Study of Cryogenic Auriculotherapy Effects on Brain Imaging in Adults with Chronic Low Back Pain

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.

AuriculoTherapy NeuroImaging