A Randomized, Single-blind, Prospective Trial of Auricular Acupuncture for the Reduction of Post-operative Tonsillectomy Pain in Adults
Phase: NA
Conditions: Tonsillitis
Sponsor: Defense and Veterans Center for Integrative Pain Management

IRBNet Number: 381600-19 
PI: Dr. Anthony Plunkett 
Protocol Title: A randomized, single-blind, prospective trial of auricular acupuncture for the 
reduction of post-operative tonsillectomy pain in adults.   
Initial Date Submitted: 6/13/2013 
Revision Date: 7/17/17 
WAMC Protocol Template Revised 23 November 2012 
 
Page 1 of 22 
381600-18_Auricular_Plunkett_v. 23 May 17 
Application and Request for Approval of Study Proposal 
 
1.0 PROTOCOL TITLE: A randomized, single-blind, prospective trial of auricular 
acupuncture for the reduction of post-operative tonsillectomy pain in adults.   
 
2.0 PRINCIPAL INVESTIGATOR:   
Name: Anthony Plunkett, MD,  
Title: Director of Research 
Department: Anesthesiology 
Name/Address of Institution: Womack Army Medical Center, Ft. Bragg, NC 28310 
Phone: 910-643-2423 
Fax: 910-907-7939 
AKO Email: anthony.r.plunkett.civ@mail.mil  
Preferred Email:  anthonyrplunkett@gmail.com  
 
2.1 ASSOCIATE INVESTIGATORS:  
 
    
Name: Michael Bartoszek, MD, MAJ, MC 
Title: Staff Anesthesiologist 
Department: Anesthesiology 
Name/Address of Institution: Womack Army Medical Center, Ft. Bragg, NC 28310 
Phone: 910-907-7668 
Fax: 910-907-7939 
AKO Email: Michael.bartoszek@us.army.mil  
 
2.2 COLLABORATOR:  
 
 
Name: Robin S. Howard, MA  
 
Titles: Supervisory Biostatistician, Deputy Chief (Civilian),  
 
Department: Department of Research Programs 
 
Name/Address of Institution: Walter Reed National Military Medical Center Building 17, 
 
3rd Floor, Room 3063/3279   8901 Rockville Pike, Bethesda, MD 20889-5638 
 
Phone:  301-295-8235 < tel:301-295-8235 > Email: robin.s.howard.civ@mail.mil 
2.3 ROLES AND RESPONSIBILITIES:  The Principal Investigator (PI) will be involved in 
patient recruitment, patient consent, data collection and input, design and oversight of 
experimental methodology,   acupuncture application, any subject follow up if needed,  literature 
review and manuscript writing and continued regulatory communication.  Anesthesiologist AIs 
will be involved in patient recruitment and consent, acupuncture and possibly regulatory 
communication, data collection, subject follow up if needed,  input and coverage of PI in any 
absences. Robin Howard, MA will doing the final analysis.  
3.0 RESPONSIBILITIES OF THE PRINCIPAL/ASSOCIATE INVESTIGATOR IN 
HUMAN SUBJECTS RESEARCH:   
 

IRBNet Number: 381600-19 
PI: Dr. Anthony Plunkett 
Protocol Title: A randomized, single-blind, prospective trial of auricular acupuncture for the 
reduction of post-operative tonsillectomy pain in adults.   
Initial Date Submitted: 6/13/2013 
Revision Date: 7/17/17 
WAMC Protocol Template Revised 23 November 2012 
 
Page 2 of 22 
381600-18_Auricular_Plunkett_v. 23 May 17 
The principal investigator is the individual who is primarily responsible for the actual execution of 
the clinical investigation.  He/she is responsible for the conduct of the study, obtaining subjects' 
consent, providing necessary reports, and maintaining study documents. The Associate Investigator 
will assist the Principal Investigator with the responsibilities stated below.    
 
As the Principal Investigator or Associate Investigator:  
 
A. I will not enroll a subject into a study until the study has been approved by the appropriate 
authority and, when appropriate, the subject's primary care provider has granted approval for him/her 
to enter a study. 
 
B. By signing this protocol, I warrant that any use of Protected Health Information (PHI) for 
reviews preparatory to research met the following requirements: 
i. The review of PHI was done solely to prepare a research protocol, or for similar purposes 
preparatory to research;  
ii. No PHI was taken outside the Military Health Care System or disclosed to persons not having 
a need for this information; and  
iii. This review of PHI was necessary for research purposes 
 
C. I am responsible for assuring that the prospective volunteer is not participating as a subject in 
other research that will significantly increase the research risks to the subject. 
 
D. I am responsible for assuring the quality of each subject's consent in accordance with current 
federal regulations.  This will include ensuring that any "designee" that obtains consent on my behalf 
is completely conversant with the protocol and is qualified to perform this responsibility. 
 
E. I will obtain the WAMC IRB approval for advertisements used to recruit research subjects. 
 
F. I will not accept any outside personal remuneration for implementation of a study. 
 
G. I will take all necessary precautions to ensure that the study does not generate hazardous 
chemical waste. 
 
H. I will obtain the proper WAMC clearance prior to all presentations, abstracts, and 
publications.  The following require WAMC approval: 
i.   Reports involving WAMC subjects and/or patients. 
ii. Reports that cite WAMC in the title or byline. 
iii. Reports of WAMC approved clinical investigation or research. 
iv. Reports of research performed at WAMC. 
v. Reports of research conducted by WAMC assigned personnel. 
 
I. I will obtain proper Office of the Surgeon General (OTSG) publication clearance prior to 
all presentations, abstracts, and publications that involve: 

IRBNet Number: 381600-19 
PI: Dr. Anthony Plunkett 
Protocol Title: A randomized, single-blind, prospective trial of auricular acupuncture for the 
reduction of post-operative tonsillectomy pain in adults.   
Initial Date Submitted: 6/13/2013 
Revision Date: 7/17/17 
WAMC Protocol Template Revised 23 November 2012 
 
Page 3 of 22 
381600-18_Auricular_Plunkett_v. 23 May 17 
i. Traumatic brain injury 
ii. Post-traumatic stress disorder 
iii. Poly-pharmacy 
iv. Pain 
 
(Contact Ms. Zabel at ethel.m.zabel.civ@mail.mil for assistance.) 
 
J. I must submit to the Clinical Investigation Service (CIS): 
 
i.    Any source of outside funding. 
ii.   An annual Continuing Review Report (CR), due in the anniversary month of the protocol’s 
initial approval or due in the month as determined by the IRB for continuing review and 
approval. 
iii. Reports of adverse effects occurring in subjects as a result of study participation or of any 
protocol deviations and submit these reports to Research Monitor if there is one for the study. 
iv. An Addendum, prior to any changes made to the study or a change in the funding status.  
v. Listing of presentations, abstracts, and publications arising from the study for inclusion in the 
CR. 
 
K. I will maintain a Study File that must be kept for six years following completion of the study 
if no IND/IDE used (32 CFR 219.115(b).  If IND medication or IDE appliances are used, the file 
must be kept for 2 years after FDA approval and can then be destroyed; or if no application is filed 
or approved, until 2 years after the study is discontinued and FDA notified (21CFR 312.62(c).  The 
records should be kept in the Department/Service where the research took place (AR 40-38).  If I am 
scheduled to PCS or ETS, I will notify the Clinical Investigation Service as soon as I am aware but 
at least 3 months prior to departure. Records will be given to a new WAMC PI or the 
Department/Service Chief.   
 
L. I will be familiar with all applicable regulations governing research, and will adhere to all of 
the requirements outlined in the WAMC’s DOD Assurance and Federal-Wide Assurance granted by 
the Office for Human Research Protections, Department of Health and Human Services. 
 
M. Research Monitor 
If it is determined that a Research Monitor is assigned to the research study, I agree to provide 
the name, human subject protection training and curriculum vitae of the research  monitor.  I 
acknowledge that this individual will be qualified (e.g., Medical Doctor, Nurse Practitioner, etc).  
The research monitor will review all unanticipated problems involving risk to the subjects or 
others, serious adverse events and all subject deaths associated with the protocol and provide an 
unbiased written report of the event.  At a minimum, the research monitor will comment on the 
outcomes of the event or problem, and in the case of a serious adverse event or death, comment 
on the relationship to participation in the study.  The research monitor will also indicate whether 
he/she concurs with the details of the report provided by the study investigator.  Reports for 
events determined by either the investigator or research monitor to be possibly or definitely 

IRBNet Number: 381600-19 
PI: Dr. Anthony Plunkett 
Protocol Title: A randomized, single-blind, prospective trial of auricular acupuncture for the 
reduction of post-operative tonsillectomy pain in adults.   
Initial Date Submitted: 6/13/2013 
Revision Date: 7/17/17 
WAMC Protocol Template Revised 23 November 2012 
 
Page 4 of 22 
381600-18_Auricular_Plunkett_v. 23 May 17 
related to participation and reports of events resulting in death will be promptly forward to the 
WAMC IRB.  
 
 
N. Active Duty Military Personnel as Study Subjects 
Special consideration will be given to the recruitment process for military personnel.  The Chain 
of Command will not be involved in the recruitment of military personnel and will not encourage 
or order soldiers to participate in research study.   An ombudsman will be used when conducting 
group briefings with active duty personnel to ensure that volunteers understand that participation 
is voluntary.  Restrictions on compensation for active duty military members will be adhered to 
as applicable.  
 
O. Title 10 United States Code 980 
I acknowledge the requirements of Title 10 United States Code 980: “Funds appropriated to the 
Department of Defense may not be used for research involving a human being as an 
experimental subject unless-(1) the informed consent of the subject is obtained in advance; or (2) 
in the case of research intended to be beneficial to the subject, the informed consent may be 
obtained from a legal representative of the subject.” 
 
If an individual cannot give his or her own consent (e.g., incapacitated individuals, incompetents, 
minors) to participate in the research study, consent of the individual’s legally authorized 
representative will be obtained prior to the individual’s participation in the research.  Moreover,  
such subjects will not be enrolled in DoD sponsored research unless the research is intended to 
benefit each subject enrolled in the study. 
 
4.0 LOCATION OF STUDY:  Womack Army Medical Center 
 
5.0 DURATION OF STUDY:   
 
Expected Start Date for Data Collection:  July 2013 
 
Expected Completion Date for Data Collection: July 2017 
 
Expected Completion Date for Study (to include data analysis):  January 2018 
 
6.0 BACKGROUND AND LITERATURE REVIEW: 
 
 
Date of Search: 01 April 2013 
Period Searched: 1970s-present 
Sources Searched: Pubmed; OVID 
Keywords Searched: acupuncture; tonsillectomy; auricular acupuncture; battlefield 
acupuncture 

IRBNet Number: 381600-19 
PI: Dr. Anthony Plunkett 
Protocol Title: A randomized, single-blind, prospective trial of auricular acupuncture for the 
reduction of post-operative tonsillectomy pain in adults.   
Initial Date Submitted: 6/13/2013 
Revision Date: 7/17/17 
WAMC Protocol Template Revised 23 November 2012 
 
Page 5 of 22 
381600-18_Auricular_Plunkett_v. 23 May 17 
 
Tonsillectomy is one of the most commonly performed surgical procedures in the United 
States.  While the procedure is more commonly performed in pediatric patients, greater than 
130,000 were performed for patients older than 15 years in 1996.1  Indications for tonsillectomy 
in adults primarily include recurrent tonsillitis, soft tissue obstruction, and neoplasm. 2   Several 
variations of surgical technique are available, each having a different impact on post-surgical 
bleeding and pain. 3, 4, 5 These most commonly include cold dissection, electrosurgery, harmonic 
scalpel, laser dissection, guillotine tonsillectomy, argon plasma coagulation, and coblation.  Each 
of these methods possesses its advantages and disadvantages, and the decision on which to use 
typically rests on the surgeon’s own preference and training. 6 However, all of these techniques 
result in significant post-operative pain, with this found to be worse in adults. 7 Patients 
experience a high level of pain usually for the first four days after surgery, and pain can persist 
for up to ten days.  Opioids are the most commonly prescribed analgesics for post-operative pain 
in adults. 8   
Opioids, steroids, and non-steroidal anti-inflammatory agents have all been utilized in the 
attempt to minimize pain. 9,10,11  Although shown to be effective in controlling post-operative 
pain, the use of narcotics comes with unpleasant side effects such as nausea, vomiting, and 
constipation. 12  As dehydration is a common complication after a tonsillectomy due to limited 
swallowing capability, the side effects of narcotics can further exacerbate this problem. 13 Other 
commonly used treatments for pain include non-steroidal anti-inflammatory drugs (NSAIDs) and 
acetaminophen.  Both have been found to be effective in controlling post-operative pain, but 
should be used with caution.  Due to their antiplatelet effect, NSAIDs in particular can be 
harmful after tonsillectomy, as bleeding is a common morbidity with this surgery.  
Acetaminophen has little impact on clotting; however, long-term usage or over dosage can result 
in liver failure. 14  Steroids (typically dexamethasone) are used to prevent inflammation, but may 
also have some analgesic benefit.   While no adverse effects have been shown, efficacy studies 
have produced mixed results, with some reporting an improvement in pain post-operatively and 
others reporting no effect observed. 15,16,17  Another alternative treatment for post-operative pain 
is a local anesthetic administered either by infiltration or applied topically.  While moderately 
improving pain after surgery, this method was not found to reduce the use of supplemental 
analgesia. 18  As demonstrated, pharmacotherapy has its benefits and its risks.  As such, alternate 
methods for controlling post-operative pain should be considered. 
Acupuncture is an ancient Chinese method of treating pain in which needles are inserted 
into zones on the body that correspond to certain body parts. 19  Although used in traditional 
Chinese medicine for centuries, acupuncture as an alternative method of treating pain in the 
Western world has been a topic of increased clinical studies over the past few decades, as it is 
relatively low-risk and cost-effective.  A literature review of studies dating back to the 1970s 
indicated that a vast majority of the data pointed to the efficacy of acupuncture in treating neck 
and back pain, dental pain, musculoskeletal and arthritic pain, as well as chronic pain. 20,21,22,23,24  
A more recent meta-analysis demonstrated further mounting evidence of the analgesic effects of 
acupuncture on a wide variety of pain, including osteoarthritis and migraines. 25  Its potential in 
post-operative analgesia has also been studied, and acupuncture has been shown to reduce pain 
as well as decrease the use of opioids after a number of various surgeries. 26  Although a few 

IRBNet Number: 381600-19 
PI: Dr. Anthony Plunkett 
Protocol Title: A randomized, single-blind, prospective trial of auricular acupuncture for the 
reduction of post-operative tonsillectomy pain in adults.   
Initial Date Submitted: 6/13/2013 
Revision Date: 7/17/17 
WAMC Protocol Template Revised 23 November 2012 
 
Page 6 of 22 
381600-18_Auricular_Plunkett_v. 23 May 17 
studies have given inconclusive results, there is an overwhelming amount of promising data to 
suggest that acupuncture may play an important role in analgesia. 
Many different acupuncture techniques are commonly used for managing pain; 
specifically, auricular acupuncture has been a long-standing therapeutic modality dating back 
thousands of years.  The use of auricular acupuncture has been applied to many conditions 
including headache, allergic rhinitis, chronic fatigue, anxiety and pain.27,28,29,30,31  The 
hypothesized efficacy of auricular acupuncture comes from the premise that the external ear 
represents a microsystem of the entire body.  The ear serves as a miniature homunculus, whereby 
specific points on the ear correspond to specific areas of the body.32  A modified technique, 
referred to as Battlefield Acupuncture (BA), was developed by Dr. Richard Niemtzow in 2001 
and utilizes only five major auricular points (see Figure 1).  Dr. Niemtzow collaborated with a 
neurophysiologist to determine which areas of the brain were activated in patients experiencing 
pain.  They utilized functional MRI to visualize these pain centers and found less activity in 
these areas after the application of auricular acupuncture. 32  BA is an appealing method of 
analgesia since it can be easily taught, easily applied, does not require highly specialized 
equipment or sterile operating conditions, and is inexpensive.  Furthermore, its risks are minimal, 
including irritation or possible infection of the ear. 32   To our knowledge, this is the first single-
blinded, prospective, randomized trial evaluating the efficacy of BA in reducing post-operative 
pain for adult tonsillectomy.   
 
 
 
 
6.1 REFERENCES:  
 
1. Owings MF, Kozak LJ. Ambulatory and inpatient procedures in the United States, 1996. 
Vital Health Stat 13.  1998 Nov;139:1-119. 
2. Hoddeson EK, Gourin CG. Adult tonsillectomy:  current indications and outcomes. 
Otolaryngol Head Neck Surg. 2009 Jan;140(1):19-22. 
3. Lowe D, van der Meulen J, National Prospective Tonsillectomy Audit. Tonsillectomy 
technique as a risk factor for postoperative haemorrhage. Lancet. 2004 
Aug;364(9435):697-702. 
4. Pinder D, Hilton M. Dissection versus diathermy for tonsillectomy. Cochrane Database 
Syst Rev. 2001;(4):CD002211. 
5. Leinbach RF, Markwell SJ, Colliver JA, Lin SY. Hot versus cold tonsillectomy: a 
systematic review of the literature. Otolaryngol Head Neck Surg. 2003 Oct;129(4):360-
364. 
6. Burton MJ, Doree C. Coblation versus other surgical techniques for tonsillectomy. 
Cochrane Database Syst Rev. 2007 Jul 18;(3):CD004619.  
7. Lavy, JA.  Post-tonsillectomy pain: the difference between younger and older patients. 
Int J Pediatr Otorhinolaryngol. 1997 Oct 18;42(1):11-15. 
8. Toma AG, Blanshard J, Eynon-Lewis N, Bridger MW. Post-tonsillectomy pain: the first 
ten days.  J Laryngol Otol. 1995 Oct;109(10):963-964. 

IRBNet Number: 381600-19 
PI: Dr. Anthony Plunkett 
Protocol Title: A randomized, single-blind, prospective trial of auricular acupuncture for the 
reduction of post-operative tonsillectomy pain in adults.   
Initial Date Submitted: 6/13/2013 
Revision Date: 7/17/17 
WAMC Protocol Template Revised 23 November 2012 
 
Page 7 of 22 
381600-18_Auricular_Plunkett_v. 23 May 17 
9. Kelley PE. Painless tonsillectomy. Curr Opin Otolaryngol Head Neck Surg. 2006 
Dec;14(6):369-374. 
10. Lachance M, Lacroix Y, Audet N, Savard P, Thuot F. The use of dexamethasone to 
reduce pain after tonsillectomy in adults: a double-blind prospective randomized trial. 
Laryngoscope. 2008 Feb;118(2):232-236. 
11. Cardwell M, Siviter G, Smith A. Non-steroidal anti-inflammatory drugs and 
perioperative bleeding in paediatric tonsillectomy. Cochrane Database Syst Rev. 2005 
Apr 18:(2):CD003591. 
12. Vaiman M, Krakovski D, Haitov Z. Oxycodone and dexamethasone for pain management 
after tonsillectomy: a placebo-controlled EMG assessed clinical trial. Med Sci Monit. 
2011 Oct;17(10):P125-P131. 
13. Salonen A, Kokki H, Nuutinen J.  Recovery after tonsillectomy in adults: a three-week 
follow-up study. Laryngoscope. 2002 Jan;112(1):94-98. 
14. Lundeberg S, Lonnqvist PA.  Update on systemic postoperative analgesia in children. 
Paediatr Anaesth. 2004 May;14(5):394-397. 
15. Tewary AK, Cable HR, Barr GS. Steroids and control of post tonsillectomy pain. J Laryn 
Otol. 1993 Jul;107(7):605-606. 
16. Carr MM, Williams JG, Carmichael L, Nasser JG. Effect of steroids on posttonsillectomy 
pain in adults. Arch Otolaryngol Head Neck Surg. 1999;125(12):1361-1364. 
17. Al-Shehri AM. Steroid therapy for post-tonsillectomy symptoms in adults: a randomized, 
placebo-controlled study. Ann Saudi Med. 2004 Sep-Oct;24(5):365-367. 
18. Grainger J, Saravanappa N.  Local anaesthetic for post-tonsillectomy pain:  a systematic 
review and meta-analysis. Clin Otolaryngol. 2008 Oct;33(5):411-419. 
19. Niemtzow, RC. Battlefield Acupuncture. Medical Acupuncture. 2007;19(4):225-228. 
20. Eshkevari, L. Acupuncture and pain: a review of the literature. AANA J. 2003 
Oct;71(5):361-370. 
21. Peng AT, Behar S, Yue SJ. Long-term therapeutic effects of electro-acupuncture for 
chronic neck and shoulder pain – a double blind study.  Acupunct Electrother Res. 
1987;12(1):37-44. 
22. Chapman CR, Chen AC, Bonica JJ. Effects of intrasegmental electrical acupuncture on 
dental pain: evaluation by threshold estimation and sensory decision theory.  Pain. 1977 
Jun;3(3):213-227. 
23. Berman BM, Singh BB, Lao L, Langenberg P, Li H, Hadhazy V, Bareta J, Hochberg M.  
A randomized trial of acupuncture as an adjunctive therapy in osteoarthritis of the knee.  
Rheumatology. 1999 Apr;38(4):346-354. 
24. Chen GS, Hwang YC.  Therapeutic effect of acupuncture for chronic pain.  Am J Chin 
Med. 1977;5:45-61. 
25. Dorsher, PT.  Acupuncture for chronic pain. Techniques in Regional Anesthesia and Pain 
Management. 2011 Apr;15(2):55-63. 
26. Sun Y, Gan TJ, Dubose JW, Habib AS. Acupuncture and related techniques for 
postoperative pain: a systematic review of randomized controlled trials. Br J Anaesth. 
2008 Aug;101(2):151-160. 

IRBNet Number: 381600-19 
PI: Dr. Anthony Plunkett 
Protocol Title: A randomized, single-blind, prospective trial of auricular acupuncture for the 
reduction of post-operative tonsillectomy pain in adults.   
Initial Date Submitted: 6/13/2013 
Revision Date: 7/17/17 
WAMC Protocol Template Revised 23 November 2012 
 
Page 8 of 22 
381600-18_Auricular_Plunkett_v. 23 May 17 
27. Alimi D, Rubino C, Pichard-Leandri E, Fermand-Brule S, Dubreuil-Lemaire ML, Hill C. 
Analgesic effect of auricular acupuncture for cancer pain: a randomized, blinded, 
controlled trial. J Clin Oncol. 2003 Nov 15;21(22):4120-4126. 
28. Simmons MS, Oleson TD. Auricular electrical stimulation and dental pain threshold. 
Anesth Prog. 1993;40(1):14-19. 
29. Wang SM, Peloquin C, Kain ZN. The use of auricular acupuncture to reduce preoperative 
anxiety. Anesth Analg. 2001 Nov;93(5):1178-1180. 
30. Taguchi A, Sharma N, Ali SZ, Dave B, Sessler DI, Kurz A. The effect of auricular 
acupuncture on anaesthesia with desflurane. Anaesthesia. 2002 Dec;57(12):1159-1163. 
31. Usichenko TI, Dinse M, Hermsen M, Witstruck T, Pavlovic D, Lehmann Ch. Auricular 
acupuncture for pain relief after total hip arthroplasty – a randomized controlled study. 
Pain. 2005 Apr;114(3):320–327. 
32. Niemtzow, RC. Battlefield Acupuncture. Medical Acupuncture. 2007;19(4):225-228. 
33. Kehlet H, Dahl JB.  The value of “multimodal” or “balanced analgesia” in postoperative 
pain treatment.  Anesth Analg. 1993;77(5):1048-1056. 
34. Buvanendran A, Kroin JS.  Multimodal analgesia for controlling acute postoperative 
pain.  Curr Opin Anaesthesiol. 2009;22(5):588-593. 
35. American Society of Anesthesiologists.  Practice Guidelines for acute pain management 
in the perioperative setting: an updated report by the ASA Task Force on acute pain 
management.  Anesthesiology. 2012;116(2):248-273. 
36. Haskell, S. G., C. A. Brandt, et al. (2009). "Pain among Veterans of Operations Enduring 
Freedom and Iraqi Freedom: Do Women and Men Differ?" Pain Med 10(7): 1167-73. 
37. Hall, A. J., J. E. Logan, et al. (2008). "Patterns of abuse among unintentional 
pharmaceutical overdose fatalities." Jama 300(22): 2613-20. 
38. http://www.time.com/time/magazine/article/0,9171,1713485,00.html.  Thompson, M. 
Time Magazine.  Dying Under the Army's Care. February 14, 2008.  Accessed May 12, 
2012. 
39. http://www.foxnews.com/politics/2010/05/06/number-troops-seeking-opiate-addiction-
treatment-skyrockets/.  Berger, J. Fox News.  Number of Soldiers Seeking Opiate Abuse 
Treatment Skyrockets. May 6, 2010.  Accessed May 12, 2012. 
40. Pereira J, Lawlor P, Vigano A, Dorgan M, Bruera E. Equianalgesic dose ratios for 
opioids: a critical review and proposals for long-term dosing. J Pain Symptom Manage 
2001; 22:672-687. 
41. Milano, C. (2012, March). Less pain, lower costs: Can integrative medicine do both?. 
Retrieved from 
http://www.managedcaremag.com/archives/1203/1203.pain_integrative.html 
 
 
 
 
7.0 PURPOSE:  To determine if auricular acupuncture significantly reduces post-operative pain 
in comparison to the standard of care.  Post-operative pain score will be collected by subject self-

IRBNet Number: 381600-19 
PI: Dr. Anthony Plunkett 
Protocol Title: A randomized, single-blind, prospective trial of auricular acupuncture for the 
reduction of post-operative tonsillectomy pain in adults.   
Initial Date Submitted: 6/13/2013 
Revision Date: 7/17/17 
WAMC Protocol Template Revised 23 November 2012 
 
Page 9 of 22 
381600-18_Auricular_Plunkett_v. 23 May 17 
report of pain according to the Numerical Rating Scale (NRS) (0= no pain, 10 = worst 
imaginable pain) up to 10 days post-operation.   
 
7.1 HYPOTHESES/RESEARCH QUESTIONS: We hypothesize that subjects receiving intra-
opertive auricular acupuncture during a tonsillectomy will have statistically significantly less 
post-opertaive pain scores in comparison to subjects receiving standard of care.   
 
7.2 SPECIFIC AIMS/SIGNIFICANCE:   
Aims:  The specific aim of this study is to compare post-operative pain, as measured by Sum of 
Pain Intenstity (SPI) from the time of first to waking to 10 days post-opertative using the 
Numerical Rating Sacle (NRS), between subjects receiving intra-operative auricular acupuncture 
or standard of care during a tonsillectomy.   
 
Significance:  Post-opertive pain in adults after a tonsillectomy is significant, despite surgical 
technique and medication management.  Identification of an intra-opertive intervention that 
results in significant reduction in post-operative pain would improve patient’s quality of life, and 
may reduce medication usage and improve return-to-duty time.   
 
Secondary aims:  We will also compare outpatient pain medication use and resumption of normal 
diet between subjects receiving intra-operative auricular acupuncture or standard of care during a 
tonsillectomy.   
 
7.3 DESIGN:   
 Design type:  Prospective, randomized control trial 
 Sample 
- Description of the population:  All adults (>18 years) undergoing a tonsillectomy 
with or without adenoidectomy at WAMC are eligible for participation in the study.    
- Sample Size:  125 subjects.  A target of 45 subjects per group for a total of 90 
subjects, and accounting for a 10% drop out rate.   With current diary return low, 
to ensure complete data for analysis we will continue to recruit and enroll up to 
125 subjects.   
- Power Analysis: Under the assumption of a linear time by treatment interaction, 
assuming subject-level randomization, five time-points, power of 80%, a Type I error 
rate of 5% and no attrition, to detect a 1.6 difference in pain score requires a total 
sample size of 90 subjects or 45 per treatment arm. 
- Inclusion Criteria: 
 All adults (males and females) 18yrs of age or older having a 
tonsillectomy or tonsillectomy with adenoidectomy.  
 ASA I-III 
- Exclusion Criteria: 
 Chronic pain syndromes (pain symptoms lasting greater than three months 
or taking opioids on a daily basis for > 3 months) 
 ASA IV 

IRBNet Number: 381600-19 
PI: Dr. Anthony Plunkett 
Protocol Title: A randomized, single-blind, prospective trial of auricular acupuncture for the 
reduction of post-operative tonsillectomy pain in adults.   
Initial Date Submitted: 6/13/2013 
Revision Date: 7/17/17 
WAMC Protocol Template Revised 23 November 2012 
 
Page 10 of 22 
381600-18_Auricular_Plunkett_v. 23 May 17 
 Prior neck or throat surgery 
 Allergy to gold 
 Number of Participants:  Up to 125 subjects will be enrolled with a target of 90 subjects 
(45 per group) that have completed the study. . 
 
 Explanation of the process from consenting to data collection: 
o Randomization:  Before the study begins, a randomized, sequential set of 100 
numbered opaque evelopes will be prepared containing assignment to either the 
acupuncture group or the control group.  The randomization list will be 
generated by a computer program.  The evelopes will be stored in the PIs office 
and opened according to subject number on the day of surgery. To continue 
enrollment up to 125 another 25 will be randomized using a computer 
randomization program.  
 
Recruitment:  
Recruitment to participants discharge will follow the following steps: .   
 Patient sees ENT surgeon for standard of care visit to discuss upcoming (to be scheduled) 
tonsillectomy with or without adenoidectomy at which time, IRB-approved study flyers 
will be available to patients in the surgeons’ exam rooms. 
 
 The surgeon who is planning a patient’s tonsillectomy with or without adenoidectomy  
gives the clinic Medical Support Assistant (MSA) a surgical scheduling form 
(STANDARD OF CARE) 
 
 Approximately 30 days prior to surgery, the MSA schedules the patient’s tonsillectomy 
with or without adenoidectomy if a time slot is available; if not, the MSA calls the patient 
within next 30 days when a slot is available. The MSA also schedules an appointment for 
the patient to see CRNA and RN  (1-3 days pre surgery) (STANDARD OF CARE.)  At 
this time the MSA gives the patient an OPTIONAL RESEARCH PACKET (Appendix 
G) in which there is the following: 
 
 Study Flyer (Appendix G) 
 Patient Information sheet (Appendix G) 
 
 The MSA’s will go by a specific script on what to say to potential candidates when giving 
them the OPTIONAL RESEARCH PACKET. (Appendix F) .  
 
  
  The PI, AI or any other designated team members will use the S3 list for  potential 
participants that are scheduled for a tonsillectomy with or without adenoidectomy and 
will call them as previously approved for those that had no address. They will utilize the 
previously approved script that has been adjusted slightly for their role.  (Appendix G1) 
The PI or AI will go over the consent at the PAU appointment or morning of surgery 

IRBNet Number: 381600-19 
PI: Dr. Anthony Plunkett 
Protocol Title: A randomized, single-blind, prospective trial of auricular acupuncture for the 
reduction of post-operative tonsillectomy pain in adults.   
Initial Date Submitted: 6/13/2013 
Revision Date: 7/17/17 
WAMC Protocol Template Revised 23 November 2012 
 
Page 11 of 22 
381600-18_Auricular_Plunkett_v. 23 May 17 
giving the potential participants ample time for questions or concerns.  
 
  If a potential participant contacts the study team, a team member will arrange for the 
participant to review the consent at his or her pre-admission appointment. The study team 
will ask if the patient would like an emailed copy of the consent document. If yes, the 
team member will send her/him the consent form by email or postal mail to review. The 
study team member will not maintain the email or postal address on file.  
 
  
 
  If screening criteria based on inclusion and exclusion criteria are not met  the potential 
participant will be thanked for their time and informed that they do not qualify for the 
study.  
 
 If the patient meets the screening criteria and verbalizes interest in participating in the 
study, he or she is notified that s/he can be scheduled to further review and complete the 
consent paperwork if s/he wishes with study staff when s/he is present for the pre-
admission appointment or at another time convenient for the potential participant.  Then, 
at that time, the potential participant will have a chance to review any questions s/he 
may have about the study and complete the study consent paperwork if s/he wishes to 
participate.  Consenting will take place in advance of the day of the procedure; if 
possible and if not a team member  will meet with potential participant on the day of 
surgery in holding.   Once a subject has consented to be in the study, the individual 
consenting them will interview them for demographics, medical history, medication 
history, and allergies (Appendix A). The pain diary will be reviewed at this time as well.  
If the subject is determined to be eligible for the study, her/his scheduled date of surgery 
will be confirmed .  The PI will keep a list of all subjects and their respective surgery 
dates in a password protected electronic enrollment log kept in the V drive.  
 
   Home diary teaching:  At the Pre admit and/or  consent appointment,  a research team 
member  will review the home pain diary with the subject.  They will be asked to record 
their pain score in 6 hour intervals for 24 hours after hospital discharge and every 24 
hours for a total of 10 days after the surgery.  Subjects will not be asked to wake up at 
night to record pain level.  Subjects will be asked to return their pain scores by 
phone,email, or mail (addressed envelope provided).  If the subject has not sent their 
diary by  day 15, an attempt at a reminder to the  subject via phone call or email 
(whichever the subject prefers, as collected during enrollment) will be done. .   
 
 On the day of the surgery:  On the day of surgery, the randomization category will be 
determined by the PI or AI acupuncturists by opening the corresponding subject number 
envelope. Prior to surgery, the PI or AI acupuncturists will introduce him or herself to 
the subject (if not already done so) and confirm enrollment in the study.  Anesthesia for 
the surgical case will then proceed per standard of care.   

IRBNet Number: 381600-19 
PI: Dr. Anthony Plunkett 
Protocol Title: A randomized, single-blind, prospective trial of auricular acupuncture for the 
reduction of post-operative tonsillectomy pain in adults.   
Initial Date Submitted: 6/13/2013 
Revision Date: 7/17/17 
WAMC Protocol Template Revised 23 November 2012 
 
Page 12 of 22 
381600-18_Auricular_Plunkett_v. 23 May 17 
 
After the patient has been fully anesthetized, and prior to the start of the tonsillectomy, 
the study PI or AI acupuncturists will place the acupuncture needles if randomized to the 
acupuncture group.  Initiation of the surgical case will not be delayed for acupuncture 
needle placement.  If the patient is randomized to the control group, no intervention will 
occur. 
 
The procedure for the auricular acupuncture is standardized based on the Battlefield 
Acupuncture technique.  The ear will be cleaned with alcohol prior to insertion of the 
needles.  Five sterile, single-use, gold needles will be placed in each ear according to the 
figure below.  The needles penetrate about a millimeter (or 4/100ths of an inch) into the 
skin.   
  
 
Figure 1.  Five points of Battlefield Acupuncture 
 
 
At the end of the surgical case, prior to fully awakening the patient, the PI or his 
designeewill remove the acupuncture needles.   
 
Per standard of care, the providing anesthesiologist or PACU nurse will document 
in Essentris the subject’s pain score every 15 minutes for one hour and then 
hourly until discharge from the PACU.  A pain score will also be recorded in 

IRBNet Number: 381600-19 
PI: Dr. Anthony Plunkett 
Protocol Title: A randomized, single-blind, prospective trial of auricular acupuncture for the 
reduction of post-operative tonsillectomy pain in adults.   
Initial Date Submitted: 6/13/2013 
Revision Date: 7/17/17 
WAMC Protocol Template Revised 23 November 2012 
 
Page 13 of 22 
381600-18_Auricular_Plunkett_v. 23 May 17 
Essentris when prescribed as needed (PRN) pain medications are requested.   
 
Anesthesia and pain medication will be provided per standard of care by the 
anesthesiologist assigned to the surgical case.  All medications given will be 
documented in Essentris.  All discharge instructions by the surgeon and 
anesthesiologist will be per standard of care. 
 
PACU nurse education will be per standard of care only; the PACU nurse will not 
be responsible for any study education.   
 
Data will be collected by the PI, AIs, on the day of surgery and recorded on the 
form found in Appendix B.   
 
Data collection:  Data will be collected and entered into three forms (Appendices A-C).  All 
forms will be maintained in a locked file cabinet in the PI’s locked office.  Data will be collected 
during the initial subject interview by the individual consenting them (Appendix A), on the day 
of surgery by the PI (Appendix B), and from the home pain diary. (Appendix C).  Data on the 
day of surgery may also be collected from Essentris or the anesthesia record once the patient has 
been discharged (as all data needed will be recorded in Essentris or the anesthesia record).  Data 
will be transferred from these forms to an electronic Data base.  Each patient will be allocated a 
study ID number, and thereafter will be referred to by that number in the database. . An Excel 
spreadsheet with all current data will be where the data is to be entered  by a research team 
member. It will be maintained in the V drive with limited password access.  Only research team 
members will have access.   
 
o Total doses of opioid analgesics in the preoperative, intraoperative and 
postoperative period will be converted to IV morphine equivalents by the PI or 
research staff member.  They will use John Hopkins Opioid Program’s  
conversion at  http://www.hopweb.org/hop/hop.cfm 
40 
o Acupuncture Competence:  The PI cpmpleted the 300 CME Helms Medical 
Acupuncture Course, the DOD wide approved acupuncture course.  
 
 Data Collection Instrument:  
o Appendix A:  Data collection form for demographic and contact 
information to be collected after initial consent prior to surgery 
o Appendix B:  Data form for day of surgery data collection 
o Appendix C:  The home diary to be completed by the subject 
 
 Other Appendices 
 
o Appendix D: Flow chart of recruitment to discharge 
o Appendix E : Screening inclusion/exclusion 
o Appendix F: Script for MSA’s (Medical Support Assistants) 

IRBNet Number: 381600-19 
PI: Dr. Anthony Plunkett 
Protocol Title: A randomized, single-blind, prospective trial of auricular acupuncture for the 
reduction of post-operative tonsillectomy pain in adults.   
Initial Date Submitted: 6/13/2013 
Revision Date: 7/17/17 
WAMC Protocol Template Revised 23 November 2012 
 
Page 14 of 22 
381600-18_Auricular_Plunkett_v. 23 May 17 
o Appendix G: Optional Research Packet (flyer/information sheet/envelope) 
o Appendix H: Data Excel 
 
 Variables/Data Points: 
 
Figure 2.  Table of Variables/Data Points 
 
Variable 
Data Source 
Age 
Patient report 
Race 
Patient report 
Gender 
Patient report 
Height and Weight 
Essentris or Ahlta 
Pain scores 
Patient report and Essentris 
Pre op and PACU pain scores 
Essentris 
Total time in OR 
Essentris 
Surgical date 
Patient report, confirmed in S3 
Total OR time 
Essentris 
Needle retention time 
Documented by the PI 
Type of Surgery 
Essentris 
Needle type  
Documented by the PI 
Intraoperative anesthetic 
Essentris 
Dexamethasone dose 
Essentris 
Total Morphine Equivalent 
Essentris and  John Hopkins Converstion 
Daily pain scores 
Home diary 
Post op Nausea/Vomiting 
Essentris notes 
Day diet returned to normal 
Home diary 
Oral pain meds at home 
Home diary  
 
 
 
 
 
7.4 RISKS TO SUBJECTS:  Acupuncture is considered a safe technique with minimal risk to 
the subject.  Acupuncture needles only penetrate the skin approximately one millimeter.  Despite 
the minimal penetratuion, needle insertion poses the risk of infection, bleeding and bruising.  All 
acupuncture needles used in this study will be sterile and inserted after alcohol preparation of the 
ear surface.  The needles are made of gold and pose minimal, if any, allergic reaction.   
 

IRBNet Number: 381600-19 
PI: Dr. Anthony Plunkett 
Protocol Title: A randomized, single-blind, prospective trial of auricular acupuncture for the 
reduction of post-operative tonsillectomy pain in adults.   
Initial Date Submitted: 6/13/2013 
Revision Date: 7/17/17 
WAMC Protocol Template Revised 23 November 2012 
 
Page 15 of 22 
381600-18_Auricular_Plunkett_v. 23 May 17 
8.0 DATA ANALYSIS:  The primary metric  for this study is pain score.  Pain scores will be 
collected for 10 days post-operatively, as previous studies have demonstrated a return to baseline 
by this time.  Pain scores will be collected daily during this time period, resulting in repeated 
measures for each subject.  Analysis will be conducted by mixed models to evaluate both (1) 
difference in pain scores by groups and (2) rate of change in pain score over time.   
 
Age and sex will be considered as potential confounders.  Duration of needle 
insertion may also be evaluated for effect on outcome, if significant variability in length is noted.  
The type of surgical technique (cold knife coblation versus cautery) may be a potential 
confounder.  Finally, intra-operative anesthesia and dexamethosone dose will be evaluated for 
potential confounding.     
 
Figure 3.  Data Analysis Table 
 
Statistical Test 
Independent Variable/ 
Predictors Variables 
Dependent Variable/ 
Outcome Variables 
Mixed model analysis 
Study group randomized to 
(auricular acupuncture or standard of 
care) 
Pain scores on the NRS (from 
immediately post-operative to 10 
days post-operative) 
Student’s ttest 
Study group randomized to 
(auricular acupuncture or standard of 
care) 
Day full diet resumed 
Student’s ttest 
Study group randomized to 
(auricular acupuncture or standard of 
care) 
Total morphine equivalent of 
home pain meds 
 
 
 
9.0 MILITARY RELEVANCE:  The use of Battlefield Acupuncture is increasing in all 
services in the military as a treatment option for pain.  The DOD as a whole is implementing and 
employing BA as taught by Richard Niemtzow to as many medical treatment locations as 
possible.  The military is using it to treat pain and PTSD, and acupuncturists are being hired at 
the major military medical centers.  Several grants have been offered to physicians to attend 
medical acupuncture courses.  Therefore, Battlefield Acupunture techniques will become 
increasing more common for military physicians.  The efficacy of Battlefield Acupuncture for 
post-operative pain is inconclusive (or untested?).  This study may provide the intial work for 
future incorportion of Battlefield Acupuncture in the operating room, further expanding the role 
of this technique in the military.   
 
