AuriculoTherapy NeuroImaging

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 30, 2025

Primary Completion Date

April 30, 2029

Study Completion Date

April 30, 2029

Conditions
Low Back PainChronic Low-back PainBack Pain, LowLumbar Disc DiseaseLumbar Discogenic PainLumbar Pain SyndromeLumbar Post-Laminectomy SyndromeBack Pain Lower Back ChronicBack Pain Without RadiationPain;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.

Trial Locations (1)

15213

RECRUITING

University of Pittsburgh, Pittsburgh

All Listed Sponsors
lead

Keith M Vogt

OTHER

NCT06825390 - AuriculoTherapy NeuroImaging | Biotech Hunter | Biotech Hunter