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NCT Number: NCT06100172

Transcutaneous Auricular Neurostimulation After Lumbar Surgery

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.

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Key information

Conditions

Pain, Postoperative Back Injuries Lumbar Spine Injury Neurologic Manifestations Opioid Use Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Spinal Injuries Wounds and Injuries

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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 treatment groups:

  • Group 1 (n=10): Active tAN + standard care
  • Group 2 (n=10): Sham tAN + standard care

Stimulation:

Participants undergoing lumbar surgery will be randomized to receive either active or sham tAN 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

Blood Draws

Participants will have blood samples collected at the following time points:

  • Day 1 (Day of Surgery)
  • Day 2 (Day 1 post-surgical)

Follow up Visits Participants will have study follow up visits on Days 7 and Day 14. These visits can either be conducted either via a secure telehealth video visit, or in person visit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)

Device

This method of simultaneous vagal and trigeminal stimulation via the external ear is known as transcutaneous auricular neurostimulation (tAN), as the targets of electrical stimulation include the auricular branch of the vagus nerve (ABVN) and auriculotemporal nerve (ATN), which is a branch of the mandibular division of the trigeminal nerve. Electrodes applied to select dermatome regions can target ear neural structures and deliver non-invasive vagus nerve stimulation (VNS) and trigeminal nerve stimulation (TNS). Use of tAN for pain relief is an attractive alternative to pharmacologic and opioid-based approaches because it is safe and effective and presents no addiction liability.

Sham Control Device

Device

This device looks like the active device, but no stimulation will be delivered.

Primary outcomes

  1. Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 3 hours post-operation

    Time frame: Baseline, 3 hours post-operation

    Patients will be asked to report their level of pain using the Visual Analog Scale. Possible scores for VAS pain scale ranges from 0-10 where 0="no pain" to 10="severe pain"

  2. Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 6 hours post-operation

    Time frame: Baseline, 6 hours post-operation

    Patients will be asked to report their level of pain using the Visual Analog Scale. Possible scores for VAS pain scale ranges from 0-10 where 0="no pain" to 10="severe pain"

  3. Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at day 2 post-operation

    Time frame: Baseline, day 2 post-operation

    Patients will be asked to report their level of pain using the Visual Analog Scale. Possible scores for VAS pain scale ranges from 0-10 where 0="no pain" to 10="severe pain"

  4. Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at day 14 post-operation

    Time frame: Baseline, day 14 post-operation

    Patients will be asked to report their level of pain using the Visual Analog Scale. Possible scores for VAS pain scale ranges from 0-10 where 0="no pain" to 10="severe pain"

Secondary outcomes

  1. Mean total postoperative opioid consumption (morphine equivalent dose) at 3 hours post-surgery

    Time frame: 3 hours post-surgery

    During the in-patient hospital stay, the dose and frequency of post -operative opioid use will recorded for both the placebo and active groups. The opioid usage between the 2 groups will be compared to determine if the active group required less opioid medications for pain reduction.

  2. Mean total postoperative opioid consumption (morphine equivalent dose) at 6 hours post-surgery

    Time frame: 6 hours post-surgery

    During the in-patient hospital stay, the dose and frequency of post -operative opioid use will recorded for both the placebo and active groups. The opioid usage between the 2 groups will be compared to determine if the active group required less opioid medications for pain reduction.

  3. Mean total postoperative opioid consumption (morphine equivalent dose) at Day 2 post-surgery

    Time frame: Day 2 post-surgery

    During the in-patient hospital stay, the dose and frequency of post -operative opioid use will recorded for both the placebo and active groups. The opioid usage between the 2 groups will be compared to determine if the active group required less opioid medications for pain reduction.

  4. Mean total postoperative opioid consumption (morphine equivalent dose) at Day 7 post-surgery

    Time frame: Day 7 post-surgery

    During the in-patient hospital stay, the dose and frequency of post -operative opioid use will recorded for both the placebo and active groups. The opioid usage between the 2 groups will be compared to determine if the active group required less opioid medications for pain reduction.

  5. Mean total postoperative opioid consumption (morphine equivalent dose) at Day 14 post-surgery

    Time frame: Day 14 post-surgery

    During the in-patient hospital stay, the dose and frequency of post -operative opioid use will recorded for both the placebo and active groups. The opioid usage between the 2 groups will be compared to determine if the active group required less opioid medications for pain reduction.

  6. Mean percent change in C-reactive protein (CRP) levels from baseline at Day 1 (intra-op)

    Time frame: Baseline and at Day 1 (intra-op)

    CRP blood samples collected will be used to measure the amount of inflammation in the body at the time points stated, and changes will be recorded and compared between the 2 groups. Plasma levels of C-reactive protein will be determined by the immunoprecipitation method using an in vitro diagnostic assay.

  7. Mean percent change in C-reactive protein (CRP) levels from baseline at 6 hours post-op

    Time frame: Baseline and at 6 hours post-op

    CRP blood samples collected will be used to measure the amount of inflammation in the body at the time points stated, and changes will be recorded and compared between the 2 groups. Plasma levels of C-reactive protein will be determined by the immunoprecipitation method using an in vitro diagnostic assay.

  8. Mean percent change in C-reactive protein (CRP) levels from baseline at Day 2 post-op

    Time frame: Baseline and at Day 2 post-op

    CRP blood samples collected will be used to measure the amount of inflammation in the body at the time points stated, and changes will be recorded and compared between the 2 groups. Plasma levels of C-reactive protein will be determined by the immunoprecipitation method using an in vitro diagnostic assay.

  9. Mean percent change in Tumor Necrosis factor (TNF)-alpha levels from baseline at Day 1 (intra-op)

    Time frame: Baseline and at Day 1 (intra-op)

    TNF-alpha blood samples collected will be used to measure the amount of inflammation in the body at the time points stated, and changes will be recorded and compared between the 2 groups.

  10. Mean percent change in TNF-alpha levels from baseline at 6 hours post-op

    Time frame: Baseline and at 6 hours post-op

    TNF-alpha blood samples collected will be used to measure the amount of inflammation in the body at the time points stated, and changes will be recorded and compared between the 2 groups.

  11. Surgery time (incision to closure)

    Time frame: Day 1- during surgery [Surgery start (incision) to closure of surgical site]

    A comparison of the surgery times from incision to closure will be compared between the 2 groups to determine if the tAN affects the surgery time. The times will be recorded for each case, and then compared between the two groups. Surgery time - calculated as time from first incision to closure.

  12. Estimated mean total blood loss

    Time frame: Day 1- During surgery [Surgery start (incision) to closure]

    During surgery, blood will be collected using cell saver technology which allows for accurate recording of total blood loss. The volume of blood loss will be recorded for each case, and then the 2 groups will be compared. Comparison is based on end volume recorded at incision closure.

Study contacts

Contact information is provided by the study sponsor or research team.

Alex Valadka, MD

CONTACT

[email protected]

214-645-2300

Tyfe Oderinde, MS

CONTACT

[email protected]

214-648-9905

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 25, 2023
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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