Evaluating Personalized Percutaneous Auricular Vagus Nerve Stimulation with Standard Rehabilitation to Improve Function in Adults With Chronic Back Pain

What this Trial Is About

Researchers are evaluating the use of percutaneous auricular Vagus Nerve Stimulation pVNS combined with standard rehabilitation training in patients with chronic musculoskeletal or myofascial back pain. This pilot study aims to assess the feasibility, efficacy, and safety of personalized pVNS therapy using the VIVO4 wearable medical device, compared to standard care alone, during a 3-week inpatient rehabilitation period. The study builds on previous findings that pairing vagus nerve stimulation with exercise can benefit pain management in stroke and back pain patients. Participants will be randomly assigned to one of two groups the treatment group will receive personalized pVNS therapy alongside standard rehabilitation care, while the control group will receive standard care only. Personalized pVNS involves adjusting the stimulation amplitude to a comfortable tingling sensation at the ear to activate certain nerve fibers without causing pain. Participants and investigators can adjust the stimulation levels using the VIVO4 device during the rehabilitation stay. Treatment lasts for 3 weeks, with optional follow-up periods at 3 and 6 months to evaluate sustained effects. During the study, participants will undergo assessments including questionnaires on pain, disability, usability of the device, quality of life, and mental health. Researchers will monitor pain levels, functional outcomes using the Oswestry Disability Index, and socioeconomic data from baseline through treatment and follow-up. All medications and therapies used by participants will be carefully recorded. The total participation period includes the 3-week treatment and follow-up evaluations to assess lasting benefits and safety.

Percutaneous Auricular Vagus Nerve Stimulation With Conventional Rehabilitation Training in Chronic Back Pain Patients