Open-Label Randomized Controlled Trial to Assess Preoperative Acupuncture for Patients Undergoing Total Knee or Hip Arthroplasty
Phase: NA
Conditions: Knee Arthropathy, Hip Arthropathy, Anxiety
Sponsor: Hartford Hospital

 
 
 
 
Open-Label Randomized Controlled Trial to Assess 
Preoperative Acupuncture for Patients Undergoing Total 
Knee or Hip Arthroplasty 
 
OVERVIEW 
Acupuncture has been extensively practiced and studied worldwide, particularly as a 
part of Eastern medicine, but it is a relatively uncommon therapy offered in Western 
medical institutions, such as those in the United States. Considering the commonly cited 
benefits of acupuncture, such as reduced anxiety and pain, hospitals throughout the 
United States have the opportunity to implement acupuncture as a cost-effective and 
safe technique for improving surgical outcomes. 
 
Acupuncture administered in the preoperative period can be particularly effective for 
reducing preoperative anxiety, postoperative pain, postoperative opioid consumption, 
and postoperative nausea and vomiting. Consequently, preoperative acupuncture can 
improve patient satisfaction and decrease hospital costs. However, due to lack of 
implementation and experience, further research is needed to establish the safety and 
efficacy of preoperative acupuncture in the United States medical practices. 
 
At the Bone-and-Joint Institute at Hartford Hospital, where this study is proposed, a 
quality study on total knee or hip arthroplasty patients found that 21% of its monthly 
patients were “high-anxiety” according to the Amsterdam Preoperative Anxiety and 
Information Scale (APAIS). Thus, there is a significant population of patients that would 
benefit from a procedure to reduce preoperative anxiety at our facility. 
 
This proposal is for a prospective, open-label, randomized controlled trial to determine 
the effect of preoperative acupuncture on preoperative anxiety and postoperative pain 
for high-anxiety patients undergoing total hip arthroplasty or total knee arthroplasty. We 
hypothesize that preoperative acupuncture will reduce preoperative anxiety and 
postoperative pain as well as reduce postoperative nausea and vomiting and opioid 
consumption and improve patient satisfaction. The study population is to include adult 
patients undergoing lower extremity total joint arthroplasty, including of the hip and knee 
joints, at the Bone-and-Joint Institute at Hartford Hospital. 
 
 
 
 
 
 
 
 
 
 
 
 
 
IRB APPROVAL DATE:06/02/2023
IRB NUMBER: HHC-2021-0348
HHC-IRB

 
 
 
Table of Contents 
OVERVIEW 
1 
1.0 OBJECTIVES AND SCIENTIFIC AIMS 
3 
2.0 BACKGROUND AND RATIONALE 
3 
3.0 OVERVIEW OF STUDY DESIGN/INTERVENTION 
5 
3.1 Design 
5 
3.2 Randomization 
5 
3.3 Acupuncture Intervention 
5 
3.4 Therapy Materials 
6 
4.0 CRITERIA FOR SUBJECT ELIGIBILITY 
6 
4.1. Subject Inclusion Criteria 
6 
4.2. Subject Exclusion Criteria 
6 
5.0 RECRUITMENT PLAN 
6 
6.0 PRETREATMENT EVALUATION 
7 
7.0 INTERVENTION ORDER OF EVENTS 
8 
7.1 Acupuncture Group 
8 
7.2 Control Group 
8 
8.0 OUTCOME EVALUATION 
8 
9.0 DATA MANAGEMENT 
11 
9.1 Quality Assurance 
11 
9.2 Data and Safety Monitoring 
11 
10.0 PROTECTION OF HUMAN SUBJECTS 
11 
10.1 Privacy 
12 
10.2 Adverse Events 
12 
10.3 Serious Adverse Event (SAE) Reporting 
13 
11.0 STATISTICAL ANALYSES 
15 
12.0 REFERENCES 
17 
 
 
 
 
 
 
 
 
 
 
 
IRB APPROVAL DATE: 06/02/2023
IRB NUMBER: HHC-2021-0348
HHC-IRB

 
 
 
1.0 OBJECTIVES AND SCIENTIFIC AIMS 
Primary Objectives: In patients with high anxiety undergoing THA or TKA: 
1) Determine if preoperative acupuncture reduces preoperative anxiety in the 
acupuncture group. 
2) Examine postoperative pain following acupuncture compared to control. 
 
Secondary Objective: To determine the safety of preoperative acupuncture by 
recording complications throughout hospital length of stay; to determine whether 
preoperative acupuncture reduces postoperative nausea and vomiting, reduces 
postoperative opioid consumption, reduces anxiolytics need during hospitalization 
and improves satisfaction compared to control in high-anxiety patients undergoing 
THA or TKA. 
 
2.0 BACKGROUND AND RATIONALE 
Acupuncture has been a practice of Chinese medicine for over 2,500 years for treating 
diseases, relieving pain, and more recently for improving the outcomes of surgery.[1] In 
the United States, however, acupuncture was relatively unheard of as a medical 
practice until the 1970s, and the nation has since remained hesitant to implement it in 
the hospital.[2] As a result, while the research on acupuncture shows potential benefits 
for both patients and providers, most of these studies have been conducted outside of 
the United States, which likely has contributed to the nation’s cautious stance. 
Practitioners and researchers, therefore, need to demonstrate and determine whether 
the touted benefits of acupuncture can be extended to practices in the United States. 
 
Postoperative pain is commonly studied as a primary outcome of acupuncture 
treatment, and improvements in pain are often cited as a benefit.[3-11] For example, in a 
large study that aimed to evaluate an acupuncture rehabilitation program on 2,282 
patients who underwent total knee arthroplasty (TKA) or total hip arthroplasty (THA), 
patients on average reported a 45% reduction in pain following acupuncture treatment.[3] 
Another study randomized 80 patients who received TKA to receive either postoperative 
acupuncture treatment or standard rehabilitation care, and results showed that patients 
in the acupuncture group experienced significantly reduced postoperative pain, 
increased knee range-of-motion, and faster rehabilitation time.[7] Heightened 
postoperative pain is, understandably, a strong predictor of worsened surgical outcomes 
and patient dissatisfaction, and, according to a systematic review of nearly 30,000 TKA 
patients, the most consistent predictor of postoperative pain is preoperative pain.[12] 
Therefore, perhaps the best method for improving surgical outcomes and patient 
satisfaction is to target both postoperative and preoperative pain. Since few studies 
have explored the analgesic effects of acupuncture in the preoperative period, there is 
an opportunity for future research to determine whether the pain-reducing effects of 
acupuncture can be used in the preoperative period to improve surgical outcomes and 
patient satisfaction. 
 
Intra- and postoperative opioid consumption is another commonly studied outcome of 
acupuncture.[13] In a randomized controlled trial (RCT) of 54 patients receiving THA, 
researchers randomized patients to receive either auricular (of the ear) or sham 
acupuncture treatment and compared the amount of piritramide (a synthetic opioid 
closely related to fentanyl and commonly used in European cHoHCu-nItrRieBs) used 
IRB NUMBER: HHC-2021-0348
IRB APPROVAL DATE: 06/02/2023

 
 
 
 
intraoperatively.[9] The results showed that patients in the acupuncture group required 
significantly less piritramide intraoperatively compared with sham (37 ± 18 mg vs. 54 
± 21 mg). A similarly constructed RCT also studied the effects of preoperative 
auricular acupuncture on intraoperative opioid use, but researchers instead studied 
fentanyl use and included patients undergoing TKA.[14] These researchers, too, found 
that patients in the acupuncture group required significantly less opioid during 
surgery than patients in the sham acupuncture group (620.7 ± 258.2 µg vs. 868.6 ± 
319.3 µg). Further, these patients on average lasted longer before requesting 
analgesia and exhibited lower visual pain scores. Several other studies have also 
demonstrated that preoperative acupuncture lessens the need for opioids during and 
after surgery.[4,10,15,16] Reducing opioid consumption through the introduction of safely 
administered acupuncture poses a potential net improvement for patient safety and 
hospital costs. 
 
