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

NCT07173400 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-01-15

No results posted yet for this study

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 study evaluates a non-invasive technique called transcutaneous auricular vagus nerve stimulation (TaVNS), which delivers gentle electrical impulses to a part of the ear connected to the vagus nerve. The vagus nerve plays an important role in regulating pain, stress, and autonomic body functions such as sleep.

In this randomized controlled pilot trial, participants with fibromyalgia are assigned to receive either active TaVNS or sham (placebo) stimulation for 30 minutes per day, five days per week, over a four-week period. Participants are followed for a total of 8 weeks. The investigators will assess outcomes including pain intensity, sleep quality, central sensitization, and fear of movement (kinesiophobia).

Conditions

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.

Sponsors & Collaborators

  • Hatice Betigul Meral

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2025-10-10
Completion
2025-10-10

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07173400 on ClinicalTrials.gov