Non-invasive pain management after lumbar fusion surgery
Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Non-Opioid Pain Management Therapy for Patients Undergoing Lumbar Surgery
This study is testing if a new non-opioid pain relief method called transcutaneous auricular neurostimulation can help people feel less pain after lumbar fusion surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06100172 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of transcutaneous auricular neurostimulation (tAN) as a non-opioid pain management therapy for patients undergoing lumbar fusion surgery. In a randomized, double-blind, sham-controlled design, 20 participants will be assigned to receive either active tAN or a sham treatment alongside standard care. The tAN will be administered at various time points before, during, and after surgery, with follow-up visits scheduled to assess outcomes. Blood samples will also be collected to evaluate physiological responses to the treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 who are medically cleared for lumbar fusion surgery and can provide informed consent.
Not a fit: Patients with uncontrolled medical conditions, neurological disorders, or those using certain medical devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide an effective non-opioid alternative for pain management in postoperative patients.
How similar studies have performed: While the use of tAN is a novel approach in this context, similar non-invasive techniques have shown promise in pain management in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Medically cleared to undergo a lumbar spine surgery, either spinal fusion with or without multilevel laminectomies, or lumbar multilevel laminectomies alone. 2. 18-85 years of age 3. English Proficiency 4. Participants must be able to provide informed consent and function at an intellectual level sufficient for study requirements Exclusion Criteria: 1. Current evidence of an uncontrolled and/or clinically significant medical condition 2. History of bleeding disorders or coagulopathy 3. History of seizures or epilepsy 4. History of neurological diseases or traumatic brain injury 5. Use of illegal recreational drugs 6. Presence of devices, e.g. pacemakers, cochlear prosthesis, neuro-stimulators 7. Use of acupuncture within 4 weeks of surgery 8. Grossly abnormal external ear anatomy or active ear infection 9. Women of childbearing potential, not using effective contraception per investigator judgment or not willing to comply with contraception for the duration of the study 10. Females who are pregnant or lactating 11. 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
Where this trial is running
Dallas, Texas
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Alex Valadka, MD — University of Texas Southwestern Medical Center
- Study coordinator: Alex Valadka, MD
- Email: alex.valadka@utsouthwestern.edu
- Phone: 214-645-2300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.