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Not yet recruiting NCT07189247

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

— Observational Fibromyalgia PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Fibromyalgia, PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries. Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Primary outcome measures

  • HADS (Hospital Anxiety and Depression Scale) [Time frame: 1 month]
  • 2016 ACR Fibromyalgia Criteria-The Widespread Pain Index (WPI) [Time frame: 1 month]
  • 2016 ACR Fibromyalgia Criteria-Symptom Severity Scale (SSS) [Time frame: 1 month]
  • 2016 ACR Fibromyalgia Criteria-The Fibromyalgia Severity Scale (FSS) [Time frame: 1 month]
  • Fibromyalgia Impact Questionnaire Revised (FIQ-R) [Time frame: 1 month]
  • Pressure Pain Threshold (BPT) Measurement (Algometer) [Time frame: 1 month]
  • VAS (Visual Analog Scale) [Time frame: 1 month]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-crossover

Study locations

Turkey (Türkiye) · 1 center
  • Ufuk University — Ankara

Identifiers

NCT: NCT07189247 · 12024861-19

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