Status:
RECRUITING
Transcutaneous Auricular Neurostimulation After Lumbar Surgery
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Pain, Postoperative
Opioid Use
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 wh...
Detailed Description
This study is designed as a randomized, double-blind, sham-controlled, single-center, clinical trial in which 20 patients undergoing lumbar spine surgery will be randomized 1:1 into one of two treatme...
Eligibility Criteria
Inclusion
- 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
- Current evidence of an uncontrolled and/or clinically significant medical condition
- History of bleeding disorders or coagulopathy
- History of seizures or epilepsy
- History of neurological diseases or traumatic brain injury
- Use of illegal recreational drugs
- Presence of devices, e.g. pacemakers, cochlear prosthesis, neuro-stimulators
- Use of acupuncture within 4 weeks of surgery
- Grossly abnormal external ear anatomy or active ear infection
- Women of childbearing potential, not using effective contraception per investigator judgment or not willing to comply with contraception for the duration of the study
- Females who are pregnant or lactating
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
Key Trial Info
Start Date :
October 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06100172
Start Date
October 29 2024
End Date
December 1 2027
Last Update
December 15 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390