Investigation of the Relationship Between Central Sensitization and Balance in Fibromyalgia

Recruiting · NCT06851091 · Observational (researchers observe without assigning treatment) · Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

View the official record on ClinicalTrials.gov →

Fibromyalgia

Interventions studied

Biodex Balance SystemCentral Sensitization Inventory (CSI)Conditioned Pain Modulation (CPM)Fatigue Severity Scale (FSS)Hospital Anxiety and Depression Scale (HAD)Numeric Rating Scale (NRS)Pressure Pain Threshold (PPT) Measurement with AlgometerRevised Fibromyalgia Impact Questionnaire (FIQ)S-LANSS Pain Score (Self-administered Leeds Assessment of Neuropathic Symptoms and Signs)SF-12 Health Survey (SF-12 Quality of Life Scale)Slowly Repeated Evoked Pain Assessment Protocol (SREP)Tampa Kinesiophobia Scale (TKS)Timed Up and Go Test (TUG)

What this trial is about

The aim of the study is to investigate the relationship between central sensitization parameters and changes in static and dynamic balance in patients with fibromyalgia. The main questions it aims to answer are: * Do central sensitization parameters differ in patients with fibromyalgia compared to healthy individuals? * How is balance performance in these individuals compared to healthy controls? * Do central sensitization parameters affect static and dynamic balance in patients with fibromyalgia? * Do central sensitization parameters lead to quantitative changes in balance in patients with fibromyalgia?

Who can take part

Age range

18 Years to 65 Years

Sex

Female

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not specified

Study type

Observational (researchers observe without assigning treatment)

Inclusion criteria

Diagnosis of FMS according to the ACR 2016 diagnostic criteria
Being between the ages of 18 and 65
Being literate
Providing informed consent by signing the voluntary consent form

Exclusion criteria

Being under 18 years old or over 65 years old
Presence of vestibular disorders
Having undergone spinal and/or extremity surgery (such as for back/hip/knee/foot) within the last 6 months
History of lower extremity amputation
Presence of spinal deformities
Peripheral arterial disease
Vitamin B12 deficiency
Any neurological disorder (e.g., stroke, traumatic brain injury, multiple sclerosis, Parkinson's disease, central nervous system malignancies, etc.)
Severe cardiopulmonary insufficiency (stage 3-4)
Uncontrolled systemic diseases such as hypertension and diabetes
Presence of systemic inflammatory diseases, malignancies, or active infections
Pregnancy

Where it is running

1 location listed.

Sultan 2. Abdülhamid Han Training and Research Hospital, İstanbul, Üsküdar - Istanbul, Üsküdar, Turkey (Türkiye)

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →