Effectiveness of Photobiomodulation Compared to Usual Care for Plantar Fasciitis
Phase: NA
Conditions: Plantar Fascitis
Sponsor: Landstuhl Regional Medical Center

Protocol Title:  Effectiveness of Photobiomodulation Compared to Usual Care for Plantar Fasciitis 
Version #:  8.1 
Date:   08 Apr 2019  
 
 
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PROTOCOL TITLE:  Effectiveness of Photobiomodulation Compared to Usual Care for Plantar Fasciitis  
 
SECTION A:  RESEARCH TEAM AND LOCATIONS 
 
A1.  RESEARCH TEAM 
 
Study Role 
Institution/Company and Contact Information 
Sponsor 
Organization/Institution/Company:  TriService Nursing 
Research Program (c/o The Geneva Foundation) 
Address: 917 Pacific Ave, Suite 600, Tacoma, WA 98402 
Point of Contact:  Ms. Kathy Robinson 
Name and Degree:  N/A 
Title:  Senior Grant and Contract Manager 
Phone Number:  253-682-3818 
Email:  krobinson@genevausa.org 
 
Principal Investigator 
Name, Rank, and Degree: Ann Kobiela Ketz, LTC, Ph.D. 
Title:  Deputy, Center for Nursing Science and Clinical Inquiry 
(CNSCI) 
Institution:  Landstuhl Regional Medical Center (LRMC) 
Address:  CMR 402 APO, AE 09180 
Phone Number:  DSN: 314-530-4229, Comm: 01149-6371-
9464-4229 
Email:  ann.k.ketz.mil@mail.mil 
 
Associate Investigator(s) 
 
Name, Rank, and Degree:  Juanita Anders, Ph.D. 
Title:  Professor of Anatomy, Physiology and Genetics, 
Professor of Neuroscience 
Institution/Company:  Edward Hébert School of Medicine, 
Uniformed Services University of the Health Sciences 
Address:  4301 Jones Bridge Road 
Bethesda, Maryland 20854 
Phone Number:  301-295-3203 
Email:  juanita.anders@usuhs.edu 
Name, Rank, and Degree:  Nicholas Koreerat, CPT, DPT 
Title:  OIC, Harmony Church Physical Therapy 
Institution/Company:  Fort Benning, GA 
Address:  6600 Van Aalst Blvd 
Phone Number:   DSN 486-5807 
Email:  nicholas.r.koreerat.mil@mail.mil 
Name, Rank, and Degree:  George Smolinski, LTC, MD 
Title:  Physician 
Institution/Company:  Office of the Command Surgeon 
Address:  CMR 402 APO, AE 09180 
Phone Number:  01149-6371-9464-5758 
Email:  george.j.smolinski.mil@mail.mil 
Name, Rank, and Degree:  Ali Akber Turabi, MAJ, MD 
Title:  Anesthesiologist 

Protocol Title:  Effectiveness of Photobiomodulation Compared to Usual Care for Plantar Fasciitis 
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Institution/Company:  LRMC 
Address:  CMR 402 APO, AE 09180 
Phone Number:  01149-6371-9464-5868 
Email:  ali.a.turabi.mil@mail.mil 
Name, Rank, and Degree:  Daniel H. Huffman, CPT, DPT 
Title:  Physical Therapist 
Institution/Company:  LRMC 
Address:  CMR 402, APO AE 09180 
Phone Number:  011-49-6371-9464-5762 
Email: Daniel.h.huffman7.mil@mail.mil 
Name, Rank, and Degree:  Louis Magyar, MAJ, DNP 
Title:  Nurse Practitioner, Family Medicine 
Institution/Company:  LRMC 
Address:  CMR 402 APO, AE 09180 
Phone Number:  01149-637194645762 
Email:  louis.m.magyar2.mil@mail.mil 
Other Key Research  
Personnel (as applicable) 
 
Name, Rank, and Degree:  Candice Turner, PT, MSPT 
Title:  Research Coordinator 
Institution/Company:  Geneva Foundation 
Address: 917 Pacific Ave, Suite 600, Tacoma, WA 98402 
Phone Number:  253-682-3818 
Email:  cturnerpt@gmail.com 
 
Other Individuals 
Supporting  
the Research (as 
applicable) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Research Monitor 
 
 
Name, Rank, and Degree:  Cheryl Napier, MS 
Title:  Research Coordinator 
Institution/Company:  Geneva Foundation 
Address:  917 Pacific Ave, Suite 600, Tacoma, WA 98402 
Phone Number:  253-682-3818 
Email:  cnapier@genevausa.org 
Name, Rank, and Degree:  Misty Hull, MSN, FNP-C 
Title:  Research Coordinator 
Institution/Company:  Geneva Foundation 
Address:  917 Pacific Ave, Suite 600, Tacoma, WA 98402 
Phone Number:  253-682-3818 
Email:  mistyhaines@hotmail.com 
Name, Rank, and Degree:  Judy Orina 
Title:  Research Coordinator 
Institution/Company:  Geneva Foundation 
Address:  917 Pacific Avenue, Suite 600, Tacoma WA  98402 
Phone Number:  253-682-3818 
Email: jorina@genevausa.org 
Name, Rank, and Degree:   
Title:   
Institution/Company:   

Protocol Title:  Effectiveness of Photobiomodulation Compared to Usual Care for Plantar Fasciitis 
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Consultants (Subject  
Matter Experts, others) 
 
  
 
Name, Rank, and Degree:  Dale Glaser, Ph.D. 
Title:  CEO 
Institution/Company:  Glaser Consulting 
Address:  3115 4th Avenue, San Diego, CA 92103 
Phone Number:  619-220-0602 
Email:  glaserconsult@sbcglobal.net 
Name, Rank, and Degree:  Betty K. Garner, Ph.D. 
Title:  Proprietor 
Institution/Company:  Betty K. Garner, Sole Proprietorship  
Address:  595 Haybale Ct, Sparks, NV  89441 
Phone Number:  253-228-6159 
Email:  betty.garner2011@yahoo.com 
 
A2.  ROLES AND RESPONSIBILITIES 
      
       A2.1  Key Research Personnel   
 
            Name(s):  Ann Kobiela Ketz, LTC, Ph.D. 
            Research Role:  Principle Investigator 
           Study Responsibilities:  LTC Ketz will serve as the Principal Investigator for the study.  She will be 
responsible for the overall conduct and oversight of the study. She will coordinate the efforts of the research 
team and consultants to include supervising and training the Research Coordinator. She will provide the 
necessary scientific leadership, administrative oversight and support for all aspects of the study and will ensure 
that all personnel and departmental resources are properly aligned.   
            Name(s):  Daniel Huffman, CPT, DPT 
 
            Research Role:  Associate Investigator 
           Study Responsibilities:  CPT Daniel Huffman will serve as an Associate Investigator for this study.  His 
primary responsibilities will include screening of potential participants, instructing participants on the 
Usual Care Protocol, and performing ankle dorsiflexion measures. He will also assist with the 
interpretation and dissemination of the study results.  
             
