Recruiting

Auriculotherapy

Sponsor:

Keith M Vogt

Code:

NCT06825390

Conditions

Low Back Pain

Chronic Low-back Pain

Back Pain, Low

Lumbar Disc Disease

Lumbar Discogenic Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cryo-auriculotherapy

Sham auriculotherapy

Experimental auricular stimulation

Study Details

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

Low Back Pain

Chronic Low-back Pain

Back Pain, Low

Lumbar Disc Disease

Lumbar Discogenic Pain

Study ID

NCT06825390

Start date

Jul 30, 2025

Status verified date

Feb, 2026

Completion date

Apr 30, 2029

Anticipated

Primary completion date

Apr 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

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.

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.

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.

Primary outcome measure

  • functional near-infrared spectroscopy response, Lumbar spine vs. thumb auricular points [ Time Frame: 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Carly Riedmann, MPH

412-623-4147riedmannca@upmc.edu

Amy Monroe, MPH, MBA

412-623-6382monroeal@upmc.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Keith M Vogt, MD, PhD

4126473147vogtkm@upmc.edu

Amy Monroe, MPH, MBA

412-623-6382monroeal@upmc.edu

More Information

Sponsor

Keith M Vogt

Last update posted

Feb 18, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Keith M Vogt on 2026-02-18.