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Recruiting NCT06773065

Central Awareness in Women With Endometriosis

Observational Endometriosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Endometriosis. Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Role Of Central Sensitisation In Women With Endometriosis: A Prospective Observational Study

Overview

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.

Primary outcome measures

  • Prevalence of central sensitisation syndrome (CSS) [Time frame: At the first visit after enrollment]
Secondary outcome measures (5)
  • Difference in mean value of the Central Sensitization Inventory (CSI) score [Time frame: At the first visit after enrollment]
  • Correlation of the CSI value with the degree of various endometriosis symptoms [Time frame: At the first visit after enrollment]
  • Correlation of the CSI value with the time duration of hormone therapy [Time frame: At the first visit after enrollment]
  • Correlation of the CSI value with the localizazion of endometriosis lesions [Time frame: At the first visit after enrollment]
  • Correlation of the CSI value with other clinical characteristics [Time frame: At the first visit after enrollment]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna

Identifiers

NCT: NCT06773065 · STUDIO CS 2021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