Nurse Initiated Auricular Acupressure for Post-operative Pain Management in Knee and Hip Arthroplasty Patients
Phase: NA
Conditions: Pain, Postoperative, Pain, Acute
Sponsor: Wake Forest University Health Sciences

Protocol version: 5 5OCT2020 
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Official Title: Nurse Initiated Auricular Acupressure for Post-operative Pain Management in Knee and 
Hip Arthroplasty Patients 
NCT04044716 
IRB-Approved Date: 10/19/20 

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Return Code for Ignite Grant: 4WHMKYRL 
EIRB: 00057513 
Study Title:  Nurse initiated auricular acupressure for post-operative pain management in knee and hip 
arthroplasty patients 
Principal Investigator, Co-investigator(s): Carolyn Huffman, WHNP, PhD; Remy Rene Coeytaux, MD 
 
Sponsor or funding source: Departmental 
 
Background, Rationale and Context 
Postoperative pain management has become an area of concern over the last decade due to the 
opioid epidemic and concerns that the use of opioids as a primary pain management strategy in 
the post-operative period may promote misuse or abuse of opioids in the outpatient setting (Hah, 
Bateman, Ratliff, Curtin, and Sun, 2017; Alam, Gomes, Zheng, Mamdani, Juurlink & Bell, 2012). 
As of January 1, 2018, The Joint Commission requires hospitals to have non-pharmacologic 
modalities available for pain management in an effort to decrease the need for opioids.  
Acupuncture and acupressure have been used for centuries in the management of a variety of 
disorders including pain.  A recent meta-analysis (Zhong et al., 2019) of 26 RCTs (all included 
studies were in China) favored the use of acupressure for pain management over usual care based 
on total effective rate (RR =1.25, [CI= 1.13, 1.37], p <.0001) and total analgesia use (RR=0.41, 
[CI= 0.24, 0.68] p = .0006).  There were no serious adverse events reported in the 26 trials 
(N=1063 in treatment groups) and no withdrawals from the studies were reported due to adverse 
events.  Unlike acupuncture, acupressure can be easily applied with training and is within the 
scope of practice for nurses, according to the North Carolina Board of Nursing (NCBON, 2013).  
Although acupressure has been used for centuries in traditional Chinese medicine, there are few 
studies assessing the use of nurse initiated acupressure in hospital settings as an adjuvant to post-
operative pain management.   
 
Battlefield acupuncture (BFA) was developed by Dr. Richard Niemtzow, a U.S. Air Force 
radiation oncologist. BFA utilizes 5 acupoints that are thought to be involved in central 
processing of pain. Dr. Niemtzow’s protocol has been used in the United States military in the 
treatment of pain for over 15 years. In the last few years, the Veterans Administration in 
conjunction with the Department of Defense has expanded BFA training to providers within the 
VA system (Walker, et al., 2016). A cross sectional study of 753 patient BFA encounters (284 
individual patients) within the West Haven VA Medical Center, found that patients receiving 
BFA showed on average a 2 point decrease in pain scores (measured on a 0-10 scale) with each 
BFA encounter (p < .001) (Federman et al., 2018). More recently, in an effort to increase access 
to non-pharmacological modalities for pain management, the VA has developed a battlefield 
auricular acupressure (BAA) protocol. The BAA protocol uses the same acupoints as the BFA 
protocol but instead of piercing the skin with needles to stimulate the acupoints, tiny beads or 
seeds are placed on the sites and stimulation of the sites is achieved when manual pressure is 
applied to the seed. The advantage of BAA is that since it does not require needles, patients may 
tolerate or be more open to its use, application of the seeds or beads is within the scope of 
practice of registered 
 
The purpose of this pilot is to test the feasibility of nurse initiated post-operative battlefield 
auricular acupressure as an adjunct to medication for post-operative pain management.  
 
Objectives 
 
1. To determine if battlefield auricular acupressure applied in the immediate pre-operative 
period improves post-operative pain management related to:  

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a. total opioid intake over 5 days  
b. aggregated mean pain score over 5 days 
c. acceptability of auricular acupressure as pain management tool 
2. To determine the feasibility of nurse initiated battlefield acupressure related to nurse time, 
cost and perceptions related to auricular acupressure and workflow. 
Methods and Measures 
 
