18 and older, any sex, with Acute Pain or Surgery. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Opioid Consumption Following Rotator Cuff SurgeryPrimary· 24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative
Investigate the efficacy of auriculotherapy in reducing perioperative opioid consumption in opioid-naïve patients undergoing elective rotator cuff surgery. This is reported in consumption of oral morphine mg equivalents (OME) at 24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative as well as the total sum of these intervals
24 Hours
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
31
± 20
Auriculotherapy With Nitrogen Gas
25
± 20
48 Hours
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
25
± 17
Auriculotherapy With Nitrogen Gas
21
± 17
72 Hours
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
19
± 19
Auriculotherapy With Nitrogen Gas
12
± 13
96 Hours
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
12
± 15
Auriculotherapy With Nitrogen Gas
9
± 10
120 Hours
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
10
± 13
Auriculotherapy With Nitrogen Gas
5
± 7
Total
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
96
± 67
Auriculotherapy With Nitrogen Gas
62
± 46
Post-Operative Pain With MovementSecondary· 24 hrs through 90-days post-operative
Numerical Rating Scale (NRS) Pain with movement on a scale from 0-10, with 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a worse outcome.
24 Hours
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
8.11
± 2.11
Auriculotherapy With Nitrogen Gas
7.42
± 2.67
48 Hours
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
6.83
± 2.28
Auriculotherapy With Nitrogen Gas
6.21
± 2.70
72 Hours
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
6.28
± 2.19
Auriculotherapy With Nitrogen Gas
5.37
± 2.22
96 Hours
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
5.44
± 2.59
Auriculotherapy With Nitrogen Gas
4.65
± 2.30
120 Hours
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
4.72
± 2.61
Auriculotherapy With Nitrogen Gas
3.80
± 2.28
Day 14
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
5.84
± 2.39
Auriculotherapy With Nitrogen Gas
4.47
± 2.12
Day 30
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
5.00
± 2.78
Auriculotherapy With Nitrogen Gas
5.27
± 2.84
Day 60
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
4.15
± 3.48
Auriculotherapy With Nitrogen Gas
3.64
± 2.90
Post-Operative Pain at RestSecondary· Time of discharge through 90-days post-operative
Numerical Rating Scale (NRS) pain at rest on a scale from 0-10, with 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a worse outcome.
Discharge
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
0.89
± 1.91
Auriculotherapy With Nitrogen Gas
0.45
± 0.76
24 Hours
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
6.17
± 3.01
Auriculotherapy With Nitrogen Gas
5.75
± 3.32
48 Hours
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
4.67
± 3.18
Auriculotherapy With Nitrogen Gas
4.50
± 2.69
72 Hours
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
3.89
± 2.72
Auriculotherapy With Nitrogen Gas
3.50
± 2.19
96 Hours
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
3.50
± 2.41
Auriculotherapy With Nitrogen Gas
3.45
± 2.44
120 Hours
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
2.88
± 2.00
Auriculotherapy With Nitrogen Gas
2.65
± 2.28
Day 14
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
2.26
± 1.59
Auriculotherapy With Nitrogen Gas
1.71
± 1.76
Day 30
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
2.13
± 2.00
Auriculotherapy With Nitrogen Gas
1.20
± 1.37
Non-narcotic Analgesic ConsumptionSecondary· Day of surgery through 5-days post-operative
Investigate the efficacy of auriculotherapy in reducing total perioperative consumption of non-narcotic analgesics.
