Pain Processing in Adults With Migraines

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.

Study Overview

• Status: Completed
• Conditions: Migraines
• Intervention / Treatment: Other: Questionnaires; Other: Quantitative Sensory Testing (QST) Pain Measurements

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 Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Migraine; 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; Before the experimental session, participants will use REDCap to complete several questionnaires used to assess outcomes.; Other: Quantitative 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
ACTIVE_COMPARATOR: Healthy Controls; Healthy Controls will complete one study visit where they will complete several questionnaires and will complete Quantitative Sensory Testing (QST) Pain Measurements.	Other: Questionnaires; Before the experimental session, participants will use REDCap to complete several questionnaires used to assess outcomes.; Other: Quantitative 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

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 24, 2016
• Primary Completion (ACTUAL): July 16, 2019
• Study Completion (ACTUAL): July 16, 2019

Study Registration Dates

• First Submitted: April 11, 2016
• First Submitted That Met QC Criteria: April 19, 2016
• First Posted (ESTIMATE): April 22, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 8, 2020
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Migraines; Pain responses
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: IRB00027845

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Access Criteria: Please contact the study principal investigator, Dr. Rebecca Wells rewells@wakehealth.edu, for the study protocol and other information
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No