Auriculotherapy for Surgical Pain

NCT03860259 | Completed Results FDA Device

• 1 other identifier: PRO18050099
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Pain; Surgery; Shoulder Pain

Keywords

opioids; auriculotherapy; acute pain; shoulder surgery

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption Following Rotator Cuff Surgery

  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 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative

Secondary Outcomes (11)

• Post-Operative Pain With Movement

  24 hrs through 90-days post-operative

• Post-Operative Pain at Rest

  Time of discharge through 90-days post-operative

• Non-narcotic Analgesic Consumption

  Day of surgery through 5-days post-operative

• Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12)

  Day of surgery through 90 days post-operative

• Length of Recovery Room Stay

  Day of surgery through recovery room discharge, up to 142 min post-operative

Study Arms (2)

Auriculotherapy without nitrogen gas

PLACEBO COMPARATOR

Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.

Device: Auriculotherapy cryopuncture device without nitrogen gas

Auriculotherapy with nitrogen gas

ACTIVE COMPARATOR

Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.

Device: Auriculotherapy cryopuncture device with nitrogen gas

Interventions

Auriculotherapy cryopuncture device without nitrogen gas DEVICE

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 without nitrogen gas

Auriculotherapy cryopuncture device with nitrogen gas DEVICE

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

Auriculotherapy with nitrogen gas

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is greater than 18 years of age
• Subject is willing and able to provide informed consent
• Subject is scheduled to undergo elective rotator cuff surgery
• Subject has consented to an interscalene block

You may not qualify if:

• Opioid dependence
• Any subject diagnosed with a chronic pain condition which daily opioid use is needed
• Anatomical malformation, which in the investigator's opinion may interfere with the placement of the nerve block
• Raynaud's disease diagnosis
• Vasculopathy
• Patient refusal

Sponsors & Collaborators

• Jacques E. Chelly: lead

Study Sites (1)

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (36)

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MeSH Terms

Conditions

Acute Pain; Shoulder Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Jacques E. Chelly, MD, PhD, MBA
• Organization: University of Pittsburgh Medical Center Department of Anesthesiology and Perioperative Medicine

chelje@anes.upmc.edu

412-623-6382

Study Officials

• Jacques E Chelly, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The only person unblinded to treatment allocation will be the Principal investigator or designee -- the individual performing cryopuncture
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Anesthesiology (with Tenure) and Orthopedic Surgery

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: March 1, 2019
• Study Start: January 24, 2020
• Primary Completion: July 6, 2021
• Study Completion: September 29, 2021
• Last Updated: March 17, 2022
• Results First Posted: January 13, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)