NCT07189247

Evaluation of Fibromyalgia Frequency and Pain Parameters in Women With Polycystic Ovary Syndrome

Evaluation of Fibromyalgia Frequency and Pain Parameters in Women With Polycystic Ovary Syndrome: A Prospective Single-Blind Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 140 (estimated)
• Sponsor: Ufuk University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The primary objective was to determine the prevalence of fibromyalgia in women with PCOS and to examine the relationship between fibromyalgia and psychological status (depression and anxiety). Secondary objectives were to explore the potential link between fibromyalgia and insulin resistance, taking into account phenotypic differences. To assess the relationship between fibromyalgia severity and quality of life and pressure pain threshold measurements. To analyze the impact of pain and mood disorders on PCOS phenotypes and to demonstrate the role of insulin resistance in predicting fibromyalgia. Participants will be women aged 18-40 diagnosed with PCOS according to the Rotterdam criteria, and a healthy control group of a similar age. When making a PCOS diagnosis, clinical (hirsutism, acne, menstrual irregularity), biochemical (free testosterone, DHEAS, androstenedione, etc.), and ultrasonographic (polycystic ovary morphology) findings will be evaluated. The control group will consist of healthy volunteers presenting with gynecological complaints other than PCOS and without chronic diseases. Examination and Assessment Process Obstetrics and Gynecology Outpatient Clinic: PCOS diagnosis, demographic data, biochemical tests (glucose, insulin, HOMA-IR, etc.), and phenotyping. Physical Therapy and Rehabilitation: Application of the 2016 ACR fibromyalgia criteria in a single-blind trial, including measurement of pressure pain threshold (algometer), fibromyalgia severity scale, and recording of Fibromyalgia Impact Questionnaire scores. Psychological Assessment The HADS (Hospital Anxiety and Depression Scale) will be administered to assess depression and anxiety levels. Scores obtained will be compared with fibromyalgia diagnosis and PCOS phenotypes to examine the influence of psychological factors on pain perception.

Conditions

• Fibromyalgia
• PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2025-09-23
• Last updated: 2025-09-23

Locations

1 site across 1 country: Turkey (Türkiye)