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AuriculoTherapy NeuroImaging

Description

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.

Conditions

Low Back PainChronic Low-back PainBack Pain, LowLumbar Disc DiseaseLumbar Discogenic PainLumbar Pain SyndromeLumbar Post-Laminectomy SyndromeBack Pain Lower Back ChronicBack Pain Without RadiationPain;Back Low;Chronic
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Related Conditions:

Low Back PainChronic Low-back PainBack Pain, LowLumbar Disc DiseaseLumbar Discogenic PainLumbar Pain SyndromeLumbar Post-Laminectomy SyndromeBack Pain Lower Back ChronicBack Pain Without RadiationPain;Back Low;Chronic

Study Overview

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Study Details

Study 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.

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

AuriculoTherapy NeuroImaging

Condition
Low Back Pain
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

University of Pittsburgh, Pittsburgh, Pennsylvania, United States, 15213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.)
  • 8. Pregnancy or active attempts at conception;
  • 9. Implanted metal or electronic device;
  • 10. severe claustrophobia

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Keith M Vogt,

Keith M Vogt, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh, UPMC

Study Record Dates

2029-04-30