Investigation of the Relationship Between Central Sensitization and Balance in Fibromyalgia
Key facts
- Who runs it
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Where
- Istanbul, TürkiyeSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 75 people, planned
- Started
- 18 Feb 2025
- Planned end
- Dec 2025
- Type of study
- Observational, 2 groups
- Treatments tested
- Biodex Balance System
- Pressure Pain Threshold (PPT) Measurement with Algometer
- Conditioned Pain Modulation (CPM)
- Slowly Repeated Evoked Pain Assessment Protocol (SREP)
- Central Sensitization Inventory (CSI)
- Numeric Rating Scale (NRS)
- Revised Fibromyalgia Impact Questionnaire (FIQ)
- S-LANSS Pain Score (Self-administered Leeds Assessment of Neuropathic Symptoms and Signs)
- Tampa Kinesiophobia Scale (TKS)
- Hospital Anxiety and Depression Scale (HAD)
- SF-12 Health Survey (SF-12 Quality of Life Scale)
- Fatigue Severity Scale (FSS)
- Timed Up and Go Test (TUG)
- Record updated
- 12 September 2025
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- Having undergone spinal and/or extremity surgery (such as for back/hip/knee/foot) within the last 6 months
- Presence of vestibular disorders
- History of lower extremity amputation
- Peripheral arterial disease
- 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
- Being under 18 years old or over 65 years old
- Presence of spinal deformities
- Vitamin B12 deficiency
- Pregnancy
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in Türkiye
- Sultan 2. Abdülhamid Han Training and Research Hospital, İstanbul, ÜsküdarIstanbul, TürkiyeContact: Melike Ünsal Küçük, Principal InvestigatorTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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?
The 2 groups in the trial
- Group 1 (Healthy volunteers)
Healthy volunteers without a diagnosis of Fibromyalgia Syndrome will be included in Group 1. (n=20)
Treatment: Biodex Balance System, Pressure Pain Threshold (PPT) Measurement with Algometer, Conditioned Pain Modulation (CPM), Slowly Repeated Evoked Pain Assessment Protocol (SREP), Central Sensitization Inventory (CSI), Numeric Rating Scale (NRS), Revised Fibromyalgia Impact Questionnaire (FIQ), S-LANSS Pain Score (Self-administered Leeds Assessment of Neuropathic Symptoms and Signs), Tampa Kinesiophobia Scale (TKS), Hospital Anxiety and Depression Scale (HAD), SF-12 Health Survey (SF-12 Quality of Life Scale), Fatigue Severity Scale (FSS), and Timed Up and Go Test (TUG)
- Group 2 (Patients with fibromyalgia syndrome)
Patients diagnosed with Fibromyalgia Syndrome according to ACR 2016 criteria will be included in Group 2. (n=55)
Treatment: Biodex Balance System, Pressure Pain Threshold (PPT) Measurement with Algometer, Conditioned Pain Modulation (CPM), Slowly Repeated Evoked Pain Assessment Protocol (SREP), Central Sensitization Inventory (CSI), Numeric Rating Scale (NRS), Revised Fibromyalgia Impact Questionnaire (FIQ), S-LANSS Pain Score (Self-administered Leeds Assessment of Neuropathic Symptoms and Signs), Tampa Kinesiophobia Scale (TKS), Hospital Anxiety and Depression Scale (HAD), SF-12 Health Survey (SF-12 Quality of Life Scale), Fatigue Severity Scale (FSS), and Timed Up and Go Test (TUG)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Investigation of the Relationship Between Central Sensitization Parameters and Balance Changes in Patients With Fibromyalgia
- Fit questions
- Built from NCT06851091, who can take part
- Record updated
- 12 September 2025