AuriculoTherapy NeuroImaging

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Keith M Vogt
Study ID
NCT06825390
Status
Recruiting
Apply to this trial

Conditions

  • Back Pain Lower Back Chronic
  • Back Pain Without Radiation
  • Back Pain, Low
  • Chronic Low-back Pain
  • Low Back Pain
  • Lumbar Disc Disease
  • Lumbar Discogenic Pain
  • Lumbar Pain Syndrome
  • Lumbar Post-Laminectomy Syndrome
  • Pain;Back Low;Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cryo-auriculotherapy — DEVICE
    The cryo-IQ device (containing compressed nitrous oxide) with a narrow-tip nozzle will be used. After disinfection of the device and both ears, 7 inter-related points in the auricular cartography will be treated with a 1-2 second application of cold gas, applied to both ears. Treatment points will be: mesoderm master, spine, reticular formation, sensory master point, thalamus, adrenocorticotropic hormone, and corpus callosum.
  • Sham auriculotherapy — DEVICE
    For the sham procedure, an empty gas canister will be used in the cryo-IQ device. This will make the same noise and temporary skin imprint on the ear, but does not deliver any cooling effect. The same 7 ear points will be sham-treated in a protocol that is imperceptibly different from the verum auriculotherapy treatment.
  • Experimental auricular stimulation — OTHER
    Three points on each ear will be repeatedly stimulated with a plastic (von Frey) filament. This will be felt, but not be painful and should not result in lasting irritation.

Study Details

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 Dates

Start date
Jul 30, 2025
Status verified
Feb 2026
Primary completion
Apr 30, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Active cryo-auriculotherapy first / sham second
    Participants randomly assigned to Group 1 will receive verum cryo-auriculotherapy treatment first, at the end of visit 1. They will return 5-7 days later for follow-up imaging (visit 2). After at least a 2 month wash-out period, all will return for their third visit, which will end with sham auricular intervention. Visit 4 is the second follow-up imaging session. All visits involve fNIRS imaging with auricular stimulation using von Frey filaments, prior to sham/cryo intervention.
  • Experimental: Sham first / active cryo-auriculotherapy second
    Participants randomly assigned to Group 2 will receive sham auricular intervention first, at the end of visit 1. They will return 5-7 days later for follow-up imaging (visit 2). After at least a 2 month wash-out period, all will return for their third visit, which ends with verum cryo-auriculotherapy treatment. Visit 4 is the second follow-up imaging session. All visits involve fNIRS imaging with auricular stimulation using von Frey filaments, prior to sham/cryo intervention.

Primary Outcome Measure

functional near-infrared spectroscopy response, Lumbar spine vs. thumb auricular points [ Time Frame: Baseline visit, over 10 minutes of data collection ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PittsburghPittsburghPennsylvania15213
Keith M Vogt, MD, PhD
[email protected]
4126473147
Amy Monroe, MPH, MBA
[email protected]
412-623-6382

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By research site
University of Pittsburgh· Pittsburgh, PA

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