RECRUITING

AuriculoTherapy NeuroImaging

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2025-07-30
Study Completion:2029-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06825390

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult, at least 18 years old
  2. 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. 1. active lesions, skin disruptions, or neuropathy of either ear;
  2. 2. recent (\<1 month) analgesic procedures or surgery;
  3. 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. 4. history of chronic pain in shoulder or thumb (to avoid confounding at control stimulation points);
  5. 5. recent (\< 3 months) illicit drug use;
  6. 6. prior substance misuse/abuse;
  7. 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. 8. Pregnancy or active attempts at conception;
  9. 9. Implanted metal or electronic device;
  10. 10. severe claustrophobia

Contacts and Locations

Study Contact

Carly Riedmann, MPH
CONTACT
412-623-4147
riedmannca@upmc.edu
Amy Monroe, MPH, MBA
CONTACT
412-623-6382
monroeal@upmc.edu

Principal Investigator

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

Study Locations (Sites)

University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: Keith M Vogt

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-30
Study Completion Date2029-04-30

Study Record Updates

Study Start Date2025-07-30
Study Completion Date2029-04-30

Terms related to this study

Keywords Provided by Researchers

  • auriculotherapy
  • auricular stimulation
  • functional near-infrared spectroscopy
  • functional magnetic resonance imaging
  • functional connectivity
  • cryo-auriculotherapy

Additional Relevant MeSH Terms

  • 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