Clinical trial NCT02748577: Pain Processing in Adults With Migraines
Official title: Pain Processing in Adults With Migraines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraines
Keywords: Migraines
Pain responses
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Heat Pain Intensity coefficient and intercept from stimulus response curve
timeFrame: One visit
measure: Heat Pain Unpleasantness coefficient and intercept from stimulus response curve
timeFrame: One visit
measure: Pain Catastophizing score
timeFrame: One Visit
measure: Difficulty in Emotions Regulation score
timeFrame: One Visit
Secondary outcomes:
measure: Heat Pain Threshold Temperature
timeFrame: One Visit
measure: Anxiety
timeFrame: One Visit
measure: Depression
timeFrame: One Visit
measure: Mindfulness
timeFrame: One Visit
measure: Stress
timeFrame: One Visit
measure: Hope
timeFrame: One Visit
measure: Optimism
timeFrame: One Visit
measure: Social Connectedness
timeFrame: One Visit
measure: Flourishing
timeFrame: One Visit
measure: Resilience
timeFrame: One Visit
measure: Sleep
timeFrame: One Visit
measure: Global Health
timeFrame: One Visit
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Rebecca E Wells, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: