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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

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

1. Adult, at least 18 years old
2. 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 Criteria:

1. active lesions, skin disruptions, or neuropathy of either ear;
2. recent (\<1 month) analgesic procedures or surgery;
3. 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);
4. history of chronic pain in shoulder or thumb (to avoid confounding at control stimulation points);
5. recent (\< 3 months) illicit drug use;
6. prior substance misuse/abuse;
7. 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:
8. Pregnancy or active attempts at conception;
9. Implanted metal or electronic device;
10. severe claustrophobia

About the study

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.

What is being tested

• Cryo-auriculotherapy (device)
• Sham auriculotherapy (device)
• Experimental auricular stimulation (other)

Sponsor: Keith M Vogt · Participants: 60 · Started: Jul 30, 2025

Contact the study team

• Carly Riedmann, MPH · Phone: 412-623-4147
• Amy Monroe, MPH, MBA · Phone: 412-623-6382

Official record on ClinicalTrials.gov — NCT06825390

Locations in the U.S.

Conditions

• Low Back Pain
• Back Pain

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.