Fibromyalgia Syndrome and Chronic Pelvic Pain

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: Completed
• Conditions: Pain; Fibromyalgia; Fibromyalgia Syndrome; Chronic Pelvic Pain; Chronic Pelvic Pain Syndrome (CPPS)

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: Observational
• Enrollment (Actual): 128

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	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	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	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

Outcome Measure	Measure Description	Time Frame
Fibromyalgia Impact Questionnaire	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

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
• Investigators: Study Director: Banu Kuran, Professor, Sisli Hamidiye Etfal Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Actual): January 15, 2026
• Study Completion (Actual): February 1, 2026

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: pain; fibromyalgia; chronic pelvic pain
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Fibromyalgia
• Other Study ID 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