AuriculoTherapy NeuroImaging

Keith M Vogt60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Low Back Pain

Interventions

Cryo-auriculotherapyDEVICE

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 auriculotherapyDEVICE

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 stimulationOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

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

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.

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

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.