Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06825390

AuriculoTherapy NeuroImaging

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Low Back Pain Back Pain Back Pain Lower Back Chronic Back Pain Without Radiation Back Pain, Low Chronic Low-back Pain Intervertebral disc disease Lumbar Disc Disease Lumbar Discogenic Pain Lumbar Pain Syndrome Lumbar Post-Laminectomy Syndrome Mental Disorders Neurologic Manifestations Pain Pain;Back Low;Chronic Pathological Conditions, Signs and Symptoms Signs and Symptoms Somatoform Disorders post laminectomy syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult, at least 18 years old
  • 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

  • active lesions, skin disruptions, or neuropathy of either ear;
  • recent (<1 month) analgesic procedures or surgery;
  • 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);
  • history of chronic pain in shoulder or thumb (to avoid confounding at control stimulation points);
  • recent (< 3 months) illicit drug use;
  • prior substance misuse/abuse;
  • 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:
  • Pregnancy or active attempts at conception;
  • Implanted metal or electronic device;
  • severe claustrophobia

Treatment and study plan

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.

Other names: von Frey filament

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Monroe, MPH, MBA

CONTACT

[email protected]

412-623-6382

Carly Riedmann, MPH

CONTACT

[email protected]

412-623-4147

Sponsors and collaborators

Lead sponsor

Keith M Vogt

Other

Registry information

Official study title

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

Acronym: ATNI

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Feb 13, 2025
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.