Back Pain, Low, Back Pain Lower Back Chronic, Back Pain Without Radiation, Chronic Low-back Pain, Low Back Pain, Lumbar Disc Disease, Lumbar Discogenic Pain, Lumbar Pain Syndrome, Lumbar Post-Laminectomy Syndrome, Pain;Back Low;Chronic
Conditions
Keywords
auriculotherapy, auricular stimulation, functional near-infrared spectroscopy, functional magnetic resonance imaging, functional connectivity, cryo-auriculotherapy
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.
Interventions
DEVICECryo-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.
DEVICESham 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.
OTHERExperimental 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.
Sponsors
Keith M Vogt
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Only the investigator delivering the sham/verum auriculotherapy treatment will know the assignment.
Intervention model description
1:1 randomized, double-blind, within-subject crossover design for mechanistic neuroimaging clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| functional near-infrared spectroscopy response, Lumbar spine vs. thumb auricular points | Baseline visit, over 10 minutes of data collection | 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 | Baseline, 5-7 days; 2 months, 9 weeks | 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 | Baseline, 5-7 days; 2 months, 9 weeks | 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. |
Countries
United States
Contacts
CONTACTCarly Riedmann, MPH
CONTACTAmy Monroe, MPH, MBA
PRINCIPAL_INVESTIGATORKeith M Vogt, MD, PhD
University of Pittsburgh, UPMC
Outcome results
None listed