Migraines
Conditions
Keywords
Migraines, Pain responses
Brief summary
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.
Detailed description
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.
Interventions
OTHERQuestionnaires
Before the experimental session, participants will use REDCap to complete several questionnaires used to assess outcomes.
OTHERQuantitative Sensory Testing (QST) Pain Measurements
Investigators will administer noxious thermal stimulation to assess pain threshold temperatures and assess responses to pain on measures of pain intensity and pain unpleasantness
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Inclusion criteria for Healthy Controls: * ≥18yo; 2. Inclusion Criteria for Migraineurs: * ≥18yo with \>1 yr of migraines and currently 4-20 days/month with migraines, although no migraine within 48 hrs of study visit.
Exclusion criteria
1. Any major unstable medical/psychiatric illness (e.g., hospitalization within 90 days, suicide risk, etc.) 2. Severe clinical depression/anxiety 3. Chronic pain condition (e.g., fibromyalgia, migraines for healthy controls, etc.) or sensory abnormalities (e.g., neuropathy, Raynaud's, etc.) 4. Diagnosis of medication overuse headache or chronic migraine. 5. Migraineurs will be studied after being headache-free for at least 48 hours (interictally). 6. Participants may be currently taking migraine medications, as long as they do not have a diagnosis of medication overuse headache. 7. Pregnant subjects will be excluded from all portions of the study due to possible unknown risks of frankly noxious stimuli. 8. Due to unknown risks and potential harm to the unborn fetus, sexually active women of childbearing potential must use a reliable method of birth control while participating in this study 9. Volunteers with no pain ratings to frankly noxious stimuli (temperatures \> 49°C) or excessive responses to threshold temperatures (\ 43°C)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heat Pain Intensity coefficient and intercept from stimulus response curve | 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 |
| Heat Pain Unpleasantness coefficient and intercept from stimulus response curve | 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 |
| Pain Catastophizing score | One Visit | Score on the Pain Catastrophizing instrument |
| Difficulty in Emotions Regulation score | One Visit | Score on the Difficulty in Emotions Regulation score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heat Pain Threshold Temperature | One Visit | Temperature of heat pain threshold |
| Anxiety | One Visit | Score on the Generalized Anxiety Disorder (GAD-7) instrument |
| Depression | One Visit | Score on the Patient Health related questionnaire-depression module (PHQ-9) instrument |
| Mindfulness | One Visit | Score on the Five Factor Mindfulness (FFM) instrument |
| Optimism | One Visit | Score on the Life Orientation Test instrument |
| Hope | One Visit | Score on the Herth Hope Index instrument |
| Sleep | One Visit | Score on the NIH Promis Measure of sleep disturbance instrument |
| Global Health | One Visit | Score on the 1st question of the NIH Promis Global Health measure |
| Stress | One Visit | Score on the Perceived Stress Scale (PSS) instrument |
| Social Connectedness | One Visit | Score on the Social Connectedness Scale instrument |
| Flourishing | One Visit | Score on the Flourishing scale instrument |
| Resilience | One Visit | Score on the Brief Resilience scale instrument |
Countries
United States
Outcome results
None listed