Trans-Auricular Stimulation for Postoperative Inflammation in Spine Surgery
Alexander T. Yahanda
Summary
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.
Description
Long-segment spinal fusions are effective interventions to relieve pain, neurological compromise, or disability related to a variety of causes of advanced spinal degeneration or spinal deformity. Despite advancements in minimally invasive spine surgery, revision of prior instrumentation, correction of coronal or sagittal imbalance, bony decompression, and multilevel arthrodesis often must be performed via open surgery. While these procedures can produce excellent results with regards to postoperative alignment, neural decompression, and functional improvement, they are long and invasive cases…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * Patients \<18 years of age * Shorter-segment spinal fusions than those described above * Undergoing current active cancer therapy * Undergoing treatment with immunosuppressive drugs * Additional spinal surgery within past 6 months * Sustained bradycardia or presence of pacemaker * History of substance abuse
Interventions
- DeviceAuricular vagus nerve stimulation
Transcutaneous auricular vagal nerve stimulation
- DeviceSham Auricular Vagus nerve Stimulation
Transcutaneous auricular vagal nerve stimulator applied without utilizing stimulating current.
Location
- Washington University School of MedicineSt Louis, Missouri