Central Sensitization in Women With Adenomyosis: Prevalence, Risk Factors, and Treatment Failure
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
- 试验地点
- 14
- 主要终点
- Association of the central sensitization inventory with the presence of central sensitization syndrome in women with adenomyosis.
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ultrasound diagnosis of adenomyosis (previously established);
- •Acquisition of informed consent for participation in the study and for the processing of personal data.
排除标准
- •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).
结局指标
主要结局
Association of the central sensitization inventory with the presence of central sensitization syndrome in women with adenomyosis.
时间窗: 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)
次要结局
- 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)
- Short form of the Central Sensitization Inventory(Baseline)