Central Awareness in Women With Endometriosis

NCT06773065 | Recruiting

• 1 other identifier: STUDIO CS 2021
• Study Type: observational
• Target: 310
• Locations: 1 country
• Sites: 1

Brief Summary

Gathering some information obtained during the gynaecological examination and transvaginal ultrasound check-up to be able to assess the prevalence of Central Sensitisation Syndrome (CSS) in women with endometriosis and also to be able to assess related risk factors. CSS has been defined as an algic syndrome due to a hyperactivation of the sensitivity circuit at a central level; the diagnosis is based on the result obtained from a questionnaire, the Central Sensitisation Inventory (CSI), which evaluates the presence and intensity of 25 clinical symptoms. For this reason, a questionnaire is proposed to be completed at the time of the check-up visit.

Conditions

Endometriosis

Keywords

endometriosis; central awareness; central sensitisation syndrome

Outcome Measures

Primary Outcomes (1)

• Prevalence of central sensitisation syndrome (CSS)

  Prevalence of CSS in women with endometriosis by Central Sensitization Inventory (CSI) questionnaire. It consists of two parts: * A: assesses clinical symptoms related to CSS, based on the frequency of each symptom, with a subjective scale from 0 (never) to 4 (always), the maximum score is 100. Higher scores are associated with a higher degree of symptomatology reported by the patient. * B: previous diagnosis of restless legs syndrome, chronic fatigue syndrome, fibromyalgia, temporomandibular disorders, migraine or headache, irritable bowel syndrome, multiple chemical sensitivity cervical lesions, anxiety or panic attacks, depression. 7 are typical of CSS if 3 are closely related to CSS. Patients are asked whether they have ever been diagnosed with one of the conditions and in which year they were diagnosed. The total score on Part A will then be calculated and the presence or absence o of CSS diagnoses noted. CSS will be defined as a score greater than or equal to 40.

  At the first visit after enrollment

Secondary Outcomes (5)

• Difference in mean value of the Central Sensitization Inventory (CSI) score

  At the first visit after enrollment

• Correlation of the CSI value with the degree of various endometriosis symptoms

  At the first visit after enrollment

• Correlation of the CSI value with the time duration of hormone therapy

  At the first visit after enrollment

• Correlation of the CSI value with the localizazion of endometriosis lesions

  At the first visit after enrollment

• Correlation of the CSI value with other clinical characteristics

  At the first visit after enrollment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with endometriosis

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Diego Raimondo, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diego Raimondo, MD

CONTACT

+393290636618; die.raimondo@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: January 14, 2025
• Study Start: January 14, 2022
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: January 14, 2025

Record last verified: 2024-12

Locations

IT (1)