FibromyalgiaNCT07189247
Evaluation of Fibromyalgia Frequency and Pain Parameters in Women With Polycystic Ovary Syndrome
An observational study of Fibromyalgia and PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, run by Ufuk University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 1 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elzem Bolkan Günaydın contact
About this study
Official title: Evaluation of Fibromyalgia Frequency and Pain Parameters in Women With Polycystic Ovary Syndrome: A Prospective Single-Blind Study
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.
Read more
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.
- Medical subject headings
- Fibromyalgia, Polycystic Ovary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ufuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elzem Bolkan Günaydın, Ufuk University
- Investigators
- Elzem Bolkan Günaydın, Principal investigator, Ufuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189247
- Sponsor's protocol ID
- 12024861-19
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fibromyalgia Frequency and Pain Parameters in Women With Polycystic Ovary Syndrome: A Prospective Single-Blind Study
- ClinicalTrials.gov ID
- NCT07189247
- Acronym / sponsor ID
- 12024861-19
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Ufuk UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HADS (Hospital Anxiety and Depression Scale)
Time frame: 1 month
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.
2016 ACR Fibromyalgia Criteria-The Widespread Pain Index (WPI)
Time frame: 1 month
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.
2016 ACR Fibromyalgia Criteria-Symptom Severity Scale (SSS)
Time frame: 1 month
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.
2016 ACR Fibromyalgia Criteria-The Fibromyalgia Severity Scale (FSS)
Time frame: 1 month
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.
Fibromyalgia Impact Questionnaire Revised (FIQ-R)
Time frame: 1 month
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.
Pressure Pain Threshold (BPT) Measurement (Algometer)
Time frame: 1 month
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.
VAS (Visual Analog Scale)
Time frame: 1 month
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elzem Bolkan Günaydın contact
Elzem Bolkan Günaydın principal investigator
Ufuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, run by Ufuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elzem Bolkan Günaydın (elzembolkan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HADS (Hospital Anxiety and Depression Scale) (time frame: 1 month). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.