About this trial

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.

Eligibility criteria

Qualifiers

Adult, at least 18 years old

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.

Disqualifiers

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);

Trial design

Treatments tested in this trial

  • Cryo-auriculotherapy
  • Sham auriculotherapy
  • Experimental auricular stimulation

Treatment groups

60 Participants
are divided into 2 treatment groups

Locations

1
University of Pittsburgh15213, PittsburghPennsylvania, United States

Sponsors and collaborators

Keith M Vogt

Lead sponsor

University of Pittsburgh

Sponsor institution