Assessing Central Awareness in Women with Endometriosis
Official title: The Role Of Central Sensitisation In Women With Endometriosis: A Prospective Observational Study
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06773065 · Data updated 2026-11-12
This study is trying to see how common a condition called Central Sensitisation Syndrome is in women with endometriosis and how it relates to their chronic pelvic pain.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 310 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Status | Recruiting |
| Started | January 14, 2022 |
| Main results expected | January 31, 2025 |
| Study ends | January 31, 2025 |
| Registry record updated | January 14, 2025 |
| Trial ID | NCT06773065 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women aged 18 to 50 with a clinical, ultrasound, or surgical diagnosis of endometriosis who are starting or currently on hormone therapy.
✕Probably not a fit
Patients who are post-menopausal, have a history of neurological diseases, or are not compliant with hormone therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to gather information from gynecological examinations and transvaginal ultrasounds to evaluate the prevalence of Central Sensitisation Syndrome (CSS) in women diagnosed with endometriosis. Participants will complete the Central Sensitisation Inventory (CSI) questionnaire to assess the presence and intensity of various clinical symptoms associated with CSS. The study focuses on understanding the relationship between endometriosis and chronic pelvic pain, considering the role of central sensitisation in pain perception. By identifying risk factors and the prevalence of CSS, the study seeks to enhance the understanding of pain mechanisms in women with endometriosis.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for women suffering from endometriosis.
How similar studies have gone: While the approach of assessing central sensitisation in endometriosis is gaining attention, this specific study's methodology is relatively novel and has not been extensively tested in prior research.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women with a clinical, ultrasound and/or surgical diagnosis of endometriosis * Aged between 18 and 50 years * Patients starting or already taking hormone therapy * Patients coming for a first visit or outpatient follow-up visit * Signature of informed consent to participate in the study Exclusion Criteria: * Post-menopausal women (spontaneous or iatrogenic) * Virgo patients * Patients with poor compliance with hormone therapy, who are not taking it properly or have discontinued therapy spontaneously * Positive history of any malignant neoplasm * Positive medical history of specific medical conditions that adversely affect the central nervous system, such as: brain or spinal cord damage, neurological diseases or peripheral nerve damage, multiple sclerosis
Where it's running
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy Recruiting
Study contacts
- Principal investigator: Diego Raimondo, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Diego Raimondo, MD
- Email: die.raimondo@gmail.com
- Phone: +393290636618
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Comparing different techniques to treat endometriosis
This study is testing different methods to treat endometriosis, like laser and heat techniques, to see which one works best for relieving pain in women who are already having surgery for the condition.
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Postoperative Pain Trajectories After Endometriosis Surgery
This study tests how pain changes after endometriosis surgery and whether perioperative pain testing can predict who will have ongoing pain.
-
Imaging endometriosis with a special PET tracer in adult women
This study tests whether a PET/CT scan using [18F]AlF-FAPI-74 can help detect endometriosis lesions in women who are planning laparoscopy.
-
Fiber supplement for digestive symptoms in endometriosis
A fiber-based supplement is being tested to see if it is safe and helps with gut and vaginal microbiomes and digestive symptoms in women with endometriosis.
-
Stellate ganglion block and dexmedetomidine for better sleep after gynecologic laparoscopy
The study tests whether giving a preoperative stellate ganglion block plus intraoperative dexmedetomidine improves sleep after laparoscopic gynecologic surgery in women.
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Atypical Endometriosis: Histology, Immunophenotype and Molecular Features
Researchers will look at how endometriotic tissue that looks atypical under the microscope relates to clinical features and ultrasound findings to better separate benign from potentially atypical lesions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.