AuriculoTherapy NeuroImaging

Summary

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

• Low Back Pain
• Chronic Low-back Pain
• Back Pain, Low
• Lumbar Disc Disease
• Lumbar Discogenic Pain
• Lumbar Pain Syndrome
• Lumbar Post-Laminectomy Syndrome
• Back Pain Lower Back Chronic
• Back Pain Without Radiation
• Pain;Back Low;Chronic

Interventions

DEVICE

Cryo-auriculotherapy

The cryo-IQ device (containing compressed nitrous oxide) with a narrow-tip nozzle will be used. After disinfection of the device and both ears, 7 inter-related points in the auricular cartography will be treated with a 1-2 second application of cold gas, applied to both ears. Treatment points will be: mesoderm master, spine, reticular formation, sensory master point, thalamus, adrenocorticotropic hormone, and corpus callosum.

DEVICE

Sham auriculotherapy

For the sham procedure, an empty gas canister will be used in the cryo-IQ device. This will make the same noise and temporary skin imprint on the ear, but does not deliver any cooling effect. The same 7 ear points will be sham-treated in a protocol that is imperceptibly different from the verum auriculotherapy treatment.

OTHER

Experimental auricular stimulation

Three points on each ear will be repeatedly stimulated with a plastic (von Frey) filament. This will be felt, but not be painful and should not result in lasting irritation.

Sponsors & Collaborators

• Keith M Vogt

  lead OTHER

Principal Investigators

• Keith M Vogt, MD, PhD · University of Pittsburgh, UPMC

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-30

Primary Completion

2029-04-30

Completion

2029-04-30

FDA Device

Yes

Countries

• United States

Study Locations