Additionally, faster post-operative recovery (as measured by pain) may benefit the 
military by decreased healthcare burden and earlier return to duty.   
 

IRBNet Number: 381600-19 
PI: Dr. Anthony Plunkett 
Protocol Title: A randomized, single-blind, prospective trial of auricular acupuncture for the 
reduction of post-operative tonsillectomy pain in adults.   
Initial Date Submitted: 6/13/2013 
Revision Date: 7/17/17 
WAMC Protocol Template Revised 23 November 2012 
 
Page 16 of 22 
381600-18_Auricular_Plunkett_v. 23 May 17 
10.0 MEDICAL APPLICATION:   
 
Over the last decade, the concept of multi-modal analgesia has been utilized in the 
treatment of acute post-operative pain.33, 34 The American Society of Anesthesiologists published 
a practice guideline stating: “Whenever possible, anesthesiologists should use multimodal pain 
management therapy. Central regional blockade with local anesthetics should be considered. 
Unless contraindicated, patients should receive an around-the-clock regimen of COXIBs ( Cox-2 
Inhibitors), NSAIDs (Non-Steroid Anti-inflammatory Drugs), or acetaminophen.35”  The 
treatment of both acute and chronic pain has received national attention.36  Several media outlets 
have reported on the complex problem of adequately treating pain, while trying to minimize or 
eliminate the misuse potential of narcotic analgesics.37-39  Furthermore, in an environment where 
downsizing and costs savings are required, the potential to save money on medical management 
and reduced adverse side effect related problems will become a major part of military healthcare 
in the coming years.  In 2009, Abbott Northwestern Hospital in Minneapolis conducted a 
retrospective observational study of the pain management effect of nontoxic, 
nonpharmacological integrative approaches among 1,839 in-patients to include acupuncture. 
Two thirds of subjects, mainly post-surgical, had never previously received integrative services. 
The immediate effect on self-reported pain scores was an average reduction of approximately 55 
percent, without increased risk of adverse effects.
41 
 
 
11.0 BUDGET:  
Will any outside organization provide funding or other resources?  
  Yes 
  No          
 
The funding for this study has ended. The PI chooses to continue enrollment for a larger pool for 
analysis.  
12.0 HIPAA AUTHORIZATION:   
 
i. Are you intending to collect subject’s Protected Health Information (PHI) and any of the following 
18 personal identifiers?  
 No – HIPAA does not apply – go to question #iv 
 Yes – please check which ones:  
  1. Names 
  2. Street address, city, county, 5-digit zip code 
  3. Months and dates (years are OK) and ages >89 (unless all persons over 89 years are 
aggregated into a single category) 
  4. Telephone numbers 
  5. Fax numbers 
  6. E-mail addresses 
  7. Social security number 
  8. Medical record number 

IRBNet Number: 381600-19 
PI: Dr. Anthony Plunkett 
Protocol Title: A randomized, single-blind, prospective trial of auricular acupuncture for the 
reduction of post-operative tonsillectomy pain in adults.   
Initial Date Submitted: 6/13/2013 
Revision Date: 7/17/17 
WAMC Protocol Template Revised 23 November 2012 
 
Page 17 of 22 
381600-18_Auricular_Plunkett_v. 23 May 17 
  9. Health plan beneficiary number 
 10. Account number 
 11. Certificate/license number 
 12. Vehicle identification number (VIN) and/or license plate number 
 13. Device identifiers and serial numbers 
 14. URLs (Uniform Resource Locators) 
 15. Internet protocol address number 
 16. Biometric identifiers, such as finger and voice prints 
 17. Full face photographic images or any comparable images 
 18. Any other unique identifying number, characteristic, or code such as patient initials 
 
ii. Can you limit your collection of personal identifiers to just #2, 3 or 18 above?   
 Yes – then your dataset may qualify as a Limited Data Set – please contact 
wamcirbadmin@amedd.army.mil for further instructions before completing HIPAA authorizations 
or waivers thereof. Then go to question #iv. 
 No – Go to question #iii. 
 
iii. Is obtaining patient Authorization “impracticable”?  
 Yes – Authorization may qualify to be waived by the IRB. Please contact 
wamcirbadmin@amedd.army.mil for instructions.  
 No – Research subjects will need to sign a HIPAA Authorization.  
 
iv. What precautions will you take to protect the confidentiality of research source documents (Case 
Report Forms, questionnaires, etc.), the research data file, and the master code (if any)?  
- 
All the enrolled subjects will be assigned a study identification number which will not be 
linked to any Identifiable Protected Health Information (PHI).  There will be a master list 
linking the subject, including the subject’s social security number, with the study ID 
which is kept in a password protected file on the V: drive .  The subject’s Social Security 
or other PHI will not be included in the study database.  The master list will be destroyed 
after the study has been completed and all the data has been analyzed.   
 
- 
Deidentified database without links to subject identifiers in an Excel spreadsheet will be 
stored on the WAMC V: drive.  The deidentified data will only be shared among the PI, 
AI and collaborators of this study. 
   
- 
The pain diary along with other case report forms will only be marked with the study ID 
and will be kept in a locked file cabinet in the research coordinator’s locked office.   
 
v. When will you destroy the research source documents, data file, and the master code?  
 Research data to include ICF/HIPAA authorization will be kept for 6 years after completion of 
study and then destroyed in accordance with current data destruction policy.   
 
vi. Will research data including identifiable Protected Health Information be sent outside of 

IRBNet Number: 381600-19 
PI: Dr. Anthony Plunkett 
Protocol Title: A randomized, single-blind, prospective trial of auricular acupuncture for the 
reduction of post-operative tonsillectomy pain in adults.   
Initial Date Submitted: 6/13/2013 
Revision Date: 7/17/17 
WAMC Protocol Template Revised 23 November 2012 
 
Page 18 of 22 
381600-18_Auricular_Plunkett_v. 23 May 17 
WAMC? 
 Yes  
 No 
 
vii. Linkage of extracted data to other databases:  N/A 
 
12.1 BENEFITS:  Identification of a minimal risk intra-operative technique that minimizes post-
operative pain benefits the healthcare system as a whole.  Acupuncture is a relatively 
inexpensive and quick procedure.  Implimentation of this technique may reduce healthcare costs.  
Additionally, individual subjects may benefit from decreased post-operative pain and experience 
shorter recovery time. 
 
12.2 RISKS:  The only risk of data collection during the study is potential loss of 
privacy/confidentiality of enrollment in the study.  The consents forms with the subject’s name 
will be stored in a locked file cabinet in  the anesthesia office area  at WAMC.  The master link 
between subject name and ID will be stored in a password protected Excel file on the V drive at 
WAMC, with access limited to only the study team.  This file will be separate from the file 
containing the collected data,.   
 
12.3 HIPAA AUTHORIZATION WAIVER 
If you wish to obtain and use identifiable protected health information for a study without obtaining 
written approval (“HIPAA Authorization”) from the subject, please complete a HIPAA 
Authorization Waiver Form to provide justification for IRB review and approval. Contact 
wamcirbadmin@amedd.army.mil for assistance. 
 
13.0 WAIVER OF THE REQUIREMENT TO OBTAIN INFORMED CONSENT:   
  The research involves no more than minimal risk to the subjects and,  
 The waiver will not adversely affect the rights and welfare of the subjects and, 
The research could not practicably be carried out without the waiver.  
 
  Not applicable 
 
13.1 WAIVER OF THE REQUIREMENT TO DOCUMENT INFORMED CONSENT:  
  1. The only record linking the subject and the research would be the consent document 
and the principal risk would be potential harm resulting from a breach of confidentiality. Each 
subject will be asked whether the subject wants documentation linking the subject with the 
research, and the subject's wishes will govern; or 
 
  2. The research presents no more than minimal risk of harm to subjects and involves no 
procedures for which written consent is normally required outside of the research context. 
In cases in which the documentation requirement is waived, the IRB may require the 
investigator to provide subjects with a written statement regarding the research. 
 

IRBNet Number: 381600-19 
PI: Dr. Anthony Plunkett 
Protocol Title: A randomized, single-blind, prospective trial of auricular acupuncture for the 
reduction of post-operative tonsillectomy pain in adults.   
Initial Date Submitted: 6/13/2013 
Revision Date: 7/17/17 
WAMC Protocol Template Revised 23 November 2012 
 
Page 19 of 22 
381600-18_Auricular_Plunkett_v. 23 May 17 
  3. Not applicable. 
 
 
 
14.0 IMPACT STATEMENTS:   
Department/ 
Service 
Necessary for Which Proposals? 
Indicate if this is required 
for your study.   
Information 
Management 
Directorate 
(IMD)  
 
Study involves use of the Internet and/or E-mail for 
patient recruitment and/or data collection; use of 
Web page design, data collection, or other Web-
based applications 
Yes     
No 
Laboratory  
Study involves laboratory staff or resources 
Yes     
No 
Nursing 
Study requires any involvement of Nursing 
personnel paid by WAMC 
Yes     
No 
If yes, complete the detailed 
Nursing Impact Statement found 
on the IRB Web site 
Pharmacy 
Study uses any drugs, IND or otherwise 
Yes     
No 
PAD/Medical 
Records 
Study involves review of medical records 
Yes     
No 
Radiology 
Study requires any radiological services 
Yes     
No 
Other 
For example, a specific clinic,  service or 
department 
Yes     
NoIPMC  
 
 
 
 
 
 
 
15.0 SIGNATURES: 
 
I verify that the contents of this proposal are accurate and that I have read and agree to 
comply with the statements above which outline my responsibilities as a Principal Investigator 
or Associate Investigator.  
 
 
 
 
 
 
 
Principal Investigator Signature 
Name and Date:  
 
 
 

IRBNet Number: 381600-19 
PI: Dr. Anthony Plunkett 
Protocol Title: A randomized, single-blind, prospective trial of auricular acupuncture for the 
reduction of post-operative tonsillectomy pain in adults.   
Initial Date Submitted: 6/13/2013 
Revision Date: 7/17/17 
WAMC Protocol Template Revised 23 November 2012 
 
Page 20 of 22 
381600-18_Auricular_Plunkett_v. 23 May 17 
 
 
 
 
Associate Investigator Signature 
                                                         
 
Name and Date:                           
 
 
 
 
 
Associate Investigator Signature 
 
 
Name and Date:                           
 
 
 
 
 
 
 
Associate Investigator Signature  
                                                        
 
Name and Date:                           
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Associate Investigator Signature                                                         
 
Name and Date:                           
 
 
 
 
15.1 OTHER SIGNATURES FOR APPROVAL:   
 
I concur with the submission of this proposal to the Clinical Investigation Service for 
review and approval.   
 
 
 
 
 
 
 
 
 
Service Chief Signature 
       
 
 
Name and Date:                       
 
 
 
              
                                           
 
 
 
 
 

IRBNet Number: 381600-19 
PI: Dr. Anthony Plunkett 
Protocol Title: A randomized, single-blind, prospective trial of auricular acupuncture for the 
reduction of post-operative tonsillectomy pain in adults.   
Initial Date Submitted: 6/13/2013 
Revision Date: 7/17/17 
WAMC Protocol Template Revised 23 November 2012 
 
Page 21 of 22 
381600-18_Auricular_Plunkett_v. 23 May 17 
Department Chief Signature                
                                                 
Name and Date:  
 
 
 
 
 
 
Checklist of Support Documents that Must Accompany Protocol 
 
 
__ 1.  Protocol Application  Submit the entire protocol as a word document without 
signatures in order to allow track changes. Section 15 is the signature page(s). After it is 
completed, scan in as a pdf file and submit these pages as a “signature” file. Alternatively, 
you can submit a digitally signed word document.    
 
__ 2.  General Impact Statement  Required on all research protocols.  If you answer yes, 
you must provide a more detailed Impact statement.   
 
__ 3.  Complete Specific Impact Statement as applicable: Unsigned word documents are 
not required for these items.  
a.  Information Management Directorate (IMD)   
b.  Laboratory Impact Statement 
c.  Nursing Impact Statement 
d.  Pharmacy Impact Statement (required if study uses any drugs, IND or otherwise) 
e.  Pathology Impact Statement 
d.  Radiology Impact Statement 
e.  Examples may include specific clinic or service. 
 
 
__ 4.  Consent Form if applicable See section 13.0-13.1 above. Contact 
wamcirbadmin@amedd.army.mil for assistance.  
 
__ 5.  HIPAA Waiver Form if applicable 
 
__ 6.  Figures / Graphs / Appendices 
 
__ 7.  Data Collection Sheets / Questionnaire 
 
__ 8.  Letters related to loaned equipment 
 
__ 9.  Memorandum related to acceptance of gift/donation 

IRBNet Number: 381600-19 
PI: Dr. Anthony Plunkett 
Protocol Title: A randomized, single-blind, prospective trial of auricular acupuncture for the 
reduction of post-operative tonsillectomy pain in adults.   
Initial Date Submitted: 6/13/2013 
Revision Date: 7/17/17 
WAMC Protocol Template Revised 23 November 2012 
 
Page 22 of 22 
381600-18_Auricular_Plunkett_v. 23 May 17 
 
__ 10.  Cooperative Authorization and Development Agreement (CRADA) If receiving 
outside funding, contact wamcirbadmin@amedd.army.mil for assistance. The Clinical 
Investigations Regulatory Office has final approval of this study.  
 
__ 11. Conflict of Interest Statement Must be completed for ALL Investigators 
 
 
__ 12. Advertisement Request 
 
__ 13. Responsibilities of Principal Investigator and Associate Investigator Section 3 and 16-
18 must be signed. 
 
__ 14.  Copy of Curriculum Vitae (CV)  From Principal Investigator and all Associate 
Investigator(s).  The IRB may request CVs from Collaborators depending on their role in the 
study. 
 
__ 15.  Certificate on Human Participant Protections Course for all Investigators   
Access at http://www.citiprogram.org/.  Select New Users or login using previous 
username/password.   Select Womack Army Medical Center as the Participating Institution. 
Training is good for 3 years.