Auricular Vagus Nerve Stimulation Using the VIVO4 Device Added to Standard Care for Adults Aged 30 to 60 with High-Impact Chronic Low Back Pain

What this Trial Is About

Researchers are evaluating whether auricular vagus nerve stimulation aVNS using the VIVO4 device can improve function and reduce pain when added to standard medical care for adults aged 30 to 60 with high-impact chronic low back pain. This prospective, open-label, randomized controlled trial aims to assess the effectiveness, safety, and usability of aVNS compared to standard care alone. The study addresses the need for additional treatments due to insufficient relief from current therapies. Participants are randomly assigned to either standard care alone or standard care combined with the VIVO4 device. Those in the intervention group wear the VIVO4 device on the ear continuously for six weeks, with weekly device replacement alternating ears, and can adjust stimulation intensity using a handheld controller. Standard care may involve medications, physiotherapy, or other treatments as prescribed by their physician. The treatment phase lasts six weeks, followed by a 12-month follow-up to monitor long-term effects, safety, and usability. During the study, participants attend a baseline visit for medical history, physical exam, and questionnaires on pain, function, mood, sleep, and quality of life. Weekly visits occur during treatment to assess clinical outcomes and safety. Participants keep diaries of pain levels and treatments used. Outcomes measured include changes in disability using the Oswestry Disability Index after six weeks, as well as pain intensity, quality of life, mood, sleep, neuropathic pain features, employment status, medication use, satisfaction, and adverse events throughout follow-up. Safety and usability are monitored continuously over 12 months.

Auricular Vagus Nerve Stimulation in Patients With High Impact Chronic Low Back Pain