Self-Administration of Auricular Acupuncture Pilot Project
Phase: NA
Conditions: Chronic Pain Syndrome, Pain, Fibromyalgia, Low Back Pain, Neuropathic Pain, Neuropathy, Painful, Musculoskeletal Pain, Chronic Pain
Sponsor: Chillicothe VA Medical Center

COVER PAGE
STUDY TITLE: SELF-ADMINISTRATION OF AURICULAR 
ACUPUNCTURE PILOT PROJECT
NCT: 04208659
DATE OF DOCUMENT APPROVAL: 30 SEP 2019

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Self-Administration of Auricular Acupuncture Pilot Project IRB 
Proposal 
I. OBJECTIVES/SPECIFIC AIMS:
a. The primary aim of this pilot project is to assess the safety and feasibility of a
program that formally trains veterans to self-administer Battlefield Acupuncture
(BFA) for pain relief. Safety is defined as no serious adverse events in any of the
participants during six months of self-administration of BFA. Feasibility is defined
as whether it is physically possible for greater than 90% of participants to self-
administer BFA with or without assistive devices. This is primarily an innovation
project to evaluate a method for self-administration of BFA.
The project will focus on veterans who have had a prior “good” response to BFA
performed by a provider. A “good” response is one that lasts at least three days
AND causes either a 3-point decrease in the pain score or allows the recipient to
ambulate or perform other functional tasks easier as determined subjectively.
However, the primary purpose of this project is not to detect a treatment effect,
but to innovate a safe and convenient way for self-administration of BFA. If results
are promising, the project will be submitted for consideration of rapid diffusion
throughout VA and as an impetus towards more extensive, multi-center studies
that are powered to detect other parameters such as long-term efficacy,
progressive improvement in pain and function and reduction of oral medication
use.
b. Key Predictions/Hypotheses:
i. Veterans trained by providers who routinely perform BFA will be able to self-
administer BFA per pre-existing BFA protocol (defined later) without any
serious adverse effects over a period of six months. At least 90% of
participants will remain able and willing to consistently self-administer BFA
without major difficulties for the study period, either with or without a prosthetic
assistive device.
ii. Self-administered auricular acupuncture (SAAA) will be subjectively non-
inferior in terms of perceived efficacy to provider-administered auricular
acupuncture (PAAA) i.e. BFA performed by a provider. The main measure of
this will be that participants continue to want to self-administer BFA after the
study.
iii. 3D-printed ear molds will facilitate placement of the BFA needles. This will be
tested by providing the prosthesis several months after the participants have

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been self-administering BFA without the prosthesis.  
 
II. BACKGROUND/SIGNIFICANCE 
a. Why this study? The PI was unable to find any formal studies that looked at self-
administration of auricular acupuncture or those that involve the use of a 3D-
printed prosthesis to guide acupuncture needle insertion. The PI believes that 
formally allowing patients to self-treat with BFA is novel enough to warrant 
supervision by research regulatory bodies.  This is both for safety purposes and to 
establish BFA self-treatment as legitimate for future research projects and clinical 
implementation. When administered by a provider, BFA is considered a procedure 
of “negligible” risk by VA and only requires verbal consent. However, the risk is 
not “minimal” from a research approval standpoint as it entails more potential 
harm than a review of records or a routine physical exam.  
b. What is acupuncture? Acupuncture is a system of medical treatment that is chiefly 
associated with but not exclusive to Traditional Chinese Medicine (TCM). TCM 
involves manipulation of purported energy channels (meridians) that connected 
and controlled many bodily functions. Vital “energy” or qi (pronounced “chee”) 
flowed along these channels and could be modulated by application of needles to 
various points along the channels. In Western medicine, acupuncture is becoming 
more widely used, especially for pain, for which it has been well studied. However, 
Western practitioners generally favor a more “Western” physiologic explanation 
for its pain relieving effects. A brief exploration of purported physiological 
mechanisms of action (MOA) is included below.  
c. Origin of BFA: BFA is an auricular, or ear, acupuncture (AA) protocol developed in 
2001 by Air Force physician Col. Richard Niemtzow. It is the result of an effort to 
find an efficient way to rapidly relieve pain that was not associated with the 
sedative effects of most narcotic analgesics. The points used in BFA appear to be 
drawn from several different schools of acupuncture.  
d. What is BFA? BFA is an AA protocol that uses special indwelling needles to 
cause pain relief. This protocol involves up to five points on each ear that are 
believed to be effective for pain control. “Indwelling” 
acupuncture needles are special acupuncture 
needles that are supposed to stay in for more than a 
short time to make the effect last longer. The BFA 
protocol allows the needles to remain for up to seven 
days but they usually fall out before that. The needles 
used in BFA are very small, short needles that are 

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designed to stay in the skin but not penetrate too deeply. To the right is a picture 
of an ASP Gold needle (the ones commonly used in BFA). Each needle comes in 
a sterile blister pack and comes with a sterile plastic applicator to facilitate 
insertion.  
Pictured below is the needle with the applicator that comes in sterile packaging. 
The needle may be difficult to see depending on the color status and quality of 
paper if this document is printed. 
 
 
e. Patient Education Sheet: A non-local VA patient education sheet is attached after 
the reference section of this proposal. This education sheet states that bleeding 
disorders and anti-coagulation are a contraindication to “acupuncture”. This 
education sheet is not meant to be an authoritative literature for BFA, it is simply 
one that a specific VA facility put together and is a visual aid to allow reviewers to 
become more familiar with BFA. BFA can be safely done in patients on anti-
coagulation with a minor increase in bleeding risk, which will be explained during 
the consent process.  
f. Purported Mechanism(s) of Action: The purported mechanism(s) of action of 
acupuncture in general include central modulation of pain via various structures in 
the central nervous system (CNS). These include the hypothalamus, thalamus, 
cingulate gyrus and cerebral cortex. Evidence for the involvement of these 
structures come from functional MRI (fMRI) studies showing that they are 
activated when the BFA needles are in place. Other mechanisms of acupuncture 
in general have evidence to support them, but they are not directly relevant to the 
chiefly clinical research proposal under consideration. These mechanisms will be 
briefly summarized in the following subsection.  
 
 
 

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g. Relevant Literature Review 
i. The PI is unable to find any existing articles pertaining to self-administration 
of auricular acupuncture for any condition or the use of 3D-printed prostheses 
to guide acupuncture needle insertion.  
ii. References are included at the end of the proposal and prior to the patient 
education sheet.  
iii. Mechanisms of Action: Purported mechanisms of action (MOA) for 
acupuncture are briefly summarized in this section. References for these 
MOAs are included in the secondary source An Introduction to Western 
Medical Acupuncture1, which is cited in the reference section and in turn 
includes more references. Extensive citations are not included because a 
detailed exploration of acupuncture MOAs is beyond the scope of this 
proposal for a small pilot project prior to a potentially larger and more 
academic study.  
1. Local Effects: Acupuncture stimulates A-delta fibers in skin and muscle. 
Stimulation of A-delta fibers in turn causes release of several 
neuropeptides that affect the surrounding tissue. The most important 
neuropeptides include calcitonin gene-related peptide (CGRP) and 
histamine. These substances are vasoactive and promote increased blood 
flow to the area. 
2. Segmental Analgesia: Stimulation of A-delta fibers lead to activation of 
intermediate cells in the dorsal horn of the spinal cord. These intermediate 
cells release enkephalin, which blocks the transmission of pain in the 
substantia gelatinosa, which is part of the pain transmission pathway. 
3. Extrasegmental Analgesia: Acupuncture causes the release of beta-
endorphin in the brain. Serotonin and oxytocin are also involved in the 
body’s response to acupuncture. Acupuncture also potentiates activity in 
the periaqueductal gray matter (PAG), which is the closest thing in the 
body to a “pain control center.” The beta-endorphin release caused by the 
acupuncture affects the PAG, which causes general activation of the 
descending pain inhibitory system in the body. Activation of this system 
causes multi-level suppression of nociceptive activity in the dorsal horn.  
4. Central Regulatory Effects: Through unclear mechanisms, acupuncture is 
thought to positively affect the limbic system and the resultant affective 
states in response to pain.  
 
iv. Clinical Literature Review of AA and BFA in Different Contexts 
1. This subsection contains summary statements of various studies involving 
BFA/AA. It is not meant to be an extensive summary of the literature but to 

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provide evidence that AA has been used in several contexts with 
reasonably good results and thus should be considered for self-
administration by trained patients. 
2. BFA is used throughout VA and DoD for acute and chronic pain relief.  
3. Auricular acupressure was shown to significantly lower post-operative 
opioid use after total knee arthroplasty (TKA)9.  
4. Indwelling AA was shown to reduce pain medication (opioid) use after total 
hip arthroplasty (THA)6. 
5. BFA + standard care was shown to reduce low back pain (LBP) acutely in 
the emergency department (ED) setting compared to standard care 
alone11.  
6. Other articles are included in the “references” section for reviewers’ 
perusal. 
 
h. Context of the Opioid Epidemic: Given societal concerns about the opioid 
epidemic, it is critical to identify and disseminate effective pain control modalities 
to mitigate the lack of effective care for chronic pain as a barrier to addressing the 
opioid epidemic. This effort is further confounded by access issues to obtain BFA 
and other complementary and integrative health (CIH) modalities in a rural VA 
setting. These can include transportation difficulties and significant financial and 
temporal constraints for providers and patients. SAAA would reduce these 
difficulties by allowing patients to administer treatment to themselves. The PI 
hopes that SAAA will empower the veterans to be more actively engaged in their 
care, reduce dependence on others to manage their problems and reduce oral 
medication use. 
 
i. Appropriateness as a self-administered treatment: It can be argued that allowing 
patients to needle themselves with acupuncture needles without supervision will 
have some risk of harm associated with it. While these concerns are valid, these 
risks are certainly less than the risks associated with either self-administration of 
insulin, which can be lethal if done incorrectly, or the use of oral opioid 
medications for chronic pain, which can be lethal even if done correctly. These 
needles are very small and are designed specifically to prevent penetrating too 
deeply. BFA does not require advanced knowledge to utilize correctly.  
 
j. Ultimate Goal: The purpose of this pilot project is 1) to determine whether a brief 
education program can allow the safe self-administration of BFA and 2) whether 
3D-printed ear prostheses with guide holes will allow easier application. “Safety” 
of the procedure is defined as no serious adverse events occur within six months 

6 
 
of self-administration by 30-40 participants. After project completion, the results 
will be presented to a higher level in the VA for rapid diffusion and further and 
hopefully multi-center studies that can examine efficacy and impact on pain 
medication use.  
 
III. PRELIMINARY STUDIES 
 No formal preliminary studies have been conducted prior to this proposed study, 
which is itself a pilot study. The PI was unable to find any scientific articles 
pertaining to self-administration of auricular acupuncture or the use of 3D-printed 
prostheses to guide acupuncture placement.  
 
IV. INVESTIGATOR EXPERIENCE 
The PI is board-certified in Physical Medicine and Rehabilitation and has a 
graduate-level psychology background, which includes formal education in 
experimental design and statistical analysis in the context of experimental design. 
The PI also has substantial training in quality improvement methods from his 
residency program which includes but is not limited to root cause analysis, 
statistical analysis and coordination of multi-disciplinary efforts to accomplish 
organizational goals.  
V. METHODOLOGY 
 
a. Methods and Procedures: An hour-long educational session will be given to 
veterans in a face-to-face visit. The veteran will demonstrate self-placement of 
the needles prior to leaving. At a separate visit, participants will have their ears 
scanned by a 3D-ultrasound scanner to provide a basis for ear prothesis 
development. After several months of non-guided self-administration, bilateral 
3D-printed ear prostheses will be given to the veteran. These ear molds will have 
guide holes to facilitate easy and precise insertion of the BFA via self-
administration. The questions to be addressed will be those listed under the 
“Hypotheses” subsection of the “Objectives” section. There is currently a 
“Battlefield Acupuncture” note template that is used for routine clinical and 
research purposes at a national level. This template will be used in this project to 
record data and will be used to record data in CPRS as a “Battlefield 
Acupuncture note”. This note will be considered a part of routine clinical care as it 
would if a provider had administered the BFA.This template already includes free 
response sections so that any difficulties experienced by participants can be 
recorded without altering the template.  A print-out of this template will be 

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included at the end of this document.  
 
i. Description of the BFA procedure: BFA is a type of auricular (ear) 
acupuncture that involves the insertion of specialized indwelling acupuncture 
needles into sequential points in the ears. The needles are inserted with the 
aid of plastic applicators. There are five points on each ear. The standard 
needle is the ASP Gold needle, which is made of stainless steel coated in 
24K gold and comes in sterile packaging. Ears are cleansed with alcohol 
swabs prior to needle insertion. In the BFA protocol, the first point needled is 
on the side of the body where the pain is most prominent. After a needle is 
inserted, the patient is instructed to ambulate for one to two minutes and see 
if the pain diminishes. If the pain has not reached the target of 0-1 out of 10, 
the next needle is inserted on the same point in the contralateral ear.  After 
repeated ambulation, if pain has not reached target, the next point is needled. 
There are five points on each ear, or ten total points. Intermittent needling and 
ambulation continues until all ten needles have been inserted or the pain 
reaches 0-1/10.  
 