Name(s):  Nicholas Koreerat, CPT, DPT 
 
            Research Role:  Associate Investigator 
           Study Responsibilities:  CPT Nicholas Koreerat will serve as an Associate Investigator for this study.   
He will assist with the interpretation and dissemination of the study results. Access to de-identified data 
only. 
 
Name(s):  George Smolinski, LTC, MD 
 
            Research Role:  Associate Investigator 
Address:   
Phone Number:   
Email:   
 
Ombudsman  
  
Name, Rank, and Degree:        
Title:        
Institution/Company:        
Address:        
Phone Number:        
Email:        

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           Study Responsibilities:  MAJ George Smolinski will serve as an Associate Investigator for this study. He 
will assist with the interpretation and dissemination of the results.  Access to de-identified data only. 
 
            Name(s):  Ali Turabi, MAJ, MD 
 
            Research Role:  Associate Investigator 
           Study Responsibilities:  MAJ Ali Turabi will serve as an Associate Investigator for this study. His primary 
responsibilities will include medical oversight of participants, screening of potential participants, provide 
necessary supervision for the photobiomodulation protocol, and deliver photobiomodulation treatment if 
needed. He will also assist with the interpretation and dissemination of the results. In the event that 
LTC Ketz is deployed, MAJ Turabi will serve as the on-site PI. 
 
Name(s):  Louis Magyar, MAJ, DNP  
            Research Role:  Associate Investigator 
           Study Responsibilities:  MAJ Louis Magyar will serve as an Associate Investigator for this study. His 
primary responsibilities will include screening of potential participants, instructing participants on the 
Usual Care Protocol, and delivering photobiomodulation treatment if needed. He will also assist with the 
interpretation and dissemination of the results. 
 
Name(s):  Candice Turner, PT, MSPT 
Research Role:  Research Coordinator 
Study Responsibilities:  The Research Coordinator (Physical Therapist or Advanced Practice Nurse) 
will be responsible for recruiting and enrolling participants, delivering photobiomodulation treatment, 
collecting data, inputting data, maintaining study files, filing IRB documents, and assisting in the 
preparation or manuscripts and dissemination materials.  
 
Name(s):  Cheryl Napier, MS 
Research Role:  Secondary Research Coordinator 
Study Responsibilities:  The Secondary Research Coordinator will be responsible for recruiting and 
enrolling participants, inputting data, maintaining study files, filing IRB documents, and assisting in the 
preparation of manuscripts and dissemination materials.  
 
Name(s):  Judy Orina 
Research Role:  Research Coordinator 
Study Responsibilities:  The Research Coordinator will be responsible for inputting data, maintaining 
study files, data cleaning, filing IRB documents, and assisting in the preparation of manuscripts and 
dissemination materials.  
 
Name(s): Misty Hull, MSN, FNP-C 
Research Role:  Tertiary Research Coordinator 
Study Responsibilities:  The Tertiary Research Coordinator (Physical Therapist or Advanced Practice 
Nurse) will be responsible for recruiting and enrolling participants, delivering photobiomodulation 
treatment, collecting data, inputting data, maintaining study files, filing IRB documents, and assisting in 
the preparation of manuscripts and dissemination materials. 
 
 
 
 
       A2.2. Others Involved in the Research, as applicable  
 
            Name(s):  Betty Garner, PhD. 
            Research Role:  Mentor 
           Study Responsibilities:  Dr. Betty Garner will serve as the military nursing Mentor for this study.  As 

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Mentor and on the proposed study, she will participate in data analysis and dissemination.  As Dr 
Garner is joining the study team after enrollment is complete, her primary responsibility will be to help 
guide completion, wrap-up and data analysis of the study data. 
 
            Name(s):  Juanita Anders, Ph.D. 
            Research Role:  Associate Investigator/Mentor 
Study Responsibilities:  Dr. Anders’ responsibilities will include providing guidance and support on the 
development and implementation of the protocol. Additionally she will assist with coordinating with the 
laser device company, data analysis, interpretation of results and preparation of dissemination efforts 
pertaining to the study. 
 
Name(s):  Dale Glaser, Ph.D. 
            Research Role:  Statistician 
           Study Responsibilities:  Dr Glaser will serve as the Statistician for the study.  He will conduct baseline, 
interim and final data analyses; provide consultation on the interpretation of findings; and assist with the 
drafting and writing of all reports, manuscripts, and dissemination materials.  
 
 
 
A3.  RESEARCH LOCATIONS    
 
Landstuhl Regional Medical Center will serve as the site for all recruitment, enrollment, and interventions. 
 
A4.  MULTISITE RESEARCH   
 
Lead Site:  N/A 
Lead Site Investigator:        
IRB that will review for the lead site:       
Function/Role of Lead Site:       
 
 
Performance Site:  N/A 
Performance Site Investigator:        
IRB that will review for the Performance Site:        
Function/Role of Performance Site:        
 
 
 
 
SECTION B:  RESEARCH METHODOLOGY 
 
B1.  ABSTRACT   
 
BACKGROUND:  Plantar fasciitis, a degenerative injury of the connective tissue in the foot, results in pain-
related disability in Service Members and beneficiaries and contributes to decreased physical activity and 
excessive healthcare costs. Even if effective, current treatment protocols may require 6-12 months of therapy 
to return individuals to pain-free activity. Photobiomodulation (PBM), or low level laser therapy, uses non-
ionizing light to elicit biological changes in tissues resulting in beneficial therapeutic outcomes. Evidence 
supports use of PBM for other degenerative connective tissue conditions, such as Achilles tendinopathy and 
epicondylitis.  Unfortunately, previous studies of PBM for treatment of plantar fasciitis lack optimized treatment 
parameters and therefore have been inconclusive on its clinical effectiveness.  
 

Protocol Title:  Effectiveness of Photobiomodulation Compared to Usual Care for Plantar Fasciitis 
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SPECIFIC AIMS: 1. Establish feasibility of and adherence to a photobiomodulation protocol in conjunction with 
and compared to usual care for plantar fasciitis treatment. 2. Assess the clinical effectiveness of 
photobiomodulation in conjunction with and compared to usual care to improve function and decrease pain in 
patients. 3. Assess the difference between two photobiomodulation dose parameters in conjunction with and 
compared to usual care for plantar fasciitis treatment.  
 
DESIGN: We will use a prospective randomized controlled trial to meet the aims of this exploratory study.  
METHOD: A sample of 96 military healthcare beneficiaries will be randomly assigned to usual care, usual care 
plus PBM lower dose, or usual care plus PBM higher dose groups. At baseline, during the treatment protocol, 
and at long term (3 and 6 month) follow-up, measures of foot function and pain will be collected for analysis. 
The proposed methods will allow the study team to establish if PBM accelerates recovery compared to usual 
care, as well as determining the optimal dose for future trials comparing PBM to other, more invasive, 
therapies for plantar fasciitis.  
 
LONG TERM GOAL: The long term goals of this research team include developing PBM protocols for broad 
application to other painful and duty-limiting conditions. 
 
 
B2.  BACKGROUND AND SIGNIFICANCE   
Plantar fasciitis, a degenerative disease of the connective tissue supporting the foot, is the number one cause 
of heel pain in ambulatory settings, affecting up to 10% of adults (1-3). Both extrinsic and intrinsic risk factors 
contribute to risk for developing PF.(4) Intrinsic factors include anatomic risk such as obesity and flat or high 
foot arches, as well as biomechanic factors such as weak foot musculature and overpronation.  Environmental 
extrinsic factors include poor biomechanics, deconditioning, repetitive impact on hard surfaces, poor footwear, 
and prolonged weight bearing.(5, 6) Despite few direct reports of PF prevalence in the military, it is reasonable 
to conclude that military members are susceptible to many of the intrinsic and extrinsic risk factors. Though 
military members must adhere to strict fitness standards, their propensity to be physical active and bear a 
combat load for extended periods of time in austere conditions could expose them to increased risk for PF. In 
regards to the risk of obesity, consider that in an adult male with a Body Mass Index (BMI) of 23 (5’11” tall and 
165 pounds), carrying a full combat load of 80 pounds increases his BMI to 34, which is classified as obese 
according to definition from the National Institutes of Health.(7, 8) It is logical, then, that a prevalence study 
conducted in an Infantry Brigade Combat Team while deployed to Afghanistan reported that PF was one of the 
top five diagnosed musculoskeletal injuries seen by physical therapists during their deployment.(9) Scher and 
colleagues conducted an analysis using the Defense Medical Epidemiology Database and reported the 
incidence of PF in active duty service members to be 10.5 per 1000 person-years.(1) Roy and colleagues 
reported that while deployed to Afghanistan, Soldiers who carried heavier loads were at increased risk for all 
musculoskeletal injuries.(10) Despite limited reporting of PF, it is known that musculoskeletal injuries are 
leading causes of disability discharge, nonbattle evacuations from theater, and result in lost duty time and 
decreased readiness.(11)  
 
Though the name is misleading, PF is not primarily an inflammatory condition.(12, 13) An acute inflammatory 
process occurs in response to repetitive trauma to the connective tissue; however the result is tissue 
destruction, leading to chronic fibrosis (Figure 1). Histological analysis of plantar fascia and adjacent muscle 
from individuals with heel pain demonstrated fascial thickening, collagen necrosis, matrix calcification, 

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perifascial edema, and alterations in vascularization.(12, 14-17) 
 
Figure 1. Operational Model of Plantar Fasciitis Injury Process 
 
Conservative PF treatment, though effective in a majority of cases, generally takes six months to a year, and 
improvements are often not seen until after six to eight weeks of therapy.(2, 3, 5) Even in cases where 
conservative therapy is beneficial, continuing pain and decreased function limits physical activity. Physical 
activity limitations in Active Duty Service members may have negative consequences at both the individual and 
unit level.(18, 19) In some resistant cases, more aggressive, painful, and invasive treatments are 
recommended, such as corticosteroid injections, radiation,(20) platelet-rich plasma injections,(14) and even 
surgery.(2, 3, 21) Innovative, safe, non-invasive therapies are needed that can address the root cause of the 
injury, decrease the pain of PF quickly, and return individuals to increased function and physical activity.   
 
 
Photobiomodulation is defined as “a form of light therapy that utilizes non-ionizing forms of light sources, 
including lasers, LEDs, and broadband light, in the visible and infrared spectrum …involving endogenous 
chromophores eliciting photophysical and photochemical events at various biological scales. This process 
results in beneficial therapeutic outcomes, including, but not limited to, the alleviation of pain or inflammation, 
immunomodulation, and promotion of wound healing and tissue regeneration” (p. 184).(22) PBM has been 
shown to have beneficial effects on a wide range of injuries and pathologies.(23, 24) In the 810-980 nanometer 
(nm) wavelength range (proposed use in this study), the primary mechanism includes the absorption of light by 
the terminal enzyme in the mitochondrial respiratory chain, cytochrome C oxidase (CCO).(25, 26) Research 
has shown that the light absorption spectrum of CCO is similar to the biological response spectra initiated by 
light.(26) The energy absorbed by the CCO leads to increased enzyme activity and production of adenosine 
triphosphate.(27-29) Recent research indicates that critical downstream signaling cascades are also activated, 
promoting beneficial changes at the molecular and protein level.(26, 30, 31) 
 
 
PBM is used therapeutically to reduce inflammation, reduce edema, treat chronic joint disorders and treat pain, 
among other uses.(25) PBM has shown efficacy in reducing pain and improving function in painful conditions 
such as carpal tunnel syndrome, arthritis,(32, 33) and acute and chronic neck pain.(34) Several studies using 
PBM to treat tendinopathies (lateral epicondylitis, shoulder tendinopathy, and Achilles tendinopathy) have 
demonstrated a positive effect when using optimized wavelengths and dosing parameters.(35-38) The success 
of PBM in treating painful tendinopathies may be contributed to the effect on collagen production. In a rabbit 
model of Achilles tendon injury, PBM enhanced healing of the tendon by increasing collagen production, 
suggesting that PBM accelerated healing and improved mechanical integrity of the tendon.(23) PBM has also 
been shown to improve alignment of collagen fibers, an essential step in regeneration of injured tissue.(39) Yet 
another study demonstrated that rats with an Achilles tendon injury that were subjected to PBM along with 
exercise had greater tensile strength of their injured tendon compared to animals with either exercise or PBM 
alone.(40)     
 
 
Despite positive results in some tendinopathy studies, a lack of consistent application of dosing parameters 
and study methodology make it difficult for systematic reviews and meta-analyses to conclude that PBM is of 

