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Unilateral and Bilateral taVNS in Fibromyalgia
Sponsor: Istanbul Gelisim University
Summary
This randomized controlled trial aimed to compare the effects of unilateral (left-sided) and bilateral transcutaneous auricular vagus nerve stimulation (taVNS) combined with a home exercise program on clinical outcomes, autonomic nervous system function, and exercise performance in individuals with fibromyalgia syndrome (FMS). Participants diagnosed with fibromyalgia were randomly assigned to one of three groups: unilateral taVNS, bilateral taVNS, or a home exercise program. The intervention period lasted two weeks and included ten treatment sessions. Clinical outcomes were assessed using validated scales including the Fibromyalgia Impact Questionnaire (FIQ), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), and Pittsburgh Sleep Quality Index (PSQI). Autonomic function was evaluated using heart rate variability (HRV) parameters, and exercise performance was assessed based on repetition capacity. The study aimed to determine whether bilateral stimulation provides additional benefits compared to unilateral stimulation and exercise alone. The findings may contribute to understanding the role of neuromodulation strategies in improving autonomic regulation, symptom severity, and functional performance in individuals with fibromyalgia.
Official title: Comparison of Unilateral and Bilateral Transcutaneous Auricular Vagus Nerve Stimulation on Autonomic Function and Exercise Performance in Fibromyalgia
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2022-01-01
Completion Date
2023-06-20
Last Updated
2026-05-11
Healthy Volunteers
No
Conditions
Interventions
taVNS
Transcutaneous auricular vagus nerve stimulation applied via the auricular branch of the vagus nerve for neuromodulation purposes.
Home Exercise Program
A structured home-based exercise program including strengthening and mobility exercises performed over a two-week period.
Locations (1)
Darülaceze Medical Center
Istanbul, Turkey (Türkiye)