RecruitingNot ApplicableNCT06825390

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

Sponsor

Keith M Vogt

Enrollment

60 participants

Start Date

Jul 30, 2025

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria2

Adult, at least 18 years old
Episodes of chronic low back pain at least daily for at least 6 months, with an average pain score within the last week of 3/10.

Exclusion Criteria11

active lesions, skin disruptions, or neuropathy of either ear;
recent (\<1 month) analgesic procedures or surgery;
recent (\<1 month) start of new analgesic or psychoactive medication (including marijuana, opioids, tramadol, methadone, gabapentinoids, anti-depressants, anti-epileptics, mood-stabilizers, anti-psychotics, or stimulants);
history of chronic pain in shoulder or thumb (to avoid confounding at control stimulation points);
recent (\< 3 months) illicit drug use;
prior substance misuse/abuse;
cold-activated diseases (including: agammaglobulinemia, cold urticaria, cold agglutinin disease, cryofibrinogenemia, cryoglobulinemia, immunosuppression, Raynaud's disease, collagen or autoimmune diseases, multiple myeloma, platelet deficiency disorders, pyoderma gangrenosum.)
\- MRI-specific exclusions additionally include:
Pregnancy or active attempts at conception;
Implanted metal or electronic device;
severe claustrophobia

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Interventions

DEVICECryo-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.

DEVICESham 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.

OTHERExperimental 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.