AdenomyosisADENOCSNCT07455721
Central Sensitization in Women With Adenomyosis: Prevalence, Risk Factors, and Therapeutic Failure
An observational study of Adenomyosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 14 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Adenomyosis
- How many people
- 1,200 participants
- Where
- 14 sitesItaly
- Study dates
- 9 Dec 2025to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: 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.
Who may be able to join
- Ultrasound diagnosis of adenomyosis (previously established);
- Acquisition of informed consent for participation in the study and for the processing of personal data.
Who cannot join
- Age >18 years;
- Age <50 years;
- Previous hysterectomy;
- No prior vaginal sexual intercourse;
- History of past or current gynecologic cancers;
- History of neurological lesions or diseases that may negatively affect the central nervous system (e.g., brain or spinal cord injury, multiple sclerosis).
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Italy14 sites
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Università di Cagliari, Dipartimento di Scienze Chirurgiche
Cagliari, Cagliari, 09124
Università degli Studi "Magna Grecia" di Catanzaro, Azienda Ospedaliero-Universitaria Renato Dulbecco
Catanzaro, Catanzaro, 88100
Università di Firenze, Ospedale Santa Maria Annunziata
Florence, Firenze, 50012
IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Milano, 20122
Università di Milano, Ospedale Macedonio Melloni
Milan, Milano, 20129
IRCCS Ospedale San Raffaele di Milano
Milan, Milano, 20132
ARNAS Ospedale Civico di Palermo
Palermo, Palermo, 90127
AOR San Carlo
Potenza, Potenza, 85100
Università di Roma Tor Vergata, Policlinico Tor Vergata
Roma, Roma, 00133
Università di Roma La Sapienza, Policlinico Umberto I
Roma, Roma, 00161
Università di Siena, Policlinico Santa Maria alle Scotte
Siena, Siena, 53100
Presidio Ospedaliero Universitario "Santa Maria della Misericordia", Azienda Sanitaria Universitaria Friuli Centrale, Udine
Udine, Udine, 33100
Università di Verona, Ospedale Borgo Roma
Verona, Verona, 37126
About this study
Official title: 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;
Read more
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
- Conditions
- Adenomyosis
- Medical subject headings
- Adenomyosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline
Secondary outcomes (6)
Prevalence of central sensitization in women with adenomyosis
Prevalence of women with adenomyosis with a Central Sensitization Inventory score ≥ the identified cut-off
Measured: Baseline
Risk factors for central sensitization in women with adenomyosis
Association between clinical and demographic characteristics and the presence of central sensitization
Measured: Baseline
Relationship between Central Sensitization Inventory score and pain symptoms/pain-related conditions
Pain intensity (Numerical Rating Scale) and number of associated pain conditions
Measured: Baseline
Persistence of pain in patients with adenomyosis and central sensitization
Persistence of pain defined as a Numerical Rating Scale score ≥ 5 after treatment
Measured: 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).
Measured: 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)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start9 Dec 2025
- Primary completion9 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455721
- Sponsor's protocol ID
- ADENOCS
- Acronym
- ADENOCS
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Sensitization in Women With Adenomyosis: Prevalence, Risk Factors, and Treatment Failure
- ClinicalTrials.gov ID
- NCT07455721
- Acronym / sponsor ID
- ADENOCS / ADENOCS
- Conditions
- Adenomyosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 9 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Ultrasound diagnosis of adenomyosis (previously established);
- Acquisition of informed consent for participation in the study and for the processing of personal data.
Key exclusion criteria (6 listed)
- Age >18 years;
- Age <50 years;
- Previous hysterectomy;
- No prior vaginal sexual intercourse;
- History of past or current gynecologic cancers;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association of the central sensitization inventory with the presence of central sensitization syndrome in women with adenomyosis.
Time frame: Baseline
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)
6 secondary outcomes
Prevalence of central sensitization in women with adenomyosis
Time frame: Baseline
Risk factors for central sensitization in women with adenomyosis
Time frame: Baseline
Relationship between Central Sensitization Inventory score and pain symptoms/pain-related conditions
Time frame: Baseline
Persistence of pain in patients with adenomyosis and central sensitization
Time frame: 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
Time frame: 12-month follow-up
Short form of the Central Sensitization Inventory
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
Related trials for Adenomyosis
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
Not yet recruitingObservational study
Linzagolix in Adenomyosis and Recurrent Implantation Failure
Adenomyosis of Uterus, Implantation Failure
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
Recruiting
Stellate Ganglion Block and Dexmedetomidine for Postoperative Sleep in Women Undergoing Laparoscopic Gynecologic Surgery
Uterine Fibroids (Leiomyoma), Adenomyosis of Uterus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenomyosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 14 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of the central sensitization inventory with the presence of central sensitization syndrome in women with adenomyosis. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.