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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the presence and related risk factors of Central Sensitisation Syndrome (CSS) in women with endometriosis. Endometriosis is a chronic condition where endometrial cells grow outside the uterus, causing symptoms like pelvic pain and discomfort. Since many women with endometriosis experience chronic pelvic pain that may not be fully resolved by hormone therapy or surgery, this study explores how CSS, a condition involving heightened central nervous system sensitivity to pain, might contribute to their symptoms. Participants will complete the Central Sensitisation Inventory (CSI) questionnaire during their gynecological examination and transvaginal ultrasound check-up. This questionnaire assesses 25 symptoms related to CSS to help diagnose the syndrome. The study focuses on women aged 18 to 50 years who have a clinical, ultrasound, or surgical diagnosis of endometriosis and are starting or already on hormone therapy. During the first visit after enrollment, researchers will measure the prevalence of CSS and analyze the CSI scores in relation to various factors, such as endometriosis symptoms, hormone therapy duration, lesion location, and other clinical characteristics. Participants will be evaluated through standard medical examinations and the CSI questionnaire. The study aims to better understand CSS in women with endometriosis to inform future care approaches.
CONDITIONS
Brief 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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single visit at enrollment
Participants who undergo routine care for endometriosis are observed and complete questionnaires to evaluate the presence and severity of central sensitisation syndrome and related symptoms.
1 visit (in-person)
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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