RecruitingNCT06785129

Endometriosis and Migraine

Mechanisms Underlying Endometriosis and Migraine Comorbidity


Sponsor

Washington University School of Medicine

Enrollment

120 participants

Start Date

Feb 12, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This study aims to determine differences in experimental pain and sex hormone levels between patients with migraine, patients with endometriosis, patients with migraine and endometriosis, and healthy controls. Participants will complete surveys, experimental pain paradigms and collection of samples for hormone analyses.


Eligibility

Sex: FEMALEMin Age: 12 YearsMax Age: 45 Years

Inclusion Criteria4

  • Patients with diagnosed endometriosis, migraine, or both endometriosis and migraine
  • Healthy control subjects with no history of chronic pain
  • Age 12-45
  • Assigned female sex at birth

Exclusion Criteria5

  • Pregnancy or breastfeeding
  • Presence of prolactinoma
  • Presence of psychiatric, neurological, endocrinological and/or developmental conditions and taking medications for these conditions
  • Current use of dopamine agonist or SSRI medications
  • For patients aged 12-17 not having a parent/legal guardian willing to sign the consent and answer surveys about their child's health

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Interventions

DEVICEThermal stimuli

The Thermal Sensory Analyzer (TSA-II or PATHWAY platform - Medoc, Ramat Yishai, Israel) will be used to safely deliver heat and cold stimuli. These devices can deliver relatively complex stimuli via computer control. All targeted stimulus temperatures will be less than 50°C, and participants will be free to remove their arm or leg at any time from the thermode. Noxious cold stimuli will also be delivered with a plastic water container or a water bath (FISHER, USA). Participants will be free to pull out of the water bath at any time

DEVICEPressure stimuli

Pressure stimuli will be applied by using a handheld algometer (Wagner Instruments) or the Pressure Algometer (Medoc, Ramat Yishai, Israel). These devices have a round probe that allows quantifying the amount of pressure that is being applied. The Pressure Algometer allows a real-time visual feedback to control and monitor applied pressure rates. Pressure will be applied to the lower leg, volar forearm, or trapezius.

BEHAVIORALPain ratings

Pain intensity and pain unpleasantness ratings will be assessed.

BEHAVIORALConditioned pain modulation (CPM) response

The CPM paradigm assesses endogenous inhibitory pain modulation efficiency. CPM testing includes the application of a "test" stimulus without conditioning (control run, pressure pain thresholds) and a subsequent application of the same test stimulus together with a conditioning stimulus (conditioning run, a 60 second of foot immersion in cold water). The CPM response is the difference in the pressure pain thresholds between the control and the conditioning runs.

BIOLOGICALHormonal assessment

Blood samples (approximately 2 tablespoons) and/or saliva and/or urine will be collected for analyses of sex hormone levels (e.g., prolactin, testosterone, estradiol).


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT06785129


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