Trial Outcomes & Findings for Brain and Genetic Predictors of Individual Differences in Pain and Analgesia (NCT NCT03781570)
NCT ID: NCT03781570
Last Updated: 2025-06-04
Results Overview
Self reported pain using a Visual Analogue Scale (VAS) ranging from 0-100 (with 0 representing "no pain at all" and 100 representing "most intense pain imaginable (in the context of the experiment)). Higher scores indicate more pain. 0 is the minimum value and 100 is the maximum value. This scale is used for both thermal and mechanical pain. Reported values reflect averages of VAS ratings for individual stimuli for each of thermal and mechanical pain.
COMPLETED
541 participants
Measured during pain tasks at a single 4 hour experimental session (within one month of screening completion).
2025-06-04
Participant Flow
Participant milestones
| Measure |
Main
All participants completed all conditions, with no groups/arms.
|
|---|---|
|
Overall Study
STARTED
|
541
|
|
Overall Study
COMPLETED
|
492
|
|
Overall Study
NOT COMPLETED
|
49
|
Reasons for withdrawal
| Measure |
Main
All participants completed all conditions, with no groups/arms.
|
|---|---|
|
Overall Study
Technical Issues (equipment failure)
|
31
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Physical Constraints
|
11
|
Baseline Characteristics
Brain and Genetic Predictors of Individual Differences in Pain and Analgesia
Baseline characteristics by cohort
| Measure |
Main
n=460 Participants
All participants completed all conditions, with no groups/arms.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
460 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
36.25 years
STANDARD_DEVIATION 2.65 • n=5 Participants
|
|
Sex: Female, Male
Female
|
272 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
188 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
434 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
418 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
460 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured during pain tasks at a single 4 hour experimental session (within one month of screening completion).Population: All participants completed both the placebo condition and the control condition. Participants completed both conditions and all analyses were completed within participants. Descriptions of arms and interventions are detailed in the Protocol Section.
Self reported pain using a Visual Analogue Scale (VAS) ranging from 0-100 (with 0 representing "no pain at all" and 100 representing "most intense pain imaginable (in the context of the experiment)). Higher scores indicate more pain. 0 is the minimum value and 100 is the maximum value. This scale is used for both thermal and mechanical pain. Reported values reflect averages of VAS ratings for individual stimuli for each of thermal and mechanical pain.
Outcome measures
| Measure |
Main
n=460 Participants
All participants completed all conditions, with no groups/arms.
|
|---|---|
|
Pain Rating Scores Made on a Visual Analog Scale (VAS)
Placebo thermal pain ratings
|
0.136 Score on a scale
Standard Deviation 0.123
|
|
Pain Rating Scores Made on a Visual Analog Scale (VAS)
Control thermal pain ratings
|
0.190 Score on a scale
Standard Deviation 0.141
|
|
Pain Rating Scores Made on a Visual Analog Scale (VAS)
Placebo mechanical pain ratings
|
0.126 Score on a scale
Standard Deviation 0.174
|
|
Pain Rating Scores Made on a Visual Analog Scale (VAS)
Control mechanical pain ratings
|
0.160 Score on a scale
Standard Deviation 0.178
|
Adverse Events
Main
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place