beta
IA Trial Radar
El ensayo clínico NCT07189247 para Fibromialgia, Síndrome de ovario poliquístico (SOP) de ovarios bilaterales está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
Un estudio coincide con los criterios de filtro
Vista de tarjeta

Evaluation of Fibromyalgia Frequency and Pain Parameters in Women With Polycystic Ovary Syndrome 140

Aún no recluta
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07189247 es un estudio observacional para Fibromialgia, Síndrome de ovario poliquístico (SOP) de ovarios bilaterales. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 1 de noviembre de 2025 hasta completar 140 participantes. Dirigido por Ufuk University, se espera que finalice el 1 de noviembre de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 23 de septiembre de 2025.
Resumen
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...Mostrar más
Título oficial

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

Condiciones médicas
FibromialgiaSíndrome de ovario poliquístico (SOP) de ovarios bilaterales
Otros ID del estudio
  • 12024861-19
Número del NCT
Inicio del estudio (real)
2025-11-01
Última actualización
2025-09-23
Fecha de finalización (estimada)
2026-11-01
Inscripción (prevista)
140
Tipo de estudio
Observacional
Estado general
Aún no recluta
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
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
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto
Edad mínima
18 Years
Criterios de sexo
Mujer
Admisión de voluntarios sanos
  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

  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
Ufuk University logoUfuk University
Parte responsable del estudio
Elzem Bolkan Günaydın, Investigador principal, MD, Ufuk University
Contactos centrales del estudio
Contacto: Elzem Bolkan Günaydın, [email protected]
Contacto: Elzem Bolkan Günaydın, +0905309787303, [email protected]
1 Centros del estudio en 1 países
Ufuk University, Ankara, 6520, Turkey (Türkiye)