Central Awareness in Women With Endometriosis

January 8, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

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.

Study Overview

Status

Recruiting

Conditions

Endometriosis

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.

Study Type

Observational

Enrollment (Estimated)

310

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Diego Raimondo, MD
Phone Number: +393290636618
Email: die.raimondo@gmail.com

Study Locations

Italy
- - Bologna, Italy, 40138
    - Recruiting
    - IRCCS Azienda Ospedaliero-Universitaria di Bologna
    - Contact:
      
      Diego Raimondo, MD
      
      Phone Number: +393290636618
      
      Email: die.raimondo@gmail.com
    - Principal Investigator:
      
      Diego Raimondo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with endometriosis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of central sensitisation syndrome (CSS) Time Frame: At the first visit after enrollment	Prevalence of CSS in women with endometriosis by Central Sensitization Inventory (CSI) questionnaire. It consists of two parts: A: assesses clinical symptoms related to CSS, based on the frequency of each symptom, with a subjective scale from 0 (never) to 4 (always), the maximum score is 100. Higher scores are associated with a higher degree of symptomatology reported by the patient. B: previous diagnosis of restless legs syndrome, chronic fatigue syndrome, fibromyalgia, temporomandibular disorders, migraine or headache, irritable bowel syndrome, multiple chemical sensitivity cervical lesions, anxiety or panic attacks, depression. 7 are typical of CSS if 3 are closely related to CSS. Patients are asked whether they have ever been diagnosed with one of the conditions and in which year they were diagnosed. The total score on Part A will then be calculated and the presence or absence o of CSS diagnoses noted. CSS will be defined as a score greater than or equal to 40.	At the first visit after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in mean value of the Central Sensitization Inventory (CSI) score Time Frame: At the first visit after enrollment	Difference in mean value of the CSI score in women with endometriosis in relation to response to hormone therapy. It consists of two parts: A: assesses clinical symptoms related to CSS, based on the frequency of each symptom, with a subjective scale from 0 (never) to 4 (always), the maximum score is 100. Higher scores are associated with a higher degree of symptomatology reported by the patient. B: previous diagnosis of restless legs syndrome, chronic fatigue syndrome, fibromyalgia, temporomandibular disorders, migraine or headache, irritable bowel syndrome, multiple chemical sensitivity cervical lesions, anxiety or panic attacks, depression. 7 are typical of CSS if 3 are closely related to CSS. Patients are asked whether they have ever been diagnosed with one of the conditions and in which year they were diagnosed. The total score on Part A will then be calculated and the presence or absence o of CSS diagnoses noted. CSS will be defined as a score greater than or equal to 40	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 degree of various endometriosis symptoms assessed on a Visual Analogue Scale (VAS) from 0 (no pain) to 10 (worst pain)	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 time duration of hormone therapy	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 the localization of endometriosis lesions	At the first visit after enrollment
Correlation of the CSI value with other clinical characteristics Time Frame: At the first visit after enrollment	Correlation of the CSI value with other clinical characteristics	At the first visit after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

Principal Investigator: Diego Raimondo, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2022

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)