Endometriosis and Migraine

NCT06785129 | Recruiting

• 1 other identifier: 202405127
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine; Endometriosis

Keywords

Migraine; endometriosis; hormones; pain

Outcome Measures

Primary Outcomes (2)

• Conditioned pain modulation (CPM) response

  This psychophysical test examine the inhibitory pain modulation efficiency. In this test, pressure pain thresholds (measures by kilopascal) are assessed before and during immersion of the foot in cold water.

  Baseline

• Sex Hormones

  prolactin levels

  baseline

Study Arms (4)

migraine

patients with migraine

Device: Thermal stimuli; Device: Pressure stimuli; Behavioral: Pain ratings; Behavioral: Conditioned pain modulation (CPM) response; Biological: Hormonal assessment

Endometriosis

patients with endometriosis

Device: Thermal stimuli; Device: Pressure stimuli; Behavioral: Pain ratings; Behavioral: Conditioned pain modulation (CPM) response; Biological: Hormonal assessment

migraine and endometriosis

patients with migraine and endometriosis

Device: Thermal stimuli; Device: Pressure stimuli; Behavioral: Pain ratings; Behavioral: Conditioned pain modulation (CPM) response; Biological: Hormonal assessment

control

healthy participants with no migraine or endometriosis

Device: Thermal stimuli; Device: Pressure stimuli; Behavioral: Pain ratings; Behavioral: Conditioned pain modulation (CPM) response; Biological: Hormonal assessment

Interventions

Thermal stimuli DEVICE

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

Endometriosis; control; migraine; migraine and endometriosis

Pressure stimuli DEVICE

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.

Endometriosis; control; migraine; migraine and endometriosis

Pain ratings BEHAVIORAL

Pain intensity and pain unpleasantness ratings will be assessed.

Endometriosis; control; migraine; migraine and endometriosis

Conditioned pain modulation (CPM) response BEHAVIORAL

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.

Endometriosis; control; migraine; migraine and endometriosis

Hormonal assessment BIOLOGICAL

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).

Endometriosis; control; migraine; migraine and endometriosis

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

participants with migraine OR with endometriosis OR with migraine and endometriosis OR with no chronic pain condition

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood, saliva, urine

MeSH Terms

Conditions

Migraine Disorders; Endometriosis; Pain

Interventions

carboxypeptidase M

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hadas Nahman-Averbuch, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alana McMichael, MA

CONTACT

314-273-6194; painlab@wustl.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 21, 2025
• Study Start: February 12, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2030
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

US (1)