Fibromyalgia (FM)NCT07173400
Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Symptom Severity, Sleep Quality, Central Sensitization, and Kinesiophobia in Fibromyalgia
A study testing Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS) in people with Fibromyalgia (FM) and Chronic Pain, run by Hatice Betigul Meral at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia (FM), Chronic Pain
- What is being tested?
- Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 10 Oct 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Istanbul, Bagcılar, 34815
About this study
Official title: Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Symptom Severity, Sleep Quality, Central Sensitization, and Kinesiophobia in Fibromyalgia: A Randomized Controlled Trial
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).
Read the detailed description
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
- Fibromyalgia (FM), Chronic Pain
- Being tested
- Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS), Sham Transcutaneous Auricular Vagus Nerve Stimulation
- Keywords
- Vagal Nerve Stimulation, fibromyalgia, pain, chronic pain
- Medical subject headings
- Fibromyalgia, Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS)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 Transcutaneous Auricular Vagus Nerve StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active TaVNS | Experimental | 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. Receives: Device: Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS) |
| Sham TaVNS | Placebo comparator | 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. Receives: Device: Sham Transcutaneous Auricular Vagus Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact Questionnaire (FIQ)
The FIQ evaluates the overall health status and functional impact of fibromyalgia, including physical functioning, pain, fatigue, and mood. Scores range from 0 to 100, with higher scores reflecting greater disease impact.
Measured: Baseline, Week 2, Week 4, Week 8
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a validated self-report questionnaire that assesses subjective sleep quality and disturbances over the past month. Scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Measured: Baseline, Week 2, Week 4, Week 8
Central Sensitization Inventory (CSI)
The CSI is a 25-item self-report questionnaire assessing symptoms related to central sensitization, including sensitivity to pain, fatigue, and cognitive complaints. Scores range from 0 to 100, with higher scores indicating greater sensitization.
Measured: Baseline, Week 2, Week 4, Week 8
Secondary outcomes (2)
Tampa Scale for Kinesiophobia (TSK)
The TSK is a 17-item self-report questionnaire measuring fear of movement or reinjury. Items are scored on a 4-point Likert scale, with total scores ranging from 17 to 68. Higher scores indicate greater kinesiophobia.
Measured: Baseline, Week 2, Week 4, Week 8
Visual Analog Scale (VAS) for Pain
Pain intensity is assessed using a 10-cm visual analog scale, with 0 representing "no pain" and 10 representing "worst imaginable pain." Participants mark their pain level along the line, which is recorded as a numeric score.
Measured: Baseline, Week 2, Week 4, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Aug 2025
- Primary completion10 Oct 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fibromyalgia (FM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Model description
- This study used a two-arm, randomized, sham-controlled, parallel group design with a 1:1 allocation ratio
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hatice Betigul Meral
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hatice Betigul Meral, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173400
- Sponsor's protocol ID
- E-10840098-202.3.02-4945 (30/0
- Status last verified
- Jan 2026
- First submitted
- 5 Sep 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study is a small, single-center pilot trial. Due to the limited sample size and ethical/privacy considerations, individual participant data will not be shared in a public repository. De-identified data may be made available from the corresponding author upon reasonable request.
Publications
Paccione CE, Stubhaug A, Diep LM, Rosseland LA, Jacobsen HB. Meditative-based diaphragmatic breathing vs. vagus nerve stimulation in the treatment of fibromyalgia-A randomized controlled trial: Body vs. machine. Front Neurol. 2022 Nov 3;13:1030927. doi: 10.3389/fneur.2022.1030927. eCollection 2022.
PubMed 36438970Abdel-Baset AM, Abdellatif MA, Ahmed HHS, El Shaarawy NK. Pain neuroscience education versus transcutaneous vagal nerve stimulation in the management of patients with fibromyalgia. Egypt Rheumatol. 2023;45:191-195. doi:10.1016/j.ejr.2023.03.001.
Kutlu N, Ozden AV, Alptekin HK, Alptekin JO. The Impact of Auricular Vagus Nerve Stimulation on Pain and Life Quality in Patients with Fibromyalgia Syndrome. Biomed Res Int. 2020 Feb 28;2020:8656218. doi: 10.1155/2020/8656218. eCollection 2020.
PubMed 32190684Turk Kalkan T, Tarakci D, Kilic G, Celikyurt C. Investigation of the Effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and Vestibular Rehabilitation in Patients with Unilateral Vestibular Hypofunction. Medicina (Kaunas). 2025 May 9;61(5):872. doi: 10.3390/medicina61050872.
PubMed 40428830
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Symptom Severity, Sleep Quality, Central Sensitization, and Kinesiophobia in Fibromyalgia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07173400
- Acronym / sponsor ID
- E-10840098-202.3.02-4945 (30/0
- Conditions
- Fibromyalgia (FM), Chronic Pain
- Keywords
- Vagal Nerve Stimulation, fibromyalgia, pain, chronic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hatice Betigul MeralUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study used a two-arm, randomized, sham-controlled, parallel group design with a 1:1 allocation ratio
| Arm | Type | Receives |
|---|---|---|
| Active TaVNS | Experimental | Device: Active Transcutaneous Auricular Vagus Nerve Stimulation (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. |
| Sham TaVNS | Placebo comparator | Device: Sham Transcutaneous Auricular Vagus Nerve StimulationParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Pregnancy
- History of epilepsy or cardiac arrhythmia
- Acute or chronic infection
- Heart failure (NYHA class II-IV)
- Renal failure stage II or higher
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Active TaVNS |
| Sham Transcutaneous Auricular Vagus Nerve StimulationSham 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. | Device | Sham TaVNS |
Primary outcome
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: Baseline, Week 2, Week 4, Week 8
The FIQ evaluates the overall health status and functional impact of fibromyalgia, including physical functioning, pain, fatigue, and mood. Scores range from 0 to 100, with higher scores reflecting greater disease impact.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, Week 2, Week 4, Week 8
The PSQI is a validated self-report questionnaire that assesses subjective sleep quality and disturbances over the past month. Scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Central Sensitization Inventory (CSI)
Time frame: Baseline, Week 2, Week 4, Week 8
The CSI is a 25-item self-report questionnaire assessing symptoms related to central sensitization, including sensitivity to pain, fatigue, and cognitive complaints. Scores range from 0 to 100, with higher scores indicating greater sensitization.
2 secondary outcomes
Tampa Scale for Kinesiophobia (TSK)
Time frame: Baseline, Week 2, Week 4, Week 8
Visual Analog Scale (VAS) for Pain
Time frame: Baseline, Week 2, Week 4, Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Results publication: PubMed 36438970Paccione CE, Stubhaug A, Diep LM, Rosseland LA, Jacobsen HB. Meditative-based diaphragmatic breathing vs. vagus nerve stimulation in the treatment of fibromyalgia-A randomized controlled trial: Body vs. machine. Front Neurol. 2022 Nov 3;13:1030927. doi: 10.3389/fneur.2022.1030927. eCollection 2022.
- Results publicationAbdel-Baset AM, Abdellatif MA, Ahmed HHS, El Shaarawy NK. Pain neuroscience education versus transcutaneous vagal nerve stimulation in the management of patients with fibromyalgia. Egypt Rheumatol. 2023;45:191-195. doi:10.1016/j.ejr.2023.03.001.
- Results publication: PubMed 32190684Kutlu N, Ozden AV, Alptekin HK, Alptekin JO. The Impact of Auricular Vagus Nerve Stimulation on Pain and Life Quality in Patients with Fibromyalgia Syndrome. Biomed Res Int. 2020 Feb 28;2020:8656218. doi: 10.1155/2020/8656218. eCollection 2020.
- Results publication: PubMed 40428830Turk Kalkan T, Tarakci D, Kilic G, Celikyurt C. Investigation of the Effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and Vestibular Rehabilitation in Patients with Unilateral Vestibular Hypofunction. Medicina (Kaunas). 2025 May 9;61(5):872. doi: 10.3390/medicina61050872.
- Individual participant dataSharing planned: No. This study is a small, single-center pilot trial. Due to the limited sample size and ethical/privacy considerations, individual participant data will not be shared in a public repository. De-identified data may be made available from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS) in people with Fibromyalgia (FM) and Chronic Pain, run by Hatice Betigul Meral 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 8 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 15 Jan 2026. 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. Some participants in this study may receive a placebo. 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 (FIQ) (time frame: Baseline, Week 2, Week 4, Week 8). The study lists 3 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 NCT07173400, which also lists 4 linked publications.
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 15 Jan 2026.