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benefit. Specifically in PF studies, no difference between treatment and placebo was found in a study using the 
World Association of Laser Therapy Guidelines(41) using 830nm wavelength light at 30mW power.(42) 
Another series of studies, using 635 nm wavelength red light, and 17mW power, reported positive findings; 
however, the questionable methods and extremely low powered parameters used lack convincing evidence of 
an effective treatment.(43, 44)  
 
There are anecdotal reports from practitioners successfully using PBM for PF with specific parameters with 
810-980 nm wavelength light that have yet to be tested in a clinical trial.(45, 46) A female military member with 
chronic PF was treated with the device proposed to be used in this study; a Class IV diode laser, 10 Watt 
output power, for 6 sessions of 4,800 Joules (J) each. After completion of the protocol, she reported 90% 
improvement in her pain and a return to her pre-injury activity level.(47) This proposed study will assess the 
effectiveness of PBM in the 810-980 nm wavelength range, which has been shown to penetrate to the 
appropriate depth to deliver light to the target tissue of the plantar fascia, with both a 10W and 25W power 
dose. Testing two specific dosage levels will allow us to determine preferred dosing parameters, with the 
higher power output dose potentially allowing the treatment to be delivered over fewer sessions. We 
hypothesize that both PBM treatment groups will result in decreased pain and increased function in a shorter 
time course than usual care alone, and further, that the 25W treatment group will report increased function and 
decreased pain after fewer treatments than the 10W treatment group.  
 
B3.  MILITARY RELEVANCE    
 
In the U.S. Military, musculoskeletal injuries, including tendinopathies, are responsible for 5 to 10 times more 
lost training days than illness, and injury-related disability costs the military $750 million annually. Plantar 
fasciitis is one of the contributors to the disability cost. Physical activity-limiting conditions are incompatible with 
maintaining a fit and ready force and improving the health of those entrusted to our care. This innovative 
therapy has tremendous potential to provide the best possible outcomes for both military members and their 
families by optimizing their overall health by allowing them to enhance their physical activity free from pain. 
 
This study will produce new scientific knowledge about the optimal dosing parameters of PBM to best reduce 
pain and improve function for those entrusted to our care who are limited by PF. The long term goals of this 
research team include developing PBM protocols for broad application to other painful and duty-limiting 
conditions, and exploring the application of this portable device in forward-deployed environments. This 
innovative therapy that can be delivered by nursing staff and advanced practice nurses, has the potential to 
promote a fit and ready force by returning service members to duty quickly, reducing health care costs, and 
promoting operational readiness.  
 
This Nurse Scientist-led collaborative research study is also relevant to strategic goals of the current OTSG 
Research Priorities and the OTSG Pain Management Task Force Recommendations to develop collaborative 
pain research strategies that advance Warrior pain care and rapidly translate effective findings into practice. 
The PI has the unique opportunity to work with international leaders in the field of PBM and build a program of 
research to benefit military members and beneficiaries suffering from a variety of painful conditions. 
 
B4.  OBJECTIVES/SPECIFIC AIMS/RESEARCH QUESTIONS   
 
1. Establish feasibility of and participant adherence to a photobiomodulation protocol in conjunction with and 
compared to usual care for PF treatment.  
 
2. Assess the clinical effectiveness of photobiomodulation in conjunction with and compared to usual care to 
improve function and decrease pain in patients.  
 
3. Assess the difference between two photobiomodulation dose parameters in conjunction with and compared 
to usual care for PF treatment.   

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Results of this exploratory study will allow the team to obtain data necessary to develop further prospective, 
randomized control trials to compare the effectiveness of optimized PBM parameters to other, more invasive, 
treatments for PF. The long term goals of this research team include developing PBM protocols for broad 
application to other painful and duty-limiting conditions. This innovative therapy has the potential to promote a 
fit and ready force by returning service members to duty quickly, reducing health care costs, and promoting 
operational readiness. 
 
 
 
 
B5.  RESEARCH PLAN    
 
       B5.1  Research Design   
 
We will use a prospective randomized controlled trial to meet the aims of this study.  
 
      B5.2  Research Subjects/Population(s) 
 
                B5.2.1  Subject Population(s)   
The target population of this study is male and female adults (aged 18-65 years) with a diagnosis of 
PF/plantar heel pain. The accessible population for this study includes beneficiaries of care at 
Landstuhl Regional Medical Center (LRMC), including both Active Duty Service Members and other 
beneficiaries; totaling approximately 52,000 individuals. Because the safety of PBM has not been 
established for pregnancy, females who are pregnant or plan on becoming pregnant will not be 
included. Patients with PF are seen at several clinics at LRMC, with the majority seeking care at 
Family Medicine, Podiatry, Physical Medicine, and Physical Therapy clinics. LRMC Clinics have 
coded over 1500 cases of PF per year for the past 2 years (>3000 cases/year). Therefore, this study 
is both feasible and justified in this setting.  
 
                B5.2.2  Number of Subjects, Records, and/or Specimens   
 
An n = 96, (n = 32 per group) will be used. In this study, the 3 and 6 month follow up questionnaires 
will be distributed either by hand as a paper copy, mailed, emailed, or automated to enable 
compliance; however, because we do not have pilot data to guide historic attrition rates for this 
specific intervention, we will over-recruit by 20% (n = ~114, or n = 38 participants per group) to 
account for potential attrition. 
 
 
                B5.2.3  Inclusion Criteria 
 
(1) Between ages of 18 – 65 years 
(2) Eligible for care at LRMC 
(3) Diagnosis of PF by healthcare provider based on accepted diagnostic criteria 
(4) Have experienced symptoms of PF for at least 3 months 
(5) Able to read and understand English language for consent purposes 
(6) Able to commit to 6 week intervention and 3 and 6 month follow-up 
 
                B5.2.4  Exclusion Criteria 
 
(1) Pregnant or plan on becoming pregnant during intervention period (Safety of PBM not 
established in pregnancy) 

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(2) History of traumatic injury to symptomatic foot/feet 
(3) Diagnosis of calcaneal fracture 
(4) Have previously had corticosteroid injections, surgery, or other invasive treatment for same 
condition 
(5) Greater than 15% of calf area covered in tattoos/ink/scarring (Pigment in ink can absorb light, 
causing overheating of skin) 
(6) History of neuropathy or unable to detect changes in skin temperature (increased risk of skin 
warming due to inability to detect change) 
(7) Currently using medications associated with sensitivity to heat or light (e.g. amiodarone, 
chlorpromazine, doxycycline, hydrochlorothiazide, nalidixic acid, naproxen, piroxicam, tetracycline, 
thioridazine, voriconazole) 
(8) Concurrent participation in another research study addressing pain issue 
(9) Current or chronic sciatica (lumbosacral 
radiculopathy) resulting in chronic or intermittent lower extremity pain, numbness, or 
tingling. 
 
 
      B5.3  Research Procedures   
 
Recruitment: Participants will be recruited directly from the Family Medicine, Podiatry, and Physical 
Therapy clinics (where they are seen the most often), as well as indirectly through advertisements posted 
around LRMC (Appendix A), on the LRMC Facebook page as well as the Facebook pages of other KMC 
affiliated organizations catering to the local military community in local newspapers (Appendix B), the 
LRMC Adjutant’s electronic newsletter, through the LRMC official Twitter feed, and via the Armed Forces 
Network (Appendix C). A process flowsheet can be found in Appendix D. Participants who contact the 
study team directly will be instructed to access the Physical Therapy clinic or their primary care manager 
for a physical exam and diagnosis of PF, or confirmation of a previous PF diagnosis (Appendix E). The 
Physical Therapy Clinic is a direct access clinic that does not require a referral. Participants may also be 
identified by providers in the Family Medicine, Podiatry, Physical Medicine, and Physical Therapy clinics; 
study advertisements will be made available for the clinics to supply to potential participants. Prior to the 
start of the study and periodically during study conduct, the PI will brief clinic staff at staff meetings, a study 
team member will attend the clinic morning huddles as needed, and will provide the advertisement to the 
clinics which will include instructions for contacting the study team. 
 
Screening: Interested participants will then be screened in person or over the phone by a member of the 
study team using the Screening Script (Appendix F) to determine eligibility. Individuals who do not meet 
Inclusion/Exclusion criteria will be instructed to continue to seek care with their primary care provider 
and/or direct access at physical therapy. 
 
Enrollment: A team member will explain the research protocol and obtain informed consent/HIPPA in 
person along with baseline outcome measures (Participant Information Sheet, FAAM, DVPRS, Ankle 
Dorsiflexion). See Appendix G for the data collection matrix timeline. A study team member will also 
acquire measurements of calf, ankle, and foot to calculate the appropriate PBM dose (Appendix H). 
Participants will then be randomly assigned to a group using an Excel random number generator.  
 
Treatment & Data Collection: All participants will be asked to complete the UC Protocol (UC) (Appendix I). 
The UC protocol is a daily regime of stretching and cryotherapy that includes 3-5 minutes of stretching 
upon waking, then approximately 3-5 minutes of stretching and 3-5 minutes of cryotherapy throughout the 
day (See appendices I & J for instructions and participant handout). Those randomized to one of the PBM 
treatment groups will also receive nine PBM treatments over the course of three weeks (3 treatments per 
week). PBM treatments will take approximately 5-15 minutes to administer at each session. PBM 
treatments will be performed at flexible times to accommodate participants’ duty schedules. Specific 

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treatment parameters will be based on measurements of calf, ankle, and foot using pre-calculated 
treatment tables (Appendix H).  
 
The Research Coordinator will contact participants in the UC alone group weekly (via email, telephone call, 
or text) compliance checks and to address any questions. Participants in all groups will report to the study 
team at 3 and 6 week time points to complete the FAAM, ankle dorsiflexion, and turn in their Pain Diary. 
Long-term follow up questionnaires at 3 and 6 months will be given to participants via paper copy handout, 
mailed by post, emailed, or automated.  Copies of the paper survey may be provided to participants at their 
last appointment (at 6 weeks), along with addressed, stamped envelopes.  Reminder phone calls and 
emails will be sent to participants at the phone and email address provided to the study team before the 3 
and 6 month follow-up time points using a modified Dillmans Total Design Method.  
 
Missed appointments and removal from study:  If a participant misses a scheduled appointment, he/she will 
be rescheduled in order to maintain the three times a week for three weeks schedule.  In the event that a 
participant "no-shows" for an appointment, study staff will make one attempt on each of three separate 
days for a total of at least three total attempts to reschedule.  If the participant cannot be reached or does 
not respond/reschedule, he/she will be removed from the study for non-compliance 
Follow-up: If a participant does not respond to their satisfaction, the study team will refer them to their 
primary care provider, to direct access at Physical Therapy, or to Physical Medicine Clinic for further 
assessment and treatment at the end of the 6 week data collection point. 
 
 
 
 

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      B5.4  Data Collection Please see Appendix G for data collection timeline/matrix.    

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Instrument 
Characteristics 
Outcome Measure 
Participant 
Information 
Sheet 
The Participant Information Sheet (Appendix J) 
will be used to obtain demographic information, 
Fitzpatrick Skin Phototype (Appendix K), and 
foot, ankle, and calf measurements for PBM 
dosage calculation. The Fitzpatrick Skin 
Prototype is a rating of susceptibility to skin 
damage from UV radiation.(49) 
Demographic Information; 
measurements for dose calculation 
Participant 
Adherence 
Log 
Self-created (Appendix L) 
Aim 1: description of retention and 
completion of follow-up assessments 
Foot and 
Ankle Ability 
Measure 
(FAAM) 
The FAAM is a 29-item self-report instrument 
that assesses physical function in foot and ankle 
impairments which included PF cases in 
development. There are two subscales, 
Activities of Daily Living (21-item) and Sports (8-
item). Each item is scored on a 5-point Likert 
scale (4=’no difficulty at all’ to 0=’unable to do’); 
points are transformed to a percentage 
(100%=no dysfunction).  Test-retest 0.89 & 0.87 
for ADL & Sports subscale; internal consistency 
α=.98, minimum clinically important difference 8 
& 9 points for ADL & Sports subscale, 
respectively.(50) (Appendix M).  Approved for 
use. 
Aim 2/3: Primary outcome measure for 
function; collected at baseline, 3/6 
weeks, 3/6 months. 
Pain Diary 
Defense and 
Veterans Pain 
Rating Scale 
(DVPRS) 
Defense and Veterans Pain Rating Scale 
(DVPRS) 72. This 5-item scale integrates a 
numeric pain rating scale with visual facial cues 
and word descriptors as well as 4 supplemental 
questions on pain interference. Construct 
validity using component factor analysis 
revealed one item group (factor loadings >.78 
and >.81) for outpatient and inpatient 
participants, respectively, with high internal 
consistency (.87-.90).(51, 52)  
The daily Diary will include the DVPRS, and 
space to document any medications taken and 
activity completed during each 24 hour period to 
attempt to explain potential variation. (Appendix 
N) 
Aim 2/3: Primary outcome measure for 
pain; DVPRS collected at baseline, 3/6 
weeks, 3/6 months. 
 
DVPRS will also be recorded daily in 
the Pain Diary to further analyze 
interindividual trends in pain. 
Ankle 
Dorsiflexion 
Measures range of motion of ankle in weight-
bearing conditions; recorded as distance from 
great toe to wall at maximal dorsiflexion 
(1cm=3.6°); with novice rater (ICC=98-.99), 
minimal detectable change 1.5cm.(53, 54) 
(Appendix O) 
Aim 2/3: Secondary measure for 
improved function; only collected at 
baseline and 3/6 week time points.   
 
 
 
 
B5.5  Managing Data and/or Human Biological Specimens for this Research   
To ensure confidentiality, each participant will be assigned a numeric identification number upon 

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enrollment. This identifier will be used throughout the study. All study files will be stored in a locked file 
cabinet in the Research Coordinator’s office.  The code book linking full names and identification numbers 
will be kept separate from all other study documents in a locked desk drawer in the RC’s office.  All data 
will be saved to a CAC enabled/password protected laptop connected to the hospital servers. The only 
people who will have access to this information are the PI, AIs, and the Research Coordinator. After the 
completion and closure of the study, files will be store in the LRMC’s Clinical Investigation file storage 
room.  After six years, all data will be shredded and disposed. 
 
      B5.6  Managing Data and/or Human Biological Specimens for Future Research   
 
N/A 
 
      B5.7  Devices, Drugs, Dietary Supplements, Nutritional Supplements, And Biologics   
 
                B5.7.1  Devices 
 
5.7.1.1 FDA-approved device being used in this research according to the approved 
labeling 
 
N/A 
 
 
                            
 
5.7.1.2 FDA-approved device being used in this research in 
a manner other than its approved labeling 
 
 
The LightForce® EXP therapy laser (Figure 2), which will be 
provided through a Cooperative Research and Development 
Agreement between the Clinical Investigation Regulatory Office, 
U.S. Army Medical Research and Materiel Command and 
LiteCure, LLC (Dover, DE), is an FDA approved device for the 
treatment of pain and inflammatory conditions. Because this 
study will evaluate the effectiveness of the device to decrease 
pain and improve function, the PI will meet the FDA abbreviated investigational device 
exemption (IDE) requirements. The laser device to be used in this study does not meet the 
definition of a Significant Device according to 21 CFR 812.3(m): 
It does not present a potential for serious risk to the health, safety, or welfare of the subject, 
and,  
- It is not an implantable device; 
- It is not used to support or sustain human life; 
- It is not used for substantial importance in diagnosing, curing, mitigating, or treating disease, 
or otherwise preventing impairment of human health. 
 
Furthermore, similar devices are listed as an example of NSR devices (Low Power Lasers for 
treatment of pain).  
 
Complete specifications of the PBM device can be found in Appendix P.   
 
                B5.7.2  Drugs 
 

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B5.7.2.1 FDA-approved and used in accordance with the approved labeling 
 
N/A 
 
B5.7.2.2 FDA-approved and used in a manner not in accordance with its approved 
labeling 
 
N/A 
 
B5.7.2.3 Any drug not approved by the FDA 
 
N/A 
 
     B5.8  Statistical Analysis 
 
B5.8.1  Sample Size Estimation 
 
Because this is an exploratory study, and similar studies reported in the literature using the same 
treatment parameters are lacking, establishing an effect size is difficult.  Power analysis was 
performed with consultation from Glaser Consulting for this 3 x 5 (group x time) design utilizing a 
mixed (between and within subject) ANOVA, setting parameters at power of 1 – β = .8, level of 
significance of α= .05 and an autocorrelation parameter ranging from 0.3 to 0.7 and a standardized 
effect size (F) ranging from small (0.1) to medium (0.25) in .05 increments. The table in Appendix Q 
presents the recommended total sample sizes using the freely available G*Power software.57, 58 
Considering the exploratory nature of the study, the timeline of the exploratory award (2 years), and 
given the estimated population of accessible participants, an small to medium effect size of 0.15 and 
autocorrelation of 0.3 will be chosen, requiring n = 96 participants, or n = 32 participants per group.  
Attrition rates vary in other plantar fasciitis studies depending on the length of follow-up and the 
treatment provided. In this study, data from the 3 and 6 month follow up time points will be collected 
by paper handout, mailed, emailed or may be automated/electronic to enable compliance, however, 
because we do not have pilot data to guide historic attrition rates for this specific intervention, we will 
over-recruit by 20% (n = ~114, or n = 38 participants per group) to account for the potential attrition. 
Assuming n = 32 per group is obtained, resulting in a total sample size of n = 96, it is possible to also 
analyze the data using a multilevel modeling (MLM) approach.  
 
 
B5.8.2  Data analysis   
 
For all data analysis, descriptive statistics and effect sizes will be furnished and data cleaning will be 
conducted including examination of outliers, non-normality, and homoscedasticity/heterogeneous 
variances, and missing data. All analysis will be conducted using SPSS 23.0, HLM 7.01, and/or Mplus 
7.4. Given that this is an exploratory analysis, all tests of significance will be based on a level of 
significance of α = .05, unless a more conservative correction to alpha is warranted, hence 
addressing concomitant inflated Type I error rate. Appropriate corrections for multiple comparisons 
may also be warranted in the case of exploratory analysis. 
 
Aim 1:  The feasibility and adherence of the PBM protocol will be assessed using descriptive 
measures of enrollment and retention (Appendix L). 
 
Aim 2 and 3: A mixed ANOVA approach for this 3 x 5 (group x time) design will be performed, testing 
the group by time interaction. All assumptions will be closely examined and tested, such as sphericity 
and homogeneity of variance/covariance matrices.66 If the first order interaction is significant simple 

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effects analysis will be performed, comparing the groups at each wave of data collection, and if the 
simple effects are significant simple comparisons using the Sidak multiple comparison procedure 
(MCP) test will be used so as to compare pairwise differences at each point of time.  Moreover, if the 
first order interaction is significant, trend analysis will be conducted so as to examine any nonlinear 
effects. Graphic displays will also be furnished so as to illuminate the findings. 
 
