Status:
COMPLETED
Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Symptom Severity, Sleep Quality, Central Sensitization, and Kinesiophobia in Fibromyalgia
Lead Sponsor:
Hatice Betigul Meral
Conditions:
Fibromyalgia (FM)
Chronic Pain
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Fibromyalgia is a chronic condition characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and sensitivity to touch. Current treatments often provide only partial relief. This ...
Detailed Description
Fibromyalgia (FM) is a chronic pain syndrome associated with widespread musculoskeletal pain, fatigue, sleep disturbances, and autonomic dysregulation. Current treatments provide only partial relief, ...
Eligibility Criteria
Inclusion
- Age between 18 and 65 years
- Diagnosis of fibromyalgia according to the 2016 revised ACR criteria
- Receiving stable pharmacological and/or non-pharmacological treatment for at least 3 months
- Ability to understand study procedures and provide informed consent
Exclusion
- Pregnancy
- History of epilepsy or cardiac arrhythmia
- Acute or chronic infection
- Heart failure (NYHA class II-IV)
- Renal failure stage II or higher
- Active malignancy
- Psychotic disorders or current psychiatric treatment
- Diagnosis of immune-mediated rheumatic disease
Key Trial Info
Start Date :
January 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07173400
Start Date
January 10 2025
End Date
June 25 2025
Last Update
September 15 2025
Active Locations (1)
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1
Istanbul Medipol University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Istanbul, Bagcılar, Turkey (Türkiye), 34815