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RECRUITING
NCT06785129

Endometriosis and Migraine

Sponsor: Washington University School of Medicine

View on ClinicalTrials.gov

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.

Official title: Mechanisms Underlying Endometriosis and Migraine Comorbidity

Key Details

Gender

FEMALE

Age Range

12 Years - 45 Years

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2025-02-12

Completion Date

2030-01-01

Last Updated

2025-08-13

Healthy Volunteers

Yes

Interventions

DEVICE

Thermal 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

DEVICE

Pressure 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.

BEHAVIORAL

Pain ratings

Pain intensity and pain unpleasantness ratings will be assessed.

BEHAVIORAL

Conditioned 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.

BIOLOGICAL

Hormonal 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