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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active cryo-auriculotherapy first / sham second | Experimental | 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. |
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| Sham first / active cryo-auriculotherapy second | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryo-auriculotherapy | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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);
recent (< 3 months) illicit drug use;
prior substance misuse/abuse;
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:
Pregnancy or active attempts at conception;
Implanted metal or electronic device;
severe claustrophobia
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carly Riedmann, MPH | Contact | 412-623-4147 | riedmannca@upmc.edu | |
| Amy Monroe, MPH, MBA | Contact | 412-623-6382 | monroeal@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Keith M Vogt, MD, PhD | University of Pittsburgh, UPMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
All of the individual participant data collected during the trial will be publicly shared, after deidentification.
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De-identified individual participant data are anticipated to be available via open-access database within one year of study completion.
This will be publicly available.
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1:1 randomized, double-blind, within-subject crossover design for mechanistic neuroimaging clinical trial
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Only the investigator delivering the sham/verum auriculotherapy treatment will know the assignment.
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| Sham auriculotherapy | 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. |
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| Experimental auricular stimulation | 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. |
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| Baseline, 5-7 days; 2 months, 9 weeks |
| Baseline, 5-7 days (before/after active treatment) |
| 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. | Baseline, 5-7 days (before/after active treatment) |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| C535531 | Intervertebral disc disease |
| D013001 | Somatoform Disorders |
| C000711512 | post laminectomy syndrome |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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