Effects of Left and Bilateral Transcutaneous Auricular Vagus Nerve Stimulation on Pain, Mood, and Autonomic Function in Female Fibromyalgia Patients
NCT ID: NCT06871306
Last Updated: 2025-07-02
Study Results
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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COMPLETED
NA
40 participants
INTERVENTIONAL
2021-08-02
2022-10-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Left taVNS
Left taVNS group received taVNS stimulation through the left ear for 11 sessions.
Transcutaneous Auricular Vagus Nerve Stimulation
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.
Bilateral taVNS
Bilateral taVNS group received taVNS stimulation through the bilateral ears for 11 sessions.
Transcutaneous Auricular Vagus Nerve Stimulation
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.
Interventions
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Transcutaneous Auricular Vagus Nerve Stimulation
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Diabetes
* Neuropathic disorders
* Chronic inflammation
* Immune deficiencies
* Cardiac diseases
* 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.
18 Years
45 Years
FEMALE
No
Sponsors
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Fenerbahce University
OTHER
Responsible Party
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Burcu AKKURT
PHD
Locations
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Sancak Tıp Merkezi
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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12.08.2021/31
Identifier Type: -
Identifier Source: org_study_id
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