Trial Outcomes & Findings for True Functional Restoration and Analgesia in Non-Radicular Low Back Pain (NCT NCT01455519)
NCT ID: NCT01455519
Last Updated: 2017-10-24
Results Overview
The McGill Pain Questionnaire - Short Form (MPQ-SF) is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are added together to compute a total score. The scale ranges from 0-45 (0=no pain, 45=the most pain).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
51 participants
Primary outcome timeframe
Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
Results posted on
2017-10-24
Participant Flow
51 subjects were enrolled at baseline. 13 withdrew from the study after visit 1, and 3 no longer met criteria at visit 2.
Participant milestones
| Measure |
Sugar Pill
Subjects may receive a pill with no medicine.
|
Hydromorphone ER
Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
23
|
|
Overall Study
COMPLETED
|
8
|
18
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
True Functional Restoration and Analgesia in Non-Radicular Low Back Pain
Baseline characteristics by cohort
| Measure |
Sugar Pill
n=12 Participants
Subjects may receive a pill with no medicine.
|
Hydromorphone ER
n=23 Participants
Subjects received study drug: Hydromorphone ER
Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.8 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
46.6 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
47.7 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Body Mass Index
|
32.8 kg/m2
STANDARD_DEVIATION 10.4 • n=5 Participants
|
29.3 kg/m2
STANDARD_DEVIATION 8.4 • n=7 Participants
|
30.5 kg/m2
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Duration of Pain
|
12.6 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
8.7 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
10.0 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post interventionThe McGill Pain Questionnaire - Short Form (MPQ-SF) is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are added together to compute a total score. The scale ranges from 0-45 (0=no pain, 45=the most pain).
Outcome measures
| Measure |
Sugar Pill
n=8 Participants
Subjects may receive a pill with no medicine.
|
Hydromorphone ER
n=18 Participants
Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
|
|---|---|---|
|
Change in McGill Pain Questionnaire - Short Form
|
-0.73 units on a scale
Standard Error 2.33
|
-3.78 units on a scale
Standard Error 1.7
|
PRIMARY outcome
Timeframe: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post interventionVisual Analogue Scale is a self report pain scale on a scale 0(no pain) to 100 (the worst pain imaginable).
Outcome measures
| Measure |
Sugar Pill
n=8 Participants
Subjects may receive a pill with no medicine.
|
Hydromorphone ER
n=18 Participants
Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
|
|---|---|---|
|
Change in VAS
|
-10.57 units on a scale
Standard Error 9.54
|
-10.67 units on a scale
Standard Error 6.91
|
SECONDARY outcome
Timeframe: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post interventionAnxiety scores were collected at least two data points. The Pain Anxiety Symptoms Scale (PASS) is a scale from 0 - 100, where 0 = no anxiety and 100 = the most anxiety.
Outcome measures
| Measure |
Sugar Pill
n=8 Participants
Subjects may receive a pill with no medicine.
|
Hydromorphone ER
n=18 Participants
Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
|
|---|---|---|
|
Change in PASS
|
-7.14 units on a scale
Standard Error 2.94
|
-5.85 units on a scale
Standard Error 2.21
|
SECONDARY outcome
Timeframe: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post interventionThe Pain Disability Index (PDI) is a seven-item, validated instrument that assesses perceived disability in seven key life areas. It provides a total disability score, and is an indirect measure of self efficacy. The Pain Disability Scale is a scale from 0 - 70, where 0 = no Disability and 70 = the most Disability.
Outcome measures
| Measure |
Sugar Pill
n=8 Participants
Subjects may receive a pill with no medicine.
|
Hydromorphone ER
n=18 Participants
Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
|
|---|---|---|
|
Change in Pain Disability
|
-9.84 units on a scale
Standard Error 4.56
|
-9.25 units on a scale
Standard Error 3.36
|
SECONDARY outcome
Timeframe: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post interventionTime to climb 1 flight of stairs
Outcome measures
| Measure |
Sugar Pill
n=8 Participants
Subjects may receive a pill with no medicine.
|
Hydromorphone ER
n=18 Participants
Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
|
|---|---|---|
|
Change in Stair Climb Time
|
1.28 seconds
Standard Error 1.08
|
-1.25 seconds
Standard Error 0.8
|
SECONDARY outcome
Timeframe: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post interventionTreadmill distance walked in 6 minutes
Outcome measures
| Measure |
Sugar Pill
n=8 Participants
Subjects may receive a pill with no medicine.
|
Hydromorphone ER
n=18 Participants
Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
|
|---|---|---|
|
Change in Treadmill Distance Walked
|
0.02 miles
Standard Error 0.02
|
0.02 miles
Standard Error 0.01
|
SECONDARY outcome
Timeframe: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post interventionSit to stand repetitions completed in 1 minute
Outcome measures
| Measure |
Sugar Pill
n=8 Participants
Subjects may receive a pill with no medicine.
