Back to resultsTranscutaneous Auricular Neurostimulation After Lumbar Fusion Surgery
Primary Purpose
Pain, Postoperative, Opioid Use, Lumbar Spine Injury
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)
Sham Control Device
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring Lumbar Fusion, Transcutaneous auricular neurostimulation (tAN)
Eligibility Criteria
Inclusion Criteria: Medically cleared to undergo a lumbar fusion surgery 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
Sites / Locations
- UT Southwestern Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active tAN + standard of care (SOC) for post-operative pain management for lumbar fusion patients.
Sham tAN + standard of care (SOC) for post-operative pain management for lumbar fusion patients.
Arm Description
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
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
Outcomes
Primary Outcome Measures
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"
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"
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"
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"
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
Mean percent change in 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.
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.
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.
Estimated mean total blood loss
The volume of blood loss will be recorded for each case, and then the 2 groups will be compared. Comparision is based on end volume recorded at incision closure.
Full Information
NCT ID
NCT06100172
First Posted
September 14, 2023
Last Updated
October 20, 2023
Sponsor
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT06100172
Brief Title
Transcutaneous Auricular Neurostimulation After Lumbar Fusion Surgery
Official Title
Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Non-Opioid Pain Management Therapy for Patients Undergoing Lumbar Fusion Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study, entitled "Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Non-Opioid Pain Management Therapy for Patients Undergoing Lumbar Fusion Surgery", is to demonstrate whether transcutaneous auricular neurostimulation (tAN) can non-invasively reduce the perception of pain in patients undergoing lumbar fusion 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 fusion 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 fusion 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Opioid Use, Lumbar Spine Injury
Keywords
Lumbar Fusion, Transcutaneous auricular neurostimulation (tAN)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double blind, sham controlled.
Masking
ParticipantInvestigator
Masking Description
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 fusion patients.
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active tAN + standard of care (SOC) for post-operative pain management for lumbar fusion patients.
Arm Type
Active Comparator
Arm Description
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
Arm Title
Sham tAN + standard of care (SOC) for post-operative pain management for lumbar fusion patients.
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Control Device
Intervention Description
This device looks like the active device, but no stimulation will be delivered.
Primary Outcome Measure Information:
Title
Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 3 hours post-operation
Description
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"
Time Frame
Baseline, 3 hours post-operation
Title
Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 6 hours post-operation
Description
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"
Time Frame
Baseline, 6 hours post-operation
Title
Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at day 2 post-operation
Description
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"
Time Frame
Baseline, day 2 post-operation
Title
Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at day 14 post-operation
Description
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"
Time Frame
Baseline, day 14 post-operation
Secondary Outcome Measure Information:
Title
Mean total postoperative opioid consumption (morphine equivalent dose) at 3 hours post-surgery
Description
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.
Time Frame
3 hours post-surgery
Title
Mean total postoperative opioid consumption (morphine equivalent dose) at 6 hours post-surgery
Description
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.
Time Frame
6 hours post-surgery
Title
Mean total postoperative opioid consumption (morphine equivalent dose) at Day 2 post-surgery
Description
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.
Time Frame
Day 2 post-surgery
Title
Mean total postoperative opioid consumption (morphine equivalent dose) at Day 7 post-surgery
Description
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.
Time Frame
Day 7 post-surgery
Title
Mean total postoperative opioid consumption (morphine equivalent dose) at Day 14 post-surgery
Description
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.
Time Frame
Day 14 post-surgery
Title
Mean percent change in C-reactive protein (CRP) levels from baseline at Day 1 (intra-op)
Description
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.
Time Frame
Baseline and at Day 1 (intra-op)
Title
Mean percent change in C-reactive protein (CRP) levels from baseline at 6 hours post-op
Description
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.
Time Frame
Baseline and at 6 hours post-op
Title
Mean percent change in C-reactive protein (CRP) levels from baseline at Day 2 post-op
Description
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.
Time Frame
Baseline and at Day 2 post-op
Title
Mean percent change in TNF-alpha levels from baseline at Day 1 (intra-op)
Description
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.
Time Frame
Baseline and at Day 1 (intra-op)
Title
Mean percent change in TNF-alpha levels from baseline at 6 hours post-op
Description
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.
Time Frame
Baseline and at 6 hours post-op
Title
Surgery time (incision to closure)
Description
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.
Time Frame
Day 1- during surgery [Surgery start (incision) to closure of surgical site]
Title
Estimated mean total blood loss
Description
The volume of blood loss will be recorded for each case, and then the 2 groups will be compared. Comparision is based on end volume recorded at incision closure.
Time Frame
Day 1- During surgery [Surgery start (incision) to closure]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Medically cleared to undergo a lumbar fusion surgery
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alex Valadka, MD
Phone
214-645-2300
Email
alex.valadka@utsouthwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Fehmel
Phone
214-648-9157
Email
jennifer.fehmel@utsouthwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Valadka, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex Valadka, MD
Phone
214-645-2300
Email
alex.valadka@utsouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Jennifer Fehmel
Phone
214-648-9157
Email
jennifer.fehmel@utsouthwestern.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Transcutaneous Auricular Neurostimulation After Lumbar Fusion Surgery
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