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Clinical Trials/NCT06785129
NCT06785129RecruitingNot Applicable

Mechanisms Underlying Endometriosis and Migraine Comorbidity

Washington University School of Medicine2 sites in 1 country120 target enrollmentStarted: February 12, 2025Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
120
Locations
2
Primary Endpoint
Conditioned pain modulation (CPM) response

Study Overview

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 Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
12 Years to 45 Years (Child, Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • •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

Arms & Interventions

Endometriosis

patients with endometriosis

Intervention: Conditioned pain modulation (CPM) response (Behavioral)

control

healthy participants with no migraine or endometriosis

Intervention: Hormonal assessment (Biological)

migraine

patients with migraine

Intervention: Thermal stimuli (Device)

migraine

patients with migraine

Intervention: Pressure stimuli (Device)

migraine

patients with migraine

Intervention: Pain ratings (Behavioral)

migraine

patients with migraine

Intervention: Conditioned pain modulation (CPM) response (Behavioral)

migraine

patients with migraine

Intervention: Hormonal assessment (Biological)

Endometriosis

patients with endometriosis

Intervention: Thermal stimuli (Device)

Endometriosis

patients with endometriosis

Intervention: Pressure stimuli (Device)

Endometriosis

patients with endometriosis

Intervention: Pain ratings (Behavioral)

Endometriosis

patients with endometriosis

Intervention: Hormonal assessment (Biological)

migraine and endometriosis

patients with migraine and endometriosis

Intervention: Thermal stimuli (Device)

migraine and endometriosis

patients with migraine and endometriosis

Intervention: Pressure stimuli (Device)

migraine and endometriosis

patients with migraine and endometriosis

Intervention: Pain ratings (Behavioral)

migraine and endometriosis

patients with migraine and endometriosis

Intervention: Conditioned pain modulation (CPM) response (Behavioral)

migraine and endometriosis

patients with migraine and endometriosis

Intervention: Hormonal assessment (Biological)

control

healthy participants with no migraine or endometriosis

Intervention: Thermal stimuli (Device)

control

healthy participants with no migraine or endometriosis

Intervention: Pressure stimuli (Device)

control

healthy participants with no migraine or endometriosis

Intervention: Pain ratings (Behavioral)

control

healthy participants with no migraine or endometriosis

Intervention: Conditioned pain modulation (CPM) response (Behavioral)

Outcomes

Primary Outcomes

Conditioned pain modulation (CPM) response

Time Frame: 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

Time Frame: baseline

prolactin levels

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hadas Nahman-Averbuch

Assistant professor

Washington University School of Medicine

Study Sites (2)

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