Pain Processing in Adults With Migraines

Migraines Clinical Trial

Official title:

Pain Processing in Adults With Migraines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02748577
• Other study ID #: IRB00027845
• Status: Completed
• Phase: N/A
• Start date: August 24, 2016
• Est. completion date: July 16, 2019

Study information

• Verified date: August 2019
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: July 16, 2019
• Est. primary completion date: July 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Migraine Disorders
• Migraines

Intervention

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

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heat Pain Intensity coefficient and intercept from stimulus response curve	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	One visit
Primary	Heat Pain Unpleasantness coefficient and intercept from stimulus response curve	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	One visit
Primary	Pain Catastophizing score	Score on the Pain Catastrophizing instrument	One Visit
Primary	Difficulty in Emotions Regulation score	Score on the Difficulty in Emotions Regulation score	One Visit
Secondary	Heat Pain Threshold Temperature	Temperature of heat pain threshold	One Visit
Secondary	Anxiety	Score on the Generalized Anxiety Disorder (GAD-7) instrument	One Visit
Secondary	Depression	Score on the Patient Health related questionnaire-depression module (PHQ-9) instrument	One Visit
Secondary	Mindfulness	Score on the Five Factor Mindfulness (FFM) instrument	One Visit
Secondary	Stress	Score on the Perceived Stress Scale (PSS) instrument	One Visit
Secondary	Hope	Score on the Herth Hope Index instrument	One Visit
Secondary	Optimism	Score on the Life Orientation Test instrument	One Visit
Secondary	Social Connectedness	Score on the Social Connectedness Scale instrument	One Visit
Secondary	Flourishing	Score on the Flourishing scale instrument	One Visit
Secondary	Resilience	Score on the Brief Resilience scale instrument	One Visit
Secondary	Sleep	Score on the NIH Promis Measure of sleep disturbance instrument	One Visit
Secondary	Global Health	Score on the 1st question of the NIH Promis Global Health measure	One Visit