AuriculoTherapy NeuroImaging
RecruitingNot applicableNCT06825390
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- 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
- Conditions
- 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
- Interventions
- Device: Cryo-auriculotherapy
- Device: Sham auriculotherapy
- Other: Experimental auricular stimulation
- Sponsor
- Keith M Vogt
- Organization
- University of Pittsburgh
- Start date
- 2025-07-30
- Primary completion
- 2029-04-30
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06825390