The recommended frequency of BFA is that repeated needling of the same 
point be done not less than two weeks apart to avoid irritation of the ear. This 
is largely anecdotal but our protocol will adhere to this recommendation. In 
most people, the needles will remain in for two to four days before coming out 
on their own, but in some they will remain in much longer if they are not 
removed. BFA protocol advises that the needles do not remain in longer than 
7 days. There is no easy way to ensure that needling will not be done more 
frequently other than dispensing a very limited amount of needles at a time, 
which essentially defeats the purpose of this project and will drive up costs to 
provide needles. Participants will be removed from the study if it is discovered 
they are using the needles in a manner that is inconsistent with the protocol. 
 
ii. Self-administration method: The participants will first learn to self-administer 
BFA without an ear mold and will follow the original BFA protocol. Later, 
veterans will also be given 3D-printed auricular prostheses (AP) with guide 
holes to facilitate BFA needle insertion. Veterans will then be able to try 
needle insertion with and without the AP to see which is easier. The following 
steps will be followed with the ear molds: 
1. Needles are not inserted into the same point more than once every two 
weeks to avoid skin irritation. 
2. Cleanse the ears and APs with the provided alcohol prep pads. 

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3. Place the AP over the ear as appropriate. 
4. Verify that the guide holes are in the correct place using a hand-out or 
other visual aid that is provided. This will be done in a mirror and 
confirmed with a handout. Correct placement will also be verified at the 
time of AP dispensing by visual examination. 
5. Verify that the AP is securely in place and will not easily slide off the 
correct site.  
6. Insert the needle at the first point starting on the side of the body where 
the pain is worst. 
7. Ambulate intermittently between insertions for one to two minutes. 
8. Continue in sequence until all needles are inserted or pain is 0-1/10. 
 
iii. Educational program 
1. The providers participating in the study will spend an hour with each 
participant training them to insert the needles, first on a silicone ear, then 
on the participants themselves. These providers routinely perform BFA in 
clinical practice and are credentialed to do so. These providers are study 
staff and investigators.  
2. Participants will demonstrate correct self-insertion in all five points in both 
ears prior to being given an 80-count box of BFA needles. These needles 
and their applicators are single-use and disposable. 
3. Participants will also be given a silicone practice ear, an 80-count box of 
ASP Gold needles (the standard BFA needles), and simple written 
instructions to follow.  
4. The use of needles by or on someone other than the participant will result 
in the participant’s immediate dismissal from the study. This event will be 
reported to IRB immediately. It will be strongly emphasized to the 
participants that the needles are only for self-administration and only to 
be used on the participants themselves.  
 
iv. Auricular prosthesis development 
1. The purpose of the AP is to severely limit the possibility of incorrect or 
angulated needle insertion and increase participant confidence.  
2. Several materials commonly used in 3D-printed prosthetics will be trialed 
for suitability.  
3. If the APs are unwieldy or unhelpful, the participants will revert to use of 
unassisted self-insertion. 

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4. The APs will be given to participants after several months of non-guided 
administration. This will help assess how helpful they are because 
participants will be used to doing them without guidance of the AP.  
5. The participant’s ears will be scanned with a 3D ultrasound scanner.  
6. The ear scan data will be uploaded into a VA secure computer and 
processed to be utilized by the 3D printing program.  
7. The AP will be printed. 
8. Fit of the AP will be verified at a subsequent visit to receive the AP. 
9. The ear scanning and fitting/giving of the AP is anticipated to take two visits 
total. 
10. BFA points will be manually marked on the AP, or the points may be 
identified through digital subtraction of the parts of the AP overlying the 
points prior to printing so the guide holes will be printed automatically.  
11. If manual marking of the guide holes is more feasible, a small caliber hole 
will be bored into the marked BFA points of the AP and the hole will be 
smoothed with fine sandpaper to remove jagged edges. 
12. The key aspect of guide hole development and use will be to keep them 
as tightly toleranced as possible. In other words, the guide holes will be 
barely large enough to allow insertion of the ASP Gold needle applicator. 
This will prevent angulation of the applicator, which is the primary factor in 
suboptimal placement and poor retention of the needle.  
13. The materials used to print the ear prostheses will consist of either silicone 
or another hypoallergenic material that is commonly used for 3D-printed 
prostheses.  
 
v. Ear prosthesis cleaning and maintenance: Prior to each use, the auricular 
protheses will be cleansed with standard isopropyl alcohol prep pads, which 
will be provided to participants along with the BFA needles.  
 
