NCT06825390

AuriculoTherapy NeuroImaging

Mechanistic Clinical Trial of Auricular Stimulation and Cryogenic Auriculotherapy in Patients With Chronic Low-back Pain, Using Functional Near-infrared Spectroscopy and Magnetic Resonance Imaging

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Keith M Vogt · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a 1:1 randomized, double-blind, sham-controlled, within-subject crossover trial of cyro-auriculotherapy in patients with chronic low back pain. Cryo-auriculotherapy is an effective alternative to needles, in which compressed gas provides focal (\~1 mm2) persistent stim of auricular points, with minimal pain. Both before and 5-7 days after (time of peak effect) active vs. sham cryo-AT, resting brain connectivity will be measured with functional MRI and responses to a non-therapeutic experimental auricular stim paradigm (using von Frey filaments) will be recorded with functional near infra-red spectroscopy. After a 2-month washout period, patients will return for the same data collection surrounding the crossover intervention.

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

Type	Name	Description
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.

Timeline

• Start date: 2025-07-30
• Primary completion: 2029-04-30
• Completion: 2029-04-30
• First posted: 2025-02-13
• Last updated: 2026-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study