Acupuncture for Plantar Fasciosis in the Primary Care Setting
Phase: NA
Conditions: Plantar Fascitis
Sponsor: Mike O'Callaghan Military Hospital

4/24/2019 
Acupuncture for Plantar Fasciosis in the Primary Care Setting 
NCT03246087 
 
 

 
59th Medical Wing Institutional Review Board 
PROTOCOL FOR NON-EXEMPT RESEARCH INVOLVING HUMAN SUBJECTS Title: 
Acupuncture for Plantar Fasciosis in the Primary Care Setting: A randomized control trial. 
IRB #: 
FWH20170077H Principal Investigator (PI) Rank / Civ Rating Branc h AD/DoD Civ/ 
Ctr/Civilian Dept/Base Phone # E-mail 
Stephen Cagle, MD 
Capt 
USAF 
AD 
FMR/Scott AFB 
(870) 
723-8815 
Stephen.cagle.2@us.af.mi l Co-PI (at Joint Site, if applicable) Rank / Civ Rating Branc h 
AD/DoD Civ/ Ctr/Civilian Dept/Base Phone # E-mail 
Carlton Covey, MD 
LtCol 
USAF 
AD 
FMR/Nellis 
(702) 
653-3298 
carlton.j.covey.mil@mail.m il 
The research relevance of this protocol focuses on: 
Diagnosis 
Treatment 
Medical Utilization/Managed Care 
Prevention 
Medical Readiness 
Other: 
1. LOCATION AND SPONSOR Collaborating Facilities: None AF Sites Seeking Regional 
IRB: 
Stephen Cagle, MD, Capt, Scott AFB, (870) 723-8815, Stephen.cagle.2@us.af.mil Jill Clark, 
Nellis AFB, (702) 653-3298, jill.m.clark15.ctr@mail.mil Study Sponsors: None 
2. RESEARCH PLAN Purpose of Study: 
To determine if the addition of acupuncture to a standard of care prescribed exercise 
program is more effective at improving pain and function in adult patients with plantar 
fasciosis. Hypotheses, Research Questions, or Objectives: 
We want to investigate whether a specific acupuncture protocol, when added to the 
standard of care treatment, can improve pain and function in adults with plantar fasciosis. 

We hypothesize that there will be a significant improvement in both pain and functional 
outcomes, both acutely and over time, in the experimental group compared to the control 
group. We will measure foot pain immediately prior to treatment (baseline), immediately 
after the initial treatment and at 2 weeks, 4 weeks, 6 weeks, and 12 weeks. The Foot 
Function Index Revised short form will be used during the same intervals to evaluate foot 
function. At 3 months, patients in the non-acupuncture group will cross-over into the 
acupuncture group if still experiencing pain. Significance: 
Acupuncture, combined with a standard of care prescribed exercise program, is superior to 
a standard of care prescribed exercise program alone in military beneficiaries would result 
in less: lost duty days, profiles, and physical fitness testing exemptions in our active duty 
population, as well as an improved quality of life for all patients. Military Relevance: 
Plantar fasciosis has a lifetime prevalence of 10% in the general population and can have a 
significant impact on quality of life.2,4 Overuse injuries including plantar fasciosis are 
commonplace in the military with reports being as high as 22% personnel experiencing 
overuse injuries in a deployed army unit.11 
A recent combat training article showed that lower extremity overuse injuries accounted for 
over 70% of attrition rates during US Army combat training.8 Another study showed that of 
all chronic lower extremity injuries in military recruits, plantar fasciosis had the highest 
incidence.9 Current reports show an incidence of 10.5 cases of plantar fasciosis per 1000 
patient years in the military. This indicates that 1 in 100 members will develop plantar 
fasciosis each year and a significant portion of these members will seek care in the primary 
care clinic.11 In the active duty population these individuals are placed on fitness 
restrictions which usually last 6 to 12 months leading to a significant impact on mission 
readiness. 
Version: 6 February 2017 Revised by PR 2019 1 
59th Medical Wing Institutional Review Board 
Various levels of acupuncture training have been taught to several hundred military 
physicians. A barrier to more widespread implementation has been the lack of scientifically 
rigorous clinical trials to prove its efficacy in spite of anecdotal reports purporting its value 
in treating plantar fasciosis. Most conventional treatment trials incorporate vigorous 
treatment protocols that are time consuming and are not a reasonable treatment option to 
perform in a primary care setting. The goal of this trial is to develop a treatment protocol 
that can easily be performed in the primary care setting and will establish the efficacy of 
acupuncture for treating plantar fasciosis and develop a technique that a non- 
acupuncturist can easily learn. Learning whether or not acupuncture is an effective 
treatment for plantar fasciosis in military beneficiaries could result in fewer lost duty days, 
decreased profiles and physical fitness testing exemptions, and improved quality of life. 
Background and Review of Literature: 
Plantar fasciosis is characterized by calcaneal heel pain that is most severe with initial steps 
in the morning or after a prolonged period of rest. Palpation of the medial calcaneal 
tubercle, the site of the plantar fascia origin, will elicit the pain.2,4,7 Plantar fasciosis is 

