Auriculotherapy Neuroimaging for Chronic Low Back Pain
This study is investigating how auriculotherapy, a type of ear stimulation, might help people with chronic low back pain. Researchers will use brain imaging to understand its effects. You could be eligible if you are at least 18 years old and have had low back pain daily for at least six months, with an average pain score of 3 out of 10 in the last week. The study will test cryo-auriculotherapy, which uses a device to apply a focused jet of cold to seven small areas on both ears. This is generally not painful and is less invasive than needles. Success will be measured by changes in brain activity, specifically how different parts of the brain respond and connect after receiving the real auriculotherapy compared to a sham (inactive) treatment. The current recruitment status is unclear.
- Study design
- This is a randomized, double-blind, sham-controlled study involving 60 participants. It uses a crossover design, meaning participants will receive both the active and sham treatments at different times.
- What's involved
- You would have four study visits, divided into two pairs. These visits occur before and 5-7 days after receiving either the real or sham auriculotherapy treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Brain activity and connectivity will be measured at baseline, 5-7 days after treatment, and again at 2 months (9 weeks) after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
AuriculoTherapy NeuroImaging
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Keith M Vogt, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh, UPMC
Who to contact
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What this trial measures
- functional near-infrared spectroscopy response, Lumbar spine vs. thumb auricular pointsBaseline 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 stimulationBaseline, 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 stimulationBaseline, 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.