Fibromyalgia Syndrome and Chronic Pelvic Pain

February 25, 2026 updated by: Selda Çiftci, Sisli Hamidiye Etfal Training and Research Hospital

Relationship Between Fibromyalgia Syndrome and Chronic Pelvic Pain: A Cross-Sectional Study

This study aimed to compare patients with and without fibromyalgia syndrome in terms of chronic pelvic pain and pelvic floor dysfunction.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The study planned for two patient groups in the Physical Medicine and Rehabilitation outpatient clinic: female patients followed up for fibromyalgia and a control group matched for age and gender without fibromyalgia syndrome. Demographic data, symptom duration, chronic pelvic pain, and pelvic dysfunction symptoms will be assessed in both groups. Pain levels will be measured using the Visual Analog Scale and the McGill Pain Questionnaire Short Form. Additionally, the Fibromyalgia Impact Questionnaire, the Chronic Pelvic Pain Impact Questionnaire, and the Short Form-12 for quality of life assessment will be completed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Contacts and Locations

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

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Şişli Hamidiye Etfal Training and Research Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Female participants aged 18 and over, with and without fibromyalgia syndrome

Description

Inclusion Criteria:

  • Female participants aged 18 and over
  • Voluntary participation in the study

Exclusion Criteria:

  • Individuals with cognitive impairment
  • History of pelvic surgery within the last 3 months
  • Severe cardiac, renal, liver disease, respiratory or endocrine dysfunction, uncontrolled psychiatric illness
  • Pregnant or breastfeeding women
  • Individuals with neuropathy or central nervous system disorders
  • History of neoplasm in the pelvic region

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Those with fibromyalgia syndrome
Female patients with a history of follow-up and treatment due to fibromyalgia syndrome
Female patients presenting to the outpatient clinic who do not have fibromyalgia syndrome
Patients who do not have a history of fibromyalgia syndrome and who present to the outpatient clinic for other reasons

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: Day 1
The score is obtained by measuring, with a ruler, the distance in millimeters along the 10-cm line from the "no pain" reference point to the mark indicated by the patient, yielding a total score between 0 and 100, where higher values reflect increased pain severity.
Day 1
Short-Form McGill Pain Questionnaire
Time Frame: Day 1
The Short-Form McGill Pain Questionnaire was developed as a condensed version of the original instrument. Its core section includes 15 pain descriptors, consisting of 11 sensory and 4 affective items, each rated according to intensity on a 4-point scale from 0 (no pain) to 3 (severe pain).
Day 1
Pelvic Pain Impact Questionnaire
Time Frame: Day 1
The self-administered Pelvic Pain Impact Questionnaire assesses the effect of pelvic pain on daily life. It comprises 8 mandatory and 2 optional items, each rated on a 5-point Likert scale, yielding a total score from 0 to 32, with higher scores indicating greater impact on daily functioning.
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fibromyalgia Impact Questionnaire
Time Frame: Day 1
The Fibromyalgia Impact Questionnaire (FIQ) is a self-administered tool consisting of 10 items; the first item includes 11 questions assessing physical functioning, each rated on a 4-point Likert-type scale.
Day 1

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sisli Hamidiye Etfal Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Banu Kuran, Professor, Şişli Hamidiye Etfal Training and Research Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4926 (June 17, 2025)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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