Overview
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.
Description
This is a 1:1 randomized, double-blind, sham-controlled, within-subject crossover trial of cyro-auriculotherapy in patients with chronic low back pain. Cryo-auriculotherapy is an effective alternative to needles, in which compressed gas provides focal (~1 mm2) persistent stim of auricular points, with minimal pain. Both before and 5-7 days after (time of peak effect) active vs. sham cryo-AT, resting brain connectivity will be measured with functional MRI and responses to a non-therapeutic experimental auricular stim paradigm (using von Frey filaments) will be recorded with functional near infra-red spectroscopy. After a 2-month washout period, patients will return for the same data collection surrounding the crossover intervention.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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);
- recent (< 3 months) illicit drug use;
- prior substance misuse/abuse;
- cold-activated diseases (including: agammaglobulinemia, cold urticaria, cold
agglutinin disease, cryofibrinogenemia, cryoglobulinemia, immunosuppression,
Raynaud's disease, collagen or autoimmune diseases, multiple myeloma, platelet
deficiency disorders, pyoderma gangrenosum.)
- MRI-specific exclusions additionally include:
- Pregnancy or active attempts at conception;
- Implanted metal or electronic device;
- severe claustrophobia