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.
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.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Diego Raimondo, MD, +393290636618, die.raimondo@gmail.com
Diego Raimondo, MD
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.
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)
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
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
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
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
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.
- First posted14 Jan 2025
- Study start14 Jan 2022
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diego Raimondo, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role Of Central Sensitisation In Women With Endometriosis: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06773065
- Acronym / sponsor ID
- STUDIO CS 2021
- Conditions
- Endometriosis
- Keywords
- endometriosis, central awareness, central sensitisation syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients diagnosed with endometriosis
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Diego Raimondo, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
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.