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
Locations
1Sponsors and collaborators
Keith M Vogt
Lead sponsor
University of Pittsburgh
Sponsor institution