AuriculoTherapy NeuroImaging

NCT06825390 | Recruiting FDA Device

• 1 other identifier: STUDY24090084
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

auriculotherapy; auricular stimulation; functional near-infrared spectroscopy; functional magnetic resonance imaging; functional connectivity; cryo-auriculotherapy

Outcome Measures

Primary Outcomes (3)

• functional near-infrared spectroscopy response, Lumbar spine vs. thumb auricular points

  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

  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

  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 Outcomes (2)

• Change in fNIRS response for Lumbar auricular point, for post- vs. pre- verum auriculotherapy, comparing male vs. female participants

  Baseline, 5-7 days (before/after active treatment)

• Change in functional connectivity, for post- vs. pre- verum auriculotherapy, comparing male vs. female participants

  Baseline, 5-7 days (before/after active treatment)

Study Arms (2)

Active cryo-auriculotherapy first / sham second

EXPERIMENTAL

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; Device: Sham auriculotherapy; Other: Experimental auricular stimulation

Sham first / active cryo-auriculotherapy second

EXPERIMENTAL

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; Device: Sham auriculotherapy; Other: Experimental auricular stimulation

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.

Active cryo-auriculotherapy first / sham second; Sham first / active cryo-auriculotherapy second

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.

Active cryo-auriculotherapy first / sham second; Sham first / active cryo-auriculotherapy second

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.

Also known as: von Frey filament

Active cryo-auriculotherapy first / sham second; Sham first / active cryo-auriculotherapy second

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)
• Pregnancy or active attempts at conception;
• Implanted metal or electronic device;
• severe claustrophobia

Sponsors & Collaborators

• Keith M Vogt: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Low Back Pain; Intervertebral disc disease; Somatoform Disorders; post laminectomy syndrome; Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Keith M Vogt, MD, PhD

  University of Pittsburgh, UPMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carly Riedmann, MPH

CONTACT

412-623-4147; riedmannca@upmc.edu

Amy Monroe, MPH, MBA

CONTACT

412-623-6382; monroeal@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the investigator delivering the sham/verum auriculotherapy treatment will know the assignment.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology & Perioperative Medicine and Bioengineering

Model Details: 1:1 randomized, double-blind, within-subject crossover design for mechanistic neuroimaging clinical trial

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 13, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: De-identified individual participant data are anticipated to be available via open-access database within one year of study completion.
• Access Criteria: This will be publicly available.

Locations

US (1)