Fibromyalgia Syndrome and Chronic Pelvic Pain

NCT07344675 | Completed

• 1 other identifier: 4926 (June 17, 2025)
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain; Fibromyalgia; Fibromyalgia Syndrome; Chronic Pelvic Pain; Chronic Pelvic Pain Syndrome (CPPS)

Keywords

fibromyalgia; chronic pelvic pain; pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Fibromyalgia Impact Questionnaire

  Day 1

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Şişli Hamidiye Etfal Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Banu Kuran, Professor

  Şişli Hamidiye Etfal Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 15, 2026
• Study Start: July 1, 2025
• Primary Completion: January 15, 2026
• Study Completion: February 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

TU (1)