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COMPLETED
NCT07577102
NA

Unilateral and Bilateral taVNS in Fibromyalgia

Sponsor: Istanbul Gelisim University

View on ClinicalTrials.gov

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

Interventions

DEVICE

taVNS

Transcutaneous auricular vagus nerve stimulation applied via the auricular branch of the vagus nerve for neuromodulation purposes.

BEHAVIORAL

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)