Mechanisms Underlying Endometriosis and Migraine Comorbidity
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
Hadas Nahman-Averbuch
Assistant professor
Washington University School of Medicine
