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Central Sensitization in Women With Adenomyosis: Prevalence, Risk Factors, and Treatment Failure
This is an observational, prospective, multicenter, non-profit study. The study aims to investigate the association between the Central Sensitization Inventory (CSI) score and the presence of Central Sensitization Syndrome (CSS) in women with adenomyosis, identifying a potential predictive threshold value. Additionally, the study aims to: Estimate the prevalence of Central Sensitization (CS) in women with adenomyosis using the previously defined cut-off value; Identify risk factors for CS in the study population; Examine the relationship between CSI scores and concomitant pain symptoms/pain-related conditions; Investigate the association of CSI scores and the identified cut-off with pain persistence at 6 months in relation to the pharmacological or surgical treatment performed; Assess changes in CSI scores at 12 months from the initiation of pharmacological therapy or surgical intervention, both in women with improvement of pain symptoms and in those with persistent pain; Develop a short Italian version of the CSI to be used in women with adenomyosis. Participants aged 18-50 years attending the outpatient clinics of the participating centers with an ultrasound diagnosis of adenomyosis (defined as at least two features according to MUSA criteria, including one direct feature) will be enrolled. Patients will be treated according to standard clinical practice, ensuring the highest quality of care, and will not undergo additional visits beyond routine care. At baseline (T0), relevant demographic and medical history data will be collected. Pain scores will be assessed using the Numerical Rating Scale (NRS), pelvic floor hypertonia will be evaluated via bimanual gynecological examination, and a transvaginal ultrasound will be performed. The indication for pharmacological therapy or surgical intervention will be recorded, and the CSI questionnaire will be administered. At the 6- and 12-month follow-ups (T1 and T2, respectively), the gynecologist will update medical history, evaluate pain scores (NRS), assess adherence to pharmacological therapy (if prescribed at T0), and record postoperative course and complications (if the patient underwent surgery). The bimanual gynecological examination and transvaginal ultrasound will be repeated. At the 12-month visit, the gynecologist will repeat the T1 assessments and re-administer the CSI questionnaire. A total of 1,200 patients will participate in this study
Age
18 - 50 years
Sex
FEMALE
Healthy Volunteers
No
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy
Università di Cagliari, Dipartimento di Scienze Chirurgiche
Cagliari, Cagliari, Italy
Università degli Studi "Magna Grecia" di Catanzaro, Azienda Ospedaliero-Universitaria Renato Dulbecco
Catanzaro, Catanzaro, Italy
Università di Firenze, Ospedale Santa Maria Annunziata
Florence, Firenze, Italy
IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Milano, Italy
Università di Milano, Ospedale Macedonio Melloni
Milan, Milano, Italy
IRCCS Ospedale San Raffaele di Milano
Milan, Milano, Italy
ARNAS Ospedale Civico di Palermo
Palermo, Palermo, Italy
AOR San Carlo
Potenza, Potenza, Italy
Università di Roma Tor Vergata, Policlinico Tor Vergata
Roma, Roma, Italy
Start Date
December 9, 2025
Primary Completion Date
December 9, 2027
Completion Date
June 30, 2028
Last Updated
March 6, 2026
1,200
ESTIMATED participants
Lead Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07335432