usually a self-limiting condition that resolves in 6 to 12 months without interventions. 
2,4,7,11 However, there can be a significant impact on quality of life and physical function 
during a period of prolonged symptoms. 
Management of plantar fasciosis focuses on stretching and strengthening of the associated 
structures involved to include the plantar fascia and gastroc-soleus complex. Orthotics are 
currently utilized to improve support and prevent over pronation of the foot when walking. 
2,4 The evidence to support these modalities are limited given that most of these are 
performed in conjunction with other treatment modalities and there is no clear evidence to 
support one treatment modality over the other. 14 The goals of treatment are decreased 
pain and improved function. 
The Foot Function Index-Revised short form is a validated assessment tool utilized in lower 
extremity tendinopathies and has been validated in the use of plantar fasciitis. It is a 34 item 
questionnaire with each question being scored from 1-4, with the highest possible score 
being 136 and the lowest being 34. The Foot Function Index-Revised form assesses pain and 
function during activities of daily living. The mean minimal difference associated with a 
significant patient oriented outcome is a decrease of 12 points in pain on the pain section of 
the questionnaire, a decrease of 7 in the function section of the questionnaire, or an overall 
decrease of 7 points on the Foot Function Index-Revised short form.6 
Acupuncture is a nonpharmacologic treatment approach that has been proven to reduce 
pain acutely in plantar fasciitis. 1,3,12,15 However, the studies utilized daily therapies 
lasting 30 minutes, which make these treatments less likely to be performed in the primary 
care setting. 5,14, 15 Some of the methods used have poor or insufficient evidence to 
support the specific acupuncture points that were used in treatment. 3 This represents a 
significant research and knowledge gap. We propose to fill this gap by conducting a large, 
carefully designed, and randomized controlled trial that directly compares the efficacy of 
the addition of acupuncture to a standard of care prescribed home exercise program. 
The needles being used are Hwato 0.3x100mm stainless steel needles which are approved 
by the FDA for use in acupuncture and will be used in accordance with their FDA 
approved labeling. As part of this study, the acupuncture needles themselves are not the 
object of the investigation, the process of acupuncture and the effect it has is what we are 
studying. The needles are merely the avenue we use to perform the acupuncture. 
According to 21 CFR 880.5580, an acupuncture needle is a device intended to pierce the skin 
in the practice of acupuncture.13 There are no known restrictions on the use of the 
acupuncture needles that prevent them from being used by qualified practitioners of 
acupuncture as they deem appropriate. Bibliography: 
1. Cotchett, M, K Landorf, and S Munteau, “Effectiveness of dry needling and injections of 
myofascial trigger points associated with plantar heel pain:a systematic review,” Journal of 
Foot and Ankle Research. 2010 Sep 1;3:18. 
2. Covey, CJ, Mulerd, MD “Plantar fasciitis: How best to treat?” Journal of Family Practice. 
2013 Sep:62(9):466-71. 

3. Glickmon-Simon, R, J. Wallace “Acupuncture for Knee Osteoarthitis, Chastberry for 
Premenstrual Syndrome, Probiotics for Irritable Bowel Syndrone, Yoga for Hypertension, 
and Trigger Point Dry Needling for Plantar Fasciitis,” Explore. Mar-Apr;11(2):157-61. 
4. Goff, J, R Crawford, “Diagnosis and Treatment of Plantar Fasciitis,” Am Fam Physcian. 
2011 Sep 15;84(6):676-682. 
5. Kumnerddee, W, N Pattapong. “Efficacy of Electro-Acupuncture in Chronic Plantar 
Fasciitis: A Randomized Control Trial,” The American Journal of Chinese Medicine. 2012: 
Vol. 40, No. 6, 1167-1176. 
6. Landorf, K, J Radford, “Minimal important difference: Values for the Foot Health Status 
Questionnaire, Foot Function Index and Visual Analogue Scale,” The Foot. Mar 2008 
18(1):15-19. 
7. Li, S, T Shen, Y Liang, et al “Miniscalpel-Needle versus Steroid Injection for Plantar 
Fasciitis: A Randomized Controlled Trial with a 12-Month Follow-up,” Evid Mased 
Complement Alternat Med. Epub 2014 Jul 8. 
Version: 6 February 2017 Revised by PR 2019 2 
59th Medical Wing Institutional Review Board 
8. Oren S, T Libenson, N Astman, L Haim, “Attrition Due to Orthopedic Reasons During 
Combat Training: Rates, Types of Injuries, and Comparison Between Infantry and 
Noninfantry Units,” Mil Med. Aug 2014 179(8):897-900. 
9. Owens, B J Wolf, A seeling, et al. “Risk Factors for Lower Extremity Tendinopathies in 
Military Personnel,” Orthop J Sports Med. 2013 Jun11;1(1). 
10. Roy T, “Diagnosese and mechanisms of musculoskeletal injuries in an infantry brigade 
combat team deployed to Afghanistan evaluated by the brigade physical therapist,” Mil 
Med. 2011 Aug;176(8):903-8. 
11. Scher D, P Belmont, R Bear, et al. “The incidence of plantar fasciitis in the United States 
Military,” J Bone Joint Surg Am. 2009 Dec;91(12):2867-72. 
12. Thiagarajah, A. “How effective is acupuncture for reducing pain due to plantar 
fasciitis?” Singapore Medical Journal. 
13. U.S. Food and Drug Administration. General Hospital and Personal Use Therapeutic 
Devices. Retrieved July 17, 2015 from 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=880.5580. 
14. Woitzik, Erin, C Jacobs, J Wong, et al. “The effectiveness of exercise on recovery and 
clinical outcomes of soft tissue injuries of the leg, ankle, and foot: A systematice review by 
the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration,” Manual 
Therapy. 20 (2015);633-645. 
Zhang, S, T Yip, and Q Li, “Acupuncture Treatmet for Plantar Fasciitis: A Randomized 
Controlled Trial with Six Months Follow-Up,” Evid Based Complement Alternat Med. 
Epub 20011 Feb 15. 
3. RESEARCH DESIGN AND METHODS 
All of the below items are research-related unless marked as ‘standard of care’: 
Screening Visit: 

• Obtain and document signed Informed Consent document and HIPAA Authorization. 
• Review past medical history in Armed Forces Health Longitudinal Technology 
Application (AHLTA) to verify the inclusion/exclusion criteria including previous 
encounter, vital signs review, medication list, co-morbidities, demographics, and problems 
list. 
• Record: Date of birth, age, gender, race, ethnicity, last 4 of social security number, name of 
standard of care medications (over-the-counter and prescription), current email address (to 
be used for scheduling), height (in inches), weight (in pounds), history of prior foot injury, 
and note any prior acupuncture received. 
• We will ask what the subjects expectations are regarding acupuncture's effectiveness for 
plantar fasciitis. 
• If the subject is an active duty member, we will ask: 
o Have you or are you currently on a fitness restriction for plantar fasciitis. 
o If so, what are the dates of the restriction. 
• There are several standard of care treatments for plantar fasciitis which include physical 
therapy and a standard of care prescribed home exercise program. We will standardize 
what patients in this study are receiving by having all subjects follow the standard of care 
prescribed home exercise program and discontinue any formal physical therapy when 
entering this study (regular physical activity such as exercise is allowed). 
Visit 1-Day 1 (may be same day as screening visit): 
• Subjects will be given a study diary to document the number of times they performed the 
standard of care prescribed home exercise program. Subjects will be advised to complete 
the stretching exercises daily and the strengthening exercises every other day. 
• Administer the Foot Function Index-Revised short form (FFI-R short) 
• Subjects will be randomized into one of two groups and the intervention will be 
performed: 
o Group 1: Self-reported pain severity pre-intervention (0 for no pain to 10 being the worst 
pain) Acupuncturist will be given a copy of the Protocol for Needle Insertion. Acupuncture 
will be performed and the standard of care prescribed home exercise program will be 
reviewed. Research Coordinator will record the name of the investigator performing the 
acupuncture, the number of acupuncture needles placed, and the position placed. Subjects 
will be instructed to perform the stretching exercises daily and the strengthening exercises 
every other day. Self-reported pain severity post-intervention (0 for no pain to 10 being the 
worst pain) 
o Group 2: Self-reported pain severity (0 for no pain to 10 being the worst pain) The 
standard of care prescribed home exercise program will be reviewed. Subjects will be 
instructed to perform the stretching exercises daily and the strengthening exercises every 
other day. 
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Visit 2-Week 2: 

• We will review subjects study diary and document the number of days the standard of 
care prescribed home exercise program was performed. 
• Administer the Foot Function Index-Revised short form (FFI-R short) 
• Group 1: 
o Self-reported pain severity pre-intervention (0 for no pain to 10 being the worst pain) 
o Acupuncturist will be given a copy of the Protocol for Needle Insertion. 
o Acupuncture will be performed and the standard of care prescribed home exercise 
program will be reviewed. 
o Research Coordinator will record the name of the investigator performing the 
acupuncture, the number of acupuncture needles placed, and the position placed. 
o Subjects will be instructed to perform the stretching exercises daily and the strengthening 
exercises every other day. 
o Self-reported pain severity post-intervention (0 for no pain to 10 being the worst pain) 
• Group 2: 
o Self-reported pain severity (0 for no pain to 10 being the worst pain) 
o The standard of care prescribed home exercise program will be reviewed. 
o Subjects will be instructed to perform the stretching exercises daily and the strengthening 
exercises every other day. 
Visit 3-Week 4: 
• We will review subjects study diary and document the number of days the standard of 
care prescribed home exercise program was performed. 
• Administer the Foot Function Index-Revised short form (FFI-R short) 
• Group 1: 
o Self-reported pain severity pre-intervention (0 for no pain to 10 being the worst pain) 
o Acupuncturist will be given a copy of the Protocol for Needle Insertion. 
o Acupuncture will be performed and the standard of care prescribed home exercise 
program will be reviewed. 
o Research Coordinator will record the name of the investigator performing the 
acupuncture, the number of acupuncture needles placed, and the position placed. 
o Subjects will be instructed to perform the stretching exercises daily and the strengthening 
exercises every other day. 
o Self-reported pain severity post-intervention (0 for no pain to 10 being the worst pain) 
• Group 2: 
o Self-reported pain severity (0 for no pain to 10 being the worst pain) 
o The standard of care prescribed home exercise program will be reviewed. 
o Subjects will be instructed to perform the stretching exercises daily and the strengthening 
exercises every other day. 
Visit 4-Week 6: 
• We will review subjects study diary and document the number of days the standard of 
care prescribed home exercise program was performed. 
• Administer the Foot Function Index-Revised short form (FFI-R short) 

