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NCT06825390NARecruiting

AuriculoTherapy NeuroImaging

Keith M Vogt

Start Date

7/30/2025

Completion Date

4/30/2029

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

Cryo-auriculotherapy

DEVICE

Sham auriculotherapy

OTHER

Experimental auricular stimulation

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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

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania 15213

United States