Endometriosis and Migraine

ConditionsMigraine Endometriosis

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age12-45

SponsorWashington University School of Medicine

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

participants with migraine OR with endometriosis OR with migraine and endometriosis OR with no chronic pain condition

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Thermal stimuli
Device
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
Device
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
Behavioral
Pain intensity and pain unpleasantness ratings will be assessed.
Conditioned pain modulation (CPM) response
Behavioral
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
Biological/Vaccine
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).

Treatment groups

120 Participants

are divided into 4 treatment groups

Group A: migraine5 interventions

Group B: Endometriosis5 interventions

Group C: migraine and endometriosis5 interventions

Group D: control5 interventions

Trial outcomes

Primary outcomes

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.

Time frame

Baseline

Sex Hormones

prolactin levels

Time frame

baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

Source ClinicalTrials.gov

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