Endometriosis and Migraine

Last updated: March 26, 2025
Sponsor: Washington University School of Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain (Pediatric)

Oral Facial Pain

Headaches

Treatment

Conditioned pain modulation (CPM) response

Pain ratings

Pressure stimuli

Clinical Study ID

NCT06785129
202405127
  • Ages 12-45
  • Female
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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

Exclusion Criteria:

  1. Pregnancy or breastfeeding

  2. Presence of prolactinoma

  3. Presence of psychiatric, neurological, endocrinological and/or developmentalconditions 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 theconsent and answer surveys about their child's health

Study Design

Total Participants: 120
Treatment Group(s): 5
Primary Treatment: Conditioned pain modulation (CPM) response
Phase:
Study Start date:
February 12, 2025
Estimated Completion Date:
January 01, 2030

Study 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.

Connect with a study center

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

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