Pain, PostoperativeNCT06100172
Transcutaneous Auricular Neurostimulation After Lumbar Surgery
A study testing Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) in people with Pain, Postoperative and Opioid Use, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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 whether transcutaneous auricular neurostimulation (tAN) can non-invasively reduce the perception of pain in patients… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pain, Postoperative, Opioid Use, Lumbar Spine Injury
- What is being tested?
- Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Alex Valadka, MD, 214-645-2300, alex.valadka@utsouthwestern.edu
Tyfe Oderinde, MS, 214-648-9905, Bolutyfe.Oderinde@utsouthwestern.edu
About this study
Official title: Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Non-Opioid Pain Management Therapy for Patients Undergoing 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.
Read the 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 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.
- Conditions
- Pain, Postoperative, Opioid Use, Lumbar Spine Injury
- Being tested
- Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN), Sham Control Device
- Keywords
- Lumbar Surgery, Transcutaneous auricular neurostimulation (tAN)
- Medical subject headings
- Pain, Postoperative, Spinal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 DeviceDevice
This device looks like the active device, but no stimulation will be delivered.
| Study group | Role | What they receive |
|---|---|---|
| Active tAN + standard of care (SOC) for post-operative pain management for lumbar spine patients. | Active comparator | 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 Receives: Device: Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) |
| Sham tAN + standard of care (SOC) for post-operative pain management for lumbar spine patients. | Placebo comparator | 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 Receives: Device: Sham Control Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 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"
Measured: Baseline, 3 hours post-operation
Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 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"
Measured: Baseline, 6 hours post-operation
Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 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"
Measured: Baseline, day 2 post-operation
Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 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"
Measured: Baseline, day 14 post-operation
Secondary outcomes (12)
Mean total postoperative opioid consumption (morphine equivalent dose) at 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.
Measured: 3 hours post-surgery
Mean total postoperative opioid consumption (morphine equivalent dose) at 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.
Measured: 6 hours post-surgery
Mean total postoperative opioid consumption (morphine equivalent dose) at 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.
Measured: Day 2 post-surgery
Mean total postoperative opioid consumption (morphine equivalent dose) at 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.
Measured: Day 7 post-surgery
Mean total postoperative opioid consumption (morphine equivalent dose) at 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.
Measured: Day 14 post-surgery
Mean percent change in C-reactive protein (CRP) levels from baseline 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.
Measured: Baseline and at Day 1 (intra-op)
Mean percent change in C-reactive protein (CRP) levels from baseline 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.
Measured: Baseline and at 6 hours post-op
Mean percent change in C-reactive protein (CRP) levels from baseline 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.
Measured: Baseline and at Day 2 post-op
Mean percent change in Tumor Necrosis factor (TNF)-alpha levels from baseline 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.
Measured: Baseline and at Day 1 (intra-op)
Mean percent change in TNF-alpha levels from baseline 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.
Measured: Baseline and at 6 hours post-op
Surgery time (incision to closure)
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.
Measured: Day 1- during surgery [Surgery start (incision) to closure of surgical site]
Estimated mean total blood loss
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.
Measured: Day 1- During surgery [Surgery start (incision) to closure]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start29 Oct 2024
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double blind, sham controlled.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex Valadka, University of Texas Southwestern Medical Center
- Investigators
- Alex Valadka, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100172
- Sponsor's protocol ID
- STU-2023-0197
- Status last verified
- Dec 2025
- First submitted
- 14 Sep 2023
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Non-Opioid Pain Management Therapy for Patients Undergoing Lumbar Surgery
- ClinicalTrials.gov ID
- NCT06100172
- Acronym / sponsor ID
- STU-2023-0197
- Conditions
- Pain, Postoperative, Opioid Use, Lumbar Spine Injury
- Keywords
- Lumbar Surgery, Transcutaneous auricular neurostimulation (tAN)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double blind, sham controlled.
| Arm | Type | Receives |
|---|---|---|
| Active tAN + standard of care (SOC) for post-operative pain management for lumbar spine patients. | Active comparator | Device: Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)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 |
| Sham tAN + standard of care (SOC) for post-operative pain management for lumbar spine patients. | Placebo comparator | Device: Sham Control DeviceSubjects 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)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. | Device | Active tAN + standard of care (SOC) for post-operative pain management for lumbar spine patients. |
| Sham Control DeviceThis device looks like the active device, but no stimulation will be delivered. | Device | Sham tAN + standard of care (SOC) for post-operative pain management for lumbar spine patients. |
Primary outcome
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"
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"
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"
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"
12 secondary outcomes
Mean total postoperative opioid consumption (morphine equivalent dose) at 3 hours post-surgery
Time frame: 3 hours post-surgery
Mean total postoperative opioid consumption (morphine equivalent dose) at 6 hours post-surgery
Time frame: 6 hours post-surgery
Mean total postoperative opioid consumption (morphine equivalent dose) at Day 2 post-surgery
Time frame: Day 2 post-surgery
Mean total postoperative opioid consumption (morphine equivalent dose) at Day 7 post-surgery
Time frame: Day 7 post-surgery
Mean total postoperative opioid consumption (morphine equivalent dose) at Day 14 post-surgery
Time frame: Day 14 post-surgery
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)
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
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
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)
Mean percent change in TNF-alpha levels from baseline at 6 hours post-op
Time frame: Baseline and at 6 hours post-op
Surgery time (incision to closure)
Time frame: Day 1- during surgery [Surgery start (incision) to closure of surgical site]
Estimated mean total blood loss
Time frame: Day 1- During surgery [Surgery start (incision) to closure]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alex Valadka, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) in people with Pain, Postoperative and Opioid Use, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alex Valadka, MD (214-645-2300, alex.valadka@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 3 hours post-operation (time frame: Baseline, 3 hours post-operation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.