[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579522":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":37,"centralContacts":42,"locations":52,"responsibleParty":71,"collaborators":26,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":26,"enrollmentInfo":85,"targetDuration":26,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":103,"overallStatus":54,"whyStopped":26,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Active cryo-auriculotherapy first \u002F sham second","EXPERIMENTAL","Participants randomly assigned to Group 1 will receive verum cryo-auriculotherapy treatment first, at the end of visit 1. They will return 5-7 days later for follow-up imaging (visit 2). After at least a 2 month wash-out period, all will return for their third visit, which will end with sham auricular intervention. Visit 4 is the second follow-up imaging session. All visits involve fNIRS imaging with auricular stimulation using von Frey filaments, prior to sham\u002Fcryo intervention.",[13,14,15],"Device: Cryo-auriculotherapy","Device: Sham auriculotherapy","Other: Experimental auricular stimulation",{"label":17,"type":10,"description":18,"interventionNames":19},"Sham first \u002F active cryo-auriculotherapy second","Participants randomly assigned to Group 2 will receive sham auricular intervention first, at the end of visit 1. They will return 5-7 days later for follow-up imaging (visit 2). After at least a 2 month wash-out period, all will return for their third visit, which ends with verum cryo-auriculotherapy treatment. Visit 4 is the second follow-up imaging session. All visits involve fNIRS imaging with auricular stimulation using von Frey filaments, prior to sham\u002Fcryo intervention.",[13,14,15],[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Cryo-auriculotherapy","The cryo-IQ device (containing compressed nitrous oxide) with a narrow-tip nozzle will be used. After disinfection of the device and both ears, 7 inter-related points in the auricular cartography will be treated with a 1-2 second application of cold gas, applied to both ears. Treatment points will be: mesoderm master, spine, reticular formation, sensory master point, thalamus, adrenocorticotropic hormone, and corpus callosum.",[9,17],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham auriculotherapy","For the sham procedure, an empty gas canister will be used in the cryo-IQ device. This will make the same noise and temporary skin imprint on the ear, but does not deliver any cooling effect. The same 7 ear points will be sham-treated in a protocol that is imperceptibly different from the verum auriculotherapy treatment.",[9,17],{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Experimental auricular stimulation","Three points on each ear will be repeatedly stimulated with a plastic (von Frey) filament. This will be felt, but not be painful and should not result in lasting irritation.",[9,17],[36],"von Frey filament",[38],{"name":39,"affiliation":40,"role":41},"Keith M Vogt, MD, PhD","University of Pittsburgh, UPMC","PRINCIPAL_INVESTIGATOR",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":26,"email":47},"Carly Riedmann, MPH","CONTACT","412-623-4147","riedmannca@upmc.edu",{"name":49,"role":45,"phone":50,"phoneExt":26,"email":51},"Amy Monroe, MPH, MBA","412-623-6382","monroeal@upmc.edu",[53],{"facility":5,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"RECRUITING","Pittsburgh","Pennsylvania","15213","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-79.99589,40.44062,{"lat":64,"lon":63},[67,70],{"name":39,"role":45,"phone":68,"phoneExt":26,"email":69},"4126473147","vogtkm@upmc.edu",{"name":49,"role":45,"phone":50,"phoneExt":26,"email":51},{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Keith M Vogt","Associate Professor of Anesthesiology & Perioperative Medicine and Bioengineering","100579522","auriculotherapy-neuroimaging-100579522",false,"NCT06825390","AuriculoTherapy NeuroImaging","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","ATNI","Inclusion Criteria:\n\n1. Adult, at least 18 years old\n2. 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\u002F10.\n\nExclusion Criteria:\n\n1. active lesions, skin disruptions, or neuropathy of either ear;\n2. recent (\\\u003C1 month) analgesic procedures or surgery;\n3. recent (\\\u003C1 month) start of new analgesic or psychoactive medication (including marijuana, opioids, tramadol, methadone, gabapentinoids, anti-depressants, anti-epileptics, mood-stabilizers, anti-psychotics, or stimulants);\n4. history of chronic pain in shoulder or thumb (to avoid confounding at control stimulation points);\n5. recent (\\\u003C 3 months) illicit drug use;\n6. prior substance misuse\u002Fabuse;\n7. 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.)\n\n   \\- MRI-specific exclusions additionally include:\n8. Pregnancy or active attempts at conception;\n9. Implanted metal or electronic device;\n10. severe claustrophobia","ALL","18 Years",{"count":86,"type":87},60,"ESTIMATED","INTERVENTIONAL",[90],"NA","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.",[93,94,95,96,97,98,99,100,101,102],"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",[104,105,106,107,108,109],"auriculotherapy","auricular stimulation","functional near-infrared spectroscopy","functional magnetic resonance imaging","functional connectivity","cryo-auriculotherapy","2026-02-13",{"date":112,"type":113},"2026-02-18","ACTUAL",{"date":115,"type":113},"2025-07-30",{"date":117,"type":87},"2029-04-30",{"name":73,"class":6},1]