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| Name | Class |
|---|---|
| QIMR Berghofer Medical Research Institute | OTHER |
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The purpose of the study is to gain a better understanding of pain processing in the brain. Our understanding of how pain is processed in the brain is limited. We are testing for individual differences in pain perception and emotion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single group | All participants are administered Control and Placebo creams (two interventions), with thermal and mechanical painful stimuli delivered repeatedly after each intervention. The order of intervention testing is Control, Placebo, Placebo, Control in a fixed order. All interventions are completed within a single testing session. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Cream | Behavioral | In the Placebo intervention, participants are given an inert cream with instructions that it is "Prodicaine, an effective pain-relieving drug". The cream is applied to two fingers on the left hand. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Rating Scores Made on a Visual Analog Scale (VAS) | 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. | Measured during pain tasks at a single 4 hour experimental session (within one month of screening completion). |
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Inclusion Criteria:
Exclusion Criteria:
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The CTS includes 727 same-sex twin pairs between 26-38 years old (as of Spring 2017), originally derived from the Colorado Twin Registry, a population based registry, housed at the Institute for Behavioral Genetics (IBG) at the University of Colorado since 1984, with three previous waves of data collection (1997-2002, 2002-2008, and 2009-2014).
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| Name | Affiliation | Role |
|---|---|---|
| Tor Wager, PHD | University of Colorado, Boulder | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado, Boulder | Boulder | Colorado | 80309 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Main | All participants completed all conditions, with no groups/arms. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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32 participants (out of 492) were excluded from analysis: The first 10 participants completed a different experimental design (with different stimuli timing, intensities and ratings), 20 participants were excluded because all their pain ratings were with reaction time over the allotted time for rating or too short to be deliberate, one participant was insensitive to pain (due to their profession), and one participant was excluded due to data loss.
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| ID | Title | Description |
|---|---|---|
| BG000 | Main | All participants completed all conditions, with no groups/arms. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Rating Scores Made on a Visual Analog Scale (VAS) | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Measured during pain tasks at a single 4 hour experimental session (within one month of screening completion). |
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Adverse events were monitored for each participant during their participation (i.e., from the beginning to the end of their in person session). Participants were instructed to report any unusual events happening shortly after the experiment.
one 4-hour session
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Main | All participants completed all conditions, with no groups/arms. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tor D Wager, PhD | Dartmouth College | (603)-646-2196 | Tor.D.Wager@Dartmouth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 11, 2023 | Feb 16, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 13, 2024 | Feb 16, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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We will collect saliva samples during the fMRI scan day and genotype using the same facility (same laboratory, personnel, platform, and protocols), following standard GWAS quality control procedures.
| Control Cream | Behavioral | In the Control intervention, participants are given an inert cream with instructions that it is "a control cream with no effects" . The cream is applied to two fingers on the left hand. |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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All participants completed all conditions, with no groups/arms.
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| 541 |
| 0 |
| 541 |
| 0 |
| 541 |
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