The goal of this study is to measure the test retest reliability of offset analgesia (OA) and onset hyperalgesia (OH) across multiple study visits. OA and OH are quantitative sensory tests (QST) thought to measure how the brain modulates pain. This study will use a heat thermode to induce OA and OH in healthy, pain-free volunteers across 3 study visits. Additional QST measures and survey data relevant to pain modulation will be collected. This study lays the foundation required to use OA and OH as tools to measure pain modulation in clinical trials. Following their validation, we anticipate that OA and OH will serve as predictive and therapeutic biomarkers, which will aid both in the development of novel analgesics and in treatment selection leading to the personalization of pain management.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
74
A computer-controlled probe delivers temperatures to the skin to measure pain, OA, and OH
Standard methods involving pinprick, pressure, heat, and cold applied to the skin are used to measure sensation and pain
QST and computer tasks are used to measure changes in pain intensity
UPMC Pain Medicine at Centre Commons
Pittsburgh, Pennsylvania, United States
Offset analgesia and onset hyperalgesia
Pain intensity difference during heat stimuli measured on a 0-100 sliding scale (0 is no pain, 100 is the most intense pain imaginable) at baseline
Time frame: baseline
Test retest reliability of offset analgesia and onset hyperalgesia
Pain intensity difference during heat stimuli measured on a 0-100 sliding scale (0 is no pain, 100 is the most intense pain imaginable) at 1 week after baseline
Time frame: 1 week post baseline
Test retest reliability of offset analgesia and onset hyperalgesia
Pain intensity difference during heat stimuli measured on a 0-100 sliding scale (0 is no pain, 100 is the most intense pain imaginable) at 4 weeks after baseline
Time frame: 4 weeks post baseline
Differences in brain region activation- QST (quantitative sensory tests)
Difference in brain region activation (as measured by oxygenated hemoglobin, HbO) between central nervous system inhibition and control stimuli during QST procedures.
Time frame: baseline
Test retest reliability in brain region activation- QST (quantitative sensory tests)
Difference in brain region activation (as measured by oxygenated hemoglobin, HbO) between central nervous system inhibition and control stimuli during QST procedures at 1 week after baseline
Time frame: 1 week post baseline
Test retest reliability in brain region activation- QST (quantitative sensory tests)
Difference in brain region activation (as measured by oxygenated hemoglobin, HbO) between central nervous system inhibition and control stimuli during QST procedures at 4 weeks after baseline
Time frame: 4 weeks post baseline
Differences in resting fNIRS signaling
Differences in fNIRS resting state connectivity as measured by brain region activation
Time frame: baseline
Questionnaire score- State Trait Anxiety Inventory (STAI) Y1-2
Standardized survey score of state trait anxiety inventory Y1 and Y2 assessing anxiety before QST procedures on visit 1 only. State Anxiety Score ranges from 20-80. Trait Anxiety Score ranges from 20-80. Higher scores indicate worse anxiety state and trait symptoms.
Time frame: baseline
Questionnaire score- Pain Catastrophizing Scale (PCS)
Standardized survey score assessing pain perception before QST procedures at visit 1 only. Rumination subscale score ranges from 0-16. Magnification subscale score ranges 0-12. Helplessness subscale score ranges from 0-24. Total score can be calculated by summing subscales. Total score ranges from 0-52, with higher scores indicating more pain catastrophizing.
Time frame: baseline
Questionnaire score- STAI Y1 post testing
Standardized survey score of state trait anxiety inventory Y1 assessing anxiety immediately after QST procedures measured at all 3 visits. Higher scores indicate worse anxiety state.
Time frame: baseline
Questionnaire score- STAI Y1 post testing
Standardized survey score of state trait anxiety inventory Y1 assessing anxiety immediately after QST procedures measured at all 3 visits. Higher scores indicate worse anxiety state.
Time frame: 1 week after baseline
Questionnaire score- STAI Y1 post testing
Standardized survey score of state trait anxiety inventory Y1 assessing anxiety immediately after QST procedures measured at all 3 visits. Higher scores indicate worse anxiety state.
Time frame: 4 weeks after baseline
Questionnaire score- Situational Pain Catastrophizing Scale post testing
Standardized survey score assessing pain perception immediately after QST procedures are completed at each visit. Scores range from 0-24, with higher scores representing more pain catastrophizing.
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Time frame: baseline
Questionnaire score- Situational Pain Catastrophizing Scale post testing
Standardized survey score assessing pain perception immediately after QST procedures are completed at each visit. Scores range from 0-24, with higher scores representing more pain catastrophizing.
Time frame: 1 week after baseline
Questionnaire score- Situational Pain Catastrophizing Scale post testing
Standardized survey score assessing pain perception immediately after QST procedures are completed at each visit. Scores range from 0-24, with higher scores representing more pain catastrophizing.
Time frame: 4 weeks after baseline
Questionnaire score- Beck Depression Inventory-II (BDI-II)
Standardized survey assessing depression at the start of visit 1. Scores range from 0-63. Total score of 0-13 is considered minimal range of depression, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depression.
Time frame: baseline
Questionnaire score- Generalized Anxiety Disorder 2-item (GAD-2)
Standardized survey score of GAD-2 assessing anxiety at the start of visit 1. Scores range from 0-6. Higher scores indicate higher likelihood of having GAD.
Time frame: baseline
Questionnaire score- Multidimensional Assessment of Interoceptive Awareness (MAIA) Version 2
Standardized survey score of MAIA-2 assessing mindfulness at the start of visit 1. Total scores range from 0-160 with 8 subscales. Higher scores indicate higher levels of mindfulness.
Time frame: baseline
Questionnaire score- Multidimensional Assessment of Interoceptive Awareness (MAIA) Version 2 post testing
Standardized survey score of MAIA-2 assessing mindfulness after QST measured at all 3 visits. Total scores range from 0-160 with 8 subscales. Higher scores indicate higher levels of mindfulness.
Time frame: baseline
Questionnaire score- Multidimensional Assessment of Interoceptive Awareness (MAIA) Version 2 post testing
Standardized survey score of MAIA-2 assessing mindfulness after QST measured at all 3 visits. Total scores range from 0-160 with 8 subscales. Higher scores indicate higher levels of mindfulness.
Time frame: 1 week after baseline
Questionnaire score- Multidimensional Assessment of Interoceptive Awareness (MAIA) Version 2 post testing
Standardized survey score of MAIA-2 assessing mindfulness after QST measured at all 3 visits. Total scores range from 0-160 with 8 subscales. Higher scores indicate higher levels of mindfulness.
Time frame: 4 weeks after baseline
Pain intensity
Changes in pain intensity during quantitative sensory tests and computer tasks measured on a 0-100 sliding scale (0 is no pain, 100 is the most intense pain imaginable)
Time frame: baseline
Pain intensity
Changes in pain intensity during quantitative sensory tests and computer tasks measured on a 0-100 sliding scale (0 is no pain, 100 is the most intense pain imaginable)
Time frame: 1 week after baseline
Pain intensity
Changes in pain intensity during quantitative sensory tests and computer tasks measured on a 0-100 sliding scale (0 is no pain, 100 is the most intense pain imaginable)
Time frame: 4 weeks after baseline