Clinical trial NCT06825390: AuriculoTherapy NeuroImaging
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Low Back Pain
Chronic Low-back Pain
Back Pain, Low
Lumbar Disc Disease
Lumbar Discogenic Pain
Lumbar Pain Syndrome
Lumbar Post-Laminectomy Syndrome
Back Pain Lower Back Chronic
Back Pain Without Radiation
Pain;Back Low;Chronic
Keywords: auriculotherapy
auricular stimulation
functional near-infrared spectroscopy
functional magnetic resonance imaging
functional connectivity
cryo-auriculotherapy
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 1:1 randomized, double-blind, within-subject crossover design for mechanistic neuroimaging clinical trial
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed 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 criteria: Inclusion Criteria:

1. Adult, at least 18 years old
2. 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:

1. active lesions, skin disruptions, or neuropathy of either ear;
2. recent (\<1 month) analgesic procedures or surgery;
3. 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);
4. history of chronic pain in shoulder or thumb (to avoid confounding at control stimulation points);
5. recent (\< 3 months) illicit drug use;
6. prior substance misuse/abuse;
7. 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:
8. Pregnancy or active attempts at conception;
9. Implanted metal or electronic device;
10. severe claustrophobia

Primary outcomes:
measure: functional near-infrared spectroscopy response, Lumbar spine vs. thumb auricular points
timeFrame: Baseline visit, over 10 minutes of data collection
measure: Change in fNIRS response for Lumbar auricular point, for post- vs. pre- verum auriculotherapy, compared to post- vs. pre- sham auricular stimulation
timeFrame: Baseline, 5-7 days; 2 months, 9 weeks
measure: Change in functional connectivity, for post- vs. pre- verum auriculotherapy, compared to post- vs. pre- sham auricular stimulation
timeFrame: Baseline, 5-7 days; 2 months, 9 weeks
Secondary outcomes:
Other outcomes:
measure: Change in fNIRS response for Lumbar auricular point, for post- vs. pre- verum auriculotherapy, comparing male vs. female participants
timeFrame: Baseline, 5-7 days (before/after active treatment)
measure: Change in functional connectivity, for post- vs. pre- verum auriculotherapy, comparing male vs. female participants
timeFrame: Baseline, 5-7 days (before/after active treatment)
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh, UPMC
name: Keith M Vogt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: