NCT06871306

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Fenerbahce University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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). 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.

Conditions

• Fibromyalgia Syndrome

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2021-08-02
• Primary completion: 2021-08-30
• Completion: 2022-10-31
• First posted: 2025-03-11
• Last updated: 2025-07-02

Locations

1 site across 1 country: Turkey (Türkiye)