Exploring how central sensitization affects balance in fibromyalgia patients
Investigation of the Relationship Between Central Sensitization Parameters and Balance Changes in Patients With Fibromyalgia
This study looks at how central sensitization affects balance in people with fibromyalgia to see if it makes them more likely to fall compared to healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey Academic / other |
| Locations | 1 site (Istanbul, Üsküdar) |
| Trial ID | NCT06851091 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between central sensitization and balance in individuals diagnosed with fibromyalgia syndrome (FMS). It aims to compare central sensitization parameters and balance performance between fibromyalgia patients and healthy controls. The study utilizes various assessments, including the Biodex Balance System and pain threshold measurements, to evaluate static and dynamic balance. By understanding these relationships, the study seeks to shed light on how central sensitization may influence balance and the risk of falls in fibromyalgia patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 who have been diagnosed with fibromyalgia according to the ACR criteria.
Not a fit: Patients with vestibular disorders, recent surgeries, or significant neurological or systemic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for balance disorders in fibromyalgia patients, enhancing their quality of life.
How similar studies have performed: While the relationship between central sensitization and balance is being explored, this specific investigation appears to be novel and untested in the context of fibromyalgia.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Istanbul, Üsküdar
- Sultan 2. Abdülhamid Han Training and Research Hospital, İstanbul, Üsküdar — Istanbul, Üsküdar, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Melike Ünsal Küçük, Principal Investigator
- Email: melikeunsal463@gmail.com
- Phone: +90 537 739 62 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.