Pilot Study: Effect of Battlefield Acupuncture Needle Selection on Symptom Relief and Patient Tolerance in the Treatment of Pain
Phase: NA
Conditions: Musculoskeletal Pain, Acute Pain
Sponsor: Paul Crawford

Pilot Study: Effect of Battlefield Acupuncture Needle Selection on 
Symptom Relief and Patient Tolerance in the Treatment of Pain
NCT04464954
Feb 16, 2021

EIRB Protocol Template (Version 1.6)
1.0
General Information
*Please enter the full title of your study:
Pilot Study: Effect of Battlefield Acupuncture Needle Selection on Symptom Relief and Patient 
Tolerance in the Treatment of Pain
*Please enter the Protocol Number you would like to use to reference the protocol:
FWH20200117H
* This field allows you to enter an abbreviated version of the Protocol Title to quickly identify
this protocol.
Is this a multi-site study (i.e. Each site has their own Principal Investigator)?
No
Does this protocol involve the use of animals?
Yes
No
2.0
Add Site(s)
2.1 List sites associated with this study:
Primary 
Dept?
Department Name
USAF - 99 MDG/MOFMC
3.0
Assign project personnel access to the project
3.1 *Please add a Principal Investigator for the study:
Crawford, Paul F
Select if applicable
Student
Site Chair
Resident
Fellow
3.2 If applicable, please select the Research Staff personnel:
A) Additional Investigators
Crawford, Kristy J, BSN 
Site Investigator
Crawford, Kristy J, BSN 
N

 Associate Investigator
Moss, David 
 Associate Investigator
Moss, Jennie B 
 Associate Investigator
Tate, Rachel A 
 Associate Investigator
B) Research Support Staff
Bogdanovich, Tracy Lee 
 Research Coordinator
Clark, Jill Marie, MBA/HCM 
 Research Coordinator
Crawford, Amanda J 
 Research Coordinator
Crawford, Kristy J, BSN 
 Research Coordinator
Estrada, Jonica 
 Research Coordinator
Haney, Thomas A 
 Research Coordinator
Huffman, Sandra G 
 Research Coordinator
Moss, Jennie B 
 Research Coordinator
Shaffer, Daniel WILLIAM 
 Research Coordinator
Tate, Rachel A 
 Research Coordinator
3.3 *Please add a Protocol Contact:
 
Clark, Jill Marie, MBA/HCM 
Crawford, Paul F 
Huffman, Sandra G 
The Protocol Contact(s) will receive all important system notifications along with the Principal 
Investigator. (i.e. The protocol contact(s) are typically either the Protocol Coordinator or the 
Principal Investigator themselves).
3.4 If applicable, please select the Designated Site Approval(s):
 
Add the name of the individual authorized to approve and sign off on this protocol from your Site 
(e.g. the Site Chair).
4.0
 
Project Information
4.1  * Has another IRB/HRPP reviewed this study or will another IRB/HRPP be reviewing this study?
If Yes, answer the questions according to the IRB/HRPP Determination.
  Yes   
  No

IRB Name
Review Date
Determination
No records have been added
4.2  * Is this a research study or a Compassionate Use/Emergency Use/HUD project?
 Yes   
 No
4.3  What type of research is this?
Biomedical Research
Clinical trial (FDA regulated)
Behavioral Research
Educational Research
Psychosocial Research
Oral History
Other
Describe other:
Operational Testing and Evaluation
4.4  Are you conducting this project in pursuit of a personal degree?
  Yes   
  No
4.6  * Is this human subjects research? (As defined by 32 CFR 219) 
 
Human subject means a living individual about whom an investigator (whether professional or 
student) conducting research: 
   (i) Obtains information or biospecimens through intervention or interaction with the individual, 
and uses, studies, or analyzes the information or biospecimens; or 
  (ii) Obtains, uses, studies, analyzes or generates identifiable private information or identifiable 
biospecimens.  
 Yes   
 No
4.7  * Do you believe this human subjects research is exempt from IRB review?
  Yes   
  No
5.0
 
Personnel Details
5.1  List any Research Team members without EIRB access that are not previously entered in the 
protocol:
Name:
(Last, First, M.I.)
Burton, Samuel 2d Lt
Role on Protocol:
Phone Number:
 
(703) 600-9209
Email Address:
 
samuel.
burton@usuhs.edu
Associated Institution:
 
USUHS

Associate Investigator
5.2  
Will you have a Research Monitor for this study?
Yes 
No 
N/A 
6.0
 
Data/Specimens
6.1  Does the study involve the use of existing data or specimens only (no interaction with human 
subjects)?
  Yes   
  No
7.0
 
Funding and Disclosures
7.1  Source of Funding:
Funding Source
Funding Type
Amount
No records have been added
Total amount of funding:
7.2  Do you or any other Investigator(s) have a disclosure of a personal interest or financial nature 
significant with sponsor(s), product(s), instrument(s) and/or company(ies) involved in this study?
  Yes   
  No
If Yes, complete and attach Conflict of Interest forms for all key personnel
8.0
 
Study Locations
8.1  Is this a collaborative or multi-site study? (e.g., are there any other institutions involved?)
  Yes   
  No
8.2  Study Facilities and Locations:
Institution
Site Name
Site Role
FWA or DoD 
Assurance 
Number
Assurance 
Expiration 
Date
Is there an 
agreement?
IRB 
Reviewing 
for Site
Air Force
99MDG
/Nellis AFB
Performance 
site
P60002
03/27/2021
: IAIR
WHASC 
IRB 

