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.
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.
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);
Crossover
Cryo-auriculotherapy
DeviceThe 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
DeviceFor 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
Other interventionThree 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.
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.
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.
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.
Change in fNIRS response for Lumbar auricular point, for post- vs. pre- verum auriculotherapy, comparing male vs. female participants
fNIRS stimulation data from the after and before active auriculotherapy treatment will be analyzed for changes, performing a group level comparison between male and female participants. This will reveal sex-based differences in brain-response to auricular stimulation following auriculotherapy. A group-level T-statistic for the described contrast will be calculated from as a single summary statistic reflecting the overall magnitude of difference in brain response after/before auriculotherapy treatment for males vs. females. A T-statistic of 0 indicates no difference; larger positive values indicate greater change in response for males \> females. Larger negative T-statistics will indicate a larger change in response for females \> males. Dispersion measures cannot be calculated for the T-statistic in this analysis framework.
Change in functional connectivity, for post- vs. pre- verum auriculotherapy, comparing male vs. female participants
MRI data from the after and before active auriculotherapy treatment will be analyzed for changes in functional connectivity, performing a group level comparison between male and female participants. This will reveal sex-based differences in response to auriculotherapy. 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 for males vs. females. A T-statistic of 0 indicates no difference; larger positive values indicate greater change in connectivity for males \> females. Larger negative T-statistics will indicate a larger change in connectivity for females \> males. Dispersion measures cannot be calculated for the T-statistic in this analysis framework.
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Keith M Vogt
Lead sponsor
University of Pittsburgh
Sponsor institution
