Pain Processing in Adults With Migraines

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status

Completed

Conditions

Migraines

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02748577
IRB00027845

Details and patient eligibility

About

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.

Full 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.

Enrollment

121 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

121 participants in 2 patient groups

Migraine
Experimental group
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
Treatment:
Other: Questionnaires
Other: Quantitative Sensory Testing (QST) Pain Measurements
Healthy Controls
Active Comparator group
Description:
Healthy Controls will complete one study visit where they will complete several questionnaires and will complete Quantitative Sensory Testing (QST) Pain Measurements.
Treatment:
Other: Questionnaires
Other: Quantitative Sensory Testing (QST) Pain Measurements

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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