Trial Outcomes & Findings for Percutaneous Auricular Neuromodulation for Postoperative Analgesia (NCT NCT05521516)
NCT ID: NCT05521516
Last Updated: 2025-03-04
Results Overview
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. The outcome will the mean value of daily average pain scores measured with the Numeric Rating Scale. The primary outcome measure will be the mean value of the average daily pain measured on postoperative days 1-5.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
122 participants
Primary outcome timeframe
The first 5 postoperative days
Results posted on
2025-03-04
Participant Flow
Participant milestones
| Measure |
Active Percutaneous Auricular Neuromodulation With NSS-2 Bridge
Application of 5 days of percutaneous auricular Neuromodulation with NSS-2 Bridge device
Active Percutaneous Auricular Neuromodulation with NSS-2 Bridge: Application of 5 days of percutaneous auricular neuromodulation with NSS-2 Bridge device
|
Sham Treatment
Application of 5 days of a nonfunctional sham device
Sham Treatment: Application of 5 days of a nonfunctional sham device
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
61
|
|
Overall Study
COMPLETED
|
60
|
60
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Active Percutaneous Auricular Neuromodulation With NSS-2 Bridge
Application of 5 days of percutaneous auricular Neuromodulation with NSS-2 Bridge device
Active Percutaneous Auricular Neuromodulation with NSS-2 Bridge: Application of 5 days of percutaneous auricular neuromodulation with NSS-2 Bridge device
|
Sham Treatment
Application of 5 days of a nonfunctional sham device
Sham Treatment: Application of 5 days of a nonfunctional sham device
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Active Percutaneous Auricular Neuromodulation With NSS-2 Bridge
n=60 Participants
Application of 5 days of percutaneous auricular Neuromodulation with NSS-2 Bridge device
Active Percutaneous Auricular Neuromodulation with NSS-2 Bridge: Application of 5 days of percutaneous auricular neuromodulation with NSS-2 Bridge device
|
Sham Treatment
n=60 Participants
Application of 5 days of a nonfunctional sham device
Sham Treatment: Application of 5 days of a nonfunctional sham device
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 15 • n=60 Participants
|
62 years
STANDARD_DEVIATION 15 • n=60 Participants
|
61 years
STANDARD_DEVIATION 15 • n=120 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=60 Participants
|
33 Participants
n=60 Participants
|
65 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=60 Participants
|
27 Participants
n=60 Participants
|
55 Participants
n=120 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
60 participants
n=60 Participants
|
60 participants
n=60 Participants
|
120 participants
n=120 Participants
|
|
Weight
|
79 kg
STANDARD_DEVIATION 17 • n=60 Participants
|
78 kg
STANDARD_DEVIATION 16 • n=60 Participants
|
78 kg
STANDARD_DEVIATION 16 • n=120 Participants
|
|
Height
|
170 cm
STANDARD_DEVIATION 11 • n=60 Participants
|
170 cm
STANDARD_DEVIATION 11 • n=60 Participants
|
170 cm
STANDARD_DEVIATION 11 • n=120 Participants
|
|
Body Mass Index
|
27 kg / m^2
STANDARD_DEVIATION 5 • n=60 Participants
|
27 kg / m^2
STANDARD_DEVIATION 5 • n=60 Participants
|
27 kg / m^2
STANDARD_DEVIATION 5 • n=120 Participants
|
PRIMARY outcome
Timeframe: The first 5 postoperative daysThe numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. The outcome will the mean value of daily average pain scores measured with the Numeric Rating Scale. The primary outcome measure will be the mean value of the average daily pain measured on postoperative days 1-5.
Outcome measures
| Measure |
Active Percutaneous Auricular Neuromodulation With NSS-2 Bridge
n=60 Participants
Application of 5 days of percutaneous auricular Neuromodulation with NSS-2 Bridge device
Active Percutaneous Auricular Neuromodulation with NSS-2 Bridge: Application of 5 days of percutaneous auricular neuromodulation with NSS-2 Bridge device
|
Sham Treatment
n=60 Participants
Application of 5 days of a nonfunctional sham device
Sham Treatment: Application of 5 days of a nonfunctional sham device
|
|---|---|---|
|
AVERAGE Pain Measured With the Numeric Rating Scale First 5 Postoperative Days
|
1 units on a scale
Interval 0.0 to 3.0
|
3 units on a scale
Interval 1.0 to 4.0
|
PRIMARY outcome
Timeframe: Postoperative days 0-5Total opioid consumption from recovery room discharge until the data collection phone call on postoperative day 5 (measured in oral oxycodone equivalents).
Outcome measures
| Measure |
Active Percutaneous Auricular Neuromodulation With NSS-2 Bridge
n=60 Participants
Application of 5 days of percutaneous auricular Neuromodulation with NSS-2 Bridge device
Active Percutaneous Auricular Neuromodulation with NSS-2 Bridge: Application of 5 days of percutaneous auricular neuromodulation with NSS-2 Bridge device
|
Sham Treatment
n=60 Participants
Application of 5 days of a nonfunctional sham device
Sham Treatment: Application of 5 days of a nonfunctional sham device
|
|---|---|---|
|
Total OPIOID Consumption From Recovery Room Discharge Until the Data Collection Phone Call on Postoperative Day 5 (Measured in Oral Oxycodone Equivalents)
|
5 mg
Interval 0.0 to 22.5
|
17.5 mg
Interval 0.0 to 60.0
|
SECONDARY outcome
Timeframe: Recorded on postoperative days 1-8 for the previous 24-hour periodThe numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale
Outcome measures
| Measure |
Active Percutaneous Auricular Neuromodulation With NSS-2 Bridge
n=60 Participants
Application of 5 days of percutaneous auricular Neuromodulation with NSS-2 Bridge device
Active Percutaneous Auricular Neuromodulation with NSS-2 Bridge: Application of 5 days of percutaneous auricular neuromodulation with NSS-2 Bridge device
|
Sham Treatment
n=60 Participants
Application of 5 days of a nonfunctional sham device
Sham Treatment: Application of 5 days of a nonfunctional sham device
|
|---|---|---|
|
AVERAGE Pain Measured With the Numeric Rating Scale
Day 1
|
2.3 units on a scale
Standard Deviation 2
|
2.8 units on a scale
Standard Deviation 2.3
|
|
AVERAGE Pain Measured With the Numeric Rating Scale
Day 2
|
1.9 units on a scale
Standard Deviation 2.2
|
3.3 units on a scale
Standard Deviation 2.4
|
|
AVERAGE Pain Measured With the Numeric Rating Scale
Day 3
|
1.8 units on a scale
Standard Deviation 2.1
|
3 units on a scale
Standard Deviation 2.5
|
|
AVERAGE Pain Measured With the Numeric Rating Scale
Day 4
|
1.5 units on a scale
Standard Deviation 1.8
|
2.7 units on a scale
Standard Deviation 2
|
|
AVERAGE Pain Measured With the Numeric Rating Scale
Day 5
|
1.5 units on a scale
Standard Deviation 1.6
|
2.5 units on a scale
Standard Deviation 1.9
|
|
AVERAGE Pain Measured With the Numeric Rating Scale
Day 6
|
1.5 units on a scale
Standard Deviation 1.6
|
2.3 units on a scale
Standard Deviation 1.9
|
|
AVERAGE Pain Measured With the Numeric Rating Scale
Day 7
|
1.5 units on a scale
Standard Deviation 1.6
|
2.1 units on a scale
Standard Deviation 1.9
|
|
AVERAGE Pain Measured With the Numeric Rating Scale
Day 8
|
1.6 units on a scale
Standard Deviation 1.9
|
1.8 units on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Recorded on postoperative days 1-8 for the previous 24-hour periodThe numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale
Outcome measures
| Measure |
Active Percutaneous Auricular Neuromodulation With NSS-2 Bridge
n=60 Participants
Application of 5 days of percutaneous auricular Neuromodulation with NSS-2 Bridge device
Active Percutaneous Auricular Neuromodulation with NSS-2 Bridge: Application of 5 days of percutaneous auricular neuromodulation with NSS-2 Bridge device
|
Sham Treatment
n=60 Participants
Application of 5 days of a nonfunctional sham device
Sham Treatment: Application of 5 days of a nonfunctional sham device
|
|---|---|---|
|
WORST (Highest or Maximum) Pain Measured With the Numeric Rating Scale
Day 1
|
4.3 units on a scale
Standard Deviation 2.5
|
4.9 units on a scale
Standard Deviation 2.8
|
|
WORST (Highest or Maximum) Pain Measured With the Numeric Rating Scale
Day 2
|
4 units on a scale
Standard Deviation 3
|
5.5 units on a scale
Standard Deviation 2.8
|
|
WORST (Highest or Maximum) Pain Measured With the Numeric Rating Scale
Day 3
|
3.7 units on a scale
Standard Deviation 2.9
|
4.9 units on a scale
Standard Deviation 2.6
|
|
WORST (Highest or Maximum) Pain Measured With the Numeric Rating Scale
Day 4
|
3 units on a scale
Standard Deviation 2.5
|
4.4 units on a scale
Standard Deviation 2.4
|
|
WORST (Highest or Maximum) Pain Measured With the Numeric Rating Scale
Day 5
|
3.1 units on a scale
Standard Deviation 2.6
|
4.1 units on a scale
Standard Deviation 2.6
|
|
WORST (Highest or Maximum) Pain Measured With the Numeric Rating Scale
Day 6
|
3.1 units on a scale
Standard Deviation 2.7
|
4 units on a scale
Standard Deviation 2.6
|
|
WORST (Highest or Maximum) Pain Measured With the Numeric Rating Scale
Day 7
|
3 units on a scale
Standard Deviation 2.7
|
3.8 units on a scale
Standard Deviation 2.8
|
|
WORST (Highest or Maximum) Pain Measured With the Numeric Rating Scale
Day 8
|
2.9 units on a scale
Standard Deviation 3.1
|
3.2 units on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Recorded on postoperative days 2, 4, 6, and 8 for the previous 24-hour periodThe numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale
Outcome measures
| Measure |
Active Percutaneous Auricular Neuromodulation With NSS-2 Bridge
n=60 Participants
Application of 5 days of percutaneous auricular Neuromodulation with NSS-2 Bridge device
Active Percutaneous Auricular Neuromodulation with NSS-2 Bridge: Application of 5 days of percutaneous auricular neuromodulation with NSS-2 Bridge device
|
Sham Treatment
n=60 Participants
Application of 5 days of a nonfunctional sham device
Sham Treatment: Application of 5 days of a nonfunctional sham device
|
|---|---|---|
|
LEAST (Lowest or Minimum) Pain Measured With the Numeric Rating Scale
Day 2
|
1 units on a scale
Standard Deviation 1.6
|
1.8 units on a scale
Standard Deviation 1.9
|
|
LEAST (Lowest or Minimum) Pain Measured With the Numeric Rating Scale
Day 4
|
.7 units on a scale
Standard Deviation 1.3
|
1.2 units on a scale
Standard Deviation 1.5
|
|
LEAST (Lowest or Minimum) Pain Measured With the Numeric Rating Scale
Day 6
|
.6 units on a scale
Standard Deviation 1.2
|
1.2 units on a scale
Standard Deviation 1.5
|
|
LEAST (Lowest or Minimum) Pain Measured With the Numeric Rating Scale
Day 8
|
.6 units on a scale
Standard Deviation 1.2
|
.9 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Recorded on postoperative days 2, 4, 6, and 8The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale
Outcome measures
| Measure |
Active Percutaneous Auricular Neuromodulation With NSS-2 Bridge
n=60 Participants
Application of 5 days of percutaneous auricular Neuromodulation with NSS-2 Bridge device
Active Percutaneous Auricular Neuromodulation with NSS-2 Bridge: Application of 5 days of percutaneous auricular neuromodulation with NSS-2 Bridge device
|
Sham Treatment
n=60 Participants
Application of 5 days of a nonfunctional sham device
Sham Treatment: Application of 5 days of a nonfunctional sham device
|
|---|---|---|
|
CURRENT Pain at the Time of the Data-collection Phone Call Measured With the Numeric Rating Scale
Day 2
|
1.5 units on a scale
Standard Deviation 2
|
3 units on a scale
Standard Deviation 2.6
|
|
CURRENT Pain at the Time of the Data-collection Phone Call Measured With the Numeric Rating Scale
Day 4
|
1.3 units on a scale
Standard Deviation 1.8
|
2 units on a scale
Standard Deviation 1.9
|
|
CURRENT Pain at the Time of the Data-collection Phone Call Measured With the Numeric Rating Scale
Day 6
|
1.3 units on a scale
Standard Deviation 1.9
|
1.9 units on a scale
Standard Deviation 2
|
|
CURRENT Pain at the Time of the Data-collection Phone Call Measured With the Numeric Rating Scale
Day 8
|
1.2 units on a scale
Standard Deviation 1.8
|
1.6 units on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Recorded on postoperative days 1-8Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)
Outcome measures
| Measure |
Active Percutaneous Auricular Neuromodulation With NSS-2 Bridge
n=60 Participants
Application of 5 days of percutaneous auricular Neuromodulation with NSS-2 Bridge device
Active Percutaneous Auricular Neuromodulation with NSS-2 Bridge: Application of 5 days of percutaneous auricular neuromodulation with NSS-2 Bridge device
|
Sham Treatment
n=60 Participants
Application of 5 days of a nonfunctional sham device
Sham Treatment: Application of 5 days of a nonfunctional sham device
|
|---|---|---|
|
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
Day 7
|
3 mg
Standard Deviation 6.5
|
4 mg
Standard Deviation 9
|
|
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
Day 1
|
4.5 mg
Standard Deviation 8
|
8 mg
Standard Deviation 11.5
|
|
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
Day 2
|
6 mg
Standard Deviation 10
|
8 mg
Standard Deviation 12
|
|
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
Day 3
|
5 mg
Standard Deviation 10
|
8 mg
Standard Deviation 12
|
|
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
Day 4
|
4 mg
Standard Deviation 7.5
|
7.5 mg
Standard Deviation 12.5
|
|
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
Day 5
|
3 mg
Standard Deviation 5.5
|
7 mg
Standard Deviation 11.5
|
|
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
Day 6
|
2.5 mg
Standard Deviation 6
|
5 mg
Standard Deviation 9
|
|
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
Day 8
|
3.5 mg
Standard Deviation 8
|
4 mg
Standard Deviation 8
|
SECONDARY outcome
Timeframe: Recorded on postoperative days 2, 4, 6, and 8 for the previous 24-hour periodThe interference sub scale of the Brief Pain Inventory short form is an instrument specifically designed to assess pain's impact on physical and emotional functioning. It is comprised of 7 questions involving physical and emotional functioning using a 0-10 Likert scale \[0=no interference, good;10=complete interference, bad\]: general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. The responses for these 7 questions are summed, resulting in a final scale of 0 (no interference=good) to 70 (complete interference=bad).
Outcome measures
| Measure |
Active Percutaneous Auricular Neuromodulation With NSS-2 Bridge
n=60 Participants
Application of 5 days of percutaneous auricular Neuromodulation with NSS-2 Bridge device
Active Percutaneous Auricular Neuromodulation with NSS-2 Bridge: Application of 5 days of percutaneous auricular neuromodulation with NSS-2 Bridge device
|
Sham Treatment
n=60 Participants
Application of 5 days of a nonfunctional sham device
Sham Treatment: Application of 5 days of a nonfunctional sham device
|
|---|---|---|
|
Brief Pain Inventory, Short Form (Interference Subscale)
Day 2
|
14 score on a scale
Standard Deviation 17
|
23 score on a scale
Standard Deviation 20
|
|
Brief Pain Inventory, Short Form (Interference Subscale)
Day 4
|
11 score on a scale
Standard Deviation 15
|
18 score on a scale
Standard Deviation 17
|
|
Brief Pain Inventory, Short Form (Interference Subscale)
Day 6
|
12 score on a scale
Standard Deviation 17
|
17 score on a scale
Standard Deviation 17
|
|
Brief Pain Inventory, Short Form (Interference Subscale)
Day 8
|
9 score on a scale
Standard Deviation 14
|
13 score on a scale
Standard Deviation 16
|
SECONDARY outcome
Timeframe: Recorded on postoperative days 1-8 for the previous nightThe number of times the participant awoke the previous night due to pain
Outcome measures
| Measure |
Active Percutaneous Auricular Neuromodulation With NSS-2 Bridge
n=60 Participants
Application of 5 days of percutaneous auricular Neuromodulation with NSS-2 Bridge device
Active Percutaneous Auricular Neuromodulation with NSS-2 Bridge: Application of 5 days of percutaneous auricular neuromodulation with NSS-2 Bridge device
|
Sham Treatment
n=60 Participants
Application of 5 days of a nonfunctional sham device
Sham Treatment: Application of 5 days of a nonfunctional sham device
|
|---|---|---|
|
Awakenings Due to Pain
Day 1
|
0 number of awakenings
Interval 0.0 to 0.0
|
0 number of awakenings
Interval 0.0 to 0.0
|
|
Awakenings Due to Pain
Day 2
|
0 number of awakenings
Interval 0.0 to 1.0
|
0 number of awakenings
Interval 0.0 to 1.0
|
|
Awakenings Due to Pain
Day 3
|
0 number of awakenings
Interval 0.0 to 0.0
|
0 number of awakenings
Interval 0.0 to 0.8
|
|
Awakenings Due to Pain
Day 4
|
0. number of awakenings
Interval 0.0 to 0.5
|