• Group 1: 
o Self-reported pain severity pre-intervention (0 for no pain to 10 being the worst pain) 
o Acupuncturist will be given a copy of the Protocol for Needle Insertion. 
o Acupuncture will be performed and the standard of care prescribed home exercise 
program will be reviewed. 
o Research Coordinator will record the name of the investigator performing the 
acupuncture, the number of acupuncture needles placed, and the position placed. 
o Subjects will be instructed to perform the stretching exercises daily and the strengthening 
exercises every other day. 
o Self-reported pain severity post-intervention (0 for no pain to 10 being the worst pain) 
• Group 2: 
o Self-reported pain severity (0 for no pain to 10 being the worst pain) 
o The standard of care prescribed home exercise program will be reviewed. 
o Subjects will be instructed to perform the stretching exercises daily and the strengthening 
exercises every other day. 
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59th Medical Wing Institutional Review Board 
Visit 5-Week 12: 
• We will collect subjects study diary. 
• Administer the Foot Function Index-Revised short form (FFI-R short) 
• Group 1: 
o Self-reported pain severity (0 for no pain to 10 being the worst pain) 
o We will ask if their expectations were met or changed regarding acupuncture's 
effectiveness for plantar fasciitis. 
• Group 2: 
o Self-reported pain severity (0 for no pain to 10 being the worst pain) 
* CROSSOVER: At Visit 5 (final visit), those in the non-acupuncture group still experiencing 
pain and symptoms will be rolled into the acupuncture treatment arm of the study as 
outlined above. If the acupuncture group is still having pain they will be referred back to 
their primary care manager for further evaluation. 
Those subjects in Group 2 (non-acupuncture) that cannot make it to a follow up visit, may 
have their follow up visits via telephone. 
Acupuncture: 
This type of Acupuncture for this indication is routinely done as part of standard of care in 
our Family Medicine and acupuncture clinics in conjunction with a standard of care 
prescribed exercise program and as a stand-alone therapy. The Research Coordinator will 
record the name of the investigator performing the acupuncture and also the number of 
acupuncture needles placed for each treatment. 
Acupuncture treatments will be utilizing the KB-2 points with manual manipulation 
accomplished by vigorously running the acupuncturists thumb nail up and down the 
handle until a perceived sensation change is noted in the patient’s foot. A single needle will 

be inserted as stated above and if the sensation change is not noted throughout the entire 
plantar and dorsal surfaces of the foot a second needle will be inserted over the first needle. 
This needle will be manipulated in the same manner as the first needle. This can be 
repeated up to a third needle if the desired change in sensation is not noted. No more than 3 
KB-2 needles will be placed per leg. The needles will be removed after the treatment is 
complete, which will last approximately 5-10 minutes (standard care). 
Acupuncture treatments will be as defined: The KB-2 points (see figure 1 below) will be 
used as the treatment points. KB-2 are generally not defined specific points, but are referred 
to the placement of the needle into the lateral leg and advanced through the interosseous 
membrane. The initial KB-2 point will be placed in the lower 1/3 of the leg above the lateral 
malleolus. The second needle will be placed in the middle 1/3 only if pain is still present 
after insertion and stimulation of the first needle. The third needle will be placed in the 
upper 1/3 only if pain is still present after insertion and stimulation of the first 2 needles. 
This study will follow all FDA requirements for the safe use of these devices. 
The acupuncture being performed in this study is a standard acupuncture technique for the 
treatment of plantar fasciitis. The physicians performing the treatment are trained in this 
acupuncture technique. As such, all physicians trained in this procedure will be able to 
perform the acupuncture for treatment of research subjects. The Food and Drug 
Administration (FDA) regulates acupuncture needles as a class II medical device, because 
they are intended for use in the cure, mitigation, treatment, or prevention of disease in man 
or are intended to affect the structure or function of the body of man. The FDA regulates the 
acupuncture needles (see 21 CFR 880.5580). The needles being used are Hwato 0.30X100mm 
Acupuncture needles (see figures 2-3 above), which are exempt from premarket notification 
by the FDA for use in acupuncture and will be used in accordance with their FDA 
approved labeling. 
Home Therapy: 
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59th Medical Wing Institutional Review Board 
No acupuncture will be performed on this group for treatment of plantar fasciosis. This 
group will only receive the standard of care prescribed home exercise regimen at the initial 
visit and have the exercises demonstrated to them. These subjects will follow-up at 2 weeks 
and 4 weeks and education and demonstration will be performed again with these patients 
at subsequent visits. a. Interventions and Observations: 
We will measure subject’s pain level and administer the FFI-R short at the first visit, 2 
weeks, 4 weeks, 6 weeks, and 12 weeks. Acupuncture treatments will be placed in the 
manner as described above. The number of needles will be recorded. b. Setting: 
Male and female (DoD beneficiaries). Age 18 years or older, who are diagnosed with 
plantar fasciosis and enrolled to the Scott AFB O’Fallon Family Medicine Residency Clinic 
located at 3 St. Elizabeth’s Blvd, Suite 4000, O’Fallon, IL and Nellis AFB MTF. c. Date(s): 
May 2017 through May 2020 d. Subjects: 

Male and female (DoD beneficiaries). Age 18 years or older, have been diagnosed with 
plantar fasciosis. No other special populations (e.g., children, military basic trainees, 
prisoners, detainees) will be recruited. e. Inclusion/Exclusion Criteria: 
Inclusion Criteria 
Inclusion: 
• Male and female DoD beneficiaries, age 18 years or older, who have been diagnosed with 
plantar fasciitis/fasciosis (in one or both of their feet) OR Patients meeting criteria of pain in 
the bottom of the foot/heel with first steps in the morning & tender to palpation over the 
medial calcaneal tubercle (where the plantar fascia inserts). Those with acute and chronic 
diagnoses will be included. 
Exclusion Criteria 
• Pregnant 
• Any of the following in the foot being included into the study: 
o Active cellulitis of lower extremity 
o Prior surgery for plantar fasciitis 
o Steroid injections in the last 12 weeks for plantar fasciitis; if received in last 12 weeks 
subjects will be offered to be involved in the study after they have completed a 12 week 
wash out period. 
o If they have every had any prior acupuncture for plantar fasciitis using the defined KB-2 
points Any regenerative therapy to include proliferation therapy or platelet rich plasma 
therapy in the last 12 weeks for plantar fasciitis; if received in last 12 weeks subject will be 
offered to be involved in the study after they have completed a 12 week wash out period. 
o Botox injections for plantar fasciitis injections in the last 12 weeks for plantar fasciitis; if 
received in last 12 weeks subject will be offered to be involved in the study after they have 
completed a 12 week wash out period. 
• Use of anticoagulants 
f. Source of Research Material: Will you be using private information in this study? 
No – Only using publically available information Yes – If Yes, protected health information 
(PHI) held by a covered entity other types of private information 
Describe: research information (non-PHI) that is not publically available (i.e., student 
records) 
Describe: Use of identifiers with private information 
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Identifiers to be Used? Column A Looked at by research team Column B Recorded on 
enrollment log, subject list, or key list Column C Recorded on data collection tool (survey, 
spreadsheet, etc.) Column D Recorded on specimen containers Column E Shared w/ others 
not on research team Column F Stored after study ended NONE STOP STOP STOP 
Names 
Study codes linked to individuals’ identities using a key only accessible by the researcher 
Addresses 

Dates (except year) 
Ages over 89 
Phone/Fax Numbers 
E-mails 
- SSNs 
- Scrambled SSNs 
- last four of SSN 
Specify:spo nsor last 4 
Specify: 
Specify: 
Specify: 
Specify: 
Specify: 
Numbers: 
- Medical record # 
- Account # 
- Certificate/license # 
- Health plan beneficiary # 
- Vehicle identifier/serial # 
- License plate # 
- Device identifier/serial # 
Specify: 
Specify: 
Specify: 
Specify: 
Specify: 
Specify: 
Web URLs or IP addresses 
- Biometric Identifiers, including finger/voice prints 
- Full-face photo images and comparable images 
Specify: 
Specify: 
Specify: 
Specify: 
Specify: 
Specify: 
Any other pre-existing unique identifying number, characteristic, or code 
Coding Plan? Describe the method that will be used to create and assign unique study 
codes to data. 
The unique study code will be assigned in a sequential order beginning with 001 and 
ending with 100. The code will be placed in a Master Key of identifiable PHI/PII for each 

subject at each collaborating site Describe the method that will be used to create and assign 
unique study codes to specimens. 
N/A, not collecting specimens What is the format of the key? 
Paper Electronic 
Who will have access to the 
Research Coordinators 
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key? 
Where will the key be stored and how will it be protected? 
Location(s): Each collaborating site will maintain a Master Key of identifiable PHI/PII that 
will be kept in an electronic database, which will be encrypted, password protected and the 
access will be restricted to the Research Coordinator. The Master Key will be electronically 
stored separately from the coded de-identified research data. The Master Key will not be 
stored on any non-government or personal computers or laptops. At the conclusion of the 
study, the data from each site will be de-identified prior to review and analysis. 
Confidentiality measures: The coded research data will be kept in a locked cabinet in a 
locked office and only the research department has the key. The coded research data will be 
retained until the conclusion of the research study. Once a Final Report has been approved 
by the IRB, all the paper records will be de-identified and any key linking the subject to 
their records will be destroyed, based on AFI 33-332, “The Air Force Privacy and Civil 
Liberties Program” and the National Institute of Standards and Technology Special 
Publication (NIST SP 800-88) for the approved methods to destroy PII. The anonymized 
research data will not be utilized for further research activity beyond the protocol 
stipulations without additional IRB approval. Complete the table. 
Source of Research Material per Participant (Procedures) # Routine Care # Research Driven 
# Total Procedures 
Self-Reported Pain Severity 
0 
7 
7 
Foot Function Index-Revised short form (FFI-R short) 
0 
4 
4 g. Instrumentation: N/A 
4. HUMAN SUBJECT PROTECTION Recruitment and Consent Processes: 
All potentially eligible patients will be offered an opportunity to participate. Primary Care 
Manager (PCM) referrals and posted advertisements will be utilized for recruiting subjects 
to the study. Some patients may be patients of the PI or AI, however, they will have the 
study staff recruit their patients to prevent any misconception of coercion or undue 
influence. When a potential subject is identified by the treating PCM, the patient will either 

be provided a contact number to the Research Staff, the Research Staff will be given the 
potential subjects contact information by the PCM, or the Research Staff will speak with the 
patient directly. 
Consent Processes: 
Informed Consent and HIPAA authorization will be sought in advance from each 
prospective subject and appropriately documented in accordance with 32 CFR 219.117. 
Potential candidates will be notified about the study either through posted advertisements 
or by their care provider and will be given the opportunity to consent by one of the referred 
study coordinators. The study coordinator will provide a written copy of the Informed 
Consent Document (ICD). The subject may decline to consent without prejudice. At the 
subject’s discretion, they may take the ICD home to discuss further prior to making a 
decision. If the subject consents, a copy of the ICD will be given to the subject. No 
vulnerable populations are included in this research study. Subjects who cannot provide 
Informed Consent will not be allowed to participate. No Legally Authorized 
Representatives (LAR) will be utilized. Each subject will be asked to place their 
study-related PHI/PII into the “Nellis Acupuncture Research Data Repository 
(FWH20140048H) for future research. If the subject does not give their authorization, then 
all PHI/PII will be destroyed no later than at the closure of the study. 
Recruiting Service Members 
Will you be recruiting service members in a group setting? 
Yes 
No 
Participation Compensation: 
Subjects will not be paid for participation in this study. 
Assent Process: N/A 
Benefits: 
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Subjects may experience an improvement in pain and physical function in both the 
treatment and control groups, however, this is not a guarantee. 
Risks: 
The potential risks to participate in this study are minimal. The risks of acupuncture 
associated with participating in this research study include: 
LIKELY: Likely and not serious: 
• Pain 
• Bleeding 
LESS LIKELY: Less Likely and not serious: 
• Infection 
• Muscle cramp/spasm 
Costs: N/A 
Safeguards for Protecting Information: 

The research consents will be stored in a locked cabinet in a locked room. Medical records 
will be annotated with ICD- 10 code Z00.6 to reflect the subject’s participation in a research 
study. All research data including patient demographics will be kept in an electronic 
database, which will be encrypted, double password protected and the access will be 
restricted. The research data will be coded and any links to identifiable data will be 
destroyed as soon as the Final Report Approval has been obtained from the IRB with the 
exception of those that consent to place their study-related PHI/PII into the “Nellis 
Acupuncture Research Data Repository (FWH20140048H)” for future research. The 
anonymized research data will not be utilized for further research activity beyond the 
protocol stipulations without additional IRB approval. At the conclusion of the study, the 
data from each site will be de-identified prior to review and analysis. Data and Specimen 
Storage Plan 
Not applicable, coded or identifiable information will not be collected. 
How will coded or identifiable data/specimens be stored? 
. 
Paper data, including completed consent forms 
The research consents and HIPAA Authorization Documents will be stored in a locked 
cabinet in a locked room with restricted access. 
Electronic data 
Medical records will be annotated to reflect the subject’s participation in a research study. 
All coded, de-identified research data will be electronically stored separately from the 
Master Key of identifiable patient demographics and PHI/PII. 
Long-term storage (following completion of the study and inactivation of IRB approval) 
The research data will be coded and any links to identifiable data will be destroyed, based 
on AFI 33-332, “The Air Force Privacy and Civil Liberties Program” and the National 
Institute of Standards and Technology Special Publication (NIST SP 800-88) for the 
approved methods to destroy PII, as soon as possible or no later than at the closure of the 
study, with the exception of those study subjects that consent to place their de-identified 
research data into the “Nellis Acupuncture Research Data Repository” (FWH20140048H) 
for future research. The anonymized research data will not be utilized for further research 
activity beyond the protocol stipulations without additional IRB approval. All de-identified 
research data will be maintained for 3 years following study closure. 
Safeguards for Protecting Subjects Relative to Reasonably Expected Risks: 
Version: 6 February 2017 Revised by PR 2019 9 
59th Medical Wing Institutional Review Board 
The principal investigator will be responsible for the protocol safety monitoring. The PI will 
make study documents (e.g., consent forms, data pulls) and pertinent hospital or clinical 
records readily available for inspection by the local IRB and over sight staff for confirmation 
of the study data. 

These risks will be minimized by cleaning the acupuncture site with an alcohol swab prior 
to placement. If at any time the patient reports a side effect, they will be referred to one of 
the Investigators for care. 
Categories of subjects-None 
Clinical Care: 
All subjects will receive standard of care regardless of inclusion into this study. If at any 
time a subject experiences any injury or adverse effects, appropriate clinical care will be 
given or subject will be referred to appropriate provider. 
Injury Compensation: N/A 
Data Safety 
N/A – none of the Msitounaittioonrisnglisted above ap 
ply 
5. ALTERNATIVES Alternatives: 
Acupuncture for plantar fasciitis is done in the Family Medicine Residency as part of 
standard of care. Subjects may choose to get this type of acupuncture without participating 
in this study. 
6. DATA ANALYSIS Data Analysis: 
Outcome Measures: 
Primary outcomes: The primary outcome measures are the 11-point numerical pain rating 
score (NPRS-11) and the FFI-R short form scores as described above. The FFI-R scores are 
interval variables and can be assessed with parametric methods. Parametric methods can be 
used with the Visual Analog Score (VAS) if less than 16% of subjects rank pain as 0 or 10, 
and the NPRS-11 and VAS have been found to be equivalent in being able to detect 
differences in treatment. (16, 17) Therefore, parametric methods may also be used for the 
NPRS-11. 
Due to the manner in which data will be collected, data analysis will be conducted in two 
parts. The first analysis, a repeated measures mixed effects design with a control group, will 
be of the outcome measures taken from patients randomly assigned to the acupuncture and 
non-acupuncture groups at the first visit, 2 weeks, 4 weeks, and 3 months. The second 
analysis, a regression point displacement design (RPDD), will be of the patients initially 
randomly assigned to the non-acupuncture group and then crossover into the acupuncture 
group at visit 5. 
16. Breivik EK, Björnsson GA, Skovlund E. A comparison of pain rating scales by sampling 
from clinical trial data. Clin J Pain. 2000 Mar;16(1):22-28. 
17. Ludington E, Dexter F. Statistical Analysis of Total labor Pain Using the Visual Analog 
Scale and Application to Studies of Analgesic Effectiveness During Childbirth. Anesth 
Analg 1998;87:723-727. 
Sample Size Estimation/Power Analysis: 
Version: 6 February 2017 Revised by PR 2019 10 
59th Medical Wing Institutional Review Board 

A priori power for a repeated measures ANOVA, mixed effects design, was assessed using 
G*Power Version 3.1.9.2. 
(18) Effect size was based on the NPRS-11 detecting a 1SD difference within groups having 
a 1SD difference for 4 repeated measures. The results indicate that as few as 5 subjects per 
treatment group, or 10 total subjects, will have a power of 0.92 to detect a difference of 1SD 
for the NPRS- 11 at alpha = 0.019. However, post-hoc tests of differences among groups and 
time periods would require a sample size of 13 subjects per group, 26 total subjects, to 
achieve a power of 0.81 at alpha = 0.048. 
However, sample size must also be based on the RPDD analysis. Effect size is determined 
by the variance explained by the intervention variable, acupuncture, and the residual 
variance. Power is based on the alternate hypothesis that the intervention coefficient in the 
regression model is greater than 0. A priori, both of these variances are unknown for this 
study. Therefore, power and sample size are based on an assumed small effect size of 0.15. 
Given there are two predictors, time of repeated measure (fixed effect) and non-
acupuncture or acupuncture intervention (covariate), a sample size of 43 subjects in the 
non-acupuncture to acupuncture sequence will have a power of 0.803 to test this hypothesis 
at alpha = 0.05. If the number of subjects for the non-acupuncture to acupuncture cohort is 
kept to 13 in conformance with the first part of the analysis, we will have a power of 0.78 to 
detect a large effect size of 0.50 at an alpha = 0.055. 
18. Faul F, Erdfelder E, Lang A-G, Buchner A. G*Power 3: A flexible statistical power 
analysis program for the social, behavioral, and biomedical sciences. Behavior Research 
Methods. 2007; 39 (2): 175-191. 
Statistical Analysis: 
Sample means and standard errors of measurement will be calculated for normally 
distributed interval variables and medians and interquartile ranges (IQR) for non-normally 
distributed interval variables. Frequency distributions of nominal and ordinal variables will 
be calculated. For the first analysis, to test the null hypothesis that there are no differences 
in outcome measure means between the acupuncture and non-acupuncture groups 
controlling for within- subject variation and to examine interaction effects, we will employ a 
mixed effects, repeated measures ANOVA linear model with the data collected for both 
groups in the first 4 visits. For the second analysis, to test the null hypothesis that the 
intervention coefficient in the regression model is equal to 0, we will employ a repeated 
measures ANCOVA linear model with the data collected for the non-acupuncture and 
acupuncture in 5 visits. Multiple comparison tests to investigate post hoc effects, will be 
corrected by either the Bonferroni or Holm methods to maintain the alpha level of 
significance at p=0.05. (19,20) Mr. Danny Sharon, Senior Research Biostatistician Subject 
Matter Expert for Clinical Research Management under contract W911QY-11-D-0065, is the 
statistical consultant support for this study. 
Statistical analysis will be performed with R Version 3.3.2. (21) 
19. Abdi H. Bonferroni and Šidák corrections for multiple comparisons. In N.J. Salkind 
(ed.). Encyclopedia of Measurement and Statistics. 2007; Thousand Oaks, CA: Sage. 

