Clinical trial NCT06101303: Endometriosis Pain
Official title: The Mechanisms Underlying Endometriosis Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pelvic Pain
Endometriosis
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 120
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients with pelvic pain scheduled for an operative laparoscopic surgery for endometriosis diagnosis and/or treatment

Brief summary: 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).

Detailed description: 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.

During the surgery, the endometriosis lesions will be excised as part of routine care. At least one lesion will be sent to pathology and one lesion for the study team. In the absence of lesions, peritoneally biopsies of bilateral infra-ovarian fossa will be collected per routine practice. One will be sent to pathology, and one for the study team. Vials of health abdominal peritoneum, and endometrial biopsy (if uterus present) will be collected for study purpose.

Before or on the day of the surgery, blood, urine, and/or saliva samples will be collected for hormonal, immune and genetic testing. Additional samples will be stored in a biobank for future hormonal, immune and/or genetic analyses.

In addition, after the surgery, participants will be asked to complete surveys assessing pain and other symptoms which will be sent every week for the first month and then monthly for 1 year.

After the surgery, participants will have the option to return for additional study visits that will include the same psychophysical procedures and collection of blood (about 20 ml), urine, and/or saliva samples (3 months, 6 months and 1 year after surgery).

During the study period, new about pelvic pain, new/changes in diagnosis, treatment changes (medication titration, physical therapy, mental health, and alternative therapies), surgery related data, additional pain-related diagnoses, and additional markers (i.e., vitamin D, hormone levels) will also be collected via EPIC and/or health history interview.

All study procedures are optional and participants can stop or not complete tests if they want.

Participants need to meet all the inclusion criteria to be included in the study. After consenting and the first study visit, changes in health will not automatically lead to excluding participants from the study. Before the follow-up visits, the investigators will ask the participants about changes in their health (from the last visit). Based on the responses, continuation/withdrawal from the study and/or omission of study activities will be determined at the discretion of the PI and/or study staff.

Eligibility criteria: Inclusion criteria:

* Patients with pelvic pain with and without endometriosis scheduled for an operative laparoscopic surgery for endometriosis diagnosis and/or treatment
* Age 12-45
* Females

Exclusion criteria:

* 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

Primary outcomes:
measure: Pain ratings of clinical pain
timeFrame: Baseline and follow up (3 months, 6 months and 1 year after surgery)
measure: Estrogen levels
timeFrame: Baseline
measure: Estrogen receptor expression in the lesion
timeFrame: Baseline
measure: Conditioned pain modulation (CPM) response
timeFrame: Baseline and follow up (3 months, 6 months and 1 year after surgery)
Secondary outcomes:
measure: Pressure pain thresholds (PPT)
timeFrame: Baseline and follow up (3 months, 6 months and 1 year after surgery)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Hadas Nahman-Averbuch, PhD
role: PRINCIPAL_INVESTIGATOR
References: