EICHORCondition: Adenomyosis · Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 (T…
This description comes directly from the study's public registry record.
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| 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 | — |
| Università di Roma La Sapienza, Policlinico Umberto I | Roma, Roma, Italy | — |
| Università di Siena, Policlinico Santa Maria alle Scotte | Siena, Siena, Italy | — |
+ 2 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07455721