Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Symptom Severity, Sleep Quality, Central Sensitization, and Kinesiophobia in Fibromyalgia
CompletedNot applicableNCT07173400
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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).
Study details
- Official title
- Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Symptom Severity, Sleep Quality, Central Sensitization, and Kinesiophobia in Fibromyalgia: A Randomized Controlled Trial
- Conditions
- Interventions
- Device: Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS)
- Device: Sham Transcutaneous Auricular Vagus Nerve Stimulation
- Sponsor
- Hatice Betigul Meral
- Organization
- Medipol University
- Start date
- 2025-08-01
- Primary completion
- 2025-10-10
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- Turkey (Türkiye)
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 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 Exclusion Criteria: 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07173400