Pain Processing in Adults With Migraines

Not Applicable

Completed

• Conditions: Migraines
• Interventions: Other: Questionnaires; Other: Quantitative Sensory Testing (QST) Pain Measurements

• Registration Number: NCT02748577
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study First Submitted: 2016-04-11
• Study First Submitted QC: 2016-04-19
• Study First Posted: 2016-04-22
• Study Start: 2016-08-24
• Primary Completion: 2019-07-16
• Study Completion: 2019-07-16
• Status Verified: 2019-08
• Last Update Submitted: 2020-05-08
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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.

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Controls	Quantitative Sensory Testing (QST) Pain Measurements	Healthy Controls will complete one study visit where they will complete several questionnaires and will complete Quantitative Sensory Testing (QST) Pain Measurements.
Migraine	Questionnaires	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
Healthy Controls	Questionnaires	Healthy Controls will complete one study visit where they will complete several questionnaires and will complete Quantitative Sensory Testing (QST) Pain Measurements.
Migraine	Quantitative Sensory Testing (QST) Pain Measurements	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

Primary Outcome Measures

Name	Time	Method
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
Difficulty in Emotions Regulation score	One Visit	Score on the Difficulty in Emotions Regulation score
Pain Catastophizing score	One Visit	Score on the Pain Catastrophizing instrument

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States