Perhaps the most commonly cited benefit of acupuncture is increased relaxation and 
decreased anxiety, and several systematic reviews have reported that these benefits 
persist in the clinic.[1,3,17] For patients with anxiety, depression, or other mental ailments, 
this is an important finding considering the substantial evidence linking poor mental 
health with significantly worse surgical outcomes.[18-27] For example, one systematic 
review that accounted for 53,562 patients undergoing THA concluded that depression 
and anxiety were associated with increased postoperative pain, and another that 
accounted for 95,560 patients undergoing TKA found that the most consistent and 
significant indicator of dissatisfaction related to surgery was preoperative anxiety.[27,28] 
Despite this evidence that poor preoperative mental health is detrimental to both 
practitioners and patients of surgery, there are currently no guidelines for improving 
preoperative mental health conditions.[25] 
 
Preoperative acupuncture can serve as an ideal therapy to safely reduce preoperative 
anxiety and improve surgical outcomes. It has been repeatedly demonstrated as a safe, 
cost-effective, and time-effective procedure for reducing preoperative anxiety, 
postoperative pain, total opioid consumption, and postoperative nausea and vomiting 
while increasing patient satisfaction.[4,13,29] However, medical practices in the United 
States have largely forgone the potential upsides of acupuncture due to minimal existing 
research undertaken within the country. Therefore, there is an opportunity for United 
States medical researchers and practitioners to demonstrate the potential for 
preoperative acupuncture as a safe and effective therapy to improve surgical outcomes 
for both patients and providers. 
 
This proposal suggests a robust study to evaluate the safety and efficacy of 
preoperative acupuncture performed on high-anxiety patients undergoing THA or TKA 
at the Bone-and-Joint Institute (BJI) at Hartford Hospital. Evidence suggests that the 
outcomes of THA and TKA in particular are associated with preoperative anxiety and 
postoperative pain.[30] Patients will be classified as high-anxiety based on having an 
APAIS-A-T (Appendix I) score greater than 10, a threshold used in previous studies.[31- 
34] 
IRB APPROVAL DATE: 06/02/2023
IRB NUMBER: HHC-2021-0348
HHC-IRB

 
 
 
 
3.0 OVERVIEW OF STUDY DESIGN/INTERVENTION 
 
3.1 Design 
This is a prospective, open-label, randomized controlled trial to determine the efficacy 
and safety of preoperative acupuncture on high-anxiety patients undergoing TKA or 
THA. Patients scheduled for THA or TKA to be performed by one of the IRB approved 
orthopedic surgeons at the BJI will be screened for high preoperative anxiety one week 
prior to procedure in the PREPARE Center, the BJI’s preoperative services clinic, using 
printed copies of the APAIS questionnaire. The APAIS will be used as a screening tool 
and is considered optional for the patient to complete and not a standard of care 
measure. High-anxiety patients consenting to the study will be randomized to receive 
either 1) preoperative acupuncture (Acupuncture) or 2) no intervention (Control). 
Results from a quality study at the PREPARE clinic demonstrates that number of 
patients with high-anxiety entering the clinic is 30 per month. Accounting for the 
availability of investigators and surgeons, the study period is estimated to last 
approximately two years to obtain the 50 patients, 25 per group that we aim to enroll in 
this study. There will be an interim analysis after enrolling 14-15 patients in each group 
(60%) to re-estimate the sample size using more appropriate data (see sample size 
estimate section). Each patient will be enrolled in the study from the time of consent and 
will be followed up to 30 days postoperatively. Investigators performing the acupuncture 
will be licensed and certified throughout the study duration. 
 
3.2 Randomization 
Patients will be randomized immediately following the consenting process. 
Randomization will be achieved using a random number generator, which will randomly 
produce a 0, representing the Acupuncture group, or a 1, representing the Control 
group, for each patient. Patients will immediately be informed, for their convenience, of 
their group assignment given the non-blinded nature of the trial. 
 
3.3 Acupuncture Intervention 
Prior to acupuncture treatment, all patients in the acupuncture group will receive a 
medical assessment including a review of the patient’s medical chart. The acupuncture 
intervention will include a combination of auricular and body acupuncture. The auricular 
points used will include: Shen men, Zero point, Tranquilizer point and Master cerebral. 
The body point will be the wrist acupuncture point PC6. All points will be bilateral. With 
the patient seated, body and auricular points will be wiped with 70% isopropyl alcohol 
wipes. After about 1 minute of drying, the acupuncture needles will be inserted. The 
needles used on both ear and wrist points will be the DBC Detox-5 needles. They will 
be retained for approximately 20 minutes, removed and placed into a sharps container. 
IRB APPROVAL DATE: 06/02/2023
IRB NUMBER: HHC-2021-0348
HHC-IRB

 
 
 
 
3.4 Therapy Materials 
• Alcohol wipes 
o Disposable, individually sealed alcohol prep pads 
o Each pad is saturated with 70% isopropyl alcohol 
o 1” x 2.5” 
• Acupuncture needles 
o 1) SEIRIN J-Type Acupuncture Needles (SKU: 
SJ.18X30; Figure 1) 
▪ Length: 30 mm 
▪ Diameter: 0.18 mm 
o 2) SEIRIN J-Type Acupuncture Needles (SKU: 
SJ.20X30) 
▪ Length: 30 mm 
▪ Diameter: 0.20 mm 
o 3) DBC™ Detox-5 Acupuncture Needles(SKU: 
DTX.20X13; Figure 2) 
▪ Length: 13 mm 
▪ Diameter: 0.20 mm 
 
4.0 CRITERIA FOR SUBJECT ELIGIBILITY 
 
4.1. Subject Inclusion Criteria 
 
 
 
Figure 1. Seirin 
needles (SEIRIN® 
(SKU: SJ.18X30) 
 
 
Figure 2. DBC™ Detox-5 
Acupuncture Needles 
(SKU: DTX.20X13). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IRB APPROVAL DATE: 06/02/2023 
IRB NUMBER: HHC-2021-0348
HHC-IRB
through Force Therapeutic platform 30 days prior to their scheduled surgery date. A
questionnaire form with the other preoperative forms that they are typically receiving
Potential patients who are scheduled for either TKA or THA will receive the APAIS
5.0 RECRUITMENT PLAN
●
Revision TKA or THA
●
Non-English speaking
acupuncture is not recommended with pregnancy
●
Women in reproductive age or under the age of 52 years old, as
on current anticoagulant use which increases bleeding risk.
●
Patients with active ongoing coagulopathy based on lab data (INR >1.5) and/or
<70,000, if available)
●
Abnormal laboratory blood work values (INR>1.5, if available; plateletcount
●
Known allergy to metals
●
Infection at any of the acupuncture points
●
Uncontrolled diabetes (HbA1c ≥8.0%)
●
Unable to give consent
4.2. Subject Exclusion Criteria
●
Age: 52 to 85
●
High-anxiety (APAIS-A-T >10)
Joint Institute at Hartford Hospital
●
Female or male patients undergoing TKA or THA surgery at the Bone-and-

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IRB APPROVAL DATE: 06/02/2023
IRB NUMBER: HHC-2021-0348
HHC-IRB
●
Known allergy to metal
●
History of TKA or THA surgery
●
History of mental illness
●
Present infection at the sites of acupuncture
●
Uncontrolled diabetes mellitus
●
History of acupuncture treatment
●
History of coagulopathy
●
History of bleeding disorders
●
BMI
●
Race and ethnicity
●
Gender
●
Age
Clinical Demographic Variables of Interest
results will be gathered if they occurred within 60 days prior to surgery.
listed below. Laboratory tests, shown below, are also recommended, and corresponding
of the Bone-and-Joint Institute will be used to collect the clinical demographic variables
Baseline preoperative history and physical exam evaluations from the PREPARE clinic
6.0 PRETREATMENT EVALUATION
secured, password-protected HHC server.
their corresponding medical record numbers (MRNs), and this file will be stored on a
assigned study group. A linkage file will be created connecting the patient study IDs to
REDCap database and given a unique study ID number along with their randomly
scanned and uploaded to EPIC. Enrolled patients will be registered into a study-specific
surgery. Documentation of the consenting process and the printed consent form will be
stored in a patient binder, and the other will be given to the patient on the day of
For enrolled patients, two signed consent forms will be printed, of which one will be
(REDCap) database.
be sent via email using an HHC-licensed Research Electronic Database Capture
Healthcare (HHC) consenting guidelines, and the link to the electronic consent form will
consent will be conducted via video call or by telephone, following the Hartford
If the consenting process cannot be conducted in-person, the same discussion of
enrolled in the study.
therefore, be randomized to one of two study groups. Patients providing consent will be
Specifically, patients will be made aware that this is a randomized trial and that they will,
and enrollment process and will be given necessary time for questions and concerns.
the consenting process, patients will be informed of the study details, benefits, risks,
potential subjects for consenting after they complete their visit with the provider. During
separate room for consenting. A member of the study personnel will meet with the
anxiety patients a day prior to their PREPARE visit to plan to keep those patients in a
(EMR) system (EPIC). The study personnel will notify PREPARE providers of high-
potential subjects for the other eligibility criteria using our electronic medical record
member of the study personnel will receive the completed APAIS and will screen

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
IRB APPROVAL DATE: 06/02/2023
IRB NUMBER: HHC-2021-0348
after 3 hours. Postoperative antiemetics used wHHillCa-IlsRoBbe collected from
hour from their arrival to the post-anesthesia recovery unit (PACU), and
The patient will be reevaluated for PONV/Impact score two times; after an
6.
hours.
the post-anesthesia recovery unit (PACU), after an hour, and after three
The patient will be reevaluated for pain three times; when they arrive to
5.
The patient will undergo their surgical procedure.
4.
and pain.
A member of the study personnel will assess the patient’s baselineanxiety
3.
the preoperative area.
The patient will be placed in bay #1 or other bay if #1 is not availablein
2.
in the preoperative area.
On the day of surgery and prior to procedure, study patients will be waiting
1.
7.2 Control Group
discharge from the hospital.
Patient satisfaction regarding surgery will be evaluated within a weekafter the
12.
total hospital length of stay.
patient’s chart retrospectively, following enrollment and used to determine
Admission and discharge dates & times will be collected directly from the
11.
following enrollment.
hospitalization will be collected from the patient’s chart retrospectively,
Postoperative opioid consumption and anxiolytics used throughout
10.
the patient’s chart retrospectively, following enrollment.
after 3 hours. Postoperative antiemetics used will also be collected from
hour from their arrival to the post-anesthesia recovery unit (PACU), and
The patient will be reevaluated for PONV/Impact score two times; after an
9.
hours.
the post-anesthesia recovery unit (PACU), after an hour, and after 3
The patient will be reevaluated for pain three times; when they arrive to
8.
The patient will undergo their surgical procedure.
7.
after the procedure.
Anxiety and pain will be reassessed by a member of the study personnel
6.
assigned acupuncturist.
The patient will then undergo the acupuncture procedure given by the
5.
assessment and chart review on the patient prior tointervention.
The assigned acupuncturist will conduct a preoperative medical
4.
and pain.
A member of the study personnel will assess the patient’s baselineanxiety
3.
the preoperative area.
The patient will be placed in bay #1 or other bay if #1 is not availablein
2.
in the preoperative area.
On the day of surgery and prior to procedure, study patients will be waiting
1.
7.1 Acupuncture Group
7.0 INTERVENTION ORDER OF EVENTS
●
Platelet count (if available)
●
INR (if available)

 
 
 
the patient’s chart retrospectively, following enrollment. 
7. Postoperative opioid consumption and anxiolytics used throughout 
hospitalization will be collected from the patient’s chart retrospectively, 
following enrollment. 
8. Admission and discharge dates & times will be collected directly from the 
patient’s chart retrospectively, following enrollment and used to determine 
total hospital length of stay. 
9. Patient satisfaction regarding surgery will be evaluated within a week after 
the discharge from the hospital. 
 
8.0 OUTCOME EVALUATION 
All outcomes will be measured during the time periods illustrated in Table 1 using the 
following measurement methods: 
 
• PreOP anxiety: Amsterdam Preoperative Anxiety and Information Scale (APAIS; 
Appendix I) 
• State anxiety: Visual Analogue Score (VAS; Appendix VI) will be compared between 
pre and post acupuncture in the same patient within the acupuncture group. 
• State anxiety: Visual Analogue Score (VAS; Appendix VI) preop anxiety assessment 
will be compared between the two groups to assess their baseline preop anxiety 
status on day of surgery. 
• Pain: 11-point Numeric Pain Rating Scale (NPS; Appendix V) will be compared 
between the two groups 
• Postoperative opioid consumption: collected through EPIC and 
converted into morphine milligram equivalents (MMEs) using 
Appendix IV. This will be compared between the two 
groups.Postoperative nausea and vomiting (PONV): PONV impact 
score (Appendix VII) will be compared between the two groups. 
Additionally, postoperative antiemetics needed during hospital 
admission will be collected directly from EPIC and compared between 
the two groups. 
• Satisfaction with surgery: questionnaire (Appendix III) provided by a member of 
the study personnel by phone within a week after the discharge from the hospital. 
• Adverse events related to the interventions will be recordedthroughout 
enrollment. 
• Anxiolytics medication needed throughout hospitalization will be 
collected directly from EPIC and compared between the two groups. 
• Hospital length of stay will be collected directly from EPIC using 
hospital admission and discharge dates & times; this will be compared 
between the two groups. 
Table 1. Outcome measurement time, researcher-to-patient interface, and method for 
all study outcomes. 
 
Time 
Interface 
Outcome/ Measurement 
(Acupuncture) 
Outcome/ Measurement 
(Control) 
-10 to -7 days 
PREPARE 
Center 
• Preoperative 
anxiety/APAIS 
 
HHC-IRB 
• Preoperative 
anxiety/APAIS 
IRB NUMBER: HHC-2021-0348
IRB APPROVAL DATE: 06/02/2023

 
 
 
 
PreAQ/PreOP 
Holding bay 
• Anxiety/VAS 
• Pain/NPS 
• Anxiolytics 
PostAQ/PreOP 
Holding bay 
• Anxiety/VAS 
• Pain/NPS 
• Anxiety/VAS 
• Pain/VAS 
• Anxiolytics 
NA 
 
PostOP 
PACU: on 
arrival, 1 hour, 
and 3 hours 
• Pain/NPS 
• Anxiolytics 
• Pain/NPS 
• Anxiolytics 
PostOP 
PACU: 1 
hour, and 3 
hours after 
arrival 
• PONV/impact score 
• PONV/impact score 
PO- 
Discharge 
 
 
 
Within a week from 
discharge 
chart review 
• Opioid use/MME 
• Anxiolytics 
• Antiemetics 
• Hospital 
length of stay 
Phone call 
• Satisfaction 
questionnaires 
• Opioid use/MME 
• Anxiolytics 
• Antiemetics 
• Hospital 
length of stay 
• Satisfaction 
questionnaires 
Abbreviations: NPS, numeric pain rating scale; PACU, post-anesthesia care unit; 
PONV, postoperative nausea and vomiting; POD, postoperative day. 
 
Figure 3. Protocol schema. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IRB APPROVAL DATE: 06/02/2023
IRB NUMBER: HHC-2021-0348
HHC-IRB

 
 
 
 
 
 
 
 
 
9.0 DATA MANAGEMENT 
A Clinical Research Coordinator (CRC) will be assigned to the study. The 
responsibilities of the CRC will include project compliance, data collection, abstraction 
and entry, data reporting, regulatory monitoring, problem resolution and prioritization, 
and coordination of the activities of the protocol study team. 
 
The data collected for this study will be entered into a database in an HHC-licensed 
version of REDCap. Source documentation will be available to support the 
computerized patient record and will be stored at the clinical anesthesia research office 
in a double-locked environment. All efforts will be made to ensure maintenance of 
patient confidentiality and HIPAA compliance. All data will be maintained on the 
REDCap database which will be stored on a secure HHC server and access will be 
protected by password. This database will only be accessible to the trained study 
personnel. 
 
IRB NUMBER: HHC-2021-0348
HHC-IRB
IRB APPROVAL DATE: 06/02/2023

 
 
 
 
9.1 Quality Assurance 
Monthly meetings will be conducted to monitor patient accruals and quality of data. 
Potential problems will be brought to the attention of the entire study team during the 
monthly meeting for discussion, action, and resolution. 
 
At approximately 55-60% enrollment (14-15 per group depending on enrollment pace) 
point of the study, the research team will assess the accrued results in a planned 
interim analysis to determine whether any changes are necessary. 
 
9.2 Data and Safety Monitoring 
The study investigators will be responsible for the safety of the study participants, and 
they will stress the importance of reporting adverse events to the participants. 
Investigators will also consistently monitor each participant for adverse events. Adverse 
events, related or unrelated to the acupuncture procedure, will be reported, attributed, 
and graded for severity by the clinician and documented in EPIC. Serious adverse 
events or unanticipated problems will be reported to the IRB. 
 
10.0 PROTECTION OF HUMAN SUBJECTS 
Every effort will be made to ensure the safety of our patients and the confidentiality of 
their medical information. During the enrollment and consent process, all risks, benefits, 
side effects, and alternatives will be discussed. Also, it will be stressed that this is a 
voluntary study and that the patient can withdraw without prejudice at any time. 
 
Benefits 
The potential benefit of this study is that preoperative acupuncture is effective in 
reducing preoperative anxiety and postoperative pain in patients undergoing lower 
extremity total joint arthroplasty. Such a reduction in postoperative pain and anxiety 
could potentially increase overall patient satisfaction. Further, patients will not be 
compensated for participating in this study, but they will receive the acupuncture service 
at no cost. 
Risks 
The risks of participation include the risks associated with performing acupuncture 
include, but are not limited to, the following: minor bleeding, pain, pneumothorax, 
abdominal injuries, heart injuries, CNS injuries, neck injuries, eye injuries, peripheral 
nerve injuries, and infection. 
 
Alternatives 
The alternative to acupuncture for addressing high-anxiety patients is the standard of 
care. For pain, this includes the use of standard pain medications, including opioid and 
non-opioid analgesics, in addition to regional blocks. For anxiety, this includes the 
regular use of anxiolytic medications and psychological consultation referrals. These 
standard-of-care procedures will not be replaced by acupuncture and rather performed 
in adjunct. A patient’s decision on whether or not to participate in this study will not 
affect the availability of standard and supportive measures. 
 
Costs 
There will be no additional cost incurred by the participant toHpHaC-rtIicRiBpate in the study. 
IRB NUMBER: HHC-2021-0348
IRB APPROVAL DATE: 06/02/2023

 
 
 
 
Acupuncture materials and service will be provided at no additional cost to the patients 
enrolled in the study and will be provided by one of the study investigators. 
Voluntary Nature of Study 
Participation in this study is entirely voluntary. Patients will be informed of the extent of 
the risks, benefits, adverse events, alternatives/options for treatment, financial 
costs/burdens, and the voluntary nature of the study. The responsible investigator will 
ensure that this study is conducted in agreement with the Declaration of Helsinki 
(Tokyo, Venice, Hong Kong, Somerset West, and Edinburgh amendments). The study 
will seek in every way to protect the rights of human subjects. No patient will be required 
to participate in the study, and participation or lack of participation will not affect the 
patient’s subsequent care or treatment. 
 
Participation will be entirely voluntary and subjects will not be reimbursed for 
participation in the study. Throughout the study, patient confidentiality will be 
maintained. No results of the study will be presented or discussed in a fashion that will 
allow identification of a particular patient in the study. All adverse events will be fully 
disclosed to the IRB in a timely fashion as required. 
 
10.1 Privacy 
HHC’s Privacy Office may allow the use and disclosure of protected health information 
pursuant to a completed and signed Research Authorization form. The use and 
disclosure of protected health information will be limited to the individuals described in 
the Research Authorization form. A Research Authorization form must be completed by 
the Principal Investigator and approved by the IRB and HRPP (IRB/HRPP). 
 
10.2 Adverse Events 
The incidence and severity of adverse events is highly dependent on the experience 
and skill of the practitioner, and when provided by a physician, acupuncture is accepted 
as a safe treatment.[29,36,37] Acupuncture-related adverse events occur in about 6% of 
cases; the vast majority of these are usually minor and most commonly include 
bleeding, discomfort, and residual pain at the insertion points.[36] Serious acupuncture- 
related adverse events occur in just 0.024% of cases.[37] Of these, the most frequently 
cited include: pneumothorax, abdominal injuries, heart injuries, CNS injuries, neck 
injuries, eye injuries, peripheral nerve injuries, and infection.[37] Though acupuncture- 
related deaths have been reported, the incidence is statistically negligible, and even 
surveys covering more than 3 million acupuncture treatments report no cases of 
death.[38] 
 
Adverse events will be monitored during and after acupuncture and throughout 
admission. Events will be recorded as safety measures. Emergency visits and hospital 
readmissions stated in EPIC will be recorded up to thirty days postoperatively. 
 
10.3 Serious Adverse Event (SAE) Reporting 
The risks associated with acupuncture are viewed as minimal risk. Although we have 
assessed the proposed study as one of minimal risk, the potential exists for anticipated 
and/or unanticipated adverse events, serious or otherwise, to occur since it is not 
possible to predict with certainty the absolute risk of this procedure in this context. 
Therefore, we provide a plan for monitoring the safety of theHpHaCr-tIicRipBants in the study as 
IRB NUMBER: HHC-2021-0348
IRB APPROVAL DATE: 06/02/2023

 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IRB APPROVAL DATE: 06/02/2023
IRB NUMBER: HHC-2021-0348
information: subject’s initials, medical record number, protocHoHl Cn-uImRBber, and title. The
patient's study chart for auditing purposes. The report should contain the following
SAE electronically using iRIS. A copy of the SAE report should be retained in the
sent to the IRB within 5 calendar days of the event. The IRB requires submitting the
If an SAE requires submission to the IRB office per IRB SOP, the SAE report must be
required for 30 days after the participant’s last investigational treatment or intervention.
SAE reporting is required as soon as the participant signs consent. SAE reporting is
protocol data collection sheets.
and residual pain at the insertion points. These will be tracked separately through the
will be considered expected on study and not reportable as SAEs: bleeding, discomfort,
an SAE. Additionally, grade 1-3 events from the following list of protocol complications
Note: hospital admission for a planned procedure/disease treatment is not considered
surgical intervention to prevent one of the outcomes listed in thisdefinition
judgment, they may jeopardize the patient or subject and may require medical or
or require hospitalization may be considered serious when, based upon medical
●
Important Medical Events (IME) that may not result in death, be life threatening,
●
A congenital anomaly/birth defect
conduct normal life functions
●
A persistent or significant incapacity or substantial disruption of the ability to
existing hospitalization
●
An adverse event that results in inpatient hospitalization or prolongationof
●
A life-threatening adverse event
●
Death
An adverse event is considered serious if it results in ANY of the following outcomes:
Severe adverse event
3.
Moderate adverse event
2.
Mild adverse event
1.
the study:
The following scale will be used in grading the severity of adverse events noted during
Grading Adverse Events
procedures(s)/agent(s)
●
Unrelated: Adverse event is clearly not related toinvestigational
procedures(s)/agent(s)
●
Unlikely: Adverse event is likely not to be related to theinvestigational
●
Possible: Adverse event may be related to investigationalprocedures(s)/agent(s)
●
Probable: Adverse event is likely related to investigational procedures(s)/agent(s)
●
Definite: Adverse event is clearly related to investigationalprocedures(s)/agent(s)
following categories:
attributed to the study procedures / design by the principal investigator according to the
Adverse events will be monitored for each subject participating in the study and
Attribution of Adverse Events
follows:

 
 
 
 
PI’s signature and the date it was signed are required on the completed report. 
Data to be entered for SAEs: 
• The date the adverse event occurred 
• The adverse event 
• The grade of the event 
• Relationship of the adverse event to the treatment (drug, device, or 
intervention) 
• If the AE was expected 
• The severity of the AE 
• The intervention 
• Detailed text that includes the following 
• An explanation of how the AE was handled 
• A description of the subject’s condition 
• Indication if the subject remains on the study 
• If an amendment will need to be made to the protocol and/or consent form 
• If the SAE is an Unanticipated Problem 
Reporting Adverse Events to Investigators 
For the current study, all investigators listed on the protocol will be notified, and the 
principal investigator will conduct a review of all adverse events upon completion of 
every study subject. The principal investigator will evaluate the frequency and 
severity of the adverse events and determine if modifications to the protocol or 
consent form are required. 
 
11.0 STATISTICAL ANALYSES 
Sample Size 
There was only one study[14] that provided appropriate data for a power analysis for the 
primary outcome, pain, and one study that provided appropriate data for the primary 
outcome, anxiety[39]. The sample size requirements based on the results from each of 
the studies are displayed in the following tables. Since our time points differ from these 
two studies, we have chosen to perform an interim analysis after approximately 55-60% 
(14-15 per group depending on enrollment pace) of patients have been enrolled in order 
to re-estimate the required sample size. Our current sample size enrollment (50 
patients) is simply based on what the study team considers the maximum number of 
patients that can be feasibly enrolled within the anticipated study enrollment time-frame. 
As shown, this number of patients (50) are more than double that of the estimated 
sample size needed (22) at 90% power, while accounting for 10% attrition. 
 
Primary Outcomes: Pain 
Study: Chen et al. 2015 
Measurement 
Total N 
Total N 
Total N 
Total N needed 
Method: VAS 
Needed needed 
Needed 
accounting for 
(made relative to 
0-10 scale) 
@ 0.80 
power 
accounting for 
10% attrition 
@ 0.90 
power 
10% attrition 
 
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Post- 
Op 
Time 
Group difference 
(mean±SD) 
2 hr 
1.4±0.9 
16 
18 
20 
22 
4 hr 
1.2±0.4 
8 
10 
8 
10 
8 hr 
0.8±0.1 
4 
6 
4 
6 
12 hr 
1.0±0.2 
6 
8 
6 
8 
24 hr 
0.8±0.1 
4 
6 
4 
6 
 
Primary Outcomes: Anxiety 
Study: Karst et al. 2006 (treatment vs no treatment) 
Measurement 
Method (time 
change) 
Group Mean 
difference of 
change 
score 
N Needed 
@ 0.80 
power 
N needed 
accounting 
for 10% 
attrition 
N Needed 
@ 0.90 
power 
N needed 
accounting 
for 10% 
attrition 
STAI (Baseline 
post-treatment) 
2.83±0.72 
6 
8 
6 
8 
VAS (Baseline to 
post-treatment) 
1.44±0.34 
6 
8 
6 
8 
 
 
An interim analysis was performed using data for the primary outcomes, pain and 
anxiety. Of note, this interim analysis was performed to re-estimate the sample size 
since the initial sample size estimate was based on a study with different time points 
than this study. Therefore, the sole purpose of this interim analysis was to re-estimate 
the sample size, and was not to test the hypothesis. 
 
 
For the primary aim pain, based on data from the first 31 patients enrolled, our sample size 
calculation indicates that a minimum of 26 subjects per group are needed using a repeated 
measures design (each subject is measured 4 times) with 2 groups for a total of 52 
subjects. This design achieves 81% power to test factor B1 if a Geisser-Greenhouse 
Corrected F Test is used with a 5% significance level and the actual effect standard 
deviation is 0.255 (an effect size of 0.40319). We estimate an attrition rate of 10%, which 
will require 58 subjects; however we will aim to enroll 60 subjects (30 per group). 
For the second primary aim anxiety, we performed two sample size calculations. One 
based on the data of all 17 patients in the acupuncture group, and another excluding the 3 
patients for which protocol deviations were reported due to methods collecting the anxiety 
measure. With all 17 patients, the difference in the response of anxiety from pre to post 
acupuncture was normally distributed with a standard deviation 26.27. If the true difference 
in the mean response of matched pairs is 35.64, we will need to study 6 pairs of subjects to 
be able to reject the null hypothesis that this response difference is zero with probability 
(power) 0.8. The Type I error probability associated with this test of this null hypothesis is 
0.05. With the 3 patients removed, the difference in the response of anxiety from pre to 
post acupuncture was normally distributed with standard deviation 26.588. If the true 
difference in the mean response of matched pairs is 39.14, we will need to study 6 pairs of 
subjects to be able to reject the null hypothesis that this response difference is zero with 
probability (power) 0.8. The Type I error probability associated with this test of this null 
hypothesis is 0.05. 
 
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Pain is the more appropriate primary outcome of the two primary outcomes to base 
the sample size on because there are 4 time points of data for each group for this 
variable. The other primary outcome, anxiety does not have a post measure for the 
control group (per the study design), and therefore a within-group pre to post change 
in the acupuncture group is being performed to examine this outcome. We 
acknowledge that this within group design is weaker than the design to assess the 
pain outcome measure. 
 
 
Statistical Methods 
Patient demographic and clinical (including operative) characteristics will be compared 
between groups using an independent samples t-test if continuous data are normally 
distributed), or Mann Whitney U if continuous data are not normally distributed. A chi- 
square or Fisher’s exact test (if cell counts are <5) will be used to compare these 
characteristics between groups for categorical variables. All continuous variables will be 
expressed as mean±SD or median, IQR as appropriate. Categorical variables will be 
expressed as frequency (%). 
 
The primary and secondary study outcomes will be compared between groups two 
ways. First, an independent samples t-test or Mann Whitney U test if deemed more 
appropriate for the scale data (which may be considered ordinal) will be used to 
compare outcomes at each time point between the two groups. Second, a mixed model 
for repeated measures will be used to compare the study outcomes that are repeated 
over time (e.g., Pain). This model was chosen instead of a repeated measures ANOVA 
due to the ordinal nature of the repeated outcome measures in addition to this test 
being more appropriate for non-normal residuals, missing data, as well as the ability to 
treat the time points as discrete categories or as true numbers, which accounts for any 
variability in when the measures are administered to patients. 
We anticipate that the timing of the measures being administered may fluctuate slightly 
due to measures being taken PostOP. 
 
All analyses will be conducted using SPSS version 26.0. P (2-sided) < .05 will be 
deemed the level of statistical significance. 
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IRB APPROVAL DATE: 06/02/2023
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https://www.hindawi.com/journals/ecam/2014/850367/
Alternative Medicine. 2014; Article ID 850367.
Perioperative Anxiety: A Meta-Analysis. Evidence-Based Complementary and
e Hyojeong, Bae Hyunsu, Min B, Cho S. Efficacy of Acupuncture in Reducing
13.Ba
2015;114(4):551-561. doi:10.1093/bja/aeu441
knee arthroplasty: a systematic review and meta-analysis. Br J Anaesth.
wis GN, Rice DA, McNair PJ, Kluger M. Predictors of persistent pain aftertotal
12.Le
doi:10.13703/j.0255-2930.2018.03.006
randomized controlled trial. Zhongguo Zhen Jiu. 2018;38(3):251-255.
postoperative analgesia after total knee arthroplasty and functional rehabilitation: a
ang Y, Zhang L, Lu M. Acupuncture combined with femoral nerve block for
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1343-1348. https://doi.org/10.1111/j.1365-2044.2008.05632.x
control: a systematic review of randomised clinical trials. Anaesthesia. 2008; 63:
ichenko TI, Lehmann C, Ernst E. Auricular acupuncture for postoperative pain
10.Us
study. Pain. 2005;114(3):320-327. doi:10.1016/j.pain.2004.08.021
acupuncture for pain relief after total hip arthroplasty - a randomized controlled
Usichenko TI, Dinse M, Hermsen M, Witstruck T, Pavlovic D, Lehmann C. Auricular
9.
728. doi:10.1177/0269215507077362
total knee arthroplasty--a randomized controlled trial. Clin Rehabil.2007;21(8):719-
and sham acupuncture in addition to physiotherapy in patients undergoingbilateral
Tsang RC, Tsang PL, Ko CY, Kong BC, Lee WY, Yip HT. Effects of acupuncture
8.
Tradit Chin Med. 2012;32(4):545-548.doi:10.1016/s0254-6272(13)60068-0
acupuncture during post-acute phase of rehabilitation after total knee arthroplasty.J
Mikashima Y, Takagi T, Tomatsu T, Horikoshi M, Ikari K, Momohara S. Efficacy of
7.
Orthop Sports Phys Ther. 2014;44(4):252-260. doi:10.2519/jospt.2014.5108
[published correction appears in J Orthop Sports Phys Ther. 2015 Apr;45(4):329]. J
needling in patients with acute mechanical neck pain: a randomized clinical trial
pain sensitivity, and cervical range of motion after the application of trigger point dry
Fernández-de-Las-Peñas C. Short-term changes in neck pain, widespreadpressure
Mejuto-Vázquez MJ, Salom-Moreno J, Ortega-Santiago R, Truyols-Domínguez S,
6.
Otolaryngol Head Neck Surg. 1999;125(5):567-572.doi:10.1001/archotol.125.5.567
acupuncture for pain control after oral surgery: a placebo-controlled trial. Arch
Lao L, Bergman S, Hamilton GR, Langenberg P, Berman B. Evaluation of
5.
2001;95(2):349-356. doi:10.1097/00000542-200108000-00015
pain, nausea and vomiting, analgesic requirement, and sympathoadrenal responses. Anesthesiology.
Kotani N, Hashimoto H, Sato Y, et al. Preoperative intradermal acupuncture reduces postoperative
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1203. doi:10.1111/pme.12685
relief for patients in a total joint replacement program. Pain Med. 2015;16(6):1195-
Crespin DJ, Griffin KH, Johnson JR, et al. Acupuncture provides short-term pain
3.
doi:10.1089/acu.2012.0921
on U.S. Medicine and Society. Med Acupunct. 2013;25(5):311-316.
Lu DP, Lu GP. An Historical Review and Perspective on the Impact of Acupuncture
2.
200505000-00024
techniques. Anesthesiology. 2005;102(5):1031-1078.doi:10.1097/00000542-
Chernyak GV, Sessler DI. Perioperative acupuncture and related
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15. Usichenko TI, Dinse M, Lysenyuk VP, Wendt M, Pavlovic D, Lehmann C. Auricular 
acupuncture reduces intraoperative fentanyl requirement during hip arthroplasty--a 
randomized double-blinded study. Acupunct Electrother Res.2006;31(3-4):213-221. 
doi:10.3727/03601290682444265 
16. Wetzel B, Pavlovic D, Kuse R, et al. The effect of auricular acupuncture on fentanyl 
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2011;27(3):262-267. doi:10.1097/AJP.0b013e3181fd516c 
17. Li M, Xing X, Yao L, et al. Acupuncture for treatment of anxiety, an overview of 
systematic reviews. Complement Ther Med. 2019;43:247-252. 
doi:10.1016/j.ctim.2019.02.013 
18. Ali A, Lindstrand A, Sundberg M, Flivik G. Preoperative Anxiety and Depression 
Correlate With Dissatisfaction After Total Knee Arthroplasty: A Prospective 
Longitudinal Cohort Study of 186 Patients, With 4-Year Follow-Up. J Arthroplasty. 
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19. Ayers DC, Franklin PD, Ploutz-Snyder R, Boisvert CB. Total knee replacement 
outcome and coexisting physical and emotional illness. Clin Orthop Relat Res. 
2005;440:157-161. doi:10.1097/01.blo.0000185447.43622.93 
20. Bachmeier CJ, March LM, Cross MJ, et al. A comparison of outcomes in 
osteoarthritis patients undergoing total hip and knee replacement surgery. 
Osteoarthritis Cartilage. 2001;9(2):137-146.doi:10.1053/joca.2000.0369 
21. Blackburn J, Qureshi A, Amirfeyz R, Bannister G. Does preoperative anxiety and 
depression predict satisfaction after total knee replacement?. Knee. 2012;19(5):522- 
524. doi:10.1016/j.knee.2011.07.008 
22. Brander V, Gondek S, Martin E, Stulberg SD. Pain and depression influence outcome 5 years after 
knee replacement surgery. Clin Orthop Relat Res. 2007;464:21-26. 
doi:10.1097/BLO.0b013e318126c032 
23. Riddle DL, Wade JB, Jiranek WA, Kong X. Preoperative pain catastrophizing 
predicts pain outcome after knee arthroplasty. Clin Orthop Relat Res. 
2010;468(3):798-806. doi:10.1007/s11999-009-0963-y 
24. Rolfson O, Dahlberg LE, Nilsson JA, Malchau H, Garellick G. Variables determining 
outcome in total hip replacement surgery. J Bone Joint Surg Br. 2009;91(2):157-161. 
doi:10.1302/0301-620X.91B2.20765 
25. Stamenkovic DM, Rancic NK, Latas MB, et al. Preoperative anxiety and implications 
on postoperative recovery: what can we do to change our history. Minerva 
Anestesiol. 2018;84(11):1307-1317. doi:10.23736/S0375-9393.18.12520-X 
26. Xu J, Twiggs J, Parker D, Negus J. The Association Between Anxiety, Depression, and Locus of 
Control With Patient Outcomes Following Total Knee Arthroplasty. J Arthroplasty. 2020;35(3):720- 
724. doi:10.1016/j.arth.2019.10.022 
27. Yang MMH, Hartley RL, Leung AA, et al. Preoperative predictors of poor acute postoperative pain 
control: a systematic review and meta-analysis. BMJ Open. 2019;9(4):e025091. Published 2019 Apr 
1. doi:10.1136/bmjopen-2018-025091 
28. Kahlenberg CA, Nwachukwu BU, McLawhorn AS, Cross MB, Cornell CN, Padgett DE. Patient 
Satisfaction After Total Knee Replacement: A Systematic Review. HSS J. 2018;14(2):192-201. 
doi:10.1007/s11420-018-9614-8 
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29. Acar HV. Acupuncture and related techniques during perioperative period: A 
literature review. Complement Ther Med. 2016;29:48-55. 
doi:10.1016/j.ctim.2016.09.013 
30. Alattas SA, Smith T, Bhatti M, Wilson-Nunn D, Donell S. Greater pre-operative 
anxiety, pain and poorer function predict a worse outcome of a total knee 
arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2017;25(11):3403–3410. 
doi:10.1007/s00167-016-4314-8 
31. Eberhart L, Aust H, Schuster M, et al. Preoperative anxiety in adults - a cross- 
sectional study on specific fears and risk factors. BMC Psychiatry. 2020;20(1):140. 
Published 2020 Mar 30. doi:10.1186/s12888-020-02552-w 
32. Song B, Yang Y, Teng X, Li Y, Bai W, Zhu J. Use of pre-operative anxiety score to 
determine the precise dose of butorphanol for intra-operative sedation under 
regional anesthesia: A double-blinded randomized trial. Exp Ther Med. 
2019;18(5):3885-3892. doi:10.3892/etm.2019.8040 
33. Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative 
Anxiety and Information Scale (APAIS). Anesth Analg. 1996;82(3):445-451. 
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34. Kuzminskaitė V, Kaklauskaitė J, Petkevičiūtė J. Incidence and features of 
preoperative anxiety in patients undergoing elective non-cardiac surgery. Acta Med 
Litu. 2019;26(1):93-100. doi:10.6001/actamedica.v26i1.3961 
35. Stuyt EB, Voyles CA. The National Acupuncture Detoxification Association protocol, 
auricular acupuncture to support patients with substance abuse and behavioral 
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https://doi.org/10.2147/SAR.S99161 
36. Furuse N, Shinbara H, Uehara A, et al. A Multicenter Prospective Survey of Adverse 
Events Associated with Acupuncture and Moxibustion in Japan. Med Acupunct. 
2017;29(3):155-162. doi:10.1089/acu.2017.1230 
37. Zhang J, Shang H, Gao X, Ernst E. Acupuncture-related adverse events: a 
systematic review of the Chinese literature. Bull World Health Organ. 
2010;88(12):915-921C. doi:10.2471/BLT.10.076737 
38. Xu S, Wang L, Cooper E, et al. Adverse events of acupuncture: a systematic review 
of case reports. Evid Based Complement Alternat Med. 2013;2013:581203. 
doi:10.1155/2013/581203 
39. Karst, M., Winterhalter, M., Münte, S., Francki, B., Hondronikos, A., Eckardt, A., ... & 
Fink, M. (2007). Auricular acupuncture for dental anxiety: a randomized controlled 
trial. Anesthesia & Analgesia, 104(2), 295-300. 
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Informed Consent for Research
Principal Investigator: 
Pranjali Kainkaryam, MD
Anesthesiology
(860) 972-2117
You have been asked to participate in the research study, Open-Label Randomized Controlled Trial to 
Assess Preoperative Acupuncture for Patients Undergoing Total Knee or Hip Arthroplasty. 
This research study is expected to last two years. The number of patients expected to be enrolled is 60.
The Hartford HealthCare Institutional Review Board (IRB) has reviewed the information in this consent 
document and has given approval for the study doctor to do the study.  An IRB is an independent committee 
established to help protect the rights of research subjects.  This does not mean the IRB has approved your 
participation in the study.  You must think about the information in this consent document for yourself.  You 
must then decide if you want to be in the study.
KEY INFORMATION FOR Open-Label Randomized Controlled Trial to Assess Preoperative 
Acupuncture for Patients Undergoing Total Knee or Hip Arthroplasty:
We are asking you to choose whether or not to volunteer for a research study about acupuncture given before 
total knee or total hip replacement surgery, also known as total knee or hip arthroplasty. This page is to give you 
key information to help you decide whether to participate. We have included detailed information after this 
page. Ask the research team questions. If you have questions later, the contact information for the research 
investigator in charge of the study is below.
WHAT IS THE STUDY ABOUT AND HOW LONG WILL IT LAST?
The purpose of this study is to determine whether acupuncture given before total knee or hip replacement 
surgery reduces anxiety before surgery and pain after surgery in high-anxiety patients. High-anxiety participants 
in the study, whose anxiety will be determined a week prior to surgery using a validated questionnaire (the 
Amsterdam Preoperative Anxiety and Information Scale [APAIS]), will be randomized to receive either a short, 
30-minute acupuncture procedure before surgery or to receive normal care procedures, also known as the 
standard of care procedures. These two groups will be compared by several outcomes: the patients’ anxiety and 
pain as well as by their opioid use, nausea and vomiting, and overall satisfaction after surgery. 
By doing this study, we hope to learn whether an acupuncture procedure given before total knee or hip 
arthroplasty is feasible as well as effective for reducing patient anxiety and pain. Your participation in this 
research will last about 7 to 10 days, beginning at the time of consent and ending when all outcomes are 
measured (satisfaction questionnaires may occur post-discharge over the phone).
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WHAT ARE KEY REASONS YOU MIGHT CHOOSE TO VOLUNTEER FOR THIS STUDY?
The most important reasons you might choose to volunteer for this study are to benefit from the potential 
anxiety- and pain-reducing effects of the acupuncture treatment. In addition, you may experience a decreased 
need for pain medication as well as decreased nausea and vomiting after surgery. Overall, you may also 
experience greater satisfaction with your surgery due to these improvements. Your participation in this study 
will serve to aid the medical community by allowing further research of a medical intervention. 
WHAT ARE KEY REASONS YOU MIGHT CHOOSE NOT TO VOLUNTEER FOR THIS STUDY?
You may not benefit from the procedure, or you may not receive the procedure if you are randomized to the 
group that will not receive acupuncture.  Additionally, there may be risks involved. (see section B on page 4 for 
risks involved).
DO YOU HAVE TO TAKE PART IN THE STUDY?
If you decide to take part in the study, it should be because you really want to volunteer. You will not lose any 
services, benefits, or rights you would normally have if you choose not to volunteer.
WHAT IF YOU HAVE QUESTIONS, SUGGESTIONS OR CONCERNS?
The person in charge of this study is Pranjali Kainkaryam (Principal Investigator, PI) from the Hartford 
HealthCare Department of Anesthesiology. If you have questions, suggestions, or concerns regarding this study 
or you want to withdraw from the study his/her contact information is: Pranjali.Kainkaryam@hhchealth.org 
(email); (860) 972-2117 (phone). 
If you have any questions, suggestions or concerns about your rights as a volunteer in this research, contact 
representatives from the Hartford HealthCare Human Research Protection Program (HRPP) between the 
business hours of 8am and 5pm EST, Monday-Friday at 860-972-2893.
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A.  The Purpose and procedures of this research
A.1.  What is the purpose of this research?
The purpose of this study is to evaluate whether acupuncture given before surgery, or preoperative acupuncture, 
can reduce preoperative anxiety and postoperative pain in high-anxiety patients undergoing total knee or hip 
arthroplasty surgery. 
A.2.  What procedures are involved with participation in this research study?
Should you decide to participate in this study, you will finish reading this consent form, ask any questions that 
you have, and sign the last page. At that point, you will be randomized (like flipping a coin) to receive either 
acupuncture or standard of care (meaning the care that would be provided to you regardless of your 
participation in this study) prior to your surgery. You will have a 50% chance of receiving acupuncture before 
your procedure, or standard of care.  
Participants in the acupuncture group will undergo a preoperative acupuncture procedure, which will take place 
in your preoperative holding bay. First, an acupuncturist will explain the details of the procedure to you. After 
all questions/concerns are addressed, the acupuncturist will then begin the procedure. The procedure involves 
the placement of 10 small needles at 5 specific points on each side of your body, including on your ear and 
wrist, which will be cleaned with alcohol pads beforehand. The needles are inserted roughly 1 millimeter (about 
1/25 of an inch) into the skin. It will only last approximately 5 minutes to insert the needles. The needles will 
then remain inserted for approximately 20 minutes. After the 20 minutes, the needles will be removed by an 
acupuncturist of the study team, which, in addition to any questions and comments from the patient, will take 5 
minutes. The total procedure will last 30 minutes. 
Participants in both groups will be required to complete questionnaires and datasheets to measure their anxiety, 
pain, postoperative nausea and vomiting, and satisfaction. These will occur both in the preoperative area as well 
as in the postoperative area and over-the-phone if needed.
A.3.  Which of these procedures is experimental?  
The acupuncture procedure is experimental. Though acupuncture is routinely provided in our facility and others, 
it has not been provided in our facility immediately before surgery. 
A.4.  Where will participation take place?
Your study participation will take place at the Bone-and-Joint Institute (BJI) at Hartford Hospital, located at 32 
Seymour Street, Hartford, CT 06106. 
A.5.  How long will participation last? 
Your participation is expected to last between 7 to 10 days.
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B.
The possible risks, discomforts and side effects of the procedures are 
described below, including safeguards to be used for your protection.
The percentage of patients who experience complications related to acupuncture has been shown to be as high 
as 6%. The vast majority of complications related to acupuncture are minor and include local bleeding, 
discomfort, and residual pain at the insertion points. Serious adverse events have been shown to occur in 
0.024% of cases (about 2 out of 1,000) and include pneumothorax, abdominal injury, heart injury, central 
nervous system (CNS) injury, eye injury, neck injury, peripheral nerve injury, and infection. Death related to 
acupuncture has been reported; though, the frequency of this is so rare that the prevalence is unknown; there 
have been studies covering more than 3 million acupuncture treatment cases that reported no cases of death 
related to acupuncture. 
All measures will be taken to prevent potential adverse events related to acupuncture. Primarily, this will 
include having only highly skilled acupuncturists administering the acupuncture treatments. This will also 
include constant monitoring by the study team. 
C.
There are possible benefits to you or others to be expected from your 
participation in this research.
There may be no direct benefit to you for participating in this study.   
Participants in this study randomized to receive the acupuncture treatment may experience one or more benefits 
due to the acupuncture treatment. While this study aims to measure acupuncture’s effect on anxiety before and 
after surgery, acupuncture has already been shown to promote feelings of relaxation and to reduce short-term 
anxiety immediately after the procedure’s completion. 
If you receive acupuncture, you may also experience a reduction in anxiety leading to your surgery as well as 
pain after your surgery, which we expect to find in this study. You may also experience reduced postoperative 
nausea and vomiting as well as a reduced need for opioids after surgery. Finally, you may also experience 
greater satisfaction with your overall surgical experience. 
If you are randomized to receive standard of care, you will not receive any potential benefits from the 
acupuncture treatment; however, you will receive the normal standard of care procedures. 
D.
There are alternatives to participation in this study that you should 
consider.
Should you decide not to participate in this study, you will receive the standard of care preoperative treatment 
for your procedure. This may include, should your provider(s) deem it appropriate, the administration of anti-
anxiety or relaxation medications prior to procedure.
HHC-IRB
IRB NUMBER: E-HHC-2021-0348
IRB APPROVAL DATE: 11/28/2022
IRB EXPIRATION DATE: 11/08/2023

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IRB #:
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Version:
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IRB Use Only.
Informed Consent for Research
E.
Who can you call if you have questions about this study? 
You do not have to sign this consent form until all the questions you have at this time are answered.  The 
investigator is willing to answer any questions you may have about the study procedures.  Below is a list of 
contacts if you should have any questions about the study.
Questions about:
Contact
Phone #
the research, research-related treatments, or 
a research related injury
Pranjali Kainkaryam, MD
(860) 972-2117
your rights as a research participant
An IRB Representative
(860) 972-2893
a confidential issue that you would like to 
discuss with someone not associated with 
research
Patient Advocates
(860) 972-1100
F.
Your participation in the research is voluntary.
You may refuse to participate, withdraw your consent, and discontinue participation in the research at any time.  
You may do so without penalty, or loss of benefits to which you are otherwise entitled.  Your decision whether 
to participate will not affect your future medical care at Harford HealthCare.  
G. 
You will not receive financial compensation for your participation in this 
research.
H.
Your confidentiality will be guarded to the greatest extent possible.  
Hartford HealthCare will protect all the information about you and your part in this study, just as is done for all 
patients at Hartford HealthCare.  Your records will be maintained in accordance with applicable state and 
federal laws.  However, private identifiable information about you may be used or disclosed for purposes of this 
research project as described in the study’s authorization form.  
Records of your participation in this study will be held confidential to the extent permitted by the applicable 
laws and regulations, and consistent with the Health Insurance Portability and Accountability Act (“HIPAA”) 
Authorization that you will be asked to sign.  The study doctor, the sponsor or persons working on behalf of the 
sponsor, and under certain circumstances, the United States Food and Drug Administration (FDA), as well as 
governmental agencies in other countries where the study device may be considered for approval and the Ethics 
Committee/Institutional Review Board (IRB) will be able to inspect and copy confidential study specific records 
HHC-IRB
IRB NUMBER: E-HHC-2021-0348
IRB APPROVAL DATE: 11/28/2022
IRB EXPIRATION DATE: 11/08/2023

