Actively Recruiting
The Role of Central Sensitisation in Women With Endometriosis A Prospective Observational Study
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-14
310
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the prevalence of Central Sensitisation Syndrome (CSS) in women with endometriosis, a condition where endometrial cells grow outside the uterus causing symptoms like chronic pelvic pain and other related discomforts. The study aims to better understand how CSS, characterized by hypersensitivity to pain and other symptoms like fatigue and depression, relates to endometriosis. CSS is identified using the Central Sensitisation Inventory (CSI), a questionnaire assessing 25 clinical symptoms to diagnose this pain syndrome. Participants are women aged 18 to 50 with a clinical, ultrasound, or surgical diagnosis of endometriosis, who may be starting or already on hormone therapy. The study involves collecting information during gynecological exams and transvaginal ultrasound check-ups, with participants completing the CSI questionnaire during their visit. There are no additional treatments or interventions as this is an observational study. During the study, women will undergo their usual gynecological and ultrasound evaluations while completing the CSI questionnaire to assess symptoms of CSS. Researchers will measure how common CSS is among these women at their first visit after enrollment. The study also collects data on related risk factors and tracks participants' hormone therapy compliance and medical history. Safety and adherence to the study are monitored through these evaluations.
CONDITIONS
Official Title
Central Awareness in Women With Endometriosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138
Actively Recruiting
Research Team
D
Diego Raimondo, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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