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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.
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:
Stimulation:
Participants undergoing lumbar surgery will be randomized to receive either active or sham tAN treatment according to the following time points:
Blood Draws
Participants will have blood samples collected at the following time points:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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| 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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" | 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" | 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" | 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" | Baseline, day 14 post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 hours post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alex Valadka, MD | Contact | 214-645-2300 | alex.valadka@utsouthwestern.edu | |
| Tyfe Oderinde, MS | Contact | 214-648-9905 | Bolutyfe.Oderinde@utsouthwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alex Valadka, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D013124 | Spinal Injuries |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Randomized, double blind, sham controlled.
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On the day of surgery, subjects will be randomized 1:1 to either the active stimulation group or the sham group. In the sham group, the device looks like the active device, but it will not deliver any electrical stimulation to the vagus or trigeminal nerves.
Both groups will receive the SOC for post-operative pain management for lumbar surgery patients.
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| Sham Control Device | Device | This device looks like the active device, but no stimulation will be delivered. |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Day 1- During surgery [Surgery start (incision) to closure] |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |