Clinical trial NCT06773065: Central Awareness in Women With Endometriosis
Official title: The Role Of Central Sensitisation In Women With Endometriosis: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometriosis
Keywords: endometriosis
central awareness
central sensitisation syndrome
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 310
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with endometriosis

Brief summary: Gathering some information obtained during the gynaecological examination and transvaginal ultrasound check-up to be able to assess the prevalence of Central Sensitisation Syndrome (CSS) in women with endometriosis and also to be able to assess related risk factors. CSS has been defined as an algic syndrome due to a hyperactivation of the sensitivity circuit at a central level; the diagnosis is based on the result obtained from a questionnaire, the Central Sensitisation Inventory (CSI), which evaluates the presence and intensity of 25 clinical symptoms. For this reason, a questionnaire is proposed to be completed at the time of the check-up visit.

Detailed description: Endometriosis is a chronic benign condition characterised by the presence of endometrial cells within the uterine wall and/or in anatomical locations outside the uterus; 1 in 10 women of reproductive age are affected. Various symptoms are associated with endometriosis: dysmenorrhoea, chronic pelvic pain, peri-ovulatory pain, dyspareunia, dyschezia, dysuria. Chronic pelvic pain (CPD) is one of the most common symptoms of clinical manifestation of endometriosis; 71% to 87% of women surgically diagnosed with endometriosis suffer from it. Therapies have focused on hormone therapy and surgery; although they can control the extent of the disease, most patients fail to resolve DPC. It has therefore been suggested to consider a polycentric chronic pelvic pain (DPC) origin perspective, as suggested by the myofascial and central sensitisation syndrome, which seem to contribute to pain through activation of different trigger points.

In central sensitisation (CS), peripheral nociceptive signal transmission pathways (such as those due to the presence of endometriosis lesions) can lead to adaptive changes in neurons of the central nervous system, including presynaptic effects (e.g. changes in neurotransmitter release) and postsynaptic effects (e.g. increased calcium entry into N-methyl-D-aspartate channels). This leads to a reduction in the activation threshold of central neurons and consequently to a hypersensitisation to pain associated with symptoms of hyperalgesia and allodynia. Together with pain, other symptoms of central sensitisation may occur, such as fatigue, depression, hypersensitivity. While the direct innervation of endometriotic lesions results in the activation of visceral nociception and peripheral sensitisation, CS creates a pain-feeding circuit that is independent of the underlying pathology. In some women with endometriosis, hyperalgesia, allodynia, psychological comorbidities and extension of receptor zones have been observed. Neuroimaging studies have identified changes in the grey matter in women with endometriosis and chronic pelvic pain, further supporting the hypothesis of a central component in women with endometriosis.

CS in some pathologies has led to the definition of a true algic syndrome, called Central Sensitisation Syndrome (CSS). For the identification of this syndrome in clinical practice, the Central Sensitisation Inventory (CSI) has been proposed. It takes the form of a screening tool, based on the patient's completion of a questionnaire, and helps to determine the severity of the symptoms characteristic of this syndrome, enabling its diagnosis. The CSI has been studied and validated for the diagnosis of CSS in patients suffering from fibromyalgia, irritable bowel syndrome and migraine.

Despite the practicality and applicability of the CSI, there appears to be only one study in the literature evaluating its application in women with endometriosis. In particular, this study analyses the correlation between the CSI score and two symptoms characteristic of endometriosis: deep dyspareunia and bladder and/or pelvic floor pain. To date, there appear to be no studies in the literature reporting the prevalence of CSS in patients with endometriosis.

Eligibility criteria: Inclusion Criteria:

* Women with a clinical, ultrasound and/or surgical diagnosis of endometriosis
* Aged between 18 and 50 years
* Patients starting or already taking hormone therapy
* Patients coming for a first visit or outpatient follow-up visit
* Signature of informed consent to participate in the study

Exclusion Criteria:

* Post-menopausal women (spontaneous or iatrogenic)
* Virgo patients
* Patients with poor compliance with hormone therapy, who are not taking it properly or have discontinued therapy spontaneously
* Positive history of any malignant neoplasm
* Positive medical history of specific medical conditions that adversely affect the central nervous system, such as: brain or spinal cord damage, neurological diseases or peripheral nerve damage, multiple sclerosis

Primary outcomes:
measure: Prevalence of central sensitisation syndrome (CSS)
timeFrame: At the first visit after enrollment
Secondary outcomes:
measure: Difference in mean value of the Central Sensitization Inventory (CSI) score
timeFrame: At the first visit after enrollment
measure: Correlation of the CSI value with the degree of various endometriosis symptoms
timeFrame: At the first visit after enrollment
measure: Correlation of the CSI value with the time duration of hormone therapy
timeFrame: At the first visit after enrollment
measure: Correlation of the CSI value with the localizazion of endometriosis lesions
timeFrame: At the first visit after enrollment
measure: Correlation of the CSI value with other clinical characteristics
timeFrame: At the first visit after enrollment
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Diego Raimondo, MD
role: PRINCIPAL_INVESTIGATOR
References: