Central Sensitization in Women With Adenomyosis: Prevalence, Risk Factors, and Therapeutic Failure

NCT07455721 | Active Not Recruiting

• 1 other identifier: ADENOCS
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 14

Brief 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. 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

Conditions

Adenomyosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Prevalence of central sensitization in women with adenomyosis

  Baseline

• Risk factors for central sensitization in women with adenomyosis

  Baseline

• Relationship between Central Sensitization Inventory score and pain symptoms/pain-related conditions

  Baseline

• Persistence of pain in patients with adenomyosis and central sensitization

  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

  12-month follow-up

Eligibility Criteria

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

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.

You may qualify if:

• Ultrasound diagnosis of adenomyosis (previously established);
• Acquisition of informed consent for participation in the study and for the processing of personal data.

You may not qualify if:

• 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).

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (14)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

Location

Università di Cagliari, Dipartimento di Scienze Chirurgiche

Cagliari, Cagliari, 09124, Italy

Location

Università degli Studi "Magna Grecia" di Catanzaro, Azienda Ospedaliero-Universitaria Renato Dulbecco

Catanzaro, Catanzaro, 88100, Italy

Location

Università di Firenze, Ospedale Santa Maria Annunziata

Florence, Firenze, 50012, Italy

Location

IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Milano, 20122, Italy

Location

Università di Milano, Ospedale Macedonio Melloni

Milan, Milano, 20129, Italy

Location

IRCCS Ospedale San Raffaele di Milano

Milan, Milano, 20132, Italy

Location

ARNAS Ospedale Civico di Palermo

Palermo, Palermo, 90127, Italy

Location

AOR San Carlo

Potenza, Potenza, 85100, Italy

Location

Università di Roma Tor Vergata, Policlinico Tor Vergata

Roma, Roma, 00133, Italy

Location

Università di Roma La Sapienza, Policlinico Umberto I

Roma, Roma, 00161, Italy

Location

Università di Siena, Policlinico Santa Maria alle Scotte

Siena, Siena, 53100, Italy

Location

Presidio Ospedaliero Universitario "Santa Maria della Misericordia", Azienda Sanitaria Universitaria Friuli Centrale, Udine

Udine, Udine, 33100, Italy

Location

Università di Verona, Ospedale Borgo Roma

Verona, Verona, 37126, Italy

Location

MeSH Terms

Conditions

Adenomyosis

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 6, 2026
• Study Start: December 9, 2025
• Primary Completion (Estimated): December 9, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 6, 2026

Record last verified: 2026-02

Locations

IT (14)