b. Data analysis and Data Monitoring:  
i. Every two weeks participants will be called by study investigators during a 
scheduled telehealth or telephone encounter, and a standardized BFA note, 
which already exists as a national-level template, will be used to record their 
responses. The responses will be recorded directly into CPRS and these 
notes will be considered equivalent to those done in routine care.  
ii. Advanced statistical analyses and comparisons are not necessary for this 
pilot project as the chief question is whether it can be done safely for six 
months by a significant number of participants (i.e. thirty to forty). We will 

10 
 
attempt to recruit forty participants to allow for up to a 25% attrition rate, 
although we expect a high retention rate for this study. 
iii. The primary metric of this project is whether any significant adverse events 
occur (i.e. serious infection, imbedding of the needle past the skin) that can 
be clearly attributed to BFA self-insertion. If one occurs, local research 
committee will be consulted for further guidance on whether to continue the 
study. If none occur, this will be recorded at the end of the study.  
iv. The secondary goal of this project is to determine whether APs are helpful in 
self-administration of BFA. If there are unforeseen problems with their use or 
they seem to be overtly unhelpful from the beginning, the use of APs will be 
dropped from the protocol. If there is significant difficulty with producing the 
APs, they will be discarded from the protocol.  
v. Data will be made available to regulatory bodies upon request.  
 
c. Data Storage and Confidentiality: Data will be stored in CPRS in a note that is 
already used to document the BFA procedure. The only physical data will be the 
paper-based informed consent forms and other waivers used in IRB-approved 
research. There will also be a list of participants that only includes initials and last 
4 of SSN. The documents will be stored in a locked room inside a locked cabinet 
in the pain clinic area. All data to be used in analyses will be totally de-identified 
by disassociating them from any possible identifiers. Only authorized study staff 
will have access to them. No identifying data will be released except upon 
legitimate request to authorized agencies or regulatory personnel in compliance 
with federal law and VA policy.  
 
d. Setting: The setting in which the study will be conducted includes the Chillicothe 
VAMC main campus. Veterans will be recruited from both the main campus only 
by BFA providers who are study staff/investigators. Veterans will receive explicit 
training in self-administration of BFA by providers who are credentialed to perform 
it and who do it regularly. 
 
e. Laboratory methods and facilities: No laboratory tests are anticipated for this 
study.  
 
f. Estimated Time to Complete the study: 12 months total, six months for each 
participant 
 
VI. HUMAN SUBJECTS 
a. Description of human participants follows  

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b. Sample Size: 30-40 participants from Chillicothe VAMC facility and its community-
based outpatient clinics (CBOCs) 
c. Inclusion Criteria: All veterans with chronic pain who subjectively responded (as 
defined earlier) to provider-administered BFA who wish to participate and have no 
significant or absolute contraindications can be included. Veterans must be able 
to demonstrate to the investigator(s) during the training session that they can 
successfully self-administer once for continued participation. Those on blood 
thinners will be allowed to participate if they acknowledge that there is an 
increased risk of bleeding. In general, use of anticoagulant or anti-platelet 
medication is not a contraindication to BFA. 
d. Exclusion criteria include those who do not wish to participate and those who 
have significant contraindications to AA or indwelling acupuncture. These include: 
being immunocompromised, congenital or acquired defects in the tympanic 
membrane, pregnancy, severe cognitive impairment, inability to perform BFA on 
themselves. Medical anti-coagulation is not an automatic exclusion as many 
patients on these medications will not have any issues with bleeding with BFA. 
Those who have history of severe vasovagal/syncopal or other adverse response 
to skin puncture will also be excluded. Those with artificial heart valves or those 
with a history of heart valve infection are excluded because of risk of endocarditis. 
Pregnant patients will be excluded from this study to eliminate the possibility of 
harm to pregnant patients and developing children. Medical conditions that 
would exclude someone from using BFA include: 1) those with replacement 
heart valves; 2) those with history of heart valve infection; 3) those who are 
pregnant; 4) those who have a pacemaker, defibrillator, or other similar electronic 
device; 5) those who are afraid of needles, 6) those who are scheduled for an 
MRI; 7) those with non-medication induced bleeding disorders. 
Participants will be removed from the study if it is discovered they are using the 
needles in a manner that is inconsistent with the protocol. 
e. Intended gender/age range/etc.: There will be no age or any other sort of 
restrictions on this group other than pregnancy. Women who are not attempting 
pregnancy or who are unable to become pregnant will not have any additional 
criteria to be included. Since it is not possible for pediatric patients to be military 
veterans, pediatric patients will not be included by default.  
f.   Source: The source of study participants is the population of veterans at our 
facility with chronic pain who are willing to participate and who have received BFA 
at some point with subjectively positive response (as defined earlier). The primary 
source of the participants will be the current patients who receive recurring BFA 
treatment from Dr. James, Dr. Welch or Dr. Williamson.  

12 
 
g. Recruitment Plans: Veterans who experience an ongoing subjectively positive 
response to BFA during standard care for pain will be asked by their BFA provider 
(who is an investigator in the study) if they wish to participate. Again, a “good” 
response is one that lasts at least three days AND causes either a 3-point 
decrease in the pain score or allows the recipient to ambulate or perform other 
functional tasks easier as determined subjectively. Regular recipients of BFA from 
participating investigator-providers will also be asked directly. Participants may 
also include those who have had good response to BFA in the past but are not 
receiving it recurrently who are under the care of one of the investigators. 
 
VII. Risk/Benefit Assessment 
a. Level of Risk: The level of risk is considered more than “minimal” from an IRB 
standpoint, as the potential for harm is greater than expected from a review of 
medical records or a routine physical exam. However, in the VA, BFA done by a 
provider is considered a procedure of “negligible” risk and only requires verbal 
consent. Overall, the PI and the VA would consider correctly administered BFA to 
be very low risk but not “minimal” risk according to 45 CFR 46.102(i). If this project 
demonstrates that self-administration of BFA is safe, it will allow much easier 
access to this therapy and hopefully will reduce oral pain medication usage. A 
large systematic review of various auricular acupoint therapies did not mention 
any serious adverse events when performed by a provider15.  
  
b. Anticipated Benefit Justifies the Risk: In the context of very low risk, even a 
modest benefit justifies performing a study that may improve care and improve 
access to non-opioid chronic pain relief. Based on preliminary clinical experience 
and literature review, the anticipated benefit far outweighs any risk, assuming the 
procedure is administered according to protocol.  
 
c. Experiences/risks are similar to real life for participants: Again, an analogous 
procedure could be diabetic self-testing, which is a widespread medical practice. 
The experience of self-administration of BFA is likely to be very similar to BFA 
administered by the provider.  
  
d. Generalizable knowledge anticipated:  
i. That BFA is reasonably safe to formally allow suitable patients to self-
administer for pain relief. 
ii. If this study is successful and a larger study is undertaken, further research 
could facilitate: 
iii. Identification of the conditions that are most likely to respond to BFA.  

13 
 
iv. To assess the occurrence or lack thereof of progressive improvement in pain 
level that is reportedly associated with repeated acupuncture administration. 
v. That BFA can be self-administered safely, effectively and cost-effectively.  
vi. That self-administered BFA can reduce the use of oral analgesics in an 
outpatient setting 
 
e. Potential Risks or Discomforts: When the skin is penetrated, there is always the 
chance of infection or bleeding. Those on anti-coagulation may have a slight 
increase in the risk of bleeding- however, BFA is done routinely on those on 
anticoagulation with no issues and this risk will be addressed in the informed 
consent.  With appropriate cleansing of the ears with alcohol pads and screening 
of participants, the likelihood of an infection is extremely low. Diabetic blood sugar 
testing arguably has a similar, if not larger, risk because the actual intention is to 
cause bleeding. Self-administration of insulin is routinely done and is indisputably 
dangerous if done incorrectly. These procedures are routinely done by patients to 
themselves. Transient bleeding of a very small amount can occur; the harm 
associated with this is likely less than that of routine venipuncture or diabetic 
blood sugar testing. Another theoretical risk involved in BFA is damage to 
underlying structures. However, given that the needles do not penetrate more 
than 1-2 millimeters and that there are no significant vascular or neural structures 
underlying the target points, any risk of anatomic damage is largely theoretical 
and are likely to occur only if the protocol is not followed. Other rare adverse 
events that may occur include transient nausea or dizziness.  
 
Indwelling acupuncture poses a small but serious risk to those with history of 
artificial heart valves or history of endocarditis; therefore, these patients will be 
excluded. Endocarditis with indwelling acupuncture has only been reported in 
those with previous history of heart valve pathology and is extremely rare12. The 
PI can only find one case reported of endocarditis in a patient with history of 
rheumatic fever. According to one study by Stellon13, brief acupuncture does not 
seem to increase the risk for endocarditis. See references section for relevant 
citations. 
 
VIII. PAYMENT: Participants will not be remunerated for their participation. Veterans 
will receive the BFA needles and other relevant materials at no cost. If they 
incurred the pain condition during their active military service (i.e. service-
connected condition), the VA covers all costs associated with the treatment of 
that condition.  
 

14 
 
IX. SUBJECT COSTS: Subject costs may include travel to VA facility and initial 
evaluation for non-service connected conditions. Again, if the veteran is 
service-connected for the pain condition, they will not have to pay anything. 
All materials and supplies will be covered by the study funding.  
 
X. CONSENT FORM: Enclosed in separate document 
 
 
 
 
 

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References 
1. White, A, Cummings, M, Filshie Jacqueline. An Introduction to Western Medical 
Acupuncture. Philadelphia, PA: Elsevier; 2008. 
2. Alimi D, MD, Geissmann A, MD, Gardeur D, MD. Auricular Acupuncture 
Stimulation Measure on Functional Magnetic Resonance 
Imaging, MedicalAcupuncture. 2002:13(2);18-21. 
3. Goertz C, Niemtzow R, Burns S, Fritts M, Crawford C, Jonas W.  Auricular 
Acupuncture in the Treatment of Acute Pain Syndromes: A Pilot Study. Mil Med. 
2006:171(10); 1010-1014. 
4. Niemtzow RC, Burns SM, Cooper J, Libretto S, Walter JAG, Baxter J., 
Acupuncture Clinical Pain Trial in a Military Medical Center: Outcomes, Medical 
Acupuncture. 2008:20(4); 255-261 
5. Burns S, York A, Niemtzow RC, Garner BK, Steele N, Walter JAG.  Moving 
Acupuncture to the Front Line of Military Medical Care; A Feasibility 
Study, Medical Acupuncture. 2013:25(1);48-54. 
6. Usichenko, TI, et. al. Auricular acupuncture for pain relief after total hip 
arthroplasty- a randomized controlled study. Pain. 2005 Apr;114(3):320-7. 
7. Vas, J., Aranda-Regules, J. M., Modesto, M., et al. (2014). Auricular acupuncture 
for primary care treatment of low back pain and posterior pelvic pain in 
pregnancy: study protocol for a multicenter randomized placebo-controlled trial. 
Trials, 15, 288. http://doi.org/10.1186/1745-6215-15-288. 
8. Yeh, C. H., Chiang, Y. C., Hoffman, S. L., Liang, Z., Klem, M. L., Tam, W. W. S., 
… Suen, L. K.-P. (2014). Efficacy of Auricular Therapy for Pain Management: A 
Systematic Review and Meta-Analysis. Evidence-Based Complementary and 
Alternative Medicine : eCAM, 2014, 934670. http://doi.org/10.1155/2014/934670 
9. Hou, P.-W., Hsu, H.-C., Lin, Y.-W., Tang, N.-Y., Cheng, C.-Y., & Hsieh, C.-L. 
(2015). The History, Mechanism, and Clinical Application of Auricular Therapy in 
Traditional Chinese Medicine. Evidence-Based Complementary and Alternative 
Medicine : eCAM, 2015, 495684. http://doi.org/10.1155/2015/495684 
10. Chang L, Hsu C-H, Jong G-P, Ho S, Tsay S, Lin K-C. Auricular Acupressure for 
Managing Postoperative Pain and Knee Motion in Patients with Total Knee 
Replacement: A Randomized Sham Control Study. Evidence-based 
Complementary and Alternative Medicine : eCAM. 2012;2012:528452. 
doi:10.1155/2012/528452. 
11. Fox, Lindsay M. et al. Battlefield acupuncture to treat low back pain in the  
emergency department. The American Journal of Emergency Medicine , Volume 
36 , Issue 6 , 1045 – 1048. 

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12. Jan AL, Aldridge ES, Rogers IR, Visser EJ, Bulsara MK, Niemtzow RC. Does Ear 
Acupuncture Have a Role for Pain Relief in the Emergency Setting? A 
Systematic Review and Meta-Analysis. Medical Acupuncture. 2017;29(5):276-
289. doi:10.1089/acu.2017.1237. 
13. R.J.E. Lee, J.C. McIlwain, Subacute bacterial endocarditis following ear 
acupuncture. International Journal of Cardiology, Volume 7, Issue 1, 1985, 
Pages 62-63, ISSN 0167-5273, https://doi.org/10.1016/0167-5273(85)90175-5. 
(http://www.sciencedirect.com/science/article/pii/0167527385901755) 
Keywords: acupuncture; sepsis; endocarditis 
14. Stellon, A. Acupuncture in Patients with Valvular Heart Disease and Prosthetic 
Valves. Acupuncture in Medicine. 2003; 21(3):87-91. 
15.  Tan, JY, Molassiotis, A, Wang, T, Suen, LK. Adverse events of auricular 
therapy: a systematic review. Evid Based Complement Alternat Med. 
2014;2014:506758. doi: 10.1155/2014/506758. Epub 2014 Nov 10 
 
