Investigation Of Transcutaneous Auricular Vagus Nerve Stimulation Efficacy In Female Fibromyalgia Patients (TAVNS)

Fenerbahce University

Status

Completed

Conditions

Fibromyalgia Syndrome

Treatments

Device: Transcutaneous Auricular Vagus Nerve Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06871306

12.08.2021/31

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Participants were excluded from the study if they had neurological deficits, were in the perimenopausal or postmenopausal stages, had menstrual cycles of less than 28 days, had diabetes, neuropathic disorders, chronic inflammation, immune deficiencies, cardiac diseases, were pregnant, had started new medication within the last 3 months, or had any modifications to their existing treatment apart from taVNS.