: Protocol 
Office
Other:
Other 
Institution 
Site
Site Role
FWA or DoD 
Assurance 
Number
FWA or DoD 
Expiration 
Date
Is there an 
agreement?
IRB 
Reviewing 
for Site
No records have been added
8.3  Are there international sites?
Attach international approval documents, if applicable, when prompted. Note: Ensure local research 
context has been considered
  Yes   
  No
8.4  Is this an OCONUS (Outside Continental United States) study?
  Yes   
  No
Select  the area of responsibility:
Have you obtained permission from that area of responsibility? (This is a requirement prior to study 
approval)
  Yes   
  No
9.0
 
Study Details
9.1  Key Words:
Provide up to 5 key words that identify the broad topic(s) of your study
Battlefield acupuncture, pain
9.2  Background and Significance:
Include a literature review that describes in detail the rationale for conducting the study. Include 
descriptions of any preliminary studies and findings that led to the development of the protocol.  The 
background section should clearly support the choice of study variables and explain the basis for the 
research questions and/or study hypotheses.  This section establishes the relevance of the study and 
explains the applicability of its findings
The use of acupuncture has increased in popularity and scope in the United States over the last several 
decades with some 20 million Americans estimated to have tried acupuncture at least once and between 
2000 and 2010 acupuncture visits tripled . Though acupuncture is used to treat many ailments such as 
1
nausea, allergies, hot flashes, etc., it’s most common use is for alleviation of pain. The way that 
acupuncture reduces pain is explained largely by “gate theory” first cited in western literature in 1965 by 
Dr. Ronald Melzack
“The gate control theory of pain … proposes that a mechanism in the dorsal horns 
2  
of the spinal cord acts like a gate that inhibits or facilitates transmission from the body to the brain on 
the basis of the diameters of the active peripheral fibers, as well as the dynamic action of brain 
processes”  The pain theory was expanded further by neuroscientist Zang-Hee Cho in 1998 via functional 
2
MRI when he showed that the visual and auditory cortices of the brain were stimulated during 
acupuncture. He drew further conclusions concerning the activation of  beta-endorphins through the 
endocrine and autonomic systems which gave objective data to support gate theory.  Although this and 
3

other studies have shown promising insights into the physiological mechanisms behind acupuncture, 
there have been considerable doubts raised against acupuncture’s place in treating pain.
 
In 2009, a meta-analysis synthesized data from 13 RCTs comparing acupuncture, sham-acupuncture, 
and no acupuncture in the treatment of pain.  The authors concluded that a small analgesic effect was 
found when comparing acupuncture and sham acupuncture to no acupuncture, however, it was unclear if 
this effect was clinically significant. They state in their conclusion that, “ Whether needling at 
acupuncture points, or at any site, reduces pain independently of the psychological impact of the 
treatment ritual is unclear.  However, in 2018 a meta-analysis using 39 trials and over 20,000 patients 
4
compared pain and function outcomes  of acupuncture, sham-acupuncture and no acupuncture. They 
found a 0.5 SD difference between acupuncture and no acupuncture and 0.2 SD difference with sham 
acupuncture which were both significant at P<0.001 in the short term and even at one year 15% 
improvement . Another meta-analysis of 59 trials, but only 4980 patients validated its use in treating 
5
musculoskeletal pain specifically . In 2018, the academy of family physicians (AAFP) cited several other 
6
studies that further supported the effective nature of acupuncture for chronic pain making acupuncture 
practice for pain that more mainstream  and in 2019, Medicaid began coverage acupuncture for the 
7
treatment of lower back pain in conjunction with NIH trials due to the mounting evidence and a desire to 
combat the opioid epidemic.  Other government departments have implemented acupuncture for similar 
8
reasons.
Acupuncture, among other pain management modalities, was studied at length by a task force in 2009 
and 2010 with representation from Army, Navy, Air Force and the Veterans Affairs (VA). They ultimately 
made 109 recommendations for pain management that included the integration of acupuncture .  The 
9
Department of Defense (DOD) began employing acupuncture to treat a wide array of conditions such as 
post-traumatic stress disorder, traumatic brain injury, polytrauma, and musculoskeletal pain at dozens of 
MTFs
.  Funding for training and education was provided from a joint incentive fund (JIF) including $5.4 
10
million that was shared between the DOD and the VA and ultimately led to standard teaching of 
battlefield acupuncture (BFA)
. BFA is a subcategory of auricular/ear acupuncture that gained its name 
11
because of the rapid way and in the austere environment in which it could be applied.  USAF Col (Ret) 
Richard Niemtzow originally introduced and advocated for BFA as an efficient, cost-effective means to 
treating acute pain on the battlefield while still allowing active duty military members to return to duty 
with limited interference on capability
. Several pilot studies and case studies in the military have 
12
strengthened advocacy for and expanded application of  BFA in the acute treatment of MSK among many 
other ailments
. In one focused trial at Nellis AFB, 172 patients were observed over the course of one 
13
year for treatment of chronic pain and they found a 45% reduction in opioid use and comparable 
reductions in muscle relaxants and NSAID use. Furthermore, they reported improved pain control and 
functionality
.
14
 
Training providers on how to perform BFA is streamlined in the DOD. Where it used to be a course 
reserved for physicians, it is now taught to nurse practitioners, physical therapists, medical technicians 
and special forces providers
 and can be completed in 4 hours for Level 1 and 8 hours for Level 2 
10
training
. BFA training was originally centralized at Andrews AFB under Dr. Niemtzow at the center of 
 16
acupuncture and integrative medicine (AIM). Although it is now taught at many sites in the DOD and VA 
by hundreds of instructors, the approach remains the same and includes a stepwise progression of 
needles into five different points in the ear: Cingulate Gyrus on one ear then the other followed 
sequentially by the Thalamus, Omega 2, point zero and Shen Men. After each needle the patient’s pain is 
reassessed. If analgesic effect is reached, there is no need to continue with the subsequent needles.
Th
15 
e common needles in DOD practice are found in the chart below provided in a recent procedure 
instruction by the Defense Health Agency (DHA) in February 20, 2020
:
16
Needle J-type No2 (.18) x 15 mm
Needle L-type No3 (.20) x 30mm
Needle L-type No5 (.25) x 40mm
Needles L-type No5 (.25) x 60mm
ASP Auricular Semi-Permanent needles, Gold
ASP Auricular Semi-Permanent needles, Stainless Steel
Pyonex Press Needles by Seirin Yellow, 0.2 x 0.6 mm
Pyonex Press Needles0.2 x 0.9 mm
 
In the same report the DHA codified BFA and other forms of acupuncture and the common clinical 
settings in which it can be administered.   Despite the wide acceptance of BFA in the DHA and the 

VA  and the recently published procedural instruction there is no research that compares the commonly 
used needles against one another in terms of patient preference and treatment outcome. The Las Vegas 
VA Medical Center has chosen to use pyonex needles exclusively because of improved patient compliance 
whereas the DOD seems to prefer the ASP needles for ease of administering, but neither practice is well 
substantiated by research. This pilot study will seek to answer the question of if there is any significant 
difference between BFA needles and if so which has best overall results when considering both symptom 
relief and patient tolerance of treatment.
9.3  
Objectives/Specific Aims/Research Questions:
Describe the purpose and objective(s) of the study, specific aims, and/or research questions/hypotheses
Aim
The aim of this pilot study is to conduct an unblinded pilot randomized clinical study on the effectiveness 
and tolerability of auricular semi-permanent (ASP) vs intradermal (long), and pyonex needles in 
Battlefield Acupuncture (BFA) for the treatment of pain. 
Goals
1) Begin to identify which of 3 needles is most efficacious for BFA treatment of pain; 2) Identify patient 
experiences and tolerance of three commonly used acupuncture needles at Mike O’Callaghan Military 
Medical Center at Nellis Air Force Base. This study will compare 30 patients (10 per needling group) and 
will serve as a pilot study for a potential larger randomized control trial (RCT) across multiple MTFs in the 
Defense Health Agency (DHA) to establish better BFA care practices. We will be recruiting a total of 39 
subjects, which is inclusive of a 30% drop out rate to accommodate those that may be lost to the study 
or have missing data to achieve a final total of 30 subjects.
Hypothesis
1)   There is a difference in BFA effectiveness and tolerance between ASP, long, and pyonex needles for 
the treatment of acute MSK pain. 2)   Pyonex needles are the most effective and tolerated acupuncture 
needle for the BFA treatment of pain.
9.4  Study Design:
Describe study design in one to two sentences (e.g., prospective, use of existing records/data
/specimens, observational, cross-sectional, interventional, randomized, placebo-controlled, cohort, etc.). 
Specify the phase – Phase I, II, III, or IV – for FDA-regulated investigational drug research
Randomized clinical trial comparing ASP, long, and pyonex needles by recruiting and treating 13 patients 
per group with the goal of analyzing at least 10 patients’ questionnaires per group comparatively for 
effect and tolerance of different BFA needles.
9.5  Target Population:
Describe the population to whom the study findings will be generalized
Active Duty members and DoD beneficiaries, 18 years or older, meeting the inclusion/exclusion criteria 
will be recruited.
9.6  Benefit to the DoD:
State how this study will impact or be of benefit to the Department of Defense
BFA use and application is widespread. Needle phobia prevents many patients from seeking care, and 
prior experience with painful ASP needles prevents patients from returning for a second treatment. If we 
determine that other, less painful needles are as effective and better tolerated as ASP needles, then the 
uptake of acupuncture in the DoD will increase.

10.0
 
Study Procedures, Data Management, and Privacy
10.1  Study Procedures:
Describe step-by-step how the study will be conducted from beginning to end
Active duty members and DoD beneficiaries, age 18 years or older, meeting the inclusion/exclusion 
criteria will be offered an opportunity to participate. They will be recruited from the clinics located at 
99MDG (Nellis AFB). 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 to verify the inclusion/exclusion criteria
-Collect date of birth, age, gender, contact information, DoD ID number, name of standard of care 
medications (over-the-counter and prescription)
-Women of child bearing potential will be reminded that they only reliable methods of birth control are 
total abstinence or surgical removal of the uterus. Other methods, such as the use of condoms, a 
diaphragm or cervical cap, birth control pills, intrauterine device (IUD), or sperm-killing products are not 
totally effective in preventing pregnancy. They will be asked to alert study staff if they become pregnant 
or feel that they might be pregnant.
: Subjects will be randomized using a random number generator using simple 
Randomization
randomization  into 1 of 3 research treatment groups, with approximately 13 subjects in each arm:
Group 1: Auricular semi-permanent (ASP gold) needles
Group 2: Intradermal (long) needles using J-type No. 1 (.16) x 15mm
Group 3: Pyonex Pink 1.5mm (0.2 x 1.5mm)
 
Treatment Visit (Day 0) (may be the same day as screening visit):
-Subjects will complete the Defense and Veterans Pain Rating Scale (DVPRS) and DVPRS Supplemental 
Questionnaire before treatment.
-Subjects will be prescribed naproxen 220 mg BID (twice a day) #15 as standard of care treatment for 
pain (unless they refuse or have a contraindication for use)
-Subjects will be given treatment according to their randomization group following the Acupuncture 
Procedure
below: Step 1: Either the left or right ear is chosen for the placement of the needles per 
15 
provider or patient preference. Step 2: Needles will be placed in the following points on the chosen ear: 
Cingulate Gyrus, Thalmus, Omega 2, Point Zero, and Shen Men. Step 3: If the patients desires further 
pain reduction, acupuncture needles will be placed in the same points in the opposite ear. The maximum 
number of needles in each ear is 5.
 
Post-Treatment (10-15 minutes Post Treatment) In-person:
-Subjects will complete the DVPRS and DVPRS Supplemental Questionnaire.
-Subjects will complete the Needle Tolerance Questionnaire.
 
Contact 1 (24 hours Post Treatment +/- 4 hours) In-person, via telephone, Survey Monkey or 
Google Docs:
-Subjects will complete the DVPRS and DVPRS Supplemental Questionnaire.
-Subjects will complete the Needle Tolerance Questionnaire.
 
Contact 2 (7 days Post Treatment +/- 2 days) In-person, via telephone, Survey Monkey or 
Google Docs:
-Subjects will complete the DVPRS and DVPRS Supplemental Questionnaire.
-Subjects will complete the Needle Tolerance Questionnaire.
 
Acupuncture Needles:
Auricular semi-permanent (ASP gold) needles: will be remain in your ears for 2-8 days and allowed to fall 
out on their own.
 
Intradermal (long) needles using J-type No. 1 (.16) x 15mm: remain in place for 15-30 minutes and are 
removed by a member of the study staff.
 
Pyonex needles (Pyonex Pink 1.5mm (0.2 x 1.5mm): that will be remain in your ears for 2-21 days and 
allowed to fall out on their own.
 
This study received DoD Survey License Exemption (#14)-Exempt #0033.

10.2  Data Collection:
Describe all the data variables, information to be collected, the source of the data, and how the data will 
be operationally measured.
We will measure pain utilizing the DVPRS just before BFA therapy, 10-15 minutes after, 24 hours and 7 
days post-therapy. Needle Tolerance questionnaire will be administered after DVPRS 10-15 minutes 
after, 24 hours and 7 days post-therapy.
10.3  At any point in the study, will you request, use, or access health information in any form, including 
verbal, hard copy and electronic?
  Yes   
  No
11.0
 
Statistical/Data Analysis Plan
11.1  Statistical Considerations:
List the statistical methods to be used to address the primary and secondary objectives, specific aims, 
and/or research hypotheses.  Explain how missing data and outliers will be handled in the analysis.  The 
analysis plan should be consistent with the study objectives.  Include any sub-group analyses (e.g., 
gender or age group).  Specify statistical methods and variables for each analysis.  Describe how 
confounding variables will be controlled in the data analysis
Outcome Measures: There are two outcome measures. The effectiveness outcome measure is the 
Defense and Veterans Pain Rating Scale (DVPRS). The DVPRS [1,2] consists of an 11-point numerical 
rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability 
and validity in measuring both acute and chronic pain, and is currently the standard for pain 
measurement throughout DoD and VA health systems. The DVPRS demonstrates linear scale qualities 
allowing parametric methods to be used. There will be four repeated measurements of the DVRPS: pre-
acupuncture, post-acupuncture, 24 hours and one week post-therapy. The needle tolerance outcome will 
be measured using an in-house developed questionnaire. It employs 5-point ordinal scales to evaluate 12 
post-therapy experiences or perception encompassing adverse outcomes, inconveniences, and 
satisfaction. There will be three repeated measurements: post-acupuncture, 24 hours and 1 week post-
therapy.
Missing Data and Outliers: Outliers will be checked for clerical error. If improperly recorded, the data will 
be corrected, and, if found to be properly recorded, will be retained. Medians, means and ranges will be 
calculated and assessed to accommodate extreme observations. Subjects with missing data will be 
excluded from analysis and the estimated sample size seen below adjusted for this eventuality. 
Furthermore, an analysis of sample characteristics of retained and dropped subjects will be performed to 
determine whether bias has been introduced due to exclusion.
 
Sub-group Analysis: Analysis will center on differences between the three needle groups. The three 
treatment groups will allow inferences to be made as to whether each group is statistically different from 
one another. Medication is a potential confounder, but will be addressed by standardizing the dosage 
of analgesics used by all subjects rather than as a variable in a general linear model with the needle 
group variable.
 
Null Hypotheses:
H01 — there is no difference in means of the DVPRS between needle groups; and
H02 — there is no difference in means of the DVPRS between repeated measures; and
H03 — there is no difference in the distribution of the tolerance ordinal scales between needle groups.
 

