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

Ufuk University

Status: Not yet enrolling

Conditions: Fibromyalgia; PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Study type: Observational

Funder types: Other

Identifiers

NCT07189247

12024861-19

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Women aged 18-40
2. Those diagnosed with Polycystic Ovary Syndrome by a Gynecologist and Obstetrician (according to the Rotterdam Criteria)
3. Those who agreed to participate in the study and signed the informed consent form

Exclusion criteria

1. Patients with underlying uterine or adnexal pathologies (endometrial polyps, adenomyosis, uterine fibroids, adnexal masses, etc.) identified by ultrasound
2. Patients with previous pelvic surgery
3. Secondary causes of hirsutism and oligomenorrhea (non-classical congenital adrenal hyperplasia, Cushing's syndrome, hypothyroidism, prolactinoma, androgen-synthesizing tumor)
4. Pregnant women
5. Patients with a history of muscular or rheumatological diseases
6. Patients with uncontrolled diabetes
7. Patients with severe psychiatric illnesses or a history of psychiatric medication/substance abuse