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Version:
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IRB Use Only.
Informed Consent for Research
which identify you by name.  Therefore, absolute confidentiality cannot be guaranteed.  If the results of this 
study are published or presented at meetings, you will not be identified.
I.
What happens if you are injured as a direct result of your participation in 
this research project? 
In the event that you are injured as a direct result of taking part in this research, you will receive help in the 
following way:
   
If you have medical insurance, Hartford HealthCare will collect fees for medical treatment at Hartford 
HealthCare from your insurance company.  If you are not fully covered by insurance or uninsured, the research 
sponsor of the study or Hartford HealthCare will cover these expenses.  
There is no plan for Hartford HealthCare to pay for your medical expenses at other hospitals or for pain and 
suffering, travel, lost wages, or other indirect costs of taking part in this research.  You do not waive any of your 
legal rights by signing this informed consent document. 
HHC-IRB
IRB NUMBER: E-HHC-2021-0348
IRB APPROVAL DATE: 11/28/2022
IRB EXPIRATION DATE: 11/08/2023

Page:
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Kainkaryam
IRB #:
HHC-2021-0348
Version:
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IRB Use Only.
Informed Consent for Research
J.
Signatures
You will be given a copy of this informed consent document to keep.  By signing below, it means that you have 
read it, that you voluntarily agree to participate in this research, Open-Label Randomized Controlled Trial to 
Assess Preoperative Acupuncture for Patients Undergoing Total Knee or Hip Arthroplasty, and that you 
consent to the performance of the procedures listed above.
______________________________________________________
Participant’s Signature
Printed Name
Date
_________________________________________________________________________________________
Person Obtaining Participant’s Signature
Printed Name
Date
______________________________________________________
Witness signature
Printed Name
Date
(A witness is the person observing the explanation of the above information to the participant.  A witness to the 
informed consent process is optional unless presented orally.)
HHC-IRB
IRB NUMBER: E-HHC-2021-0348
IRB APPROVAL DATE: 11/28/2022
IRB EXPIRATION DATE: 11/08/2023