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Fibromyalgia SyndromeNCT06871306

Effects of Left and Bilateral Transcutaneous Auricular Vagus Nerve Stimulation on Pain, Mood, and Autonomic Function in Female Fibromyalgia Patients

A study testing Transcutaneous Auricular Vagus Nerve Stimulation in people with Fibromyalgia Syndrome, run by Fenerbahce University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aimed to examine the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on pain, depression, anxiety, functionality, and autonomic function in fibromyalgia syndrome (FMS). Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Fibromyalgia Syndrome
What is being tested?
Transcutaneous Auricular Vagus Nerve Stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Aug 2021to 31 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Female volunteer participants
  • Aged 18-45 with regular menstrual cycles
  • Diagnosed with FMS (Widespread Pain Index≥ 17
  • Symptom Severity Scale≥ 21) according to the 2013 ACR diagnostic criteria by a specialist physician.

Who cannot join

  • Neurological deficits,
  • Diabetes
  • Neuropathic disorders
  • Chronic inflammation
  • Immune deficiencies
  • Cardiac diseases
Show all 11Show fewer
  • Pregnancy
  • Being in the perimenopausal or postmenopausal stages,
  • Menstrual cycles of less than 28 days,
  • Started new medication within the last 3 months,
  • Modifications to their existing treatment apart from taVNS.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Sancak Tıp Merkezi

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Left and Bilateral Transcutaneous Auricular Vagus Nerve Stimulation on Pain, Mood, and Autonomic Function in Female Fibromyalgia Patients: A Randomized Controlled Trial

This study aimed to examine the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on pain, depression, anxiety, functionality, and autonomic function in fibromyalgia syndrome (FMS).

primary hypothesis: TAVSS application is not an effective treatment for depression, physical limitation, functional disability, anxiety, pain and autonomic nerve system in female FMS patients.

secondary hypothesis: TAVSS application is an effective treatment for depression, physical limitation, functional disability, anxiety, pain and autonomic nerve system in female FMS patients.

Being tested
Transcutaneous Auricular Vagus Nerve Stimulation
Medical subject headings
Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcutaneous Auricular Vagus Nerve StimulationDevice

    taVNS was performed using the Vagustim device (Vagustim Health Technologies, Teknokent, Istanbul, Türkiye) at the tragus and concha regions for 30 minutes, with a frequency of 25 Hz and a pulse width of 300 µs in both groups. The difference in stimulation between the groups depends only on to which ear it was applied. Electrical stimulation was increased in 0.1 mA steps until the detection threshold was reached.

Study groups in NCT06871306
Study groupRoleWhat they receive
Left taVNSActive comparatorLeft taVNS group received taVNS stimulation through the left ear for 11 sessions.
Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation
Bilateral taVNSActive comparatorBilateral taVNS group received taVNS stimulation through the bilateral ears for 11 sessions.
Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fibromyalgia Impact Questionnaire

    Fibromyalgia Impact Questionnaire is a scale consisting of 10 questions, displaying physical function, absence from work, feeling well, fatigue, difficulty at work, pain, stillness, morning fatigue, anxiety, and depression. Apart from feeling well, low scores indicate recovery or being slightly affected by the disease. The maximum score of each subheading is 10 and the total score is 100. FIQ score was evaluated as being slightly affected under 50 points, moderately affected between 50-69, and heavily affected at 70 and more.

    Measured: From enrollment to the 28th day of control

  2. Visual Analog Scale

    Pain severity was assessed with the Visual Analog Scale (VAS), which is scored between 0 and 10, and is used to evaluate pain. 0 denotes no pain and 10 denotes unbearably severe pain. Participants were asked to mark the pain they felt on a 10 cm straight line and the value found was recorded in cm.

