Non-invasive pain management after lumbar fusion surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.