Functional Evaluation of Brain Pain Centers in Endometriosis-Associated Chronic Pelvic Pain Exploring the Impact of Central Sensitization Using a Novel MRI Technique

December 3, 2024 updated by: Isin ERDOGAN, Istanbul University - Cerrahpasa

Functional Evaluation of Brain Pain Centers in Endometriosis-Associated Chronic Pelvic Pain Exploring the Impact of Central Sensitization Using a Novel MRI Technique: A Retrospective Study

Endometriosis is a chronic inflammatory disease characterized by the presence of endometrial tissue outside the uterus, affecting about 10% of reproductive-age women. It is commonly associated with chronic pelvic pain, present in 40-50% of women with persistent pelvic pain and 30-40% of infertile women. The condition contributes to chronic pain through mechanisms like inflammation, neurogenic inflammation, neuroangiogenesis, and central sensitization.

Central sensitization involves changes in brain function and can be assessed using magnetic resonance imaging (MRI). While studies have shown the role of brain changes in chronic pain for conditions like migraine and fibromyalgia, research on pain chronicization in endometriosis is limited.

This study focuses on evaluating functional changes in brain pain centers associated with endometriosis-related chronic pelvic pain using neuroimaging. The goal is to enhance understanding of the pathophysiology of chronic pain and emphasize the potential of MRI in guiding more effective management strategies for endometriosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Endometriosis is a chronic disease defined by the presence of endometrial stroma and glands outside the uterus. It affects approximately 10% of women of reproductive age and is detected in 40-50% of women experiencing persistent pelvic pain and 30-40% of infertile women. Clinically classified as an inflammatory and systemic disease, endometriosis often manifests as pelvic pain. It is believed that endometriosis contributes to chronic pelvic pain through mechanisms such as inflammation, neurogenic inflammation, neuroangiogenesis, peripheral sensitization, central sensitization, and cross-organ sensitization.

Central sensitization can be identified by evaluating functional changes in the brain using magnetic resonance imaging (MRI). Numerous studies have demonstrated the importance of brain functional changes in the chronicization of pain in various conditions, including migraine, fibromyalgia, trigeminal neuralgia, and chronic lower back pain. However, there are limited MRI studies investigating the chronicization of pain associated with endometriosis.

In this study, we aim to highlight the benefits of neuroimaging in elucidating the pathophysiology of chronic pain by examining the functional changes in brain pain centers in chronic pelvic pain associated with endometriosis.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey, 34320
        • Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The medical records of patients who visited the Gynecology Outpatient Clinic and/or were hospitalized in the Gynecology Department of Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine, between June 1, 2022, and September 1, 2023, were reviewed retrospectively.

Description

Inclusion Criteria:

Women aged 18-45 who underwent brain magnetic resonance imaging, including those with endometriosis and those without gynecological pathology, matched for age and body mass index

Exclusion Criteria:

patients who were pregnant patients in the postmenopausal period patients who had detected pathologies in brain imaging

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Patients with chronic pelvic pain and deep infiltrating endometriosis
Resting-state Functional Magnetic Resonance Imaging and Diffusion Tensor Magnetic Resonance Imaging of the brain
Group 2
Patients with cystic endometriosis (ovarian endometriomas) without chronic pelvic pain
Resting-state Functional Magnetic Resonance Imaging and Diffusion Tensor Magnetic Resonance Imaging of the brain
Group 3
Women with no gynecological pathology, under routine outpatient follow-up, matched for age and body mass index
Resting-state Functional Magnetic Resonance Imaging and Diffusion Tensor Magnetic Resonance Imaging of the brain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuroimaging in patients suffered from endometriosis-associated chronic pelvic pain
Time Frame: baseline
The functional connectivity of brain regions involved in pain pathophysiology, including the anterior and posterior segments of the anterior cingulate gyrus, insula, thalamus, and amygdala, with other brain areas was investigated using the seed-to-voxel connectivity method.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

July 1, 2024

Study Registration Dates

First Submitted

December 3, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Estimated)

December 6, 2024

Study Record Updates

Last Update Posted (Estimated)

December 6, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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