0 number of awakenings
Interval 0.0 to 1.0
|
|
Awakenings Due to Pain
Day 5
|
0 number of awakenings
Interval 0.0 to 0.0
|
0 number of awakenings
Interval 0.0 to 0.3
|
|
Awakenings Due to Pain
Day 6
|
0 number of awakenings
Interval 0.0 to 0.0
|
0 number of awakenings
Interval 0.0 to 1.0
|
|
Awakenings Due to Pain
Day 7
|
0 number of awakenings
Interval 0.0 to 0.0
|
0 number of awakenings
Interval 0.0 to 0.0
|
|
Awakenings Due to Pain
Day 8
|
0 number of awakenings
Interval 0.0 to 0.0
|
0 number of awakenings
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Recorded on postoperative day 1Patient queried if they thought they received active stimulation (entered as "1"), a sham device (entered as "0"), or are not sure (entered as "0.5")
Outcome measures
| Measure |
Active Percutaneous Auricular Neuromodulation With NSS-2 Bridge
n=60 Participants
Application of 5 days of percutaneous auricular Neuromodulation with NSS-2 Bridge device
Active Percutaneous Auricular Neuromodulation with NSS-2 Bridge: Application of 5 days of percutaneous auricular neuromodulation with NSS-2 Bridge device
|
Sham Treatment
n=60 Participants
Application of 5 days of a nonfunctional sham device
Sham Treatment: Application of 5 days of a nonfunctional sham device
|
|---|---|---|
|
Masking
|
.5 score on a scale
Interval 0.5 to 1.0
|
.5 score on a scale
Interval 0.5 to 1.0
|
SECONDARY outcome
Timeframe: Up to 2 weeks after surgeryDay relative to the day of surgery that patient was discharged from the hospital (e.g., same day is postoperative day 0, while the day following surgery is postoperative day 1)
Outcome measures
| Measure |
Active Percutaneous Auricular Neuromodulation With NSS-2 Bridge
n=60 Participants
Application of 5 days of percutaneous auricular Neuromodulation with NSS-2 Bridge device
Active Percutaneous Auricular Neuromodulation with NSS-2 Bridge: Application of 5 days of percutaneous auricular neuromodulation with NSS-2 Bridge device
|
Sham Treatment
n=60 Participants
Application of 5 days of a nonfunctional sham device
Sham Treatment: Application of 5 days of a nonfunctional sham device
|
|---|---|---|
|
Hospitalization Duration Measured in Days
|
.2 Days
Standard Deviation .5
|
.5 Days
Standard Deviation .8
|
SECONDARY outcome
Timeframe: Intraoperative (within the operating room)Number of minutes the tourniquet was inflated
Outcome measures
| Measure |
Active Percutaneous Auricular Neuromodulation With NSS-2 Bridge
n=60 Participants
Application of 5 days of percutaneous auricular Neuromodulation with NSS-2 Bridge device
Active Percutaneous Auricular Neuromodulation with NSS-2 Bridge: Application of 5 days of percutaneous auricular neuromodulation with NSS-2 Bridge device
|
Sham Treatment
n=60 Participants
Application of 5 days of a nonfunctional sham device
Sham Treatment: Application of 5 days of a nonfunctional sham device
|
|---|---|---|
|
Tourniquet Duration
|
.8 Minutes
Standard Deviation 4.4
|
1.8 Minutes
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: Intraoperative (within the operating room)The time from surgical start to surgical stop measured in minutes and hours
Outcome measures
| Measure |
Active Percutaneous Auricular Neuromodulation With NSS-2 Bridge
n=60 Participants
Application of 5 days of percutaneous auricular Neuromodulation with NSS-2 Bridge device
Active Percutaneous Auricular Neuromodulation with NSS-2 Bridge: Application of 5 days of percutaneous auricular neuromodulation with NSS-2 Bridge device
|
Sham Treatment
n=60 Participants
Application of 5 days of a nonfunctional sham device
Sham Treatment: Application of 5 days of a nonfunctional sham device
|
|---|---|---|
|
Surgical Duration
|
92.4 minutes
Standard Deviation 41.5
|
89.3 minutes
Standard Deviation 35.9
|
Adverse Events
Active Percutaneous Auricular Neuromodulation With NSS-2 Bridge
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Brian Ilfeld, MD, MS
University of California San Diego
Phone: (858) 220-5714
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place