Assessing Central Awareness in Women with Endometriosis
The Role Of Central Sensitisation In Women With Endometriosis: A Prospective Observational Study
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 |
|---|---|
| Enrollment | 310 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06773065 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bologna
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.