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临床试验/NCT06785129
NCT06785129招募中不适用

Mechanisms Underlying Endometriosis and Migraine Comorbidity

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年2月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
2
主要终点
Conditioned pain modulation (CPM) response

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
12 Years 至 45 Years(Child, Adult)
性别
Female
接受健康志愿者
是

入选标准

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

排除标准

  • •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

研究组 & 干预措施

Endometriosis

patients with endometriosis

干预措施: Conditioned pain modulation (CPM) response (Behavioral)

control

healthy participants with no migraine or endometriosis

干预措施: Hormonal assessment (Biological)

migraine

patients with migraine

干预措施: Thermal stimuli (Device)

migraine

patients with migraine

干预措施: Pressure stimuli (Device)

migraine

patients with migraine

干预措施: Pain ratings (Behavioral)

migraine

patients with migraine

干预措施: Conditioned pain modulation (CPM) response (Behavioral)

migraine

patients with migraine

干预措施: Hormonal assessment (Biological)

Endometriosis

patients with endometriosis

干预措施: Thermal stimuli (Device)

Endometriosis

patients with endometriosis

干预措施: Pressure stimuli (Device)

Endometriosis

patients with endometriosis

干预措施: Pain ratings (Behavioral)

Endometriosis

patients with endometriosis

干预措施: Hormonal assessment (Biological)

migraine and endometriosis

patients with migraine and endometriosis

干预措施: Thermal stimuli (Device)

migraine and endometriosis

patients with migraine and endometriosis

干预措施: Pressure stimuli (Device)

migraine and endometriosis

patients with migraine and endometriosis

干预措施: Pain ratings (Behavioral)

migraine and endometriosis

patients with migraine and endometriosis

干预措施: Conditioned pain modulation (CPM) response (Behavioral)

migraine and endometriosis

patients with migraine and endometriosis

干预措施: Hormonal assessment (Biological)

control

healthy participants with no migraine or endometriosis

干预措施: Thermal stimuli (Device)

control

healthy participants with no migraine or endometriosis

干预措施: Pressure stimuli (Device)

control

healthy participants with no migraine or endometriosis

干预措施: Pain ratings (Behavioral)

control

healthy participants with no migraine or endometriosis

干预措施: Conditioned pain modulation (CPM) response (Behavioral)

结局指标

主要结局

Conditioned pain modulation (CPM) response

时间窗: 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

时间窗: baseline

prolactin levels

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hadas Nahman-Averbuch

Assistant professor

Washington University School of Medicine

研究点 (2)

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