- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06720181
Functional Evaluation of Brain Pain Centers in Endometriosis-Associated Chronic Pelvic Pain Exploring the Impact of Central Sensitization Using a Novel MRI Technique
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
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey, 34320
- Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Group 1
Patients with chronic pelvic pain and deep infiltrating endometriosis
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Resting-state Functional Magnetic Resonance Imaging and Diffusion Tensor Magnetic Resonance Imaging of the brain
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Group 2
Patients with cystic endometriosis (ovarian endometriomas) without chronic pelvic pain
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Resting-state Functional Magnetic Resonance Imaging and Diffusion Tensor Magnetic Resonance Imaging of the brain
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Group 3
Women with no gynecological pathology, under routine outpatient follow-up, matched for age and body mass index
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Resting-state Functional Magnetic Resonance Imaging and Diffusion Tensor Magnetic Resonance Imaging of the brain
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Neuroimaging in patients suffered from endometriosis-associated chronic pelvic pain
Time Frame: baseline
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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.
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baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IE1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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