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MigrainesNCT02748577

Pain Processing in Adults With Migraines

A study testing Questionnaires and Quantitative Sensory Testing (QST) Pain Measurements in people with Migraines, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Migraines
What is being tested?
Questionnaires and Quantitative Sensory Testing (QST) Pain Measurements
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
1 siteUnited States
Study dates
24 Aug 2016to 16 Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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.

Read more

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.

Read the 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.

Conditions
Migraines
Being tested
Questionnaires, Quantitative Sensory Testing (QST) Pain Measurements
Keywords
Migraines, Pain responses
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionnairesOther

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

  • Quantitative Sensory Testing (QST) Pain MeasurementsOther

    Investigators will administer noxious thermal stimulation to assess pain threshold temperatures and assess responses to pain on measures of pain intensity and pain unpleasantness

Study groups in NCT02748577
Study groupRoleWhat they receive
MigraineExperimentalParticipants 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
Receives: Other: Questionnaires; Other: Quantitative Sensory Testing (QST) Pain Measurements
Healthy ControlsActive comparatorHealthy Controls will complete one study visit where they will complete several questionnaires and will complete Quantitative Sensory Testing (QST) Pain Measurements.
Receives: Other: Questionnaires; Other: Quantitative Sensory Testing (QST) Pain Measurements

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: One visit

  2. 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

    Measured: One visit

  3. Pain Catastophizing score

    Score on the Pain Catastrophizing instrument

    Measured: One Visit

  4. Difficulty in Emotions Regulation score

    Score on the Difficulty in Emotions Regulation score

    Measured: One Visit

Secondary outcomes (12)

  1. Heat Pain Threshold Temperature

    Temperature of heat pain threshold

    Measured: One Visit

  2. Anxiety

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

    Measured: One Visit

  3. Depression

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

    Measured: One Visit

  4. Mindfulness

    Score on the Five Factor Mindfulness (FFM) instrument

    Measured: One Visit

  5. Stress

    Score on the Perceived Stress Scale (PSS) instrument

    Measured: One Visit

  6. Hope

    Score on the Herth Hope Index instrument

    Measured: One Visit

  7. Optimism

    Score on the Life Orientation Test instrument

    Measured: One Visit

  8. Social Connectedness

    Score on the Social Connectedness Scale instrument

    Measured: One Visit

  9. Flourishing

    Score on the Flourishing scale instrument

    Measured: One Visit

  10. Resilience

    Score on the Brief Resilience scale instrument

    Measured: One Visit

  11. Sleep

    Score on the NIH Promis Measure of sleep disturbance instrument

    Measured: One Visit

  12. Global Health

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

    Measured: One Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2016 (estimated)
  2. Study start24 Aug 2016
  3. Primary completion16 Jul 2019
  4. Study completion16 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02748577
Sponsor's protocol ID
IRB00027845
Status last verified
Aug 2019
First submitted
11 Apr 2016
Last updated
12 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Questionnaires and Quantitative Sensory Testing (QST) Pain Measurements in people with Migraines, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heat Pain Intensity coefficient and intercept from stimulus response curve (time frame: One visit). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02748577.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.

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