Needle-free ear cryo-stimulation and brain imaging for chronic low back pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.