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EndometriosisNCT06773065

Central Awareness in Women With Endometriosis

An observational study of Endometriosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Endometriosis
How many people
310 participants
Where
1 siteItaly
Study dates
14 Jan 2022to 31 Jan 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: Patients diagnosed with endometriosis

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Diego Raimondo, MD contact

+393290636618

die.raimondo@gmail.com

Italy1 site, 1 recruiting
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna, 40138

    Diego Raimondo, MD, +393290636618, die.raimondo@gmail.com

    Diego Raimondo, MD

    Recruiting

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Conditions
Endometriosis
Keywords
endometriosis, central awareness, central sensitisation syndrome
Medical subject headings
Endometriosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of central sensitisation syndrome (CSS)

    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.

    Measured: At the first visit after enrollment

Secondary outcomes (5)
  1. Difference in mean value of the Central Sensitization Inventory (CSI) score

    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

    Measured: At the first visit after enrollment

  2. Correlation of the CSI value with the degree of various endometriosis symptoms

    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)

    Measured: At the first visit after enrollment

  3. Correlation of the CSI value with the time duration of hormone therapy

    Correlation of the CSI value with the time duration of hormone therapy

    Measured: At the first visit after enrollment

  4. Correlation of the CSI value with the localizazion of endometriosis lesions

    Correlation of the CSI value with the localization of endometriosis lesions

    Measured: At the first visit after enrollment

  5. Correlation of the CSI value with other clinical characteristics

    Correlation of the CSI value with other clinical characteristics

    Measured: At the first visit after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2025
  2. Study start14 Jan 2022
  3. Primary completion31 Jan 2025 (estimated)
  4. Study completion31 Jan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
310 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06773065
Sponsor's protocol ID
STUDIO CS 2021
Status last verified
Dec 2024
First submitted
1 Dec 2024
Last updated
14 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Endometriosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Diego Raimondo, MD (+393290636618, die.raimondo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of central sensitisation syndrome (CSS) (time frame: At the first visit after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.

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