Neural Correlates of Auriculotherapy

NCT06358287 | Completed

• 1 other identifier: STUDY19030375
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic pain continues to be a major health issue, creating a significant societal burden, as it is an independent risk factor for opioid use disorder (OUD) and deaths. Acute pain episodes can often engender OUD due to lack of effective strategies to treat pain and prevent the transition to chronic pain. One potential non-opioid method for pain relief is auriculotherapy (AT), where acupuncture-like treatment is administered to the ear. The objective of this pilot study is to illustrate that AT-related brain effects can be found using functional connectivity MRI (fcMRI) in patients with low back pain.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Default Mode Network (DMN)-to-Anterior Cingulate Cortex (ACC) connectivity

  Group average difference in connectivity will be calculated as pre-treatment vs. post-treatment statistical contrasts. Connectivity change will have a threshold at the connection level with p \< 0.001. In this framework, a positive T-Score indicates greater connectivity before treatment (a decrease in connectivity after treatment).

  Day 3 of participation

Secondary Outcomes (3)

• Brief Pain Inventory (BPI) Severity Scores MRI #1

  Day 3 of participation

• BPI Pain Severity Scores MRI #2

  Day 3 of participation

• General Anxiety Disorder-7 (GAD-7) Scoring

  Day 3 of participation

Study Arms (1)

Cryogenic Auriculotherapy Treatment

EXPERIMENTAL

Compressed nitrogen is used to create a 'cryogenic needle', using a cryopunctor device. An orifice is placed in appropriate acupoint and nitrogen flow is used to cool and activate the point. This will occur on each ear with the following points being targeted: Omega 2, Omega, spine location point, and 3 points of the pain pathway including the sensory master point (SMP), the master point of the reticule (MPR), and the thalamus (T) as well as the corpus callosum (CC) point, the amygdala, rhinencephalon, hippocampus, FSHLH, ACTH, anterior and posterior white commissure points, and the corresponding sympathetic sensory and motor nerve points.

Procedure: cryogenic auriculotherapy

Interventions

cryogenic auriculotherapy PROCEDURE

Compressed nitrogen is used to create a 'cryonic needle', using a cryopunctor device. An orifice is placed in appropriate acupoint and nitrogen flow is used to cool and activate the point.

Cryogenic Auriculotherapy Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and above.
• Experiencing low back pain for \> 1 month and seeking treatment.
• Literate for reading and writing in English, decision competent, willing and able to provide written informed consent, and able to complete the study's schedule of assessments.

You may not qualify if:

• Subjects under 18 years of age.
• History of claustrophobia.
• Having non-MRI safe metallic or foreign objects in their body.
• History of dementia.
• History of sensory or motor deficits that preclude participation in pain fMRI.
• History of clinically unstable systemic illness that is judged to interfere with the study.
• Pregnancy or the intent to become pregnant during the study.

Sponsors & Collaborators

• Keith M. Vogt, MD, PhD: lead

Study Sites (1)

UPMC Montefiore

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Keith Vogt, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 10, 2024
• Study Start: July 15, 2021
• Primary Completion: November 7, 2022
• Study Completion: November 7, 2022
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)