20. Holm, S. 1979. A simple sequential rejective multiple test procedure. Scand. J. Statistics, 
6: 65-70. 
21. R Core Team (2014). R: A language and environment for statistical computing. R 
Foundation for Statistical Computing,Vienna, Austria. URL http://www.R-project.org/. 
Number of Subjects: # Planned to Enroll # Enrolled # Planned to Complete Study TOTAL 
Number of Subjects at Nellis AFB 
50 
0 
44 
50 Number of Subjects at Scott AF 
50 
0 
44 
50 
*If one site recruits more than the other, then they will be able to continue recruitment until 
the accrual ceiling has been reached. 
7. STUDY DURATION Duration of Study: 
Approximate duration of the study: 3 years 
8. LOCAL AND EXTERNAL SUPPORT SERVICES 
Version: 6 February 2017 Revised by PR 2019 11 
59th Medical Wing Institutional Review Board 
research team and will be administering intervention(s). 
personnel required 
9. INTRAMURAL (GME) AND EXTRAMURAL FUNDING SUPPORT Intramural (GME) 
and Extramural Funding Support: O&M Intramural grant funding from SG5i was approved 
for $17,000. 
10. DRUGS, BIOLOGICS, DIETARY SUPPLEMENTS, AND MEDICAL DEVICES Does the 
study plan dictate the use of any of the following? 
A drug 
Yes 
No 
A biologic 
Yes 
No 
A compound intended to affect structure or any function of the body 
Yes 
No Local and External Support Services: None Describe the plan for training personnel who 
are not part of the 
Not applicable – no training of non-study 
A dietary supplement or substance generally recognized as safe that will be used to 
diagnose, cure, mitigate, treat, or prevent disease 

Yes 
No 
A medical device 
Yes 
No 
10A. List all drugs covered by an Investigational New Drug (IND) from the FDA (approved 
or submitted) 
N/A, an IND has not been submitted to or approved by the FDA 10B. List all FDA 
approved drugs being used in accordance with FDA approved labeling 
Name of Drug 
Dose(s) directed by protocol 
Route(s) of administration 
N/A, no FDA approved drugs being used according to the labeling 10C. List all FDA 
approved drugs used for an unapproved use (“off-label”) 
N/A, no FDA approved drugs being used “off-label” 10D. List all biologics, compounds and 
dietary supplements 
N/A, no biologics, compounds and dietary supplements 10E. List all devices covered by an 
Investigational Device Exemption (IDE) from the FDA (approved or submitted) 
N/A, an IDE has not been submitted to or approved by the FDA 10F. List all FDA approved 
devices used for an unapproved use (“off-label”) 
N/A, no FDA approved devices being used “off-label” 10G. List all unapproved devices. 
N/A, no unapproved devices 10H. Device Storage Location(s): 
Is this research an “applicable clinical trial” which must be registered on ClinicalTrials.gov? 
Yes, Local Investigator is responsible for registering the trial. NCT02929589 
Use of a placebo in place of standard therapy: 
Is a placebo being used in place of standard therapy? 
No 
Yes 
11. MEDICAL RESEARCH AREA 
Version: 6 February 2017 Revised by PR 2019 12 
Analytical Chemistry 
Anatomy 
Anesthesiology 
Biochemistry 
Cardiovascular Surgery 
Cardiology 
Cell Biology 
Dentistry 
59th Medical Wing Institutional Review Board 
Version: 6 February 2017 Revised by PR 2019 13 
12. ATTACHMENTS 

1. Form A, Signature Sheet 
2. Form A-2, Study Personnel Listing 
3. Form D, Informed Consent Document 
4. H15 Template, HIPAA Authorization Document 
5. Plantar Fasciopathy Training Protocol 
6. Application Checklist 
7. Revised Foot Function Index (FFRI-R) 
8. Advertisement 
9. Study Diary 
10. Protocol for needle insertion 
Dermatology 
Dietetics 
Electrophysiology 
Endocrinology 
Emergency medicine 
Gastroenterology 
General Surgery 
Hematology 
Histology 
Immunology/Allergy 
Infectious Disease 
Microbiology 
Molecular Biology 
Neonatology 
Neurology 
Neurosurgery 
Nursing 
OB/GYN 
Occupational Medicine 
Occupational Therapy 
Oncology 
Ophthalmology 
Oral/Maxillofacial Surgery 
Orthopedics 
Pathology 
Pediatrics 
Pharmacology 
Physical Therapy 
Mental Health 
Radiology/Imaging 
Urology 

Wellness 
Other: 
Family Medicine Residency