Auricular Acupressure as a Non-Opioid Adjuvant in Opioid Tolerant Patients
Phase: NA
Conditions: Opioid Use Disorder
Sponsor: Wake Forest University Health Sciences

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Official Title: Auricular Acupressure as a Non-Opioid Adjuvant in Opioid Tolerant Patients 
NCT05711537 
IRB-Approved Date:  5/19/23 
 
 

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Title: “AURICULAR (EAR) ACUPRESSURE FOR PAIN MANAGEMENT AS A NON-OPIOID, 
ADJUVANT THERAPY FOR OPIOID TOLERANT PATIENTS” 
 
Principal investigator: Heather A. Columbano, MD 
Co-investigator(s): Robert W. Hurley, MD, PhD, Cherie C. Avants, NP, and Jena Lynn Welch 
Coltrane, NP,  Zachary Moore, MD 
 
Sponsor or funding source: 
Wake Forest Anesthesiology Department 
 
Background and justification for the research:  
Despite recent CDC guidelines for limiting the use of opioids in non-malignant related 
pain, millions of Americans still rely on opioid analgesics for daily pain control. Physicians 
have been encouraged to seek non-opioid alternatives since there is lack of evidence for 
opioid efficacy in chronic pain and, even worse, serious adverse effects including 
dependence, respiratory suppression, and death. When chronic pain patients are 
admitted to the hospital due to an acute medical problem, controlling their pain becomes 
problematic.  Physicians need to address pain levels (which are often increased), but 
ideally would like to do so with minimal opioids to avoid CNS and respiratory depression. 
At Wake Forest Baptist Health, our chronic pain team is consulted to provide safe, 
effective pharmacological recommendations,  
There is growing evidence in the literature for efficacy of auricular acupuncture therapy 
for chronic pain. Auricular acupressure (AA) is a related technique that uses the same 
external ear points for stimulation. It is widely held that AA is relatively easy to initiate, 
has rare adverse effects and is accepted by patients who may have an aversion to 
needles.  There are studies currently underway addressing use of AA in outpatient, 
elderly chronic low back pain patients and in the perioperative setting, however, no 
reports of AA as an adjunct for opioid dependent patients during hospitalization. Thus, 
we propose assessing the effectiveness of AA for pain control on this population via 
initiating it during chronic pain consults. In addition, by analyzing secondary measures 
and demographics we hope to characterize patients that may benefit most from AA.  
 
Battlefield Auricular Acupressure (BAApress) Training and Intervention Fidelity 
(IRB00084011) 
This feasibility trial is being performed in collaboration with the BAApress Training and 
Intervention Fidelity study (IRB00084011).  Under this grant, individual study teams 
conduct non-randomized feasibility trials to assess intervention feasibility and provide 
initial parameter estimates on specified outcomes.   

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The AA interventionists for this study will complete Auricular Acupressure training 
modules and complete competency assessments and intervention assessments 
throughout the study.  Study teams will include the possibility that a study participant 
may be part of a competency assessment and that their session may be recorded and 
securely uploaded to a server per IRB and Institutional policies.  
Objectives: 
The purpose of this study is to determine if the addition of auricular acupressure to the 
typical pharmacological regimen given to patients on the chronic pain/addiction service 
will lower pain scores and decrease pain medication usage.  
Setting: 
This will be a study utilizing the location of Atrium Health Wake Forest Baptist (Main 
Campus) for initiation of study procedures. 
 
Subject selection criteria 
Any patient admitted to Atrium Health Wake Forest Baptist for which our chronic 
pain/addiction medicine service is consulted.  
Inclusion: 
Patient admitted to the hospital with a chronic pain/addiction medicine service consult.  
1. Age > or equal to 18 
2. History of documented chronic pain with or without opioid use disorder  
a. Polysubstance abuse or opioid use disorder  
b. Or opioid use (documented as home medication)  
3. Expected length of stay (admission) is at least 5 days at the time of recruitment  
4. Able to read and understand the informed consent form 
 
Exclusion: 
1. Patient refusal 
2. Patients who are at a risk of leaving against medical advice (AMA) during their 
current admission may be excluded per the investigator’s discretion 
3. Since this is a feasibility pilot, only English-speaking participants will be eligible. 
4. Inability to communicate via telephone  
5. Participants with a history of skin disease (e.g., psoriasis) involving the ear, adhesive 
allergy, recent scar tissue on ear, or current abrasions or cuts on ear, 
6. Cognitive impairment (delirium, dementia)  
7. Physical impairment preventing them from applying pressure to the beads  
8. Patients with cardiac pacemakers (contraindication to POINTER PAL) 

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9. Use of some types of hearing aids (obstructing the placement of beads)  
10. Any chronic or acute illness or psychiatric conditions that would impact 
adherence to the study requirements 
 
Sample Size 
A total of 20 patients will be recruited from chronic pain patients hospitalized at Wake 
Forest Baptist Health Main Campus 
 
 
Interventions and Interactions: 
  
A. The chronic pain Advanced Practice Provider will evaluate the patient and 
determine if and when they can be included in the study. If the patient is 
determined to be eligible, the participant will be consented by a study team 
member prior to collection of any study data. 
 
Baseline 
-Review the home dose of opioid w/ participant collecting type, frequency and 
milligram use and date and time of last use prior to admission.   
- A study team member will provide the participant with the study questionnaire 
packet as well as instructions for completing the questionnaires. 
- Participants will be informed of the reminders that they will receive to complete 
the questionnaires twice a day for three days (i.e., verbal reminder from staff, 
signage placed in the room). Participant contact information will be collected to 
ensure appropriate and timely follow up. 
- A study team member will perform the pain score assessment with the 
participant to establish baseline pain score. 
- The participants will be asked to complete baseline questionnaires prior to the 
initiating placement of the acupressure including: Discomfort on Initiation of 
Acupressure (on 0-10 NRS scale), Pain Intensity, Enjoyment, General Activities 
Scale (PEG), Pain Catastrophizing Scale (PCS), Generalized Anxiety Disorder Scale 
(GAD-7), Patient Global Impression of Change Scale (PGIC) (only collected after 
Acupressure applied) and PROMIS sleep disturbance scale. 
 
Day 1 
 
The Baseline and Day 1 visits can take place on the same day. 
Following completion of baseline questionnaires, the trained Auricular 
Acupressure nurse will place the acupressure pads and instruct the participant 
how to do acupressure three times daily for 3 days.  
 
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. 

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o If the participant consented to the recording portion of the study, they will be 
reminded of the process and the acupressure nurse will confirm that the 
participant still agrees to participate in the recording portion of the study.    
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. 
o 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 or a POINTER-PAL trigger point locator will be used if one is available. 
o The acupressure pads will be placed by visual identification of the preselected 
acupoints as per BAA protocol. The pads will be placed on the identified site by 
hand or with the assistance tweezers, with the seed portion of the pad aligning 
with the identified acupoint.   
o 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”. 
o Participants will tell the acupressure nurse when they feel a tingling sensation in 
the ear or feel moderate tenderness or pressure as confirmation that moderate 
pressure is being applied. 
o The acupressure nurse will document acupressure pad placement and activation 
in Wake One. 
- If the acupressure pads fall off before day 3 the participant will be instructed to 
note which pad fell off in the study participant questionnaire. The acupressure 
pads will not be replaced during the study. 
o After completion of the day 3 study activities, the study team will instruct the 
participant 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. 
 
The interventionist (Acupressure nurse) may record and take pictures of the treatment 
visit.  These recordings will be used to ascertain fidelity to the intervention protocol as it 
relates to a) proper placement of acupressure seeds and b) and provision of instructions 
to the participant.   
Each study participant will be asked to sign a separate consent giving permission for the 
intervention to be recorded and used for educational and research purposes.  The 
recordings will be done to limit exposure of the study participant’s face.  

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The interventionist’s time will be measured in minutes from time the interventionist 
enters room to place acupressure pads to when the interventionist exits room. 
Qualitative questions will be used to assess overall feasibility. 
 
 
o The study team will perform the pain score assessment with participants  (on 0-10 
NRS scale) two (2) times a day for 3 days.  If the study team is unable to perform 
the pain scores assessment in person, we will use the pain score that has been 
assessed by the clinical team as part of their regular care and documented in the 
participant’s medical record. 
 
Study participants will be reminded to complete their daily study activities.   
- A member of the study team will remind the participant to complete their 
assessment(s) or the study nurse can place an order in Wake One to prompt the 
care team to remind the participant.  
- A sign will be placed in the participant’s room reminding them to complete their 
study activities.  
 
Monitoring opioid usage: data abstraction will be done and verified in Wake One 
if the participant remains inpatient for the 3 days. 
 
  
End of Study Assessment:  
Within 24 hours of the completion of the assessments and the removal of the 
acupressure beads, a member of the study team will assess patients’ 
 
- Pain scores 
- Opioid medication frequency and dosage  
 
- Verify completion of Day 3 study questionnaires: Pain Catastrophizing Scale 
(PCS); Generalized Anxiety Disorder Scale (GAD-7); Pain, Enjoyment, General 
Activities Scale (PEG); Patient Global Impression of Change Scale (PGIC); PROMIS 
sleep disturbance scale 
 
Participant will also be asked to complete “Willingness or desire to decrease opioid 
dependence and usage” and Acupressure Acceptability questionnaires on Day 3 
 
 
 
 
Outcome Measures: 
 
Since this is a feasibility study, results will be analyzed initially using descriptive statistics 
of main outcome measures.   
To evaluate the efficacy of the auricular acupressure the following outcomes will be 
assessed: 
 

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Primary Outcomes:  
Patient reported pain scores – change in patient reported pain scores (derived from the 
NRS and PEG scale) from baseline and Day 1-Day 3. 
Secondary Outcomes to be measured:  
Opioid use - Pre-Admission Opioid requirement and change from baseline (medication 
used during the intervention and as reported afterwards vs. home dose before the study 
started) collecting type, frequency and milligram use and date and time of last use prior to 
admission measuring mean/median changes from Baseline to Day 3 post evaluation. 
Trajectory of am and pm pain scores.  
Generalized Anxiety Disorder Scale (GAD-7) – A Self-administered 7 item scale that draws 
from DSM-V criteria for General Anxiety Disorder (GAD) to identify GAD and measure 
symptom severity. It is routinely used as a tool to measure longitudinal changes and track 
treatment progress. 
Patients are asked to rate the frequency of anxiety symptoms over the last 2 weeks on a 
Likert Scale (0-3). In general, patients with GAD or other common anxiety disorders 
exhibit GAD-7 scores of 10 or greater.  
 
Pain Catastrophizing Scale (PCS) - The assessment of thoughts and feelings of the patients 
will be assessed using questions that are rated 0 for not at all to 4 for all the time. The 
Pain Catastrophizing Scale (PCS) assesses the extent of catastrophic thinking due to low 
back pain according to 3 components: rumination, magnification, and helplessness.  It is a 
13-item scale, with a total range of 0 to 52. Higher scores are associated with higher 
amounts of pain catastrophizing. 
 
Composite Pain, Enjoyment and General Activity Scale (PEG) Assessment of pain intensity 
and interference. We will compare scores before and after initiation of Auricular 
Acupressure. 
 
Patient Global Impression of Change (PGIC) – patient reported assessment of 
improvement or decline of their pain 
 
PROMIS Sleep disturbance – patient reported outcome on the quality of their sleep. 
 
Acupressure Acceptability questions - We will ask acceptability questions. "How satisfied 
were you with how your pain has been treated?" using the Likert scale to measure "Very 
satisfied =5, Satisfied=4, Somewhat satisfied = 3, Somewhat dissatisfied= 2, Dissatisfied 1, 
Very Dissatisfied 0.  Would you consider using auricular acupressure in the future for pain 
or if recommended by your nurse or physician? a. No, would not use again (Score of 0) b. 
Maybe (Score of 1), c. Yes, I would consider using in the future (Score of 2) 3. Is there 
anything else you would like to tell us that may be helpful for us to know regarding ear 
acupressure? (Each answer will be collected and assessed for future studies). 

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Willingness or desire to decrease opioid dependence and usage (Assessed using Likert 
Scale). Assessment of patient's willingness or desire to decrease opioid dependence and 
usage will be assessed through having the patient answer by stating (1) Strongly disagree; 
(2) Disagree; (3) Neither agree nor disagree; (4) Agree; (5) Strongly agree to determine 
patients with a higher score denoting a greater willingness to decrease dependence. 
 
BAA Press placement survey (interventionists only) 
The Interventionist’s (Acupressure nurse) will be asked to capture time related to 
completion of study tasks and other qualitative questions to assess overall feasibility. 
 
 
Additional Data collection: contact information, relevant demographic data that will be 
recorded are DOB, age, gender identity, sex at birth, BMI, ethnicity/race, educational 
level, employment status, relationship status, disability insurance status and 
socioeconomic status.  Relevant medical history will be duration of narcotic use (in years) 
and comorbid pain syndrome diagnoses.  
 
