Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Symptom Severity, Sleep Quality, Central Sensitization, and Kinesiophobia in Fibromyalgia

NACompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

January 10, 2025

Primary Completion Date

June 20, 2025

Study Completion Date

June 25, 2025

Conditions
Fibromyalgia (FM)Chronic Pain
Interventions
DEVICE

Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS)

Active TaVNS delivered with the VagusStim® device (Vagus Medical Technologies, Istanbul, Türkiye). The bipolar electrode was placed on the left cymba concha. Stimulation was applied for 30 minutes per day, 5 days per week, for 4 weeks (20 sessions). Parameters included frequency 1-30 Hz, pulse width 50-250 μs, and current intensity individually adjusted (0.1-36 mA) to the participant's sensory threshold.

DEVICE

Sham Transcutaneous Auricular Vagus Nerve Stimulation

Sham stimulation delivered with the same VagusStim® device under identical conditions. The electrode was rotated and placed on the left earlobe, which lacks vagal innervation. Sessions lasted 30 minutes per day, 5 days per week, for 4 weeks (20 sessions). No effective vagus nerve stimulation was delivered, preserving participant blinding.

Trial Locations (1)

34815

Istanbul Medipol University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Istanbul

All Listed Sponsors
lead

Hatice Betigul Meral

OTHER

NCT07173400 - Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Symptom Severity, Sleep Quality, Central Sensitization, and Kinesiophobia in Fibromyalgia | Biotech Hunter | Biotech Hunter