Design 
• 
Randomized controlled trial.  
Setting 
Davie Medical Center 
 
Subjects selection criteria 
• 
Inclusion Criteria 
Adults 18-80 admitted for knee or hip arthroplasty. Pre-surgery morphine equivalent < 50, 
ASA score < 3 
• 
Exclusion Criteria 
Participants with a history of skin disease (e.g., psoriasis) involving the ear, adhesive allergy, 
latex allergy, recent scar tissue on ear, or current abrasions or cuts on ear, history of delirium, 
or cognitive impairment. Some hearing aids may prevent proper placement of acupressure 
pads and thus, require exclusion. Since this is a feasibility pilot, only English speaking 
participants will be eligible.  
• 
Sample Size 
Based on previous published literature, we estimate a total sample size of 48 -52 needed (24-
26 each arm) to detect a 30% difference in pain scores or 25% reduction in analgesia.  
Recruitment target will be 30 in each arm (N=60) to allow for attrition. In order to identify 
the 60 subjects needed, we may need to screen as many as 120 because some people will not 
qualify to be included in the study.   
 
Interventions and Interactions 
 
Terms:   AA = Auricular acupressure  
Acupressure pad= hypoallergenic adhesive pad containing a 2 mm Vaccaria  seeds 
(Earseeds®)  
 
 
 Acupoint = specific area of body where acupressure is applied. 
 BAA= Battlefield Auricular Acupressure 
 
 
  
The three regional anesthesia nurses at Davie will be trained to deliver the intervention.  All three 
nurses have been CITI trained and for this protocol will be referred to as auricular acupressure (AA) 
nurses.  In addition to the three AA nurses, CTSI will provide study coordination.  
 
• 
Training of the AA nurses for auricular acupressure will be done by the Wake Forest Center 
for Integrative Medicine (CIM) providers.  Training will have both didactic and hands-on 
practice components:  basic concepts of auricular acupressure, anatomy and physiology of the 
ear, assessment of ear anatomy, proper identification of therapeutic acupoints, proper 
cleaning of the ear, application of acupressure pads and activation, and patient education 
related to activation of the acupressure pads with manual pressure. Competency will be 
assessed both by assessment of knowledge (written assessment) and direct observation by 
CIM acupuncturist of the AA nurse’s ability to correctly identify auricular acupressure points 
through visual inspection, proper application of acupressure pads and activation of the 
acupoints via manual pressure applied to the acupressure pads.   

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• 
Participants will be informed of the study at the time of their surgical consult with their 
physician or at their pre-operative appointment via flyers made available to the surgical 
clinics.  Prior to the pre-assessment visit, study personnel will review the chart of patients 
who express interest in the study to confirm eligibility. Informed consent will be obtained at 
the pre-operative assessment visit by study personnel and the participant questionnaire will be 
reviewed with instructions on the day of surgery, the AA nurse will confirm consent for 
participation.  Random assignment will be generated by REDCap and emailed to the AA 
nurse by the study coordinator. If participant is assigned to treatment, the acupressure pads 
will be placed in the pre-operative holding room. The participant’s designee will be given the 
study questionnaire packet as well as instructions for completing.  
• 
AA nurses will record time from the moment they enter participant’s room in holding room 
for the purposes of placing acupressure pads and activating each pad until they exit room.  
AA nurses will make notation if recorded time includes activity unrelated to placement of 
acupressure pads.  After placement of acupressure pads, AA nurse will enter procedure note 
in WakeOne and complete the REDCap nurse questionnaire. 
 
• 
Treatment Group: The AA nurses will place the acupressure pads on the participant pre-
operatively while the participant is in the PACU using the following BAA protocol:  
 
o Before acupressure pad placement, pain assessment will be performed and 
recorded in the study chart by the AA nurses.  AA nurse will also ensure that a 
responsible family member is in the pre-operative holding room with participant 
to listen to instructions. 
o Acupressure pads will be placed prior to any amnesic or pain medication. 
o AA nurse will have participant don surgical cap, being careful to keep all hair 
under the cap.   
o If the ear contains lesions, skin breakdown, or show signs of irritation, the 
acupressure pads will not be placed and this will be noted in the study record.   
o A total of 10 adhesive acupressure pads will be placed, 5 acupressure pads per 
ear. The pads will be placed bilaterally on the following 5 auricular sites: 1) 
Cyngulate gyrus, 2)  Thalamus, 3) Omega 2 4) Point Zero, and 5) Shen Men. 
These sites were selected based on the  WV’s Battlefield Auricular Acupressure 
Protocol for acute and chronic pain.  This is the protocol the Veterans 
Administration uses for acupressure therapy for acute and chronic pain 
management and is taught to both nurses and physicians. Each ear will be 
cleansed with alcohol, beginning at the base of the ear (lobule) to the apex.  The 
acupoints will be visually located and marked with a sterile surgical marker.  The 
pads will be placed by visual identification of the preselected acupoints as per 
BAA protocol. The pads will be placed on the on the identified site by hand or 
with the assistance tweezers, with the seed portion of the pad aligning with the 
identified acupoint.  To secure the pad, gentle but firm pressure will be applied to 
the pad, making sure that pressure is applied to the entire pad. 
o After placement, the study nurse will apply moderate pressure to each 
acupressure pad for 30 seconds (total time 2.5 minutes per ear). Both right and 
left ear site will be stimulated at the same time with pressure in the following 
order: 1) Cyngulate gyrus, 2) Thalamus, 3) Omega 2, 4) Point Zero, and 5) Shen 
Men   Participants will tell the AA nurse when they feel a tingling sensation in 
the ear or feel moderate tenderness or pressure as confirmation that moderate 
pressure is being applied.  

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o The AA nurse will document in WakeOne acupressure pad placement and 
activation.   
o Once participant is transferred to the floor, the AA nurse will review with 
participant and family how and when to activate each pad and give participant or 
designee a picture of a right and left ear with the acupressure pads in place with 
pads labeled 1-5.  Participants will be reminded to gently press on each pad for 
30 seconds three times a day to activate and to do this three times a day for a total 
of 5 days (roughly every 6-8 hours, while awake during the day).  The provided 
picture will be used by the participant to account for any missing pads on the 
participant questionnaire.  If the participant requests, the AA nurse will take a 
picture with the participant’s smartphone of the participant’s ears with the pads in 
place. The study questionnaire will also direct participants to apply moderate 
pressure using thumb and forefinger to each pad for 30 seconds each three times 
a day.   
o If acupressure pads fall off while the participant is still in the hospital, the 
participant and/or nursing staff will be instructed to call the AA nurse on call for 
replacement of the pads prior to discharge.  
o Participants may stimulate both ear sites at the same time beginning with site 1 
and ending with site 5.  Studies have placed acupressure pads for 3-8 days 
depending on study outcomes (He et al., 2013; Yeh et al., 2014), the pads will be 
placed for a total of 5 days based on manufacturer’s recommendation and the 
BAA protocol (See example of Earseeds instruction brochure). On the day of 
surgery, the participant will be informed to apply pressure one to 2 more times 
that day, depending upon the time the acupressure pads were placed.  Participants 
will be informed that if any acupressure pads fall off while home, they are not to 
be replaced, but to record on the study questionnaire (see participant 
questionnaire). Staff nurses will remind participants to complete their 
questionnaires and to call the AA nurses with any questions related to the 
acupressure pads or the study. 
o At time of discharge, the study personnel will ensure that the participant has 
participant questionnaire and the addressed and stamped envelope. Instructions 
for activation of the acupressure pads and questionnaire completion will be 
reviewed.  Participants will be informed that they will either receive a phone call 
or text reminder twice daily to complete the questionnaire and to activate their 
pads 3 times per day. Participant is to continue to apply pressure to remaining 
pads until the end of the study.    
o On post-operative day 4, the study personnel will call the patient and instruct 
them to remove the acupressure pads by gently pulling on the edges of the pad 
and lifting off with their fingers or using tweezers to loosen the pad if needed. 
Participants will be reminded to  mail questionnaire in the provided postage paid 
envelope, if they have not done so already  
 
• 
Control Group:  The AA nurse will give participants in the control group the study 
questionnaire once they arrive to the floor and remind participant and family to complete the 
questionnaire as indicated.  At time of discharge, study personnel will ensure that participant 
has study questionnaire and the addressed and postage paid envelope. Participants will be 
informed that they will either receive twice daily phone calls or text messages to complete the 
questionnaire. On postoperative day 4, study personnel will call and remind participate to 
mail questionnaire in the provided postage-paid envelope.   
 

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• 
Contact information will be obtained at time of study enrollment/consent in order to remind 
participants daily to complete study document.  The reminders will be via telephone call by 
study personnel and/or via text messaging depending on participant preference. Participants 
may also be contacted to complete the final questionnaire over the phone if the document if 
this section is incomplete when received by the study team. 
 
 
Ambulatory 
Appointment 
Preoperative 
Assessment   
Day of 
Surgery 
Recovery 
Rm 
PO-
0 
PO-
1 
PO-
2 
PO-
3 
PO-
4 
Study flyer 
 
 
Study flyer 
 
Informed  
Consent  
 
R 
Informed 
Consent 
O1 
X 
O2 
X 
O3 
X 
O4 
X 
O5 
X 
O6 
X 
O1 
O2 
O3 
O4 
O5 
O6 
Note: O= Observation; R = Randomization, X = Acupressure pellet placement and/or activation with 
manual pressure. 
 
Outcome Measure(s) 
1) Pain:  Both inpatient and outpatient pain scores will be measured using the VAS as documented 
on the participant study questionnaire.  
a. am pain score on rising aggregated over 4 days (post-op day 1 –post-op day 4) 
b. pm (worse pain throughout the day) pain score aggregated over 5 days (post-op day 0 –  
post-op day 4)  
c. trajectory of am and pm pain scores  
2) Inpatient opioid pain medication will be collected via the MAR in WakeOne.  Outpatient usage 
will be self-reported in study questionnaire. Inpatient and outpatient total opioid use will be 
converted to total Morphine equivalent.  
a. Total morphine equivalent aggregated over day 0-4 
b. Trajectory of morphine equivalent from day 0 - 4 
3) Overall participant satisfaction will be measured on post-op day 4 via participant questionnaire.  
4) Nurse time will be measured in minutes from time AA nurse enters room to place acupressure 
pads to when AA nurse exits room. Qualitative questions will be used to assess overall feasibility 
of nurse initiated auricular acupressure. 
 
 

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Outcome  
Measure 
Baseline 
Post-op Day 1-2 
Post-op days  
         1-4  
Pain  
Visual Analogue 
X 
 
X 
 
 
 
 
 
Medication 
Inpatient 
WakeOne MAR 
Participant 
Questionnaire 
 
X 
X 
Medication Use 
Outpatient 
Participant 
Questionnaire 
 
 
X 
Pellet Retention 
Days 
Participant 
Questionnaire 
 
X 
X 
Pain 
Management 
satisfaction 
Participant 
Questionnaire 
 
 
X 
Nurse Time  
Questionnaire 
 
X 
 
Nurse Feasibility 
Questionnaire 
 
X 
 
 
Analytical Plan 
 
Results will be analyzed initially using descriptive statistics.  Comparison between groups will be done 
using chi square tests for proportions, and t-tests or ANOVA procedures for continuous variables.  
Multilevel modeling will be used to determine difference in pain and morphine equivalents over time.  
 
Human Subjects Protection 
 
Subject Recruitment Methods 
 
Several strategies will be implemented to assist with recruitment. Participants may be identified by 
screening provider schedules. They will be recruited by mailed recruitment letter, myWakeHealth 
message, telephone, and/or in person when presenting for their surgical consent or pre-operative 
assessment visit (as allowed by institutional and government policies). 
Informational flyers describing the study will be disseminated to the orthopedic clinics at Davie Medical 
Center.  Recruitment will also be done through the orthopedic clinic at the time of a patient’s pre-
operative assessment visit in one of three ways: 1) patients will be given an informational flyer and 
instructed to call study phone line if interested in participating, 2) they may ask to receive a call from the 
study team, or 3) they may meet directly with a study team member the day of their pre-operative 
assessment visit if a study team member is available. 
 Study personnel will review eligibility questionnaire with participant (confirm age, date of pre-
assessment appointment, date of surgery, type of surgery, presence of pacemaker or other electrical 
device, hearing aid use, skin disorder or allergies, current medications).  If eligible based on phone or in 
person screen, study personnel will do second stage eligibility screen via WakeOne chart review to 
calculate current morphine equivalent, medical history for delirium, ASA status, and cognitive 
impairment or delirium. If eligible, participant will be consented by study personnel at their pre-
assessment anesthesia visit or on the day of surgery. The study personnel will maintain a record of 
eligible study participants.  This list will include name, MRN, surgery type, pre-assessment appointment, 
and surgery date will be kept in a secure file on a secure computer. The file of eligible participants will be 
destroyed at the end of recruitment. 
 
Informed Consent 
 

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Signed informed consent will be obtained from each subject.  The study personnel will obtain informed 
consent at the time of the pre-operative assessment or on the day of surgery. The AA nurse will be 
contacted to come and speak with patient to answer any questions prior to signing consent. During 
COVID-19, we plan to obtain consent remotely in cases where the study team is not able to have face to 
face contact with the participant. In order to obtain legally effective consent, the investigator or member 
of the study team will provide two copies of the approved consent form for documentation. After 
received, the study team member will speak with the participant, presenting the elements of consent, the 
content of the study, and answer any questions. At the end of the discussion, the study team member will 
advise the participant to sign and date one form and return the signed consent form to the study team.  
The study team will clarify that the second consent form should be kept by the participant for 
documentation. Upon receipt of the signed form, the study team member will sign and date with the 
current date, and add a note detailing the date discrepancy. No study procedures will begin until the IRB 
approved method of obtaining consent is completed. Participants will be reminded that if the signed 
consent form is not received prior to the surgery and if there is not a study team member available to 
consent prior to the surgery, they will not be able to participate in the study. 
 
 
 
Confidentiality and Privacy 
Confidentiality will be protected by collecting only information needed to assess study outcomes, 
minimizing to the fullest extent possible the collection of any information that could directly identify 
subjects, and maintaining all study information in a secure manner.  To help ensure subject privacy 
and confidentiality, only a unique study identifier will appear on the stored data collection forms.  
Any collected patient identifying information corresponding to the unique study identifier will be 
maintained on a linkage file, store separately from the data.  The linkage file will be kept secure, with 
access limited to designated study personnel.  Following data collection, subject identifying 
information will be destroyed three years after closure of the study, and files will be erased. Each 
study participant will be assigned a unique identifier that will be linked to their name.   The 
participant study questionnaire will contain the patient’s name and after collection of the study 
questionnaire from the patient, the study coordinator will replace the name on the study questionnaire 
with the participant’s unique identifier and data will be transferred to the study data base with data 
validation producing an anonymous analytical data set.  Data access will be limited to study staff.  
Data and records will be kept locked and secured with any computer data password protected.  No 
reference to any individual participant will appear in reports, presentations, or publications that may 
arise from the study. 
 
Data and Safety Monitoring 
The principal and co- investigator will be responsible for the overall monitoring of the data and safety 
of study participants.  They will be assisted by other members of the study staff.  Although no serious 
safety events have been reported in the literature related to auricular acupressure, participants will be 
asked to report any events to study personnel.  Participants will be instructed to monitor and report 
any concerns related to acupressure pads to the AA nurse on-call and these will be escalated to the PI 
and then to the Co-investigator for evaluation, if needed.  The co-investigator or a licensed 
acupuncture provider at the Center for Integrative Medicine will serve as consulting 
physician/acupuncturist for any adverse event that is determined to be potentially related to the study, 
including physical examination and treatment if necessary. 
 
Reporting of Unanticipated Problems, Adverse Events or Deviations 
Any unanticipated problems, serious and unexpected adverse events, deviations or protocol changes 
will be promptly reported by the principal investigator or designated member of the research team to 
the IRB and sponsor or appropriate government agency if appropriate. 

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References 
1. Alam, A., Gomes, T, Zheng, H., Mandani, M. M., Juurlink, D. N., & Bell, C. M. (2012). Long-
term analgesic use after low-risk surgery: A retrospective cohort study.  Journal of the American 
Medical Association, 172(5), 425-430.  
2. Hah, J.M., Bateman, B.T., Ratliff, J., Curtin, C., & Sun, E. (2017).  Chronic opioid use after 
surgery: Implications for perioperative management in the face of the opioid epidemic.  
Anesthesia & Analgesia, 125(5), 1733-1740.  
3. He, B. J., Tong, P. J., Li, J., Jing, H. T., & Yaom X. M. (2013).  Auricular acupressure for 
analgesia in peri-operative period of total knee arthroplasty, Pain Medicine, 14, 1608-1613.  
4. North Carolina Board of Nursing (2013). Complimentary Therapies: Position statement for RN 
and LPN practice.   
5. The Joint Commission (2017, August 29). Pain assessment and management standards for 
hospitals. R3 Report, 11.  
6. Yeh, C.H., Chien, L-C, Huang, L. C., Suen, L. (2014).  Auricular point acupressure for chronic 
pain: A feasibility study of 4-week treatment protocol. Holistic Nursing Practice, 28(3), 184-194.  
7. Zhong, Q., Wang, D., Bai, Y-M., Du, S., Song, Y-L., & Zhu, J. (2019).  Effectiveness of auricular 
acupressure for acute postoperative pain after surgery: A systematic review and meta-analysis, 
Chinese Journal of Integrative Medicine, 25(3), 225-232.  
 
Appendix 
1. Participant Study Questionnaire  
2. Nurse questionnaire  
3. Consent form  
4. Acupressure Sites 
5. Davie Medical Center Total Joint Program Inclusion Criteria