Pain Processing in Adults With Migraines

NCT02748577 | Completed DMC

• 1 other identifier: IRB00027845
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraines

Keywords

Migraines; Pain responses

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• Heat Pain Threshold Temperature

  One Visit

• Anxiety

  One Visit

• Depression

  One Visit

• Mindfulness

  One Visit

• Stress

  One Visit

Study Arms (2)

Migraine

EXPERIMENTAL

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; Other: Quantitative Sensory Testing (QST) Pain Measurements

Healthy Controls

ACTIVE COMPARATOR

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

Other: Questionnaires; Other: Quantitative Sensory Testing (QST) Pain Measurements

Interventions

Questionnaires OTHER

Before the experimental session, participants will use REDCap to complete several questionnaires used to assess outcomes.

Healthy Controls; Migraine

Quantitative Sensory Testing (QST) Pain Measurements OTHER

Investigators will administer noxious thermal stimulation to assess pain threshold temperatures and assess responses to pain on measures of pain intensity and pain unpleasantness

Healthy Controls; Migraine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18yo;
• ≥18yo with \>1 yr of migraines and currently 4-20 days/month with migraines, although no migraine within 48 hrs of study visit.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Rebecca E Wells, MD, MPH

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 22, 2016
• Study Start: August 24, 2016
• Primary Completion: July 16, 2019
• Study Completion: July 16, 2019
• Last Updated: May 12, 2020

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Access Criteria: Please contact the study principal investigator, Dr. Rebecca Wells rewells@wakehealth.edu, for the study protocol and other information

Locations

US (1)