1. Polomano RC, Galloway KT, Kent ML, Brandon-Edwards H, Kwon KN, Morales C, Buckenmaier C' 3rd. 
Psychometric Testing of the Defense and Veterans Pain Rating Scale (DVPRS): A New Pain Scale for 
Military Population. Pain Med. 2016 Aug;17(8):1505-19.
2. Nassif TH, Hull A, Holliday SB, Sullivan P, Sandbrink F. Concurrent Validity of the Defense and 
Veterans Pain Rating Scale in VA Outpatients. Pain Med. 2015 Nov;16(11):2152-61.
11.2  Sample Size:
A priori power analysis was performed using the DVPRS variable as described below. The analysis 
indicates a minimum of 10 subjects in each needle group, for a total sample size of 30, will have a power 
of 0.44 to detect the minimal clinically important difference at alpha = 0.14. We will be recruiting a total 
of 39 subjects, which is inclusive of a 30% drop out rate to accommodate those that may be lost to the 
study or have missing data to achieve a final total of 30 subjects.
11.3  Total number of subjects requested (including records and specimens):
39
11.4  If you are recruiting by study arm, please identify the arms of the study and how many subjects will 
be enrolled in each arm
Randomization: Subjects will be randomized using a random number generator using simple 
randomization into 1 of 3 research treatment groups, with approximately 13 subjects in each arm:
Group 1: Auricular semi-permanent (ASP gold) needles
Group 2: Intradermal (long) needles using J-type No. 2 (.18)x 15mm
Group 3: Pyonex Pink 1.5mm (0.2 x 1.5mm)
11.5  Please provide a justification for your sample size
The study is organized as a mixed effects, randomized design with repeated measures. Subject, gender 
and age are random effects as subjects are presumed to be a random representation of the population of 
adult male and female patients seeking treatment for this ailment and obtaining similar care at this and 
other Air Force medical treatment facilities. Time of repeated measure is a fixed effect as the pre- and 
post-therapy times cannot be generalized to other times. Needle group is a fixed effect as the needle 
employed cannot be generalized to other needles and conditions.
A priori power was assessed using G*Power Version 3.1.9.3 using the DVPRS for effect size. [4] DVPRS 
mean (SD) pain intensity for a broad sample consisting of inpatients and outpatients suffering from acute 
and chronic pain has been found to be 4.4 (2.4). The minimal clinically important difference of an 11-
point pain scale in patients as will be included in this study has been determined to be a 25% percent 
change in the score. [5] This difference, mean and SD were used for the DVPRS effect size.
 
A priori power analysis of the DVPRS variable using the statistical method described below indicates 10 
subjects in each research group, for a total sample size of 30, will have a power of 0.44 to detect the 
minimal clinically important difference at alpha = 0.14.
 
[4] 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.
[5] Sloman R, Wruble AW, Rosen G, Rom M. (2006). "Determination of clinically meaningful levels of 
pain reduction in patients experiencing acute postoperative pain." Pain Manag Nurs 7(4): 153-158.
11.6  Data Analysis Plan: Complete description: Background, Objectives, Design, Step by Step how the 
project is going to be done, Data analysis plan:

Sample and needle group means, standard deviations, medians, interquartile ranges (IQR) and ranges 
will be calculated for interval variables. Frequency distributions will be produced for nominal and ordinal 
variables.
The null hypotheses H01 and H02 for the DVPRS outcome measure will be tested by a mixed effects 
repeated measures analysis of variance (rANOVA). In the event a null hypothesis is rejected, contrasts 
will be used to investigate effects and differences between and within research and time groups. Null 
hypotheses H03 will be tested with Chi Squared or Fisher’s Exact tests. The significance level of multiple 
comparison tests will be corrected to α = .05 by the Holm method. [6]
Mr. Danny Sharon, Senior Research Biostatistician Subject Matter Expert for Clinical Research 
Management under contracts OMNI 0004 3-82 and OMNI 0005 3-126, is the statistical consultant 
supporting this study. Statistical analysis will be performed with R Version 3.5.1. [7]
[6] Holm, S. 1979. A simple sequential rejective multiple test procedure. Scand. J. Statistics, 6: 65-70.
[7] R Core Team. R: A language and environment for statistical computing. R Foundation for Statistical 
Computing, Vienna, Austria. 2016 URL 
.
http://www.R-project.org/
12.0
 
Participant Information
12.1  Subject Population:
Active Duty members and DoD beneficiaries, 18 years or older, meeting the inclusion/exclusion criteria 
will be recruited.
12.2  Age Range:
Check all the boxes that apply. if the age range of potential subjects (specimens, records) does not 
match the range(s) selected, please specify in the text box.
0-17
18-24
25-34
35-44
45-54
55-64
65-74
75+
12.3  Gender:
Male
Female
Other
12.4  Special categories, check all that apply
Minors /Children
Students
Employees - Civilian
Employees - Contractor
Resident/trainee
Cadets /Midshipmen
Active Duty Military Personnel

Wounded Warriors
Economically Disadvantaged Persons
Educationally Disadvantaged Persons
Physically Challenged (Physical challenges include visual and/or auditory impairment)
Persons with Impaired Decisional Capacity
Prisoners
Pregnant Women, Fetuses, and Neonates
Non-English Speakers
International Research involving Foreign Nationals - Headquarters Review is necessary
12.5  Inclusion Criteria:
Order 
Number
Criteria
1 
Inclusion Criteria: (adapted
)
17
-Active duty and DoD Beneficiaries aged 18 years or older
-Pain
 
12.6  Exclusion Criteria:
Order 
Number
Criteria
1 
Exclusion Criteria: (adapted
)
17
-Contra-indication to needle use including known bleeding disorder and psychogenic 
issues related to needle use (e.g., needle-phobia)
-Allergy to metal or neutropenia
-Women who are pregnant, may be pregnant, or attempting to become pregnant
 
13.0
 
Recruitment and Consent
13.1  Please describe the recruitment process, including how subjects will be identified and selected for 
the study.
All potentially eligible patients will be offered an opportunity to participate. Primary Care Manager (PCM) 
referrals, with the patient’s oral or written authorization, 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 
another 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 patients directly.
13.2  Compensation for Participation:
Subjects will not be paid for their participation.
13.3  

Please describe the pre-screening process. If no pre-screening, enter Not Applicable in the text 
editor
Pre-Eligibility review: Subjects who responded to advertisements or have given their permission to be 
contacted will be approached by a study staff member to discuss the subjects’ interest in the research 
study and to receive a pre-eligibility screening for study participation. The attached “Pre-Eligibility 
Review Script” will be used and response will be recorded. If the subject is interested in participating in 
the study, the study staff member will schedule a screening visit while the subject waits on the phone or 
in-person, in order to confirm the schedule appointment with the subject. Following the pre-screening 
procedure, the script will be shredded.
13.4  Consent Process:
 
Revised Common Rule, Section 219.116:  General requirements for informed consent, whether 
written or oral, are set forth in this paragraph and apply to consent obtained in accordance with the 
requirements set forth in paragraphs (b) through (d) of this section. Broad consent may be 
obtained in lieu of informed consent obtained in accordance with paragraphs (b) and (c) of this 
section only with respect to the storage, maintenance, and secondary research uses of identifiable 
private information and identifiable biospecimens.
Are you requesting a waiver or alteration of informed consent?
  Yes   
  No
Please explain the consent process:
Informed Consent and HIPAA authorization will be sought in advance of any screening and study-related 
procedures from each prospective study 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 healthcare 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 subjects’ discretion, they may take the ICD 
home to discuss further with family members or another physician prior to making a decision. If they 
decide they are interested in participating in the study, they can contact the research department. If the 
subject consents, a copy of the signed ICD and HIPAA Authorization Document 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 de-identified research data into the “Nellis Acupuncture 
Data Repository” (FWH20140048H) for future research. If the subject does not give their authorization, 
then the de-identified research data will be destroyed no later than at 3 years after closure of the study. 
HIPAA forms will be maintained in hardcopy format for a minimum of 6 years.
13.5  DoDI 3216.02 requires an ombudsman to be present during recruitment briefings when research 
involves greater than minimal risk and recruitment of Service members occurs in a group setting. If 
applicable, you may nominate an individual to serve as the ombudsman.
N/A 
Propose ombudsman 
13.6  Withdrawal from Study Participation:
Explain the process for withdrawal and specify whether or not the subjects will be given the opportunity 
to withdraw their data their data/specimens in the event they wish to withdraw from the study
If a participant first agrees to participate and then changes their mind, they are free to withdraw consent 
and discontinue participation at any time. Their decision will not affect their ability to receive medical 
care and will not be penalized or lose any benefits to which they would otherwise be entitled. There are 
no risks from withdrawing. They will be advised in the Informed Consent process that if they decide to 
withdraw from the study early, we will ask them to discuss their decision with the study staff. The 
researcher may withdraw them from the study prior to the study’s end without their consent for one or 
more of the following reasons: Failure to follow the instructions of the researchers and study staff. The 

researcher decides that continuing their participation is not in their best interests. The study is cancelled. 
Other administrative reasons. Unanticipated circumstances. They become Pregnant. If they lose their 
status as a military health care beneficiary, they can no longer be included in the study.
14.0
 
Risks and Benefits
14.1  
Risks of Harm:
Identify all research-related risks of harm to which the subject will be exposed for each research 
procedure or intervention as a result of participation in this study.  Consider the risks of breach of 
confidentiality, psychological, legal, social, and economic risks as well as physical risks.  Do not describe 
risks from standard care procedures; only describe risks from procedures done for research purposes
The potential risks to participate in this study are minimal. There is a risk of accidental breach of 
confidentiality. Other risks associated with participating in this research study include:
 
ACUPUNCTURE:
LIKELY: Likely and not serious:
-Pain
-Bleeding
-Flare of signs and symptoms
 
LESS LIKELY: Less Likely and not serious:
Infection
-
14.2  
Measures to Minimize Risks of Harm (Precautions, safeguards):
For each research procedure or intervention, describe all measures to minimize and/or eliminate risk of 
harms to subjects and study personnel
Safeguards are in place for protecting subjects and their health data. The research consents and HIPAA 
Authorization Documents will be stored in a locked cabinet in a locked room. Subjects do not have to 
participate or answer any question that they do not want to complete. If at any time the patient reports 
a side effect, they will be referred to one of the Investigators for care.
 
