Ear-Zapping device may quiet lupus pain and fatigue

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * SLE (defined by the ACR or SLICC criteria), * Musculoskeletal pain ≥ 4 on a non-anchored VAS 10 cm scale, * BILAG C or greater on the Musculoskeletal Domain of the BILAG 2004, * If on corticosteroids, the dose must be stable and ≤ 10 mg/day (prednisone or equivalent) for at least 14 days before baseline, * If on background immunosuppressive treatment the dose must be stable for at least 28 days before baseline, * If on NSAIDS, the dose must be stable for at least 7 days before baseline and the subject must be willing not to change the dose during the trial (except for toxicity), * Able and willing to give written informed consent and comply with the requirements of the study protocol. Exclusion Criteria: * Initiation of immunosuppressive or antimalarial treatment within 3 months of baseline, * Treatment with cyclophosphamide within 2 months of baseline, * Initiation of anifrolumab within 3 months of baseline * Initiation of belimumab within 6 months of baseline, * Expectation to increase steroids and/or immunosuppressive treatment, * Anti-phospholipid syndrome, * Fibromyalgia, * Treatment with an anti-cholinergic medication, including over the counter medications, * Any implantable electronic devices including pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators, * Current tobacco or nicotine user (to limit potential confounding effects of exposure to nicotine), * Joint replacement within 60 days prior to study enrollment or planned within the course of the study, * Any planned surgical procedure requiring general anesthesia within the course of the study, * Intra-articular cortisone injections within 28 days of the start of study, * Chronic inflammatory disorders apart from SLE affecting the joints, * Investigational drug and/or treatment during the 28 days or seven half-lives of the investigational drug prior to the start of study drug dosing (Day 0), whichever is the greater length of time, * Active infection including hepatitis B or hepatitis C at baseline, * Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention, * Pregnancy or lactation (Pregnancy status will be determined via serum blood test \& lactation will be determined via self-report), * Comorbid disease that has previously required administration of corticosteroid use, * Known allergy to mannitol or lactulose, * Chronic treatment with narcotic medication, * Prior receipt of transauricular vagus nerve stimulation in a clinical trial, * Inability to comply with study and follow-up procedures.