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

NCT ID: NCT06720181

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Novel MRI Technique

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

chronic pelvic pain endometriosis brain pain centers functional connectivity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Patients with chronic pelvic pain and deep infiltrating endometriosis

MRI

Intervention Type DIAGNOSTIC_TEST

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

MRI

Intervention Type DIAGNOSTIC_TEST

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

MRI

Intervention Type DIAGNOSTIC_TEST

Resting-state Functional Magnetic Resonance Imaging and Diffusion Tensor Magnetic Resonance Imaging of the brain

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MRI

Resting-state Functional Magnetic Resonance Imaging and Diffusion Tensor Magnetic Resonance Imaging of the brain

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Isin ERDOGAN

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IE1

Identifier Type: -

Identifier Source: org_study_id