Endometriosis and Migraine

Recruiting

• Conditions: Migraine; Endometriosis
• Interventions: Device: Thermal stimuli; Device: Pressure stimuli; Behavioral: Pain ratings; Behavioral: Conditioned pain modulation (CPM) response; Biological: Hormonal assessment

• Registration Number: NCT06785129
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Participants will be recruited via the pain, headache and Ob/Gyn clinics, via Volunteers for Health, via other studies in the lab, study staff, and via EPIC. When potential participants are inquiring about studies with the Pain the Lifespan Lab, the study team will describe this study among the options. Potential participants might be identified via EPIC records using age, sex, diagnoses, notes, problem list, medications, and phone number.

A research staff member will contact a potential participant and provide a description of the project. Potentially eligible participants will be invited to participate in the study, which will be conducted at Washington University School of Medicine. Participants will also be provided with a written summary of or the consent form for the study. The consent will be signed electronically using Docusign e-consent process either remotely during a phone call or a video call (WUSTL Zoom) with a study staff or in person.

After confirming the inclusion criteria and signing the consent form, participants will complete a 2.5-3 hour study visit of psychophysical assessments of thermal and pressure stimuli. Participants will also complete various questionnaires including demographic, social, health, behavioral, and psychological questionnaires. For adolescents, a parent/legal guardian will be asked to assist in completing some of the health-related surveys (i.e., physical developmental survey, health survey, migraine history survey). Obstetric, gynecologic, fertility, surgical history, medications, and pain will be abstracted from the medical record and/or via health history interview. Blood, urine, and/or saliva samples will be collected for hormonal, immune, and/or genetic testing. Additional samples will be stored in a biobank for future hormonal, immune and/or genetic analyses. Participants will then complete follow-up surveys once monthly for up to 1 year after the study visit which will assess changes to their pain symptoms and treatments. All study procedures are optional, and participants can stop or not complete tests if they want.

Study Timeline

• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-01-15
• Study Start: 2025-02-12
• Status Verified: 2025-03
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-02
• Primary Completion: 2028-01-01
• Study Completion: 2030-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
migraine	Thermal stimuli	patients with migraine
migraine	Pressure stimuli	patients with migraine
migraine	Pain ratings	patients with migraine
migraine	Hormonal assessment	patients with migraine
migraine	Conditioned pain modulation (CPM) response	patients with migraine
Endometriosis	Thermal stimuli	patients with endometriosis
Endometriosis	Pressure stimuli	patients with endometriosis
Endometriosis	Hormonal assessment	patients with endometriosis
migraine and endometriosis	Thermal stimuli	patients with migraine and endometriosis
Endometriosis	Pain ratings	patients with endometriosis
Endometriosis	Conditioned pain modulation (CPM) response	patients with endometriosis
migraine and endometriosis	Pressure stimuli	patients with migraine and endometriosis
migraine and endometriosis	Pain ratings	patients with migraine and endometriosis
migraine and endometriosis	Conditioned pain modulation (CPM) response	patients with migraine and endometriosis
migraine and endometriosis	Hormonal assessment	patients with migraine and endometriosis
control	Thermal stimuli	healthy participants with no migraine or endometriosis
control	Pressure stimuli	healthy participants with no migraine or endometriosis
control	Pain ratings	healthy participants with no migraine or endometriosis
control	Conditioned pain modulation (CPM) response	healthy participants with no migraine or endometriosis
control	Hormonal assessment	healthy participants with no migraine or endometriosis

Primary Outcome Measures

Name	Time	Method
Conditioned pain modulation (CPM) response	Baseline	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.
Sex Hormones	baseline	prolactin levels

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States