Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Non-Opioid Pain Management Therapy for Patients Undergoing Lumbar Fusion Surgery

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study, entitled Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Non-Opioid Pain Management Therapy for Patients Undergoing Lumbar Fusion Surgery, is to demonstrate whether transcutaneous auricular neurostimulation (tAN) can non-invasively reduce the perception of pain in patients undergoing lumbar fusion 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
United States
Texas
UT Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Alex Valadka, MD
alex.valadka@utsouthwestern.edu
214-645-2300
Backup
Aisha Qureshi
aisha.qureshi@utsouthwestern.com
214-648-9905
Time Frame
Start Date: 2024-10-29
Estimated Completion Date: 2025-12
Participants
Target number of participants: 20
Treatments
Active_comparator: Active tAN + standard of care (SOC) for post-operative pain management for lumbar fusion patients.
Subjects will be randomized to receive the active device on the day of surgery.~Subjects will receive treatment according to the following time points:~* Pre-operative: 30 minutes in the hour prior to surgery~* Intra-operative: 30 minutes before the end of surgery~* Post-operative: 30 minutes at 3 and 6 hours after surgery~* Inpatient: Four 30-minute sessions on Day 2
Placebo_comparator: Sham tAN + standard of care (SOC) for post-operative pain management for lumbar fusion patients.
Subjects will be randomized to receive the sham device on the day of surgery.~Subjects will receive treatment according to the following time points:~* Pre-operative: 30 minutes in the hour prior to surgery~* Intra-operative: 30 minutes before the end of surgery~* Post-operative: 30 minutes at 3 and 6 hours after surgery~* Inpatient: Four 30-minute sessions on Day 2
Related Therapeutic Areas
Sponsors
Leads: University of Texas Southwestern Medical Center

This content was sourced from clinicaltrials.gov