Pain Processing in Adults With Migraines

Completed · Not applicable

Conditions studied: Migraines

In brief

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.

Key facts

Study ID

NCT02748577

Run by

Wake Forest University Health Sciences

People needed

121

Starts

2016-08-24

Expected to finish

2019-07-16

Last updated by the study team

2020-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

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)

Where it is running

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

Full record on ClinicalTrials.gov

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