Pain Processing in Adults With Migraines

Study Overview
=================
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.

Official Title
-----------------
Pain Processing in Adults With Migraines

Conditions
-----------------
Migraines

Intervention / Treatment
-----------------
* Other: Questionnaires
* Other: Quantitative Sensory Testing (QST) Pain Measurements


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria for Healthy Controls: ≥18yo; 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: Any major unstable medical/psychiatric illness (e.g., hospitalization within 90 days, suicide risk, etc.) Severe clinical depression/anxiety Chronic pain condition (e.g., fibromyalgia, migraines for healthy controls, etc.) or sensory abnormalities (e.g., neuropathy, Raynaud's, etc.) Diagnosis of medication overuse headache or chronic migraine. Migraineurs will be studied after being headache-free for at least 48 hours (interictally). Participants may be currently taking migraine medications, as long as they do not have a diagnosis of medication overuse headache. Pregnant subjects will be excluded from all portions of the study due to possible unknown risks of frankly noxious stimuli. 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 Volunteers with no pain ratings to frankly noxious stimuli (temperatures > 49°C) or excessive responses to threshold temperatures ( 43°C)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Migraine<br>Participants with migraines will complete one study visit where they will complete several questionnaires and will also complete Quantitative Sensory Testing (QST) Pain Measurements. They must be migraine-free during the visit and no migraine within 48 hrs of study visit | Other: Questionnaires<br>* Before the experimental session, participants will use REDCap to complete several questionnaires used to assess outcomes.<br>Other: Quantitative Sensory Testing (QST) Pain Measurements<br>* Investigators will administer noxious thermal stimulation to assess pain threshold temperatures and assess responses to pain on measures of pain intensity and pain unpleasantness<br>|
| Active Comparator: Healthy Controls<br>Healthy Controls will complete one study visit where they will complete several questionnaires and will complete Quantitative Sensory Testing (QST) Pain Measurements. | Other: Questionnaires<br>* Before the experimental session, participants will use REDCap to complete several questionnaires used to assess outcomes.<br>Other: Quantitative Sensory Testing (QST) Pain Measurements<br>* Investigators will administer noxious thermal stimulation to assess pain threshold temperatures and assess responses to pain on measures of pain intensity and pain unpleasantness<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heat Pain Intensity coefficient and intercept from stimulus response curve | 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 | One visit | 
| Heat Pain Unpleasantness coefficient and intercept from stimulus response curve | 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 | One visit | 
| Pain Catastophizing score | Score on the Pain Catastrophizing instrument | One Visit | 
| Difficulty in Emotions Regulation score | Score on the Difficulty in Emotions Regulation score | One Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heat Pain Threshold Temperature | Temperature of heat pain threshold | One Visit | 
| Anxiety | Score on the Generalized Anxiety Disorder (GAD-7) instrument | One Visit | 
| Depression | Score on the Patient Health related questionnaire-depression module (PHQ-9) instrument | One Visit | 
| Mindfulness | Score on the Five Factor Mindfulness (FFM) instrument | One Visit | 
| Stress | Score on the Perceived Stress Scale (PSS) instrument | One Visit | 
| Hope | Score on the Herth Hope Index instrument | One Visit | 
| Optimism | Score on the Life Orientation Test instrument | One Visit | 
| Social Connectedness | Score on the Social Connectedness Scale instrument | One Visit | 
| Flourishing | Score on the Flourishing scale instrument | One Visit | 
| Resilience | Score on the Brief Resilience scale instrument | One Visit | 
| Sleep | Score on the NIH Promis Measure of sleep disturbance instrument | One Visit | 
| Global Health | Score on the 1st question of the NIH Promis Global Health measure | One Visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Migraines, Pain responses