Screening for Fibromyalgia Among Patients With Suspected Endometriosis

NCT07037251 | Recruiting

• 1 other identifier: 0129-23-AAA
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Fibromyalgia; Endometriosis

Keywords

fibromialgia; endometriosis

Outcome Measures

Primary Outcomes (1)

• Occurrence of Fibromyalgia in patients with endometriosis

  Occurrence of Fibromyalgia on first visit to endometriosis clinic

  within 2 years from the beginning of the study

Secondary Outcomes (2)

• 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.

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

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

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

Interventions

there is no intervention OTHER

there is no intervention only observation

Eligibility Criteria

• Gender Eligibility Details: women
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Proven fibromyalgia prior to the first visit.

Sponsors & Collaborators

• Assuta Ashdod Hospital: lead

Study Sites (1)

Assuta Ashdod University Hospital

Ashdod, Israel

RECRUITING

MeSH Terms

Conditions

Fibromyalgia; Endometriosis

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Oshri Barel, MD

CONTACT

+972559382117; oshrib@assuta.co.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2024
• First Posted: June 25, 2025
• Study Start: July 1, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)