The Mechanisms Underlying Endometriosis Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pain ratings of clinical pain
研究概览
简要总结
Aim 1. To determine the factors contributing to pain in patients with chronic pelvic pain with and without endometriosis Aim 2. To determine the changes following endometriosis lesion removal surgery in pain and sex hormone levels.
Aim 3. To identify factors predicting clinical pain reduction after lesion removal surgery.
Additional exploratory aims might compare subgroups of patients such as patients with vs. without endometriosis, with vs. without additional chronic pain syndromes, and with vs. without hormonal treatment. In addition, the role of lesion-specific immune signatures and psychological factors on pain will be explored.
Patients with pelvic pain potentially due to endometriosis will complete questionnaires including social, health, behavioral, and psychological questionnaires. Patients will also complete a 2.5 hours study visit of psychophysical assessments of thermal and pressure stimuli. In addition, blood, urine, and saliva samples will be collected for hormonal, immune, and genetic analyses. Additional samples might be collected and stored for future analyses. For some participants, these procedures will be completed several times, including before the surgery as well as 3 months, 6 months and 1 year after surgery. After the surgery, surveys assessing pain and other symptoms will be sent every week on the first month and then monthly for 1 year. In addition, during the surgery, biopsies will be collected and analyzed to determine hormonal, immune and genetic factors.
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).
详细描述
Pre-Study Period
Participants will be recruited via the pain and Ob/Gyn clinics and via EPIC. Potential participants might be identified via EPIC records using age, sex, diagnoses, notes, problem list, medications, date of scheduled surgery, name of physician performing the surgery, 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 or the consent of the study. The consent will be signed electronically, using Docusign e-consent process or remotely during a phone call or a video call (WUSTL Zoom) with a study staff or in person.
Study Design
After confirming the inclusion criteria and signing the consent form, patients with pelvic pain potentially due to endometriosis will complete a 2.5 hours study visit of psychophysical assessments of thermal and pressure stimuli. Patients 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, and surgical history will be abstracted from the medical record and/or via health history interview. These procedures will be completed before the surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Patients with pelvic pain with and without endometriosis scheduled for an operative laparoscopic surgery for endometriosis diagnosis and/or treatment
- •Age 12-45
排除标准
- •Pregnancy
- •Planned hysterectomy or oophorectomy
- •Co-occurring vaginismus and/or vulvodynia
- •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
Pelvic pain
Patients with pelvic pain with and without endometriosis scheduled for an operative laparoscopic surgery for endometriosis diagnosis and/or treatment
干预措施: Psychophysical assessment (Other)
Pelvic pain
Patients with pelvic pain with and without endometriosis scheduled for an operative laparoscopic surgery for endometriosis diagnosis and/or treatment
干预措施: Psychophysical assessments of experimental pain (Behavioral)
Pelvic pain
Patients with pelvic pain with and without endometriosis scheduled for an operative laparoscopic surgery for endometriosis diagnosis and/or treatment
干预措施: Blood, urine and saliva samples (Diagnostic Test)
Pelvic pain
Patients with pelvic pain with and without endometriosis scheduled for an operative laparoscopic surgery for endometriosis diagnosis and/or treatment
干预措施: Biopsy and surgery-related data. (Procedure)
结局指标
主要结局
Pain ratings of clinical pain
时间窗: Baseline and follow up (3 months, 6 months and 1 year after surgery)
Rating the pain intensity level using a numerical pain scale (0-100) or visual analog scale
Estrogen levels
时间窗: Baseline
systemic estrogen level and local estrogen level from the lesion
Estrogen receptor expression in the lesion
时间窗: Baseline
analyzing the levels of estrogen receptor expression in the endometriosis lesion
Conditioned pain modulation (CPM) response
时间窗: Baseline and follow up (3 months, 6 months and 1 year after surgery)
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.
次要结局
- Pressure pain thresholds (PPT)(Baseline and follow up (3 months, 6 months and 1 year after surgery))
研究者
Hadas Nahman-Averbuch
Asst Prof of Anesthesiology
Washington University School of Medicine