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Clinical Trial NCT07189247 for Fibromyalgia, PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Evaluation of Fibromyalgia Frequency and Pain Parameters in Women With Polycystic Ovary Syndrome 140
Clinical Trial NCT07189247 is an observational study for Fibromyalgia, PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries and is currently not yet recruiting. Enrollment is planned to begin on 1 November 2025 and continue until the study accrues 140 participants. Led by Ufuk University, this study is expected to complete by 1 November 2026. The latest data from ClinicalTrials.gov was last updated on 23 September 2025.
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 p...Show More
Official Title
Evaluation of Fibromyalgia Frequency and Pain Parameters in Women With Polycystic Ovary Syndrome: A Prospective Single-Blind Study
Conditions
FibromyalgiaPCOS (Polycystic Ovary Syndrome) of Bilateral OvariesOther Study IDs
- 12024861-19
NCT ID Number
Start Date (Actual)
2025-11-01
Last Update Posted
2025-09-23
Completion Date (Estimated)
2026-11-01
Enrollment (Estimated)
140
Study Type
Observational
Status
Not yet recruiting
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
Female
Accepts Healthy Volunteers
Yes
- 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
- 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
Study Responsible Party
Elzem Bolkan Günaydın, Principal Investigator, MD, Ufuk University
Study Central Contact
Contact: Elzem Bolkan Günaydın, [email protected]
Contact: Elzem Bolkan Günaydın, +0905309787303, [email protected]
1 Study Locations in 1 Countries
Ufuk University, Ankara, 6520, Turkey (Türkiye)