NCT07358754

Brief Summary

Fibromyalgia is a chronic pain syndrome characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and cognitive symptoms. Central sensitization is considered a key mechanism in the pathophysiology of fibromyalgia; however, the underlying biological markers have not been fully clarified. Brain-derived neurotrophic factor (BDNF) and S100B protein have been suggested to play roles in neuroinflammation and central pain processing. This observational, cross-sectional study aims to evaluate serum S100B and BDNF levels in patients with fibromyalgia and to investigate their relationship with central sensitization and sleep quality. Serum biomarker levels and clinical assessment scales will be compared between patients with fibromyalgia and healthy controls.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

January 13, 2026

Last Update Submit

April 10, 2026

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

  • Association between serum S100B and serum BDNF

    Serum S100B and serum BDNF concentrations will be measured from venous blood samples and the strength of association between the two biomarkers will be analyzed

    Baseline

Secondary Outcomes (2)

  • Correlation of serum S100B and BDNF with Central Sensitization Inventory (CSI)

    Baseline

  • Correlation of serum S100B and BDNF with Pittsburgh Sleep Quality Index (PSQI)

    Baseline

Study Arms (2)

Fibromyalgia Group

Female patients aged 18-50 years diagnosed with fibromyalgia according to the 2016 American College of Rheumatology criteria.

Other: No Intervention (Observational Study)

Healthy Control Group

Age- and sex-matched healthy female volunteers without fibromyalgia or chronic widespread pain.

Other: No Intervention (Observational Study)

Interventions

No Intervention (Observational Study)OTHER

This is an observational study with no therapeutic or diagnostic intervention. Participants will undergo a single-time-point clinical assessment and venous blood sampling for biomarker measurement only.

Fibromyalgia GroupHealthy Control Group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipant eligibility is NOT based on self-representation of gender identity.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Presence of any systemic disease (hematologic, endocrine, rheumatologic, renal, cardiovascular, gastrointestinal, or respiratory) Active infection History of malignancy Major surgery or trauma within the last 1 year Any treatment for fibromyalgia within the last 3 months Pregnancy or breastfeeding Smoking Vitamin D deficiency

You may qualify if:

  • Female participants aged between 18 and 50 years
  • Diagnosis of fibromyalgia according to 2016 American College of Rheumatology (ACR) criteria
  • Symptoms present for at least 3 months
  • Ability to understand and complete study questionnaires
  • Provision of written informed consent
  • For healthy controls:
  • No diagnosis of fibromyalgia or chronic widespread pain
  • No known systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples will be collected from all participants at a single time point. Serum will be separated and used for the measurement of S100B and brain-derived neurotrophic factor (BDNF) levels. No genetic or DNA analyses will be performed.

MeSH Terms

Conditions

Fibromyalgia

Interventions

Observation

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Zeynep Karakuzu Güngör, M.D

    Kanuni Sultan Süleyman Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeynep Karakuzu Güngör, M.D

CONTACT

905077750375zeynepkarakuzu@hotmail.com.tr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Medicine and Rehabilitation Specialist

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 22, 2026

Study Start

February 1, 2026

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared publicly. De-identified aggregate data may be made available upon reasonable request from the corresponding author after publication of the study results.

Locations

TU(1)