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

NCT06720181 | Completed

• 1 other identifier: IE1
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Novel MRI Technique

Keywords

chronic pelvic pain; endometriosis; brain pain centers; functional connectivity

Outcome Measures

Primary Outcomes (1)

• Neuroimaging in patients suffered from endometriosis-associated chronic pelvic pain

  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

Study Arms (3)

Group 1

Patients with chronic pelvic pain and deep infiltrating endometriosis

Diagnostic Test: MRI

Group 2

Patients with cystic endometriosis (ovarian endometriomas) without chronic pelvic pain

Diagnostic Test: MRI

Group 3

Women with no gynecological pathology, under routine outpatient follow-up, matched for age and body mass index

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

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

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine

Istanbul, 34320, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: June 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: July 1, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)