AuriculoTherapy NeuroImaging

Launched by KEITH M VOGT · Feb 7, 2025

Keywords

ClinConnect Summary

This clinical trial, called AuriculoTherapy NeuroImaging, is designed to study how a treatment called auriculotherapy may help relieve chronic low back pain. Auriculotherapy involves gently stimulating specific points on the ear, similar to acupuncture, but instead of using needles, researchers will use a device that sends a focused jet of cold air to these areas. The study will look at patients who have had low back pain for at least six months and want to explore a new, less invasive way to manage their discomfort.

To participate, you need to be at least 18 years old and have daily low back pain that has lasted for six months or more, with a pain level of about 3 out of 10. Throughout the study, participants will have four visits: two before receiving treatment and two about a week later. During these visits, researchers will use brain imaging to see how the treatment affects the brain's response to pain. It’s important to note that certain conditions, recent surgeries, or medications may prevent someone from being eligible for the study. If you're interested in learning more or think you might qualify, discussing this with your healthcare provider could be a good next step.

Gender

ALL

Eligibility criteria

• 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