AuriculoTherapy NeuroImaging (ATNI)

Keith M Vogt

Status: Enrolling

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

Treatments: Other: Experimental auricular stimulation; Device: Cryo-auriculotherapy; Device: Sham auriculotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06825390

STUDY24090084

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Active cryo-auriculotherapy first / sham second

Experimental group

Description:

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.

Treatment:

Device: Sham auriculotherapy

Device: Cryo-auriculotherapy

Other: Experimental auricular stimulation

Sham first / active cryo-auriculotherapy second

Experimental group

Description:

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.

Treatment:

Device: Sham auriculotherapy

Device: Cryo-auriculotherapy

Other: Experimental auricular stimulation