CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Auriculotherapy cryopuncture device without nitrogen gas +1 moredevice
Likely dose
Not stated in record
Key inclusion· 4
  • Age >18 years
  • Scheduled to undergo elective rotator cuff surgery
  • Willing and able to provide informed consent
  • Consented to an interscalene block
Key exclusion· 5
  • Opioid dependence
  • Chronic pain condition requiring daily opioid use
  • Anatomical malformation that may interfere with nerve block placement
  • Raynaud's disease diagnosis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03860259
NCT03860259N/ACompleted

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

Jacques E. Chelly·interventional·Posted Mar 1, 2019·Updated Mar 17, 2022

In Brief

A clinical study evaluating Auriculotherapy cryopuncture device without nitrogen gas and Auriculotherapy cryopuncture device with nitrogen gas for Acute Pain and 2 related conditions. Completed, enrolled 50 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMar 1, 2019
Enrollment StartJan 24, 2020
Primary CompletionJul 6, 2021
Study CompletionSep 29, 2021
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 7.3 years ago

Interventions

Auriculotherapy cryopuncture device without nitrogen gasdevice

Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy

Auriculotherapy cryopuncture device with nitrogen gasdevice

Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy