tAN for Postoperative Pain After Lumbar Surgery

Overseen By Aisha Qureshi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Seizures, Neurological diseases, Pacemakers, others

Stay on Your Current Meds You can continue your current medications while participating

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new non-drug treatment, transcutaneous auricular neurostimulation (tAN), can reduce pain after back surgery. tAN gently stimulates nerves around the ear linked to pain. Participants will receive either the actual device or a sham version as part of their pain management, alongside standard care. Suitable candidates for this trial include those cleared for lumbar spine surgery who can understand and consent to participate. As an unphased trial, this study explores innovative pain management options beyond standard care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have an uncontrolled medical condition or use illegal recreational drugs, you may not be eligible to participate.

What prior data suggests that transcutaneous auricular neurostimulation (tAN) is safe for postoperative pain management?

Previous studies have examined a treatment called transcutaneous auricular neurostimulation (tAN) for its safety and effectiveness in managing pain. Research has shown that tAN might be a safe option for reducing pain. One study found it could help ease pain in individuals with knee osteoarthritis, a condition that causes joint pain. Importantly, no major side effects were reported, suggesting that tAN is generally well-tolerated. While the studies cover different types of pain, the consistent safety findings offer reassurance for those considering this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcutaneous auricular neurostimulation (tAN) for managing postoperative pain after lumbar surgery because it offers a unique, non-invasive method to potentially reduce pain. Unlike standard pain management options, which often rely on opioids and other medications, tAN uses electrical stimulation on the ear to activate the body's natural pain-relief pathways. This technique not only aims to minimize the side effects associated with traditional pain medications but also could enhance recovery by providing targeted relief at critical times before, during, and after surgery. If successful, tAN could offer a promising alternative to current pain management strategies, reducing reliance on drugs and improving patient outcomes.

What evidence suggests that transcutaneous auricular neurostimulation (tAN) is effective for postoperative pain after lumbar surgery?

This trial will compare the effects of active transcutaneous auricular neurostimulation (tAN) with a sham treatment for managing postoperative pain after lumbar fusion surgery. Research has shown that tAN can help reduce pain after surgery. In one study, tAN significantly eased postoperative pain without causing additional complications. Another study found that using tAN before surgery lowered pain levels afterward and reduced the likelihood of pain recurrence. Additionally, tAN has reduced various types of pain, such as those from uterine contractions and cuts. While it might not decrease the need for painkillers like opioids, it appears to significantly reduce sudden pain. Overall, these findings suggest that tAN could be a useful tool for managing pain after lumbar fusion surgery. ^{2 6 7 8 9}

Who Is on the Research Team?

Alex Valadka, MD

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 who are cleared for lumbar fusion surgery, speak English, and can consent to the study. It's not for those with uncontrolled medical conditions, seizures, abnormal ear anatomy or infections, pregnant or breastfeeding women, those not using effective contraception, with pacemakers or similar devices, bleeding disorders, neurological diseases or recent acupuncture.

Inclusion Criteria

Proficient in English

I am medically approved for back surgery.

I can understand and agree to the study's requirements.

Exclusion Criteria

You use illegal drugs for fun.

Women of childbearing potential, not using effective contraception per investigator judgment or not willing to comply with contraception for the duration of the study

I am not pregnant or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Participants receive tAN treatment 30 minutes in the hour prior to surgery

1 day

1 visit (in-person)

Intra-operative

Participants receive tAN treatment 30 minutes before the end of surgery

1 day

Post-operative

Participants receive tAN treatment 30 minutes at 3 and 6 hours after surgery

1 day

Inpatient

Participants receive four 30-minute tAN sessions on Day 2

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

2 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Auricular Neurostimulation (tAN)

Trial Overview The study tests if a device called Sparrow Ascent tAN reduces pain after back surgery by stimulating nerves around the ear. Participants will be randomly assigned to either this active device group or a sham control group that does not provide actual stimulation.

How Is the Trial Designed?

Group I: Active tAN + standard of care (SOC) for post-operative pain management for lumbar fusion patients. Active Control 1 Intervention

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

Group II: Sham tAN + standard of care (SOC) for post-operative pain management for lumbar fusion patients. Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive and cost-effective method for modulating the vagus nerve, making it a promising alternative to traditional surgical vagus nerve stimulation.

taVNS allows for easy and safe administration, with considerations for proper electrode placement and individual dosing based on perception thresholds, which enhances its potential for treating various central and peripheral diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. Badran, BW., Yu, AB., Adair, D., et al.[2020]

Transcutaneous auricular vagus nerve stimulation (taVNS) significantly improved upper limb motor function in 21 subacute ischemic stroke patients compared to a sham treatment, as measured by the Fugl-Meyer assessment and other functional tests after 15 days of intervention.

The study found taVNS to be safe, with only one reported case of skin redness, indicating it may be a beneficial and low-risk option for enhancing recovery in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect and Safety of Transcutaneous Auricular Vagus Nerve Stimulation on Recovery of Upper Limb Motor Function in Subacute Ischemic Stroke Patients: A Randomized Pilot Study. Wu, D., Ma, J., Zhang, L., et al.[2021]

Transcutaneous auricular vagus nerve stimulation (TaVNS) effectively normalized gastric dysrhythmias in healthy individuals during a water-load test, indicating its potential as a treatment for gastric symptoms.

The study found that TaVNS at 40 Hz improved heart rate variability and reduced bloating, suggesting it positively influences both parasympathetic and sympathetic nervous system pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Auricular Vagus Nerve Stimulation Normalizes Induced Gastric Myoelectrical Dysrhythmias in Controls Assessed by Body-Surface Gastric Mapping. Du, P., Maharjan, A., Calder, S., et al.[2023]

Transcutaneous auricular Vagal Nerve Stimulation (taVNS) did not show any significant effects on pain perception or nociception in healthy participants, as measured by event-related potentials and sensory testing across three experiments involving 22 and 15 subjects.

Both taVNS and standard cervical VNS (cVNS) failed to produce objective changes in behavioral and cerebral responses to pain stimuli, suggesting that the analgesic effects of taVNS may not be as effective as previously thought.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular VNS applied to experimental pain: A paired behavioral and EEG study using thermonociceptive CO2 laser. Dumoulin, M., Liberati, G., Mouraux, A., et al.[2021]

Transcutaneous auricular Vagus Nerve Stimulation (taVNS) can be optimized by varying electrode designs, which significantly affects the sensitivity and selectivity of nerve activation in different regions of the ear, as shown through a detailed anatomical model and finite element analysis.

The study found that smaller electrodes increase the electric field strength for a given current, allowing for more targeted stimulation of specific ear regions, which is crucial for enhancing the efficacy of taVNS in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-resolution computational modeling of the current flow in the outer ear during transcutaneous auricular Vagus Nerve Stimulation (taVNS). Kreisberg, E., Esmaeilpour, Z., Adair, D., et al.[2023]

This study will investigate the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on 15 patients with a minimally conscious state, using five different frequencies (1, 10, 25, 50, and 100 Hz) to determine the optimal stimulation parameters.

The goal is to achieve stable improvements in consciousness levels in patients with disorders of consciousness by optimizing the taVNS neuromodulation technique, with results measured through the coma recovery scale-revised (CRS-R) and resting EEG assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing the modulation paradigm of transcutaneous auricular vagus nerve stimulation in patients with disorders of consciousness: A prospective exploratory pilot study protocol. Zhai, W., Jiao, H., Zhuang, Y., et al.[2023]

Transcutaneous auricular vagus nerve stimulation (taVNS) is a safe and effective neuromodulation therapy for a variety of conditions, including epilepsy, depression, and anxiety, indicating its broad therapeutic potential.

Despite its effectiveness, there is currently no standardization among taVNS devices, and further research is needed to clarify the relationship between stimulation parameters and therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular vagus nerve stimulators: a review of past, present, and future devices. Wang, L., Wang, Y., Wang, Y., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11894745/

Impact of transcutaneous auricular vagus nerve stimulation on ... taVNS effectively alleviates postoperative pain in patients undergoing perianal surgery without increasing the risk of complications.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06912399

Effect of Transauricular Vagus Nerve Stimulation on ... Secondary outcomes include: the proportion of patients with inadequate analgesia within three days after intervention; the difference in VAS scores immediately ...

3. bmjopen.bmj.com bmjopen.bmj.com/content/15/7/e098506

Effect of transcutaneous auricular vagus nerve stimulation ... In conclusion, a scientific hypothesis can be proposed that the preoperative use of taVNS may effectively reduce the postoperative pain, thereby enhancing ...

4. journals.lww.com journals.lww.com/clinicalpain/fulltext/2025/10000/effectiveness_of_transcutaneous_auricular_vagal.6.aspx

Effectiveness of Transcutaneous Auricular Vagal Nerve... ... While taVNS did not significantly reduce opioid consumption, it significantly alleviated acute postoperative pain and reduced the incidence of rebound pain ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2838258

Transcutaneous Auricular Vagus Nerve Stimulation for ... Conclusions and Relevance In this randomized clinical trial, taVNS significantly reduced uterine contraction pain, incisional pain, depression, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12422602/

Effectiveness of Transcutaneous Auricular Vagal Nerve ... The taVNS was effective in reducing the occurrence of rebound pain following nerve block. Previous studies have shown that 40% to 50% of patients experience ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12315001/

Effect of transcutaneous auricular vagus nerve stimulation on ... In conclusion, a scientific hypothesis can be proposed that the preoperative use of taVNS may effectively reduce the postoperative pain, thereby ...

8. withpower.com withpower.com/trial/phase-opioids-use-10-2023-d8005

tAN for Postoperative Pain After Lumbar Surgery Transcutaneous auricular Vagal Nerve Stimulation (taVNS) did not show any significant effects on pain perception or nociception in healthy participants, as ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2665913124001122

Safety and preliminary efficacy of transcutaneous auricular ... Our preliminary data demonstrated that tVNS may be a safe pain-relieving treatment for people with knee OA. Our findings suggest that improvement of knee pain ...