Recruiting

Observational Study

Sponsor:

Washington University School of Medicine

Code:

NCT06785129

Conditions

Migraine

Endometriosis

Eligibility Criteria

Sex: Female

Age: 12 - 45

Healthy Volunteers: Accepted

Interventions

Thermal stimuli

Pressure stimuli

Pain ratings

Conditioned pain modulation (CPM) response

Hormonal assessment

Study Details

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

Study ID

NCT06785129

Start date

Feb 12, 2025

Status verified date

Jul, 2026

Completion date

Jan 1, 2030

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 12 - 45

Healthy Volunteers: Accepted

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

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

migraine

patients with migraine

Endometriosis

patients with endometriosis

migraine and endometriosis

patients with migraine and endometriosis

control

healthy participants with no migraine or endometriosis

Interventions

Thermal stimuli

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

Pressure stimuli

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.

Pain ratings

Pain intensity and pain unpleasantness ratings will be assessed.

Conditioned pain modulation (CPM) response

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.

Hormonal assessment

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).

Primary outcome measure

  • Conditioned pain modulation (CPM) response [ Time Frame: Baseline ]
  • Sex Hormones [ Time Frame: baseline ]

Central Contacts and Locations

Central contacts

Alana McMichael, MA

314-273-6194painlab@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Alana McMichael

314-273-6194painlab@wustl.edu

Principal Investigator:

Hadas Nahman-Averbuch, PhD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • Migraine
  • endometriosis
  • hormones
  • pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-07-13.