AuriculoTherapy NeuroImaging

NCT ID: NCT06825390

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-30
• Study Completion Date: 2029-04-30

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cryo-auriculotherapy

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Cryo-auriculotherapy

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

von Frey filament

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Keith M Vogt

OTHER

Sponsor Role: lead

Responsible Party

Keith M Vogt

Associate Professor of Anesthesiology & Perioperative Medicine and Bioengineering

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Keith M Vogt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh, UPMC

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Carly Riedmann, MPH

Role: CONTACT

riedmannca@upmc.edu

412-623-4147

Amy Monroe, MPH, MBA

Role: CONTACT

monroeal@upmc.edu

412-623-6382

Facility Contacts

Keith M Vogt, MD, PhD

Role: primary

vogtkm@upmc.edu

4126473147

Amy Monroe, MPH, MBA

Role: backup

monroeal@upmc.edu

412-623-6382

Other Identifiers

STUDY24090084

Identifier Type: -

Identifier Source: org_study_id