Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
NCT Number: NCT02748577
Primary Objective of this study: To assess experimental heat pain responses (pain intensity, pain unpleasantness, pain catastrophizing, emotional reactivity) in migraineurs vs. healthy controls.
The current tools of migraine pain measurement are inadequate to distinguish the overall burden of suffering, as there is an over reliance on a single numerical pain score to represent the entire pain experience. Measuring and targeting the affective component, in addition to the sensory component of pain, may capture this discrepancy in disease burden. The affective component of migraine pain may be just as important as the sensory component to target and measure since it significantly impacts outcomes, disability, and has therapeutic treatment implications.
Quantitative sensory testing (QST) is a robust lab paradigm (not a clinical experience) that delivers one painful noxious thermal stimuli and asks for simultaneous pain intensity and pain unpleasantness scores. By using this in the research, investigators will be able to differentiate the sensory (pain quality-what the pain feels like) from the affective (how awful/unpleasant the pain feels) components of experimental pain in normal controls vs. migrainuers.
No previous studies have evaluated differences in experimental pain intensity vs. pain unpleasantness in migraineurs vs. controls. As migraine pain uniquely involves many altered sensory phenomenon (e.g., photophobia, phonophobia), it cannot be assumed that responses to experimental pain in migraine will be the same as other clinical pain syndromes. Further, different clinical pain syndromes have distinct responses to pain intensity vs. pain unpleasantness.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Winston-Salem, North Carolina, 27157, United States
Investigators will conduct a cross-sectional study in migraineurs (interictally, i.e., between migraine attacks) and healthy controls to compare responses to experimental heat pain intensity and unpleasantness and correlate these results to differences in emotional reactivity and pain catastrophizing.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Before the experimental session, participants will use REDCap to complete several questionnaires used to assess outcomes.
Investigators will administer noxious thermal stimulation to assess pain threshold temperatures and assess responses to pain on measures of pain intensity and pain unpleasantness
Time frame: One visit
Using the logarithmic equation: log (VAS pain ratings)=log (t - 35) * coefficient + intercept where t represents stimulus temperature, we will generate stimulus-response curves for each subject
Time frame: One visit
Using the logarithmic equation: log (VAS pain ratings)=log (t - 35) * coefficient + intercept where t represents stimulus temperature, we will generate stimulus-response curves for each subject
Time frame: One Visit
Score on the Pain Catastrophizing instrument
Time frame: One Visit
Score on the Difficulty in Emotions Regulation score
Time frame: One Visit
Temperature of heat pain threshold
Time frame: One Visit
Score on the Generalized Anxiety Disorder (GAD-7) instrument
Time frame: One Visit
Score on the Patient Health related questionnaire-depression module (PHQ-9) instrument
Time frame: One Visit
Score on the Five Factor Mindfulness (FFM) instrument
Time frame: One Visit
Score on the Perceived Stress Scale (PSS) instrument
Time frame: One Visit
Score on the Herth Hope Index instrument
Time frame: One Visit
Score on the Life Orientation Test instrument
Time frame: One Visit
Score on the Social Connectedness Scale instrument
Time frame: One Visit
Score on the Flourishing scale instrument
Time frame: One Visit
Score on the Brief Resilience scale instrument
Time frame: One Visit
Score on the NIH Promis Measure of sleep disturbance instrument
Time frame: One Visit
Score on the 1st question of the NIH Promis Global Health measure
Wake Forest University Health Sciences
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03844412
Back Pain, Brain Diseases
Los Angeles, California, United States
View Trial DetailsNCT06022848
Brain Diseases, Central Nervous System Diseases
London, United Kingdom
View Trial DetailsNCT01431326
Adenoviridae Infections, Adenovirus
Anchorage, Alaska, United States
View Trial DetailsNCT00727974
Brain Diseases, Central Nervous System Diseases
Milwaukee, Wisconsin, United States
View Trial Details