Auriculotherapy as an Adjunct for Pain Management During Medication Abortion: a Randomized, Double-blinded, Three-arm Trial
Phase: NA
Conditions: Abortion Early
Sponsor: Columbia University

NCT03900728 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Columbia University Human Subjects Protocol 
Protocol: AAAS2520 
Effective Date: 03/31/2020 
Principal Investigator: Carolyn Westhoff, MD 
Title: Auriculotherapy as an adjunct for pain management during medication abortion: a 
randomized, double-blinded, three arm trial 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Purpose and Rationale 
 
The CDC reported 638,169 abortions in 2015; of these, 91% took place at 13 weeks’ gestation 
(Jatlaoui, 2018). Because several large jurisdictions do not report abortion data to the CDC, the 
correct number of U.S. abortions is larger. Abortions are being performed earlier than ever, in 
large part due to approval and increasing use of medication abortion with mifepristone and 
misoprostol prior to ten weeks gestation. The evidence-based regimen used in the U.S. consists 
of oral mifepristone 200 mg, followed by misoprostol 800 mg, generally taken at home about 24-
72 hours after the mifepristone. Most women undergoing medication abortion report moderate or 
severe pain that usually occurs during the six hours after using misoprostol. Analgesics for 
medication abortion typically include nonsteroidal anti-inflammatory drugs (ibuprofen), and 
sometimes opioids, but few studies have evaluated pain management in this setting (Westhoff, 
2000). Investigations into the role of adjunct pain medications, specifically opioids and 
anxiolytics, have consistently found them ineffective for first trimester aspiration abortion pain 
(Micks, 2012; Bayer, 2015) and unnecessarily dispensing these medications contributes to the 
opioid epidemic, but analgesia for medication abortion has undergone limited evaluation. The 
National Academy of Sciences published “The Safety and Quality of Abortion Care in the U.S.” 
highlighting the existing research gap in optimizing pain management during abortion (National 
Academy of Sciences, 2018), while the Society for Family Planning urged future investigators to 
focus on non-pharmacologic methods (Allen, 2018). Promising data suggest that acupuncture is a 
good adjunct for obstetric and gynecological pain (Borup, 2009; Smith, 2011; Kiran, 2013), 
which prompted us to carry out a randomized trial examining auricular acupuncture using 
Pyonex™ needles, as an adjunct to paracervical block and ibuprofen (usual care) (AAAR2610). 
That study revealed substantially lower pain and anxiety scores of women receiving auricular 
acupuncture compared to pain and anxiety scores of women receiving placebo or usual care 
alone during first-trimester vacuum aspiration (Ndubisi, 2018). These results are promising and 
might apply to pain management for medication abortion. Various state restrictions may limit 
provision of acupuncture with needles due to extensive training requirements (Lin, 2017). 
Auricular acupressure with beads showed labor pain reduction and may prove to be an effective 
alternative to acupuncture (Smith, 2011). Acupressure is not regulated to the same extent as 
acupuncture as it is non-invasive and without skin penetration. No studies, however, have 
examined acupressure in abortion pain management. Therefore, we propose a three-arm trial to 
assess maximum pain and anxiety scores during medication abortion with participants 
randomized to either (1) auricular acupressure with Acu-patch beads plus usual care, (2) 
auricular acupuncture with Pyonex™ needles plus usual care, or (3) placebo patches plus usual 
care. The goal of this study is to test the hypothesis that either auricular acupressure with beads, 
or with pyonex needles, in addition to usual care with ibuprofen will minimize pain during 
medication abortion up to 10 weeks gestation. Auricular acupuncture and auricular acupressure 
together constitute auriculotherapy. This study will take place in parallel with a trial to evaluate 
the same auriculotherapy interventions in women undergoing first trimester vacuum aspiration 
abortion (AAAS0917).  
 
Study Design 
 
Background: The proposed study will be a randomized, blinded, placebo-controlled, three-arm 
trial at a single abortion practice at CUIMC to evaluate the efficacy of auriculotherapy as an 

adjunct to ibuprofen for management of pain and anxiety in patients undergoing a medication 
abortion with mifepristone and misoprostol at gestational age of less than 10 weeks. We will 
recruit patients from a single abortion practice at CUIMC with the expectation to recruit about 
150 patients. We will randomize those who agree to participate to receive acupressure vs. 
acupuncture vs. placebo patches following completion of all usual care. Usual care includes 
obtaining vital signs, medical history, physical exam, ultrasonography, and collection of a blood 
sample for Rh status confirmation, and consent for the abortion treatment itself. Women receive 
the 200 mg dose of mifepristone during their clinic visit, and receive misoprostol 800 mcg 
(buccal) to use at home 24-72 hours after the mifepristone. All women also receive a prescription 
for ibuprofen 600 mg, #20, to take every 6 hours as part of their usual care and they receive a 
one-week follow-up appointment to evaluate treatment success and to initiate contraception (if 
desired). Patient-care sites for this study will include VC 10, HIP and 1790 Broadway.  
 
Recruitment: After completion of all usual patient care activities and administration of the 
mifepristone tablet, the MD caring for the patient will offer the patient the opportunity to speak 
with the research assistant about participation in this auriculotherapy study. The research 
assistant will summarize the study and state the research objectives. The research assistant will 
then proceed with the informed consent process for interested patients who meet inclusion 
criteria. After informed consent, research assistants will collect demographic information and 
baseline characteristics into a preprogrammed electronic tablet from which all information will 
be transmitted directly into the study REDCap database. The research assistant will collect 
baseline pain and anxiety scores using 100 mm VAS pre-programmed into the same tablet.  
 
Intervention: Participants will receive random assignment into one of the three study arms. The 
research assistant will give the next sequential opaque sealed envelope containing the treatment 
assignment to the auriculotherapy provider. All clinicians in our practice will be trained as part 
of an ongoing auriculotherapy study. The auriculotherapy provider will always be different from 
the research assistant and the abortion provider. The auriculotherapy provider will open the 
assignment envelope and enter the room without the research assistant or the abortion provider. 
Each auriculotherapy intervention provider will follow a script and will tell the participant that 
she “may or may not feel a sensation from the treatment”. After cleaning both ears with alcohol, 
the auriculotherapy provider will place the acupressure beads or the Pyonex™ needles, following 
the Gold protocol (see below). These treatments adhere to the ear with adhesive patches; 
participants in the placebo arm will receive placement of similarly sized adhesives. The adhesive 
patches are similar in size and appearance and thus the participants will not know which 
treatment they have received. The participants will go home wearing the auricular patches. 
Clinical use of acupuncture to treat chronic pain has demonstrated that these patches readily 
remain in place for a week or longer and do not detach with sleeping, showering or shampooing. 
During medication abortion, cramps and pain tend to occur after using misoprostol, which will 
take place about 1-3 days after the initial visit according to the patient’s preferred timing. To 
track patient pain and anxiety, we will send each patient a 2-way text message at 8pm for the 
next four days and ask her to respond with her maximum pain level during the previous 24 hours. 
Our research group has experience sending such text messages to patients to assess pain 
(Nippita, 2015), and has experience with using a text message with a web link to report pain 
scores using a VAS. For any patient who wants to participate in the study, but does not have a 
mobile phone with text and web capability, we will offer a paper diary to record pain and 

anxiety. The research assistant will remind patients to return for the routine one-week follow-up 
appointment, and during that appointment the participants will again report their maximum pain 
and anxiety scores using VAS scales; they will also complete a satisfaction survey and identify 
the treatment arm they believe they received. The research assistant will remove the adhesive 
patches. The participant will receive thanks for participating in the study and $25 for 
compensation. 
 
Statistical Procedures 
 
Number of subjects and statistical power: For this study we plan to recruit 5 patients a week to 
reach a total of 47 participants per treatment arm or 141 participants over approximately 30 
weeks. Estimating an effect size of 20 mm with standard deviation of 30 (calculated from the 
prior acupuncture study), 80% power, a 5 % level of significance, and presuming 20% dropout 
after enrollment, the study will require 47 participants in each arm (141 participants altogether). 
Prior studies selected an effect size of 20 mm to evaluate non-pharmacologic pain management 
during first-trimester aspiration abortion (Tschann, 2018; Wang, 2018). Our recent acupuncture 
trial achieved a 30-point pain reduction in the treatment group compared to the placebo group 
(Ndubisi, 2018). In our clinics about 25% of patients do not return for follow-up after a 
medication abortion – we do not know if study participation will increase or decrease this loss to 
follow-up. We also do not know whether patients will respond to the textmessaging, but in our 
previous study, text messaging response rates were excellent in a similar patient population 
(Nippita, 2015). Data Analysis: We will use descriptive statistics to report participant baseline 
characteristic including variables that may affect pain. Demographic information will include 
age, education, preferred language, BMI, race/ethnicity, illicit drug/alcohol use, anxiety or 
depression medication use in the last 30 days, and history of acupuncture use. Reproductive 
information will include dysmenorrhea history, parity and recency of last birth, gestational age, 
history of induced abortion vs. early pregnancy loss or management of abnormal pregnancy. We 
will compared demographic and baseline characteristics across the three groups with Chi-square 
tests for categorical variables and analysis of variance (ANOVA) for continuous variables in 
order to assess whether randomization was successful. The primary outcome will be maximum 
pain during medication abortion follow-up; we will assess the maximum reported pain on any of 
the four days following treatment initiation because women will vary in when they use the 
misoprostol and when they experience maximum pain. We will also evaluate maximum pain as 
reported during the follow-up visit. The primary analyses will compare acupressure vs. placebo, 
and acupuncture vs placebo; we will analyze the difference between the median subject-reported 
maximum pain score as measured by VAS among women randomized to receive usual care plus 
aurciulotherapy (needles or beads) vs. usual care plus placebo. In the previous pilot study the 
VAS scores were not normally distributed (Ndubisi, 2018), therefore we will compare the 
medians, not means. Because the previous trial found a substantial reduction in median anxiety 
in the participants who received acupuncture, our secondary analysis will evaluate differences in 
the median anxiety score as measured by VAS across the three study arms. An exploratory 
analysis will compare acupuncture to acupressure; we will analyze the difference between the 
median subject-reported maximum pain score reported using VAS among women randomized to 
receive usual care plus auriculotherapy with needles (acupuncture) vs. usual care plus beads 
(acupressure). We will also compare participant global satisfaction using a satisfaction survey, 
and describe and compare participant identification of the treatment arm. 

 
This will be an intention-to-treat analysis to maintain comparability of our treatment arms 
following randomization. Initial analyses will take place blinded to the treatment assignment in 
order to reduce bias in the analysis. Expecting that VAS scores will not be normally distributed, 
we plan to use non-parametric tests (Kruskal-Wallis and Mann-Whitney tests) to compare VAS 
pain and anxiety scores between the groups. A 20mm or greater reduction in maximum pain 
scores among participants receiving usual care plus auriculotherapy would uphold the primary 
hypothesis. 
 
Confidentiality: Study records that identify subjects will be kept confidential as required by law. 
Subjects will receive a study subject number and this code will be used for most disclosures to 
identify the subject. All personnel who will collect input or otherwise handle data have been 
trained in Good Clinical Practice and HIPAA regulations with Columbia University. All data 
will be stored on a password protected fire walled, certified secure server at Columbia 
University, Department of Obstetrics and Gynecology. The PI will develop a database in 
Research Electronic Data Capture (REDCap) – a mature, secure web-based application for 
building and managing surveys and databases – that has been IRB-approved for use here at 
CUMC. This database will contain information from our screening documents and data. This 
database will be password-protected using a strong password and encrypted and access to it will 
be restricted to personnel listed on the study’s IRB protocol. Data from REDCap will be 
uploaded to SPSS for data analysis. 
 
Study Procedures 
 
Subjects and recruitment: As stated above, we will recruit all participants from the sites that 
provide medication abortion care at CUIMC – mainly VC 10, but also the practice at 1790 
Broadway, in New York City, NY. We will invite women presenting for medication abortion to 
participate in the study after they have completed all routine care at the visit.  
 
Inclusion criteria will be as follows:  
I. 
English or Spanish speaking women  
II. 
Age 18 and older  
III. 
Seeking medication abortion  
IV. 
With confirmed intrauterine pregnancy with measured gestational age less than or 
equal to 10 weeks and 0 days  
V. 
Willing to receive auriculotherapy  
VI. 
Willing to be randomized  
 
Exclusion criteria will be as follows:  
I. 
Does not meet study criteria  
II. 
Allergy to adhesives  
III. 
Allergy to or unable to receive ibuprofen  
IV. 
Congenital anomaly or infection of the ear  
 
After completing routine patient care, including abortion consent, the clinician will refer 
interested patients to the study research assistant. If a patient states interest in the study and 

meets inclusion criteria, the research assistant will proceed with the informed consent process. 
After informed consent, research assistants will record demographic information and other 
baseline characteristics into a preprogrammed electronic tablet from which all information will 
be transmitted directly into the study REDCap database. The research assistant will collect 
baseline pain and anxiety scores using 100 mm VAS pre-programmed into the tablet. A VAS-P 
(pain) with anchors at 0 mm = no pain and 100 mm = worst pain in my life will be used to 
collect pain scores. A VAS-A (anxiety) with anchors at 0 mm = not at all anxious and 100 mm= 
worst anxiety of my life will be used to collect anxiety scores. The VAS is a validated pain scale 
measure often used to measure the intensity of pain and is also validated to measure anxiety 
(Facco, 2013; Renner, 2010).  
 
Randomization and blinding: The participants will be randomized into one of the three 
interventions: 1 - usual care for pain management (i.e., ibuprofen) plus auricular acupressure 
with Accu-Patch beads, 2 - usual care plus auricular acupuncture with Pyonex™ needles, or 3-
usual care plus similarly-sized adhesive patches. Usual care for pain management consists of a 
prescription for Ibuprfen 600mg #20, to use every 6 hours as needed. Patients do not receive 
narcotic analgesics. Prior to any recruitment, research staff not involved in participant 
recruitment will determine the 1:1:1 allocation in blocks of 6 using a random number table and 
will prepare the sequentially numbered, sealed, opaque envelopes. The auriculotherapy provider 
will open the assignment envelope and enter the room without the research assistant or the 
abortion provider. The auriculotherapy provider will not reveal the treatment assignment to the 
participant, abortion provider, research assistant, or clinical staff. The auriculotherapy provider 
will place the beads/needles/placebo patches bilaterally, out of view of the participant, and will 
inform the participant that she may or may not feel a sensation from the treatment in order to 
maintain subject blinding. The participant will then leave the clinic taking a one-week return 
appointment, a prescription for ibuprofen and the correct dose of misoprostol to use at home (all 
per routine care). Auriculotherapy protocol: For this study, auriculotherapy with be completed 
using the Gold protocol acupoints. The Gold protocol was used in the prior study (Ndubisi, 
2018) and is a modified Battlefield Acupuncture protocol (BFA). The original BFA protocol 
developed by Richard C. Niemtzow, MD, PHD, MPH in 2001 in the course of researching a 
more efficient auricular acupuncture system for the rapid relief of pain. The name “Battlefield 
Acupuncture” was coined by Richard Niemtzow with the assumption that this novel system 
could be used on the military battlefield to deliver significant attenuation of pain in just a few 
minutes. While the exact mechanism of Battlefield acupuncture for pain relief is unknown, it 
likely alters the processing and the modulation of pain in the Central Nervous System involving 
the hypothalamus, thalamus, cingulate gyrus and cerebral cortex structures. BFA includes 5 
auricular acupuncture points placed in the following sequence: cingulate gyrus, thalamus, Omega 
2, Point Zero and Shen Men. Instead of using Omega 2, which is for extremity pain, the Gold 
protocol substitutes a point that corresponds to the cervix on the left ear and a point 
thatcorresponds to the uterus on the right ear (Olesen, Auriculotherapy Manual 1996, page 105). 
The rest of the original BFA points are included in the Gold protocol because they influence pain 
perception. After proper hand washing, the auriculotherapist wil clean each of the 5 sites with 
alcohol, and will place the beads, needles or placebo patches on the designated sites. Follow-up 
procedure: Participants will receive text messages at 8pm for the next four days to assess pain 
and anxiety (during the previous 24 hours). These assessments will use the same VAS 
instruments as at baseline. At the one-week follow-up visit, the participant will complete the 

same VAS-P and VAS-A scales as at baseline and during the week. The research assistant will 
remove the patches at the follow-up visit. Criteria for subject discontinuation: Participants may 
withdraw from the study at any point. 
 
Informed Consent Process: We will recruit participants at CUIMC clinics that provide 
medication abortion VC10 and at 1790 Broadway in New York City, NY. CUIMC serves a 
largely Latin population in the Washington Heights neighborhood of Manhattan that is English 
and Spanish speaking, both privately or publicly insured. Up to 20 patients per week are 
scheduled for medication abortion visits. From the previous acupuncture study in our division, 
we expect to recruit at least 5 participants weekly for a total of 150 patients, and 50 patients per 
treatment arm over 30 weeks (Ndubisi, 2018). 
 
After completing all routine clinical care, the clinician will offer interested patients the 
opportunity to enter the study. The research assistant will determine patients eligibility and 
discuss the study with each woman. If a patient states interest in the study and meets inclusion 
criteria, the research assistant will proceed with the informed consent process; the informed 
consent process will begin with a concise and focused presentation of the key information about 
the study; potential subjects will have an opportunity to discuss the information provided; the 
informed consent process as a whole will present information in sufficient detail; this process 
will culminate with signing the required HIPAA and Columbia University consent forms. The 
consent form (and all study documents) will also have the option to use a paper-based consent 
process and to receive a copy of the consent either on paper or by email. The electronic version 
will contain all of the required elements. The research assistant will read and discuss all elements 
of the informed consent in person with the participant, and will assist in navigating the electronic 
device. The participant will not at any time have to go through the informed consent alone; the 
research assistant will always be present to read, to explain, to assess understanding, and to 
answer the participant's questions. Participants will provide a signature directly on the tablet 
screen, or if preferred on a paper version of the consent form. The date and time of the consent 
will be automatically recorded in Redcap. Redcap will provide secure storage and archiving of 
all consent forms. Note that this study will only recruit registered patients, and at the time of 
registration, per clinic routine, patients must provide proof of identity with a government-issued 
identification. All recruits to this study will be pregnant women who are registered at the clinic 
in order to obtain medication abortion with mifepristone and misoprostol. Recruitment will take 
place AFTER clinical activities are complete and after the patient has signed consent for her 
clinical care. The study consent form specifies that this is a trial of pain relief for women seeking 
abortion. Once a subject signs the consent form, she will proceed to be randomized and receive 
study treatment the same day. 
 
Research Question(s)/Hypothesis(es) 
 
The goal of this study is to test the hypothesis that auriculotherapy (with beads or needles), in 
addition to usual care with ibuprofen will minimize pain during medication abortion.  
 
Primary Objective: To assess whether usual care plus auricular acupressure with beads or 
auricular acupuncture with needles reduces subject-reported maximum pain during medication 
abortion compared to usual care plus placebo. 

Hypothesis: The median subject-reported maximum pain score, measured using a 100 mm VAS, 
among women receiving usual care plus either type of auriculotherapy, will be at least 20 mm 
less than the women receiving usual care plus placebo patches.  
 
Secondary Objective: To assess whether usual care plus either auriculotherapy reduces subject-
reported anxiety scores during medication abortion compared to women receiving usual care plus 
placebo. 
Hypothesis: The median subject-reported maximum anxiety score, measured using a 100mm 
VAS, among women receiving usual care plus either type of auriculotherapy, will be at least 15 
mm less than the women receiving usual care plus placebo patches.  
 
Exploratory Objective: To compare pain scores during medication abortion with usual care plus 
auricular acupuncture with Pyonex needles vs pain scores with usual care plus auricular 
acupressure with beads.  
Null Hypothesis: The median subject-reported maximum pain score, measured using a 100mm 
VAS, among women receiving auricular acupressure will not be different from pain score among 
women receiving auricular acupuncture. 
 
Scientific Abstract 
 
In the U.S., over 100,000 abortions per annum are medication abortions initiated before 10 
weeks gestation with nonsteroidal anti-inflammatory drugs as the only analgesics. Pain control is 
often inadequate with the majority of patients reporting moderate or severe pain. Auricular 
acupuncture and acupressure may be a safe, low-cost, effective alternative to using NSAIDs 
alone or to using opioid analgesics. A prior randomized controlled trial completed in our 
department revealed substantially lower pain and anxiety scores among women assigned to 
auricular acupuncture compared to women assigned to placebo with usual care or usual care 
alone during first-trimester vacuum aspiration. Notwithstanding these promising results, 
acupuncture with needles is highly regulated in most states, and therefore its availability may be 
limited. Acupressure is not regulated to the same extent as acupuncture as it is non-invasive and 
without skin penetration and thus may be a more easily implemented treatment. Therefore, we 
propose a three-arm trial to assess maximum pain and anxiety scores, measured with a 100mm 
VAS, during medication abortion with participants randomized to either (1) auricular 
acupressure with Accu-patch beads plus usual care, (2) auricular acupuncture with Pyonex™ 
needles plus usual care, or (3) placebo patches plus usual care. The goal of this study is to test 
the hypothesis that auriculotherapy plus ibuprofen will be associated with less pain than 
ibuprofen alone during first trimester medication abortion. 
 
Devices 
 
Device name: Seirin Pyonex Singles  
Device description: Single-use 1.2mm acupuncture press needles  
Device Model/Version #: Pyonex singles  
Manufacturer Information: Seirin-America, Inc. 
 
Device name: Accu-patch Pellets (Beads)  

Device description: Single-use gold-plated 1.2mm beads  
Device Model/Version #: LH.ACUP.G.CLR  
Manufacturer Information: Lhasa Oms, Inc. 
 
Data Safety & Monitoring 
 
The study PI and sub-investigators with medical expertise will monitor the study. In addition to 
routine medical expertise, all investigators will have received additional training in 
auriculotherapy from Dr. Melanie Gold, who is board-certified in medical acupuncture and who 
is co-PI of the project. The study coordinator will review and record possible adverse events with 
each participant at the one-week study exit visit, and an investigator will review all of these. 
During the course of the study, the PI will report in an expedited manner all Suspected 
Unexpected Serous Adverse reactions in accordance to FDA, HHS and IRB guidelines  
Adverse events (AE): The investigators (or designated coordinator) will record all adverse events 
regardless of seriousness or relationship to the study intervention occurring from the signature of 
the informed consent to the last visit planned (one week later). The investigator will specify the 
onset date, the severity grade (Mild, Moderate or Severe), actions taken with respect to the study 
intervention, corrective treatment given, additional investigations performed, outcome and will 
give an opinion as to whether there is a reasonable possibility that the adverse event was caused 
by the study intervention. The Investigator will report all serious adverse events to the IRB 
within 24hours of discovery if the investigator determines that an adverse event meets the SAE 
definition. This study is investigating a new indication for using auriculotherapy (with 
medication abortion care), but auriculotherapy is a widely used pain management technique in 
other medical settings, and is considered to be extremely safe. Data and Safety Monitoring: To 
ensure subject safety, the Quality Assurance Monitor for the Department of Obstetrics and 
Gynecology will carry out monitoring for this study. At each scheduled monitoring visit, the QA 
Monitor will randomly select a representative number of study subject charts and will perform a 
data query and review source records. Upon completion, the QA Monitor will submit a report of 
the findings to Dr. Westhoff (Principal Investigator), the research manager, the study 
coordinator, Dr. Ronald Wapner (Vice Chair of Research/Innovation) and Michelle DiVito RN, 
MSN (Senior Director of Research Administration), with corrective actions if necessary. The 
Principal Investigator will also be responsible for monitoring the trial, starting at the point the 
patient begins the study. The medical members of the research team will make the determination 
of relationship of each adverse effect to the study intervention (auriculotherapy). During the 
study, the Principal Investigator or study site personnel will be responsible for querying and 
recording adverse events and serious adverse events. 
 
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