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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2025-10-10

Brief Summary

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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).

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Detailed Description

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Fibromyalgia (FM) is a chronic pain syndrome associated with widespread musculoskeletal pain, fatigue, sleep disturbances, and autonomic dysregulation. Current treatments provide only partial relief, highlighting the need for novel therapeutic approaches.

Rationale:

The vagus nerve is a key regulator of autonomic and inflammatory processes. Transcutaneous auricular vagus nerve stimulation (TaVNS) is a non-invasive technique that can modulate vagal activity through electrodes placed on the external ear, offering a potential alternative to surgically implanted vagus nerve stimulators.

Study Design:

This is a randomized, sham-controlled pilot trial conducted at Istanbul Medipol University. Thirty participants with fibromyalgia are randomized in a 1:1 ratio to receive either active TaVNS or sham stimulation.

Intervention:

Device: VagusStim® (Vagus Medical Technologies, Istanbul, Türkiye; CE-marked).

Electrode placement: left cymba concha (active group) vs. left earlobe (sham group).

Stimulation parameters: frequency 1-30 Hz, pulse width 50-250 μs, current intensity individually adjusted (0.1-36 mA) to each participant's sensory threshold.

Schedule: 30 minutes per day, 5 days per week, for 4 consecutive weeks (20 sessions total).

Supervision: All sessions are clinician-supervised.

Outcome Measures:

Primary outcomes:

Pittsburgh Sleep Quality Index (PSQI) - subjective sleep quality.

Fibromyalgia Impact Questionnaire (FIQ) - disease severity and functional impact.

Central Sensitization Inventory (CSI) - symptoms related to central sensitization.

Secondary outcomes:

Visual Analog Scale (VAS) - pain intensity.

Tampa Scale for Kinesiophobia (TSK) - fear of movement.

Symptom Severity Scale (SSS).

Widespread Pain Index (WPI).

Assessment timepoints: baseline, week 2, week 4, and week 8.

Conditions

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Fibromyalgia (FM) Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study used a two-arm, randomized, sham-controlled, parallel group design with a 1:1 allocation ratio

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Participants and outcome assessors were blinded to group allocation. The treating clinician who applied stimulation was aware of assignment but did not participate in outcome assessment

Study Groups

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Active TaVNS

Participants received active transcutaneous auricular vagus nerve stimulation (TaVNS) using the VagusStim® device (Vagus Medical Technologies, Istanbul, Türkiye). The electrode was placed on the left cymba concha and stimulation was applied for 30 minutes per day, 5 days per week, over 4 weeks (20 sessions). Stimulation parameters included 1-30 Hz frequency, 50-250 μs pulse width, and current individually adjusted (0.1-36 mA) to each participant's sensory threshold.

Group Type EXPERIMENTAL

Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS)

Intervention Type DEVICE

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.

Sham TaVNS

Participants underwent sham stimulation using the same VagusStim® device under identical conditions. The electrode was placed on the left earlobe, an area without vagal innervation, and sessions lasted 30 minutes per day, 5 days per week, for 4 weeks. No effective vagus nerve stimulation was delivered, maintaining participant blinding.

Group Type PLACEBO_COMPARATOR

Sham Transcutaneous Auricular Vagus Nerve Stimulation

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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 Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No