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Completed

NCT Number: NCT07344675

Fibromyalgia Syndrome and Chronic Pelvic Pain

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

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Key information

Conditions

Fibromyalgia Chronic Pelvic Pain Chronic Pelvic Pain Syndrome (CPPS) Fibromyalgia Syndrome Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Şişli Hamidiye Etfal Training and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 15, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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