Needle-free ear cryo-stimulation and brain imaging for chronic low back pain
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
This trial will test whether needle-free ear cryo-stimulation can change brain activity and reduce pain in adults who have had daily low back pain for at least six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT06825390 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, sham-controlled within-subject crossover study compares real versus sham cryo-auriculotherapy in adults with chronic low back pain. Participants undergo baseline and 5–7 day post-treatment assessments including resting-state functional MRI and responses to experimental auricular stimulation measured with functional near-infrared spectroscopy, with a 2-month washout before crossover. The Cryo-IQ device delivers brief, focal cold-gas jets to seven auricular points on both ears as a needle-free auriculotherapy, and a von Frey filament protocol provides standardized experimental stimulation. The design captures within-subject changes in brain connectivity and physiological responses to characterize mechanisms and short-term effects of the intervention.
Who should consider this trial
Good fit: Adults aged 18 or older with daily chronic low back pain for at least six months and an average recent pain score around 3/10 or higher, who can attend in-person visits and do not have exclusionary ear or medical conditions, are ideal candidates.
Not a fit: Patients with active ear lesions or neuropathy, cold-sensitive diseases, recent analgesic procedures or surgeries, recent start of psychoactive medications, recent illicit drug use or a history of substance misuse, or chronic shoulder/thumb pain are unlikely to benefit or may be excluded.
Why it matters
Potential benefit: If successful, this could offer a low-pain, needle-free treatment option for chronic low back pain and provide brain-based markers to help guide therapy.
How similar studies have performed: Auricular acupuncture has shown some pain relief in prior studies, and cryo-auriculotherapy is a less-invasive but relatively under-studied alternative with limited preliminary positive data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Keith M Vogt, MD, PhD — University of Pittsburgh, UPMC
- Study coordinator: Carly Riedmann, MPH
- Email: riedmannca@upmc.edu
- Phone: 412-623-4147
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.