Actively Recruiting
Investigation of the Relationship Between Central Sensitization Parameters and Balance Changes in Patients With Fibromyalgia
Led by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · Updated on 2025-09-12
75
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore the connection between central sensitization and balance changes in people with fibromyalgia syndrome (FMS), a condition marked by widespread chronic pain and other symptoms like fatigue and mood changes. The study focuses on understanding differences in central sensitization between patients with FMS and healthy individuals, how balance performance compares, and whether central sensitization influences static and dynamic balance in FMS patients. Fibromyalgia affects about 2% to 8% of the global population and often leads to disability and reduced quality of life due to balance disorders and pain. Participants include two groups: healthy volunteers and patients diagnosed with fibromyalgia according to the American College of Rheumatology (ACR) 2016 criteria. The study involves a one-time evaluation using various diagnostic tests, including the Biodex Balance System to assess balance, pressure pain threshold measurements, conditioned pain modulation tests, and a slowly repeated evoked pain protocol. Additional assessments include questionnaires on pain intensity, fibromyalgia impact, anxiety, depression, quality of life, fatigue, and mobility. During the single study visit, participants will provide demographic information and undergo multiple assessments to measure pain sensitivity, balance, and related symptoms. Researchers will use tools like the Central Sensitization Inventory, Numeric Rating Scale, and Timed Up and Go test to gather data. The main outcomes measured over a five-month analysis period include pain threshold, pain modulation, and evoked pain responses. Secondary outcomes assess balance, quality of life, anxiety, depression, fatigue, and physical function. This observational study will help clarify how central sensitization affects balance in fibromyalgia patients, potentially guiding future rehabilitation approaches.
CONDITIONS
Brief Title
Investigation of the Relationship Between Central Sensitization and Balance in Fibromyalgia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of fibromyalgia syndrome according to the American College of Rheumatology 2016 criteria
- Age between 18 and 65 years
- Ability to read and write
- Signed voluntary informed consent form
You will not qualify if you...
- Under 18 years old or over 65 years old
- Presence of vestibular disorders
- Spinal or extremity surgery within the last 6 months
- History of lower extremity amputation
- Spinal deformities
- Peripheral arterial disease
- Vitamin B12 deficiency
- Neurological disorders such as stroke, traumatic brain injury, multiple sclerosis, Parkinson's disease, or central nervous system cancers
- Severe cardiopulmonary insufficiency (stage 3-4)
- Uncontrolled systemic diseases including hypertension and diabetes
- Systemic inflammatory diseases, active infections, or cancer
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single assessment visit
Participants undergo a comprehensive assessment including balance tests, sensory testing, pain and symptom questionnaires, and functional mobility evaluations to investigate the relationship between central sensitization and balance changes in fibromyalgia.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Sultan 2. Abdülhamid Han Training and Research Hospital, İstanbul, Üsküdar
Istanbul, Üsküdar, Turkey (Türkiye)
Actively Recruiting
Research Team
M
Melike Ünsal Küçük, Principal Investigator
F
Feyza Nur Yücel, Specialist
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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