The Effect of Auriculotherapy for Post-Operative Pain Management Following Rotator Cuff Surgery: A Randomized, Placebo-Controlled Study
Phase: NA
Conditions: Acute Pain, Surgery, Shoulder Pain
Sponsor: Jacques E. Chelly

Title: The Effect of Auriculotherapy for Post-Operative Pain Management following Rotator Cuff Surgery: 
A Randomized, Placebo-Controlled Study 
 
Protocol Title:  The Effect of Auriculotherapy for Post-Operative Pain Management following Rotator 
Cuff Surgery: A Randomized, Placebo-Controlled Study 
NCT03860259 
Document Date: October 20, 2020 
Principal Investigator:  Jacques E. Chelly, MD, PhD, MBA 
 
 
 
Professor of Anesthesiology  
 
 
 
UPMC Shadyside 
 
 
 
5230 Centre Avenue 
 
 
 
Pittsburgh, Pennsylvania 15232 
 
 
 
412.623.6904 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Title: The Effect of Auriculotherapy for Post-Operative Pain Management following Rotator Cuff Surgery: 
A Randomized, Placebo-Controlled Study 
Introduction 
The current opioid epidemic has led to a renewed interest in exploring non-pharmacological 
techniques to treat post-operative pain. An increasing number of patients are suffering from the adverse 
effects of opioid use following surgery, including post-operative nausea and vomiting, respiratory 
depression, immunosuppression, constipation, and most recently, addiction. In the United States, over 
$600 billion is spent every year on opioid addiction, including $79 billion related to opioid addiction 
following surgery. Despite many initiatives to decrease the use of opiates in the preoperative setting, 
opioids continue to be regularly prescribed before, during and after surgery. Although the risk of opioid 
addiction following surgery is recognized, the percentage of patients becoming addicted to opioids 
following surgery is not well understood. To date, there has been virtually no agreement regarding the 
duration and dosage that qualify for opioid dependence following surgery, nor that a clear estimation of 
the factors such as biological, psychosocial and socioeconomic that increase the risk of using opioids for 
extended periods of time after surgery.  
The interscalene block is the gold standard for postoperative pain management following 
shoulder surgery. However, the duration of the block does not cover rehabilitation, and in most cases, 
patients are discharged from the hospital with an opioid prescription. Therefore, there is a growing need 
to investigate complementary pain-management methods that offer a non-pharmacological solution to 
managing post-operative pain. Auriculotherapy is such a technique that has been shown in previous 
studies to provide significant analgesia without the adverse effects of opioids or other pain-relieving 
medications. The objective of this trial is to investigate the efficacy of auriculotherapy in reducing post-
operative narcotic consumption in participants undergoing rotator cuff surgery. Enrolled participants 
will be randomized to a control or interventional arm of the study, where they will either receive an 
active auriculotherapy treatment with nitrogen gas (intervention) or non-active auriculotherapy 
treatment without nitrogen gas (placebo).  

Title: The Effect of Auriculotherapy for Post-Operative Pain Management following Rotator Cuff Surgery: 
A Randomized, Placebo-Controlled Study 
Background 
Auriculortherapy is an ancient technique initially used to treat back pain and was rediscovered 
in the 1940s by French physician Dr. Paul Nogier, who postulated that the ear contains a complete 
representation of the body with the head down. The theory is that any pathological condition is 
associated with a corresponding modification of the ear point. The technique consists of invalidating the 
pathologic or dysfunctional ear point, which generates an impulse that is transmitted to the brain, 
where the brain tries to reset the ear point to homeostasis. The brain also tries to reset the 
corresponding point of the body to homeostasis. 
Auriculotherapy is grounded in the concept that the ear can be considered a keyboard of the 
computer, with the brain being the hard drive, due to its embryologic origin and innervation. From an 
embryologic perspective, the conchae originate from the ectoderm, the lobe and ascending part of the 
helix, tragus and anti-tragus originated from the endoderm, Helix originated from the mesoderm. From 
the innervation perspective, specific parts of the ear are innervated by a specific branch of cranial 
nerves and plexus. These nerves carry impulses from the body to the ear, from the ear to the brain, and 
then back from brain to the ear. The fundamental principle of action of Auriculotherapy is based on a 
temporary and reversible invalidation of the somatotopic representation zones on the auricular 
cartography innervating the different section of the ear.  
Auriculotherapy is neuro-physiologically based—a functional MRI study conducted in 2002 and 
duplicated in 2014 showed that the pain associated with the clamp of the thumb corresponded with 
illuminated sections of the brain. Over the last decades, several different cartography of the ear have 
been proposed—the most recent and scientifically-based cartography is using a segmentogram with a 
corpus collosum as the center of symmetry. Validation of this cartography has been obtained in studies 
using functional MRI.  

