Trial Outcomes & Findings for Reliability of Pupil Response to Acute Pain (NCT NCT02628314)
NCT ID: NCT02628314
Last Updated: 2026-07-31
Results Overview
pupil diameter in response to 5 second presentation of noxious heat stimuli
TERMINATED
20 participants
8 weeks
2026-07-31
Participant Flow
This was an observational study without assignment to arms or groups.
Participant milestones
| Measure |
Osteoarthritis
Study population is adult men and women with osteoarthritis.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reliability of Pupil Response to Acute Pain
Baseline characteristics by cohort
| Measure |
Osteoarthritis
n=20 Participants
Study population to include adult men and women with osteoarthritis.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 5.8 • n=9 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Calibration of the visual field using a routine in the software was not performed prior to measuring pupil diameter. Without these calibration data, pupil measurement images cannot be corrected for distortion due to gaze diverging from the center of the screen. This renders the "raw" measures of pupil diameter inaccurate. It is not possible to mathematically correct for this without calibration data.
pupil diameter in response to 5 second presentation of noxious heat stimuli
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1Participants rated their pain intensity during 5 seconds of heating the skin surface to 50 degrees. They used a scale of 0-100, with 0 being no pain at all and 100 being the worst pain imaginable. The heat was applied 5 times over 7.5 minutes and these 6 scores were averaged as their individual score.
Outcome measures
| Measure |
Osteoarthritis
n=20 Participants
Study population is adult men and women with osteoarthritis.
|
|---|---|
|
Pain Score on Visit 1
|
47.0 score on a scale
Standard Deviation 4.4
|
PRIMARY outcome
Timeframe: Week 2Participants rated their pain intensity during 5 seconds of heating the skin surface to 50 degrees. They used a scale of 0-100, with 0 being no pain at all and 100 being the worst pain imaginable. The heat was applied 5 times over 7.5 minutes and these 6 scores were averaged as their individual score.
Outcome measures
| Measure |
Osteoarthritis
n=20 Participants
Study population is adult men and women with osteoarthritis.
|
|---|---|
|
Pain Score on Visit 2
|
39.3 score on a scale
Standard Deviation 6.4
|
PRIMARY outcome
Timeframe: Month 1Participants rated their pain intensity during 5 seconds of heating the skin surface to 50 degrees. They used a scale of 0-100, with 0 being no pain at all and 100 being the worst pain imaginable. The heat was applied 5 times over 7.5 minutes and these 6 scores were averaged as their individual score.
Outcome measures
| Measure |
Osteoarthritis
n=20 Participants
Study population is adult men and women with osteoarthritis.
|
|---|---|
|
Pain Score on Visit 3
|
40.2 score on a scale
Standard Deviation 8.9
|
PRIMARY outcome
Timeframe: Month 2Participants rated their pain intensity during 5 seconds of heating the skin surface to 50 degrees. They used a scale of 0-100, with 0 being no pain at all and 100 being the worst pain imaginable. The heat was applied 5 times over 7.5 minutes and these 6 scores were averaged as their individual score.
Outcome measures
| Measure |
Osteoarthritis
n=20 Participants
Study population is adult men and women with osteoarthritis.
|
|---|---|
|
Pain Score on Visit 4
|
35.9 score on a scale
Standard Deviation 8.9
|
Adverse Events
Osteoarthritis
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. James C. Eisenach
Wake Forest University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place