|
Hydromorphone ER
n=18 Participants
Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
|
|---|---|---|
|
Change in Sit to Stand Repetitions
|
-1.07 number of repetitions
Standard Error 1.52
|
.54 number of repetitions
Standard Error 1.14
|
SECONDARY outcome
Timeframe: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post interventionDistance from fingers to Floor when bending forward. A functional test of flexibility
Outcome measures
| Measure |
Sugar Pill
n=8 Participants
Subjects may receive a pill with no medicine.
|
Hydromorphone ER
n=18 Participants
Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
|
|---|---|---|
|
Change in Distance to Floor
|
-4.61 centimeters
Standard Error 3.03
|
-4.02 centimeters
Standard Error 2.26
|
SECONDARY outcome
Timeframe: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post interventionTime to lift 13 pound box to floor and back up to table.
Outcome measures
| Measure |
Sugar Pill
n=8 Participants
Subjects may receive a pill with no medicine.
|
Hydromorphone ER
n=18 Participants
Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
|
|---|---|---|
|
Change in Time to Lift Box
|
-1.45 seconds per lift
Standard Error 1.13
|
-1.06 seconds per lift
Standard Error 0.8
|
SECONDARY outcome
Timeframe: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post interventionNumeric Rating Scale (NRS) pain score was given verbally after completing functional stair climb test on a scale 0-10 (0=none, and 10=the worst).
Outcome measures
| Measure |
Sugar Pill
n=8 Participants
Subjects may receive a pill with no medicine.
|
Hydromorphone ER
n=18 Participants
Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
|
|---|---|---|
|
Change in NRS After Stair Climb
|
0.04 NRS pain score
Standard Error 0.23
|
-0.11 NRS pain score
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post interventionNumeric Rating Scale (NRS) pain score was given verbally after completing functional treadmill walk test on a scale 0-10 (0=none, and 10=the worst).
Outcome measures
| Measure |
Sugar Pill
n=8 Participants
Subjects may receive a pill with no medicine.
|
Hydromorphone ER
n=18 Participants
Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
|
|---|---|---|
|
Change in NRS After Treadmill Walk
|
0.1 NRS pain score
Standard Error 0.44
|
-0.51 NRS pain score
Standard Error 0.32
|
SECONDARY outcome
Timeframe: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post interventionNumeric Rating Scale (NRS) pain score was given verbally after completing functional sit to stand test on a scale 0-10 (0=none, and 10=the worst).
Outcome measures
| Measure |
Sugar Pill
n=8 Participants
Subjects may receive a pill with no medicine.
|
Hydromorphone ER
n=18 Participants
Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
|
|---|---|---|
|
Change in NRS After Sit to Stand Repetitions
|
-0.24 NRS pain score
Standard Error 0.34
|
-0.57 NRS pain score
Standard Error 0.25
|
SECONDARY outcome
Timeframe: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post interventionNumeric Rating Scale (NRS) pain score was given verbally after completing functional box lift test on a scale 0-10 (0=none, and 10=the worst).
Outcome measures
| Measure |
Sugar Pill
n=8 Participants
Subjects may receive a pill with no medicine.
|
Hydromorphone ER
n=18 Participants
Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
|
|---|---|---|
|
Change in NRS After Box Lift
|
0.39 NRS pain score
Standard Error 0.58
|
-0.43 NRS pain score
Standard Error 0.36
|
Adverse Events
Sugar Pill
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Hydromorphone ER
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sugar Pill
n=12 participants at risk
Subjects may receive a pill with no medicine.
|
Hydromorphone ER
n=23 participants at risk
Subjects received study drug: Hydromorphone ER
Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
|
|---|---|---|
|
General disorders
nausea
|
0.00%
0/12
|
26.1%
6/23
|
|
General disorders
fatigue
|
0.00%
0/12
|
17.4%
4/23
|
|
General disorders
drowsiness
|
8.3%
1/12
|
39.1%
9/23
|
|
General disorders
vomiting
|
8.3%
1/12
|
8.7%
2/23
|
|
General disorders
trouble sleeping
|
0.00%
0/12
|
4.3%
1/23
|
|
General disorders
itchiness
|
16.7%
2/12
|
4.3%
1/23
|
|
General disorders
dizziness
|
0.00%
0/12
|
4.3%
1/23
|
|
Gastrointestinal disorders
stomach pain
|
8.3%
1/12
|
0.00%
0/23
|
|
General disorders
diarrhea
|
0.00%
0/12
|
4.3%
1/23
|
|
Ear and labyrinth disorders
ear infection
|
0.00%
0/12
|
4.3%
1/23
|
|
General disorders
lack of appetite
|
0.00%
0/12
|
4.3%
1/23
|
|
Gastrointestinal disorders
heartburn
|
0.00%
0/12
|
4.3%
1/23
|
Additional Information
Center for Pain Studies
Rehabilitation Institute of Chicago
Phone: 312.238.5654
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place