Title: The Effect of Auriculotherapy for Post-Operative Pain Management following Rotator Cuff Surgery: 
A Randomized, Placebo-Controlled Study 
Specific Aims 
1. 
This study will prospectively investigate the efficacy of auriculotherapy in reducing perioperative 
opioid consumption in participants undergoing rotator cuff surgery  
3. 
To prospectively investigate role that auriculotherapy may have in reducing opioid consumption 
after discharge and facilitating functional recovery 
Study Design 
The study will be conducted as a prospective, randomized, placebo-controlled trial at the University of 
Pittsburgh Medical Center (UPMC) Shadyside Hospital and Montefiore hospitals. Institutional review 
board approval will be obtained before eligible patients are recruited and consented. Trial will be 
registered at www.clinicaltrial.gov before beginning recruitment.  
Recruitment 
Potential subjects will be recruited in the pre-operative area of Shadyside hospital on the day of their 
scheduled rotator-cuff surgery. Patients who agree to participate in the trial will sign an IRB approved 
Informed Consent Form.  
Randomization Process 
Participating patients will be randomized by computer generated random numbers to either the control 
or intervention group. 
 
 
 
 

Title: The Effect of Auriculotherapy for Post-Operative Pain Management following Rotator Cuff Surgery: 
A Randomized, Placebo-Controlled Study 
Treatment Groups 
Control Arm: Control group will receive an auriculotherapy placebo- this placebo involves using the 
auriculotherapy cryopuncture device without the compressed nitrogen gas to invalidate innervated 
points on the ear, plus the standard of care interscalene block and post-operative pain management 
protocol 
Interventional Arm: Intervention group will receive actual auriculotherapy procedure, which involves 
using the auriculotherapy cryopuncture device with the nitrogen gas to invalidate innervated points on 
the ear, plus the standard of care interscalene block and post-operative pain management protocol 
Inclusion Criteria 
1. 
Subject is greater than 18 years of age 
2. 
Subject is willing and able to provide informed consent 
3. 
Subject is scheduled to undergo elective rotator cuff surgery 
4. 
Subject has consented to an interscalene block 
Exclusion Criteria 
1. Opioid dependence 
2. Any subject diagnosed with a chronic pain condition which daily opioid use is needed 
3. Anatomical malformation, which in the investigator's opinion may interfere with the placement 
of the nerve block 
4. Raynaud's disease diagnosis 
5. Patient refusal 
 
 

Title: The Effect of Auriculotherapy for Post-Operative Pain Management following Rotator Cuff Surgery: 
A Randomized, Placebo-Controlled Study 
Data Collection and Outcome Measures 
Once patient has signed the Informed Consent to participate in this trial, demographic information and 
medical history will be collected from each participant on the day of surgery. Research staff will record 
this information from the medical chart.  The Medical Outcomes Study Questionnaire 12-Item Short 
Form Health Survey (SF-12) will also be administered at this time to obtain baseline value.  
Randomization will occur by assigning the participant a subject ID number, and this ID number will 
correspond to a treatment allocation based on a pre-designed randomization schema. This treatment 
allocation (intervention/control) will be contained in a sealed, opaque, envelope with the subject ID 
number that is designated on envelope. The master randomization list will be created and held by an 
independent data monitor who will both create and hold the master randomization list.  
Once patient is randomized to a treatment group by research staff, Auriculotherapy will be performed 
using a cryopuncture device in the post-operative setting, either with nitrogen gas (intervention group), 
or an empty cryopunture with no gas (control group). Dr. Chelly is formally certified in auriculotherapy 
(diploma attached). After proper disinfection of the designated ear, the treatment consists of the 
stimulation of 9 ear points on the ipsilateral ear. These points include:-Ω2 (the master point for the 
mesoderm), the shoulder point, 6 points involved with the pain pathway (the stellar ganglion, the 
sensory and motor C7 branches, the sensory master point (MSP), the reticular master point (RMP) and 
the point corresponding to the Thalamus).   
Finally, the stimulation of the ACTH point completes the treatment. The total time required to complete 
auriulotherapy treatment is approximately 10 minutes 
 

Title: The Effect of Auriculotherapy for Post-Operative Pain Management following Rotator Cuff Surgery: 
A Randomized, Placebo-Controlled Study 
The enrolled subject will also receive an interscalene block as per standard of care.  The patient will 
receive standard of care treatment for surgery, post-operative pain management, and physical therapy.  
After surgery, the subject will be assessed at time of hospital discharge to review how to complete the 
subject diary, administer pain satisfaction questionnaire (0-6) and obtain NRS pain at rest and with 
movement scores (0-10).  
When the patient is discharged from the hospital, the subject will be asked to take home and complete 
a subject diary where they will record their total narcotic/pain medication consumption, pain 
satisfaction score (0-6), and NRS pain score (0-10), and adverse events daily for first 5 days post-
discharge, and then at post op day 14 and once a month for three months (post op days 30, 60 and 90). 
The subject will be instructed to complete the diary just before bedtime on these days. The patient will 
be contacted via telephone on Day 5 post-operatively as a reminder to return their pain diary. On the 
post-operative Day 14, 30, 60 and 90 telephone calls, functional recovery will be measured using the 
Medical Outcomes Study Questionnaire 12-Item Short Form Health Survey (SF-12). The subject will also 
be asked to assess their overall patient satisfaction at the Day 90 call, on a scale of 0 (least satisfaction) 
to 10 (most satisfaction). 
Analgesic efficacy in both groups will also be evaluated by the amount of total narcotic consumption 
(measured with oral morphine equivalent doses of analgesics used to provide pain relief). Secondary 
outcome measures will include total non-narcotic pain medication consumption for 5-days post-
discharge, time to readiness for discharge from PACU, time to hospital discharge, readmission to the 
hospital because of pain-related issues, incidence of post operative complications, overall patient 
satisfaction, patient satisfaction relating to pain management and functional recovery. Functional 
recovery will be measured using the Medical Outcomes Study Questionnaire 12-Item Short Form Health 
Survey (SF-12). 

Title: The Effect of Auriculotherapy for Post-Operative Pain Management following Rotator Cuff Surgery: 
A Randomized, Placebo-Controlled Study 
Auriculotherapy Technique  
After proper disinfection of the designated ear, the treatment consists of the stimulation of 9 ear points 
on the ipsilateral ear.  
These points include: 
-Ω2 (the master point for the mesoderm), the shoulder point, 6 points involved with the pain pathway 
(the stellar ganglion, the sensory and motor C7 branches, the sensory master point (MSP), the reticular 
master point (RMP) and the point corresponding to the Thalamus).   
Finally, the stimulation of the ACTH point completes the treatment 
 
 
 
 
 
 
 
 
 
 
 

Title: The Effect of Auriculotherapy for Post-Operative Pain Management following Rotator Cuff Surgery: 
A Randomized, Placebo-Controlled Study 
Statistical Analysis 
A non-paired T-test will be performed to determine the significance of the difference between 
the 2 groups. P value less than 0.1 will be considered significant. Data for each outcome measure 
will be expressed as mean ± standard deviation (SD). Confidence intervals and relative risks will 
be defined wherever appropriate. 
Sample size power was based on a reduction of 60% of opioids during the 2 weeks following 
surgery and discharge. To allow for up to 10% dropout rate, 5 subjects have been added to each 
group to bring total to 50 subjects. Incidence of complications and other binary variables 
between the groups will be analyzed by Chi Square test or Fisher exact test. 
 
 
 
 
 
 
 
 
 
 
 

Title: The Effect of Auriculotherapy for Post-Operative Pain Management following Rotator Cuff Surgery: 
A Randomized, Placebo-Controlled Study 
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Title: The Effect of Auriculotherapy for Post-Operative Pain Management following Rotator Cuff Surgery: 
A Randomized, Placebo-Controlled Study