    Measured: From enrollment to the 28th day of control

  3. PNS Index Activity

    The PNS Index was used to measure ANS activity, indicating the evaluation of a person's parasympathetic nervous system activity compared to normal resting values. (https://www.kubios.com/publications/) The PNS index serves as a quantitative indicator of ANS function by reflecting the activity levels of its branches. This measures play a crucial role in heart rate variability (HRV) analysis, offering valuable insights into an individual's stress levels and recovery capacity. For PNS activity reduces heart rate and enhances HRV. HRV changes in pathological conditions (ischemic heart disease etc.), and decreased variability is a predictor of worse outcomes. Cyclical fluctuations in heart rate reveal changes in the ANS. The e-motion Faros device has been classified as a Class II medical device by Health Canada. After recording the R-R intervals of heart rate by e-motion Faros, the data were transferred to Kubios software for interpretation of HRV.

    Measured: From enrollment to the 28th day of control

  4. SNS Index Activity

    The SNS Index was used to measure ANS activity, indicating the evaluation of a person's sympathetic nervous system activity compared to normal resting values. (https://www.kubios.com/publications/) The SNS index serves as a quantitative indicator of ANS function by reflecting the activity levels of its branches. This measures play a crucial role in heart rate variability (HRV) analysis, offering valuable insights into an individual's stress levels and recovery capacity. A heightened SNS index is often associated with increased sympathetic activity, commonly linked HRV changes in pathological conditions (ischemic heart disease etc.), and decreased variability is a predictor of worse outcomes. Cyclical fluctuations in heart rate reveal changes in the ANS. The e-motion Faros device has been classified as a Class II medical device by Health Canada. After recording the R-R intervals of heart rate by e-motion Faros, the data were transferred to Kubios software for interpretation of HRV.

    Measured: From enrollment to the 28th day of control

  5. Assessment of Autonomic Nervous System Activity (SNS and PNS Index)

    Autonomic nervous system (ANS) activity, including both sympathetic (SNS) and parasympathetic (PNS) indices, is assessed using the eMotion Faros device. The device continuously records electrocardiographic (ECG) signals via a single-lead chest electrode setup. It is classified as a Class II medical device by Health Canada.

    The collected ECG data are analyzed using proprietary Kubios HRV Premium software, which computes time-domain, frequency-domain, and nonlinear heart rate variability (HRV) parameters. SNS and PNS indices are derived using Kubios' built-in algorithms that combine spectral analysis (e.g., LF/HF ratio), stress index, and other HRV-derived metrics to estimate autonomic balance.

    Higher SNS index values indicate increased sympathetic activity, while higher PNS index values reflect enhanced parasympathetic tone.

    Measured: From enrollment to the 28th day of control

Secondary outcomes (2)

  1. Beck Depression Index

    The Beck Depression Index (BDI) is an evaluation questionnaire that assesses, behavioral signs of depression in adolescents and adults. The total score ranges from 0 to 63. It is interpreted as Minimal =0-9, Mild=10-16, Moderate=17-29 and Severe=30-63.

    Measured: From enrollment to the 28th day of control

  2. Beck Anxiety Inventory

    The Beck Anxiety Inventory (BAI) is suggested as a tool for evaluating clinical anxiety and distinguishing between anxious and non-anxious diagnostic groups. It is a 21-item Likert-type scale, scored from 0 to 3. The total score ranges from 0 to 63, with the following classifications: mild <21, moderate: 22-35, and severe>36

    Measured: From enrollment to the 28th day of control

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2025
  2. Study start2 Aug 2021
  3. Primary completion30 Aug 2021
  4. Study completion31 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06871306
Sponsor's protocol ID
12.08.2021/31
Status last verified
Jun 2025
First submitted
6 Mar 2025
Last updated
2 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Only IPD used in the results publication.

Publications

  • Akkurt MF, Ozden AV, Akkurt HE, Akkurt B, Bildik C. Effects of left and bilateral transcutaneous auricular vagus nerve stimulation on pain, mood, and autonomic nervous system in female patients with fibromyalgia: a randomized controlled trial. Physiother Theory Pract. 2026 May;42(5):657-667. doi: 10.1080/09593985.2025.2594572. Epub 2025 Dec 2.

    PubMed 41332177

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous Auricular Vagus Nerve Stimulation in people with Fibromyalgia Syndrome, run by Fenerbahce University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fibromyalgia Impact Questionnaire (time frame: From enrollment to the 28th day of control). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06871306, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.

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