AuriculoTherapy NeuroImaging
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Low Back Pain, Chronic Low-back Pain, Back Pain, Low, Lumbar Disc Disease, Lumbar Discogenic Pain, Lumbar Pain Syndrome, Lumbar Post-Laminectomy Syndrome, Back Pain Lower Back Chronic, Back Pain Without Radiation, Pain;Back Low;Chronic
In brief
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.
Key facts
- Study ID
- NCT06825390
- Run by
- Keith M Vogt
- People needed
- 60
- Starts
- 2025-07-30
- Expected to finish
- 2029-04-30
- Last updated by the study team
- 2026-02-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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