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FibromyalgiaNCT07037251

Screening for Fibromyalgia Among Patients With Suspected Endometriosis

An observational study of Fibromyalgia and Endometriosis, run by Assuta Ashdod Hospital at 1 site in Israel.

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

The main purposes of the study are: To determine the prevalence of fibromyalgia among patients with suspected endometriosis during their initial visit to an endometriosis clinic. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Fibromyalgia, Endometriosis
How many people
150 participants
Where
1 siteIsrael
Study dates
1 Jul 2024to May 2027
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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All women with suspected endometriosis in their first visit to endometriosis clinics in Assuta Ashdod Hospital

Who may be able to join

  • All women with suspected endometriosis in their first visit to endometriosis clinics in Assuta Ashdod Hospital

Who cannot join

  • Proven fibromyalgia prior to the first visit.

Trial locations and contacts

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

Oshri Barel, MD contact

+972559382117

oshrib@assuta.co.il

Israel1 site, 1 recruiting
  • Assuta Ashdod University Hospital

    Ashdod

    Oshri Barel, MD, 0559382117, PRIVATEPRACTICE.BAREL@GMAIL.COM

    oshri Barel, MD

    Recruiting

Other trials in Israel

About this study

The main purposes of the study are:

To determine the prevalence of fibromyalgia among patients with suspected endometriosis during their initial visit to an endometriosis clinic.

Read more

Secondary aims include staging of endometriosis in these patients according to the AAGL (16,17) endometriosis classification and correlate the prevalence of fibromyalgia with ultrasound and surgical findings. Another aim will be to assess the improvement in symptoms in patients diagnosed with both disorders in comparison to patients with either one separately.

All women with suspected endometriosis will be asked to complete the questionnaire before their first visit to the doctor's office.

Study design

  • A single center prospective cohort study
  • All patients attending to Endometriosis clinic at Assuta Ashdod University Hospital with suspected endometriosis at initial visit and who will consent and able to sign the consent form for participation.
  • Fibromyalgia will be defined by the ACR Preliminary Diagnostic Criteria, including Widespread Pain Index, Symptoms severity scale and somatic symptoms.
  • The treating physician will blinded to questionnaire results until the end of the visit.
  • At the end of the visit the questionnaire will be analyzed by one of the investigators and if fibromyalgia is found, the patient will also be referred for treatment of this disorder along with the endometriosis treatment.
  • Questionnaires will be coded with numbers from 1 to 150.
Read the detailed description

Screening for fibromyalgia among patients with suspected endometriosis Introduction Fibromyalgia is a chronic pain syndrome affecting mainly females. Most patients have soft tissue sensitivity and pain, without any abnormality indicating inflammation or damage to those tissues. Therefore, diagnosis of the disease is made promptly by ruling out other conditions and assessing the patients with physical examination and designated thorough questionnaires. For epidemiological purposes the common questionnaire is the London Fibromyalgia Epidemiology Study Screening Questionnaire (LFESSQ) based on pain and fatigue criteria, without referring to tender points. The most recent and practical questionnaire for diagnosing and assessing the severity of the syndrome is the Modified ACR Preliminary Diagnostic Criteria, first published in 2011 and revised in 2016. A patient that fulfills the diagnostic criteria according to the questionere can be diagnosed with this condition without need for other tests.

The pathophysiology of fibromyalgia is not well understood, however is has been extensitvely studied. It is suggested that changes in central pain modulation cause widespread pain and it is associated withseveral genetic and environmental risk factors. This phenomenon of central sensitization also plays a role in chronic pain in patients with endometriosis.

Fibromyalgia and its relation to endometriosis have been studied. Similarly to fibromyalgia, endometriosis is associated with chronic pain and comorbidities. Greenbaum et al. found that endometriosis and fibromyalgia are both associated with autoimmune diseases, such as inflammatory bowel disease and rheumatic arthritis. In addition, both conditions are known to reduce the quality of life and have been associated with depressive symptoms. A study by Nunes et al examined whether there is a difference in the prevalence of fibromyalgia among healthy women or those diagnosed with endometriosis. They did not find any difference in the prevalence between the two groups, however they did identify that the quality of life among women diagnosed with endometriosis was poorer. Another study by Coloma et al. found that there is a higher prevalence of fibromyalgia among women diagnosed with deep infiltrating endometriosis using the LFESSQ, and once again poorer quality of life. Diagnosing fibromyalgia in patients with endometriosis might impact our treatment in these patients, enabling us to better address their pain and offer more focused treatment.

As far as we know, no study was performed in order to assess the prevalence of fibromyalgia in patients with suspected endometriosis as part of their initial visit.

Objectives:

The main purposes of the study are:

To determine the prevalence of fibromyalgia among patients with suspected endometriosis during their initial visit to an endometriosis clinic.

Secondary aims include staging of endometriosis in these patients according to the AAGL endometriosis classification and correlate the prevalence of fibromyalgia with ultrasound and surgical findings. Another aim will be to assess the improvement in symptoms in patients diagnosed with both disorders in comparison to patients with either one separately.

All women with suspected endometriosis will be asked to complete the questionnaire before their first visit to the doctor's office.

Study design

  • A single center prospective cohort study
  • All patients attending to Endometriosis clinic at Assuta Ashdod University Hospital with suspected endometriosis at initial visit and who will consent and able to sign the consent form for participation.
  • Fibromyalgia will be defined by the ACR Preliminary Diagnostic Criteria, including Widespread Pain Index, Symptoms severity scale and somatic symptoms.
  • The treating physician will blinded to questionnaire results until the end of the visit.
  • At the end of the visit the questionnaire will be analyzed by one of the investigators and if fibromyalgia is found, the patient will also be referred for treatment of this disorder along with the endometriosis treatment.
  • Questionnaires will be coded with numbers from 1 to 150.

Inclusion criteria All women with suspected endometriosis in their first visit to endometriosis clinics in Assuta Ashdod Hospital Exclusion criteria Proven fibromyalgia prior to the first visit. Sample size According to previous studies , have used a sample size of 229 patients ,difference between fibromyalgia prevalence in patients with and without endometriosis 6,7% (CI 1.8 -20.5) we assume that 150 eligible cases will be found sufficient ( with 80% power and 5% significance level) Statistical analysis: results will be summarized in Excel table and then analyzed by statistician and the investigators.

Being tested
there is no intervention
Keywords
fibromialgia, endometriosis
Medical subject headings
Fibromyalgia, Endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • there is no interventionOther

    there is no intervention only observation

What is being measured

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

  1. Occurrence of Fibromyalgia in patients with endometriosis

    Occurrence of Fibromyalgia on first visit to endometriosis clinic

    Measured: within 2 years from the beginning of the study

Secondary outcomes (2)
  1. staging of endometriosis in these patients according to the AAGL (16,17) endometriosis classification and correlate the prevalence of fibromyalgia with ultrasound and surgical findings.

    staging of endometriosis in these patients according to the AAGL (16,17) endometriosis classification and correlate the prevalence of fibromyalgia with ultrasound and surgical findings.

    Measured: The questionnaire will be annalized at the end of the study, within 2 years of initial visit

  2. To determine the prevalence of fibromyalgia among patients with suspected endometriosis during their initial visit to an endometriosis clinic.

    Patients will fill diagnostic questionnaire for fibromialgia that will be analyzed by rheumatologists. To determine the prevalence of fibromyalgia among patients with suspected endometriosis during their initial visit to an endometriosis clinic.

    Measured: questionnaire for fibromialgia will be filled up to one day from visit to clinic

Timeline

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

  1. First posted25 Jun 2025
  2. Study start1 Jul 2024
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (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
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07037251
Sponsor's protocol ID
0129-23-AAA
Status last verified
Jun 2025
First submitted
19 May 2024
Last updated
25 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Fibromyalgia and Endometriosis, run by Assuta Ashdod Hospital at 1 site in Israel.

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 1 inclusion and 1 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 25 Jun 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 Israel. 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 Oshri Barel, MD (+972559382117, oshrib@assuta.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Fibromyalgia in patients with endometriosis (time frame: within 2 years from the beginning of the study). 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 25 Jun 2025.

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