Transcutaneous Auricular Neurostimulation After Lumbar Surgery (NCT06100172) | Clinical Trial Compass
RecruitingNot Applicable
Transcutaneous Auricular Neurostimulation After Lumbar Surgery
United States20 participantsStarted 2024-10-29
Plain-language summary
The purpose of this study, entitled "Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Non-Opioid Pain Management Therapy for Patients Undergoing Lumbar Surgery", is to demonstrate whether transcutaneous auricular neurostimulation (tAN) can non-invasively reduce the perception of pain in patients undergoing lumbar surgery. tAN is placed on and around the ear to non-invasively stimulate branches of the vagus and trigeminal nerves and modulate specific brain regions associated with pain.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Medically cleared to undergo a lumbar spine surgery, either spinal fusion with or without multilevel laminectomies, or lumbar multilevel laminectomies alone.
. 18-85 years of age
. English Proficiency
. Participants must be able to provide informed consent and function at an intellectual level sufficient for study requirements
Exclusion criteria
. Current evidence of an uncontrolled and/or clinically significant medical condition
. History of bleeding disorders or coagulopathy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 3 hours post-operation
Timeframe: Baseline, 3 hours post-operation
2
Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 6 hours post-operation
Timeframe: Baseline, 6 hours post-operation
3
Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at day 2 post-operation
Timeframe: Baseline, day 2 post-operation
4
Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at day 14 post-operation
Timeframe: Baseline, day 14 post-operation
Trial details
NCT IDNCT06100172
SponsorUniversity of Texas Southwestern Medical Center