Novel MRI TechniqueNCT06720181
Functional Evaluation of Brain Pain Centers in Endometriosis-Associated Chronic Pelvic Pain Exploring the Impact of Central Sensitization Using a Novel MRI Technique
An observational study of Novel MRI Technique, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Novel MRI Technique
- What is being tested?
- MRI
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- patients who were pregnant patients in the postmenopausal period patients who had detected pathologies in brain imaging
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine
Istanbul, 34320
About this study
Official title: 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.
Read the 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.
- Conditions
- Novel MRI Technique
- Being tested
- MRI
- Keywords
- chronic pelvic pain, endometriosis, brain pain centers, functional connectivity
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Resting-state Functional Magnetic Resonance Imaging and Diffusion Tensor Magnetic Resonance Imaging of the brain
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with chronic pelvic pain and deep infiltrating endometriosis Receives: Diagnostic Test: MRI | |
| Group 2 | Patients with cystic endometriosis (ovarian endometriomas) without chronic pelvic pain Receives: Diagnostic Test: MRI | |
| Group 3 | Women with no gynecological pathology, under routine outpatient follow-up, matched for age and body mass index Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start1 Jun 2022
- Primary completion1 Sep 2023
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Novel MRI TechniqueStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isin ERDOGAN, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720181
- Sponsor's protocol ID
- IE1
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06720181
- Acronym / sponsor ID
- IE1
- Conditions
- Novel MRI Technique
- Keywords
- chronic pelvic pain, endometriosis, brain pain centers, functional connectivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: MRIPatients with chronic pelvic pain and deep infiltrating endometriosis |
| Group 2 | – | Diagnostic Test: MRIPatients with cystic endometriosis (ovarian endometriomas) without chronic pelvic pain |
| Group 3 | – | Diagnostic Test: MRIWomen with no gynecological pathology, under routine outpatient follow-up, matched for age and body mass index |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- patients who were pregnant patients in the postmenopausal period patients who had detected pathologies in brain imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIResting-state Functional Magnetic Resonance Imaging and Diffusion Tensor Magnetic Resonance Imaging of the brain | Diagnostic test | Group 1, Group 2, Group 3 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Novel MRI Technique, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuroimaging in patients suffered from endometriosis-associated chronic pelvic pain (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.