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Pain Processing in Adults With Migraines

This study is currently recruiting participants.
Verified October 2017 by Wake Forest University Health Sciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT02748577
First Posted: April 22, 2016
Last Update Posted: October 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  Purpose

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.


Condition Intervention
Migraines Other: Questionnaires Other: Quantitative Sensory Testing (QST) Pain Measurements

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pain Processing in Adults With Migraines

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • 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

  • 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

  • Pain Catastophizing score [ Time Frame: One Visit ]
    Score on the Pain Catastrophizing instrument

  • Difficulty in Emotions Regulation score [ Time Frame: One Visit ]
    Score on the Difficulty in Emotions Regulation score


Secondary Outcome Measures:
  • Heat Pain Threshold Temperature [ Time Frame: One Visit ]
    Temperature of heat pain threshold

  • Anxiety [ Time Frame: One Visit ]
    Score on the Generalized Anxiety Disorder (GAD-7) instrument

  • Depression [ Time Frame: One Visit ]
    Score on the Patient Health related questionnaire-depression module (PHQ-9) instrument

  • Mindfulness [ Time Frame: One Visit ]
    Score on the Five Factor Mindfulness (FFM) instrument

  • Stress [ Time Frame: One Visit ]
    Score on the Perceived Stress Scale (PSS) instrument

  • Hope [ Time Frame: One Visit ]
    Score on the Herth Hope Index instrument

  • Optimism [ Time Frame: One Visit ]
    Score on the Life Orientation Test instrument

  • Social Connectedness [ Time Frame: One Visit ]
    Score on the Social Connectedness Scale instrument

  • Flourishing [ Time Frame: One Visit ]
    Score on the Flourishing scale instrument

  • Resilience [ Time Frame: One Visit ]
    Score on the Brief Resilience scale instrument

  • Sleep [ Time Frame: One Visit ]
    Score on the NIH Promis Measure of sleep disturbance instrument

  • Global Health [ Time Frame: One Visit ]
    Score on the 1st question of the NIH Promis Global Health measure


Estimated Enrollment: 98
Study Start Date: January 2016
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Migraine
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
Before the experimental session, participants will use REDCap to complete several questionnaires used to assess outcomes.
Other: Quantitative Sensory Testing (QST) Pain Measurements
Investigators will administer noxious thermal stimulation to assess pain threshold temperatures and assess responses to pain on measures of pain intensity and pain unpleasantness
Active Comparator: Healthy Controls
Healthy Controls will complete one study visit where they will complete several questionnaires and will complete Quantitative Sensory Testing (QST) Pain Measurements.
Other: Questionnaires
Before the experimental session, participants will use REDCap to complete several questionnaires used to assess outcomes.
Other: Quantitative Sensory Testing (QST) Pain Measurements
Investigators will administer noxious thermal stimulation to assess pain threshold temperatures and assess responses to pain on measures of pain intensity and 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 (with PHQ-9 scores >20)
  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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02748577


Contacts
Contact: Rebecca E Wells, MD, MPH 336-716-2357 rewells@wakehealth.edu
Contact: Nancy Buchheimer 336-716-3961 nbuchhe@wakehealth.edu

Locations
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Rebecca Wells, MD    336-716-2357    rewells@wakehealth.edu   
Contact: Nancy Buchheimer    3367163961    nbuchhe@wakehealth.edu   
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Rebecca E Wells, MD, MPH Wake Forest University Health Sciences
  More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02748577     History of Changes
Other Study ID Numbers: IRB00027845
First Submitted: April 11, 2016
First Posted: April 22, 2016
Last Update Posted: October 24, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Wake Forest University Health Sciences:
Migraines
Pain responses

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases