Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Association of the central sensitization inventory with the presence of central sensitization syndrome in women with adenomyosis. | Sensitivity and specificity of the optimal cut-off for identifying the presence of Central Sensitization Syndrome (defined as ≥3 disorders according to Orr et al., 2022) | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of central sensitization in women with adenomyosis | Prevalence of women with adenomyosis with a Central Sensitization Inventory score ≥ the identified cut-off | Baseline |
| Risk factors for central sensitization in women with adenomyosis |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Female patients aged 18 to 50 years attending the outpatient clinics of the participating centers, with an ultrasound diagnosis of adenomyosis (defined as having at least two MUSA criteria, including at least one direct feature), will be invited to participate in the present study.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Bologna | Bologna | 40138 | Italy | ||
| Università di Cagliari, Dipartimento di Scienze Chirurgiche |
Not provided
| ID | Term |
|---|---|
| D062788 | Adenomyosis |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Association between clinical and demographic characteristics and the presence of central sensitization
| Baseline |
| Relationship between Central Sensitization Inventory score and pain symptoms/pain-related conditions | Pain intensity (Numerical Rating Scale) and number of associated pain conditions | Baseline |
| Persistence of pain in patients with adenomyosis and central sensitization | Persistence of pain defined as a Numerical Rating Scale score ≥ 5 after treatment | 6-month follow-up from the initiation of pharmacological therapy or from surgical intervention |
| Change in Central Sensitization Inventory score after 12 months of treatment | The Central Sensitization Inventory (CSI) is a 25-item self-reported questionnaire with total scores ranging from 0 to 100. Higher scores indicate greater symptom severity related to central sensitization (worse outcome). | 12-month follow-up |
| Short form of the Central Sensitization Inventory | Accuracy indices (Cronbach's α, intraclass correlation coefficient, Pearson's linear correlation coefficient, area under the ROC curve, sensitivity, and specificity) | Baseline |
| Cagliari |
| Cagliari |
| 09124 |
| Italy |
| Università degli Studi "Magna Grecia" di Catanzaro, Azienda Ospedaliero-Universitaria Renato Dulbecco | Catanzaro | Catanzaro | 88100 | Italy |
| Università di Firenze, Ospedale Santa Maria Annunziata | Florence | Firenze | 50012 | Italy |
| IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan | Milano | 20122 | Italy |
| Università di Milano, Ospedale Macedonio Melloni | Milan | Milano | 20129 | Italy |
| IRCCS Ospedale San Raffaele di Milano | Milan | Milano | 20132 | Italy |
| ARNAS Ospedale Civico di Palermo | Palermo | Palermo | 90127 | Italy |
| AOR San Carlo | Potenza | Potenza | 85100 | Italy |
| Università di Roma Tor Vergata, Policlinico Tor Vergata | Roma | Roma | 00133 | Italy |
| Università di Roma La Sapienza, Policlinico Umberto I | Roma | Roma | 00161 | Italy |
| Università di Siena, Policlinico Santa Maria alle Scotte | Siena | Siena | 53100 | Italy |
| Presidio Ospedaliero Universitario "Santa Maria della Misericordia", Azienda Sanitaria Universitaria Friuli Centrale, Udine | Udine | Udine | 33100 | Italy |
| Università di Verona, Ospedale Borgo Roma | Verona | Verona | 37126 | Italy |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |