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

NCT07189247 | Not Yet Recruiting

• 1 other identifier: 12024861-19
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (7)

• HADS (Hospital Anxiety and Depression Scale)

  The HADS (Hospital Anxiety and Depression Scale) will be administered to determine depression and anxiety levels. The HADS consists of 14 questions that score both anxiety (HADS-A) and depression (HADS-D) symptoms on a scale of 0 to 3. The scores obtained will shed light on the participant's psychological state and allow for the psychological evaluation of the relationship between fibromyalgia and PCOS.

  1 month

• 2016 ACR Fibromyalgia Criteria-The Widespread Pain Index (WPI)

  The assessment of the WPI involves indicating persistent pain over the past seven days across five anatomical regions (upper left, upper right, lower left, lower right, axial) and 19 specific body areas (both jaws, shoulders, upper arms, lower arms, hips, upper legs, lower legs, neck, upper back, lower back, chest, and abdomen). Each region is assigned one point. The cumulative score varies from 0 to 19. 15 For a diagnosis of widespread pain, pain must be evident in a minimum of 4 out of 5 anatomical regions.

  1 month

• 2016 ACR Fibromyalgia Criteria-Symptom Severity Scale (SSS)

  The SSS evaluation comprises two components. In the initial section, patients evaluate the intensity of their fatigue, unrefreshing awakenings, and cognitive problems from the past week on a scale of 0 to 3. In the subsequent section, patients evaluate symptoms of headache, lower abdomen pain or cramping, and depression experienced over the preceding six months (0=none, 1=yes). The cumulative score varies from 0 to 12.

  1 month

• 2016 ACR Fibromyalgia Criteria-The Fibromyalgia Severity Scale (FSS)

  The Fibromyalgia Severity Scale (FSS) assessment involves the collection of WPI and SSS scores. The cumulative score varies between 12 and 31. A higher score signifies a greater disease severity. A total score exceeding 12 is required for a fibromyalgia diagnosis. A WPI of 7 or greater and an SSS score of 5 or above, or a WPI between 4 and 6 with an SSS score of 9 or above, indicate a diagnosis of fibromyalgia.

  1 month

• Fibromyalgia Impact Questionnaire Revised (FIQ-R)

  It is a questionnaire designed to assess functional limitations and disabilities resulting from fibromyalgia. The questionnaire comprises a total of 21 questions divided into three sections: function, overall impact, and symptoms. Responses to each inquiry are indicated on a scale ranging from 0 to 10. The overall score is determined by summing the results: the score of the first section is divided by three, the score of the second section by one, and the score of the third section by two. Elevated scores signify a greater fibromyalgia-associated impairment.

  1 month

• Pressure Pain Threshold (BPT) Measurement (Algometer)

  Pressure Pain Threshold (BPT) Measurement (Algometer): For objective pain assessment, a digital algometer will be used to measure the pressure pain threshold (the pressure level at which the patient first feels pain) at the most sensitive point on the upper trapezius muscle. The measurement will be repeated three times, and the average will be recorded.

  1 month

• VAS (Visual Analog Scale)

  VAS (Visual Analog Scale): Participants will mark the intensity of their perceived pain on a 10-cm scale, rated from 0 (no pain) to 10 (unbearable pain). This method is a simple and effective way to measure a patient's subjective perception of pain.

  1 month

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Female patients
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Participants will consist of women aged 18-40 years, diagnosed with PCOS according to the Rotterdam criteria, and a healthy control group in a similar age range.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ufuk University: lead

Study Sites (1)

Ufuk University

Ankara, 6520, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia; Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Elzem Bolkan Günaydın

  Ufuk University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elzem Bolkan Günaydın

CONTACT

elzembolkan@yahoo.com

Elzem Bolkan Günaydın

CONTACT

+0905309787303; elzembolkan@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 23, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

TU (1)