Actively Recruiting
Mechanistic Clinical Trial of Auricular Stimulation and Cryogenic Auriculotherapy in Patients With Chronic Low-back Pain Using Functional Near-infrared Spectroscopy and Magnetic Resonance Imaging
Led by Keith M Vogt · Updated on 2026-02-18
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how auriculotherapy, an acupuncture-like stimulation of the ear, may help relieve chronic low back pain lasting at least 6 months. The study is a randomized, double-blind, sham-controlled trial comparing cryo-auriculotherapy, which uses compressed cold gas instead of needles, to a sham procedure. Brain imaging techniques including functional MRI and functional near-infrared spectroscopy (fNIRS) will be used to understand brain responses associated with the treatments. Participants will undergo four visits divided into two pairs. At the first visit, they receive either real or sham cryo-auriculotherapy treatment applied to seven specific points on both ears using the cryo-IQ device. Follow-up imaging occurs 5-7 days later to assess treatment effects. After a 2-month washout period, participants crossover to the other treatment and repeat the same procedures. During all visits, experimental auricular stimulation using non-painful von Frey filaments will also be performed. Throughout the study, researchers will measure brain connectivity and responses to auricular stimulation before and after treatments using fNIRS and MRI scans. They will compare changes after real versus sham cryo-auriculotherapy at baseline and after the crossover. Safety monitoring includes screening for ear conditions and MRI compatibility. The total participation includes baseline, follow-up, and crossover visits over several months to assess the mechanisms of auriculotherapy in chronic low back pain.
CONDITIONS
Brief Title
AuriculoTherapy NeuroImaging
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult, at least 18 years old
- Chronic low back pain occurring daily for at least 6 months
- Average pain score of 3 out of 10 within the last week
You will not qualify if you...
- Active lesions, skin disruptions, or neuropathy of either ear
- Analgesic procedures or surgery within the past month
- New analgesic or psychoactive medication started within the past month
- History of chronic pain in shoulder or thumb
- Illicit drug use within the past 3 months
- Prior substance misuse or abuse
- Cold-activated diseases such as agammaglobulinemia, cold urticaria, or Raynaud's disease
- Pregnancy or active attempts to conceive (MRI-specific exclusion)
- Implanted metal or electronic device (MRI-specific exclusion)
- Severe claustrophobia (MRI-specific exclusion)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day per intervention session
Participants receive either active cryo-auriculotherapy or sham auriculotherapy treatment to specific points on both ears using a device that applies cold gas or a sham procedure. This is followed by brain imaging with functional near-infrared spectroscopy during experimental auricular stimulation using von Frey filaments.
2 visits (initial treatment and follow-up imaging 5-7 days later)
Duration - At least 2 months
Participants have a washout period without treatment to allow effects to dissipate before crossing over to the other intervention.
No visits
Duration - 1 day per intervention session
Participants receive the alternate auriculotherapy intervention (sham or active cryo-auriculotherapy) with the same procedures as the first intervention, followed by brain imaging with functional near-infrared spectroscopy during experimental auricular stimulation.
2 visits (initial treatment and follow-up imaging 5-7 days later)
Trial Site Locations
Total: 1 location
1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
C
Carly Riedmann, MPH
A
Amy Monroe, MPH, MBA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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