| NCT ID | NCT06825390 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Keith M Vogt |
| Condition | Low Back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-07-30 |
| Primary Completion | 2029-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-07-30 with a primary completion date of 2029-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Keith M Vogt, MD, PhD
PRINCIPAL INVESTIGATOR
University of Pittsburgh, UPMC
Frequently Asked Questions
Who can join the NCT06825390 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Low Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06825390 currently recruiting?
Yes, NCT06825390 is actively recruiting participants. Contact the research team at riedmannca@upmc.edu for enrollment information.
Where is the NCT06825390 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT06825390 clinical trial?
NCT06825390 is sponsored by Keith M Vogt. The principal investigator is Keith M Vogt, MD, PhD at University of Pittsburgh, UPMC. The trial plans to enroll 60 participants.