 
 
 

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BATTLEFIELD ACUPUNCTURE NATIONAL NOTE TEMPLATE EXAMPLE 
Follow up visit 
Battlefield Acupuncture was the only treatment given. 
Patient was evaluated and agreed to receive Battlefield Acupuncture 
Protocol (BFA) for the following pain condition(s): 
  Comment: low back 
Pre BFA Pain Numeric Rating Scale of site with highest pain:  
  0-10 
The patient was asked the following questions: 
During the past 24 hours, how much has your pain interfered with your 
usual activity? 
  0-10 
During the past 24 hours, how much has your pain interfered with your 
usual sleep? 
  0-10 
During the past 24 hours, how much has the pain affected your usual mood? 
  0-10 
During the past 24 hours, how much has pain contributed to your stress? 
  0-10 
Oral informed consent obtained for BFA. 
Procedure: 
  Time out was performed 
  Ear was prepped with alcohol 
Needle type: 
  Semi-permanent ASP needles 
The following points were placed: 
  All 10 points in both ears 
Complications: 
  Patient tolerated well without any complications. 
Post BFA Pain Numeric Rating Scale: 
  0-10 
The patient was provided with the following post BFA instructions: 
  -Avoid alcohol, heavy or difficult to digest meals, exercise and sexual 
  activity for six hours after today's BFA treatment. 
 
  -Showering is ok as long as the ears are only pat-dried or you can avoid 
  drying ears with towel entirely. 
 
  -If you experience new or continued redness, swelling or pain, remove 
  the needles or return to clinic for evaluation and/or needle removal. 
 
  -You may experience drowsiness, lightheadedness, or euphoria during the 
  treatment or within 30 minutes of treatment. 
 
  -Do not have an MRI scan with the needles in place (If you need to have 
  an MRI, please remove needles prior to scan). 
 
  -Continue to take all prescription medication according to your 
  provider's instructions. 
 
  -Please keep notes of your response to this treatment including effects 
  on pain, sleep, well-being, and energy, and keep us informed. 
 
  -Please keep all regularly scheduled follow-up visits. Return sooner 
  should your condition worsen. 

 

18 
 
Patient Education Information Sheet  
North Florida/South Georgia  
Veterans Health System (NF/SGVHS) 
www.northflorida.va.gov  
Primary Care 
 
Battlefield Acupuncture 
 
What is Acupuncture?  
Traditional acupuncture came from China over five thousand years ago as a way to treat many different 
health problems. Over the years research has shown that acupuncture works not only on the area with 
the needles but all over the body as well to reduce pain. This works by suppressing pain transmission at 
the spinal cord as well as releasing chemicals to reduce the feeling of pain. It has been proven a safe and 
effective way to treat pain over thousands of years. 
 
What is Battlefield Acupuncture? 
While traditionally you may think of acupuncture as many needles all over the body, Battlefield 
Acupuncture is just in the ear. The theory is that the entire body is represented in the ear and by placing 
small needles in the surface some of the pain is able to be suppressed. 
 
Who should avoid Acupuncture? 
• 
If you are pregnant (or think you may be). 
• 
Afraid of needles to the point of passing out. 
• 
Have a bleeding disorder or are on certain 
medications. 
• 
Have a Pacemaker, Defibrillator or other similar 
electronic devices 
• 
Are scheduled for an MRI. We would want to 
remove any remaining needles or magnets before 
the 
MRI procedure is performed 
 
Battlefield 
Acupuncture

19 
 
The process: 
• 
Very small needles or magnets are used.   
• 
They are placed in five points in the surface of the ear. 
• 
You may have some mild discomfort.   
• 
The needles stay in for two to six days. 
• 
If they bother you, they can easily be removed at home.  
 
After care: 
• 
Relax the day after, no heavy exercise, house work or yard work. 
• 
No alcohol for one day after. 
• 
Return to normal activity after 24 hours. 
• 
When the needles fall out dispose of them in a container with a lid. 
• 
Do not scrub the ear. 
• 
Take notes of how you feel, sleep and your pain level. 
Possible side effects: 
• 
Infection: redness, swelling, warmth, increased pain 
• 
Bleeding or bruising. 
• 
Feeling dizzy or nauseated. 
• 
Fainting. 
• 
Feeling euphoric or lightheaded. 
• 
Drowsiness.  
• 
Discoloration involving the skin where the needles are placed 
• 
It is possible for symptoms to become worse after a treatment, this is almost always temporary 
and a good sign that you are responding to the treatment.  
 
 
 
 
 

20 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Acupuncture 
Needles