MigraineEMCNCT06785129
Endometriosis and Migraine
An observational study of Migraine and Endometriosis, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Migraine, Endometriosis
- What is being tested?
- Thermal stimuli, Pressure stimuli and Pain ratings
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2025to 1 Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: participants with migraine OR with endometriosis OR with migraine and endometriosis OR with no chronic pain condition
Who may be able to join
- Patients with diagnosed endometriosis, migraine, or both endometriosis and migraine
- Healthy control subjects with no history of chronic pain
- Age 12-45
- Assigned female sex at birth
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Alana McMichael, 314-273-6194, painlab@wustl.edu
Hadas Nahman-Averbuch, PhD
About this study
Official title: Mechanisms Underlying Endometriosis and Migraine Comorbidity
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.
Read the 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.
- Conditions
- Migraine, Endometriosis
- Being tested
- Thermal stimuli, Pressure stimuli, Pain ratings, Conditioned pain modulation (CPM) response, Hormonal assessment
- Keywords
- Migraine, endometriosis, hormones, pain
- Medical subject headings
- Migraine Disorders, Endometriosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal stimuliDevice
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 stimuliDevice
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 ratingsBehavioural
Pain intensity and pain unpleasantness ratings will be assessed.
Conditioned pain modulation (CPM) responseBehavioural
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 assessmentBiological
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).
| Study group | Role | What they receive |
|---|---|---|
| migraine | patients with migraine Receives: Device: Thermal stimuli; Device: Pressure stimuli; Behavioral: Pain ratings; Behavioral: Conditioned pain modulation (CPM) response; Biological: Hormonal assessment | |
| Endometriosis | patients with endometriosis Receives: Device: Thermal stimuli; Device: Pressure stimuli; Behavioral: Pain ratings; Behavioral: Conditioned pain modulation (CPM) response; Biological: Hormonal assessment | |
| migraine and endometriosis | patients with migraine and endometriosis Receives: Device: Thermal stimuli; Device: Pressure stimuli; Behavioral: Pain ratings; Behavioral: Conditioned pain modulation (CPM) response; Biological: Hormonal assessment | |
| control | healthy participants with no migraine or endometriosis Receives: Device: Thermal stimuli; Device: Pressure stimuli; Behavioral: Pain ratings; Behavioral: Conditioned pain modulation (CPM) response; Biological: Hormonal assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conditioned pain modulation (CPM) response
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.
Measured: Baseline
Sex Hormones
prolactin levels
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start12 Feb 2025
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadas Nahman-Averbuch, Washington University School of Medicine
- Investigators
- Hadas Nahman-Averbuch, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785129
- Sponsor's protocol ID
- 202405127
- Acronym
- EMC
- Status last verified
- Jul 2026
- First submitted
- 15 Jan 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data may be shared after the completion of the study and based on a request
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms Underlying Endometriosis and Migraine Comorbidity
- ClinicalTrials.gov ID
- NCT06785129
- Acronym / sponsor ID
- EMC / 202405127
- Conditions
- Migraine, Endometriosis
- Keywords
- Migraine, endometriosis, hormones, pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 21 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| migraine | – | Device: Thermal stimuli, Device: Pressure stimuli, Behavioral: Pain ratings, Behavioral: Conditioned pain modulation (CPM) response, Biological: Hormonal assessmentpatients with migraine |
| Endometriosis | – | Device: Thermal stimuli, Device: Pressure stimuli, Behavioral: Pain ratings, Behavioral: Conditioned pain modulation (CPM) response, Biological: Hormonal assessmentpatients with endometriosis |
| migraine and endometriosis | – | Device: Thermal stimuli, Device: Pressure stimuli, Behavioral: Pain ratings, Behavioral: Conditioned pain modulation (CPM) response, Biological: Hormonal assessmentpatients with migraine and endometriosis |
| control | – | Device: Thermal stimuli, Device: Pressure stimuli, Behavioral: Pain ratings, Behavioral: Conditioned pain modulation (CPM) response, Biological: Hormonal assessmenthealthy participants with no migraine or endometriosis |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- participants with migraine OR with endometriosis OR with migraine and endometriosis OR with no chronic pain condition
Key inclusion criteria (4 listed)
- Patients with diagnosed endometriosis, migraine, or both endometriosis and migraine
- Healthy control subjects with no history of chronic pain
- Age 12-45
- Assigned female sex at birth
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermal stimuliThe 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 | Device | Endometriosis, control, migraine, migraine and endometriosis |
| Pressure stimuliPressure 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. | Device | Endometriosis, control, migraine, migraine and endometriosis |
| Pain ratingsPain intensity and pain unpleasantness ratings will be assessed. | Behavioural | Endometriosis, control, migraine, migraine and endometriosis |
| Conditioned pain modulation (CPM) responseThe 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. | Behavioural | Endometriosis, control, migraine, migraine and endometriosis |
| Hormonal assessmentBlood samples (approximately 2 tablespoons) and/or saliva and/or urine will be collected for analyses of sex hormone levels (e.g., prolactin, testosterone, estradiol). | Biological | Endometriosis, control, migraine, migraine and endometriosis |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Undecided. Data may be shared after the completion of the study and based on a request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hadas Nahman-Averbuch, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine and Endometriosis, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alana McMichael, MA (314-273-6194, painlab@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conditioned pain modulation (CPM) response (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.