We will also consider analyzing the data using a multilevel modeling (MLM) approach.  As opposed to 
the listwise deletion default of repeated measures ANOVA, and possible concomitant loss of data and 
attenuation of power (as well as potential bias of the parameter estimates) if certain cases do not 
respond, the advantage of MLM is that it will use all the available data for all the cases, even if there 
is only one repeated measure for a given case. As well, this technique is appropriate for nested 
structures as per the design for this study, where occasion (Level 1 = micro level) is nested within the 
individual (level 2 = macro level). As mentioned previously, the flexibility of a MLM approach is in that 
there can be varying patterns of missing data as well as varying timing of the measures (which can be 
coded and incorporated as a time-varying parameter). Besides reporting the parameter estimates, if 
MLM is performed, the conditional intraclass correlation coefficient (ICC) will be reported, which in 
this context will capture the interindividual variability in the intercepts with time as a fixed 
(nonrandomly varying) covariate. Additionally, a cross-level interaction (time x individual variable) will 
be examined, that being time by group interaction. As well, examining the random (stochastic) 
parameters can help identify interindividual differences in intraindividual change.   
 
De-identified data will be shared with Brooke Army Medical Center and/or San Antonio Military 
Medical Center (BAMC/SAMMC) statistician(s) to perform additional analysis or secondary analysis.   
 
 
 
SECTION C:  HUMAN RESEARCH PROTECTIONS 
 
C1.  RECRUITMENT AND CONSENT   
 
C1.1  Identification and Selection of Subjects   
The study will be advertised using a variety of media (Appendix B) to capture eligible participants from 
around the Kaiserslautern Military Community.  Participants may also be identified by providers or staff in 
the Family Medicine, Podiatry, Physical therapy, or Physical Medicine and Rehabilitation Clinics. Study 
advertisements will be made available to clinic staff.  Prior to the start of the study, a member of the study 
team will brief the staff of the Family Medicine, Physical Therapy, Podiatry, and Physical Medicine and 
Rehabilitation Clinics on the study. 
 
C1.2 Recruitment Process   
Participants may self-refer to the study. Interested parties will be able to contact a member of the study 
team (PI or RC) via phone or email. A process flowsheet can be found in Appendix D. Participants who 
contact the study team directly will be instructed to access the Physical Therapy clinic or their primary care 
manager for a physical exam and diagnosis of PF, or confirmation of a previous PF diagnosis. The 
Physical Therapy Clinic is a direct access clinic that does not require a referral. Participants who are 
identified by clinic staff will be provided with information for contacting the study team.  
 
C1.3  Eligibility   
 
Interested participants will be screened in person or over the phone by a member of the study team using 
the Screening Script to determine eligibility (Appendix F). Individuals who 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. 

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C1.4  Consent Process   
 
To mitigate the perception of coercion, all person-to-person contact with participants will be conducted in 
civilian clothing if the research team member is a military member, and members of the study team will not 
use rank to identify military members. Once a participant is found to be eligible for the study; the purpose, 
procedures, and participant expectations for the study will then be explained in a private office in the 
Center for Nursing Science and Clinical Inquiry. Participants will be informed that they may disenroll at any 
point during the study without affecting their eligibility of continuing to receive medical care. Potential 
participants will be allowed time to ask questions, and may take the consent form home and arrange to 
return at a later time if they desire. If the participant concurs, a signature will be obtained on the consent 
(Appendix R) and a copy given to the participant. The participant will then be assigned a unique Study ID 
that will be used throughout the duration of the study.  
 
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.  
 
C1.4.1  Research involving subjects with cognitive impairment or who lack capacity to 
provide informed consent 
 
N/A 
 
                 C1.4.2  Research involving non-English speaking subjects 
 
In order to participate in this study, participants must be able to read and speak English. 
 
                 C1.4.3  Research involving a waiver of the requirement to obtain informed consent OR 
alteration of the elements of informed consent 
 
N/A 
 
                 C1.4.4  Research involving a waiver of the requirement for investigator to obtain a signed 
consent form 
 
N/A 
 
                 C1.4.5  Waivers of assent or parental permission when the research involves children 
 
N/A 
 
                 C1.4.6  Research involving data collection for the USAMRMC Volunteer Registry Database 
 
N/A 
 
C2.  COMPENSATION FOR PARTICIPATION   
 
 
Participants will not receive any monetary compensation.   
 
 
Each participant, however, will receive reimbursement for gas and mileage expenses related to travel required 
for 3 study visits (Baseline enrollment, 3 week follow up, 6 week follow up). This amount will be individually 

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calculated for travel solely for the purpose of the study (excluding travel to LRMC for work or for other already 
planned medical appointments) based on the standard $.56 per mileage for a total of 3 trips to complete the 
study. The reimbursement will be given to the participants in the form of an AAFES or Visa gift card and the 
amount will be rounded up to the nearest $5 amount, not to exceed $75. (All eligible participants are expected 
to have access to AAFES and the amount on the cards can be transferred towards gas purchases. Visa gift 
cards will be given in the event the participant does not have AAFES privileges. The study is designed for 
participants from the local area. Eligible participants who choose to drive extended distances will have a cap 
on the reimbursement.) Participants must complete all study milestones through the 6 week follow up to be 
eligible for reimbursement.   
 
C3.  WITHDRAWAL FROM RESEARCH PARTICIPATION   
 
Participants will be instructed that they may withdraw from the study at any time for any reason. The 
participants will be informed that there will be no repercussions and their healthcare will not be affected if they 
participate and/or drop out of the study.  Any data collected will be used in the data analysis. 
 
C4.  PRIVACY FOR SUBJECTS   
 
Participants will self-refer to the study and screening, consent, and enrollment procedures will occur over the 
phone or in a private office.  Treatment and data collection will occur by a member of the study team in a 
private room.   
 
C5.  CONFIDENTIALITY PROCEDURES FOR RESEARCH RECORDS, DATA, HUMAN BIOLOGICAL 
SPECIMENS   
 
Participants will be assured that their identities will remain confidential; the participants will not be identified by 
name on questionnaires. Upon enrollment, each participant will be assigned a unique numeric identifier that 
will be placed on all documents administered throughout the study period. Only the research team will be able 
to identify participants by using a code number and a code book. The code book, informed consent with HIPAA 
form, phone, email, and address information, and all questionnaires will be maintained in a locked file cabinet 
in the Center for Nursing Science and Clinical Inquiry office. The code book and informed consent with HIPAA 
form will be maintained separately from the completed questionnaires. Only the research team members will 
have access to the locked files. Computer and data files will be password protected. When the results of the 
study are published, the data will be reported as aggregate data.   
 
C6.  RISKS OF HARM, MEASURES TO REDUCE THE RISKS OF HARM, AND BENEFITS OF 
PARTICIPATION 
 
       C6.1 Risks of Harm   
 
The study overall is considered to be minimal risk for the participant.  PBM treatment is used by a variety of 
healthcare practitioners for clinical conditions of pain and inflammation.  
 
        Research Procedure Name:  Photobiomodulation 
        Research Procedure Description:  Light therapy for Plantar fasciitis 
       
  Research-related Risks:   
 
Damage to eye structures  
 
uncomfortable skin heating 
 
        Measures to Minimize Risks of Harm: (Precautions, safeguards):   

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 
Protective eyewear will be worn by all participants and study team members during treatment sessions 
to avoid damaging their eyes. 
 
Along with the Laser Safety Officer, the PI will ensure that the treatment space meets all regulatory 
requirements for utilization of a treatment laser, including appropriate signage and use of laser blocking 
screens to absorb any potential scatter/refraction of light outside of the treatment area. 
 
In the rare occurrence that participants experience uncomfortable warmth over the treatment area, the 
treatment will be modified or stopped.  
 
C6.2  Incidental or Unexpected Findings   
 
N/A 
 
 
C6.3  Potential Benefits   
 
The potential benefit for study participants is the relief of heel/foot pain and improved function, which may 
be accelerated for those in the UC plus PBM groups. Information learned from their participation in this 
study may help individuals with PF in the future. 
 
C7.  DATA AND SAFETY MONITORING   
 
       C7.1 Monitoring 
 
The PI will conduct fidelity/safety checks weekly. Participants in the treatment groups will be seen three 
times a week, and the RC will contact the participants from the UC alone group weekly to assess 
compliance, any negative side effects, and any questions or concerns.  Study and participant files will be 
reviewed once a quarter by the PI or AIs to ensure proper documentation, protocol deviations, and 
compliance with all regulatory requirements. 
 
In addition to monitoring by the PI, the LRMC Human Research Protections Office (HRPO), will conduct 
regular monitoring of the protocol as required by the abbreviated IDE for NSR. Unless otherwise indicated, 
monitoring will occur at the time of Continuing Review and will be conducted with the Human Research 
Protection Program Office most recent auditing tool..  
 
       C7.2 Research Monitor  
 
The IRB determination for the preliminary study using the device deemed the protocol to be 
“Minimal Risk” so no Research Monitor was needed. 
 
C8.  REPORTABLE EVENTS    
 
       C8.1  Expected adverse events 
 
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 
plantar fasciitis. 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 use of this technology clinically and reports from other research studies, the risk of 
expected adverse events is low. The following scale, based on “Common Terminology Criteria for Adverse 
Events v4.0 (CTCAE), will be used to grade the severity of expected adverse events. The categories 
“possibly related”, “probably not related”, and “definitely related” will be used to attribute the relatedness of 
the event to the study procedures.  

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 
Grade 1 Mild (mild symptoms, intervention not indicated): mild discomfort from stretching exercises 
or ankle dorsiflexion measure  
 
Grade 2 Moderate (minimal, local or noninvasive intervention indicated): uncomfortable warming of 
skin/tissue; uncomfortable cooling from usual care ice application 
 
Grade 3 Severe (medically significant but not immediately life-threatening): n/a 
 
Grade 4 Life-threatening consequences: n/a  
 
Grade 5 Death related to AE: n/a 
 
  
 
       C8.2  Unexpected adverse events and unanticipated problems 
 
In the event that an unexpected adverse event or unanticipated problem does occur, the RC or AIs will 
contact the PI immediately. The PI will be responsible for reporting any unanticipated adverse effects and 
unanticipated problems to the FDA in accordance with abbreviated IDE requirements for NSR devices. All 
adverse events will be tracked via a reportable event log and the information will be forwarded to the IRB 
in accordance with its policy.  Unexpected adverse events and unanticipated problems will be graded as 
described in C8.1.  
 
All unanticipated problems involving risk to subjects or others and serious adverse events will be promptly 
reported by phone (301-619-2165), by e-mail (usarmy.detrick.medcom-usamm-other.irb-office@mail.mil), 
by facsimile (301-619-4165) to the HQ, USAMRMC IRB, or sent to the U.S. Army Medical Research and 
Materiel Command, ATTN: MCMR-RP, 504 Scott Street, Fort Detrick, Maryland 21702-5012. A complete 
written report will follow the initial notification. 
 
       C8.3  Adverse device effects 
 
Unanticipated adverse device effects are defined as any serious adverse effect on health or safety or any 
life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death, 
was not previously identified in a nature, severity, or degree of incidence in the investigational plan or 
application (including a supplementary plan or application), or any other unanticipated serious problem 
associated with a device that relates to the rights, safety, or welfare of subjects” (21 CFR 812.3(s)). 
Adverse device effects will be reported to both IRB and FDA in accordance with their policy (see C8.2). 
Adverse device effects will also be reported to Lite Cure, LLC, as directed in the CRADA. 
 
       C8.4  FDA-regulated research under IND and IDE 
 
The device is FDA approved for use in the treatment of pain and inflammation.  Because this study will 
evaluate the effectiveness of the device to decrease pain and improve function, this will be a non-
significant risk, abbreviated IDE study. In addition to all standard reporting requirements to the IRB, the 
Sponsor/PI will submit reports to the FDA in the event of any unanticipated adverse device effects, 
withdrawal of IRB approval, failure to obtain informed consent, or any other reports required by either the 
IRB or FDA. The Research Compliance Officer will monitor the study according to the monitoring plan in a 
separate document.    
 
 
 
 
SECTION D:  REFERENCES 
 

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Canyilmaz E, Canyilmaz F, Aynaci O, Colak F, Serdar L, Uslu GH, et al. Prospective Randomized 
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Rompe JD. Plantar fasciopathy. Sports medicine and arthroscopy review. 2009;17(2):100-4. 
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SECTION E:  ABBREVIATIONS AND ACRONYMS 
 
Center for Nursing Science and Clinical Inquiry (CNSCI) 
Landstuhl Regional Medical Center (LRMC) 
Photobiomodulation (PBM) 
Plantar fasciitis (PF) 
Body Mass Index (BMI) 
Light-emitting diode (LED) 
Nanometer (nm) 
Cytochrome C oxidase (CCO) 
UC Protocol (UC) 
Activities of Daily Living (ADL) 
Defense and Veterans Pain Rating Scale (DVPRS) 
Multilevel modeling (MLM) 
Multiple comparison procedure (MCP) 
Intraclass correlation coefficient (ICC) 
 
 
 
SECTION F: DoD PRIVACY RULE AND PROTECTED HEALTH INFORMATION (HIPAA)  
 
 NA – institution is not a covered entity 
 
 NA – will not use or disclose protected health information 
 
 HIPAA authorization will be obtained  

Protocol Title:  Effectiveness of Photobiomodulation Compared to Usual Care for Plantar Fasciitis 
Version #:  8.1 
Date:   08 Apr 2019  
 
 
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 An application for waiver/alteration of HIPAA authorization will be submitted