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Completed

NCT Number: NCT02748577

Pain Processing in Adults With Migraines

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

questionnaires

Other

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

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

Primary outcomes

  1. Heat Pain Intensity coefficient and intercept from stimulus response curve

    Time frame: One visit

    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

  2. Heat Pain Unpleasantness coefficient and intercept from stimulus response curve

    Time frame: One visit

    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

  3. Pain Catastophizing score

    Time frame: One Visit

    Score on the Pain Catastrophizing instrument

  4. Difficulty in Emotions Regulation score

    Time frame: One Visit

    Score on the Difficulty in Emotions Regulation score

Secondary outcomes

  1. Heat Pain Threshold Temperature

    Time frame: One Visit

    Temperature of heat pain threshold

  2. Anxiety

    Time frame: One Visit

    Score on the Generalized Anxiety Disorder (GAD-7) instrument

  3. Depression

    Time frame: One Visit

    Score on the Patient Health related questionnaire-depression module (PHQ-9) instrument

  4. Mindfulness

    Time frame: One Visit

    Score on the Five Factor Mindfulness (FFM) instrument

  5. Stress

    Time frame: One Visit

    Score on the Perceived Stress Scale (PSS) instrument

  6. Hope

    Time frame: One Visit

    Score on the Herth Hope Index instrument

  7. Optimism

    Time frame: One Visit

    Score on the Life Orientation Test instrument

  8. Social Connectedness

    Time frame: One Visit

    Score on the Social Connectedness Scale instrument

  9. Flourishing

    Time frame: One Visit

    Score on the Flourishing scale instrument

  10. Resilience

    Time frame: One Visit

    Score on the Brief Resilience scale instrument

  11. Sleep

    Time frame: One Visit

    Score on the NIH Promis Measure of sleep disturbance instrument

  12. Global Health

    Time frame: One Visit

    Score on the 1st question of the NIH Promis Global Health measure

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 22, 2016
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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