Trans-Auricular Stimulation for Postoperative Inflammation in Spine Surgery

ConditionsSpinal Fusion Hyperglycemia Postoperative Pain Management Postoperative Care Spine Disease Neurologic Deficits Neurological Disorder Inflammation Spine Condition Spinal (Fusion) Surgery Cytokine Levels Spine Fusion

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorAlexander T. Yahanda

About this trial

This study is a randomized controlled trial that will evaluate the effect of non-invasive auricular vagal nerve stimulation on inflammatory markers, glycemic control, postoperative pain, and inflammation-related clinical outcomes after long-segment spinal fusion surgeries when compared to current accepted management.

Eligibility criteria

Qualifiers

Long-segment spinal fusions (defined as constructs spanning at least L2-pelvis for thoracolumbar fusions or C2-T2 for cervical fusions)

Ability to undergo a reliable neurologic examination and pain assessments

Disqualifiers

Patients <18 years of age

Shorter-segment spinal fusions than those described above

Undergoing current active cancer therapy

Undergoing treatment with immunosuppressive drugs

Trial design

Treatments tested in this trial

Auricular vagus nerve stimulation
Sham Auricular Vagus nerve Stimulation

Treatment groups

50 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Alexander T. Yahanda

Lead sponsor

Washington University School of Medicine

Sponsor institution

Source ClinicalTrials.gov