Pain Processing in Adults With Migraines
Primary Purpose
Migraines
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Questionnaires
Quantitative Sensory Testing (QST) Pain Measurements
Sponsored by
About this trial
This is an interventional basic science trial for Migraines focused on measuring Migraines, Pain responses
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)
Sites / Locations
- Wake Forest University Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Migraine
Healthy Controls
Arm Description
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 will complete one study visit where they will complete several questionnaires and will complete Quantitative Sensory Testing (QST) Pain Measurements.
Outcomes
Primary Outcome Measures
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
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
Pain Catastophizing score
Score on the Pain Catastrophizing instrument
Difficulty in Emotions Regulation score
Score on the Difficulty in Emotions Regulation score
Secondary Outcome Measures
Heat Pain Threshold Temperature
Temperature of heat pain threshold
Anxiety
Score on the Generalized Anxiety Disorder (GAD-7) instrument
Depression
Score on the Patient Health related questionnaire-depression module (PHQ-9) instrument
Mindfulness
Score on the Five Factor Mindfulness (FFM) instrument
Stress
Score on the Perceived Stress Scale (PSS) instrument
Hope
Score on the Herth Hope Index instrument
Optimism
Score on the Life Orientation Test instrument
Social Connectedness
Score on the Social Connectedness Scale instrument
Flourishing
Score on the Flourishing scale instrument
Resilience
Score on the Brief Resilience scale instrument
Sleep
Score on the NIH Promis Measure of sleep disturbance instrument
Global Health
Score on the 1st question of the NIH Promis Global Health measure
Full Information
NCT ID
NCT02748577
First Posted
April 11, 2016
Last Updated
May 8, 2020
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02748577
Brief Title
Pain Processing in Adults With Migraines
Official Title
Pain Processing in Adults With Migraines
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 24, 2016 (Actual)
Primary Completion Date
July 16, 2019 (Actual)
Study Completion Date
July 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraines
Keywords
Migraines, Pain responses
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Migraine
Arm Type
Experimental
Arm Description
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
Arm Title
Healthy Controls
Arm Type
Active Comparator
Arm Description
Healthy Controls will complete one study visit where they will complete several questionnaires and will complete Quantitative Sensory Testing (QST) Pain Measurements.
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
Before the experimental session, participants will use REDCap to complete several questionnaires used to assess outcomes.
Intervention Type
Other
Intervention Name(s)
Quantitative Sensory Testing (QST) Pain Measurements
Intervention Description
Investigators will administer noxious thermal stimulation to assess pain threshold temperatures and assess responses to pain on measures of pain intensity and pain unpleasantness
Primary Outcome Measure Information:
Title
Heat Pain Intensity coefficient and intercept from stimulus response curve
Description
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
Title
Heat Pain Unpleasantness coefficient and intercept from stimulus response curve
Description
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
Title
Pain Catastophizing score
Description
Score on the Pain Catastrophizing instrument
Time Frame
One Visit
Title
Difficulty in Emotions Regulation score
Description
Score on the Difficulty in Emotions Regulation score
Time Frame
One Visit
Secondary Outcome Measure Information:
Title
Heat Pain Threshold Temperature
Description
Temperature of heat pain threshold
Time Frame
One Visit
Title
Anxiety
Description
Score on the Generalized Anxiety Disorder (GAD-7) instrument
Time Frame
One Visit
Title
Depression
Description
Score on the Patient Health related questionnaire-depression module (PHQ-9) instrument
Time Frame
One Visit
Title
Mindfulness
Description
Score on the Five Factor Mindfulness (FFM) instrument
Time Frame
One Visit
Title
Stress
Description
Score on the Perceived Stress Scale (PSS) instrument
Time Frame
One Visit
Title
Hope
Description
Score on the Herth Hope Index instrument
Time Frame
One Visit
Title
Optimism
Description
Score on the Life Orientation Test instrument
Time Frame
One Visit
Title
Social Connectedness
Description
Score on the Social Connectedness Scale instrument
Time Frame
One Visit
Title
Flourishing
Description
Score on the Flourishing scale instrument
Time Frame
One Visit
Title
Resilience
Description
Score on the Brief Resilience scale instrument
Time Frame
One Visit
Title
Sleep
Description
Score on the NIH Promis Measure of sleep disturbance instrument
Time Frame
One Visit
Title
Global Health
Description
Score on the 1st question of the NIH Promis Global Health measure
Time Frame
One Visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca E Wells, MD, MPH
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Plan to Share 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
Learn more about this trial
Pain Processing in Adults With Migraines
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