Acetaminophen
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
4438.16
± 4066.01
Auriculotherapy With Nitrogen Gas
5955.63
± 5882.27
Ibuprofen
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
785.26
± 1576.68
Auriculotherapy With Nitrogen Gas
1370.00
± 2386.17
Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12)Secondary· Day of surgery through 90 days post-operative
Functional recovery will be measured by the assessment of the participant's answers to the Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12). The SF-12 Health Survey includes questions from the SF-36 Health Survey (Version 1). Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 i
Baseline PCS
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
38.9
± 8.4
Auriculotherapy With Nitrogen Gas
38.0
± 6.6
Day 14 PCS
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
37.1
± 8.2
Auriculotherapy With Nitrogen Gas
34.0
± 4.6
Day 30 PCS
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
36.1
± 7.6
Auriculotherapy With Nitrogen Gas
35.7
± 4.7
Day 60 PCS
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
40.5
± 9.2
Auriculotherapy With Nitrogen Gas
39.0
± 8.4
Day 90 PCS
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
44.1
± 8.4
Auriculotherapy With Nitrogen Gas
44.9
± 7.8
Baseline MCS
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
60.5
± 4.4
Auriculotherapy With Nitrogen Gas
59.4
± 3.8
Day 14 MCS
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
57.4
± 8.1
Auriculotherapy With Nitrogen Gas
60.3
± 5.3
Day 30 MCS
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
61.3
± 5.1
Auriculotherapy With Nitrogen Gas
59.6
± 4.6
Length of Recovery Room StaySecondary· Day of surgery through recovery room discharge, up to 142 min post-operative
Evaluate time to readiness for discharge from post-anesthesia care unit (PACU) from out of OR time in minutes
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
59.5
± 25.7
Auriculotherapy With Nitrogen Gas
67.2
± 34.1
Length of Hospital StaySecondary· Day of surgery through time of discharge, up to 270 min post-operative
Evaluate time to hospital discharge from out of OR time in minutes
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
140.1
± 32.1
Auriculotherapy With Nitrogen Gas
148.0
± 47.4
Number of Participants Who Experienced Post-operative ComplicationsSecondary· Day of surgery through 90-days post-operative
The number of participants who experienced complications and received the standard protocol versus subjects who received the standard protocol + Auriculotherapy. Post-operative complications can be defined as unexpected problems that arise following surgery including increased bleeding, infection, recurrent rotator cuff tear, and displacement of suture anchor.
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
0
Auriculotherapy With Nitrogen Gas
0
Subjects Requiring Readmission Due to PainSecondary· Day of surgery through 90-days post-operative
Evaluate the number of subjects readmitted because of pain or pain-related issues during the 90 day study duration
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
0
Auriculotherapy With Nitrogen Gas
0
Overall Patient SatisfactionSecondary· Day of surgery through time of discharge, up to 270 min post-operative
Participants are asked to assess their overall satisfaction with care upon discharge on a 10-point satisfaction scale of 0 (least satisfaction) to 10 (highest satisfaction). The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a better outcome.
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
9.2
± 2.1
Auriculotherapy With Nitrogen Gas
9.6
± 0.6
Satisfaction With Pain ManagementSecondary· Day of surgery through 90-days post-operative
Participants are asked to assess their satisfaction with pain management at discharge, 24 hrs, 48 hrs, 72 hrs, 96, hours, 120 hrs and 14 days, 30 days, 60 days and 90 days post-operative on a 10-point satisfaction scale of 0 (least satisfaction) to 10 (highest satisfaction). The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a better outcome.
Discharge
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
5.7
± 0.7
Auriculotherapy With Nitrogen Gas
5.9
± 0.4
24 Hours
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
4.2
± 1.8
Auriculotherapy With Nitrogen Gas
4.1
± 1.4
48 Hours
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
4.7
± 1.2
Auriculotherapy With Nitrogen Gas
4.6
± 1.1
72 Hours
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
5.1
± 0.8
Auriculotherapy With Nitrogen Gas
4.9
± 1.0
96 Hours
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
4.7
± 1.5
Auriculotherapy With Nitrogen Gas
4.6
± 1.3
120 Hours
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
4.8
± 1.5
Auriculotherapy With Nitrogen Gas
4.8
± 1.1
Day 14
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
5.6
± 0.8
Auriculotherapy With Nitrogen Gas
5.6
± 0.8
Day 30
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
5.4
± 1.2
Auriculotherapy With Nitrogen Gas
5.7
± 0.5
Subjects Requiring Hospital ReadmissionSecondary· Day of surgery through 90-days post-operative
Evaluate the number of subjects readmitted to the hospital for post-operative complications other than pain-related issues.
Group
Value
95% CI
Auriculotherapy Without Nitrogen Gas
0
Auriculotherapy With Nitrogen Gas
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data was collected for the duration of the subject's participation in the study (90 days post-operative)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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. Auriculotherapy has been shown to reduce the need for opioid immediately after surgery. However, everyone agrees that more research is needed, especially due to the concern of the placebo effect when using a needle and electro-stimulation. This study is purposely based on the use of a cryopuntor device, which has been shown to produce the same effect as needles. This is a novel complementary approach to reducing the persistence of opioid prescription following rotator cuff surgery, which is considered a model of severe functional pain. Data obtained from this study will support a future NIDA proposal to expand the use of auriculotherapy for perioperative management of pain and functional recovery associated with surgery. The use of an auriculotherapy approach has the potential of providing effective non-opioid analgesia to patients not only undergoing rotator cuff surgery, but also other surgical models.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Jacques E. Chelly
Last refreshed: 17 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03860259.