AuriculoTherapy NeuroImaging (ATNI)

February 13, 2026 updated by: Keith M Vogt

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 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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a 1:1 randomized, double-blind, sham-controlled, within-subject crossover trial of cyro-auriculotherapy in patients with chronic low back pain. Cryo-auriculotherapy is an effective alternative to needles, in which compressed gas provides focal (~1 mm2) persistent stim of auricular points, with minimal pain. Both before and 5-7 days after (time of peak effect) active vs. sham cryo-AT, resting brain connectivity will be measured with functional MRI and responses to a non-therapeutic experimental auricular stim paradigm (using von Frey filaments) will be recorded with functional near infra-red spectroscopy. After a 2-month washout period, patients will return for the same data collection surrounding the crossover intervention.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: Cryo-auriculotherapy
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.
Device: Sham auriculotherapy
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.
Other: Experimental auricular stimulation
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.
Other Names:
  • von Frey filament
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.
Device: Cryo-auriculotherapy
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.
Device: Sham auriculotherapy
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.
Other: Experimental auricular stimulation
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.
Other Names:
  • von Frey filament

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
functional near-infrared spectroscopy response, Lumbar spine vs. thumb auricular points
Time Frame: Baseline visit, over 10 minutes of data collection
Calculated T-statistic for contrast of analyzed functional near-infrared spectroscopy (fNIRS) signal change, comparing responses from stimulation of the ipsilateral ear at the auricular points corresponding to the lumbar-spine vs. thumb. A T-statistic of 0 indicates no difference; more positive scores mean stronger fNIRS signal change with stimulation of the lumbar point, compared to stimulation of the thumb point; more negative scores mean change with stimulation of the thumb, compared to the lumbar spine. This outcome is a number reflecting the overall magnitude of difference between stimulation points, calculated in one summary statistic. Dispersion measures cannot be calculated for the T-statistic in this analysis framework.
Baseline visit, over 10 minutes of data collection
Change in fNIRS response for Lumbar auricular point, for post- vs. pre- verum auriculotherapy, compared to post- vs. pre- sham auricular stimulation
Time Frame: Baseline, 5-7 days; 2 months, 9 weeks
functional near-infrared spectroscopy data across the 4 sessions will be analyzed for double contrast: [(post-auriculotherapy treatment vs. pre-auriculotherapy treatment) minus (post-sham vs. pre-sham)], thus revealing significant differences in active treatment, compared to sham. The group-level T-statistic for the described contrast will be calculated from stimulation of the ipsilateral ear at the lumbar auricular point. The T-statistic is a single summary statistic reflecting the overall magnitude of differences in brain response to auricular stimulation after/before auriculotherapy treatment vs. sham. A T-statistic of 0 indicates no difference; larger positive values indicate a bigger difference in brain signal change after vs. before the active treatment, compared to after vs. before sham. Larger negative T-statistics indicate a larger change with sham, compared to active treatment. Dispersion measures cannot be calculated for the T-statistic in this analysis framework.
Baseline, 5-7 days; 2 months, 9 weeks
Change in functional connectivity, for post- vs. pre- verum auriculotherapy, compared to post- vs. pre- sham auricular stimulation
Time Frame: Baseline, 5-7 days; 2 months, 9 weeks
MRI data across the 4 sessions will be analyzed for changes in functional connectivity with the statistical comparison model: [(post-auriculotherapy treatment vs. pre-auriculotherapy treatment) minus (post-sham vs. pre-sham)], thus revealing significant differences in connectivity following the active treatment, compared to sham. A group-level T-statistic for the described contrast will be calculated from as a single summary statistic reflecting the overall magnitude of differences in brain connectivity change after/before auriculotherapy treatment vs. sham. A T-statistic of 0 indicates no difference; larger positive values indicate a bigger change in connectivity after vs. before the active treatment, compared to after vs. before sham. Larger negative T-statistics indicate a larger change with sham, compared to active treatment. Dispersion measures cannot be calculated for the T-statistic in this analysis framework.
Baseline, 5-7 days; 2 months, 9 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fNIRS response for Lumbar auricular point, for post- vs. pre- verum auriculotherapy, comparing male vs. female participants
Time Frame: Baseline, 5-7 days (before/after active treatment)
fNIRS stimulation data from the after and before active auriculotherapy treatment will be analyzed for changes, performing a group level comparison between male and female participants. This will reveal sex-based differences in brain-response to auricular stimulation following auriculotherapy. A group-level T-statistic for the described contrast will be calculated from as a single summary statistic reflecting the overall magnitude of difference in brain response after/before auriculotherapy treatment for males vs. females. A T-statistic of 0 indicates no difference; larger positive values indicate greater change in response for males > females. Larger negative T-statistics will indicate a larger change in response for females > males. Dispersion measures cannot be calculated for the T-statistic in this analysis framework.
Baseline, 5-7 days (before/after active treatment)
Change in functional connectivity, for post- vs. pre- verum auriculotherapy, comparing male vs. female participants
Time Frame: Baseline, 5-7 days (before/after active treatment)
MRI data from the after and before active auriculotherapy treatment will be analyzed for changes in functional connectivity, performing a group level comparison between male and female participants. This will reveal sex-based differences in response to auriculotherapy. A group-level T-statistic for the described contrast will be calculated from as a single summary statistic reflecting the overall magnitude of differences in brain connectivity change after/before auriculotherapy treatment for males vs. females. A T-statistic of 0 indicates no difference; larger positive values indicate greater change in connectivity for males > females. Larger negative T-statistics will indicate a larger change in connectivity for females > males. Dispersion measures cannot be calculated for the T-statistic in this analysis framework.
Baseline, 5-7 days (before/after active treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keith M Vogt

Investigators

  • Principal Investigator: Keith M Vogt, MD, PhD, University of Pittsburgh, UPMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2025

Primary Completion (Estimated)

April 30, 2029

Study Completion (Estimated)

April 30, 2029

Study Registration Dates

First Submitted

February 7, 2025

First Submitted That Met QC Criteria

February 7, 2025

First Posted (Actual)

February 13, 2025

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY24090084

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data collected during the trial will be publicly shared, after deidentification.

IPD Sharing Time Frame

De-identified individual participant data are anticipated to be available via open-access database within one year of study completion.

IPD Sharing Access Criteria

This will be publicly available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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