Women of child bearing potential will be reminded that they only reliable methods of birth control are 
total abstinence or surgical removal of the uterus. Other methods, such as the use of condoms, a 
diaphragm or cervical cap, birth control pills, intrauterine device (IUD), or sperm-killing products are not 
totally effective in preventing pregnancy. They will be asked to alert study staff if they become pregnant 
or feel that they might be pregnant.
14.3  
Confidentiality Protections (for research records, data and/or specimens):
Describe in detail the plan to maintain confidentiality of the research data, specimens, and records 
throughout the study and at its conclusion (e.g., destruction, long term storage, or banking). Explain the 
plan for securing the data (e.g., use of passwords, encryption, secure servers, firewalls, and other 
appropriate methods). If data will be shared electronically with other team members/collaborators 
outside the institution, describe the method of transmission and safeguards to maintain confidentiality. 
Explain whether this study may collect information that State or Federal law requires to be reported to 
other officials or ethically requires action, e.g., child or spouse abuse

Safeguards for Protecting Information:  The research consents and HIPAA Authorization Documents will 
be stored in a locked cabinet in a locked room with restricted access. All identifiable research data 
including patient demographics will be kept in an electronic database separate from the coded research 
data, which will be encrypted, double password protected and the access will be restricted. 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) which outlines the approved methods to destroy PII: 
The research data will be coded and any links to identifiable data (i.e., Master Key) will be destroyed as 
soon as all data mergers have occurred or no later than at the closure of the study. 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 will be de-identified prior to review and 
analysis. 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 with ICD-10 code Z00.6 to reflect the subjects’ 
participation in a research study, in which they are receiving a research-related treatment intervention. 
All research data that includes the Master Key of identifiable patient demographics and PHI/PII will be 
kept in an electronic database, separate from the coded research data, which will be encrypted, 
password protected and the access will be restricted.
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 (in approved shredding bin) 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 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. HIPAA forms will be maintained in 
hardcopy format for a minimum of 6 years. Following research study closure, the Long Term Storage 
Plan will be followed.
14.4  
Potential Benefits:
Describe any real and potential benefits of the research to the subject and any potential benefits to a 
specific community or society
If the individuals in the research are considered experimental subjects (per 10 USC 980), and they 
cannot provide their own consent, the protocol must describe the intent to directly benefit all subjects
Subjects may experience an improvement in pain; however, this is not a guarantee.
14.5  
Privacy for Subjects:
Describe the measures to protect subject’s privacy during recruitment, the consent process, and all 
research activities, etc.
Records of participation in this study may only be disclosed in accordance with Federal law, including the 
Federal Privacy Act, 5 U.S.C. § 552a, the Health Insurance Portability & Accountability Act of 1996, Public 
Law 104-109 (also known as HIPAA), and their implementing regulations. DD Form 2005, Privacy Act 
Statement- Military Health Records, contains the Privacy Act Statement for the records. The Informed 
Consent gives permission for information gained from participants in this study to be published in 
medical literature, discussed for educational purposes, and used generally to further the generalizable 
knowledge of the medical science community. They will not be personally identified; all information will 
be presented as anonymous data. We will annotate their medical record to reflect their participation in a 
research study for each visit because this study involves an intervention that is for research purposes 
only. A copy of this consent will be stored by the investigator in a locked cabinet in a locked room, as 
part of the research record. All research data will be kept in an electronic database, which will be double 
password protected, firewall-protected, encrypted, and access-restricted to people involved in this study. 
The research data will be coded. As soon as possible, any link between identity and the research 
information will be destroyed which means research information about the participant will be 
permanently de-identified. Personal identifying information will be destroyed no later than at the closure 
of the study. The research information collected for this study will not be used for any additional research 
activity beyond what was approved in the signed consent. In the unlikely event that a loss of 
confidentiality occurs, the study staff will advise the subjects to contact their local privacy office for 

assistance. Complete confidentiality cannot be promised, particularly for military personnel, because 
information regarding potential UCMJ violations or concerns regarding fitness for duty may be reported to 
appropriate medical, law enforcement, or command authorities.
14.6  
Incidental or Unexpected Findings:
Describe the plan to address incidental findings and unexpected findings about individuals from 
screening to the end of the subject’s participation in the research. In cases where the subject could 
possibly benefit medically or otherwise from the information, state whether or not the results of 
screening, research participation, research tests, etc., will be shared with subjects or their primary care 
provider. State whether the researcher is obligated or mandated to report results to appropriate military 
or civilian authorities and explain the potential impact on the subject
If significant new findings develop during the course of this study that may relate to subjects’ decision to 
continue to participate in the study, they will be informed.
15.0
 
Study Monitoring
15.1  Your study requires either Data and Safety Monitoring Plan (DSMP) or a Data and Safety Monitoring 
Board (DSMB).
DSMP 
DSMB 
Both 
Not Applicable 
16.0
 
Reportable Events
16.1  Reportable Events: Consult with the research office at your institution to ensure requirements are 
met. Describe plans for reporting unexpected adverse events and unanticipated problems. Address 
how unexpected adverse events will be identified, who will report, how often adverse events and 
unanticipated problems will be reviewed to determine if any changes to the protocol or consent 
form are needed and the scale that will be used to grade the severity of the adverse event. 
Consult with the research office at your institution to ensure requirements are met
 
• Describe plans for reporting expected adverse events. Identify what the expected adverse events will 
be for this study, describe the likelihood (frequency, severity, reversibility, short-term management and 
any long-term implications of each expected event)
 
• Describe plans for reporting unexpected adverse events and unanticipated problems. Address how 
unexpected adverse events will be identified, who will report, how often adverse events and 
unanticipated problems will be reviewed to determine if any changes to the research protocol or consent 
form are needed and the scale that will be used to grade the severity of the adverse event
Events will be reported in accordance with 59MDW IRB policies and procedures.
17.0
 
Equipment/non-FDA Regulated Devices
17.1  Does the study involve the use of any unique non-medical devices/equipment?

  Yes   
  No
18.0
 
FDA-Regulated Products
18.1  Will any drugs, dietary supplements, biologics, or devices be utilized in this study?
Drugs
Dietary Supplements
Biologics
Devices
N/A
18.5  Sponsor (organization/institution/company):
N/A
If applicable, provide sponsor contact information:
19.0
 
Research Registration Requirements
19.1  ClinicalTrials.gov Registration:
Registration is not required 
Registration pending 
Registration complete 
19.2  Defense Technical Information Center Registration (Optional):
Registration is not required 
Registration pending 
Registration complete 
20.0
 
References and Glossary
20.1  References:
1Chen YM. Clinical application of lower He-Sea points for abdominal pain [presentation] 28th Annual 
International Symposium on Acupuncture, Electro-Therapeutics Researches, Columbia University Faculty 
House, New York, NY, October 27, 2012. 
2 Melzack, Ronald.  Pain Forum. Volume 5 (2). Summer 1996. Pages 128-138. 
3 New findings of the correlation between acupoints and corresponding brain cortices using functional 
MRIZ. H. Cho, S. C. Chung, J. P. Jones, J. B. Park, H. J. Park, H. J. Lee, E. K. Wong, B. I. Min. 
Proceedings of the National Academy of Sciences Mar 1998, 95 (5) 2670-2673; DOI: 10.1073/pnas.
95.5.2670
4 Madsen MV, Gøtzsche PC, Hróbjartsson A. Acupuncture treatment for pain: systematic review of 
randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups. BMJ. 2009;
338:a3115. Published 2009 Jan 27. doi:10.1136/bmj.a3115

5 Vickers AJ, Vertosick EA, Lewith G, et al. Acupuncture for Chronic Pain: Update of an Individual Patient 
Data Meta-Analysis. J Pain. 2018;19(5):455–474. doi:10.1016/j.jpain.2017.11.005
6 Yuan QL, Wang P, Liu L, et al. Acupuncture for musculoskeletal pain: A meta-analysis and meta-
regression of sham-controlled randomized clinical trials. Sci Rep. 2016;6:30675. Published 2016 Jul 29. 
doi:10.1038/srep30675
7 Devitt M. Research Finds Acupuncture Effective for Chronic Pain [Internet]. AAFP Home | American 
Academy of Family Physicians. 2018 [cited 2020Apr1]. Available from: https://www.aafp.org/home.
html
8 Center for Medicare and Medicaid Services. Decision Summary: Proposed Decision Memo for 
Acupuncture for Chronic Low Back Pain (CAG-00452N). Center for Medicare and Medicaid Services. July 
15, 2019. https://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-
memo.aspx?NCAId=295
9Pain management task force final report77. (2010). Office of the Army Surgeon General. Retrieved from 
http://www.armymedicine.army.mil/reports/Pain_Management_Task_Force.pdf.
10Walker PH, Pock AR, et al. Battlefield acupuncture: Opening the door for acupuncture in Department of 
Defense/Veteran's Administration health care. Military and Veteran Health. Volume 64 (5). Published July 
19, 2016. Doi:10.1016/j.outlook.2016.07.008
11Defense and Veterans Center for Integrative Pain Management.(2016). Retrieved from http://www.
.
dvcipm.org/
12Spotswood, S. (2014). Auricular acupuncture: Convenient technique for battlefield pain. U.S. Medicine, 
Retrieved from http://www.usmedicine.com/agencies/department-ofdefense-dod/auricular-acupuncture-
convenient-techniquefor-battlefield-pain/.
13Koffman, R., & Helms, M. (2013). Acupuncture and PTSD: ‘come for the needles, stay for the therapy’. 
Psychiatric Annals, 43(5),236e239.
14Crawford PF, Penzien DB et al. Reduction in Pain Medication Prescriptions and Self-Reported Outcomes 
Associated with Acupuncture in a Military Patient Population. Medical Acupuncture; Volume 29 (4). 
Published Aug 01, 2017. Doi:10.1089/acu.2017.1234
15Niemtzow, R. (2007). Battlefield acupuncture. Medical Acupuncture,19, 225e228.
16DHA-PI 6025.33, Acupuncture Practice in Military Medical Treatment Facilities February 20, 2020. 
Retrieved from pdf.
 Bonakdar RA, Mills PJ. Auricular Acupuncture Therapy for Treatment of Musculoskeletal Pain in the 
17
Setting of Military Personnel: A Randomized Trial. United States Naval Medical Center San Diego in 
collaboration with Scripps Integrative Medical Center at La Jolla, CA. NIH Clinical Trail NCT02263001. 
Last Updated May 4, 2017.
20.2  Abbreviations and Acronyms:
Battlefield Acupuncture (BFA), Defense and Veterans Pain Rating Scale (DVPRS)