Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06825390

AuriculoTherapy NeuroImaging

Led by Keith M Vogt · Updated on 2026-02-18

60

Participants Needed

1

Research Sites

195 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a clinical study of patients who have low back pain (for at least 6 months). The goal is to understand, with brain imaging, how auriculotherapy (an acupuncture-like stimulation of the ear) may work to relieve pain. There are 4 total study visits, divided into two pairs of visits that occur before and 5-7 days after receiving either a real or sham auriculotherapy treatment. The cryo-IQ device will be used, to stimulate 7 small areas on both ears with a focused jet of cold as a small amount of compressed gas is released. This is generally not painful, and less invasive, compared to using needles for auriculotherapy.

CONDITIONS

Official Title

AuriculoTherapy NeuroImaging

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult, at least 18 years old
  • Chronic low back pain occurring at least daily for 6 months or more
  • Average pain score of at least 3 out of 10 in the last week
Not Eligible

You will not qualify if you...

  • Active lesions, skin disruptions, or neuropathy of either ear
  • Analgesic procedures or surgery within 1 month prior to enrollment
  • New analgesic or psychoactive medication started within 1 month prior to enrollment
  • History of chronic pain in shoulder or thumb
  • Illicit drug use within the last 3 months
  • Prior substance misuse or abuse
  • Diagnosis of cold-activated diseases such as agammaglobulinemia, cold urticaria, cold agglutinin disease, cryofibrinogenemia, cryoglobulinemia, immunosuppression, Raynaud's disease, collagen or autoimmune diseases, multiple myeloma, platelet deficiency disorders, or pyoderma gangrenosum
  • Pregnancy or actively trying to conceive
  • Implanted metal or electronic device
  • Severe claustrophobia

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

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Research Team

C

Carly Riedmann, MPH

CONTACT

A

Amy Monroe, MPH, MBA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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