and 
license numbers, biometric data, or any other data elements are health 
information created or received by an MHS health care provider, health 
plan, or business associate in relation to the physical or mental health or 
condition of an individual or payment for health care.
Yes, I will receive or obtain health information 
No, I will not receive or obtain health information 
b. If no data elements were checked in the above table, is it possible that the requested DHA 
data is or will be identifiable because of any unique data elements, triangulation, or small cell 
size?  
Data elements were checked in the above table, STOP HERE.
NOTE: A unique data element includes any unique features that alone are not identifiable but 
that could be used to identify an individual within the context of other information, such as any 
type of code (such as diagnosis or procedural), rank of general or admiral, gender, or race. 

Triangulation means using different data elements that when combined can be used to identify 
an individual, such as including the above lists of unique data elements in a data set. 
Determining whether an individual is identifiable through triangulation requires consideration of 
all data elements in combination. Within the military, the use of rank and/or diagnosis code, 
procedural codes, or any other code that changes on a predictable basis, increases the possibility 
of identification. Small cell size means that there is only a small number of eligible individuals 
that satisfy the category description. Department of Defense Manual 6025.13, Medical Quality 
Assurance and Clinical Quality Management in the Military Health System MHS, provides that the 
threshold for de-identifying data within the MHS requires a cell size of three, but also states that 
the de-identification standards must meet the DoD implementation of the HIPAA Privacy Rule. 
Centers for Medicare and Medicaid also gives guidance on small cell size stating that no data cell 
less than 11 may be published or displayed. However, the Office for Civil Rights’ OCR, which is 
the official regulatory office for the HIPAA Privacy Rule, provides that OCR does not designate a 
universal value for small cell size in accordance with the de-identification standard; instead, the 
cell size should be set at a level that is appropriate to mitigate risk of identification by the 
anticipated recipient of the data set. This means that a cell size of 3 or 11 may not meet the 
HIPAA Privacy Rule requirements if the cell size level does not appropriately mitigate risk of 
identification by the anticipated recipient of the data set.
Note: If dates are altered as a means of de-identifying the data, diagnosis and 
procedural codes need to be rolled-up or collapsed. If dates are provided “as time 
between events,” the roll-up is not necessary.   
Yes, the DHA data will become identifiable
No, the DHA data will not become identifiable
10.12  Do you believe it is possible for the MHS data to become identifiable because of triangulation, a 
small cell size, or any unique data element(s)?
Triangulation means using different data elements that are not themselves identifiable but that 
when combined can be used to identify an individual. For example, triangulation would use rank 
and race together to determine the identity of an individual with a particular health condition.
 
Small cell size means that there is only a small number of eligible individuals that satisfy the 
category description. Guidance for acceptable cell size is available from the Centers for Medicare 
and Medicaid Services. For example, the rank category of four star generals with a particular 
diagnosis may be less than 30, so the rank category may need to be expanded to include lower 
ranks.
 
A unique data element includes any unique features that are not explicitly enumerated in the 
categories of data in rows 1 – 20 of the table above (in Section 10.10), but that could be used to 
identify an individual. Unique data elements include characteristics that are not themselves 
identifying, such as the rank of general or admiral, or a race or gender, but within the context of 
other information could be identifiable.
Yes, I believe there is a reasonable possibility the MHS data will become identifiable 
No, I believe there is no reasonable possibility the MHS data will become identifiable 
10.13  Have you completed and uploaded an appropriate HIPAA document ( i.e. HIPAA Authorization will 
be obtained or Waiver/alteration of HIPAA Authorization is being requested)?
Yes 
No 
N/A 
If yes, please check which one.
HIPAA Authorization 
HIPAA Waiver (Full or Partial) 
Other (please provide copies when uploading Other Study Documents) 
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 study data directly from the study participant (including in 
person, via mail or email, or over the phone), from their attending provider(s), clinical 
evaluations or, where applicable, from the participant’s medical record (i.e., relevant medical and 
treatment history and relevant clinical notes) and record it on study Case Report Forms (CRFs). 
(See Appendices A-I). 
The completed CRFs will serve as source documents for this study. Other source documents 
include relevant clinical notes, imaging, and/or test results which, if applicable, will be redacted 
and stored in the participant’s research file.
Participants may also enter their coded data directly into REDCap using a personalized survey 
link (no log-in required). In these cases, the completed REDCap questionnaire(s) will be printed 
and added to the participant’s research record as a source document.
Electronic Data Entry:
Following each research visit, a local study team member will review any completed paper CRFs 
for accuracy and completeness and then enter the collected non-personally identifiable data from 
the paper CRFs into REDCap, an encrypted, access controlled, password protected electronic data 
capture and management system housed on a Department of Defense (DoD) server and 
maintained by the Uniformed Services University Information Technology (USU IT).
Please see Appendix R for additional information on REDCap.
Ultrasound images will also be uploaded to TeleRay, more information is outlined below.
Data Storage & Access:
With the exception of the Informed Consent Form, HIPAA Authorization, Intake CRF, and 
electronic Master List, all research data (both paper and electronic) will be identified using a 
unique study ID only, and not by the participant’s name, date of birth, DoD ID, or other 
protected identifier.
Paper research forms and source documents will be stored in a locked cabinet inside of a locked 
room within the Sports Medicine Clinic at Madigan.
Ultrasound images will be uploaded to TeleRay. Teleray ensures that all accounts stored in 
Microsoft Azure’s self-healing network with advance security protocols enabled and is only 
located in the USA Secure Connection: The sessions established are secure (with secured tokens 
that are regenerated). Random AES keys are generated by clients at the beginning of the media 
connection and, to increase security, additional keys are generated periodically throughout the 
session. TeleRay employs Transport Layer Security (TLS) to encrypt video data. The core 
protocols used are Secure Real-time Transport Protocol (SRTP) for media traffic encryption and 
Datagram Transport Layer Security (DTLS)-SRTP for key negotiation, both of which are defined 
by the Internet Engineering Task Force (IETF). The endpoints use Advanced Encryption Standard 
(AES) cipher with 256-bit keys to encrypt audio and video, and Hash-based Message 
Authentication Code- Secure Hash Algorithm 1 (HMAC-SHA1) to verify data integrity. No PHI/PII 
will be entered into TeleRay. Access to the coded data uploaded to TeleRay will be controlled and 
managed by the local MAMC research team.
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 
Department of Defense (DoD) server and maintained by the Uniformed Services University 
Information Technology (USU IT). No PHI/PII will be entered into REDCap.
This coded electronic research data will be accessible by authorized staff from 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) and is serving as the data coordinating center for this research study. 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. 
The local study team will maintain a separate electronic master list which matches unique study 
IDs with participant identifying information. The electronic master list will be stored 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.
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 and TeleRay 
only, as described above), the IRB of record, the local research office (if applicable), 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.
Informed Consent Forms and HIPAA Authorizations 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.
De-identified data will be shared with Spaulding Rehabilitation Network/Massachusetts General 
Hospital implementing a parallel study at a civilian hospital.
Appropriate data sharing agreements in place.
Is this a data repository?
 Yes   
 No
If Yes, provide name of the Repository.
USU OCIO REDCap; TeleRay
Who will have access to the Repository?
Study investigators, study team members, and MIRROR Core team members, as appropriate.
What data type will be stored in the Repository?
PHI
LDS
De-identified Data
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.
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 practical to maintain.
The de-identified data uploaded to TeleRay will be maintained by the local research team 
indefinitely, or as long as it is practical to maintain, and while funding is allotted for this service.
De-identified electronic research data will be securely transmitted from local study teams to the 
MIRROR /USU via REDCap, TeleRay, or the DoD SAFE application (or other comparable safe data 

sharing system implemented by the local site and/or the US Army/DHA). REDCap utilizes Secure 
Sockets Layer (SSL) in addition to other safeguards on its web server to maintain secure 
communication with end-users (see Appendix R). DoD SAFE uses a TLS (Transport Layer 
Security) protocol when files are uploaded and downloaded. TeleRay employs Transport Layer 
Security (TLS) to encrypt video data. The core protocols used are SRTP for media traffic 
encryption and DTLS-SRTP for key negotiation, both of which are defined by the IETF. The 
endpoints use AES cipher with 256-bit keys to encrypt audio and video, and HMAC-SHA1 to 
verify data integrity.
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 Department of Defense (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.
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.
Consent for Future Use:
The Informed Consent Form for this research study states that de-identified research data will be 
shared with MIRROR/USU and maintained indefinitely for possible use in future research. By 
consenting to participate in this research study, participants agree to allow us to maintain their 
de-identified research data indefinitely for possible use in future research.
Participants will not be given the option to opt out of us retaining their de-identified research 
data indefinitely for possible future use. The consent form 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."
Data Withdrawal from Storage:
Participants may request to have their data (including ultrasound images) withdrawn at any time 
before their personal identifiers have been removed. Once their data has been de-identified, 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; TeleRay
Who will have access to the Repository?
Study investigators, study team members, and MIRROR Core team members, as appropriate.
What data type will be stored in the Repository?
PHI
LDS
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. 
Outliers will be removed if determined to be erroneous based on relevant clinical expertise. Data 
will be analyzed on a complete-case intention-to-treat (ITT) basis. Confounding will be principally 
controlled by randomization. In order to increase the precision of our estimates, we may also 
statistically adjust for patient demographics and relevant clinical variables if warranted based on 
statistical best practices. 
Methods to be used for the Primary Aim: Time-to-event analyses (return to activity) will use 
survival analysis. All other outcome measures (including our primary outcome measure (VISA-A) 
and other aforementioned secondary outcome measures such as functional testing, ultrasound 
measures, etc.) will be analyzed using generalized additive models predicting change in each 
outcome measure by treatment group at 3 months. Sensitivity analyses for non-time-to-event 
outcome measures will be performed to evaluate trends by treatment group and will use 
longitudinal hierarchical/multilevel models incorporating random effects to account for repeated 
measures.
Methods to be used for the Secondary Aim: Due to the lack of washout period between initial and 
cross-over periods, as well as the removal of patient blinding (patients may choose the specific 
treatment they wish to receive during this final 3-month period), cross-over response will be 
analyzed as an exploratory aim versus an inferential aim. Due to the exploratory nature of this 
aim, additional or adjusted analyses may be performed to best explore and evaluate the data 
collected. Generalized additive models will be used to explore cross-over results and a limited set 
of measures will be explored (patient satisfaction, functional tests, ultrasound measures).
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 
QQ plots analyzed for best model fit. All statistical analyses will be performed using the R 
Programming language.
11.2  Sample Size:
We are requesting to enroll 160 total participants (40 per initial treatment arm) after adjusting 
for screen failures and attrition for a final sample of at least 112 (28 per initial treatment arm). 
35 patients in each initial treatment group (140 patients total) will achieve 90% power to detect 
an effect size of 16 points. 30 patients in each initial treatment group (120 patients total) will 
achieve 90% power to detect an effect size of 17 points. 25 patients in each initial treatment 
group (100 patients total) will achieve 90% power to detect an effect size of 18 points. Effect 
size for the purpose of power calculations was defined as the difference between VISA-A at 3 
months between PT only and PT + Additional Treatment (assumptions were based on PT + PBMT 
due to availability of comparable historical research), with statistical significance defined as α = 
0.05.
11.3  Total number of subjects requested (including records and specimens):
160
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 all performance sites, up to 160 participants will be randomized 1:1:1:1 to the four initial 
treatment arms (40 participants per arm)
11.5  Please provide a justification for your sample size

Power was calculated using repeated Monte Carlo Markov Chain simulations predicting 3-month 
VISA-A between treatment arms, and sourced assumptions of mean and spread from Tumilty et 
al (2016). MCID was considered to be a 6.5 point difference in VISA-A
.
14
11.6  Data Analysis Plan: Complete description: Background, Objectives, Design, Step by Step how the 
project is going to be done, Data analysis plan:
Outliers will be removed if determined to be erroneous based on relevant clinical expertise. Data 
will be analyzed on a complete-case intention-to-treat (ITT) basis. Confounding will be principally 
controlled by randomization. In order to increase the precision of our estimates, we may also 
statistically adjust for patient demographics and relevant clinical variables. 
Methods to be used for the Primary Aim: Time-to-event analyses (return to activity) will use 
survival analysis. All other outcome measures (including our primary outcome measure (VISA-A) 
and other aforementioned secondary outcome measures) will be analyzed using generalized 
additive models predicting change in each outcome measure by treatment group at 3 months. 
Sensitivity analyses for non-time-to-event outcome measures will be performed to evaluate 
trends by treatment group and will use longitudinal hierarchical/multilevel models incorporating 
random effects to account for repeated measures. Analyses under the primary aim will use the 
initial 3-month cohort only. 
Methods to be used for the Secondary Aim: Due to the lack of washout period between initial and 
cross-over periods, as well as the removal of patient blinding (patients may choose the specific 
treatment they wish to receive during this final 3-month period), cross-over response will be 
analyzed and treated as an exploratory aim versus an inferential aim. Due to the exploratory 
nature of this aim, additional or adjusted analyses may be performed to best explore and 
evaluate the data collected. Generalized additive models will be used and a limited set of 
measures will be explored (patient satisfaction, functional tests, ultrasound measures).
Hypothesis tests will be two-tailed and statistical significance will be considered at the putative 
threshold (alpha=0.05). P-values (outside of analysis of primary outcome) 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 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:
DEERS eligible, adult (between the ages of 18-64, inclusive), active-duty Service members 
diagnosed with AT. 
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+
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 
DEERs Eligible 
 
2 
Between ages of 18-64 (inclusive) years old 
 
3 
Currently AD in any of the US Armed Forces 
 
4 
Clinical diagnosis of mid-portion Achilles tendinopathy (including both unilateral 
and bilateral) by a healthcare provider based on accepted diagnostic criteria 
 
5 
Able to read and understand English language for consent purposes 
 
6 
Able to commit to 3-weeks of intervention and 6-months of follow-up
 
12.6  Exclusion Criteria:
Order 
Number
Criteria
1 
Primary insertional Achilles tendinopathy
 
2 
Platelet Rich Plasma (PRP), corticosteroid injection, or prolotherapy within 3 
months
 
Received dry needling within the past 4 weeks 

3 
 
4 
Previously completed the Silbernagel protocol for Achilles tendinopathy within the 
past 3 months
 
5 
Received SWT within the past 3 months to their Achilles
 
6 
Tattoo in the area of treatment (due to sensitivity to PBMT)
 
7 
Current use of pacemaker
 
8 
Patients with a known underlying cardiac disease that could be affected by 
shockwave therapy 
 
9 
Patients with neuropathy affecting sensation to pain 
 
10 
Current use of medications associated with sensitivity to heat or light (e.g., 
amiodarone, chlorpromazine, doxycycline, hydrochlorothiazide, nalidixic acid, 
naproxen, piroxicam, tetracycline, thioridazine, voriconazole)
 
11 
Current or chronic sciatica (lumbosacral radiculopathy) resulting in chronic or 
intermittent lower extremity pain, numbness, or tingling
 
12 
Achilles tendon tear or prior Achilles tendon surgery
 
13 
Recent lower extremity injury within the last 3 months that required professional 
medical attention (e.g., ankle sprain, meniscus)
 
14 
Concurrent participation in another research study addressing pain issue
 
15 
Previously enrolled in the study for contralateral (opposite) leg
 
16 
Currently pregnant or plan to become pregnant during intervention period (safety 
of PBM not established in pregnancy) as determined by hCG urine test
 
17 
Diagnosis of rheumatological disease/connective tissue condition, symptomatic 
arthritis of foot and ankle, a primary running related injury outside Achilles 
tendinopathy, other contraindications to PBMT or SWT
 
13.0
 
Recruitment and Consent
13.1  Please describe the recruitment process, including how subjects will be identified and selected for 
the study.
Potential participants will be identified via four methods:
 1.Under the provisions of an approved Partial HIPAA Waiver Application for this study, the local 
study team members will review 
medical records of patients coming in to the Sports Medicine, Physical Therapy, Orthopedic, 
Podiatry, and Physical Medicine & Rehabilitation (PM&R) clinics, for suspected/confirmed AT in 
order to identify prospective research participants and to seek their authorization to 
participate/use their protected health information for this research study. The study team will 
receive approval from the potential participant's provider prior to approaching for possible 
study participation.
2. Direct referral from local healthcare providers in the local Sports Medicine, Family Medicine, 
Orthopedic and Podiatry, Physical 
Therapy, Holistic Health and Fitness (H2F), and Physical Medicine & Rehabilitation (PM&R) 
clinics.

3. Patients may self-refer to participate in the study. Interested potential participants will be able 
to contact a member of the study 
team via email. Potential participants who contact the study team directly will be instructed 
to seek care with the Physical Therapy or their primary care manager for a physical exam and 
diagnosis of AT, or confirmation of a previous AT diagnosis. The Physical Therapy Clinic is a 
direct access clinic that does not require a referral. 
4. Study advertisements will be posted within the following locations, and copies will be provided 
to clinic staff:
Internal Medicine
Aviation Medicine
H2F
McChord Clinic
Winder Clinic
Okubo SCMH
Allen Soldier -Center Medical Home
SRU
Puyallup Community Medical Home
South Sound Community Medical Home
Armed Forces Wellness Center
Intrepid Spirit Center
Madigan Medical Mall
Pharmacy waiting areas, if possible
Physical Therapy
Podiatry 
Sports Medicine 
THOR3 
Physical Medicine and Rehabilitation
Coffee bar
Dining Facility entrance
Intranet screen saver page 
2/75 Ranger Clinic
Participants who are identified by clinic staff will be provided with information for contacting the 
study team.
The local research team will keep a separate electronic screening log containing DoD ID number, 
eligibility status, and date screened. This log will be password protected and stored in a secure 
folder on a secure drive accessible only by authorized local research staff. This log is needed to 
avoid any duplicative screening of those that are screen failures or who decline study 
participation. This reduces burden on potential participants, providers, and study team members 
and ensures the study team will not screen the same person twice or examine records for 
eligibility criteria when screen status has already been already established.
13.2  Compensation for Participation:
Participants may receive up to $150 for participation in this research. 
Participants will be compensated at the following intervals: 
Completion of 6-week follow-up visit: $50
Completion of 3-month follow-up visit: $50
Completion of 6-month follow-up visit: $50
Participants will receive payment in the form of a gift card or Visa-type card equivalent.
Participants will only be paid for applicable research activities that they complete. They will not 
receive compensation for research activities they do not complete.
In accordance with the DoDI 3216.02, a federal employee (e.g., service member) completing a 
research activity while 
 will not be eligible to receive compensation for their research 
on duty
participation. However, a federal employee completing a research activity while 
 will be 
off duty
eligible to receive compensation for their research participation.
In order to receive compensation for participation in this research, a study team member will ask 
the participant to confirm their leave status in accordance with US Code Title 5, Section 6382. It 
will be the responsibility of the study participant to provide accurate information regarding their 
leave status at the appropriate compensation intervals. Upon request, the PI and/or authorized 

study team member may provide certification for intermittent leave, or leave on a reduced leave 
schedule, for planned study medical treatment(s) (in accordance with US Code Title 5, Section 
6383).
13.3  Please describe the pre-screening process. If no pre-screening, enter Not Applicable in the text editor
This study has two screening phases: 1) Pre-screening based on initial inclusion/exclusion 
criteria (before informed consent) and 2) a formal screening phase to determine eligibility for 
randomization to intervention arm (after informed consent).
Pre-Screening (before consent):
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 in close collaboration with the patient’s attending provider. Pre-screening conversations 
may also take place remotely using the Screening Script (Appendix O).
Initial eligibility (see Protocol Sections 12.5 
 & 12.6 
) will be 
Inclusion Criteria
Exclusion Criteria
confirmed in-person using an Inclusion/Exclusion CRF (Appendix A). This Inclusion/Exclusion CRF 
does not record any PII/PHI.
Individuals that do not meet inclusion/exclusion criteria will be encouraged to continue to seek 
care with their primary care provider and/or direct access at physical therapy.
If the potential participant meets eligibility criteria as determined by the Inclusion/Exclusion CRF 
and expresses interest in participating in the study, an authorized study team member will 
initiate the formal consent discussion and, if applicable, obtain informed consent. See protocol 
section 13.4 for additional information on the consent process.
Formal Screening (post-consent):
As part of the formal screening procedures, all consented participants that are biological females 
of child-bearing age and capacity will be required to complete a urine hCG pregnancy test. If the 
pregnancy test is positive, per the inclusion/exclusion criteria, the participant will be formally 
withdrawn from the study at this point, and will be encouraged to seek care with their primary 
care physician. If the pregnancy test is negative, the participant will be eligible to be randomized 
to a study arm and continue with the study procedures.
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 will be obtained in accordance with principles of Belmont Report and Common Rule 
guidelines.
The consent form will describe the purpose of the study, the procedures to be followed, and the 
risks and benefits of participation. A copy of the signed consent form will be given to the 
participant and the original will be stored in a locked cabinet inside of a locked office within the 
Sports Medicine Clinic at Madigan. Documentation of consent will be recorded in the participant’s 
medical record. No Legally Authorized Representatives will be utilized.
Formal consent, as represented by the act of signing a dated, IRB approved consent statement 
for the study will only occur after confirming eligibility using the Inclusion/Exclusion CRF, a 
thorough review of what is involved in the study, and after all questions have been answered. 
Potential participants will be provided information regarding all available study treatments and 
reminded of the expectations placed on them if they enroll, including the blinding and 
randomization processes.

The potential participant will be given a copy of the informed consent document to read before, 
during, and/or after discussion of the informed consent with the Research Coordinator, Principal 
Investigator, Associate Investigator, or other 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 health information that will be 
accessed, collected, and used by the research team if they agree to participate in the study.
Questions can be raised by the potential participant at any time during the consent discussion 
and at any time during the conduct of the study. The potential participant will be instructed that 
their participation is completely voluntary and that they may withdraw from the study at any 
time without penalty. Their decision to participate or to not participate, or to withdraw from the 
study after consent, will not affect their access to health care that they are otherwise entitled to 
and it will not affect their military position.
The authorized study team member present during the consent conversation will confirm that the 
potential participant has no additional questions before deciding to provide consent.
Every effort will be made to eliminate the perception of authority, which is a particularly 
important consideration when recruiting active-duty study participants. When applicable, the 
study investigators will be in scrubs or civilian clothes instead of uniform and will introduce 
themselves as doctor rather than their military rank. Some potential participants may be patients 
of the study PI or AI. In these cases, the consent conversation will be initiated by non-physician 
study staff to prevent any misconception of coercion or undue influence.
Informed consent and HIPAA authorization will be obtained in person.
In the event that there are significant new findings regarding the therapy that may affect 
participants’ willingness to continue in the study, an information sheet will be provided to all 
current and past participants. The informed consent document will be amended for future 
participants.
Following completion of informed consent, the results of the Inclusion/Exclusion CRF will be 
entered into REDCap, an encrypted, access controlled, password protected electronic data 
capture and management system housed on a DoD server and maintained by the Uniformed 
Services University Information Technology (USU IT), and 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. Please see Appendix R for additional information on REDCap.
In order to document screen failures and refusals, the results of the Inclusion/Exclusion CRF may 
be entered into REDCap even if a patient doesn’t consent to participate in the study. The 
Inclusion/Exclusion CRF does not record any PHI/PII.
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 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.

Participants may contact the study research coordinator/assistant or Principal Investigator to 
formally withdraw from the study. Participants will be advised to follow-up with their personal 
physician if they choose to withdraw.
Withdrawal Without Participant Consent:
Participants will be withdrawn if they fail to meet the formal screening criteria outlined in 
protocol section 13.3.
Additionally, a participant may be withdrawn from the study without their consent if remaining in 
the study might be dangerous or harmful to them. Participation may also be stopped if the 
military mission requires it, if they lose their right to receive medical care at a military hospital, if 
the study is canceled, if they fail to adhere to the protocol and/or therapy plan, or if they display 
inappropriate behavior towards study personnel.
The reason for any withdrawal/removal will be documented.
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 potential risks directly associated with study-specific activities and procedures are minimal. 
Physical Therapy (PT)
Possible risks associated with physical therapy treatment include: worsening of pre-existing 
conditions, continued and/or increased pain that may limit activities, no improvement in mobility 
or strength, soreness, or failing during and/or injury from physical therapy exercises and/or 
performance-based tests. 
Research Procedure: Shockwave Therapy (SWT)
The OrthoPlus Ultra 100 is a Class I FDA approved device with minimal risk. It is a low energy 
device and no severe events have been reported. Reported discomforts of shockwave include 
bruising, swelling and rarely, tissue damage. Pain response is expected due to device treatment 
over sites of injury and use of process of clinical focusing; we will monitor each participant and 
adjust treatment settings to ensure pain is tolerable during the treatment. Participants may stop 
the SWT at any time. 
Research Procedure: Photobiomodulation (PBM) Therapy
The risks associated with PBMT are minimal. PBM treatment is used by a variety of healthcare 
practitioners for painful clinical conditions. Mild discomfort may be experienced during the 
treatment, the treatment should not be “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 and skin, which are both very rare.
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
The laser device (LightForce XPi) will be processed through MAMC Property and safety checked 
through Healthcare Technology Management and Sustainment (HTMS) before being used. A 
member of the research team will serve as a clinical laser safety officer (CLSO) to establish and 
manage the study-specific laser safety program. The designee will work with the MAMC Laser 
Safety Officer (LSO) and participate in the MAMC Laser Safety Committee (LSC) meetings 
quarterly to receive proper training. Along with the LSO and CLSO, 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.
Protective eyewear will be worn by all participants and study team members during treatment 
sessions to avoid damaging their eyes.
In the rare occurrence that participants experience uncomfortable warmth over the treatment 
area during PBMT, the treatment will be modified or stopped.
In the occurrence that participants experience a high level of pain during SWT, the treatment will 
be modified or stopped.
In order to protect participant confidentiality, research data will be identified using a unique 
study ID only, and not by participant name, date of birth, DoD ID, or other similar identifier. All 
available measures allowed by law will be taken by research staff to protect participant 
confidentiality. See protocol section 14.3 for additional information. 
Check-ins occur frequently to address any adverse events associated with the rehabilitation 
protocol. All participants will be evaluated for adverse events at each follow-up visit. All adverse 
events, regardless of severity, will be reported to the Principal Investigator. The Principal 
Investigator will review all adverse events. Adverse events will also be reported according to the 
guidelines stated in Protocol Section 16.1.
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 Informed Consent Form, HIPAA Authorization, and electronic Master List, all 
research data (both paper and electronic) will be identified using this unique study ID only, and 
not by the participant’s name, date of birth, DoD ID, or other protected identifier.
Paper research forms and source documents will be stored in a locked cabinet inside of a locked 
room within the Sports Medicine Clinic at Madigan, accessible only by local research staff 
designated and authorized by the Principal Investigator. The paper Intake CRF which records 
participant contact information, Informed Consent Forms and HIPAA Authorizations will be stored 
separately from the coded paper research forms in a locked cabinet inside of a locked room 
within the Sports Medicine Clinic, accessible only by authorized local research staff.
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 
Department of Defense (DoD) server and maintained by the Uniformed Services University 
Information Technology (USU IT). The local study team will manage the storage and upload of 
ultrasound in TeleRay, which is an encrypted and  access controlled data platform. No PHI/PII 
will be entered into REDCap or TeleRay. See Appendix R for additional information on REDCap.

The local study team will maintain a separate electronic Master List which matches the unique 
study IDs with participant identifying information. 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.
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 (except as stated in the next paragraph). 
These duties include making sure that research participants are protected.
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), 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, the paper research records, or any participant PHI/PII. There will be appropriate 
data sharing agreements in place.
Any research data shared with an approved agency for review will be linked only to the 
participant’s unique study ID and not with the personal identity of the participant (i.e., name, 
DOB, DoD ID, address, phone number, etc.). 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 recovery of AT, it is expected that all treatment arms will help AT 
recovery, some treatments potentially quicker that other, more traditional treatment options. 
This may also provide better/faster treatment pathway(s) for AT in the AD and larger physically 
active populations. 
14.5  
Privacy for Subjects:
Describe the measures to protect subject’s privacy during recruitment, the consent process, and 
all research activities, etc.
Recruitment, consent conversations, and follow-up research activities will take place in a private 
setting (e.g., closed clinic room, investigator’s office, etc.) to minimize the potential opportunity 
to be overheard or inadvertently witnessed. Information being collected will be limited to only 
the minimum amount of data necessary to accomplish the proposed research.
14.6  
Incidental or Unexpected Findings:

1.  
2.  
3.  
4.  
5.  
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 
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
There is the possibility incidental findings could reveal information the participant would not 
otherwise be aware of. In cases where the participant could possibly benefit medically or 
otherwise, the participant will be notified and, when appropriate, so will their primary care 
provider. Research representatives will not share incidental and unexpected findings with anyone 
else unless required by law.
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.
Although unlikely, incidental findings could impact a participant’s future ability to receive health 
or life insurance, as is the case with all medical care. Incidental findings may also make the 
participant feel anxious.
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 medical records and/or research 
files of enrolled participants.
Review and keep abreast of adverse events and protocol deviations that occur during the 
research.
The PI will review and sign adverse event logs/reports, protocol deviation logs/reports, 
and continuing reviews/annual 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 adverse event or protocol deviation occurs, it will be evaluated by the Principal Investigator 
and appropriate actions will be taken as outlined in Section 16.0 Reportable Events. 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 adverse event, all adverse event data will be 
tracked and evaluated.
On-site physicians will monitor the progress and health of the participants alongside our Principal 
Investigator. Participants can elect to withdraw from the study at any time. Participants may also 
be taken out of the study at any point if a research provider (or one of their treating providers) 

determines that it is no longer 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 resume standard of care 
treatment with their assigned health provider(s).
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 and Teleray 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/SAEs/UPIRTSOs:
The study overall is considered to be minimal risk for study participants, defined as not 
substantially above what would be encountered in everyday life including provision of routine 
medical care for the condition of Achilles tendinopathy. Potential risks are preventable by 
ensuring that appropriate and rigorous screening procedures are in place, and risk mitigation 
procedures (e.g., wearing appropriate eye protection) are utilized. Based on clinical use of this 
technology, and reports from other research studies, the risk of expected adverse events is low.
However, all reportable events, regardless of severity, will be reported to the Principal 
Investigator. The Principal Investigator will review all adverse events and make a determination 
of severity and relationship to participation in the research study.
All Serious Adverse Events (SAEs) that are unexpected and related, or possibly related, to study 
participation will be reported to the IRB via telephone or email within 24 hours of discovery and a 
complete written report via eIRB will follow within 5 business days.
Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSOs) will be reported to the 
IRB via telephone or email within 24 hours of discovery and a complete written report via eIRB 
will follow within 5 business days.
Unexpected (but not serious) adverse events (AEs) occurring in subjects which, in the opinion of 
the PI, are related or possibly related to study participation AND places subjects or others at a 
greater risk of harm that was previously known or recognized in the protocol will be reported to 
the IRB via telephone or email within 24 hours of discovery and a complete written report via 
eIRB will follow within 5 business days.

Expected AEs/SAEs and AEs/SAEs that are not related or not possibly related to study 
participation will be tracked by the local study team using an Adverse Event Tracking Log and 
reported to the IRB at the time of continuing review or, if applicable, at study closure. 
Continuing Review (CR) Progress Reports are generally performed on a 12-month cycle. More 
frequent
Progress Reports may be required at the discretion of the IRB.
Protocol Deviations:
All protocol deviations, both major and minor, will be reported to the Principal Investigator. The 
Principal Investigator will review all protocol deviations.
Major protocol deviations, as determined by the Principal Investigator, will be promptly reported 
to the IRB via telephone or email within 24 hours of discovery and a complete written report will 
follow within 5 working days.
Minor protocol deviations will be tracked by the local study team using a Protocol Deviation Log 
and reported to the IRB at the time of continuing review or, if applicable, at study closure. Follow 
up visits that occur outside of the windows stated in protocol will be considered minor protocol
deviations.
17.0
 
Equipment/non-FDA Regulated Devices
17.1  Does the study involve the use of any unique non-medical devices/equipment?
  Yes   
  No
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® XPi therapy laser 
Manufacturer/Supplier of 
Device
LiteCure, DJO Global 
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
 
OrthoPlus Ultra 100 
Manufacturer/Supplier of 
Device
CuraMedix 
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
 
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 FDA.
18.5  Sponsor (organization/institution/company):
N/A
If applicable, provide sponsor contact information:
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

1.  
2.  
3.  
4.  
5.  
6.  
7.  
8.  
9.  
10.  
11.  
12.  
13.  
14.  
20.1  References:
Rhim, H. C
. Comparative Efficacy and tolerability of Nonsurgical Therapies for the 
., et al
Treatment of Midportion Achilles Tendinopathy: A Systematic Review With Network Meta-
Analysis. 
  (7), 1-8 (2020)
The Orthopaedic Journal of Sports Medicine 8
Tumilty, S., et. al. Photobiomodulation and eccentric exercise for Achilles tendinopathy: a 
randomized control trial. 
 
, 127-135 (2016).
Lasers in Medical Science 31
Lopez, A. D., 
. What are the Main Running Related Musculoskeletal Injuries? A 
et al
Systematic Review. 
 
, 891-905 (2012)
Sports Medicine 42
Zafar, M. S
Basic science and clinical aspects of Achilles tendinopathy
., et al. 
. Sports Med 
(3), 190-197 (2009)
Arthrosc Rev 17
Jones B. H., 
 Medical surveillance of injuries in the U.S. Military descriptive 
et al.
epidemiology and recommendations for improvement. 
 
(1), S42-60 
Am J Prev Med. 38 
(2010).
Do Santos, S. A., 
 Parameters and Effects of Photobiomodulation in Plantar Fasciitis: 
et al.
A Meta-Analysis and Systematic Review. Photobiomodulation, Photomedicine, and Laser 
 
 (6), 327-335 (2019)
Surgery 37
CuraMedix, OrthoPulse
 Ultra Operations Manual Part No. 23300.0100, 
TM
www.
curamedix.com
Burton, I., Combined extracorporeal shockwave therapy and exercise for the treatment of 
tendinopathy: A narrative review, 
  (1), 2022, 8-17, 
Sports Medicine and Health Science, 4
ISSN 2666-3376, https://doi.org/10.1016/j.smhs.2021.11.002.
Celik, D., 
. Photobiomodulation Therapy Versus Extracorporeal Shock Wave Therapy 
et al
in the Treatment of Lateral Epincondylitis. Photobiomodulation, Photomedicine, and Laser 
 
 (5), 269-275 (2019)
Surgery 37
Silbernagel, K. G. & Crossley, K. M. A Proposed Return-to-Sport Program for Patients with 
Midportion Achilles Tendinopathy: Rationale and Implementation. Journal of Orthopaedic 
 
11), 876-886 (2015)
& Sports Physical Therapy 45(
Silbernagel, K. G., 
. Continued Sports Activity, Using a Pain-Monitoring Model, During 
et al
Rehabilitation in Patients with Achilles Tendinopathy: A Randomized Control Trial. The 
 
(6), 897-906 (2007)
American Journal of Sports Medicine 35
Azevedo, et al. Biomechanical variables Achilles tendinopathy. British Journal of Sports 
 
(4), 288-292 (2009) 
Medicine 43
Franettovich, M.M. 
. Neuromotor control of gluteal muscles, 
. 
et al
Med. Sci. Sports Exerc 4
(3), 594-599 (2014)
6
Mccormack, et al. The Minimum Clinically Important Difference On The Visa-A And Lefs 
For Patients With Insertional Achilles Tendinopathy. International Journal of Sports 
 10, 639-644. (2015)
Physical Therapy.
20.2  Abbreviations and Acronyms:
Achilles Tendinopathy (AT)
Active-Duty (AD)
Active-Duty Service Member (ADSM)
Advanced Encryption Standard (AES) 
Adverse Event (AE)
Associate Investigator (AI)
Case Report Form (CRF)
Common Access Card (CAC)
Continuing Review (CR)
Datagram Transport Layer Security (DTLS)
Date of Birth (DOB)
Defense and Veteran’s Pain Rating Scale (DVPRS) 
Defense Health Agency (DHA)
Department of Defense (DoD)
Eccentric strengthening (ECC)
Electronic Medical Record (EMR)
Extracorporeal shockwave therapy (ESWT)
Food and Drug Administration (FDA)
Hash-based Message Authentication Code- Secure Hash Algorithm 1 (HMAC-SHA1) 
Health Insurance Portability and Accountability Act (HIPAA)
Holistic Health and Fitness (H2F) 
Human Research Protection Office (HPRO)
Institutional Review Board (IRB)
Internet Engineering Task Force (IETF)

Laser Safety Officer (LSO)
Lower Extremity Functional Scale (LEFS)
Megahertz (MHz)
Musculoskeletal Injury (MSI)
Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR)
Patient-Reported Outcomes Measurement Information System (ProMIS-29)
Personally Identifiable Information (PII)
Photobiomodulation (PBM)
Photobiomodulation therapy (PBMT)
Physical Medicine & Rehabilitation (PM&R)
Physical Therapy (PT)
Platelet Rich Plasma (PRP)
Principal Investigator (PI)
Protected Health Information (PHI)
Protocol Deviation (PD)
Range of Motion (ROM)
Research Coordinator (RC)
Research Electronic Data Capture (REDCap)
Return/ing to duty (RTD)
Secure Access File Exchange (SAFE)
Secure Real-time Transport Protocol (SRTP) 
Secure Sockets Layer (SSL)
Serious Adverse Event (SAE)
Shockwave therapy (SWT)
Standard of Care (SOC)
The University of Wisconsin Running Injury and Recovery Index (UWRI)
Timepoint (T)
Transport Layer Security (TLS) 
Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSOs)
Uniformed Services University (USU)
Uniformed Services University Information Technology (USU IT)
Victorian Institute of Sports Assessment – Achilles (VISA-A)