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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Left taVNS | Active Comparator | Left taVNS group received taVNS stimulation through the left ear for 11 sessions. |
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| Bilateral taVNS | Active Comparator | Bilateral taVNS group received taVNS stimulation through the bilateral ears for 11 sessions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Auricular Vagus Nerve Stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the 28th day of control |
| 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. | From enrollment to the 28th day of control |
| 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. | From enrollment to the 28th day of control |
| SNS Index Activity |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the 28th day of control |
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Inclusion Criteria:
Exclusion Criteria:
Only female participants are eligible for this study, as fibromyalgia syndrome is more prevalent in the female population.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sancak Tıp Merkezi | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41332177 | Derived | 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. |
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Only IPD used in the results publication.
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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.
| From enrollment to the 28th day of control |
| 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. | From enrollment to the 28th day of control |
| 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 |
| From enrollment to the 28th day of control |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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