Study activity 
Baselinea 
Day 1 
Day 2 
Day 3/ end of 
study 
Informed 
Consent signed 
x 
 
 
 
Review the 
home dose of 
opioid w/ 
participant   
x 
 
 
 
Complete data 
collection form  
x 
x 
x 
x 
Distribute 
Participant 
Questionnaire 
and review 
completion 
instructions 
x 
 
 
 
Administer or 
record Pain 
score 
assessment 
(NRS)b 
x 
x 
x 
x 
Questionnaire 
completion 
reminder c 
 
x 
x 
x 

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Pain 
Catastrophizing 
Scale (PCS) 
x 
 
 
x 
Pain, 
Enjoyment, 
General 
Activities Scale 
(PEG) 
x 
 
 
x 
Patient Global 
Impression of 
Change Scale 
(PGIC) 
x 
 
 
x 
PROMIS sleep 
disturbance 
scale 
x 
 
 
x 
Generalized 
Anxiety Disorder 
Scale (GAD-7) 
x 
 
 
x 
Acupressure 
placement and 
patient 
education  
 
x 
 
 
*Optional 
interventionist 
recording of AA 
placementd 
 
x 
 
 
Willingness or 
desire to 
decrease opioid 
dependence and 
usage 
questionnaire 
 
 
 
 
x 
Acupressure 
Acceptability 
questionnaire 
 
 
 
x 
Study team 
collect 
completed 
questionnaire 
 
 
 
x 
Compensation 
administration 
 
 
 
x 

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BAA press 
placement 
survey 
(interventionist 
only) 
x 
x 
x 
x 
 
 
 
 
 
 
a Baseline and Day 1 can be completed on the same day. Baseline activities are to be completed prior to 
Acupressure administration 
b  The study team will perform the pain score assessment with the participant two times a day for three days. If the 
study team is unable to perform the pain scores assessment in person, the pain score that has been assessed by 
their clinical team as part of their regular care will be pulled 
 c Participants will receive reminders to complete the study questionnaires twice a day 
d  Only participants who agree to participate in the optional recording/photography at the time of informed consent 
will have their acupressure placement session recorded  
 
 
 
 
Analytical Plan 
Sample Size: 
This is a feasibility study with no control group.  Target enrollment is 20 participants. Data 
from this study will be used to generate parameter estimates to calculate power for future 
studies.  
  
Analysis Plan: 
Since this is a feasibility study, results will be analyzed initially using descriptive statistics of 
main outcome measures.  Any group comparisons will be done using chi square tests for 
proportions, and t-tests or ANOVA procedures for continuous variables.  Other inferential 
statistical analysis will be conducted as appropriate. 
 
Human Subjects Protection 
 
Subject Recruitment Methods 
Any patient who is on the chronic pain/addiction consult service be approached by either 
Primary Investigator or study staff regarding participation.  Only eligible patients willing 
to complete all survey’s pre and post procedures and provide written consent will 
participate. If eligible, the participant will be consented by study personnel in their 
private hospital room. If a family member of visitor is present, the study team member 
will ask the participant permission to discuss the study at that time or if they would 
prefer to discuss another time. The study team will ensure that the participant 
understands the voluntary nature of participating in the research study and that study 
participation study will not affect the care that they will receive.  
The study personnel will maintain a record of eligible study participants separate from 
the study files.  This list will include name, MRN, and hospital room number and 

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enrollment status. The list will be kept in a secure file on a secure computer, separate 
from the study files and only accessible to study staff. The file of eligible participants will 
be destroyed at the end of recruitment. 
 
Informed Consent 
Signed informed consent will be obtained from each subject prior to any study 
procedures being performed. Any study related procedures will adhere to ICH-GCP 
standards. 
 
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 data collection form.  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 3 years after the completion of the study consistent with data validation 
and study design, 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 investigator will be responsible for the overall monitoring of the data and 
safety of study participants.  The principal investigator 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 and the acupressure nurses will be instructed to monitor and 
report any concerns to the principal investigator. 
 
 
 
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. 
 
Appendix A: Data Collection Form  
Appendix B:  Pain Catastrophizing Scale (PCS) 
Appendix C: Generalized Anxiety Discorder Scale (GAD-7) 
Appendix D: Pain, Enjoyment, General Activities Scale (PEG) 

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Appendix E: Patient Global Impression of Change Scale (PGIC) 
Appendix F: PROMIS sleep disturbance scale 
Appendix G:  Study participant questionnaire 
Appendix H: Vaccaria 600 t ears seeds 
Appendix I: Acupressure Acceptability Questionnaire 
Appendix J: Willingness or desire to decrease opioid dependence and usage assessment 
Appendix K: BAA Press placement survey (interventionists)